Continuing challenges for the implementation of the EU Medical Devices Regulation (MDR) will be discussed by health ministers during the EPSCO meeting on 9 December.
The BioMed Alliance believes that a variety of measures is necessary. It will support an extension of the recertification deadline of 26 May 2024, on condition that standards for clinical evidence are maintained. Added time should be used by policy makers to rectify issues that inhibit full implementation of the MDR, including the capacity of notified bodies and the need for a special framework to support the development and certification of orphan medical devices.
Manufacturers should also use the extra time to send in applications of sufficient quality as soon as possible. At the same time, the Medical Device Expert Panels should play a greater role in the early dialogue with manufacturers, and registries should be used to support certification with conditions for market surveillance, as they already provide a wealth of information on the safety of devices and their impact on clinical outcomes. Policy makers should also consider setting up conditional approval procedures in exceptional circumstances to serve as a measure of last resort for devices that are at risk of disappearance and are used to treat life threatening conditions.
More information here
