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Does your gear have CE Approval?

The manufacturer of a product affixes the CE marking to it but has to take certain obligatory steps before the product can bear CE marking. The manufacturer must carry out a conformity assessment, set up a technical file and sign a Declaration stipulated by the leading legislation for the product. The documentation has to be made available to authorities on request.

Importers of products have to verify that the manufacturer outside the EU have undertaken the necessary steps and that the documentation is available upon request. Importers should also make sure that contact with the manufacturer can always be established.

Distributors must be able to demonstrate to national authorities that they have acted with due care and they must have affirmation from the manufacturer or importer that the necessary measures have been taken.

If importers or distributors market the products under their own name, they take over the manufacturer's responsibilities. In this case, they must have sufficient information on the design and production of the product as they will not be assuming the legal responsibility when they affix the CE marking.

There are certain rules underlying the procedure to affix the marking:

  • Products subject to certain EU directives or EU regulations providing for CE marking have to be affixed with the CE marking before they can be placed on the market.
  • Manufacturers have to check, on their sole responsibility, which EU legislation they need to apply for their products.
  • The product may be placed on the market only if it complies with the provisions of all applicable directives and regulations and if the conformity assessment procedure has been carried out accordingly.
  • The manufacturer draws up an EC (or EU) declaration of conformity or a Declaration of performance (for Construction Products) and affixes the CE marking on the product.
  • If stipulated in the directive(s) or regulation(s), an authorized third party (Notified Body) must be involved in the conformity assessment procedure or in setting up a production quality system.
  • If the CE marking is affixed on a product, it can bear additional markings only if they are of different significance, do not overlap with the CE marking and are not confusing and do not impair the legibility and visibility of the CE marking.

Since achieving compliance can be very complex, CE-marking conformity assessment, provided by a Notified Body, is of great importance throughout the entire CE-marking process, from Design Verification, and set up of Technical File to the EC Declaration of Conformity. 

CE marking signifies that the product conforms with all EU directives or EU regulations that apply to it.

The manufacturer of CE-marked goods has verified that the product complies with all applicable EU requirements, such as safety, health, and environmental protection, and, if stipulated in any EU product legislation, has had them examined by a Notified Body or produces according to a certified production quality system. The CE marking also indicates that the product complies with directives in relation to 'Electro Magnetic Compatibility'[6] - meaning the device will work as intended, without interfering with the use or function of any other device.

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