New EU harmonized standards across key medical device areas

The European Commission has published Implementing Decision (EU) 2026/1231, updating the harmonized standards supporting compliance with the Medical Devices Regulation (EU) 2017/745 (MDR).

This decision amends Implementing Decision (EU) 2021/1182 by adding revised and newly adopted standards reflecting recent technical progress.

What’s new?
Updates cover several key domains :

• Biological evaluation : EN ISO 10993 series, incl. 10993-1:2025
• Symbols & labelling : EN ISO 15223-1:2021/A1:2025
• Medical electrical equipment : IEC 60601-2-83 and its amendments and EN 60601-1
• Transfusion equipment : EN ISO 1135-4 & -5:2025
• Washer-disinfectors : EN ISO 15883 series
• Plus optics, implants, prosthetics & sharps protection

Why it matters
These standards support presumption of conformity with MDR requirements, facilitating compliance and EU market access.

The Decision entered into force upon publication, with transition periods until 2027 and 2031 for certain standards.

DOWNLOAD THE DECISION EU 2026/1231