Brussels, 18 August 2023 – Paediatricians across Europe have voiced serious concerns about the evolving shortages of medical devices in the European Union (EU) that are essential for treating sick children. Devices are withdrawn from the market due to markedly increased regulatory requirements and high costs of certifying devices under the revised EU Medical Device Regulation. Urgent action is therefore needed to protect the access to essential medical devices for children.
As part of the EU CORE-MD project (Coordinating Research and Evidence for Medical Devices), the European Academy of Paediatrics (EAP) hosted a high-level expert workshop at the Ludwig Maximilians University Munich, Germany. Experts developed recommendations on clinical investigation and on clinical evaluation of paediatric medical devices considered to be of “high-risk”. Experts from a variety of paediatric clinical subspecialties and European paediatric associations, as well as from a regulatory authority and from the European Commission Directorate General Health and Food Safety contributed.
The paediatric experts agreed on key elements for clinical investigation and evaluation of high-risk medical devices for children:
The expert recommendations are published in Acta Paediatrica
New ways to test high-risk medical devices.
Manufacturers of medical devices need to test their products before being allowed to market them. Specifically, they require clinical data showing their medical device is safe and efficient. In this context, the EU-funded CORE-MD project will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators. The project will propose how new trial designs can contribute and suggest ways to aggregate real-world data from medical device registries.
It will also conduct multidisciplinary workshops to propose a hierarchy of levels of evidence from clinical investigations, as well as educational and training objectives for all stakeholders, to build expertise in regulatory science in Europe. CORE–MD will translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators, to achieve an appropriate balance between innovation, safety, and effectiveness. A unique collaboration between medical associations, regulatory agencies, notified bodies, academic institutions, patients’ groups, and health technology assessment agencies, will systematically review methodologies for the clinical investigation of high-risk medical devices, recommend how new trial designs can contribute, and advise on methods for aggregating real-world data from medical device registries with experience from clinical practice The consortium is led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, and involves all 33 specialist medical associations that are members of the Biomedical Alliance in Europe.
