EU Medical Device Regulation threatens therapies for children with rare diseases - Open letter

European specialist societies have written an open letter to the European Commission urging it to ensure the supply of essential medical devices for children with rare diseases.


The EU Medical Devices Regulation 745/2017 has brought about a significant increase in the time and cost involved in bringing medical devices to market and keeping them on the market. This has prompted manufacturers to adjust their strategies by selling medical devices in lower volumes, withdrawing them from the EU market, or remarketing them in other jurisdictions.

As a result, the pediatric and rare disease community in the European Union is currently facing the loss of important medical devices that are essential for adequate patient care.

To express the urgent need for action to ensure continued access to important medical devices medical devices for children and for patients with rare diseases, a joint open letter from numerous specialist societies was sent to the European Commission. ERKNet supports the concerns formulated.

Find the open letter here.

In addition, please see the important article (click here) published in Kidney International that powerfully illustrates the disparity in the availability of urgently needed medical devices for small children who require long-term hemodialysis.