MDR and IVDR Revisions Bode Well for European Medtech Innovation
In December 2025, the European Commission unveiled proposed revisions to the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The changes aim to accelerate the path to market for medtech and digital health companies by making the rulebook easier to navigate without lowering the bar on patient safety. Innovators have greeted the announcement with cautious optimism.
The proposed changes to MDR and IVDR amount to the most significant reform of the regulations since their adoption in 2017, when they replaced Europe’s long-standing Medical Device Directive (MDD).
Liz Renzaglia, Biovia Domain Lead for Medtech & Digital Health, says: “Over the past few years, the MDR and IVDR have placed undue strain on European innovators. These revisions aim to decrease administrative burden, compliance-related costs and legal uncertainties — improving Europe’s health innovation to the benefit of both enterprises and patients.”