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



Guerlich, Kathrin ORCID: 0000-0001-5471-3215, Patro-Golab, Bernadeta, Barnacle, Alex, Baumann, Ulrich, Eicken, Andreas, Fraser, Alan G, Gruszfeld, Dariusz, Haas, Nikolaus A, Jonker, Anneliene H, Kammermeier, Michael
et al (show 16 more authors) (2023) European expert recommendations on clinical investigation and evaluation of high-risk medical devices for children. Acta paediatrica (Oslo, Norway : 1992), 112 (11). pp. 2440-2448.

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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: Article
Uncontrolled Keywords: European Academy of Paediatrics
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences
Depositing User: Symplectic Admin
Date Deposited: 02 Nov 2023 10:38
Last Modified: 11 Nov 2023 01:15
DOI: 10.1111/apa.16919
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3176497