The European Commission adopted Implementing Decision (EU) 2025/2078 on October 17, 2025, amending Decision 2021/1182 to add four harmonised standards that now confer a presumption of conformity with relevant requirements of Regulation (EU) 2017/745 on medical devices (MDR). These revised standards update earlier CEN/CENELEC work to reflect technical and scientific progress and to better support the MDR.
Harmonised standards added
- 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.
Why this matters
Manufacturers, potentially notified bodies and conformity-assessment teams should treat these references as the preferred route to demonstrate conformity where the standards cover relevant MDR general safety and performance requirements. The decision closes prior gaps where earlier editions were not listed under the MDR and aligns test methods and performance criteria with current practice.
Practical next steps
Regulatory teams should:
- map impacted product families (surgical textiles, face masks, sterilizers);
- review/align technical documentation and test reports to the 2025 editions;
- discuss implications with your notified body regarding ongoing assessments;
- update supplier/quality agreements and lab verification plans to reflect changed test methods or acceptance criteria.
This update is essential reading for regulatory affairs departments maintaining MDR compliance and for quality teams responsible for sterile-process equipment and protective garments.
Source: European Commission
