European expert recommendations on clinical investigation and evaluation of high‐risk medical devices for children
Kathrin Guerlich, Bernadeta Patro‐Golab, Alex Barnacle, Ulrich Baumann, Andreas Eicken, Alan G. Fraser, Dariusz Gruszfeld, Nikolaus A. Haas, Anneliene H. Jonker, Michael Kammermeier, Damien Kenny, Sanja Kolaček, Risto Lapatto, Ian Maconochie, Silke Mader, Gearóid McGauran, Tom Melvin, Oliver Muensterer, Paul Piscoi, Alberto Romano, Amulya K. Saxena, Dominik T. Schneider, Mark A. Turner, Johan Vande Walle, Berthold Koletzko,- General Medicine
- Pediatrics, Perinatology and Child Health
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 are proposed.