New harmonised standards on clinical investigations, sterilization and biological evaluation

The European Commission has published Commission Implementing Decision (EU) 2026/2479, introducing new and revised harmonized standards supporting compliance with the Regulation (EU) 2017/745 (MDR).

The publication includes key standards covering:
• Clinical investigations (EN ISO 14155:2026)
• Sterilization of medical devices (EN ISO 11137-1:2026)
• Biological evaluation, medical electrical equipment and other healthcare applications

A transitional period applies to EN ISO 14155 and EN ISO 11137-1. Previous versions will remain valid until 10 May 2028, giving manufacturers time to adapt to the revised standards.

For manufacturers, compliance with harmonized standards published in the Official Journal of the European Union provides a presumption of conformity with the corresponding MDR requirements.

This publication marks another important step in strengthening the European regulatory framework for medical devices and aligning manufacturers with the latest technical and scientific developments.

DOWNLOAD THE DECISION EU 2026/2479