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  • 1.  MDD renewal after MDR DoA

    This message was posted by a user wishing to remain anonymous
    Posted 12-Aug-2021 13:19
    This message was posted by a user wishing to remain anonymous

    Morning,

    We have been advised consultants to seek a renewal of our MDD certificates, after the DoA of the MDR.
    We won't see how this is a viable or even legal route. Has anyone else come across this?

    Thank you


  • 2.  RE: MDD renewal after MDR DoA

    Posted 13-Aug-2021 08:47
    Hello Anon,

    As far as I know this is not viable or legal.  The EU MDD is has been replaced with the EU MDR with the compliance date already passed.  I would also be interested if anyone else has this experience as well because there are no Notified Bodies designated to the EU MDD anymore, so not sure legally how they could perform a renewal.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: MDD renewal after MDR DoA

    This message was posted by a user wishing to remain anonymous
    Posted 13-Aug-2021 10:29
    This message was posted by a user wishing to remain anonymous

    Hello,
    This seems indeed difficult. I would suggest to give that task directly to those consultants and agree to only pay them when the renewal is achieved.  ;).
    Good luck.
    Original Message


  • 4.  RE: MDD renewal after MDR DoA

    This message was posted by a user wishing to remain anonymous
    Posted 16-Aug-2021 11:33
    This message was posted by a user wishing to remain anonymous

    The active implantable medical devices directive and the medical devices directive were repealed On the date of application therefore there is no legal basis for any manufacturer or notified body to undergo a renewal process under the directives. You may wish to check with the consultants that they are not getting confused with the in vitro diagnostics directive, if not then I suggest you find a new consultant.
    Original Message


  • 5.  RE: MDD renewal after MDR DoA

    Posted 13-Aug-2021 10:52
    Edited by Kevin Randall 13-Aug-2021 10:54
    After the MDR and IVDR DoA, the notified bodies designated under Directives 93/42/EEC, 90/385/EEC, or 98/79/EC are no longer allowed to issue new certificates under those Directives.  Instead, they are only allowed, during the Regulation 2017/745 Article 120 or 2017/746 Article 110 transitional periods to, via surveillance, maintain the legacy certificates that were properly issued under the Directives.  Definitive corroboration of this can be found for example at the Nando website and in preface item 95 of Regulations 2017/745 and 2017/746.

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    Kevin Randall, ASQ CQA, RAC (Europe, Canada, U.S.)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


  • 6.  RE: MDD renewal after MDR DoA

    Posted 14-Aug-2021 05:01
    I would be really interested in the theory behind the consultants' proposal, because as some have observed already the MDR does not allow renewal of an MDD certificate after the date of application. Is there anything you can share about their supporting argumentation?

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    Erik Vollebregt
    Partner
    Amsterdam
    Netherlands
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    Original Message


  • 7.  RE: MDD renewal after MDR DoA

    Posted 17-Aug-2021 02:43
    Interesting point. Based on all the answers so far, you know the answer by now. It is not possible.
    Why? All Notified Bodies designated under MDD and AIMDD have lost their designation (article 120 is rather clear on this). As such they cannot issue valid certificates anymore.
    But then again, maybe we all miss something...

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    Robert van Boxtel
    Principal Consultant Medical Device Project B.V.
    Alphen a/d Rijn
    Netherlands
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    Original Message


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