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NB fees to be paid for re-certification of legacy medical devices/certification of new medical devices under the MDR

  • 1.  NB fees to be paid for re-certification of legacy medical devices/certification of new medical devices under the MDR

    Posted 04-Sep-2021 16:03

    Dear Colleagues,

     

    I am wondering, how much will be workload of the NBs during the re-certification of legacy medical devices and certification of new medical devices under the MDR in the next few years.

    My estimation is, that as at the very first re-certification/certification the evaluation/administration  of the audit of the

    • QMS
    • manufacturing
    • compliance with all other legal obligations (PRRC, insurances, contracts, EUDAMED)
    • technical documentation of a few products (especially class II.b-III. implants) including the PMS/PMCF/vigilance activities

    may easily need 300-400 hours (7-10 full working weeks). 2-2.5 weeks for 4 auditors.

    Calculating with 250 €/hour, it means 75-100 000 €.

     

    Is this a realistic calculation?

     

    regards



    ------------------------------
    Peter Mikó M.D
    ArtPharm Ltd.
    Gyermely
    Hungary
    ------------------------------


  • 2.  RE: NB fees to be paid for re-certification of legacy medical devices/certification of new medical devices under the MDR

    Posted 05-Sep-2021 06:21
    Hi Peter,

    I think that sounds realistic in an ideal world, but I know reviews of technical documentation, clinical evaluations, and even audits do not have luxury of those hours.  Indeed I have heard rumours of costs being close to 100k Euro for companies to get certified with 3 or 4 product families between the QMS audits, unannounced audits, Tech Doc reviews, etc.  Also the costs of the actual company managing these with sufficient staff is definitely realistic.  I can say from personal experience, some small manufacturers are exiting from the EU market because they can not afford the costs any longer and more importantly they can not deal with the timelines of Notified Bodies, i.e. waiting 6 months for their certificate after completing the audit.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 3.  RE: NB fees to be paid for re-certification of legacy medical devices/certification of new medical devices under the MDR

    Posted 07-Sep-2021 12:57
    Even for large companies, I imagine that the overhead has increased drastically for every product, adding enormously to cost and potentially large adverse effects on margins. If there's no or vanishingly small margins, will even large companies sell in that market?

    I know I was involved evaluating products in product lines, and many that were on the market under MDD were removed under MDR.

    Where is the data on how many medical devices have exited the EU market?


    ------------------------------
    Corey Jaseph RAC
    Senior Research Analyst
    Wheatland CA
    United States
    ------------------------------

    Original Message


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