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CE Approval Guide for Manufacturers <9>

Regulatory Guide > European Area > European Union > CE Approval Guide for Manufacturers <9>
Manufacturers

Manufacturers play a crucial role in ensuring that products placed on the extended single market of the European Economic Area (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 6 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 6 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, 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

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.

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 2 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.


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