Will the AI Act Break European Medtech? Inside the MDR/IVDR Revision

Podcast: AI in Medicine - curated summaries making complex issues easy to understand · Mike Rawson

Opublikowano: 2026-10-10

MedTech Europe's position paper outlines a critical juncture for medical device regulation in the EU. We unpack their proposed amendments to the MDR and IVDR, focusing on how AI should be regulated, the fight over cybersecurity reporting, and why one in three manufacturers is deprioritising the EU for product launches. Key points One in three manufacturers is currently deprioritising the European Union for first regulatory approvals due to administrative burden and costs.MedTech Europe strongly supports embedding AI Act requirements into the MDR and IVDR to allow for a single conformity assessment, preventing dual-regulatory overlap.They...