Commission Implementing Decision (EU) 2024/2625 of 8 October 2024 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for aseptic processing of health care products and clinical performance studies using specimens from human subjects

• CELEX: Implementing Decision (EU) 2024/2625
• 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

‘14.

EN ISO 13408-1:2024

Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2023)

15.

EN ISO 20916:2024

In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice (ISO 20916:2019)’.