EU proposes to simplify medical devices rules

The European Commission published on 16 December a legislative proposal to reduce and simplify regulatory requirements for medical devices and in vitro diagnostic medical devices in the EU. The initiative is intended to improve device availability, streamline compliance, and support innovation while maintaining high standards of patient safety. Among the headline measures are simplified procedures for certain low‑risk devices and greater flexibility in conformity assessment and certification processes. The proposal will now be examined by the co‑legislators (the European Parliament and the Council) for review and adoption.

Separately, the EU published a draft regulation on notified bodies aimed at harmonizing rules on timelines, as well as requirements for quotations and cost transparency. Companies may provide feedback until 23 January 2026. Adoption is planned for the first quarter of 2026.