In this week’s roundup: Application portal for new European Medicines Agency device pilot to open Monday; China details plans for expanding unique device identification requirements; FDA predetermined change control plan draft guidance for AI/ML devices is almost out; the International Medical Device Regulators Forum advanced premarket efforts; EU notified body progress; CMS seat elevation coverage; and more.
Next Picks: EU Advice Pilot
What we’re watching for:
The European Medicines Agency is expected to open its submissions portal on Monday (February 27) for companies to apply to participate in a new pilot to receive feedback on Medical Device Regulation clinical trial planning from EU expert panels. Based on the submissions, EMA will select five companies to participate in April and another five in September. The goal is to streamline MDR certification for select high-risk devices. Interested firms will need to register for an EMA web account before accessing the submission portal. (See “EU Preps ‘Scientific Advice’ Pilot for 10 Firms Seeking MDR Approval,” Market Pathways, January 25, 2023.)