Growth

Manufacturers

Manufacturers

Manufacturers play a crucial role in ensuring that products placed on the extended Single Market of the EEA are safe. They are responsible for checking that their products meet EU safety, health, and environmental protection requirements. It is the manufacturer’s responsibility to carry out the conformity assessment, set up the technical file, issue the EU declaration of conformity, and affix the CE marking to a product. Only then can this product be traded on the EEA market.

If you are a manufacturer, you have to follow these six steps to affix a CE marking to your product:

  1. Identify the applicable directive(s) and harmonised standards
  2. Verify product specific requirements
  3. Identify whether an independent conformity assessment (by a notified body) is necessary
  4. Test the product and check its conformity
  5. Draw up and keep available the required technical documentation
  6. Affix the CE marking and draw up the EU Declaration of Conformity (27 KB).

These six steps may differ by product as the conformity assessment procedure varies. Manufacturers must not affix CE marking to products that don’t fall under the scope of one of the directives providing for its affixing.

For products that present higher safety risks such as gas boilers or chainsaws, safety cannot be checked by the manufacturer alone. In these cases, an independent organisation, specifically a notified body appointed by national authorities, has to perform the safety check. The manufacturer may affix the CE marking to the product only once this has been done.

Product groups

Active implantable medical devices

Directives

As a first step, you need to verify whether your product(s) fall(s) within the definition of an active implantable medical device in accordance with Article 1 paragraph 2a) to c) of Directive 90/385/EEC where also the term "active medical device" is defined. For a definition of "implantable device" see Annex IX, section I.1.2 of Directive 93/42/EEC on medical devices. Secondly, you need to verify that none of the exclusion clauses of Article 1 paragraph 3 to 6 is applicable. If all these conditions are fulfilled, Directive 90/385/EEC applies.

 

Verify requirements

The New Approach Directives for the CE marking have been designed by the European Union in such a manner that they cover, within their respective scope, all requirements for products from each of the aforementioned sectors.

However, it is possible that more than one New Approach Directive applies to the same product. Furthermore, other legislation (such as horizontal legislation on chemicals or on environment) can apply.

Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) specifies general requirements the product has to meet in order for the manufacturer to affix the CE marking. These are the so-called Essential Requirements that are listed in Annex 1 to the AIMDD. Compliance with the essential requirements must be demonstrated by a clinical evaluation in accordance with Annex 7 to Directive 90/385/EEC.

 

Need for notified body?

For all active implantable medical devices, the involvement of a Notified Body is obligatory.

To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please use NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive or by country via the NANDO homepage.

Check conformity

A Notified Body verifies, in most cases, both the quality management of the manufacturer and the design of the medical device and its compliance with the Essential Requirements. The manufacturer may also choose another conformity assessment route. In that route, the Notified Body verifies the product type for the conformity with the Essential Requirements and the conformity of the final products with the type. In both cases, the clinical evaluation must be part of the documents which the manufacturer submits to the Notified Body for assessment and the Notified Body issues (a) certificate(s) that indicate(s), by referring to one of the Annexes 2 to 4 of the AIMDD, what has been verified.

The manufacturer must draw up the Declaration of Conformity (DoC) to declare his sole responsibility for the conformity to the relevant Directive. The Declaration of Conformity must include the manufacturer’s details such as name and address, essential characteristics of the product, if applicable the identification number of the Notified Body as well as a legally binding signature on behalf of the organisation.

Technical documentation

Prior to submission of an application to the Notified Body or, at the latest, when placing the first device of the respective type on the market, the manufacturer must establish the technical documentation. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive.

The manufacturer or his authorised representative established in the European Community is required to keep copies of the technical documentation for a period of at least 15 years, after the last product has been placed on the market.

Affix CE marking

Once the necessary steps have been successfully completed, the CE marking must be affixed to the medical device. The CE marking must be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and the accompanying document. The CE marking shall consist of the initials 'CE' taking the following form:

Affixing CE marking

The various components of the CE marking must have the same vertical dimension, and may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing must be respected.

When the product is subject to other Directives covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other Directives.

If a Notified Body has been involved in the conformity assessment procedure, its identification number must also be displayed.

Appliances burning gaseous fuels

Directives

If your product(s) fall(s) within the sector of appliances burning gaseous fuels, Directive 2009/142/EC (codified version) on appliances burning gaseous fuels (GAD) may apply to it.

 

Verify requirements

The New Approach Directives for the CE marking have been designed by the European Union in such a manner that they cover all requirements for products from each of the aforementioned sectors.

Therefore, a product may be subject to more than one new Approach Directives (and also to other harmonised legislation).

The GAD specifies in detail the essential requirements related to the use of gas as fuel the product has to meet in order for the manufacturer to affix the CE marking.

Directive 2009/142/EC covers appliances burning gaseous fuels used for cooking, heating, hot water production, refrigeration, lighting or washing. It also covers fittings, defined as safety devices, controlling devices or regulating devices and sub-assemblies designed to be incorporated into an appliance.

The basic requirements for placing appliances covered by the GAD on the European market, as laid out in Annex I of the GAD, demand the appliances to be so designed and constructed as to operate safely and present no dangers, they must be accompanied by technical instructions for the installer, instructions for use and servicing for the user, bear appropriate warning notices, which must also appear on the packaging. The instructions and warning notices must be in the official language(s) of the Member State where the product is sold.

The requirements also apply to fittings where the corresponding risk exists. Fittings intended to be part of an appliance must be designed and constructed in such a manner so that they fulfil correctly their intended purpose when incorporated in accordance with the instructions for installation.

Further details on the content and layout of the instructions as well as the essential requirements on design and construction can be found in Annex I of the Directive.

After downloading Directive 2009/142/EC please study the paper carefully to ensure that your product can comply, at the time it will be placed on the market, with all the essential requirements of the Directive. Please remember to also verify if other Directives apply to your product.

 

Need for notified body?

Before proceeding with the assessment procedure, it is important to determine whether you, the manufacturer, can assess your product by yourself or whether you need to involve a Notified Body.

When dealing with the appliances covered by the gas appliances directive, the involvement of a Notified Body is obligatory.

A Notified Body verifies the compliance of a product by conducting a conformity assessment. It also ensures that the technical documentation sufficiently supports product compliance. In the framework of the GAD, a Notified Body is always involved also in the production control phase and its identification number will follow the CE marking.

When the Notified Body has assessed the compliance of the product-type and the type satisfies the applicable provisions, it issues an EC type-examination certificate to confirm this. Following completion of the production phase conformity assessment, the manufacturer will then draw up the Declaration of Conformity (DoC) to declare his sole responsibility that the product confirms to the relevant Directive. The establishment of the DoC is a legal obligation.

The Declaration of Conformity should include the manufacturer’s details such as name and address, essential characteristics the product complies with, any European standards and performance data and the identification number of the Notified Body as well as a legally binding signature.

To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please refer to NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive or by country via the NANDO homepage.

Check conformity

Article 8 of the Directive sets out the process of certifying whether an appliance observes the requirements and can be placed on the market. For series-manufactured appliances, the process has two phases:

  • First, the EC type-examination by a Notified Body, the details of which are explained in point 1 of Annex II to the Directive.
  • Second, under the surveillance of a Notified Body, the manufacturer must either complete one of three EC declarations of conformity to type procedures, or opt for the EC verification procedure. Details of these procedures are provided in points 2-5 of Annex II to the Directive.

In cases where the appliance is produced as a single unit or in small quantities, the manufacturer can opt for EC verification by single unit, which is described in point 6 of Annex II.

Following completion of the production control conformity assessment, the manufacturer must draw up and sign the EC Declaration of Conformity.

Technical documentation

Directive 2009/142/EC on appliances burning gaseous fuels requires that the application for type-examination must include, among other things, the design documentation as described in Annex IV.

The design documentation must contain the following information, in so far as is required by the Notified Body for assessment:

  • a general description of the appliance,
  • conceptual designs and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,
  • descriptions and explanations necessary for the understanding of the above, including the operation of the appliances,
  • a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements where the standards referred to in Article 5 have not been applied,
  • test reports, — manuals for installation and use,
  • where appropriate, the design documentation must contain the following elements:
    • attestations relating to the equipment incorporated in the appliance,
    • attestations and certificates relating to the methods of manufacture and/or inspection and/or monitoring of the appliance,
    • any other document making it possible for the Notified Body to improve its assessment.

The manufacturer or his authorised representative established in the European Union is requested to keep copies of the technical documentation for a period of 10 years after the last product has been placed on the market.

Affix CE marking

Once the necessary steps have been successfully completed, the logo must be affixed to the product.

The marking must be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and the accompanying document. The CE marking shall consist of the initials 'CE' taking the following form:

Affixing CE marking

The various components of the CE marking must have the same vertical dimension, and may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the graduated drawing above must be respected.

When the product is subject to other Directives covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other Directives.

The identification number of the Notified Body involved in the production control phase must follow the CE marking.

Cableway installations designed to carry persons

Directives

If your product(s) fall(s) within the sector of cableway installations to carry persons the Directive 2000/9/EC applies.

 

Verify requirements

The New Approach Directives for the CE marking have been designed by the European Union in such a manner that they cover all requirements for products from each of the aforementioned sectors.

Directive 2000/9/EC defines ’cableway installations designed to carry persons' as "installations made up of several components, designed, manufactured, assembled and put into service with the object of carrying persons". These can be, for example, funicular railways, gondolas and chair lifts or drag lifts. Article 1, Nr. 6 lists the installations not covered by the Directive.

The essential safety requirements are listed in Annex II to the Directive.

 

Need for notified body?

Before proceeding with the assessment procedure, it is important to determine whether you, the manufacturer, can assess your product by yourself or whether you have to involve a Notified Body.

In the case of cableway installations to carry persons the assistance of a Notified Body is obligatory.

A Notified Body verifies the compliance of subsystems and safety components by conducting a conformity assessment. It also ensures that the technical documentation sufficiently supports product compliance.

When the Notified Body is convinced that the product is compliant, it will issue a certificate of conformity to confirm this. The manufacturer will then draw up the Declaration of Conformity (DoC) to declare on his sole responsibility conformity to the relevant Directive. The establishment of the DoC is a legal obligation.

The Declaration of Conformity must include the manufacturer’s details such as name and address, essential characteristics the product complies with, any European standards and performance data and the identification number of the Notified Body as well as a legally binding signature on behalf of the organisation. For further details please consult your specific Directive.

To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please use NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive or by country via the NANDO homepage.

Check conformity

The Directive on cableway installations to carry persons specifies in detail the requirements and for the safety components, it offers different modes of assessing product conformity in order for the manufacturer to affix the CE marking.

The guideline set by the Directive distinguishes between the assessment of the product design and the actual production. The product design can be assessed via EC type-examination, full quality assurance and unit verification. The production process can be assessed via a production quality assurance, product verification, full-quality assurance Module or Unit verification. The details of the different conformity assessment procedures related to the safety components are set out in Annex V to the Directive. The manufacturer must then draw up and sign the EC Declaration of Conformity.

Technical documentation

Requirements regarding technical documentation for the different conformity assessment procedures are set up under Annex V to the Directive.

Affix CE marking

Once the necessary steps have been successfully completed, the logo must be affixed to the safety component.

The marking must be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and the accompanying document. The CE marking shall consist of the initials 'CE' taking the following form:

Affixing CE marking

If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing must be respected.

The various components of the CE marking must have the same vertical dimension and may not be smaller than 5 mm. This minimum dimension may be waived for small-scale safety components.

The CE marking shall be followed by the last two figures of the year in which it was affixed and by the identification number of the Notified Body that deals with the conformity assessment procedure.

When the product is subject to other Directives covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other Directives.

However, when one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the ‘CE’ marking must indicate conformity only with the Directives applied by the manufacturer. In this case, the particularities of the Directives applied, as published in the Official Journal of the European Union, must be given in the documents, notices or instructions required by the Directives and accompanying such products.

Construction products

Directives, Verify requirements, Need for notified body?, Check conformity, Technical documentation and Affix CE marking

Please consult http://ec.europa.eu/growth/sectors/construction_en.

Eco-design of energy related products

Directives

If your product(s) fall(s) within the sector of energy-related products, it (they) might be subject to Directive 2009/125/EC on the Ecodesign of energy related products (the Ecodesign Directive):

Other Directives may additionally apply depending on specific products.

 

Verify requirements

The New Approach Directives for CE marking have been designed by the European Union in order that they cover all requirements in their field of application for products from each of the aforementioned sectors.

The Ecodesign Directive (2009/125/EC) is a framework Directive that sets the ecodesign requirements related to the environmental parameters that manufacturers have to meet in order for their products to carry the CE marking.

Directive 2009/125/EC covers products which have an impact on energy consumption during use, including products, which use, generate, transfer, or measure energy, and other energy-related products such as windows, insulation materials, or certain products which consume water, all of which could contribute to significant energy savings during use.

The Directive’s concern is to reduce the overall environmental impact of products, including resource consumption and emission of pollutants by focusing on the principles of sustainable development in a product’s entire lifecycle.

The Directive’s additional scope is to ensure the free movement of the concerned products within the internal European market. The Directive does not apply to means of transport for persons or goods.

The methodology and the procedures for setting ecodesign requirements are specified in the Directive (i.e. Annexes 1 and 2 for product specific design and construction requirements).

 

Need for notified body?

Before proceeding with the assessment procedure, it is important to clear whether you, the manufacturer, can assess your product by yourself or whether you have to involve a Notified Body.

The need for involving a Notified Body is determined in the specific Implementing Measures adopted under the Ecodesign Directive 2009/125/EC.

A Notified Body verifies the compliance of a product by conducting a conformity assessment. It also ensures that the technical documentation sufficiently supports product compliance. If the Notified Body is involved in the production control phase, its identification number will follow the CE marking.

When the Notified Body is convinced of product’s compliance, it issues a certificate of conformity to confirm this. Then the manufacturer draws up a Declaration of Conformity (DoC) to declare that it is his sole responsibility to ensure conformity to the relevant Directive. The establishment of a DoC is a legal obligation.

The Declaration of Conformity must include the manufacturer’s details such as name and address, essential characteristics the product complies with, any European standards and performance data and the identification number of the Notified Body as well as a legally binding signature on behalf of the organisation. For further details please consult your specific Directive.

To find the Notified Bodies appointed by the Member States to carry out conformity assessment, the manufacturer should consult the NANDO database – the New Approach Notified and Designated Organisations. They can search for Notified Bodies by Directive or by country via the NANDO homepage.

Check conformity

The conformity assessment procedures the manufacturer can choose from are specified by the Implementing Measures. In principle, the Implementing Measures leave the manufacturer the choice between an internal design control and a harmonised standard management system. The management system must conform to the product-related requirements and include the design function. Regardless of whether a Notified Body has been involved or not, the manufacturer must draw up and sign an EC Declaration of Conformity.

Products, which have been awarded a European eco-label, are the exception, as they are presumed to comply with the eco-design requirements of the applicable implementing measure. The implementing measures

Implementing Measures are mandatory requirements in the form of regulations, which come into force without further implementation into national laws. The European Commission, after consulting the Member States, market stakeholders and other interested parties, selects product groups in the so-called Working Plan. New product groups are selected for the Working Plan every three years. Preparatory studies mandated by the European Commission compile specific data for each product group that serve as background information for the development of appropriate minimum requirements.
On the basis of the preparatory studies, the European Commission develops requirements for the environmental performance of the selected products or product groups. The Ecodesign Directive prioritises self regulations by manufacturers as an alternative to Regulations insofar they respect the criteria given in the Directive. So far, the following Implementing Measures have been published:

1. Regulation No 1275/2008 eco-design requirements for standby and off-mode electric power consumption of electrical and electronic household and office equipment
2. Regulation No 278/2009 eco-design requirements for no-load condition electric power consumption and average active efficiency of external power supplies (amending 1275/2008)
3. Regulation No 244/2009 eco-design requirements for non-directional household lamps (amended by 859/2009)
4. Regulation (EC) No 859/2009 ultraviolet radiation of non-directional household lamps (amending 244/2009)
5. Regulation No 245/2009 eco-design requirements for fluorescent lamps without integrated ballast, for high intensity discharge lamps, and for ballasts and luminaries able to operate such lamps, and repealing Directive 2000/55/EC of the European Parliament and of the Council
6. Regulation No 107/2009 eco-design requirements for simple set-top boxes
7. Regulation (EC) No 640/2009 eco-design requirements for electric motors
8. Regulation (EC) No 641/2009 eco-design requirements for glandless standalone circulators and glandless circulators integrated in products (text with EEA relevance)
9. Regulation (EC) No 642/2009 eco-design requirements for televisions
10. Regulation (EC) No 643/2009 eco-design requirements for household refrigerating appliances

Technical documentation

Upon successful assessment, the Ecodesign Directive 2009/125/EC requires technical documentation as laid out in Annex V. The technical documents must enable assessment of the conformity of the appliance with the requirements of the Directive. The technical file should comprise:

  • A general description of the product and of its intended use;
  • The results of relevant environmental assessment studies carried out by the manufacturer or alternatively references to environmental assessment literature or case studies, which have been used by the manufacturer in evaluating, documenting and determining product design solutions;
  • The ecological profile, where required by the implementing measure;
  • Documents describing the results of measurements on the eco-design requirements carried out;
  • The manufacturer must establish specifications indicating, in particular, which standards were or were not applied and ultimately, what means have been used to ensure compliance;
  • A copy of the information concerning the environmental design aspects of the product provided in accordance with the requirements (specified in Annex I, Part 2);
  • A copy of the EC declaration of conformity.

The manufacturer or his authorised representative is requested to keep copies of the technical documentation for a period of 10 years after the last product was placed into the market.

Affix CE marking

Once the necessary steps have been successfully completed, the logo must be affixed to the product.

The marking has to be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and the accompanying document. The CE marking shall consist of the initials ‘CE' taking the following form:

Affixing CE marking

The various components of the CE marking must have the same vertical dimension and may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing must be respected.

When the product is subject to other Directives covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other Directives.

However, when one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the ‘CE’ marking has to indicate conformity with the Directives applied by the manufacturer only. In this case, the particularities of the Directives applied, as published in the Official Journal of the European Union, must be given in the documents, notices or instructions required by the Directives and accompanying such products.

If a Notified Body is involved in the production control phase, its identification number must be also displayed.

Electromagnetic compatibility

Directives

The EMC Directive 2014/30/EU applies to a vast range of equipment encompassing electrical and electronic appliances, systems and installations.

Other Directives may additionally apply depending on specific products.

 

Verify requirements

The New Approach Directives for the CE marking have been designed by the European Union in such a manner that they cover all requirements for products from each of the aforementioned sectors.

Directive 2014/30/EU on Electromagnetic Compatibility (EMC) specifies in detail the essential requirements the product has to meet in order for the manufacturer to affix the CE marking.

Directive 2014/30/EU is intended to ensure that equipment liable to generate or to be affected by electromagnetic disturbance can be used in the electromagnetic environment for which it has been designed without causing disturbances to other equipment or being affected by them. The 2014 Directive updated and replaced Directive 2004/108/EC, which had previously regulated this area.

The essential requirements regarding electromagnetic compatibility for equipment are set out in Annex I of the Directive.

The EMC Directive covers apparatus sold as single functional units to end users, which are either liable to generate electromagnetic disturbance, or could see their performance affected by it. It does not cover equipment which is specifically intended to be incorporated into a fixed installation and is not otherwise commercially available.

The EMC Directive does not apply to equipment covered by Directive 1999/5/EC. Aeronautical products and radio equipment used by radio amateurs are also excluded from the scope of the Directive.

 

Need for notified body?

Under the EMC conformity assessment procedures, the manufacturer is obliged to perform an EMC assessment of the apparatus. The EMC Directive does not require the intervention of a Notified Body. However, the manufacturer or his authorised representative in the Union can present technical documentation to a Notified Body which will review it and assess whether the technical documentation properly demonstrates that the requirements of the Directive have been met. If this is the case, the Notified Body will issue a statement confirming it. This statement shall be part of the technical documentation.

Then the manufacturer draws up the Declaration of Conformity (DoC) to declare on his sole responsibility conformity to the relevant Directive. The establishment of the DoC is a legal obligation.

The Declaration of Conformity must include:

  • a reference to the Directive,
  • an identification of the apparatus,
  • the manufacturer’s details such as name and address,
  • a dated reference of the specifications under which conformity is declared
  • the date of the declaration,
  • the identity and signature of the person empowered to bind the manufacturer or his authorised representative.

To find the Notified Bodies appointed by the Member States to carry out conformity assessment, the manufacturer should consult the NANDO database – the New Approach Notified and Designated Organisations. They can search for Notified Bodies by Directive or by country via the NANDO homepage.

Check conformity

The conformity assessment process for apparatus covered by this Directive consists of an internal production control procedure carried out by the manufacturer. This entails checking that the equipment meets the electromagnetic compatibility requirements set out in Annex I, or that the relevant European Harmonised Standards have been correctly applied.

Details of these two procedures are provided in Annexes II and III of the Directive.

The manufacturer draws up and signs the EU Declaration of Conformity.

Once the chosen conformity assessment process is complete, the manufacturer can affix the CE marking to the equipment. This must be done in accordance with the instructions set out in Articles 16 and 17 of the Directive.

Technical documentation

Annex II to the EMC Directive requires the manufacturer to establish the technical documentation. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive. The technical documentation should comprise:

  • A general description of the apparatus;
  • conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
  • descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the apparatus;
  • Evidence of compliance with the harmonised standards, if any, applied in full or in part;
  • Where the manufacturer has not applied harmonised standards, or has applied them only in part, a description and explanation of the solution adopted to meet the essential requirements of the Directive, including a list of other relevant technical specifications applied;
  • results of design calculations made, examinations carried out, test reports, etc;
  • A statement from the notified body, when the procedure referred to in Annex III has been followed.

The manufacturer or his authorised representative established in the European Union is requested to keep copies of the technical documentation for a period of 10 years after the last product was placed on the market.

Affix CE marking

Once the necessary steps have been successfully completed, the CE marking must be affixed to the product.

The marking must be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and the accompanying document. The CE marking shall consist of the initials 'CE' taking the following form:

Affixing CE marking

The various components of the CE marking must have the same vertical dimension, and may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the graduated drawing above must be respected.

When the product is subject to other Directives covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other Directives.

However, when one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the ‘CE’ marking has to indicate conformity only with the Directives applied by the manufacturer. In this case, the particularities of the Directives applied, as published in the Official Journal of the European Union, must be given in the documents, notices or instructions required by the Directives and accompanying such products.

Equipment and protective systems intended for use potentially explosive atmospheres

Directives

If your product(s) fall(s) within the sector “Equipment and protective systems for potentially explosive atmospheres (ATEX)" the following Directive applies:

 

Verify requirements

The New Approach Directives for the CE marking have been designed by the European Union in such a manner that they cover all requirements for products from each of the aforementioned sectors.

The ATEX Directive 2014/34/EU on equipment and protective systems intended for use in potentially explosive atmospheres specifies in detail the essential requirements the product has to meet in order for the manufacturer to affix the CE marking.

In addition to equipment and protective systems intended for use in potentially explosive atmospheres, the Directive also applies to safety devices, controlling devices and regulating devices for use outside potentially explosive atmospheres but required for or contributing to the safe functioning of ATEX equipment and protective systems with respect to the risks of explosion. The Directive does not apply to medical devices, means of transport, seagoing vessels, or personal protective equipment covered by Directive 89/686/EEC. It also does not apply to equipment and protective systems where the hazard only results from the presence of explosive substances or unstable chemical substances, or from accidental leakage of fuel gas.

For further details on the products covered please consult Chapter 1, Article 1 of the ATEX Directive 2014/34/EU.

The essential health and safety requirements – as set out in Annex II of the Directive – foresee among others that products must be designed with a view to integrated explosion safety. They can only be manufactured after due analysis of possible operating faults in order to preclude dangerous situations as far as possible. In this sense, the products must be accompanied by instructions and must be marked legibly and indelibly with a list of minimum particulars such as the name and address of the manufacturer, designation of series or type, the specific marking of explosion protection followed by the symbol of the equipment group and category and others.

Furthermore, where necessary, they must also be marked with all information essential to their safe use.

In terms of selection of materials, the Directive requires a special selection of risk-reducing materials as laid down in Annex II, 1.1. Annex II covers further requirements regarding design and construction, potential ignition source, hazards arising from external effects, requirements in respect of safety-related devices and integration of safety requirements relating to the system. Please closely consult Annex II for a complete overview.

Also, please carefully consult 2014/34/EU to ensure that your product complies with all the essential health and safety requirements.

 

Need for notified body?

Before proceeding with the conformity assessment procedure, it is important to determine whether you, the manufacturer, can assess your product by yourself or whether you have to involve a Notified Body.

In the case of equipment and protective systems for potentially explosive atmospheres, it depends on the specific product whether the conformity assessment by a Notified Body is obligatory or not. For further details please consult 2014/34/EU.

A Notified Body verifies the compliance of a product by conducting a conformity assessment. It also ensures that the technical documentation sufficiently supports product compliance. If the Notified Body is involved in the production control phase, its identification number will follow the CE marking.

When the Notified Body is convinced of product compliance, it will issue a certificate of conformity to confirm this. The manufacturer will then draw up an EU Declaration of Conformity (DoC) to declare that it is his sole responsibility to ensure conformity to the relevant Directive. The establishment of the DoC is a legal obligation.

The EU Declaration of Conformity must include the manufacturer’s details such as his name and address, essential characteristics and requirements the product complies with, any European harmonised standards and performance data and the identification number of the Notified Body as well as a legally binding signature on behalf of the organisation. For further details please consult the Directive, in particular Annex II.

To find the Notified Bodies appointed by the Member States to carry out conformity assessment, look no further than NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive or by country via the NANDO homepage.

Check conformity

The conformity assessment procedures to be followed by manufacturers prior to affixing the CE marking on their products are set out in Chapter 3, Article 13 of the ATEX Directive 2014/34/EU. There are different procedures to be followed, depending on the type of equipment or protective system in question. The equipment groups and categories are explained in Annex I to the Directive and the details of the various conformity assessment procedures are set out in Annexes III to IX.
For example, with differences depending on the specific product group as set out in Annex I, for equipment where a very high level of protection is needed, the Directive requests an EU-type examination procedure in conjunction with production process quality assurance or product verification: the single steps are defined in Annexes III to V. In the case of internal combustion engines or electrical equipment, the manufacturer or his authorised representative, in addition to the EU-type examination, should also assess conformity to type or the product quality assurance, as described in Annexes VI to VII.

Whether a Notified Body has been involved or not, the manufacturer must draw up and sign the EU Declaration of Conformity.

Technical documentation

After completion of the conformity assessment, the procedure has to be documented as set out in ATEX Directive 2014/34/EU, Annexes III to IX, Nr. 3, for the EU-type examination. The technical documents must enable the assessment of the appliance’s conformity with the requirements of the Directive. The technical file should comprise at least the following:

  • a general type-description,
  • conceptual design and manufacturing drawings and layouts of components, sub-assemblies, circuits, etc.,
  • descriptions and explanations necessary for the understanding of said drawings and layouts and the operation of the product,
  • a list of the harmonised standards, applied in full or in part the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential health and safety requirements of this Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,
  • results of design calculations made, examinations carried out, etc.,
  • test reports.

The manufacturer or his authorised representative established in the European Union is requested to keep copies of the technical documentation for a period of 10 years after the last product was placed to the market.

Affix CE marking

Once the necessary steps have been successfully completed, the logo must be affixed to the product.

The marking must be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and the accompanying document. The CE marking shall consist of the initials 'CE' taking the following form:

Affixing CE marking

The various components of the CE marking must have substantially the same vertical dimension and may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the graduated drawing above must be respected.

When the product is subject to other Directives covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other Directives.

If a Notified Body is involved in the production control phase, its identification number must be also displayed.

Explosives for civil uses

Directives

 

If your product(s) fall(s) within the product group of explosives for civil use, Directive 2014/28/EU applies.

For a further look at the harmonised standards for explosives for civil use, please visit: http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/explosives-civil-uses_en

 

Verify requirements

The New Approach Directives for the CE marking have been designed by the European Union in such a manner that they cover all requirements for products from each of the aforementioned sectors.

Directive 2014/28/EU on explosives for civil use specifies in detail the essential requirements the product needs to meet in order for the manufacturer to affix the CE marking.

The Directive refers to explosives defined as ‘the materials and articles considered to be explosives in the United Nations recommendations on the transport of dangerous goods and falling within Class 1 of those recommendations’. It does not apply to explosives, including ammunition, intended for use, in accordance with national law, by the armed forces or the police, to pyrotechnic articles or to ammunition, except as provided for in Articles 12 (transfers),13 (security derogations) and 14 (information exchange) of the Directive.

The essential requirements specified in Annex II to the Directive encompass the minimum safety requirements and rules the product design, construction and ultimately that the final product must conform to. Among others, the rules require that each explosive device must be disposable in a manner that minimises its effect on the environment. For further details, please consult Annex II and in general, please carefully consult Directive 2014/28/EU to ensure that your product complies with all the essential requirements.

 

Need for notified body?

When dealing with explosives for civil use, the involvement of a Notified Body is obligatory.

A Notified Body verifies the compliance of a product by conducting a conformity assessment. It also ensures that the technical documentation sufficiently supports product compliance. If the Notified Body is involved in the production control phase, its identification number will follow the CE marking.

When the Notified Body is convinced of product compliance, a certificate of conformity that confirms this will be issued. The manufacturer will then draw up the EU Declaration of Conformity (DoC) to declare that he is solely responsible for the product’s conformity to the relevant Directive. The establishment of the EU DoC is a legal obligation.

The EU Declaration of Conformity must include the manufacturer’s details, such as name and address, essential characteristics the product complies with, any European standards and performance data and the identification number of the Notified Body, as well as a legally binding signature on behalf of the organisation. For further details please consult your specific Directive.

To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please use NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive or by country via the NANDO homepage.

Check conformity

The conformity assessment procedures for explosives for civil use to be followed prior to affixing the CE Marking on the products are set out in Annex III to the Directive.

Manufacturers can choose between two procedures for assessing the conformity of explosives with the harmonised safety requirements set out in the Directive.

The first option is the EU-type examination (Module B, referred to in Annex III to the Directive) accompanied by one of the following four supplementary procedures, which are all described in Annex III to the Directive:

  • the conformity to type assessment based on internal production control (Module C2)
  • the production quality assurance procedure (Module D)
  • the product quality assurance procedure (Module E)
  • the product verification procedure (Module F)

The second option is the unit verification procedure (Module G) referred to in Annex III.

The manufacturer will then draw up and sign the EU Declaration of Conformity, in accordance with the model format set out in Annex IV to the Directive.

Technical documentation

After completion of the assessment, the assessment procedure must be documented as set out in Directive 2014/28/EU, Annex III, Nr. 3.

The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive. They must, as far as is relevant for such assessment, cover the design, manufacture and operation of the appliance and contain as far as is relevant for assessment:

  • a general description of the explosive,
  • conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
  • descriptions and explanations necessary for the understanding of the drawings and diagrams and the operation of the explosive,
  • a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential safety requirements of the Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,
  • results of design calculations made, examinations carried out, etc.,
  • test reports.

The manufacturer, or his authorised representative established in the European Union, is requested to keep copies of the technical documentation for a period of 10 years after the last product is placed on the market.

Affix CE marking

Once the necessary steps have been successfully completed, the marking must be affixed to the product.

The marking must be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and the accompanying document. The CE marking shall consist of the initials 'CE' taking the following form:

Affixing CE marking

The various components of the CE marking must have the same vertical dimension and may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing must be respected.

When the product is subject to other Directives covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other Directives.

However, when one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the ‘CE’ marking must indicate conformity with the Directives applied by the manufacturer. In this case, the particularities of the Directives applied, as published in the Official Journal of the European Union, must be given in the documents, notices or instructions required by the Directives and accompanying such products.

If a Notified Body is involved in the production control phase, its identification number must be also displayed.

Hot-water boilers

Directives

If your product(s) fall(s) within the product group of hot water boilers, Directive 92/42/EEC applies.

 

Verify requirements

The 23 New Approach Directives for the CE marking have been designed by the European Union in such a manner that they cover all requirements for products from each of the aforementioned sectors.

The Directive 92/42/EEC on hot water boilers fired with liquid or gaseous fuel specifies in detail the essential requirements the product must meet in order for the manufacturer to affix the CE marking.

The basic requirements laid out in Article 5 of the Directive encompass useful efficiency requirements. According to these, boilers must comply with certain useful efficiency requirements at rated output and average boiler-water temperature of 70°C and at 30% part load and average boiler-water temperature which varies according to the type of the boiler.

Please consult Directive 92/42/EEC carefully to ensure that your product complies with all the essential requirements.

 

Need for notified body?

Before proceeding with the assessment procedure, it is important to determine whether you, the manufacturer, can assess your product by yourself or you have to involve a Notified Body.

When dealing with hot water boilers, the specific product determines whether a conformity assessment by a Notified Body is obligatory or not. For further details please consult the Directive 92/42/EEC.

A Notified Body verifies the compliance of a product type by conducting a conformity assessment. It also ensures that the technical documentation sufficiently supports product compliance. If the Notified Body is involved in the production control phase, its identification number will follow the CE marking.

When the Notified Body is convinced of product type compliance, it will issue a certificate of conformity to confirm this. The manufacturer will then draw up the Declaration of Conformity (DoC) to declare that the appliances placed on the market are in conformity with the type endorsed by the Notified Body and therefore in conformity with the Directive. This is the manufacturer's sole responsibility, and the establishment of the DoC is a legal obligation.

The Declaration of Conformity must include the manufacturer’s details, such as name and address, essential characteristics the product complies with, any European standards and performance data and the identification number of the Notified Body, as well as a legally binding signature on behalf of the organisation. For further details please consult your specific Directive.

To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please use NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive or by country via the NANDO homepage.

Check conformity

The conformity assessment procedures for series-produced boilers that must be followed prior to affixing the CE marking are set out in Article 7 of the Directive.

The procedure involves two steps:

  • Examining the efficiency of the boiler type in accordance with module B (described in Annex III to the Directive)
  • Completing a Declaration of Conformity with the approved type in accordance with module C, D or E (described in Annex IV to the Directive)

For boilers burning gaseous fuel, conformity assessment procedures are the same as those set out in the Gas Appliances Directive (2009/142/EC), namely:

  • First, the EC-type examination by a Notified Body, the details of which are explained in point 1 of Annex II to Directive 2009/142/EC
  • Second, completion of one of three EC declaration of conformity to type procedures or of the EC verification procedure by the manufacturer (details of these procedures are provided in points 2-5 of Annex II to Directive 2009/142/EC)

Whether a Notified Body has been involved or not, the manufacturer must draw up and sign the EC Declaration of Conformity.

Technical documentation

Upon successful assessment of the product, Directive 2009/142/EC demands technical documentation, as laid out in Annex III, Nr. 3. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive. The assessment must cover the design, manufacture and operation of the appliance, and contain:

  • a general type-description,
  • conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,
  • descriptions and explanations necessary for the understanding of the drawings and diagrams and the operation of the product,
  • a list of the standards referred to in Article 5 (2), applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive where the standards, as referred to in Article 5, have not been applied,
  • results of design calculations made, examinations carried out, etc.,
  • test reports.

The manufacturer, or his authorised representative established in the European Community, is requested to keep copies of the technical documentation for a period of 10 years after the last product is placed on the market.

Affix CE marking

Once the necessary steps have been successfully completed, the logo must be affixed to the product.

The marking must be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and the accompanying document. The CE marking shall consist of the initials 'CE' taking the following form:

Affixing CE marking

The various components of the CE marking must have the same vertical dimension, and may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing must be respected.

When the product is subject to other Directives covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other Directives.

However, when one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the ‘CE’ marking must indicate conformity with the Directives applied by the manufacturer only. In this case, the particularities of the Directives applied, as published in the Official Journal of the European Union, must be given in the documents, notices or instructions required by the Directives and accompanying such products.

If a Notified Body is involved in the production control phase, its identification number must be also displayed.

In vitro diagnostic medical devices

Directives

As a first step, you need to verify whether your product(s) fall(s) within the definition of an in vitro diagnostic medical device (IVD) in accordance with Article 1 paragraphs 2a), 2b) and 2c) of Directive 98/79/EC. Secondly, you need to verify that none of the exclusion clauses mentioned in Article 1 are applicable. If all these conditions are fulfilled, Directive 98/79/EC applies.

 

Verify requirements

The New Approach Directives for the CE marking have been designed by the European Union in such a manner that they cover, within their respective scope, all requirements for products from each of the aforementioned sectors.

However, it is possible that more than one New Approach Directive applies to the same product. Furthermore, other legislation (such as horizontal legislation on chemicals or on environment) may apply.

Directive 98/79/EC on in vitro diagnostic medical devices (IVDs) specifies general requirements the product must meet in order for the manufacturer to affix the CE marking. These requirements, known as Essential Requirements, are listed in Annex I of the IVD directive.

For a detailed overview, please consult Directive 98/79/EC.

 

Need for notified body?

Before proceeding with the assessment procedure, it is important to determine whether you, as a manufacturer, need to involve a Notified Body.

The involvement of a Notified Body is necessary for IVDs listed in Annex II to Directive 98/79/EC and for IVDs designed for self-testing. To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please use NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive or by country via the NANDO homepage.

Check conformity

The stringency of the conformity assessment procedures depends to which list of Annex II to Directive 98/79/EC the in vitro diagnostic medical device belongs. For each list, the manufacturer has the choice between two or three conformity assessment procedures. Each of the conformity assessment procedures consist of the application of one or more Annexes out of Annexes III to VII of the directive.

For all IVDs listed in List A or List B of Annex II to Directive 98/79/EC, the Notified Body verifies the design of the medical device and its compliance with the Essential Requirements. Also, in most cases, the Notified Body verifies the quality management of the manufacturer. In the case of IVD mentioned in List A of Annex II, the verification is complemented by a "batch release verification". Alternatively, when requested by the manufacturer, the Notified Body verifies, the compliance of the final product with the tested type. The Notified Body issues a certificate that indicates what has been verified by referring to one of the Annexes III to VI of the directive.

If the in vitro diagnostic medical device is not on any of the lists located in Annex II to Directive 98/79/EC, no involvement of the Notified Body is necessary unless the medical device is designed for self-testing. In this case, only the design of the medical device is examined by the Notified Body, unless the manufacturer requests a complete examination as outlined in the previous paragraphs.

Whether the involvement of a Notified Body is necessary or not, the manufacturer must draw up the Declaration of Conformity (DoC) to declare his sole responsibility for the conformity to the relevant Directive. The Declaration of Conformity must include the manufacturer’s details such as name and address, essential characteristics of the product, the identification number of the Notified Body if applicable, as well as a legally binding signature on behalf of the organisation.

Technical documentation

Prior to submission of an application to the Notified Body or, at the latest, when placing the first device of the respective type on the market, the manufacturer must establish the technical documentation. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive.

The manufacturer, or his authorised representative established in the European Community, is requested to keep copies of the technical documentation for a period of 10 years after the last product is placed on the market.

Affix CE marking

Once the necessary steps have been successfully completed, the CE marking must be affixed to the in-vitro device. The CE marking must be placed visibly and legibly on the device or, if not possible, affixed to the packaging and the accompanying document. The CE marking shall consist of the initials 'CE' taking the following form:

Affixing CE marking

The various components of the CE marking must have the same vertical dimension, which may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing must be respected.

When the product is subject to other Directives covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other Directives.

If a Notified Body has been involved in the conformity assessment procedure, its identification number must also be displayed.

Lifts

Directives

If your product(s) fall(s) within the sector related to lifts, the following Directive applies.

 

Verify requirements

The New Approach Directives for the CE marking have been designed by the European Union in such a manner that they cover all requirements for products from each of the aforementioned sectors.

The Directive 2014/33/EU on lifts specifies in detail the essential requirements the product must meet in order for the lift installer or the manufacturer of the safety components for lifts to affix the CE marking.

The Directive covers lifts permanently serving buildings and construction and intended for the transport of persons and/or goods. It also applies to the safety components for use in such lifts listed in Annex III.

It does not cover lifting appliances whose speed is not greater than 0,15 m/s; construction site hoists; cableways, including funicular railways; lifts specially designed and constructed for military or police purposes; lifting appliances from which work can be carried out; mine winding gear; lifting appliances intended for lifting performers during artistic performances; lifting appliances fitted in means of transport; lifting appliances connected to machinery and intended exclusively for access to workstations including maintenance and inspection points on the machinery; rack and pinion trains; escalators and mechanical walkways.

Lifts covered by this Directive must satisfy the essential health and safety requirements set out in Annex I.

Please consult Directive 2014/33/EU carefully in order to ensure that your product complies with all the essential requirements.

 

Need for notified body?

The lift installer or the manufacturer of the safety components for lifts must always involve a Notified Body in the conformity assessment procedure.

Also in the case of conformity assessment for lifts, the involvement of a Notified Body is obligatory.

A Notified Body verifies the compliance of a product by conducting a conformity assessment. It also ensures that the technical documentation sufficiently supports product compliance. If the Notified Body is involved in (a) the final inspection referred to in Annex V; (b) unit verification, referred to in Annex VIII; or (c) quality assurance referred to in Annexes X, XI or XII, its identification number will follow the CE marking.

Where the type of the safety component for lifts or lift meets the relevant conditions of the Directive, the Notified Body issues a certificate of conformity to confirm this. Then the lift installer or the manufacturer of the safety components for lifts draws up the EU Declaration of Conformity (DoC) to declare that it is his sole responsibility to ensure conformity to the relevant Directive. The establishment of the EU DoC is a legal obligation.

The EU Declaration of Conformity must include the details of the lift installer or of the manufacturer of the safety components for lifts, such as name and address, description of the safety component or of the lift, details of the type or series and serial number (and address where the lift is installed), year of manufacture of the safety component for lift and/or year of installation of lift, all relevant provisions with which the safety component for lifts and/or lift complies, a statement that the safety component or lift is in conformity with the relevant Union harmonisation legislation, where appropriate references to harmonised standards used , any harmonised standards used and the name, address and identification number of the Notified Body, as well as the name and function of the person empowered to sign the declaration on behalf of the manufacturer or installer, place and date of signature and signature. For further details please consult your specific Directive.

To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please consult NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive or by country via the NANDO homepage.

Check conformity

The conformity assessment procedures the lift installer or the manufacturer of the safety components for lifts must follow prior to affixing the CE marking are set out in Chapter III, Articles 15 and 16 of the Directive.

The conformity assessment procedure of the safety components for lifts entails different possibilities:

  • EU type examination set out in Annex IV, Part A and the conformity to type shall be ensured with random checking of the safety component for lifts set out in Annex IX
  • EU type examination set out in Annex IV, Part A and be subject to conformity to type based on product quality assurance in accordance with Annex VI
  • conformity based on full quality assurance set out in Annex VII

The conformity assessment procedure for lifts shall be one of the following:

a) if they are designed and manufactured in accordance with a model lift that has undergone an EU-type examination set out in in Annex IV, Part B:

(i) final inspection for lifts set out in Annex V

(ii) conformity to type based on product quality assurance for lifts set out in Annex X

(iii) conformity to type based on production quality assurance for lifts set out in Annex XII

(b) if they are designed and manufactured under a quality system approved in accordance with Annex XI:

(i) final inspection for lifts set out in Annex V

(ii) conformity to type based on product quality assurance for lifts set out in Annex X

(iii) conformity to type based on production quality assurance for lifts set out in Annex XII

(c) conformity based on unit verification for lifts set out in Annex VIII

(d) conformity based on full quality assurance plus design examination for lifts set out in Annex XI

The manufacturer must draw up and sign the EU Declaration of Conformity.

Technical documentation

Upon successful conformity assessment, Directive 2014/33/EU on lifts requires technical documentation (e.g. as laid out in Annex IV) according to the respective conformity assessment procedure. The technical documents must enable assessment of the conformity of the safety component for lifts or of lift with the requirements of the Directive. The assessment must cover the design, the manufacturing and the operation of the safety component for lifts or lift and contain:

  • a description of the safety component, including its area of use (in particular possible limits on speed, load and power) and conditions (in particular explosive environments and exposure to the elements); or, in case of lifts, a description of the model lift indicating clearly all the permitted variations of the model lift
  • design and manufacturing drawings or diagrams
  • explanations necessary for the understanding of those drawings and diagrams and the operation of the safety component for lifts (or lifts)
  • a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union and, where those harmonised standards have not been applied, descriptions of the solutions adopted to enable the safety component for lifts to meet the conditions referred to in point 1, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied; and in case of lifts, also a list of the essential health and safety requirements taken into consideration, and a copy of EU declaration of conformity of the safety components for lifts incorporated in the lift
  • results of design calculations performed by or for the manufacturer or installer
  • test reports
  • a copy of the instructions for the safety components for lifts or, in case of lifts, a copy of the instructions referred to in point 6.2. of Annex I
  • steps taken at the manufacturing stage to ensure that series-produced safety components conform to the safety component examined,  in case of lifts, steps taken at the installation phase to ensure that the series-produced lift conforms to the essential health and safety requirements.

The manufacturer of the safety component for lifts, the installer, or their authorised representative established in the European Union is requested to keep copies of the technical documentation for a period of 10 years after the last the safety component for lifts or lift is placed on the market.

Affix CE marking

Once the necessary steps have been successfully completed, the logo must be affixed to the product.

The marking must be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and the accompanying document. The CE marking shall consist of the initials 'CE' taking the following form:

Affixing CE marking

The various components of the CE marking must have the same vertical dimension and may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing must be respected.

When the product is subject to other Directives covering other aspects that also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other Directives.

However, when one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the ‘CE’ marking must indicate conformity only with the Directives applied by the manufacturer. In this case, the particularities of the Directives applied, as published in the Official Journal of the European Union, must be given in the documents, notices or instructions required by the Directives and accompanying such products.

The identification number of the Notified Body involved in the conformity assessment procedure must also be displayed.

Low voltage

Directives

If your product(s) fall(s) within the sector of low voltage electrical equipment, Directive 2014/35/EU applies.

Other Directives may additionally apply depending on specific products.

 

Verify requirements

The New Approach Directives for the CE marking have been designed by the European Union in such a manner that they cover all requirements for products from each of the aforementioned sectors.

Directive 2014/35/EU on Low Voltage Devices specifies in detail the essential requirements the product must meet in order for the manufacturer to affix the CE marking.

Directive 2014/35/EU is intended to remove all obstacles to the sale of low voltage electrical equipment within the EU, while at the same time ensuring that they offer the highest possible level of safety.

‘Low voltage electrical equipment’ are defined as any equipment designed for use with a voltage rating between 50 and 1,000 V for alternating current and between 75 and 1,500 V for direct current. Annex II to the Directive contains a list of equipment not covered, including electrical components of lifts, electricity meters, plugs and socket outlets for domestic use.

The Directive 2014/35/EU specifies that equipment must not endanger the safety of people, animals or property ‘when properly installed and maintained and used in applications for which it was made’. The key safety objectives for equipment covered are listed in Annex I.

It is necessary to consult the Directive in order to ensure that the product complies with all the essential requirements.

 

Need for notified body?

When placing the electrical equipment on the EU market, the manufacturer has the responsibility to ensure and to declare that the products conform to the applicable legislative requirements. Directive 2014/35/EU does not require notified bodies to carry out the conformity assessment procedure.

Check conformity

Conformity assessment for products covered by the Low Voltage Directive takes the form of an internal production control procedure carried out by the manufacturer himself, without the involvement of a third party. The details of this procedure are set out in Annex III to the Directive.

The manufacturer or his authorised representative in the EU must draw up and sign the EU Declaration of Conformity.

Annex IV of the Directive describes the content of the Declaration of Conformity as follows:

  • Product model/product (product, type, batch or serial number);
  • Name and address of the manufacturer or his authorised representative,;
  • This declaration of conformity is issued under the sole responsibility of the manufacturer;
  • Object of the declaration (identification of electrical equipment allowing traceability; it may include a colour image of sufficient clarity where necessary for the identification of the electrical equipment);
  • References to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared;
  • Additional information.

The declaration of conformity must be drawn up in at least in one of the official languages of the Union.

Technical documentation

After completion of the assessment of the product, the assessment procedure must be documented as set out in Directive 2014/35/EU, Annex III, Nr. 2.

The technical documents must enable the assessment of conformity of the product with the requirements of the Directive. It must, as far as it is relevant for such an assessment, cover the design, manufacture and operation of the electrical equipment. The technical file should comprise at least:

  • a general description of the electrical equipment,
  • conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
  • descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the electrical equipment,
  • a list of the harmonised standards applied in full or in part or international or national standards referred to in Articles 13 and 14 and, where those harmonised standards or international or national standards have not been applied, descriptions of the solutions adopted to meet the safety objectives of the Directive, including a list of other relevant technical specifications applied;
  • results of design calculations made, examinations carried out, etc.; and
  • test reports.

The manufacturer or his authorised representative established in the European Union is requested to keep the technical documentation for a period of 10 years after the electrical equipment has been placed on the market.

Affix CE marking

Once the necessary steps have been successfully completed, the CE marking must be affixed to the product.

The marking must be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and the accompanying document. The CE marking shall consist of the initials 'CE' taking the following form:

Affixing CE marking

The various components of the CE marking must have the same vertical dimension and may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing must be adhered to.

When the product is subject to other Directives covering other aspects that also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other Directives.

However, when one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the ‘CE’ marking must indicate conformity only with the Directives applied by the manufacturer. In this case, the particularities of the Directives applied, as published in the Official Journal of the European Union, must be given in the documents, notices or instructions required by the Directives and accompanying such products.

Machinery

Directives

If your product(s) fall(s) within the sector Machinery, the Directive 2006/42/EC on Machinery applies:

 

Verify requirements

The New Approach Directives for the CE marking have been designed by the European Union in such a manner that they fully cover all requirements for products from each of the aforementioned sectors.

Directive 2006/42/EC on Machinery specifies the essential health and safety requirements the product has to meet in order for the manufacturer to affix the CE marking

Directive 2006/42/EC covers machinery; interchangeable equipment; safety components; lifting accessories; chains, ropes and webbing for lifting purposes and removable mechanical transmission devices. It also includes requirements for partly completed machinery.

The first step a manufacturer should take to ensure that a machine will be compliant with the Directive is to carry out an assessment procedure, with regard to the essential requirements. This includes also to check which European Harmonised Standards are applicable, as a way to get presumption of conformity. A list of harmonised standards for machinery can be found on the European Commission’s Directorate-General (DG) for Internal Market, Industry, Entrepreneurship and SMEs website.

Annex I to Directive 2006/42/EC sets out in detail the essential health and safety requirements for the products covered.

An amendment to the Directive was agreed in 2009 introducing new requirements for machinery for pesticide application, which must be designed and manufactured in such a way as to minimise the unintended dispersal of pesticides in the environment.

This amendment becomes applicable on 15 December 2011.

Please consult the Directive to ensure that your product complies with all the essential requirements. You can also download an extensive explanatory guide (3 MB) to the Directive, published in June 2010.

 

Need for notified body?

Before proceeding with the assessment procedure, it is relevant to clear whether you, the manufacturer, can assess your product by yourself or you have to involve a Notified Body.

Directive 2006/42/EC on Machinery foresees the involvement of a Notified Body if the product to be assessed falls in one of 23 categories listed under Annex IV and it does not conform to a European Harmonised Standard which covers all of the relevant health and safety requirement. In this case, the manufacturer has to seek assistance by a Notified Body. If it is not the case, the manufacturer himself carries out internal checks on the product..

A Notified Body verifies the compliance of a product by conducting a conformity assessment. It also ensures that the technical documentation sufficiently supports product compliance. If the Notified Body is involved in the production control phase, its identification number will follow the CE marking.

When the Notified Body is convinced of product compliance, issues a certificate of conformity to confirm this. Then the manufacturer draws up the Declaration of Conformity (DoC) to declare on his sole responsibility conformity to the relevant Directive. The DoC is legally binding.

The Declaration of Conformity must include the manufacturer's, details such as name and address, essential characteristics the product complies with, any European standards and performance data and the identification number of the Notified Body as well as a legally binding signature on behalf of the organisation, if relevant. For further details please consult your specific Directive.

To find the Notified Bodies appointed by the Member States to carry out conformity assessment, look no further than NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive or by country via the NANDO homepage.

Check conformity

For machinery that does not fall under one of the 23 categories listed in Annex IV to the Directive, the manufacturer himself carries out internal checks on the conformity of the product.

If a product falls under one of those 23 categories, the manufacturer has the option of carrying out internal checks on the product only if it conforms to a European Harmonised Standard which covers all of the relevant health and safety requirements. If it is not the case then the conformity of the product must be assessed through either the EC-type examination procedure (and additional internal checks) or the full quality assurance procedure. These procedures, carried out by Notified Bodies, are explained in Annexes IX and X to the Directive.

Either a Notified Body has been involved or not, the manufacturer draws up and signs the EC Declaration of Conformity.

Manufacturers are required to work with the market surveillance authorities in each country in which the machinery is placed on the market. To identify the relevant authority, manufacturers can refer to the contact person (137 kB) in the ministry in charge of implementing the Machinery Directive in each Member State.

Technical documentation

Upon successful assessment, Directive 2006/42/EC on Machinery requires a technical documentation as laid out in Annex II. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive.

The technical file should comprise:

  • a detailed documentation on the construction of the machinery including drawings of the machinery and its parts,

  • test results,

  • description of protective measures

  • other elements as described in Annex VII, A(a).

Also, the file must contain a copy of the EC declaration of conformity.

The manufacturer must also provide documents for series production and internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of this Directive (Annex VII, A (b)).

The manufacturer must carry out the necessary tests on components, fittings or the completed machinery to determine whether it can be assembled and put into service safely. The relevant reports and results shall be included in the technical file.

The manufacturer or his authorised representative is requested to keep copies of the technical documentation for a period of 10 years after the last product was placed into the market.

Affix CE marking

Once the necessary steps have been successfully completed, the logo can be affixed on the product.

The marking has to be placed visibly and legibly on the product or, if not possible because of the nature of the product, be affixed to the packaging and the accompanying document. The CE marking shall consist of the initials 'CE' taking the following form:

Affixing CE marking

The various components of the CE marking must have substantially the same vertical dimension, which may not be less that 5 mm. If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing must be respected.

When the product is subject to other Directives covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other Directives.

However, when one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the ‘CE’ marking has to indicate conformity only with the Directives applied by the manufacturer. In that case, particularities of the Directives applied, as published in the Official Journal of the European Union, must be given in the documents, notices or instructions required by the Directives and accompanying such products.

If a Notified Body has been involved in the conformity assessment procedure, its identification number must also be displayed.

Measuring Instruments

Directives

If your product(s) fall(s) within the measuring instruments sector Directive 2014/32/EU applies.

 

Verify requirements

The New Approach Directives for the CE marking have been designed by the European Union in such a manner that they cover all requirements for products from each of the aforementioned sectors.

Directive 2014/32/EU on measuring instruments specifies in detail the essential requirements the product needs to meet in order for the manufacturer to affix the CE marking.

The Directive covers the following measuring devices and systems: water meters, gas meters and volume conversion devices, active electrical energy meters, thermal energy meters, measuring systems for continuous and dynamic measurement of quantities of liquids other than water, automatic weighing instruments, taximeters, material measures, dimensional measuring instruments and exhaust gas analysers.

The essential requirements are listed in Annex I to the Directive, while specific requirements for each type of measuring instrument are presented in the 10 sector-specific annexes (MI-001 to MI-010).

 

Need for notified body?

Before proceeding with the assessment procedure, it is important to determine whether you, the manufacturer, can assess your product by yourself or whether you have to involve a Notified Body.

When dealing with measuring instruments, the manufacturer is allowed to choose between assessment procedures stipulated in Annex II to the Directive.

A Notified Body verifies the compliance of a product by conducting a conformity assessment. It also ensures that the technical documentation sufficiently supports product compliance. If the Notified Body is involved in the production control phase, its identification number will be listed after the CE marking.

When the Notified Body is convinced of product’s compliance, it will issue a certificate of conformity to confirm this. The manufacturer will then draw up a Declaration of Conformity (DoC) to declare that he is solely responsible for the product’s conformity to the relevant Directive. The establishment of the DoC is a legal obligation.

The Declaration of Conformity must include the manufacturer’s details, such as name and address, essential characteristics the product complies with, any European standards and performance data and the identification number of the Notified Body, as well as a legally binding signature on behalf of the organisation. For further details please consult your specific Directive.

To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please use NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive or by country via the NANDO homepage.

Check conformity

Annex II to the Directive specifies conformity assessment procedures for measuring instruments and 10 sector-specific annexes (Annex III-XII) provide for choice of conformity assessment for each of the 10 sectors.

For example, manufacturers of water meters can choose from the procedures: B+F or B+D or H1 as set in Annex II.

Whether a Notified Body has been involved or not, the manufacturer must draw up and sign the EU Declaration of Conformity.

Technical documentation

According to Directive 2014/32/EU, the technical documentation shall render the design, manufacture and operation of the measuring instrument intelligible and shall permit an assessment of its conformity with the applicable requirements of the Directive. In detail, Article 18, Par. 2 lists the documentation of:

  • the definition of the metrological characteristics,
  • the reproducibility of the metrological performances of produced instruments when properly adjusted using appropriate intended means, and
  • the integrity of the instrument.

More details are listed in Article 18 depending on the type of instrument. Please consult your Directive for an extensive list.

The manufacturer, or his authorised representative, is requested to keep copies of the technical documentation for a period of 10 years after the last product is placed on the market.

Affix CE marking

Once the necessary steps have been successfully completed, the CE marking must be affixed to the product.

The marking must be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and the accompanying document. The CE marking shall consist of the initials 'CE' taking the following form:

Affixing CE marking

The various components of the CE marking must have the same vertical dimension and may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the graduated drawing above must be respected.

When the product is subject to other Directives covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other Directives.

However, when one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the ‘CE’ marking must indicate conformity with the Directives applied by the manufacturer only. In this case, the particularities of the Directives applied, as published in the Official Journal of the European Union, must be given in the documents, notices or instructions required by the Directives and accompanying such products.

The CE marking on measuring instruments must be accompanied by supplementary metrology marking consisting of the capital letter ‘M’ and the last two digits of the year of its affixing, surrounded by a rectangle. Both markings must be at least 5 mm in height.

If the measuring instrument consists of multiple devices operating together, the markings are required to be affixed on the main device. If a measuring instrument is too small or too sensitive to carry these markings, they may be displayed on the packaging and accompanying documents.

If a Notified Body is involved in the production control phase, its identification number must be also displayed.

Medical devices

Directives

As a first step, you need to verify whether your product(s) fall(s) within the definition of a medical device in accordance with Article 1 paragraph 2a) of Directive 93/42/EEC. Second, you need to exclude that your product(s) falls within the definition of an active implantable medical device (Directive 90/385/EEC) or of an in vitro diagnostic medical device (Directive 98/79/EC). Finally, you must verify that no other exclusion clause contained in the first Article of Directive 93/42/EEC is applicable. If all these conditions are fulfilled, Directive 93/42/EEC applies.

 

Verify requirements

The New Approach Directives for the CE marking have been designed by the European Union in such a manner that they cover, within their respective scope, all requirements for products from each of the aforementioned sectors.

However, it is possible that more than one New Approach Directive applies to the same product. Furthermore, other legislation (such as horizontal legislation on chemicals or environment) can apply.

Directive 93/42/EEC on Medical Devices (MDD) specifies general requirements that the product has to meet in order for the manufacturer to affix the CE marking. These are the so-called Essential Requirements that are listed in Annex I to the MDD. Compliance with the essential requirements must be demonstrated by a clinical evaluation in accordance with Annex X to Directive 93/42/EEC.

 

Need for notified body?

Before proceeding with the assessment procedure, it is important to establish whether you, the manufacturer, can assess your product by yourself or whether you have to involve a Notified Body.

In the Directive on Medical Devices, the medical device is classified in accordance with the provisions of Annex IX of the MDD as class I (low risk), class IIa or IIb (medium risk) or class III (high risk). The involvement of a Notified Body is not necessary for medical devices of class I unless they have a measuring function or are placed on the market in a sterile condition.

A Notified Body verifies in most of the cases only the quality management of the manufacturer. For all medical devices belonging to class III, and for medical devices belonging to class IIa and IIb on a representative basis, the design of the medical device and its compliance with the Essential Requirements must be examined by a Notified Body. The Notified Body issues a certificate that indicates, by referring to one of the Annexes II to VI of the MDD, what has been verified.

To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please consult NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive, country or by the Notified Body's number (indicated next to the CE marking) via the NANDO homepage.

Check conformity

Subject to the class of the medical device, the manufacturer has different options as to how to assess the conformity of the medical device. The stringency of the conformity assessment procedures depends on the class of the medical device. For each class, the manufacturer has the choice between two or more conformity assessment procedures. Each of the conformity assessment procedures consists of the application of one or more Annexes out of Annexes II to VII of the MDD. In both cases, the clinical evaluation must be part of the documents which the manufacturer submits to the Notified Body for assessment and the Notified Body issues (a) certificate(s) that indicate(s), by referring to one of the Annexes, what has been verified.

Whether the involvement of a Notified Body has been necessary or not, the manufacturer must draw up the Declaration of Conformity (DoC) to declare his sole responsibility for the conformity to the relevant Directive. The Declaration of Conformity must include the manufacturer’s details such as name and address, essential characteristics of the product, if applicable the identification number of the Notified Body as well as a legally binding signature on behalf of the organisation.

Technical documentation

Prior to submission of an application to the Notified Body or, at the latest, when placing the first device of the respective type on the market, the manufacturer must establish the technical documentation. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive.

The manufacturer or the authorised representative established in the European Community is requested to keep copies of the technical documentation for a period of at least 5 years, in the case of implantable devices at least 15 years, after the last product has been placed on the market.

Affix CE marking

Once the necessary steps have been successfully completed, the CE marking must be affixed to the medical device. The CE marking has to be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and the accompanying document. The CE marking shall consist of the initials 'CE' taking the following form:

Affixing CE marking

The various components of the CE marking must have the same vertical dimension and may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the graduated drawing above must be respected.

When the product is subject to other Directives covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other Directives.

If a Notified Body has been involved in the conformity assessment procedure, its identification number must also be displayed.

Noise emission in the environment

Directives

If your product(s) fall(s) within the sector of construction or gardening equipment, it might be subject to the Directive 2000/14/EC on Noise Emission in the Environment.

Other Directives may additionally apply depending on specific products.

 

Verify requirements

The New Approach Directives for the CE marking have been designed by the European Union in such a manner that they cover all requirements for products from each of the aforementioned sectors.

Directive 2000/14/EC on Noise Emission in the Environment specifies essential requirements regarding the permissible sound power level of specific equipment that the product must meet in order for the manufacturer to affix the CE marking.

Directive 2000/14/EC covers equipment such as machines and equipment used for construction, gardening and others. Article 12 lists the equipment subject to noise limits, Article 13 lists the equipment subject to noise labeling and Annex I lists all equipment types the Directive refers to. In this regard, certain equipment is subject to noise limits, whereas other equipment is subject to noise marking only. The detailed noise level permitted for the respective equipment is also listed in Article 12.

The first step a manufacturer should take to ensure that the equipment will be compliant with the Directive is to carry out an assessment procedure, with regard to the essential requirements. The Directive lays out different assessment procedures for that purpose: the internal production control assessment with periodical checking procedures, unit verification procedures or the full quality assurance procedure. The procedures are described in detail in Annexes V to VIII to the Directive (see art 14).

It is necessary to consult the Directive to ensure that the product complies with all the essential requirements.

 

Need for notified body?

Before proceeding with the assessment procedure, it is important to determine whether you, the manufacturer, can assess your product by yourself or whether you need to involve a Notified Body.

Directive 2000/14/EC on Noise Emission in the Environment foresees the involvement of a Notified Body (except in case of the procedure laid down under Annex V) .

A Notified Body verifies the compliance of a product by conducting a conformity assessment. It also ensures that the technical documentation sufficiently supports product compliance. If the Notified Body is involved in the production control phase, its identification number will follow the CE marking.

When the Notified Body is convinced of product compliance, it will issue a certificate of conformity to confirm this. The manufacturer will then draw up the Declaration of Conformity (DoC) to declare on his sole responsibility conformity to the relevant Directive. The establishment of the DoC is a legal obligation.

The Declaration of Conformity must include the manufacturer’s details such as name and address, essential characteristics the product complies with, any European standards and performance data and the identification number of the Notified Body as well as a legally binding signature on behalf of the organisation. For further details please consult your specific Directive.

To find the Notified Bodies appointed by the Member States to carry out conformity assessment, the manufacturer should consult the NANDO database – the New Approach Notified and Designated Organisations. They can search for Notified Bodies by Directive or by country via the NANDO homepage.

Check conformity

In accordance with basic noise emission standards referred to in Annex III, Part A and B, to the Directive, the manufacturer is required to test the noise emission of the respective equipment. The procedures and noise emission standards for each respective equipment category are laid out in the Directive. A Notified Body will then assess the conformity of the product to the requirements of Directive 2000/14/EC on Noise Emission in the Environment in one of the procedures laid out in Annexes VI to VII to the Directive.

In the procedure of internal production control with assessment of the technical documentation, the manufacturer carries out internal tests and draws up the required technical documentation for the Notified Body to assess. The Notified Body then confirms the successful fulfilment of the requirements of the Directive or in cases where deemed necessary, carries out periodical checks in order to verify continuing compliance of the manufactured equipment with the submitted technical documentation and with the requirements of the Directive.

Whether a Notified Body has been involved or not, the manufacturer needs to draw up and sign the EC Declaration of Conformity.

Additional processes are unit verification, which for instance includes noise tests carried out by the Notified Body, or full quality assurance. In the latter, the manufacturer must operate an approved quality assurance system for design, manufacture and final product inspection and testing, which will be assessed by the Notified Body.

Technical documentation

Upon successful assessment, Directive 2000/14/EC on Noise emission in the environment requires a technical documentation as laid out in Annexes V – VIII (see art 14.3). The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive. The technical file should comprise:

  • The name and address of the manufacturer or his authorised representative established in the Community
  • A description of the equipment
  • The trade name
  • The type, series and numbers
  • The technical data relevant for the identification of the equipment and the assessment of its noise emission, including, if appropriate, schematic drawings and any description and explanation necessary for their understanding
  • The reference to the Directive
  • The technical report of noise measurements carried out in accordance with the provisions of the Directive
  • The technical instruments applied and the results of the evaluation of the uncertainties due to production variation and their relation to the guaranteed sound power level.

The file must also contain a copy of the EC declaration of conformity.

The manufacturer or their authorised representative is requested to keep copies of the technical documentation for a period of 10 years after the last product has been placed on the market.

Affix CE marking

Once the necessary steps have been successfully completed, the logo must be affixed to the product.

The CE marking shall be accompanied by the indication of the guaranteed sound power level. A model of this indication is given in Annex IV. The marking must be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and the accompanying document. The CE marking shall consist of the initials 'CE' taking the following form:

Affixing CE marking

The various components of the CE marking must have the same vertical dimension, and may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the graduated drawing above must be respected.

When the product is subject to other Directives covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other Directives.

However, when one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the ‘CE’ marking must indicate conformity with the Directives applied by the manufacturer only. In this case, the particularities of the Directives applied, as published in the Official Journal of the European Union, must be given in the documents, notices or instructions required by the Directives and accompanying such products.

If a Notified Body is involved in the production control phase, its identification number must be also displayed.

Non-automatic weighing instruments

Directives

If your product(s) fall(s) within the sector of Non-automatic weighing instruments Directive 2014/31/EU applies.

Certificates issued under the repealed Directive 2009/23/EC remain valid under Directive 2014/31/EU and references to the repealed Directives 2009/23/EC and 90/384/EEC shall be construed as references to Directive 2014/31/EU in accordance with the correlation tables in Annex VI of Directive 2014/31/EU and Annex VIII of Directive 2009/23/EC.

 

Verify requirements

The New Approach Directives for the CE marking have been designed by the European Union in such a manner that they cover all requirements for products from each of the aforementioned sectors.

The Directive defines a non-automatic weighing instrument as ‘a measuring instrument serving to determine the mass of a body by using the action of gravity on that body’ and ‘requiring the intervention of an operator during weighing’.

As far as CE marking is concerned, the Directive applies to instruments intended to be used for determining mass in the following situations: commercial transactions; for calculating tolls, tariffs, taxes, bonuses, penalties, remunerations or indemnities; for the application of laws or regulations or for an expert opinion given in court proceedings; in the practice of medicine for weighing patients for purposes of monitoring, diagnosing and medical treatment; for making up medicines on prescription in a pharmacy and determination of mass in analyses carried out in medical and pharmaceutical laboratories ; or for determining a price on the basis of mass for the purposes of direct sales to the public and the making-up of prepackages.

Directive 2014/31/EU on Non-Automatic Weighing Equipment specifies the essential requirements the product must meet in order for the manufacturer to affix the CE marking in Annex I to the Directive.

 

Need for notified body?

Before proceeding with the assessment procedure, it is important to determine whether you, the manufacturer, can assess your product by yourself or whether you have to involve a Notified Body.

In the case of non-automatic weighing equipment the manufacturer can choose from different assessment procedures and for instruments intended for any of the uses -mentioned in the section "Verify requirements" must involve a Notified Body.

A Notified Body verifies the compliance of a product by conducting a conformity assessment. It also ensures that the technical documentation sufficiently supports product compliance. If the Notified Body is involved in the production control phase, its identification number will follow the CE marking.

When the Notified Body is convinced of a product’s compliance, it will issue a certificate of conformity to confirm this. The manufacturer will then draw up the EU Declaration of Conformity (DoC) to declare on his sole responsibility conformity to the relevant Directive. The establishment of the EU DoC is a legal obligation.

The EU Declaration of Conformity must include the manufacturer’s details such as name and address, essential characteristics the product complies with, any European standards and performance data and the identification number of the Notified Body as well as a legally binding signature on behalf of the organisation. For further details please consult your specific Directive.

To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please consult NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive or by country via the NANDO homepage.

Check conformity

Manufacturers can choose between two sets of procedures for assessing the conformity of their non-automatic weighing instruments with the essential requirements set out in the Directive.

The first option is the EU-type examination (Module B in Annex II), carried out by a Notified Body, and followed by either the EU declaration of type conformity (guarantee of production quality) (Module D or D1 in Annex II), or by the EU verification (Module F or F1 in Annex II).

The second option is the EU unit verification procedure, (Module G in Annex II).

After the involvement of the Notified Body, the manufacturer draws up and signs the EU Declaration of Conformity. He may also opt for an execution of the production (Modules D, D1, F, F1 or G) in two stages, subject to the conditions in Annex II, point 7 concerning common provisions.

Technical documentation

Article 6 and Annex II to the Directive non-automatic weighing instruments requires the manufacturer to establish a technical documentation. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive. The documentation shall, wherever applicable, contain at least the following elements:

  • a general description of the instrument,
  • conceptual designs and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
  • descriptions and explanations necessary for the understanding of those drawings and the operation of the instrument,
  • a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union, and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of this Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied;,
  • results of design calculations made. examinations carried out, etc.,
  • test reports.

The manufacturer, or their authorised representative established in the European Union, is requested to keep copies of the technical documentation for a period of 10 years after the last product has been placed on the market.

Affix CE marking

Once the necessary steps have been successfully completed, the logo must be affixed to the product.

The marking must be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and the accompanying document. The CE marking shall consist of the initials 'CE' taking the following form:

Affixing CE marking

The various components of the CE marking must have the same vertical dimension and may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the graduated drawing above must be respected.

When the product is subject to other Directives covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other Directives.

However, when one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the ‘CE’ marking must indicate conformity with the Directives applied by the manufacturer. In this case, the particularities of the Directives applied, as published in the Official Journal of the European Union, must be given in the documents, notices or instructions required by the Directives and accompanying such products.

As one or more Notified Bodies can be involved in the production control phase, their identification numbers must be also displayed.

Personal protective equipment

Directives

If your product(s) fall(s) within the sector of personal protective equipment Directive on Personal Protective Equipment (PPE) 89/686/EEC applies.

 

Verify requirements

23 New Approach Directives[1] provide for the affixing of CE marking on products. If products are subject to several directives, which all provide for the affixing of the CE marking, the marking indicates that the products are presumed to conform to the provisions of all these directives covering their respected sectors.

PPE Directive 89/686/EEC specifies the essential requirements that the product needs to meet in order for the manufacturer to affix the CE marking.

The Directive defines personal protective equipment (PPE) as unique products as far as the user buying it buys protection encountered at home, work and leisure. In other words: products that ensure the user's safety and health in specific circumstances. The products must satisfy the basic health and safety requirements laid down in Annex II.

The Directive makes a distinction between PPE of ‘simple design’, ‘complex design’ and neither of these, the last being a third Category. Whilst the Directive does not explicitly define these three groups as Categories, it is common practice to use the terms category I, III and II respectively. Category I is listed in Article 8.3 and consist of products designed to protect the user against gradual or unexceptional risks. They include among other things sunglasses, gardening gloves and thimbles. Category III is listed in Article 8.4 and includes for example emergency equipments for use in very high or very low temperatures, respiratory devices and PPE to protect against falls from a height. Category II PPE include PPE not defined in the above two Articles.

The Directive does not apply to PPE designed for use by the armed forces or police, for self-defense or for rescue operations on aircraft or ships. It also does not apply to helmets and visors intended for users of two or three-wheeled motor vehicles, or PPE for simple private use such as umbrellas or dishwashing gloves.

This means that harmonisation is limited to essential requirements, while technical specifications to comply with such requirements are set out in voluntary harmonised European standards. The PPE Directive is a New Approach Directive.

 

Need for notified body?

Before proceeding with the assessment procedure, it is important to determine whether you, the manufacturer, can assess your product by yourself or if you have to involve a Notified Body.

When dealing with personal protective equipment only category II and III require the involvement of a Notified Body.

A Notified Body verifies the compliance of a product by conducting a conformity assessment. It also ensures that the technical documentation sufficiently supports product compliance. If the Notified Body is involved in the production control phase (in case of category III PPE), its identification number will follow the CE marking.

For category II PPE, when the Notified Body verifies product’s compliance, it will issue an EC type-examination certificate to confirm this. In case of category III PPE additionally a production control is carried out. The manufacturer will then draw up the Declaration of Conformity (DoC) to declare on his sole responsibility the product’s conformity to the relevant Directive. The establishment of the DoC is a legal obligation.

The Declaration of Conformity must include the manufacturer’s details such as name and address, number of EC type-examination certificate (if applicable), any European standards and performance data and the identification number of the Notified Body as well as a legally binding signature on behalf of the organisation. For further details please consult your specific Directive.

To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please use NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive or by country via the NANDO homepage.

Check conformity

For category I PPE (“simple design"), the manufacturer is only required to assemble the technical documentation and to draw up the EC Declaration of Conformity to confirm that his product complies with the safety requirements of the Directive.

For category II PPE the Directive specifies an EC type-examination, which has to be carried out by a Notified Body. As for PPE of “complex design" or category III PPE, the Directive requires an EC type-examination also, which has to be assessed by a Notified Body. After successful completion of the examination, the manufacturer must choose between either the ‘EC quality control system for the final product’, or the ‘system for ensuring EC quality of control production by means of monitoring’. The details of these two options are set out in Article 11 of the Directive.

In all categories of PPE the manufacturer has to draw up and sign the EC Declaration of Conformity.

Technical documentation

The PPE Directive 89/686/EEC requires a technical documentation as laid out in Article 8 (1). It must enable the assessment of the conformity of the PPE with the requirements of the Directive. It must comprise all relevant data on the means used by the manufacturer to ensure that a PPE complies with the basic requirements relating to it. In case of category II and III PPE is shall comprise in particular:

  • the manufacturer's technical file consisting of:
  • overall and detailed plans of the PPE accompanied, where appropriate, by calculation notes and the results of prototype tests in so far as necessary for the verification of compliance with the basic requirements;
  • an exhaustive list of the basic safety requirements and of the harmonized standards or other technical specifications referred to in Articles 3 and 5, taken into account in the design of the model;
  • a description of the control and test facilities to be used in the manufacturer's plant to check compliance of production PPE with the harmonized standards or other technical specifications and to maintain quality level;
  • a copy of the information notice referred to in Annex II, 1.4.

The manufacturer or his authorised representative established in the European Union is requested to keep copies of the technical documentation for a period of 10 years after the last product has been placed on the market.

Affix CE marking

Once the necessary steps have been successfully completed, the logo must be affixed to the product.

The marking must be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and the accompanying document. The CE marking shall consist of the initials 'CE' taking the following form:

Affixing CE marking

The various components of the CE marking must have substantially the same vertical dimension and may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the graduated drawing above must be respected.

When the product is subject to other Directives covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other Directives.

However, when one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the ‘CE’ marking must indicate conformity with the Directives applied by the manufacturer only. In this case, the particularities of the Directives applied, as published in the Official Journal of the European Union, must be given in the documents, notices or instructions required by the Directives and accompanying such products.

If a Notified Body has been involved in the conformity assessment procedure, its identification number must also be displayed.

Pressure equipment

Directives

If your product(s) fall(s) within the sector of Pressure equipment, Directive 2014/68/EU applies.

 

Verify requirements

The New Approach Directives for CE marking have been designed by the European Union in such a manner that they cover all requirements for products from each of the aforementioned sectors.

Directive 2014/68/EU on Pressure Equipment specifies the essential requirements the product must meet in order for the manufacturer to affix the CE Marking.

The Directive defines pressure equipment as vessels, piping, safety accessories and pressure accessories, including, where applicable, elements attached to pressurised parts, such as flanges, nozzles, couplings supports, lifting lugs, and applies to the design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure PS greater than 0,5 bar.

The pressure equipment covered by the Directive is subject to the essential safety requirements listed in Annex I of the Directive.

 

Need for notified body?

Before proceeding with the assessment procedure, it is important to determine whether you, the manufacturer, can assess your product by yourself or whether you have to involve a Notified Body.

The pressure equipment in the scope of the Directive is classified in different categories (ranging from I to IV), according to ascending level of hazard in accordance with Annex II of the Directive.

The involvement of a Notified Body is obligatory for equipment of category II or higher.

A Notified Body verifies the compliance of a product by conducting a conformity assessment. It also ensures that the technical documentation sufficiently supports the product compliance. If the Notified Body is involved in the production control phase, its identification number will follow the CE marking.

When the Notified Body is convinced of product compliance, it will issue a certificate to confirm this. The manufacturer will then draw up the EU Declaration of Conformity ( EU DoC) to declare on his sole responsibility conformity to the relevant Directive. The establishment of the EU DoC is a legal obligation.

The EU Declaration of Conformity must include the manufacturer’s details such as name and address, essential characteristics the product complies with, any harmonised standards and performance data and the identification number of the Notified Body as well as a legally binding signature on behalf of the organisation. For further details please consult the Directive.

To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please refer to NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive or by country via the NANDO homepage.

Check conformity

According to the category in which the equipment was classified, the manufacturer will be given a choice of ‘modules’. The higher the category and therefore the greater the hazards, the more demanding the conformity assessment modules are. Equipment in Category I will be subject to the manufacturer’s own internal production control.

The modules for products in Categories II, III & IV will require the involvement of Notified Bodies, either in the approval and monitoring of the manufacturers’ quality assurance system or in direct product inspection. A description of different conformity assessment procedure is given in Annex III of the Directive.

Whether a Notified Body has been involved or not, the manufacturer must draw up and sign the EU Declaration of Conformity.

Technical documentation

Directive 2014/68/EU on Pressure Equipment requires the manufacturer to establish the technical documentation. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive. The documentation must contain, wherever applicable, at least the following elements:

  • a general description of the pressure equipment
  • conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,
  • descriptions and explanations necessary for an understanding of those drawings and diagrams and the operation of the pressure equipment
  • a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and a description of the solutions adopted to meet the essential safety requirements where harmonised standards have not been applied
  • results of design calculations made, examinations carried out etc.
  • test reports.

The manufacturer or their authorised representative established in the European Union is requested to keep copies of the technical documentation for a period of 10 years after the last product has been placed on the market.

Affix CE marking

Once the necessary steps have been successfully completed, the marking must be affixed to the product.

The marking must be placed visibly and legibly on the product or, if not possible due to the nature of the product e.g. if it is too small, it will be given on a label attached to the pressure equipment. The CE marking shall consist of the initials 'CE' taking the following form:

Affixing CE marking

The various components of the CE marking must have the same vertical dimension and may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the graduated drawing above must be respected.

When the product is subject to other Directives covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other Directives.

However, when one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the ‘CE’ marking must indicate conformity with the Directives applied by the manufacturer. In this case, the particularities of the Directives applied, as published in the Official Journal of the European Union, must be given in the documents, notices or instructions required by the Directives and accompanying such products.

If a Notified Body is involved in the production control phase, its identification number must be also displayed.

Pyrotechnics

Directives

If your product(s) fall(s) within the sector of pyrotechnics, it might be subject to the Directive 2013/29/EU on Pyrotechnic Articles.

Other Directives or Regulations may additionally apply depending on specific products.

 

Verify requirements

The New Approach Directives for the CE marking have been designed by the European Union in such a manner that they cover all requirements for products from each of the aforementioned sectors.

Directive 2013/29/EU on Pyrotechnic Articles specifies essential safety requirements regarding high levels of consumer protection, the safety of the public and environmental protection that the product must meet in order for the manufacturer to affix the CE marking.

Directive 2013/29/EU covers equipment such as fireworks, theatrical pyrotechnic articles and pyrotechnic articles for technical purposes, such as gas generators used in airbags or in seatbelt pretensioners.

The Directive excludes pyrotechnic articles intended for non-commercial use by the armed forces, the police or fire departments, equipment falling within the scope of Directive 96/98/EC on marine equipment, pyrotechnic articles intended for use in the aerospace industry and percussion caps intended specifically for toys (Directive 2009/48/EC of 18 June 2009 applies in this case). Furthermore, explosives falling within the scope of Directive 93/15/EEC on Explosives for Civil Use and ammunition are not subject to the Directive on Pyrotechnic Articles. Finally, fireworks which are built by a manufacturer for his own use and approved for use exclusively on its territory by the Member State in which the manufacturer is established, and which remain on the territory of that Member State, are also excluded from the application of the Directive.

It is necessary to consult the Directive’s Annex I to ensure that the product complies with all the essential requirements.

 

Need for notified body?

Before proceeding with the assessment procedure, it is important to determine whether you, the manufacturer, can assess your product by yourself or if you have to involve a Notified Body.

Directive 2013/29/EU on Pyrotechnic Articles always foresees the involvement of a Notified Body.

A Notified Body verifies the compliance of a product by conducting a conformity assessment. It also ensures that the technical documentation sufficiently supports product compliance. If the Notified Body is involved in the production control phase, its identification number will follow the CE marking.

When the Notified Body is convinced of product compliance, it will issue a certificate of conformity to confirm this. The manufacturer will then draw up the Declaration of Conformity (DoC) to declare on his sole responsibility conformity to the relevant Directive. The establishment of the DoC is a legal obligation.

The Declaration of Conformity must include the manufacturer’s details such as name and address, essential characteristics the product complies with, references to the relevant  European standards and performance data and the identification number of the Notified Body as well as a legally binding signature on behalf of the organisation. The DoC must have the model structure set out in Annex III of the Directive.

To find the Notified Bodies appointed by the Member States to carry out conformity assessments, the manufacturer should consult the NANDO database – the New Approach Notified and Designated Organisations. They can search for Notified Bodies by Directive or by country via the NANDO homepage.

Check conformity

Directive 2013/29/EU on Pyrotechnic Articles requires a categorisation of the products in question according to their type of use, their purpose and level of hazard, including their noise level. Article 6 of the Directive lists the different categories and their details.

All pyrotechnic articles are subject to assessment by a Notified Body; the applicable conformity assessment procedures are laid out in Article 17 of the Directive.

Also, pyrotechnic articles are subject to age limits. The period depends on their category and might span from 12 to 18 years. Additionally, distributors must not sell specific pyrotechnic articles to persons without specialist knowledge, for instance in the case of pyrotechnics used for theatrical purposes of category T2 or fireworks of category F4.

With regard to assessment procedures, the Directive allows for the following:

  • EU-type examination and conformity to type assessment,
  • EU-type examination and production quality assurance assessment,
  • EU-type examination and product quality assurance assessment,
  • unit verification assessment or,
  • for fireworks of category F4 only, the full product quality assurance procedure.

All procedures are laid out in detail in Annex II to the Directive.

The manufacturer will draw up and sign the EU Declaration of Conformity.

All pyrotechnic articles require special labelling as specified in Article 10 and 11 of the Directive. The labelling must, for instance, include the minimum age limits as indicated in Article 7(1) and (2), the relevant category and some basic instructions for use, the year of production for specific fireworks categories and, where appropriate, a minimum safety distance. The labelling must also for instance include the net equivalent quantity (NEQ) of active explosive material (= net explosive content). For a detailed overview please consult Article 10 or 11. The European Harmonised Standards EN 15947-3, EN ISO 14451-3, EN 16256-4 and EN 16261-4 specifying the minimum labelling requirements for different categories of pyrotechnic articles should also be taken into account.

Technical documentation

Upon successful assessment, Directive 2013/29/EU on Pyrotechnic Articles outlines different variations for a technical documentation depending on the assessment procedure chosen, as laid out in Annex II. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive. The technical file should basically comprise:

  • a general description of the article,
  • conceptual design and manufacturing drawings and schemes of components, sub-assemblies and circuits,
  • the descriptions and explanations necessary for the understanding of the conceptual design and manufacturing drawings, the schemes of components, sub-assemblies and circuits and the operation of the pyrotechnic article,
  • a list of the harmonised standards referred to in Article 8 of the Directive, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where the harmonised standards referred to in Article 8 of this Directive have not been applied,
  • results of design calculations made and examinations carried out,
  • test reports.

Also, the file must contain a copy of the EU Declaration of Conformity.

The manufacturer is requested to keep copies of the technical documentation for a period of 10 years after the last product has been placed on the market.

Affix CE marking

Once the necessary steps have been successfully completed, the logo must be affixed on the product.

The marking has to be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and to the accompanying documents. The CE marking shall consist of the initials 'CE' taking the following form:

 

Affixing CE marking

The various components of the CE marking must have substantially the same vertical dimension and may be not smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the graduated drawing above must be respected.

When the product is subject to other Directives covering other aspects and which also provide for the CE marking, the accompanying documents must indicate that the product also conforms to those other Directives.

However, when one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking must indicate conformity with the Directives applied by the manufacturer. In this case, the particularities of the Directives applied, as published in the Official Journal of the European Union, must be given in the documents, notices or instructions required by the Directives and accompanying such products.

If a Notified Body has been involved in the production control phase, its identification number must also be displayed.

For consumer fireworks, according to the applicable standard, a registration number for the tracing of products shall be marked in accordance with the following structure: XXXX - YY - ZZZZ..., where XXXX refers to the registration number of the notified body issuing the certificate, YY refers to the category of firework in abbreviated format (F1, F2, or F3 for category 1, 2, or 3 respectively), and where ZZZZ... is a processing number used by the notified body.

Radio equipment

Directives

If your product(s) fall(s) within the sector of Radio Equipment the Directive 2014/53/EU on Radio equipment applies..

 

Verify requirements

Directive 2014/53/EU on Radio Equipment specifies, in Article 3, the essential requirements the product must meet in order for the manufacturer to affix the CE marking.

Radio equipment encompasses all products that use the radio frequency spectrum (like mobile phones, gate openers or broadcast transmitters)..

The essential requirements as laid out in Article 3 of the Directive 2014/53/EU entail that radio equipment shall be constructed so as to ensure:

  • the protection of health and safety of persons and of domestic animals and the protection of property
  • an adequate level of electromagnetic compatibility
  • that it both effectively uses and supports the efficient use of radio spectrum so as to avoid harmful interference.

Other essential requirements of public interest (such as the protection of personal privacy and data, access to emergency services and services for users with disabilities) may also apply if specific Delegated Acts have been adopted.

Manufacturers shall ensure that radio equipment shall be so constructed that it can be operated in at least one Member State without infringing applicable requirements on the use of radio spectrum.

 

Need for notified body?

Before proceeding with the assessment procedure, it is important to determine whether you, the manufacturer, can assess your product by yourself or whether you have to involve a Notified Body.

A notified body is involved depending on which conformity assessment procedure has been applied.

A Notified Body verifies the compliance of a product by conducting a conformity assessment. It also ensures that the technical documentation sufficiently supports product compliance. If the Notified Body is involved in the production control phase, its identification number shall follow the CE marking.

When the Notified Body is convinced of product compliance, it will issue a certificate of conformity to confirm this. The manufacturer will then draw up the EU Declaration of Conformity (EU DoC) to declare on his sole responsibility conformity of each individual product to the relevant Directive. The establishment of the EU DoC is a legal obligation.

To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please refer to NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive or by country via the NANDO homepage.

Check conformity

The manufacturer shall perform a conformity assessment of the radio equipment with a view to meeting the essential requirements set out in Article 3.

Article 17 of the Directive prescribes the conformity assessment procedures which are applicable.

Whether a Notified Body has been involved or not, the manufacturer must draw up and sign the EU Declaration of Conformity. The EU Declaration of Conformity must include the manufacturer’s details such as name and address, essential characteristics the product complies with, any European standards and performance data and the identification number of the Notified Body as well as a legally binding signature on behalf of the organisation. Manufacturers shall keep the EU declaration of conformity for 10 years after the radio equipment has been placed on the market.

 

Technical documentation

The technical documentation shall be drawn up, in accordance with Article 21 of the Directive, before the radio equipment is placed on the market and shall be continuously updated.  

Manufacturers shall keep the technical documentation for 10 years after the radio equipment has been placed on the market.

Annex V describes the technical documentation. The technical documents must enable the assessment of the conformity of the product with the requirements of the Directive. The documentation must cover:

  • a general description of the product including:
    • photographs or illustrations showing external features, marking and internal layout
    • versions of software or firmware affecting compliance with essential requirements
    • user information and installation instructions
  • a conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits and other relevant similar elements
  • descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product
  • a list of the harmonised standards applied in full or in part, and where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of the Directive including a list of other relevant technical specifications applied
  • a copy of the EU declaration of conformity
  • where the conformity assessment module in Annex III has been applied, copy of the EU-type examination certificate and its annexes as delivered by the notified body involved
  • results of design calculations made, examinations carried out, etc.
  • test reports
  • an explanation of the compliance with the requirement of Article 10(2) and of the inclusion or not of information on the packaging in accordance with Article 10(10).

The manufacturer or their authorised representative established in the European Union is requested to keep copies of the technical documentation for a period of 10 years after the last product has been placed on the market.

What about information for the user? See article 10.8 of the Directive, and its language regime which depends on national regimes. Any potential restrictions or requirements for authorisation of use of the radio equipment in certain Member States shall be marked in order to alert the user.

Affix CE marking

Once the necessary steps have been successfully completed, the CE marking must be affixed in accordance with Articles 19 and 20 of the Directive.

The CE marking shall consist of the initials 'CE' taking the following form:

Affixing CE marking

When the product is subject to other Directives covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other Directives.

If a Notified Body is involved in the production control phase, its identification number must be also displayed as provided for in Article 20 (3) of the Directive.

Recreational craft

Directives

If your product(s) fall(s) within the sector of Recreational craft Directive 2013/53/EU applies.

 

Verify requirements

The New Approach Directives for the CE marking have been designed by the European Union in such a manner that they cover all requirements for products from each of the aforementioned sectors.

The Directive 2013/53/EU on recreational crafts and personal watercraft specifies in detail the essential requirements that the product must meet in order for the manufacturer to affix the CE marking.

The Directive defines 'Recreational craft' as any watercraft of any type, excluding personal watercraft, intended for sports and leisure purposes of hull length from 2,5 m to 24 m, regardless of the means of propulsion and as 'Personal watercraft' - watercraft intended for sports and leisure purposes of less than 4 m in hull length which uses a propulsion engine having a water jet pump as its primary source of propulsion and designed to be operated by a person or persons sitting, standing or kneeling on, rather than within the confines of, a hull.

Among products excluded are crafts intended solely for racing, canoes and kayaks, gondolas and pedalos, sailing surfboards, powered surfboards, along with others. For a full list please consult the Directive Chapter I, Article 2, Par. 2.

The essential safety, health, environmental protection and consumer protection requirements for recreational crafts are fully listed under Annex I to the Directive.

 

Need for notified body?

Before proceeding with the conformity assessment procedure, it is important to determine whether you, the manufacturer, can assess your product by yourself or whether you have to involve a Notified Body.

For specific crafts built for inshore and sheltered water voyages which are manufactured in compliance with European Harmonised Standards which covers all relevant safety aspects, the manufacturer can carry out internal checks on the product and can then draw up and sign the EU Declaration of Conformity.

A Notified Body verifies the compliance of the product by conducting a conformity assessment. It also ensures that the technical documentation sufficiently supports product compliance. If the Notified Body is involved in the production control phase, its identification number will follow the CE marking.

When the Notified Body is convinced of the product’s compliance, it will issue a certificate of conformity to confirm this. The manufacturer will then draw up the EU Declaration of Conformity (DoC) to declare on their sole responsibility conformity to the relevant Directive. The establishment of the EU DoC is a legal obligation.

The EU Declaration of Conformity must include the manufacturer’s details such as name and address, essential characteristics the product complies with, any harmonised standards and performance data and the identification number of the Notified Body as well as a legally binding signature on behalf of the organisation. For further details please consult the Directive.

To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please refer to NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive or by country via the NANDO homepage.

Check conformity

The applicable conformity assessment procedures are laid down in Chapter IV of Directive.
Whether a Notified Body has been involved or not, the manufacturer must draw up and sign the EU Declaration of Conformity.

Technical documentation

The technical documentation shall contain all relevant data and details of the means used by the manufacturer to ensure that the product complies with the requirements of the Directive. The technical documents must enable the assessment of the conformity of the product with the requirements of the Directive. The documentation shall, in particular, contain the following:

  • a general description of the type,
  • conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, and other relevant data,
  • descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product,
  • a list of the standards referred to in Article 14, applied in full or in part, and descriptions of the solutions adopted to fulfil the essential requirements when the standards referred to in Article 14 have not been applied,
  • results of design calculations made, examinations carried out, and other relevant data,
  • test reports, or calculations namely on stability in accordance with point 3.2 of the Essential Requirements and on buoyancy in accordance with point 3.3 of the Essential Requirements.
  • exhaust emissions test reports demonstrating compliance with Section 2 of the Essential Requirements (Annex I.B)
  • sound emissions test reports demonstrating compliance with Section 1 of the Essential Requirements (Annex I.C)

The manufacturer or their authorised representative established in the European Union is requested to keep copies of the technical documentation for a period of 10 years after the last product has been placed on the market.

Affix CE marking

Once the necessary steps have been successfully completed, the CE marking must be affixed to the product.

The marking must be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and the accompanying document. The CE marking shall consist of the initials 'CE' taking the following form:

Affixing CE marking

The various components of the CE marking must have substantially the same vertical dimension and may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing must be respected.

When the product is subject to other Directives covering other aspects and which also provide for the affixing of the CE marking, the latter shall indicate that such products are also presumed to conform to the provisions of those other Directives.

The CE marking shall indicate conformity with the applicable Directives or relevant parts thereof. In this case, the particulars of the said Directives applied by the manufacturer, as published in the Official Journal of the European Union, must be given in the documents, declaration of conformity or instructions required by the Directives and accompanying such products.

If a Notified Body is involved in the production control phase, its identification number must be also displayed.

Restriction of Hazardous Substances in Electrical and Electronic Equipment

Directives, Verify requirements, Need for notified body?, Check conformity, Technical documentation and Affix CE marking

Please consult http://ec.europa.eu/environment/waste/rohs_eee/legis_en.htm.

Safety of toys

Directives

If your product(s) fall(s) within the Toys sector the following Directive (2009/48/EC) applies.

 

Verify requirements

The Directives established for CE marking have been designed by the European Union in such a manner that they cover all requirements for products from each of the aforementioned sectors.

The Directive (2009/48/EC) on toy safety specifies in detail the essential requirements to be fulfilled by you as a manufacturer, importer or distributor, to prove that your product complies with EU regulations and finally, to be able to affix the CE marking.

The Directive (2009/48/EC) applies within all EEA countries as of 20 July 2011. The only exception concerns the chemicals provisions, for which a further two-year transition period applies – until 20 July 2013.

The 2009 Directive replaces the one adopted in 1988 (88/378/EEC). Toys that are compliant with the 1988 Directive can continue to be placed on the market until 19 July 2011, or 19 July 2013 in the case of the rules relating to chemicals.

The new Directive defines a toy as “any product or material designed or intended, whether or not exclusively, for use in play by children under 14 years of age".

The first step that a manufacturer should take is to check if his product falls into the scope of the Directive. Then, in order to ensure that a toy will be compliant with the Directive, the manufacturer has to check which European Harmonised Standards are applicable. The Commission’s Directorate-General (DG) for Internal Market, Industry, Entrepreneurship and SMEs website lists the Harmonised European Standards for toys.

Annex I to the Directive lists types of products excluded from the Directive and not considered toys. The list features products such as puzzles with more than 500 pieces or babies’ soothers, which are not considered toys but could easily be confused as such. The list is indicative only.

Annex II to the Directive specifies the safety requirements products have to comply with. Annex V specifies that when appropriate, toys have to bear a warning specifying a minimum age for users of toys and/or the need to ensure that they are used only under adult supervision where appropriate.

Please consult the Directive for the entire catalogue of requirements.

 

Need for notified body?

Before proceeding with the assessment procedure, it is important to establish whether you, the manufacturer, can assess your product by yourself or only with the involvement of a Notified Body.

With regard to the safety of toys on the European market, the Directive (2009/48/EC) on toy safety requires the assistance of a Notified Body in case the toy in question does not comply fully (or in part) with the harmonised standards as laid out in Article 13 (and therefore conformity has to be determined directly to the requirements of the Directive) or in case the manufacturer feels the toy requires a verification by a Notified Body.

A Notified Body verifies the compliance of a product by conducting conformity assessment. It also ensures that the technical documentation sufficiently supports product compliance.

When the Notified Body is convinced of a product’s compliance, it issues a certificate of conformity to confirm this. The manufacturer will then draw up the Declaration of Conformity (DoC) to attest on his sole responsibility for conformity to the relevant Directive. The establishment of the DoC is a legal obligation.

The Declaration of Conformity must include the manufacturer’s details, such as name and address, essential characteristics the product complies with, any European standards and performance data and the identification number of the Notified Body, as well as a legally binding signature on behalf of the organisation. For further details, please consult Annex III of Directive 2009/48/EC.

To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please consult NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive or by country via the NANDO homepage.

Check conformity

For toys that have been manufactured in compliance with European Harmonized Standards covering all relevant safety aspects, the manufacturer himself carries out internal checks on the product and draws up and signs the EC Declaration of Conformity.

Before starting the assessment of the conformity of the product, the manufacturer must also carry out a separate safety assessment of potential hazards related to the toy and an assessment of the potential exposure to those hazards.

If harmonised standards do not exist, have been only partly applied to the toy in question, or have been published with a restriction, or if the manufacturer feels that the toy requires third party verification, then it must be submitted to a Notified Body for an EC-type examination. This body assesses whether the technical design of the toy is compliant with the requirements of the Directive.

The manufacturer must also ensure that the production of the toy is compliant with the Directive, but this part of the process does not require the involvement of a Notified Body.

Details about the assessment procedures are specified under Chapter IV in the Directive (2009/48/EC) on toy safety.

Whether a Notified Body has been involved or not, the manufacturer must draw up and sign the EC Declaration of Conformity.

Manufacturers are required to work with the market surveillance authorities in each country where the toys are placed on the market. A list of these authorities can be downloaded (114 kB) from the Commission’s Directorate-General (DG) for Internal Market, Industry, Entrepreneurship and SMEs website.

Technical documentation

Upon successful assessment, Directive (2009/48/EC) requires a technical documentation as laid out in Article 21. The technical documents must enable the conformity of the toy with the requirements of the Directive to be assessed. The following documentation is required:

  • a description of the means (such as the use of a test report or technical file) whereby the manufacturer ensures conformity of production with the standards referred to in Article 13
  • where appropriate: an EC type-certificate drawn up by an notified body; copies of the documents the manufacturer has submitted to the notified body; a description of the means whereby the manufacturer ensures conformity with the approved model,
  • the addresses of the locations used for manufacture and storage of the product, detailed information concerning the design and manufacture of the product.

The manufacturer, or his authorised representative established in the European Community, is requested to keep copies of the technical documentation for a period of 10 years after the last product has been placed on the market.

Affix CE marking

Once the necessary steps have been successfully completed, the logo must be affixed to the product.

The marking must be placed visibly and legibly and indelibly to the toy, to an affixed label or to the packaging. In the event where this is not possible due to the size of the product, CE marking may alternatively be affixed to a label or an accompanying leaflet. If the CE mark is not visible from outside the packaging, it shall as minimum be affixed to the packaging. The CE marking shall consist of the initials 'CE' taking the following form:

Affixing CE marking

The various components of the CE marking must have the same vertical dimension, which may not be less than 5mm. If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing must be respected.

When the product is subject to other Directives covering other aspects and which also provide for the CE marking, the accompanying documents must indicate that the product also conforms to those other Directives.

However, when one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking has to indicate conformity with the Directives applied by the manufacturer. In this case, the particularities of the Directives applied, as published in the Official Journal of the European Union, must be given in the documents, notices or instructions required by the Directives and accompanying such products.

Simple pressure vessels

Directives

If your product(s) fall(s) within the sector of simple pressure vessels Directive 2014/29/EU applies.

 

Verify requirements

The New Approach Directives for CE marking have been designed by the European Union in such a manner that they cover all requirements for products from each of the aforementioned sectors.

The Directive 2014/29/EU on simple pressure vessels specifies the essential requirements the product has to meet in order for the manufacturer to affix the CE marking.

The Directive applies to simple pressure vessels manufactured in series with the following characteristics:

(a) the vessels are welded, intended to be subjected to an internal gauge pressure greater than 0,5 bar and to contain air or nitrogen, and are not intended to be fired

(b) the parts and assemblies contributing to the strength of the vessel under pressure are made either of non-alloy quality steel or of non-alloy aluminium or non-age hardening aluminium alloys

(c) the vessel is made of either of the following elements:

(i) a cylindrical part of circular cross-section closed by outwardly dished and/or flat ends which revolve around the same axis as the cylindrical part or

(ii) two dished ends revolving around the same axis

(d) the maximum working pressure of the vessel does not exceed 30 bar and the product of that pressure and the capacity of the vessel (PS × V) does not exceed 10 000 bar.L

(e) the minimum working temperature is no lower than – 50 °C and the maximum working temperature is not higher than 300 °C for steel and 100 °C for aluminium or aluminium alloy vessels.

These vessels are required to comply with the essential safety requirements set out in Annex I to the Directive.

 

Need for notified body?

A Notified Body verifies the compliance of a product with the Directive by conducting a conformity assessment. Depending on the use or not of harmonised European standards and the potential pressure hazard determined by the total energetic content of the vessels - determined by the product of PS (pressure) and V (volume) - appropriate conformity assessment procedures are defined in the Directive.

If the Notified Body is involved in the production control phase, its identification number will follow the CE marking.

If the product is in compliance with the directive, the Notified body will issue a certificate to confirm this. The manufacturer will then draw up the EU Declaration of Conformity (EU DoC) to declare on their sole responsibility conformity of the product to the relevant Directives. The establishment of the EU DoC is a legal obligation.

The EU Declaration of Conformity must include the manufacturer’s details such as name and address, object of the declaration, statement that the object of the declaration is in conformity with the relevant Union harmonisation legislation , references to the relevant harmonised standards used or references to other technical specifications in relation to which conformity is declared, and the name and identification number of the Notified Body. For further details please consult Annex IV of the specific Directive.

To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please refer to NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive or by country via the NANDO homepage.

Check conformity

Vessels of which the product of PS × V exceeds 50 bar.L shall be subject to the EU-type examination (Module B) set out to in point 1 of Annex II, as follows:

  1. for vessels manufactured in accordance with the harmonised standards referred to in Article 12, at the choice of the manufacturer, in either of the following two manners:
    1. assessment of the adequacy of the technical design of the vessel through examination of the technical documentation and supporting evidence without examination of a specimen (Module B – design type);
    2. assessment of the adequacy of the technical design of the vessel through examination of the technical documentation and supporting evidence, plus examination of a prototype, representative of the production envisaged, of the complete vessel (Module B – production type).
  2. for vessels not manufactured, or manufactured only partly, in accordance with the harmonised standards referred to in Article 12, the manufacturer shall submit for examination a prototype, representative of the production envisaged, of the complete vessel and the technical documentation and supporting evidence for examination and assessment of the adequacy of the technical design of the vessel (Module B – production type).

Vessels shall be subject to the following procedures:

  1. where the product of PS × V exceeds 3 000 bar.L, to conformity to type based on internal production control plus supervised vessel testing (Module C1) set out in point 2 of Annex II;
  2. where the product of PS × V does not exceed 3 000 bar.L but exceeds 200 bar.L, at the choice of the manufacturer, to either of the following:
  1. conformity to type based on internal production control plus supervised vessel testing (Module C1) set out in point 2 of Annex II;
  2. conformity to type based on internal production control plus supervised vessel checks at random intervals (Module C2) set out in point 3 Annex II;
  1. where the product of PS × V does not exceed 200 bar.L but exceeds 50 bar.L, at the choice of the manufacturer, to either of the following:
    1. conformity to type based on internal production control plus supervised vessel testing (Module C1) set out in point 2 of Annex II;
    2. conformity to type based on internal production control (Module C) set out in point 4 of Annex II.

Whether a Notified Body has been involved or not, the manufacturer must draw up and sign the EU Declaration of Conformity.

Technical documentation

Annex II to Directive 2014/29/EU on simple pressure vessels requires the manufacturer to prepare the technical documentation enabling the assessment of the conformity of the vessel with the requirements of the Directive. The documentation shall contain at least the following elements:

  • a general description of the vessel
  • conceptual design and manufacturing drawings and schemes of components, etc.
  • descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the vessel
  • a list of the harmonised standards applied in full or in part, the references of which have been published in the Official Journal of the European Union, and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential safety requirements of this Directive, including a list of other relevant technical specifications applied
  • results of design calculations made, examinations carried out, etc.
  • test reports
  • the instructions and safety information
  • a document describing:
    • the materials selected
    • the welding processes selected
    • the checks selected
    • any pertinent details as to the vessel design.

The manufacturer, or his authorised representative established in the European Union, is requested to keep copies of the technical documentation for a period of 10 years after the last vessel has been placed on the market.

Affix CE marking

Once the necessary steps have been successfully completed, the logo must be affixed to the product.

The marking must be placed visibly and legibly on the product or, if not possible because of the nature of the product, be affixed to a data plate. The CE marking shall consist of the initials 'CE' taking the following form:

Affixing CE marking

The various components of the CE marking must have substantially the same vertical dimension and may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing must be respected.

When the product is subject to other Directives covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other Directives.

However, when one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the ‘CE’ marking has to indicate conformity with the Directives applied by the manufacturer. In this case, the particularities of the Directives applied, as published in the Official Journal of the European Union, must be given in the documents, notices or instructions required by the Directives and accompanying such products.

If a Notified Body is involved in the production control phase, its identification number must be also displayed.

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