Tim,
No that does not exist. You would have to inquire individually with each Notified Body if they are seeking designation to the EU MDR, EU IVDR, or both. Unfortunately living here in Europe for a while, they take privacy and confidentiality a little too whole-heartedly. Which the results in activities not being very minimal transparency if no transparency at all - plus I dare say
mode operatus of the European Commission. (I have friends working in other sectors and it is not any better in those other industries.) I contrast this with the U.S. FDA who publishes guidelines, regulations, and other documents for comment before they are fully implemented. They take these comments often having a teleconference to review the comments saying which ones they accept, or do not accept, and reasons behind those decisions. While it was not completely transparent, the process of Auditing Organisations for MDSAP you could at least see information on who has applied and who is going through the process. European Commission needs to be much more transparent showing who has applied, where they are in the process, how many nonconformities were issued, where they are in the corrective action process, and what type of issues raised. Because I can tell you the EU MDR will slump into the world of EU MDD where no one is held accountable and there will be some other major issue occur. Better yet, as a service organisation, Notified Bodies should be publishing their own metrics how they are doing, i.e. review times of Technical Documentation files, audit scheduling goals, audit completions, time period for issuing certificates. I can tell you, I have clients waiting months for their MDSAP certificates, they ask what to do: I say contact US FDA, Health Canada, because at least are better able to hold AO service organisations accountable.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 19-Apr-2020 09:58
From: Tim Lawton
Subject: Pending list of Notified Bodies requesting MDR/IVDR
Dear All,
With the pretty much guaranteed delay of the MDR / IVDR - its good news more or less all round.
Over & above the different interpretations of the regulations, there clearly remains a lack of top-level transparence of Notified Bodies.
Europa / NANDO maintains a list of who's been authorised.
TeamNB produced a list in 2017 of whom from their members will be moving forwards to MDR / IVDR.
https://www.team-nb.org/wp-content/uploads/2017/12/Team-NB-MDR-IVDR-Application-20171130.pdf
I've been unable to locate an official list of the NB requestors, as such its basically a guessing game of who's requested.
This makes it difficult for startups to know where they stand & who they should contact.
Does any know of a list (official or not) of all the Notified Bodies requesting for MDR / IVDR ?
And again thanks for an excellent dynamic forum.
Tim
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Tim Lawton
Regulatory Affairs, France
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