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
What does it mean to you?
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.
About the Author
MSc Biomedical Sciences · Business Unit Manager RA IVD & Representative Services
With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.
Navigate Regulatory Complexity with Confidence
Navigate complex regulatory landscapes with expert guidance across pharmaceuticals, medical devices, and IVD.
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