CE Mark
Conformité Européene

Conformité Européene

Check whether your product meets the specific requirements It is up to you to make sure your product meets all the EU legal requirements. If harmonised European standards exist for your product and you follow them in the production process, your product will be presumed to be in conformity with the requirements laid down in the relevant EU directives.

Check whether your product must be tested by a Notified Body

For some products, special conformity assessment bodies ('Notified Bodies') must verify that your product meets the specific technical requirements. This is not obligatory for all products.

Compile the technical dossier Your technical dossier should include all the documents that prove that your product complies with the technical requirements.

Importers

While manufacturers are responsible for ensuring product compliance and affixing the CE marking, importers must make sure that the products they place on the market comply with the applicable requirements and do not present a risk to the European public. The importer has to verify that the manufacturer outside the EU has taken the necessary steps and that the documentation is available upon request.

Distributors

Distributors must have a basic knowledge of the legal requirements – including which products must bear the CE marking and the accompanying documentation – and should be able to identify products that are clearly not in compliance. They must also be able to demonstrate to national authorities that they have acted with due care and have affirmation from the manufacturer or the importer that the necessary measures have been taken. Furthermore, a distributor must be able to assist national authorities in their efforts to receive the required documentation.

Keep Your Technical Files

As your European Authorised/Authorized Representative, we store and update the Technical Files of your products sold in Europe. The Technical Files may be inspected at any time by the Competent Authorities for a period ending at least five (5) years after the last product has been manufactured.

Legislation Monitoring

We monitor and report on new developments in European product legislation relevant to your products.

Affix the CE marking and draft a declaration of conformity Finally you can affix the CE marking on your product. The marking must be visible, legible and indelible. If you had to involve a notified body in step 3, you should also put the identification number of this body on the product. You must also draft and sign an EU declaration of conformity stating that your product meets all legal requirements.

How can National Accreditation of United Kingdom help my business gain CE Marketing?

As long as your products are affixed with CE Marking, importers, distributors and sales representatives will be easier to come by as they do not have to deal with complex conformity issues and product certification which require professional in-depth expertise. Your distributor may excel in marketing and sales, but is he equipped or even interested in handling regulatory and legal issues?

Manufacturer’s Declaration of Conformity

The EC DoC is a document which may be required to accompany a product. In the document the manufacturer, or his authorised representative within the EEA should:

Indicate that the product meets all the necessary requirements of the directives applicable to the specific product make sure it has the name and address of the manufacturer together with information about the product, for example brand and serial number

The DoC must be signed by an individual working for the manufacturer or his authorised representative, and indicate the employee’s function.


 

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For your Free Queries by an ISO Specialist, contact us today!

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Contact Us

For your Free Queries by an ISO Specialist, contact us today!

Unit-1
Levenside Business Court 21 Levenside ,
Vale of Leven Industrial Estate
Dunbarton G82 3PE

Email: info@isonauk.co.uk
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