Europe pushes a MedTech regulatory reset
European regulators are driving a major reset across MDR, IVDR and AI oversight to move digital health from experimentation to validated scale, and policymakers are debating 'medical sovereignty' and supply‑chain resilience at upcoming forums argued reported. The regulatory tightening will affect cross‑border sales strategies and compliance burdens for U.S. device firms.
The European Commission formally tabled Proposal COM(2025)1023 to amend the MDR and IVDR on 16 December 2025. eur-lex.europa.eu The proposal runs to roughly 170 pages and explicitly targets software rules, re‑certification duties, and administrative burden to unblock Notified Body capacity. aoshearman.com The package recommends revised software classification, expanded use of electronic instructions for use (eIFU), participation in MDSAP, and tighter timelines for conformity assessments to cut certification bottlenecks and address device shortages. pureglobal.com EU regulator groups released joint guidance (AIB 2025‑1 / MDCG 2025‑6) in June 2025 to clarify how the AI Act and MDR/IVDR intersect for AI‑enabled devices. health.ec.europa.eu The guidance treats AI in medical devices as high‑risk under the AI Act and flags that AI‑driven SaMD will face dual MDR and AI Act obligations, with practical AI Act obligations for SaMD phased in from August 2026. raps.org Debates on “medical sovereignty” and supply‑chain resilience are scheduled at the Euronews Health Summit panel on 17 March 2026 (speakers include Adrian Van Den Hoven, Olivier Girard, Oliver Bisazza and Tomislav Sokol) and at the MedTech Forum in Stockholm on 11–13 May 2026 (sessions list Stryker’s Stuart Silk on resilience). events.euronews.com Legal and industry advisers warn those regulatory shifts and tightened AI oversight will alter market‑entry timelines and compliance costs for non‑EU device firms selling across borders. arnoldporter.com
