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

Autor: Guerlich K; Child Health Foundation (Stiftung Kindergesundheit), c/o Dr. von Hauner Children's Hospital, Munich, Germany.; Division of Metabolic and Nutritional Medicine, Department of Pediatrics, Dr. von Hauner Children's Hospital, LMU University Hospital, LMU, Munich, Germany., Patro-Golab B; Division of Metabolic and Nutritional Medicine, Department of Pediatrics, Dr. von Hauner Children's Hospital, LMU University Hospital, LMU, Munich, Germany.; European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN)., Barnacle A; Department of Interventional Radiology, Great Ormond St Hospital for Children, London, UK.; Cardiovascular and Interventional Radiological Society of Europe (CIRSE)., Baumann U; European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN).; Paediatric Gastroenterology and Hepatology Hannover Medical School, Hannover, Germany., Eicken A; German Heart Center Munich, Munich, Germany.; Association for European Paediatric and Congenital Cardiology (AEPC).; European Society of Cardiology (ESC)., Fraser AG; European Society of Cardiology (ESC).; Department of Cardiology, University Hospital of Wales, Cardiff, UK.; Biomedical Alliance in Europe., Gruszfeld D; Neonatal Department and NICU, Children's Memorial Health Institute, Warsaw, Poland.; European Society for Pediatric and Neonatal Intensive Care (ESPNIC)., Haas NA; Division of Pediatric Cardiology and Intensive Care, LMU University Hospital, LMU, Munich, Germany., Jonker AH; University of Twente, Enschede, The Netherlands., Kammermeier M; Division of Metabolic and Nutritional Medicine, Department of Pediatrics, Dr. von Hauner Children's Hospital, LMU University Hospital, LMU, Munich, Germany., Kenny D; Association for European Paediatric and Congenital Cardiology (AEPC).; Children's Health Ireland (CHI) at Crumlin and Mater Hospitals, Dublin, Ireland., Kolaček S; European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN).; Medical Faculty, University of Zagreb, Zagreb, Croatia., Lapatto R; Children's Hospital, Helsinki University Hospital, Helsinki, Finland.; European Academy of Paediatrics (EAP).; European Society of Endocrinology (ESE).; European Society for Paediatric Endocrinology (ESPE).; Society for Study of Inborn Errors of Metabolism (SSIEM).; European Reference Network on Rare Endocrine Conditions (EndoERN).; European Reference Network for Hereditary Metabolic Disorders (MetabERN)., Maconochie I; Imperial College NHS Healthcare Trust, London, UK.; European Society for Emergency Medicine (EUSEM)., Mader S; Parent Organisation European Foundation for the Care of Newborn Infants (EFCNI), Munich, Germany., McGauran G; Health Products Regulatory Authority, Dublin, Ireland.; Royal College of Physicians of Ireland., Melvin T; School of Medicine, Trinity College Dublin, Dublin, Ireland., Muensterer O; Department of Pediatric Surgery, Dr. von Hauner Children's Hospital, LMU Medical Center, Munich, Germany.; European Paediatric Surgeons' Association (EUPSA)., Piscoi P; Health Technology Unit B6, Directorate General for Health (DG SANTE), European Commission, Brussels, Belgium., Romano A; Pediatric Oncology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy., Saxena AK; European Paediatric Surgeons' Association (EUPSA).; Chelsea and Westminster NHS Fdn Trust, Imperial College London, London, UK., Schneider DT; Klinikum Dortmund, University Witten/Herdecke, Dortmund, Germany.; German Society of Pediatrics and Adolescent Medicine (Deutsche Gesellschaft für Kinder- und Jugendmedizin - DGKJ)., Turner MA; European Academy of Paediatrics (EAP).; Department of Women's and Children's Health, Instiute of Life Cycle and Medical Sciences, University of Liverpool, Liverpool, UK.; Royal College of Paediatrics and Child Health.; European Society for Developmental, Perinatal and Paediatric Pharmacology.; conect4children., Walle JV; Department of Pediatric Nephrology, University Hospital Ghent, Ghent, Belgium.; European Society of Pediatric Nephrology (ESPN), Chair of the European Pediatric Dialysis Working group (EPDWG).; International Pediatric Nephrology Association (IPNA).; European Rare Kidney Disease Reference Network (ERKNet)., Koletzko B; Child Health Foundation (Stiftung Kindergesundheit), c/o Dr. von Hauner Children's Hospital, Munich, Germany.; Division of Metabolic and Nutritional Medicine, Department of Pediatrics, Dr. von Hauner Children's Hospital, LMU University Hospital, LMU, Munich, Germany.; European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN).; European Academy of Paediatrics (EAP).
Jazyk: angličtina
Zdroj: Acta paediatrica (Oslo, Norway : 1992) [Acta Paediatr] 2023 Nov; Vol. 112 (11), pp. 2440-2448. Date of Electronic Publication: 2023 Aug 15.
DOI: 10.1111/apa.16919
Abstrakt: 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.
(© 2023 The Authors. Acta Paediatrica published by John Wiley & Sons Ltd on behalf of Foundation Acta Paediatrica.)
Databáze: MEDLINE
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