New EU Harmonized Standards for Surgical Clothing, Medical Face Masks, and Sterilizers
What is Decision (EU) 2025/2078?
On 17 October 2025, the European Commission adopted Implementing Decision (EU) 2025/2078, which amends Implementing Decision (EU) 2021/1182 regarding harmonized standards applicable
to surgical clothing and drapes, medical face masks, and sterilizers for medical purposes.
Read the full text on EUR-Lex.
The main goal is to include newly revised European standards (EN) that reflect the latest technical
and scientific developments in the field.
Why is it important?
- Harmonized standards provide presumption of conformity with the essential requirements of Regulation (EU) 2017/745 on medical devices.
- By updating standards EN 13795-1 and 2 (surgical clothing), EN 14683 (medical face masks), and EN 14180 (sterilizers) to their 2025 versions, the EU seeks to improve product quality, safety, and reliability across the internal market.
- For manufacturers, distributors, notified bodies, and healthcare professionals, being aware of these updates is crucial to ensure compliance and to avoid marketing products that no longer meet EU regulatory expectations.
Which standards are included?
- 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
What changes for stakeholders?
- Manufacturers of surgical clothing, drapes, medical face masks, and sterilizers must assess their products against the updated standards to maintain presumption of conformity.
- Testing and certification bodies need to align their procedures and assessments with the 2025 versions of the standards.
- Distributors and healthcare institutions must ensure that all marketed or procured products comply with the latest harmonized versions.
- Market surveillance authorities will increase oversight of compliance, as the new standards represent a higher technical benchmark.
When does it enter into force?
The Decision enters into force on the date of its publication in the Official Journal of the European Union. From that date, the listed standards are recognized for presumption of conformity purposes.
Conclusion
Implementing Decision (EU) 2025/2078 is a key update for the medical devices sector, introducing revised harmonized standards for surgical clothing, medical face masks, and sterilizers.
Manufacturers, distributors, and healthcare operators should promptly review and adapt their processes to ensure compliance with these updated standards — maintaining product quality, regulatory alignment, and patient safety.
