How to establish a compliant declaration of conformity
The EC Declaration of Conformity (DoC) is the formal act of a manufacturer to declare that the product (medical device) is conforming to the EU regulations. this is accompanied by affixing the CE-mark onto the product and label of the product.
In times of COVID-19, the minimal requirements of a DoC become more and more important.
To be clear from the beginning: There is no pre-defined format in which the DoC has to be presented! With this, it becomes obvious why so many different layouts and presentations of DoC’s are out there but makes it harder to distinguish a compliant DoC from others.
There is some confusion around what can and should be certified.
A DoC has ALWAYS to be established by the manufacturer, irrelevant of the risk class of a medical device or in-vitro diagnostic.
Next to a DoC, a conformity assessment, either as type-examination or as technical documentation assessment, is carried out by Notified Bodies for products with a higher risk class then class I. A successful conformity assessment will result in a certificate issued by the Notified Body. These Certificates of Conformity (CoC) are official, authority authored documents.
So, the only two documents to be expected are the Declaration of Conformity (DoC) or/and the Certificate of Conformity (CoC). Any other title or reference will indicate an adulterated document or raise suspicion on counterfeit product.
The Medical Device Regulation MDR 2017/745 in Annex IV, as well as its former version the Medical Device Directive 93/42/EEC in Annex VII, lay down the minimum requirements to be stated in a DoC. These minimum requirements are:
- Manufacturer’s name (or registered trade name or registered trade mark)
- Manufacturer’s address
- If available, the Single Registration Number (SRN)
- If applicable, contact details of the EC Authorized Representative
- Basic UDI
- Name of the product
- Classification and Classification Rule of the product
- Notified Body details
- Conformity assessment route
- Applicable Common Specifications and harmonized standards
- A statement of the manufacturer’s sole responsibility
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