Regulatory Affairs Updates
Discover the latest news in Regulatory Affairs
New Harmonised Standards listed
- Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager
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).
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.
Get in touch with our experts
Did you find this article interesting? Thanks for sharing it with your network:
Here you find all news related to Regulatory Affairs