ARTICLE SUMMARY:
Incomplete MDR submissions are still common, but the number is decreasing. Excerpted from Pathways’ Picks May 22: EU Submissions, Device Trial Endpoints, FDA on the Hill, and More.
A majority of notified bodies say most Medical Device Regulation submissions are still coming in the first time with key documents missing, although the numbers are slowly improving, according to the latest notified body survey data reported by the European Commission May 17. As of February, 33 of 43 (77%) MDR notified bodies surveyed reported that less than 50% of applications are received with a complete set of documentation to support conformity assessment. That is an improvement from the 87% of bodies that reported less-than-50% completeness in March 2023. IVDR notified bodies are reporting similar experiences and trends. The results show the total number of submissions coming in, and resulting certifications, continue to grow, with 20,424 MDR and 1,634 IVDR submissions and 6,978 MDR and 798 IVDR certifications as of February.