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Friday, October 24th

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New Harmonized Standards for Medical Devices

On October 17, 2025, the European Commission adopted Implementing Decision (EU) 2025/2078, updating harmonized standards for:

Surgical clothing and drapes
Medical face masks
Sterilizers for medical purposes

The newly adopted standards – EN ISO 13795-1:2025, EN ISO 13795-2:2025, EN ISO 14683:2025, and EN ISO 14180:2025 – reflect the latest technical and scientific advancements and ensure alignment with the requirements of Regulation (EU) 2017/745 on medical devices.

Effective date: October 20, 2025

DOWNLOAD THE IMPLEMENTING DECISION (EU) 2025/2078

New Harmonized Standards for Medical Devices

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