Hi Julie, The current approach (as was confirmed by the CAMD in their FAQ document published in early 2018) that Notified Bodies which issued the certificates will continue to be responsible for the appropriate surveillance (including to handle changes) during the transitional provisions, despite their designation under MDD/AIMDD becoming void on May 26
th, 2020. Notified Bodies will have this task regardless of whether or not they have applied for an MDR designation (MDCG 2019-10).
This will lead to the situation where Notified Bodies, not (yet) being designated for the MDR and not anymore designated for the MDD have to obligation to assess compliance with the MDD and the requirements regarding PMS, Vigilance and registration for EOs.
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Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs
Arnhem
Netherlands
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Original Message:
Sent: 29-Feb-2020 16:51
From: Julie Omohundro
Subject: Soft Transition?
Peter, you have noted previously some apparent conflicts inherent in the MDR/Corrigendum related to the MDD-designated NBs and certificates that they issued. Initially it seemed everyone agreed that, for the "soft transition," you also had to have an MDD-designated notified body to continue to provide routine audits and otherwise service your CE Mark. What is your take on this now?
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
Original Message:
Sent: 28-Feb-2020 03:35
From: Peter Reijntjes
Subject: Soft Transition?
Hi anonymous,
I appreciate your attempt to 'summarize' the requirements of the transitional provisions in MDR Article 120 as per Corrigendum II, but your summary and your listing of the 'products' is not complete. I advise you to follow all 'the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices' more extensively, which also includes capturing these in your QMS (Article 10). It depends on the current set up and structure of your QMS what the gaps are with the requirements mentioned above. A listing of 'products' however is to simple.
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Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs
Arnhem
Netherlands
Original Message:
Sent: 25-Feb-2020 14:14
From: Anonymous Member
Subject: Soft Transition?
This message was posted by a user wishing to remain anonymous
As I understand the "Soft Transition" called out in MDR Article 120, non-Class I products can continue to be CE marked to the MDD until your EC certificate expires. This is provided you don't make any significant changes and that you do comply with Post-Market Surveillance, Market Surveillance, Vigilance, and registration of devices & Economic Operators.
Does this mean by May 26th, all "soft transition" products must have:
- a PMS Plan
- market surveillance (survey) for all devices
- continued Vigilance reporting for all devices
- all devices registered
- make sure all EOs are registered?