Shikha,
If you are planning any type of change to a Class IIb product post May 2021, be prepared to transition at that time to EU MDR. The type of changes which will be allowed under the "transition" or grace period will be very limited especially higher risk devices. We already have understanding the level of acceptable changes is going to be very low because of liability, EU MDD would no longer be legal, and most honestly the Notified Bodies are already in EU MDR mode (not wanting to address any EU MDD actions). Without knowing the type of design and material changes no conclusion can be made, but if you are considering already material changes, the likelihood of a Class IIb device being accepted under EU MDD certificate most likely will be a low probability.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 25-Mar-2021 04:14
From: Britta Cyron
Subject: EU MDR Question
Hi Shikha,
you should consult MDCG 2020-3 with guidance regarding changes with heristage devices. There are some changes for which you need approval of your Notified Body without the need of a new certification.
If you come to the conclusion that this might be applicable for your case, I strongly recommend talking to your NB.
I hope this helps.
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Britta Cyron
Bochum
Germany
Original Message:
Sent: 24-Mar-2021 22:07
From: Shikha Malik
Subject: EU MDR Question
Hello all,
If a manufacturer is planning to make some design and material related changes for a class IIb device post 26 May 2021. I suppose manufacturer need to submit under EU MDR and cannot leverage extended MDD certification rule. Please advise.
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Shikha Malik
Regulatory Affairs Specialist II
Dallas TX
United States
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