Brussels, 27 June 2023 – The European Academy of Paediatrics (EAP) and 22 other European associations dedicated to child health and medical care are joining forces to address the critical issue of maintaining access to essential medical devices for children and other patients with orphan diseases. In an open letter to Commissioner Kyriakides, the EAP calls for urgent action to prevent the loss of crucial medical devices necessary for optimal patient care.

While the EU Medical Device Regulation 745/2017 (EU MDR) aimed to improve the evaluation and safety of high-risk medical devices, its implementation has unintentionally resulted in increased time and costs for manufacturers. For example, one company received invoices of over €800,000 for conformity assessment for a single device for giving at most, 5 years market access. This is over 150 times the cost of a United States lifetime market access cost same device of approximately €5,000. For medical devices for children sold only in small numbers, manufacturers cannot recover such high regulatory costs cannot be recovered, therefore, such products are withdrawn from the market even though they are essential for adequate treatment of children with specific disorders.

The EAP highlights the need for immediate action. The transition period for the EU MDR has been extended, but this will not halt the disappearance of essential medical devices for children from the EU market, because further marketing requires a contract to be in place between the device manufacturer and notified body by September 2024, with very high costs. Additionally, the absence of a comprehensive EU-wide monitoring mechanism hampers the identification of devices at risk of disappearing from the market. The EAP calls for the establishment of an efficient monitoring system to protect public health.