European expert recommendations on clinical investigation and evaluation of high‐risk medical devices for children-Reference-Cited by-同舟云学术

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

Published:2023-08-15 Issue:11 Volume:112 Page:2440-2448
ISSN:0803-5253
Container-title:Acta Paediatrica
language:en
Short-container-title:Acta Paediatrica

Author:

Guerlich Kathrin¹²^ORCID,Patro‐Golab Bernadeta²³,Barnacle Alex⁴⁵,Baumann Ulrich³⁶,Eicken Andreas⁷⁸⁹,Fraser Alan G.⁹¹⁰¹¹,Gruszfeld Dariusz¹²¹³,Haas Nikolaus A.¹⁴,Jonker Anneliene H.¹⁵,Kammermeier Michael²,Kenny Damien⁸¹⁶,Kolaček Sanja³¹⁷,Lapatto Risto¹⁸¹⁹²⁰²¹²²,Maconochie Ian²³²⁴,Mader Silke²⁵,McGauran Gearóid²⁶²⁷,Melvin Tom²⁸,Muensterer Oliver²⁹³⁰,Piscoi Paul³¹,Romano Alberto³²,Saxena Amulya K.³⁰³³,Schneider Dominik T.³⁴³⁵,Turner Mark A.¹⁹³⁶³⁷³⁸³⁹,Walle Johan Vande⁴⁰⁴¹⁴²⁴³,Koletzko Berthold¹²³¹⁹,

Affiliation:

1. Child Health Foundation (Stiftung Kindergesundheit), c/o Dr. von Hauner Children's Hospital Munich Germany

2. Division of Metabolic and Nutritional Medicine, Department of Pediatrics, Dr. von Hauner Children's Hospital LMU University Hospital, LMU Munich Germany

3. European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN)

4. Department of Interventional Radiology Great Ormond St Hospital for Children London UK

5. Cardiovascular and Interventional Radiological Society of Europe (CIRSE)

6. Paediatric Gastroenterology and Hepatology Hannover Medical School Hannover Germany

7. German Heart Center Munich Munich Germany

8. Association for European Paediatric and Congenital Cardiology (AEPC)

9. European Society of Cardiology (ESC)

10. Department of Cardiology University Hospital of Wales Cardiff UK

11. Biomedical Alliance in Europe

12. Neonatal Department and NICU Children's Memorial Health Institute Warsaw Poland

13. European Society for Pediatric and Neonatal Intensive Care (ESPNIC)

14. Division of Pediatric Cardiology and Intensive Care LMU University Hospital, LMU Munich Germany

15. University of Twente Enschede The Netherlands

16. Children's Health Ireland (CHI) at Crumlin and Mater Hospitals Dublin Ireland

17. Medical Faculty University of Zagreb Zagreb Croatia

18. Children's Hospital Helsinki University Hospital Helsinki Finland

19. European Academy of Paediatrics (EAP)

20. European Society of Endocrinology (ESE)

21. European Society for Paediatric Endocrinology (ESPE)

22. Society for Study of Inborn Errors of Metabolism (SSIEM)

23. Imperial College NHS Healthcare Trust London UK

24. European Society for Emergency Medicine (EUSEM)

25. Parent Organisation European Foundation for the Care of Newborn Infants (EFCNI) Munich Germany

26. Health Products Regulatory Authority Dublin Ireland

27. Royal College of Physicians of Ireland

28. School of Medicine Trinity College Dublin Dublin Ireland

29. Department of Pediatric Surgery, Dr. von Hauner Children's Hospital LMU Medical Center Munich Germany

30. European Paediatric Surgeons’ Association (EUPSA)

31. Health Technology Unit B6 Directorate General for Health (DG SANTE), European Commission Brussels Belgium

32. Pediatric Oncology Unit Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy

33. Chelsea and Westminster NHS Fdn Trust Imperial College London London UK

34. Klinikum Dortmund University Witten/Herdecke Dortmund Germany

35. German Society of Pediatrics and Adolescent Medicine (Deutsche Gesellschaft für Kinder‐ und Jugendmedizin – DGKJ)

36. Department of Women's and Children's Health, Instiute of Life Cycle and Medical Sciences University of Liverpool Liverpool UK

37. Royal College of Paediatrics and Child Health

38. European Society for Developmental, Perinatal and Paediatric Pharmacology

39. conect4children

40. Department of Pediatric Nephrology University Hospital Ghent Ghent Belgium

41. European Society of Pediatric Nephrology (ESPN), Chair of the European Pediatric Dialysis Working group (EPDWG)

42. International Pediatric Nephrology Association (IPNA)

43. European Rare Kidney Disease Reference Network (ERKNet)

Abstract

AbstractSeveral 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.

Publisher

Wiley

Subject

General Medicine,Pediatrics, Perinatology and Child Health

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/apa.16919

Reference21 articles.

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2. European Medicines Agency (EMA).Medical devices. Accessed July 10 2023.https://www.ema.europa.eu/en/human‐regulatory/overview/medical‐devices

3. Medical Device Coordination Group.MDCG 2021‐24 Guidance on classification of medical devices. October 2021. Accessed July 10 2023.https://health.ec.europa.eu/system/files/2021‐10/mdcg_2021‐24_en_0.pdf

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