EU Pediatric Devices Could Be Lost Under MDR, Medical Associations Say

The European Academy of Paediatrics (EAP) and 22 other European medical associations have written to the European Commission (EC) to warn that critical pediatric medical devices are being squeezed out of the market by the high cost of implementing the EU Medical Device Regulation 745/2017 (EU MDR).

An open letter from the groups — which include the European Association for Paediatric and Congenital Cardiology and the European Paediatric Surgeons’ Association — to EC Commissioner Stella Kyriakides says that while EU MDR is aimed at improving the evaluation and safety of high-risk medical devices, its implementation has unintentionally resulted in increased time and costs for manufacturers, causing some to pull their products from the market.

The transition period for the EU MDR has been extended, but the groups said in their letter that this will not halt the disappearance of essential medical devices for children from the EU market, as there also must be a contract for conformity assessment in place between the device manufacturer and a notified body by September 2024. And the cost of that contract is very high because of the lack of a sufficient number of notified bodies.

For example, one company received invoices of more than 800,000 euros ($873,266) for conformity assessment for a single device that would give the device five years market access at most — more than 150 times the cost of a U.S. lifetime market access for the same device, the letter says.

Read the letter here.

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