Simon Medtech Solutions
New EU Harmonized Standards Enter Into Force for Medical Masks, Gowns, and Sterilizers
On 17 October 2025, the European Commission issued Implementing Decision (EU) 2025/2078, updating the list of harmonized standards applicable to several categories of medical devices. The revision covers:
Surgical gowns and drapes
Medical face masks
Steam sterilizers and low-temperature formaldehyde sterilizers
The newly adopted standards – EN ISO 13795-1:2025, EN ISO 13795-2:2025, EN ISO 14683:2025, and EN ISO 14180:2025 – ensure stronger alignment with Regulation (EU) 2017/745 and incorporate the latest technical and scientific developments.
Application date: 20 October 2025.
These regulatory updates require continuous monitoring and swift adaptation from manufacturers, distributors, and importers. With its expertise in medical device compliance, Simon MedTech Solutions supports companies in assessing, updating, and implementing these new standards, ensuring a smooth transition and full regulatory alignment for market access
