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CE Approval Guide for Manufacturers <22>

Regulatory Guide > European Area > European Union > CE Approval Guide for Manufacturers <22>
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 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.


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