Please be advised that two new EU expert groups for medical devices including IVDs are to be established for Paediatrics and for Rare diseases. These will be established and organised by EMA.
Interesting to see where Rare diseases and Paediatrics cross over as most rare diseases are detected, and have most opportunity to be impacted in paediatrics.
MedTech Europe are pleased to inform you that The European Commission Implementing Decision (EU) 2025/1324 of 7 July 2025 amending Implementing Decision (EU) 2019/1396 as regards certain administrative aspects related to expert panels and as regards the designation of an additional expert panel in the field of medical devices has been published in the Official Journal of the EU: Implementing decision – EU – 2025/1324 – EN – EUR-Lex
With this implementing decision, the Commission officially sets up an additional expert panel in the field of paediatrics and rare diseases. This panel should cover both medical devices and IVDs -depending on the ability to gather relevant experts.
This implementing decision also updates certain administrative aspects related to the management of the expert panels.
