Anon,
If a company lets the AIMDD CE Certificate lapse, those certification activities would stop at that point. The company would no longer be able to place product on the market (ship across or into the EU) and the Declaration of Conformity would for all purposes be cancelled. Notified Bodies have methods for when CE Certificates are expired or cancelled, you should contact them directly. They do not revoke the CE Certificate, it the certificates expires, then it does exactly that, expire. There are indeed companies (too many sadly) who are deciding not to transition to EU MDR, so products can be placed on the market until either May 2024 or the certificate expires, and products can be sold (placed into service) up until May 2025. As an AIMDD device, the company should have in place a robust "end of life" process, because while the CE Certificate would expire/cancel, no Notified Body involvement would continue, the medical device Manufacturer still has obligations to support product implanted in patients; also including post market reporting. This would then have to be handled and managed by the individual Member States ... or at least that is the way its supposed to work.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 16-Sep-2022 09:00
From: Anonymous Member
Subject: AIMDD CE certificate letting it to lapse
This message was posted by a user wishing to remain anonymous
Hi All,
What are the consequences if a company let their AIMDD CE certificate to lapse? Would NB revoke the current CE certificate if the company decided not to go forward with the MDR transition? What would happen to the scheduled microbiology audit prior to May 26, 2024?
I appreciate your response.
Thank you,
Anon