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

• DOI: 10.1111/apa.16919
• Publication Date: 2023-07-24T10:30:10Z
• Authors: Kathrin Guerlich; Bernadeta Patro‐G...; 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
• Keywords: European commission; Medical device

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