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  • 1.  EU MDR - CER Review Experience

    Posted 15-Jul-2021 15:29
    Greetings,

    After a few good reads of the first opinion published under the Clinical Evaluation Consultation Procedure (CECP), I'm honestly a bit rattled.  I knew that this would be a challenge, but wow.  

    I'm curious about your real-life experiences with CER review feedback from NBs to-date.  Any info you're willing to share would be of great interest. (I'm particularly interested in lessons learned for Class III legacy devices with more published clinical data on similar devices than studies on the subject device. )

    Thanks in advance for your shares!

    Tina



    ------------------------------
    Tina O'Brien RAC, MS
    Director of Regulatory Affairs
    Airport Oaks
    New Zealand
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  • 2.  RE: EU MDR - CER Review Experience

    Posted 16-Jul-2021 04:44
    Hi Tina,

    Yes, it is scary and worrisome especially for higher risk devices in the EU.  I am not sure the European Union is being quite pragmatic in its approach balancing safety versus patient benefit or more precisely keeping medical devices on the market for patient use.

    I can not share anything myself due to confidentiality, though maybe I can work on "vanillising" the information.  However, we have seen everything under the bright blue sky - from valid nonconformities, to questionable statements which are more preferences, to absolutely horrid mis-representation of MEDDEV 2.7/1 being applied.  It would be interesting of others could share because it will allow everyone to see and anticipate the type of issues being raised.

    I can say probably the biggest ones I see so far is renewal MDD certificates reviewing Clinical Evaluation and NBs are already auditing to EU MDR requirements.  No clinical plan, no safety and performance objectives, claims are not justified, equivalent device(s) is not valid, no inclusion of PMS, or no benefit/risk analysis are some of the main ones I see today.

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


  • 3.  RE: EU MDR - CER Review Experience

    Posted 16-Jul-2021 10:06

    Dear Colleagues,

     

    my experience is, that the principles of the MEDDEV 2.7.1.rev.4. are applied more and more stringently. There are growing emphasis on the quality/logic of the state-of-the art's presentation and literature survey.

    Till know the use of MEDDEV 2.7.1. rev.4 template was accepted and expected.

    Use of equivalency disappeared.

    Clinical evidence obtained with the use of the medical device, that is the subject of evaluation is required, unless the device is a very simple one (e.g. surgical knife, measuring device, syringe and so on).

    Clinical validation of full medical device systems (e.g. ABPM/Holter + standalone software, or CT/MRI/x-ray/PET CT + analytic/picture management software) is required.

     

    regards



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


  • 4.  RE: EU MDR - CER Review Experience

    Posted 16-Jul-2021 10:22
    Richard,

    My experiences mirror yours
    "biggest ones I see so far is renewal MDD certificates reviewing Clinical Evaluation and NBs are already auditing to EU MDR requirements.  No clinical plan, no safety and performance objectives, claims are not justified, equivalent device(s) is not valid, no inclusion of PMS, or no benefit/risk analysis are some of the main ones I see today."

    With one addition:
    Failure to implement a holistic lifecycle QMS.  While many organizations have "compliant" QMS, they are so fragmented and "patched together" that the QMS does not present as an "Integrated and Holistic" continuous performance and safety feedback and action system", but rather a collection of disparate and loosely connected siloed procedures.

    ------------------------------
    Michael Chellson
    MSc, RAC
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    Original Message


  • 5.  RE: EU MDR - CER Review Experience

    Posted 18-Jul-2021 14:44
      |   view attached
    Well isn't this an interesting development - apparently the opinion I referenced has been removed from the CECP site. I've attached a copy - hopefully since it was previously in the public domain I'm not breaking any laws...

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    Tina O'Brien RAC, MS
    Director of Regulatory Affairs
    Airport Oaks
    New Zealand
    ------------------------------

    Attachment(s)

    pdf
    2021-000201_nb0483_opinion.pdf   1018 KB 1 version
    Original Message


  • 6.  RE: EU MDR - CER Review Experience

    Posted 19-Jul-2021 04:27
    With a wild laughter from Rocket in Guardians of the Galaxy hahahaha

    • 16.06.2021, NB0483, Ivory Graft Ltd, 2021-000201_NB0483_opinion: Following a request from the notified body the opinion has been temporarily removed.

    The European Union really are fanatics and rule-breakers.  They go completely against their own requirements and public transparency is a joke.  Just because a Notified Body was called out ... why would that still not be public information?

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

    Original Message


  • 7.  RE: EU MDR - CER Review Experience

    Posted 20-Jul-2021 05:26
    Edited by Katarzyna Chrusciel 20-Jul-2021 05:33
    I’m wondering….

    Is it so important for people to know the name of notified body involved…? EU Commission can even take this information out…or obscure! The opinion is the source of very important and of great value information that gives unique opportunity to accelerate approval process but not only! To improve safety of products, CER creation and submission….and at the end, to guarantee fast availability of the products on the market! This should be the final scope I think…

    Who don’t read the warning letters from FDA?

    Exactly the same approach… read and learn from other manufacturers experience.

    I hope they will fix it asap.

    K

    ---------------------------------
    Katarzyna Chrusciel
    Chemical, Clinical and Material's Engineer

    Italy
    ---------------------------------



    Original Message


  • 8.  RE: EU MDR - CER Review Experience

    This message was posted by a user wishing to remain anonymous
    Posted 30-Jul-2021 08:43
    This message was posted by a user wishing to remain anonymous

    The opinion was removed because the product and notified body were identified. 


    the opinion aligns with what the larger notified bodies have been saying under MDD. Every indication needs to be supported by data, clinical data should be sufficient, I.e in both quantity and quality. PMCF should be robust to reflect all indications and lifetime of the device. 


    The difference now is notified bodies have a mandate to push back with the legal text of the MDR rather than relying on a guidance document. 


    The expert panel opinions should be welcomed by all, they will provide consistency across notified bodies in their decision making and manufacturers will all have a fair vantage whoever they apply to. 




    Original Message


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