Medical Devices Update: Council adopts new measures to help prevent shortages!
The European Council recently updated regulations on medical devices to address potential shortages and improve transparency. These changes aim to strike a balance between ensuring device safety and facilitating market access.
Firstly, the transition period for certain in-vitro diagnostic medical devices (IVDs) has been extended. This ensures continued availability of critical IVDs while new safety regulations are implemented.
Secondly, the rollout of the European database on medical devices (EUDAMED) will be gradual. Manufacturers can begin registering devices in existing modules without waiting for the entire system to be complete. Full mandatory registration is expected by late 2025.
Finally, manufacturers are now required to provide advanced notice of potential supply disruptions for critical medical devices and IVDs. This will allow relevant authorities and healthcare providers to prepare and potentially mitigate shortages.
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