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  • 1.  EU MDR-current experience

    Posted 02-Feb-2022 14:17

    Dear colleagues,

     

    let me share a few current experiences about the MDR, what I have heard informally:

    • there is a huge number of medical devices under the CE-certificates to be renewed in 2024, much more than that seems to be manageable by the NBs,
    • the current net auditing period is 8-14 months,
    • there are long clock-stops (few months) in the evaluation process as the manufacturers have difficulties to fix the mistakes or fill up the gaps in the submitted technical documentation,
    • the majority of the difficulties are around the technical documentation quality, not around the on-site audits,
    • the consistency of the corresponding data in different parts of the technical documentation is dissatisfactory,
    • there are difficulties to switch from the DHF/DMR documentation system to Annex II-III of the MDR.
    regards

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


  • 2.  RE: EU MDR-current experience

    Posted 03-Feb-2022 04:26
    Hello Peter,

    This sounds fairly consistent with what we are seeing - there was a previous post describing some of these issues.  Indeed seeing many issues with technical documentation especially for products which have been around for a long time on the market as the level of design documentation and changes is not at current levels of expectations.  Many companies forget Notified Bodies are looking at files from a completely new perspective.

    I find amazing already it is 2022 when the Regulation was published in 2017 already more than 5 years ago.  Maybe by 2027 ... 10 years later things will be a bit more expected and normal haha.

    ------------------------------
    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 3.  RE: EU MDR-current experience

    Posted 03-Feb-2022 08:14
    There was a survey perhaps last year about the status of MDR. I dont recall exactly but a small % had been approved under MDR, A slightly larger had just submitted to MDR clearance. The vast majority were MDD devices expiring in 2023 or 2024. 

    I have also sensed a drop in performance of our NB in work not related to MDR. MDSAP comes to mind as being a bit neglected by our NB.

    ------------------------------
    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
    ------------------------------

    Original Message


  • 4.  RE: EU MDR-current experience

    Posted 10-Jun-2022 08:59
    Hi Peter,
    My team is going through EU MDR for two certificates (two legal manufacturers).
    We have experienced all of the things you mention above.
    Our first certificate expired in February.
    We submitted our first tech file for review in early September.
    We were told in October that we had to upgraded from standard to dedicated review (3x the cost) in order to have timely service.
    In November we switched and the reviewing started in January.
    We have yet to get any of the four tech files approved.
    The biggest challenge is the clinical review but the technical review is not a slam dunk either.

    If anyone would like to share what they're hearing or experiencing, it would be much appreciated.

    Thanks,
    Rob

    ------------------------------
    Rob Yamashita
    Grand Rapids MI
    United States
    ------------------------------

    Original Message


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