Medical device standards update: December 2025

By Charlotte Holleran2025-12-15T12:43:00

Introduction

This edition of our regular column updates the progress of applicable standards to November 2025.

The past six months have seen a continued slowdown in new harmonised standards under the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), with only a handful of additions, limited to purely European standards. This reflects the ongoing legal and copyright disputes affecting the citation of international ISO and IEC standards in the Official Journal of the European Union (OJEU).

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