EU Commission Decision Update! (Expert Panels – Medical Devices)
The European Commission has published Implementing Decision (EU) 2025/1324, amending Decision (EU) 2019/1396, introducing changes to the governance and scope of expert panels under the Medical Devices Regulation (EU) 2017/745 and IVDR (EU) 2017/746.
Key points:
– A new expert panel has been designated specifically for Paediatrics and Rare Diseases, responding to growing innovation and unmet needs in these high-impact areas.
– Updates the role of EMA as the official Secretariat for all expert panels, reflecting its enhanced role under Regulation (EU) 2022/123.
– Improves the administrative framework:
Clarifies procedures for assigning experts across panels.
Enables creation of sub-groups and appointment of rapporteurs, co-rapporteurs, reviewers for opinions.
Reinforces public transparency through a dedicated web platform for publishing expert panel outputs.
– Adjusts remuneration frameworks for experts based on task complexity and roles, ensuring sustainable participation.
– Reflects evolving needs in scientific guidance, common specifications, and device evaluation practices.
Access it here:
https://lnkd.in/d9JXWXGy