Pathways' Pick of the Week: Survey Spotlights MDR Challenges

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A new MedTech Europe survey, commissioned by the EU Medical Device Coordination Group, lays bare MDR gaps. Excerpted from Pathways' Picks July 20: Outpatient Pay, User Fee Disarray, and Global Picks.

CE mark reviews under the Medical Device Regulation are, on average, taking notified bodies 13-18 months—about double the time it took under the legacy EU device directives. That’s according to MedTech Europe Survey Report – Analysing the availability of Medical Devices in 2022 in connection to the Medical Device Regulation (MDR) implementation, a survey of companies covering about 60%-70% of EU device market reviews reported out by trade group MedTech Europe (MTE) July 15. The survey, conducted in April of 475 device firms, was commissioned by the EU Medical Device Coordination Group to monitor MDR capacity and also included additional questions that came from MTE alone. Review was still ongoing at the time for 70% of submitted applications from the respondents, and less than 15% of devices previously certified under EU directives had gained an MDR CE mark. “Solutions are still urgently needed to course-correct the MDR, and to thereby ensure that all categories of medical devices can remain available to patients,” MTE concluded in the report. Some other key data points:

  • 54% of respondents plan product portfolio reductions
  • At least 15% of small and medium-sized companies were lacking an MDR-certified notified body
  • About 6,000 “new” devices (no directive CE mark) have been MDR certified, plus about 63,000 legacy devices—compared to almost 500,000 certified under directives
  • 45% of respondents said they had “deprioritised” the EU market for first regulatory approval

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