EU Commission Implementing Decision (EU) 2025/2078 on Harmonised Standards

The European Commission’s Implementing Decision (EU) 2025/2078 amends Implementing Decision (EU) 2021/1182, updating harmonised standards for surgical clothing, drapes, medical face masks, and sterilizers for medical purposes. These revised EN standards reflect the latest technical and scientific advancements under the EU Medical Device Regulation (MDR) and serve as the new benchmark for conformity assessment. Manufacturers must now align product testing and documentation with the updated specifications to maintain MDR compliance.

Key Updates Introduced by Implementing Decision (EU) 2025/2078

The Decision lists four new and revised European harmonised standards (EN) under the MDR framework:

• EN 13795-1:2025 – Surgical clothing and drapes – Part 1: Surgical drapes and gowns

• EN 13795-2:2025 – Surgical clothing and drapes – 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

These standards replace earlier editions and ensure stronger alignment with infection control, material performance, and sterilization safety principles.

Impact on Manufacturers and Market Surveillance

Manufacturers can now use the updated EN standards to presume conformity with the MDR. However, the changes may require:

• Additional testing to meet revised specifications.

• Technical documentation updates to demonstrate alignment with the latest test methods.

• Quality management adjustments reflecting new performance thresholds.

Market surveillance authorities will treat these standards as state-of-the-art, setting the benchmark for compliance evaluations across the EU.

Why the Update Matters

This Decision reinforces the EU’s commitment to public health protection and regulatory clarity. Updated standards ensure that surgical textiles, face masks, and sterilizers meet the most recent safety, biocompatibility, and performance requirements.

It also promotes innovation, allowing manufacturers to adopt the latest materials and sterilization technologies while ensuring continued compliance with MDR Annex I.

Next Steps for Compliance

To stay compliant:

• Review and integrate the new EN standards into your technical files and risk management systems.

• Update testing protocols and quality documentation.

• Consult your Notified Body for any required conformity re-assessments.

Healthcare providers and procurement teams should ensure that purchased devices conform to these updated harmonised standards.

External links:

• Official text of Implementing Decision (EU) 2025/2078 (EUR-Lex)

• EU Medical Device Classification & Regulation (MDR/IVDR)

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