Today, 20 October 2025, the Official Journal of the EU released Commission Implementing Decision (EU) 2025/2078. This Decision amends Implementing Decision (EU) 2021/1182 to include references to the new harmonised standards for surgical clothing and drapes, medical face masks and sterilizers for medical purposes.
Harmonised standards: EN 13795-1:2025, EN 13795-2:2025, EN 14683:2025 and EN 14180:2025
Following a request from the Commission to revise the existing harmonised standards under the previous medical devices Directives and to draft new harmonised standards under Regulation (EU) 2017/745 (MDR), CEN and CENELEC revised EN 13795-1:2019 and EN 13795-2:2019 on surgical clothing and drapes, EN 14683:2019+AC:2019 on medical face masks, and EN 14180:2014 on sterilizers for medical purposes. These standards were developed in support of the previous Directives and were not referenced in the Official Journal of the EU in support of the current Regulation, due to the latest technological and scientific developments.
After the Commission’s evaluation, EN 13795-1:2025, EN 13795-2:2025, EN 14683:2025 and EN 14180:2025 are deemed reflecting the current scientific and technological developments, and thus, harmonised and included to Implementing Decision (EU) 2021/1182.
Do you have questions on medical devices compliance? Contact us here or at mdlaw@obelis.net.
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