EN ISO 13408-1:2024 Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2023) is now a harmonised standard under both the MDR and the IVDR, whereas EN ISO 20916:2024 In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice (ISO 20916:2019) is now a harmonised standard under the IVDR.
Commission Implementing Decision (EU) 2024/2625 amending Implementing Decision (EU) 2021/1195
Commission Implementing Decision (EU) 2024/2631 amending Implementing Decision (EU) 2021/1182
Compliance with standards ISO 13408-1:2023 or ISO 20916:2019, while not mandatory, now confers a presumption of conformity with the corresponding requirements set out in either the MDR or the IVDR.