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

Guerlich, Kathrin ; Patro‐Golab, Bernadeta; Barnacle, Alex; Baumann, Ulrich; Eicken, Andreas; Fraser, Alan G.; Gruszfeld, Dariusz; Haas, Nikolaus A.; Jonker, Anneliene H.; Kammermeier, Michael; Kenny, Damien; Kolaček, Sanja; Lapatto, Risto; Maconochie, Ian; Mader, Silke; McGauran, Gearóid; Melvin, Tom; Muensterer, Oliver; Piscoi, Paul; Romano, Alberto; Saxena, Amulya K.; Schneider, Dominik T.; Turner, Mark A.; Walle, Johan Vande and Koletzko, Berthold (2023): European expert recommendations on clinical investigation and evaluation of high‐risk medical devices for children. In: Acta Paediatrica, Vol. 112, No. 11: pp. 2440-2448

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.

• Item Type: Journal article
• Faculties: Medicine > Medical Center of the University of Munich > Paediatric Surgery Clinic and Polyclinic in the Dr. von Hauner Children's Hospital
• Subjects: 600 Technology > 610 Medicine and health
• ISSN: 0803-5253
• Language: English