@article{cb81ab53d3e24927958574504755f7d1,
title = "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 are proposed.",
keywords = "children, clinical evaluation, clinical investigation, expert workshop, high-risk medical devices, recommendations",
author = "Kathrin Guerlich and Bernadeta Patro-Golab and Alex Barnacle and Ulrich Baumann and Andreas Eicken and Fraser, \{Alan G.\} and Dariusz Gruszfeld and Haas, \{Nikolaus A.\} and Jonker, \{Anneliene H.\} and Michael Kammermeier and Damien Kenny and Sanja Kola{\v c}ek and Risto Lapatto and Ian Maconochie and Silke Mader and Gear{\'o}id McGauran and Tom Melvin and Oliver Muensterer and Paul Piscoi and Alberto Romano and Saxena, \{Amulya K.\} and Schneider, \{Dominik T.\} and Turner, \{Mark A.\} and Walle, \{Johan Vande\} and Berthold Koletzko",
note = "Funding Information: The workshop referred to in this paper received funding from the European Union's Horizon 2020 Research and Innovation programme under grant agreement No 965246 (CORE‐MD). Funding Information: BK is the Else Kr{\"o}ner Senior professor of Paediatrics at LMU—University of Munich, financially supported by Else Kr{\"o}ner‐Fresenius‐Foundation, LMU Medical Faculty and LMU University Hospitals. RL received funding from the Helsinki University Hospital and from Finnish Funds (private and societies). BPG is supported by a grant from the Alexander von Humboldt Foundation, Bonn, Germany. Funding Information: UB received financial support from Albireo, Alexion, Mirum, Nestle, Vivet. AE is a proctor for Medtronic and a consultant for Lifetech, Gore. DK is a proctor for Venus Medtech, Edwards Lifesciences, Medtronic and Occlutech. TM has acted as unpaid advisory board member of Pumpinheart Ltd., and previously as senior medical officer in medical devices at the Health Products Regulatory Authority, Ireland and previous co‐chair of the Clinical Investigation and Evaluation Working Group of the European Commission. OM received financial support from ASENSUS Surgical, Corza, Aesculap AG, and Hollister/Dansac Academy. The other authors declare no potential conflict of interest in relation to the content of this manuscript. Publisher Copyright: {\textcopyright} 2023 The Authors. Acta Paediatrica published by John Wiley \& Sons Ltd on behalf of Foundation Acta Paediatrica.",
year = "2023",
month = nov,
doi = "10.1111/apa.16919",
language = "English",
volume = "112",
pages = "2440--2448",
journal = "Acta paediatrica",
issn = "0803-5253",
publisher = "Wiley-Blackwell",
number = "11",
}