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  • 1.  New MDR Transition Timelines and Notified Body Capacity - Team NB Position Paper

    Posted 13-Aug-2023 04:38
    Edited by Stephanie Grassmann 13-Aug-2023 05:23

    Dear Community

    The following Team NB Position Paper and NB Survey on Certifications and Applications is being posted:

    (i) to outline the stumbling blocks that the notified bodies face

    (ii) to show the enormous number of MDR applications still to be submitted (possible dramatic situation in 2024) and also

    (ii) to give those in the RA department further supporting arguments to enable the expedition of the MDR application submission.

    https://www.team-nb.org/wp-content/uploads/2023/08/Team-NB-PositionPaper-MDRTransitionTimelines-NotifiedBodyCapacity-V1.pdf

    Notified Bodies Survey on Certifications and Applications (MDR/ IVDR)

    https://health.ec.europa.eu/system/files/2023-07/md_nb_survey_certifications_applications_en.pdf

    Take-aways:

    •       Number of MDR certificates issued to this timepoint is a drop in the bucket.
    •       Average timeframe between MDR application submitted and written agreement signed is 2-3 months
    •       NBs still do not have sufficient resources

                   o   208 MDR applications refused by NBs in March 2023 since outside of scope

                   o   31 MDR applications refused due to in insufficient NB resources

    -> More efficient use of resources -> proposing an expedited process for legacy devices e.g. those whose design is described in textbooks and their use are stated as safe and efficient in which sufficient evidence already exists.  Other proposals are in the Team NB Position Paper. 

    All these MDCGs should really be integrated into a revised MDR. If this process was performed, the lawmakers in Brussels would better understand the complaints of users: i.e.  MDCG text not always being aligned with the MDR or existing legislation (national/ regional) and they in some case are extending and expanding the work scope of the manufacturer.  

    Please do not leave MDR application submission to 2024 based on the "state of affairs". 

    Best Regards,

    Stephanie



    ------------------------------
    Stephanie Grassmann
    Founder & Managing Director of MedTechXperts Ltd
    Biberstein
    Switzerland
    ------------------------------



  • 2.  RE: New MDR Transition Timelines and Notified Body Capacity - Team NB Position Paper

    Posted 14-Aug-2023 03:12

    I fully agree with Stephanie; you must immediately start working on getting an application for MDR certification filed with a notified body. This also implies that you must be ready for that certification process. 

    I think most regulatory professionals reading this forum are well aware about the urgency of this process and I expect their companies to be ahead of the game. The problem is for all those organizations that haven't been reached by this message. How on earth will we get them to understand their time is running out quickly...?



    ------------------------------
    Ronald Boumans
    MDR Expert
    Super PRRC
    Netherlands
    ------------------------------

    Original Message


  • 3.  RE: New MDR Transition Timelines and Notified Body Capacity - Team NB Position Paper

    Posted 14-Aug-2023 08:40

    The notified bodies each have an overview of all their customers still having MDD, AIMD, and IVD CE certificates under the transitional provisions. I expect/hope for a proactive approach in reaching out to those manufacturers informing and helping them to get things done in time in an effective and efficient way. That's not only beneficial for the manufacturers but also for the Notified Body themselves!

    This leaves us with manufacturers who under the "old" Directives did not have anything to do with notified bodies and due to "upclassifiaction" are making use of the transitional provisions. They can be informed and supported proactively by the respective competent authorities, where they had to register their medical devices under the directives and did not change/update/revoke that.

    But again, that requires a focused proactive approach of the notified bodies and competent authorities.



    ------------------------------
    Peter Reijntjes
    Principal Consultant Regulatory & Quality Affairs | Head of Training
    Arnhem
    Netherlands
    ------------------------------

    Original Message


  • 4.  RE: New MDR Transition Timelines and Notified Body Capacity - Team NB Position Paper

    Posted 15-Aug-2023 01:07
    Edited by Stephanie Grassmann 15-Aug-2023 02:22

    Dear Ronald and Peter

    Thanks a lot for your comments. 

    Regulatory professionals reading this forum are aware, I agree.

    But as we all know, sometimes management is looking at the bottom line and are not always on board in getting some projects done in an expedited manner since this costs money.

    The links may provide for some RA individuals, the arguments to use to convince management.

    The number of existing MDR certificates is a drop in the bucket so I believe that many issues have led to this state of affairs and that this is not strictly related to the notified bodies and competent authorities having inadequate communication with the manufacturers. 

    The whole system has to be really re-thought i.e. expedited process for legacy devices with sufficient high quality evidence. Right now, these devices receive a MDR certificate after the Technical File has been submitted 12-18 months later.

    In addition, what is the ecological footprint of re-reviewing these devices in such detail? A lot of talk about saving the environment in Brussels ("Green Plan"), but the regulatory process should also be within the analysis.  

    Looking at the numbers of MDR certificates granted, the EU may have a dramatic shortage in medical devices next year and in the years to come. This will not only impact EU but also countries outside the EU  and drive up prices since the EU will try to acquire the medical devices in short supply outside the EU. We may all be affected. 

    Hope to see you at RAPS Convergence in Montreal to discuss further, 

    Stephanie



    ------------------------------
    Stephanie Grassmann
    Founder & Managing Director of MedTechXperts Ltd
    Biberstein
    Switzerland
    ------------------------------

    Original Message


  • 5.  RE: New MDR Transition Timelines and Notified Body Capacity - Team NB Position Paper

    Posted 14-Aug-2023 12:28

    Dear Stephanie,

    Thank you for the comments and for sharing the two links. I wanted to ask for more details on the following comments you made:

    "More efficient use of resources -> proposing an expedited process for legacy devices e.g. those whose design is described in textbooks and their use are stated as safe and efficient in which sufficient evidence already exists."

    Is this your own proposal/idea or was it included in one of the links you posted? I think it is a great idea and would like to see it become a reality.



    ------------------------------
    Vineet Sarin PhD
    President & CEO
    Camarillo CA
    United States
    ------------------------------

    Original Message


  • 6.  RE: New MDR Transition Timelines and Notified Body Capacity - Team NB Position Paper

    Posted 15-Aug-2023 01:17

    Dear Vineet

    Thank you for your comments back; they are appreciated. 

    This recommendation is unfortunately not in the links.

    I made this recommendation at the RAPS EURO Convergence Meeting May 2023 at the the "Conversations That Matter: Interactions with Health Authorities" in which several lawmakers and notified bodies were in attendance including Flora Giorgio of the European Commission. I have also mentioned this recommendation when talking one-to-one with key individuals of the notified bodies who were in attendance or at other meetings. 

    Stephanie



    ------------------------------
    Stephanie Grassmann
    Founder & Managing Director of MedTechXperts Ltd
    Biberstein
    Switzerland
    ------------------------------

    Original Message


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