Shikha,
This is a question you should ask directly to your Notified Body on how they are going to issue CE Certificates to your product families. There is really no such thiing as a Design Examination Certificate under the EU MDR - all products reviewed by the Notified Body would go through the conformity assessment routes as defined by Article 52 and Annex IX - XI. Because there are now requirements for content and substance of a CE Certificate the traditional way of having 1 CE Certificate for many, many Class IIa products on one cert may not be acceptable. There were funny things how Notified Bodies issued CE Certificates especially where product families had Class IIb and maybe some Class IIa products in the same system, thus same CE certificate. Again, you should have this discussion with your Notified Body in relation to your product families because they will be the ones issuing the certs. We can all give lots of advice, comments, and personal reflections here, but the main one you should be addressing is how your Notified Body will be handling this under the EU MDR.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 09-Apr-2021 18:04
From: Shikha Malik
Subject: MDR Certificate questions
Hi all,
A few questions for you on how the MDR certificates work for Class IIa and IIb products.
- Will Class IIa and IIb products be on an MDR product certificate (Design Examination Certificate)? Today they are not on a product cert, only covered by the FQA by product grouping and listed on the DoC.
- If they are on the MDR product certificates, are there different certificates based on device class? For example, will Class IIb and Class IIa products be on the same certificate?
- Is there any guidance to consult for this information.
Thanks!
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Shikha Malik
Regulatory Affairs Specialist II
Dallas TX
United States
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