ARTICLE SUMMARY:
The latest EU notified body survey results show an acceleration in MDR activity. Excerpted from Pathways Picks November 13: EU Activity, Health Commissioner Holdup, and Global Picks.
The rate of new EU Medical Device Regulation application submissions to notified bodies and resulting certifications is increasing, according to the latest data from European Commission survey of notified bodies reported last week. Device firms had submitted 16,185 MDR applications and notified bodies had certified 8,905 of those devices as of June 30, representing increases of 28% and 27%, respectively, from the prior survey outcomes point in February. At that time, submission volume had grown only 14% from the prior data point and certifications had grown by 25%. Certifications include quality management system (QMS) certifications, which are required for most products, and product certifications, required for higher risk devices. Submissions and certifications also increased under the IVD Regulation, but the growth decelerated a bit in the latest report, with a 7% rise in applications (down from 10%) and an 18% rise in certifications (down from 25%). Other takeaways from the survey results reporting on activity through June:
- Incomplete submissions remain a challenge: Thirty eight of 49 MDR notified bodies, and 9 of 12 IVDR bodies, reported that less than half of submissions they receive initially from manufacturers are sufficiently complete.
- Most QMS certificates take from six to 18 months to award, while the process to award most product certificates takes between 13 and 24 months.
- A majority of the QMS and conformity assessment process time is taken up by manufacturers (such as in responding to notified body reviews), according to notified bodies responding to the survey.