Commission Implementing Decision (EU) 2026/197 of 28 January 2026 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilization of health care products and information supplied by the manufacturer (labelling)

• CELEX: Implementing Decision (EU) 2026/197
• 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

‘18.

EN ISO 17665:2024

Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024)

19.

EN ISO 18113-1:2024

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022)

20.

EN ISO 18113-2:2024

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022)

21.

EN ISO 18113-3:2024

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2022)

22.

EN ISO 18113-4:2024

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022)

23.

EN ISO 18113-5:2024

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022)’.