A new Meeting Report has been published from Acta Pediatrica by the authors: Kathrin Guerlich, Bernadeta Patro-Golab, Alex Barnacle, Ulrich Baumann, Andreas Eicken, Alan G. Fraser, Dariusz Gruszfeld, Nikolaus A. Haas, Anneliene H. Jonker, Michael Kammermeier, Damien Kenny, Sanja Kolaček, Risto Lapatto, Ian Maconochie, Silke Mader, Gearóid McGauran, Tom Melvin, Oliver Muensterer, Paul Piscoi, Alberto Romano, Amulya K. Saxena, Dominik T. Schneider, Mark A. Turner, Johan Vande Walle, Berthold Koletzko, the European Academy of Paediatrics.
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.
Putting a broken arm in plaster, delivering drugs and fluids via an infusion pump, or implanting a prosthetic heart valve to replicate native valve function: These medical interventions would not be possible without the use of medical devices. In the European Union (EU) the Medical Device Regulation (EU 2017/745; MDR) aims at ensuring the safety and efficacy of medical devices by regulating their approval for introduction to the EU market. […]
Recently, European clinicians and their associations have expressed concerns about serious shortages of some paediatric high-risk medical devices in the EU. A report on orphan medical devices and paediatric cardiology and a survey on the availability of medical devices by the Biomedical Alliance in Europe indicate that a large number of devices that are essential for treating sick children have been withdrawn from the market. […] Manufacturers indicate that devices are being withdrawn from the market because they cannot shoulder the increased regulatory requirements that result from implementation of the EU MDR,1 whose original goal was to ensure the safety of patients.
The project ‘Coordinating Research and Evidence for Medical Devices’ (CORE-MD) is an EU Horizon 2020 funded project that reviews methodologies for the clinical investigation and evaluation of high-risk medical devices. It aims to recommend an appropriate balance between clinical efficacy, safety, innovation and availability for meeting patient needs. […] As part of this task, EAP (European Academy of Paediatrics) hosted a high-level expert workshop on 16 January 2023 at Ludwig Maximilian University Munich, Germany, followed by a further virtual meeting on 23 March 2023.
The report explains the aims and conclusions of the workshop within the following sections:
- Introduction
- Aims and Objectives of the Workshop
- Methods
- Results
To continue reading the report, you can find the original source here and the pdf file here.
