Hello Peter,
I would think the LM would be having serious discussions with the NB and Competent Authorities about recall of all of its devices distributed in the EU under the CE certification. I think that would be the responsible expectation. No new sales, recover inventory not yet sold, and discuss if product already in use must be recalled (maybe not if not a safety issue). If they do not need to be recalled, then how long will or must the LE provide service and handle complaints? More discussions with NB and CA.
Also, discuss if country device listings are deactivated in their databases.
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Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com------------------------------
Original Message:
Sent: 03-Sep-2019 09:23
From: Peter Miko
Subject: consequences of the suspension of CE-certificate
Dear Colleagues,
taking into consideration the the realities of the current EU medical device regulations' application, what are obligations of the legal manufacturer (LM) and its NB, when the NB had informed the LM, that its CE-certificate has been suspended due to non-conformities?
regards
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Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary
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