What is the EU Declaration of Conformity?
The CE marking directive places an obligation on the manufacturer or his authorised representative established in Europe to draw up a declaration of conformity as part of the conformity assessment procedure. The declaration must be issued before the product is placed on the European market.
The EU Declaration of Conformity is a document in which the manufacturer declares that the product conforms to the essential requirements of applicable legislation. By drawing up and signing the EU declaration of conformity, the manufacturer assumes responsibility for the conformity of the product.
What does the EU Declaration of Conformity contain?
The declaration of conformity must contain all relevant information to establish compliance with the published EU regulations. These documents must also contain the contact details of the manufacturer, authorised representative and notified body (if applicable), as well as details of the product and, where appropriate, harmonised standards or other technical specifications.
In Decision 768/2008/EC, a model declaration based on ENISO/IEC17050-1 is provided. The declaration may take the form of a document, label or contract and must contain sufficient information to enable all products covered by it to be traced.
The model declaration of Decision 768/2008/EC contains:
1. Product identification number, which can refer to product, batch, type or serial number, at the discretion of the manufacturer;
2. the name and address of the manufacturer or the authorized representative issuing the declaration;
3. A statement that the statement is issued by the manufacturer under the sole responsibility;
4. Product traceability;
5. Comply with all relevant EU legislation;
6. the name and identification number of the notified body involved in the conformity assessment procedure;
7. Any additional information that may be required (e.g. grade, category);
8. The date of issue of the Declaration, signature and equivalent mark of ownership or authorisation, may be any date after the conformity assessment has been completed.
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