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CE Approval Guide for Manufacturers <8>

Regulatory Guide > European Area > European Union > CE Approval Guide for Manufacturers <8>
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 explosives for civil use, Directive 2014/28/EU applies.

More on harmonised standards for explosives for civil use.

 

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 2 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.


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