The EU Commission has published Implementing Decision (EU) 2025/2078, which amends Decision (EU) 2021/1182 by adding four more harmonised standards under the MDR (Regulation (EU) 2017/745). From 20 October 2025, compliance with these standards gives presumption of conformity for the MDR requirements they cover.
So what’s newly harmonised?
- EN 13795-1:2025 – Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
- EN 13795-2:2025 – Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
- EN 14683:2025 – Medical face masks - Requirements and test methods
- EN 14180:2025 – Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
Next Steps and Recommendations
- Legal effect: Decision enters into force on the day of publication (20 October, 2025). The presumption of conformity will apply from that date.
- Context: Earlier editions (EN 13795-1/-2:2019, EN 14683:2019+AC:2019, EN 14180:2014) were not OJEU‑listed under the MDR. The 2025 editions were assessed and are now listed.
- Obtain the 2025 editions and review Annex ZA in each for the MDR requirements covered. Perform a gap assessment and update testing/documentation accordingly.
