Regulatory & Reimbursement
Action Packed in the EU, FDA AI Guide, and Global Picks
In this week’s Pathways Picks: In the EU, nine member states propose an MDR reform framework, the first centralized clinical investigation database is launched, a EUDAMED Q&A is posted, and notified bodies weigh in on artificial intelligence; at the FDA, a final guide on predetermined change control plans for AI, a key promotion, and ethylene oxide policies; and medtech policy updates from the UK, China, and Brazil.
