Commission Implementing Decision (EU) 2025/679 of 8 April 2025 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilization of medical devices

• CELEX: Implementing Decision (EU) 2025/679
• Articles: 3

Article 1

The Annex to Implementing Decision (EU) 2021/1195 is amended in accordance with the Annex to this Decision.

Article 2

This Decision shall enter into force on the day of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX

ANNEX

In the Annex to Implementing Decision (EU) 2021/1195, the following entries are added:

No

Reference of the standard

‘16.

EN 556-1:2024

Sterilization of medical devices - Requirements for medical devices to be designated “STERILE” - Part 1: Requirements for terminally sterilized medical devices

17.

EN 556-2:2024

Sterilization of medical devices - Requirements for medical devices to be designated “STERILE” - Part 2: Requirements for aseptically processed medical devices’