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  • 1.  Notified Body MDR Certification Availability

    This message was posted by a user wishing to remain anonymous
    Posted 10-Aug-2022 09:49
    This message was posted by a user wishing to remain anonymous

    Can anyone recommend a Notified Body that is taking new clients for MDR Certifications?   My company has only one small family of devices so the file itself is not large.  Given the small size and scope of the file, I'm looking for a Notified Body that WON'T put me on a 2 year wait list.  If you believe there aren't any available Notified Bodies, do you have any suggestions for what we can do?

    Additional Info: My company has a certified QMS through a large Notified Body that is designated under MDR, but they won't even look at our MDR Device File until 2024, which is nearly 2 years away and that is just to start the review.  Furthermore, they estimate 18 months review time for new files.  Therefor, by sticking with this Notified Body for our MDR certification, we would be looking at launching in EU in 2025/26, which is too long of a delay.

  • 2.  RE: Notified Body MDR Certification Availability

    Posted 11-Aug-2022 04:44
    Hello Anon,

    There are a couple other threads on this.  Good luck on the adventure :(.

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

  • 3.  RE: Notified Body MDR Certification Availability

    Posted 12-Aug-2022 10:43
    We submit next Monday for admin review. The technical review is in September. The current feedback is 18-24 months for clearance for MDR for us. If you dont have a NB yet I would assume its going to be a long haul :-(

    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets -

  • 4.  RE: Notified Body MDR Certification Availability

    Posted 13-Aug-2022 18:11
    Edited by Mark Swanson 13-Aug-2022 18:11
    This is probably assuming you already have a quality management system certification and likely working with your current Notified Body. Don't forget that if you are new to the scene (start-up or no current ISO 13485/EU MDR or IVDR certificate) that you will need to start with a phase I quality management system audit and then phase II can be scheduled (assume Annex IX).

    Also, MDCG issued a position paper (MDCG 2022-11) as a notification to manufacturers regarding timely compliance--link here.

    Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
    Becker MN
    United States