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CE Marking (CE mark) EU/EC Declaration of Conformity: definition and required content (template)


As of 21 March 2010, a Single EU/EC European Authorised/Authorized Representative must be designated by a non-EU manufacturer of medical devices as required by directive 2007/47/EC, are you ready?
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Definition:
The EC declaration of conformity
is the written statement and the a single declaration drawn up by the manufacturer to demonstrate the fulfilment of the EU requirements relating to a product bearing the CE marking he has manufactured. The declaration shall be in respect of all Community acts applicable to the product containing all information required for the identification of Community harmonisation legislation to which the declaration relates.

This declaration must cover one or more products manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer, or his European Authorised Representative if the manufacturer is based outside the EU.


Required content (template)
for the CE marking EC Declaration of Conformity


The newest required (minumum) content for Declaration of Conformity (DoC) according to the EU Official Journal published in August 2008 are:

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EC DECLARATION OF CONFORMITY

1.
No xxxxxx (unique identification of the product):

2.
Name and address of the manufacturer and/or his authorised representative:

3.
This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer):

4.
Object of the declaration (identification of product allowing traceability. It may include a photograph, where appropriate):

5.
The object of the declaration described above is in conformity with the relevant Community harmonisation legislation:

6.
References to the relevant harmonised standards used or references to the specifications in relation to which conformity is declared:

7.
Where applicable, the notified body ... (name, number) performed (description of intervention) and issued the certificate: .

8.
Additional information:

Signed for and on behalf of: .

(place and date of issue)

(name, function) (signature)

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