doctor explaining treatment to a child and her mother


Kathrin Guerlich1,2*,
Bernadeta Patro-Golab2*,
Michael Kammermeier2 ,
Berthold Koletzko1,2,3, LMU Munich, on behalf of the European Academy of Paediatrics

1 – Stiftung Kindergesundheit, c/o Dr. von Hauner Children’s Hospital
2 – Division of Metabolic and Nutritional Medicine, Department of Pediatrics, Dr. von Hauner Children’s Hospital, LMU University Hospital Munich, Germany
3 – European Academy of Paediatrics, Brussels, Belgium

*equal contribution

The Medical Device Regulation (EU) 2017/745 (MDR) aims to ensure a high level of health protection for patients and users and sets high standards of quality and safety. This includes ensuring the reliability and robustness of data generated in clinical investigations and protecting the safety of subjects participating in such studies.

The CORE-MD project (Coordinating Research and Evidence for Medical Devices – a Coordination and Support Action that is funded by EU Horizon 2020 and led by the ESC), aims to recommend an appropriate balance between clinical efficacy, safety, and innovation for high-risk medical devices. The EAP (European Academy of Paediatrics) is leading one of the project’s tasks, which involves reviewing the evaluation methodologies applied to high-risk medical devices for children and formulating recommendations for their assessment.

Recently, this task has gained traction among European medical professionals (and especially paediatric cardiologists) and it has become a political issue, because of increasing concerns that certain high-risk and orphan medical devices for children may become unavailable as they are pulled from the market by manufacturers who struggle to meet the new EU MDR requirements and deadlines (despite the recent postponement of the date for its full implementation until 2027).

Eighteen experts from various paediatric clinical specialities and European paediatric subspecialty associations, as well as regulatory authorities, attended a CORE-MD workshop on January 16th, 2023, at the Dr. von Hauner Children’s Hospital in Munich, Germany. Presentations and discussions focused on the urgent need to ensure the continued availability of high-risk medical devices for children. These experts will support the development of appropriate guidance for clinical evaluation of high-risk medical devices for children (for example at the Task Force for Orphan Medical Devices, that has been set up by the European Commission) but they also highlighted the need for political decisions to secure children’s access to healthcare.

The group will publish a scientific article summarizing their recommendations, and members will work with their national and subspecialty pediatric associations to raise awareness about the impact of the EU MDR on the availability of essential medical devices for pediatric patients.