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European Medical Device Certifications—Watch out…the bar is much higher than before!

By Mark Swanson

Well, here we are fully engaged in the transition time for product certifications under the European Medical Device Regulation (EU MDR). Last May the date of application passed for medical device companies to transition their quality system processes to the EU MDR, however the transition provisions allow product certifications under the Medical Device Directives (MDD) to exist until their certificate expiration OR May 2024,...whichever one comes FIRST.

WARNING: if you haven’t verified your product certification expiry date, you may be in for a surprise that you don’t have as long as you think.

Our clients are experiencing what we've all been warned was coming…the bar has been raised significantly. In our experience, on average, the initial EU MDR submissions are receiving 50-80 questions or comments that could lead to citations as nonconformances. As part of this submission and review process, you are generally allowed a maximum of 3 responses before any nonconformances are issued.

The common issues that we are seeing include:

  1. Inadequate incorporation of proactive feedback in clinical evaluation (including not incorporating post-market clinical follow-up)

  2. Inadequate planning of post-market surveillance (PSUR/PMSR)

  3. Deficiencies in other technical documentation (verification/validation including usability), and

  4. Labeling deficiencies

For many, the ability to remediate these comments require additional expertise, or manpower. Contact QRx if you have any questions or concerns with your upcoming reviews.

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