European expert recommendations on clinical investigation and evaluation of high‐risk medical devices for children

Abstract

Several high‐risk medical devices for children have become unavailable in the European Union (EU), since requirements and costs for device certification increased markedly due to the EU Medical Device Regulation. The EU‐funded CORE‐MD project held a workshop in January 2023 with experts from various child health specialties, representatives of European paediatric associations, a regulatory authority and the European Commission Directorate General Health and Food Safety. A virtual follow‐up meeting took place in March 2023. We developed recommendations for investigation of high‐risk medical devices for children building on participants' expertise and results of a scoping review of clinical trials on high‐risk medical devices in children. Approaches for evaluating and certifying high‐risk medical devices for market introduction were proposed.

Paediatrics and Child Health Need a United, Credible and Strong Pan-European Voice

“…devices for interventional paediatric cardiology, dialysis equipment for young children) are becoming unavailable. EAP has led the Task on paediatric devices in the EU Horizon Framework project “ Coordinating Research and Evidence for Medical Devices ”, performed a systematic review to evaluate the availability of clinical evidence, 1 and developed und published joint recommendations with 24 organisations on the topic 2 and disseminated this widely, for example at the International Medical Device Regulators Forum and political decision makers at European and national levels We also wrote an open letter demanding rapid changes with 27 associations and received a positive response letter by the President of the European Commission, Dr. Ursula von der Leyen. Consequently, constructive collaboration has evolved with the European Commissions’s Medical Device Task Force where EAP is now participating, aiming to develop solutions.…”

Issue highlights

“…This is because some manufacturers of well‐established devices have decided to withdraw products instead of going through the costly recertification process. A group of experts present a strategy for overcoming the shortages, together with approaches for evaluating and certifying high‐risk medical devices 7 …”