On the face of it, this seems simple. Manufacturers can simply self-declare and the Q&A Document states this in section 7. Furthermore, it states that such a self-declaration could be based on a harmonised template. The downfall here is no such thing currently exists.
Additional evidence could be provided by Notified Bodies (NB) again by use of a harmonised document that currently does not exist. Additionally, any such document is likely to be limited to a proposal and contract entered between the manufacturer and NB.
Advena Ltd is offering a service to our clients to review a manufacturer’s certifications, documentation, and applicable evidence that supports the manufacturer meeting the necessary criteria. The result of which will be one of the following:
- We will issue a detailed report confirming the specific criteria have been met. This will be an independent declaration and will support a manufactures self-declaration.
- That you do not meet the criteria, but an article 97 application can be submitted.
- You must follow the MDR and comply according to the classification and route of conformity.
- Or some other advice based on the documents received.
A document such as in option 1 will surely add weight to any challenge received and Advena Ltd can be contacted to qualify and provide confirmation.
If you have appointed Advena Limited as your Authorised Representative and this service is of interest, please contact us: info@advena.mt
For markets outside the EU a manufacturer will almost certainly need a Certificate of Free Sale (CFS) to demonstrate compliance with the extended certification validity. To apply for a CFS please contact us: info@advena.mt
