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Newly Listed Harmonized Standards

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Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager
Regulatory Affairs
In Vitro Diagnostics
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On October 9th, 2024, Commission Implementing Decisions (EU) 2024/2625 and (EU) 2024/2631 were published in the Official Journal of the European Union, adopting two new harmonized standards under Regulation (EU) 2017/746 (IVDR) and one under Regulation (EU) 2017/745 (MDR). 

Newly Listed Harmonized Standards | QbD Group Regulatory Update
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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.

 

 

 

CTA RA update

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