EU Proposes Changes to Simplify Medical Device Rules and AI Oversight

The European Commission has proposed reforms to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) to reduce administrative burdens, speed patient access, and support rare disease treatments. MedTech Europe welcomed the proposals, which could save the EU around €3.3 billion annually.

Key changes include shorter conformity assessment timelines, a stronger role for the European Medicines Agency, and narrowed AI regulations for medical devices, limiting which AI-enabled devices are classified as high-risk. Some devices, including reusable surgical instruments and lab-developed tests used in clinical trials, would face lower risk classifications or exemptions.

The reforms also create pathways for orphan and breakthrough devices, allowing certain previously marketed orphan devices to be sold without a full conformity assessment. Notified bodies would prioritize these products to improve access for small patient populations.

The MDR and IVDR, effective in 2021 and 2022, continue transitioning through 2027–2028. The proposals aim to address bottlenecks, high compliance costs, and shortages of notified bodies.

19-12-2025