ARTICLE SUMMARY:
Leaning in to the potential of AI to transform medtech regulatory affairs without creating an overreliance on the technology. Leading European regulatory experts discuss how MDR might be restructured and when it could occur; until it happens, a decline in MDR/IVDR submissions leads notified bodies to cut staff. FDA unveils what it agreed to in MDUFA VI talks; companies caught off guard by CMS proposal to end simplified path to add-on payments for breakthrough devices.
