Can we still manufacture whilst awaiting return of our CE Mark?

#1
hi,

We have just been audited by our NB, just as our CE Mark was up for renewal. I have submitted responses to their findings and am awaiting the approval and subsequent return of our CE Mark for our medical device.

In the meantime can we manufacture any medical devices and quarantine them awaiting return of our CE Mark as we are doing everything to approved procedures and we do have our ISO 13485 certificate?

Thanks
 

craiglab

Involved In Discussions
#2
Assuming your product already has CE marking and your EC certificate and EN ISO 13485:2016 certificate are still valid, you have not presented any reason why you cannot continue to manufacture and ship products.
 

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