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

Kathrin Guerlich^{1

2}, Bernadeta Patro-Golab^{2

3}, Alex Barnacle^{4

5}, Ulrich Baumann^{3

6}, Andreas Eicken^{7

8

9}, Alan G Fraser^{9

10

11}, Dariusz Gruszfeld^{12

13}, Nikolaus A Haas¹⁴, Anneliene H Jonker¹⁵, Michael Kammermeier², Damien Kenny^{8

16}, Sanja Kolaček^{3

17}, Risto Lapatto^{18

19

20

21

22

23

24}, Ian Maconochie^{25

26}, Silke Mader²⁷, Gearóid McGauran^{28

29}, Tom Melvin³⁰, Oliver Muensterer^{31

32}, Paul Piscoi³³, Alberto Romano³⁴, Amulya K Saxena^{32

35}, Dominik T Schneider^{36

37}, Mark A Turner^{19

38

39

40

41}, Johan Vande Walle^{42

43

44

45}, Berthold Koletzko^{1

2

3

19}; European Academy of Paediatrics

Affiliations

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 European Reference Network on Rare Endocrine Conditions (EndoERN).
²⁴ European Reference Network for Hereditary Metabolic Disorders (MetabERN).
²⁵ Imperial College NHS Healthcare Trust, London, UK.
²⁶ European Society for Emergency Medicine (EUSEM).
²⁷ Parent Organisation European Foundation for the Care of Newborn Infants (EFCNI), Munich, Germany.
²⁸ Health Products Regulatory Authority, Dublin, Ireland.
²⁹ Royal College of Physicians of Ireland.
³⁰ School of Medicine, Trinity College Dublin, Dublin, Ireland.
³¹ Department of Pediatric Surgery, Dr. von Hauner Children's Hospital, LMU Medical Center, Munich, Germany.
³² European Paediatric Surgeons' Association (EUPSA).
³³ Health Technology Unit B6, Directorate General for Health (DG SANTE), European Commission, Brussels, Belgium.
³⁴ Pediatric Oncology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
³⁵ Chelsea and Westminster NHS Fdn Trust, Imperial College London, London, UK.
³⁶ Klinikum Dortmund, University Witten/Herdecke, Dortmund, Germany.
³⁷ German Society of Pediatrics and Adolescent Medicine (Deutsche Gesellschaft für Kinder- und Jugendmedizin - DGKJ).
³⁸ Department of Women's and Children's Health, Instiute of Life Cycle and Medical Sciences, University of Liverpool, Liverpool, UK.
³⁹ Royal College of Paediatrics and Child Health.
⁴⁰ European Society for Developmental, Perinatal and Paediatric Pharmacology.
⁴¹ conect4children.
⁴² Department of Pediatric Nephrology, University Hospital Ghent, Ghent, Belgium.
⁴³ European Society of Pediatric Nephrology (ESPN), Chair of the European Pediatric Dialysis Working group (EPDWG).
⁴⁴ International Pediatric Nephrology Association (IPNA).
⁴⁵ European Rare Kidney Disease Reference Network (ERKNet).

PMID: 37485905
DOI: 10.1111/apa.16919

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

Kathrin Guerlich et al. Acta Paediatr. 2023 Nov.

. 2023 Nov;112(11):2440-2448.

doi: 10.1111/apa.16919. Epub 2023 Aug 15.

Authors

Affiliations

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 European Reference Network on Rare Endocrine Conditions (EndoERN).
²⁴ European Reference Network for Hereditary Metabolic Disorders (MetabERN).
²⁵ Imperial College NHS Healthcare Trust, London, UK.
²⁶ European Society for Emergency Medicine (EUSEM).
²⁷ Parent Organisation European Foundation for the Care of Newborn Infants (EFCNI), Munich, Germany.
²⁸ Health Products Regulatory Authority, Dublin, Ireland.
²⁹ Royal College of Physicians of Ireland.
³⁰ School of Medicine, Trinity College Dublin, Dublin, Ireland.
³¹ Department of Pediatric Surgery, Dr. von Hauner Children's Hospital, LMU Medical Center, Munich, Germany.
³² European Paediatric Surgeons' Association (EUPSA).
³³ Health Technology Unit B6, Directorate General for Health (DG SANTE), European Commission, Brussels, Belgium.
³⁴ Pediatric Oncology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
³⁵ Chelsea and Westminster NHS Fdn Trust, Imperial College London, London, UK.
³⁶ Klinikum Dortmund, University Witten/Herdecke, Dortmund, Germany.
³⁷ German Society of Pediatrics and Adolescent Medicine (Deutsche Gesellschaft für Kinder- und Jugendmedizin - DGKJ).
³⁸ Department of Women's and Children's Health, Instiute of Life Cycle and Medical Sciences, University of Liverpool, Liverpool, UK.
³⁹ Royal College of Paediatrics and Child Health.
⁴⁰ European Society for Developmental, Perinatal and Paediatric Pharmacology.
⁴¹ conect4children.
⁴² Department of Pediatric Nephrology, University Hospital Ghent, Ghent, Belgium.
⁴³ European Society of Pediatric Nephrology (ESPN), Chair of the European Pediatric Dialysis Working group (EPDWG).
⁴⁴ International Pediatric Nephrology Association (IPNA).
⁴⁵ European Rare Kidney Disease Reference Network (ERKNet).

PMID: 37485905
DOI: 10.1111/apa.16919

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.

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References

REFERENCES

1. European Commission. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance). 2017. Accessed March 17, 2023. http://data.europa.eu/eli/reg/2017/745/oj
1. European Medicines Agency (EMA). Medical devices. Accessed July 10, 2023. https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
1. 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
1. Melvin T, Kenny D, Gewillig M, Fraser AG. Orphan medical devices and pediatric cardiology - what interventionists in Europe need to know, and what needs to be done. Pediatr Cardiol. 2023;44(2):271-279. doi:10.1007/s00246-022-03029-1
1. Biomedical Alliance Europe. Clinicians concerned about limited availability of medical devices: report of the BioMed Alliance survey conducted in cooperation with the ESC and EFORT. 2023. Accessed March 17, 2023. https://www.biomedeurope.org/images/news/2023/Report_survey_results_v3.pdf

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

Affiliations

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

Authors

Affiliations

Abstract

References

REFERENCES

Grants and funding

LinkOut - more resources

Full Text Sources