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Verify requirements

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.

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.

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.

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).

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 2004/108/EC 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 2004/108/EC 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 2004 Directive updated and replaced Directive 89/336/EEC, 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 radio equipment and telecommunications terminal equipment, as this is covered by Directive 1999/5/EC. Aeronautical products and radio equipment used by radio amateurs are also excluded from the scope of the Directive.

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 94/9/EC 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, the Directive also applies to safety devices, controlling devices and regulating devices for use outside potentially explosive atmospheres but needed for the safe functioning of ATEX equipment and protective systems. 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 I, Article 1 of the ATEX Directive 94/9/EC.

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 Directive 94/9/EC to ensure that your product complies with all the essential health and safety requirements.

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 93/15/EEC 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 such in the United Nations recommendations on the transport of dangerous goods and falling within Class I of those recommendations’. It does not apply to explosives intended for military or police use, to pyrotechnic articles or to ammunition, except as regards procedures for their safe transfer within the Union.

The basic requirements specified in Annex I 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 imply that each explosive device must be disposable in a manner that minimises its effect on the environment. For further details, please consult Annex I and in general, please carefully consult Directive 93/15/EEC to ensure that your product complies with all the essential requirements.

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.

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.

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 95/16/EC 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. It also applies to the safety components for use in such lifts listed in Annex IV.

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 95/16/EC carefully in order to ensure that your product complies with all the essential requirements.

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 2006/95/EC 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 2006/95/EC 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 devices’ 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 2006/95/EC 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.

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 Enterprise and Industry 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 guidepdf(4 MB) Choose translations of the previous link  to the Directive, published in June 2010.

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 2004/22/EC 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, heat 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 general harmonised legal metrology requirements are listed in Annex I to the Directive, while additional requirements for each type of measuring instrument are presented in the 10 sector-specific annexes (MI-001 to MI-010).

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.

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.

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; in a legal or regulatory context; in a medical context, for weighing patients; in a pharmaceutical context, for making up prescriptions; or for determining a price on the basis of mass for direct sale to the public.

Directive 2009/23/EC on Non-Automatic Weighing Equipment specifies the essential requirements the product must meet in order for the manufacturer to affix the CE marking.

The essential harmonised requirements for the non-automatic weighing instruments intended for the uses mentioned above are set out in Annex I to the Directive.

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.

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 97/23/EC 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 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. The requirements focus on hazard reduction, apply appropriate protection from hazard where it is not avoidable and inform on any hazard that cannot be eliminated.

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 2007/23/EC 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 2007/23/EC 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 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 88/378/EEC of 3 May 1988 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.

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

Verify requirements

Directive 1999/5/EC on Radio and Telecommunications terminal specifies in detail the essential the requirements the product must meet in order for the manufacturer to affix the CE marking.

Radio and Telecommunications encompasses all products that use the radio frequency spectrum (like mobile phones, gate openers or broadcast transmitters) as well as telecommunications terminal equipment like modems or telephones.

The essential requirements as laid out in Article 3 of the Directive 1999/5/EC entail ensuring the health and safety of users, as well as protection requirements with respect to electromagnetic compatibility, and an efficient use of the spectrum so as to avoid harmful interference. Other essential requirements such as the protection of personal privacy and data, access to emergency services and services for users with disabilities may also apply if specific Commission Decisions have been adopted.

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 94/25/EC on recreational crafts 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 boat of any type, regardless of the means of propulsion, from 2,5 to 24 meters hull length, measured according to the appropriate harmonised standards intended for sports and leisure purposes. Boats used for charter and for recreational boating training are also covered by this Directive when placed on the market for recreational purposes. The Directive also applies to personal watercraft defined as a vessel of less than 4 meters in length which uses an internal combustion engine which has 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 1, 3.

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

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 Enterprise and Industry 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.

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 2009/105/EC 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 defines a simple pressure vessel as ‘any welded vessel subjected to an internal gauge pressure greater than 0,5 bar which is intended to contain air or nitrogen and which is not intended to be fired’. However, only those vessels in respect of which the product of the maximum working pressure (PS) multiplied by the volume (V) exceeds 50 bar are required to bear the CE marking in order to be placed on the market in the EU. These vessels are required to comply with the essential safety requirements set out in Annex I to the Directive.

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