NEW Released EU Harmonised Standards Medical Device ( ce certification mark)

This EU legal text is a Commission Implementing Decision (EU) 2025/2078, adopted on 17 October 2025, which updates the list of harmonised standards under the Medical Device Regulation (MDR, Regulation (EU) 2017/745). It specifically adds new standards for surgical clothing and drapes, medical face masks, and sterilisers for medical purposes.

📌 What the Decision Does

• Updates Implementing Decision (EU) 2021/1182: This earlier act listed harmonised standards supporting MDR. The new decision amends it to include the latest revisions.

New harmonised standards included:

1. EN 13795-1:2025 – Surgical clothing and drapes – Requirements and test methods – Part 1: Surgical drapes and gowns

2. EN 13795-2:2025 - Surgical clothing and drapes – Requirements and test methods – Part 2: Clean air suits

3. EN 14683:2025 – Medical face masks (requirements and test methods).

4. EN 14180:2025 – Sterilizers for medical purposes (low temperature steam and formaldehyde sterilisers

⚖️ Legal Context

1. MDR (Regulation (EU) 2017/745) replaced the old Medical Device Directives in May 2021.

2. Harmonised standards are developed by CEN (European Committee for Standardisation) and CENELEC (European Committee for Electrotechnical Standardisation).

3. Publication in the Official Journal (OJ) makes these standards legally recognised for presumption of conformity.

🧾 Why It Matters

1. Manufacturers: Using these standards simplifies demonstrating MDR compliance for surgical clothing, drapes, masks, and sterilisers.

2. Notified Bodies & Regulators: They can rely on these standards when assessing conformity.

3. Healthcare providers: Assurance that products meeting these standards align with EU safety and performance requirements.

🔍 Key Takeaway

This decision ensures that updated technical standards (2025 versions) are officially recognised under MDR. Compliance with them provides a clear, legally backed pathway to CE marking for the listed categories of medical devices.

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