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EC: Updated List of Harmonised Standards for Medical Devices

The European Commission has updated its implementing decision on harmonised standards for certain medical devices. Newly added are requirements and test methods for surgical clothing and drapes, medical face masks, and sterilisers for medical purposes.

The update reflects technological and scientific advances and requirements under the Medical Device Regulation (MDR).


Source:

EC: Commission Implementing Decision (EU) 2025/2078 of 17 October 2025 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for surgical clothing and drapes, medical face masks and sterilizers for medical purposes

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