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Check conformity

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.

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.

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.

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 859/2009pdf 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

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 EC 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 Annex V of the Directive.

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 II, Article 8 of the ATEX Directive 94/9/EC. 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 EC-type examination procedure in conjunction with production 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 EC-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 EC Declaration of Conformity.

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 II 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 EC type examination (Module B, referred to in Annex II to the Directive) accompanied by one of the following four supplementary procedures:

  • the type conformity (Module C) referred to in Annex II (2)
  • the production quality assurance procedure (Module C) referred to in Annex II (3)
  • the product quality assurance procedure (Module E) referred to in Annex II (4)
  • the product verification (Module F) referred to in Annex II (5)

The second option is the unit verification procedure referred to in Annex II (6).

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

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.

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.

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 II, Article 8 of the Directive.

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

A. The manufacturer of the safety components for lifts can either:

  • submit the model of the safety component for EC type examination in accordance with Annex V and for production checks by a notified body in accordance with Annex XI; or
  • submit the model of the safety component for EC type examination in accordance to Annex V and operate a quality assurance system in accordance to Annex VIII for checking production; or
  • operate a full quality assurance system in accordance with Annex IX.

B. 1. The lift installer in order to assess the conformity of a lift design may choose one of the following alternative procedures:

  • the lift or model lift design is submitted to an EC type-examination by a Notified Body;
  • the conformity of the lift design is assessed by the installer himself under a full quality assurance system that has been approved by a Notified Body;
  • the lift design is subject to unit verification by a Notified Body.

In the case of recourse to a full quality assurance system, if a lift design does not wholly comply with the relevant harmonised standards, a design inspection must also be carried out by a Notified Body to assess the conformity of the lift in respect to those aspects of the design which deviate from the harmonised standards.

B. 2. In order to check the conformity of a lift installation (installation phase) with the design, the conformity of which was assessed during the design phase, the lift installer may choose one of the following alternative procedures:

For lift designs or designs of model lifts that are subject to an EC type-examination certificate or that have been designed under a full quality assurance system, complemented, if necessary, by a design inspection:

  • the lift installation is subject to a final inspection by a Notified Body;
  • the lift installer must carry out the final inspection and test the lift installation himself under a product quality assurance system approved by a Notified Body;
  • the lift installer must carry out the final inspection and test the lift installation himself under a production quality assurance system approved by a Notified Body;
  • the lift installer must carry out the final inspection and test the lift installation under the approved full quality assurance system that also covered the design phase.

For lift designs that have been subject to unit verification by a Notified Body, the same procedure also covers the installation phase.

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

Check conformity

Conformity assessment for products covered by the Low Voltage Devices 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 IV to the Directive.

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

Annex III.B of the Directive describes the content of the Declaration of Conformity as follows:

  • name and address of the manufacturer or his authorised representative established within the Union,
  • a description of the electrical equipment,
  • reference to the harmonised standards,
  • where appropriate, reference to the specifications regarding which conformity is declared,
  • identification of the signatory who has been empowered to enter into commitments on behalf of the manufacturer or his authorised representative established within the Union,
  • the last two digits of the year in which the CE marking was affixed (for the first time).

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

In the event of a national authority challenging a manufacturer’s conformity assessment, a Notified Body can draw up a report in response, though this must be submitted by the manufacturer or the importer.

To find the Notified Bodies appointed by the Member States, the manufacturer should consult the NANDO database – the New Approach Notified and Designated Organisations. There one can search for Notified Bodies by Directive or by country via the NANDO homepage.

Manufacturers are required to work with the market surveillance authorities in each country where the equipment is sold. The manufacturer must take all appropriate actions to eliminate risks posed by low voltage electrical equipment.

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 in the ministry in charge of implementing the Machinery Directive in each Member State.

Check conformity

Annexes A to H1 to the Directive list 14 types of conformity assessment procedures for measuring instruments ranging from an internal production control to a full quality assurance and additional design examination.

Manufacturers must refer to the 10 sector-specific annexes to see which of the 14 types of conformity assessment applies to them. For example, manufacturers of water meters can choose from the procedures set out in the following Annexes: B+F, B+D or H1.

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

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.

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.

Check conformity

Manufacturers can choose between two 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 EC-type examination (described in Annex II.1), carried out by a Notified Body, and followed by either the EC declaration of type conformity (guarantee of production quality) described in Annex II.2, or by the EC verification as described in Annex II.3.

The second option is the EC unit verification procedure, which is described in Annex II.4.

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

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.

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 summary of the module requirements 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 EC Declaration of Conformity.

Check conformity

Directive 2007/23/EC 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 3 of the Directive lists the different categories and their details.

All pyrotechnic articles are subject to assessment by a Notified Body and conformity assessments as laid out in Article 9 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 2 or fireworks of category 4.

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

  • EC type-examination and conformity of type assessment,
  • EC type-examination and production quality assurance assessment,
  • EC type-examination and product quality assurance assessment,
  • unit verification assessment or,
  • for fireworks of category 4 only, the full product quality assurance procedure.

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

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

All pyrotechnic articles require special labelling as specified in Article 12 and 13 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 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 12 or 13. The newly prepared European Standard EN 15947-3 (Minimum labelling requirements) should also be taken into account. Its reference is expected to be published in the Official Journal by November 2010.

Check conformity

The R&TTE Directive offers a number of conformity assessment procedures in Annex II to V increasing in complexity with numbers. Higher conformity assessment procedures may always be applied.

In the case of radio receivers and terminal equipment, the manufacturer has the choice to assess the product via an internal production control procedure (Annex II).

Radio equipment including a transmitter complying with harmonised standards can be assessed via an internal production control plus specific apparatus tests (Annex III). The Notified Body will identify the essential radio test suites if they are not defined in the harmonised standard.

When the product also includes a transmitter not complying or only partially complying with harmonised standards, a technical construction file is required (Annex IV). The Notified Body will offer their opinion on the conformity of the equipment based on a review of the technical construction file established by the manufacturer.

All equipment can be assessed via the most complex procedure, a full quality assurance (Annex V). In this case, the Notified Body will issue a Certification of the manufacturer’s quality system.

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

Check conformity

For the conformity assessment procedures laid down in the Directive please study the following: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1994L0025:20081211:EN:PDFpdf Whether a Notified Body has been involved or not, the manufacturer must draw up and sign the EC Declaration of Conformity.

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 downloadedpdf Choose translations of the previous link  from the Commission’s Enterprise and Industry website.

Check conformity

The first stage of the procedure a manufacturer must follow before affixing the CE marking differs depending on whether the vessel has been manufactured in full conformity with Harmonised European Standards:

  • If it has, the manufacturer can either obtain a certificate of adequacy from a Notified Body, following submission of the design and manufacturing schedule for examination; or submit a prototype to a Notified Body for the EC-type examination.
  • If it has not, the manufacturer must submit a prototype to a Notified Body for the EC-type examination.

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

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