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impact of the new European medical device regulation on Notified Bodies and manufacturersDear Colleagues, what percentage of the Notified Bodies and legal manufacturers of medical devices will be able to comply with the increased requirements of the new European medical device regulation and stay in business in the 2nd part of 2020 according to your expectation?

  • 1.  impact of the new European medical device regulation on Notified Bodies and manufacturersDear Colleagues, what percentage of the Notified Bodies and legal manufacturers of medical devices will be able to comply with the increased requirements of the new European medical device regulation and stay in business in the 2nd part of 2020 according to your expectation?

    Posted 25-Apr-2017 16:25

    Dear Colleagues,

    what percentage of the Notified Bodies and legal manufacturers of medical devices will be able to comply with the increased requirements of the new European medical device regulation and stay in business in the 2    nd part of 2020 according to your expectation?



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    Peter Mikó M.D
    ArtPharm Ltd.
    Gyermely
    Hungary
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  • 2.  RE: impact of the new European medical device regulation on Notified Bodies and manufacturersDear Colleagues, what percentage of the Notified Bodies and legal manufacturers of medical devices will be able to comply with the increased requirements of the new European medical device regulation and stay in business in the 2nd part of 2020 according to your expectation?

    Posted 25-Apr-2017 20:10

    Able to comply is one thing; comply is another.  It's the CAs that will assess their compliance, right?  I don't think we can address the "stay in business" part until we see what the CAs are prepared to accept as compliance.  Of course, due to lack of transparency, we won't be able to see that.



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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
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    Original Message


  • 3.  RE: impact of the new European medical device regulation on Notified Bodies and manufacturersDear Colleagues, what percentage of the Notified Bodies and legal manufacturers of medical devices will be able to comply with the increased requirements of the new European medical device regulation and stay in business in the 2nd part of 2020 according to your expectation?

    Posted 26-Apr-2017 04:31
    The timescale currently being discussed in the UK is for accreditation under the MDR in the first half of 2018 with NBs knowing whether they have MDR status by June 2018. The compounding factor is that the UK will leave the EU in March(?) 2019, so nobody knows whether a NB has valid EU-wide accreditation from a state that is no longer a member but has some "yet to be negotiated" deal. BSI, LRQA, SGS, Intertek and UL all currently operate as UK NBs, so there could be a significant loss in the NB cadre at precisely the time the workload is greatest.

    I believe that most of the current NBs will become NBs under the MDR but many will choose to reduce their scope of notification: dropping high-risk products and medical specialties where they can not justify a full time employee. This is an extension of the trend over the last few years which has already resulted in some manufacturers needing multiple NBs for different products on the same site.

    For many manufacturers I believe they have a hierarchy of questions to answer:
    • will I or any of my suppliers (inc. NBs) need to be changed or relocate
    • will my products be reclassified by the MDR
    • will my NB still assess my type and class of product
    ... and the list goes on. To cut to the chase, I fear that in late 2018 and 2019 there will be manufacturers running around europe trying to find suitably notified NBs with resource to help them make a rapid transition. Now is the time to be thinking of contingencies, discussing with suppliers, and laying plans!

    Good luck to all of us .... I fear we may need it!

    Neil

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    Neil Armstrong FRAPS
    CEO
    MeddiQuest Limited
    Cambridgeshire
    United KingdomRACRAC
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    Original Message


  • 4.  RE: impact of the new European medical device regulation on Notified Bodies and manufacturersDear Colleagues, what percentage of the Notified Bodies and legal manufacturers of medical devices will be able to comply with the increased requirements of the new European medical device regulation and stay in business in the 2nd part of 2020 according to your expectation?

    This message was posted by a user wishing to remain anonymous
    Posted 26-Apr-2017 11:08
    This message was posted by a user wishing to remain anonymous

    The only response to this query is - we don't know. There are too many factors involved to accurately be able to answer question like his. The best thing to do is start early - start the conversations with the NBs, CAs and upper management. One of the biggest factors is the company commitment to allocate personnel, time and budgets.....
    Original Message


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