ISO13485 cert expired - Product still CE Marked


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My company's ISO13485 certificate is expiring shortly due to issues with the NB and we may be in a situation where we will not be certified to ISO13485, but the products are CE Marked until 2018.

Can the products still be sold in Europe, while we wait for teh cert to be issued

How does this affect distribution to the US? We are compliant with 21 CFR 820 and have undergone 2 recent FDA audits with no observations.

Ronen E

Problem Solver

The MDD does not mandate ISO 13485 certification, so the fact that you won't be ISO 13485 certified does not negate your EU compliance (and the right to CE Mark).

Technically, you may be EC certified until 2018, but practically that certification needs to be ascertained annually, via a NB surveillance audit. In your next such audit you will have to convince the NB that your organization meets the quality management system requirements in the MDD, that apply. Even then, ISO 13485 certification (or compliance) is a preferred path, but it's certainly not the only path. If you comply with the applicable MDD requirements (in the relevant annex), that should suffice. So, don't despair.

From a regulatory standpoint, your ISO 13485 certification (or lack thereof) should not affect your situation in the USA. Compliance with 21 CFR part 820, especially one concurred by the FDA, is enough. There may, however, be some marketing significance because some organizations require their suppliers to be ISO 13485 certified.

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