Two new harmonised standards have been added for IVD under the EU IVD regulation.
In the Annex to Implementing Decision (EU) 2021/1195, the following entries are added:
No ‘14. Reference of the standard EN ISO 13408-1:2024 Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2023)
No ‘15. EN ISO 20916:2024 In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice (ISO 20916:2019)’
