ARTICLE SUMMARY:
In this week’s Pathways Picks: Incomplete MDR submissions are still common; EU upgrades combination product process; the Netherlands looks at authorized representatives; UK looks abroad, and also to tighten IVD requirements; Medicare panel addresses diabetes device endpoints, while FDA looks at study tools for Parkinson’s and ophthalmic implants; center directors appear on Capitol Hill, and more from the FDA.
EU Picks
Eye on submissions, authorized representatives
Incomplete submissions. 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.
