No longer just a rumor, EUDAMED’s delay was confirmed by the European Commission (EC) on October 30, 2019. The ongoing work on the new EUDAMED database implementation is aimed to improve transparency and coordination of information regarding Medical Devices available on the EU market.
EUDAMED will be used to monitor the safety and performance of devices and is part of the EU’s broader overhaul of device regulation.
The current state of play of the implementation of EUDAMED is as follows:
- EUDAMED will contain different modules on:
- Actors (manufacturers and economic operators);
- UDI & devices;
- Notified Bodies & certificates;
- Vigilance;
- Clinical investigations and performance studies;
- Market surveillance.
- Only when the entire system and its different modules would have achieved full functionality and would have been subject to an independent audit, will it be possible to make EUDAMED operational;
- The new EUDAMED launch date will coincide with the implementation date foreseen for in-vitro Medical Devices (May 2022) and will be done simultaneously for both medical and in-vitro diagnostic Medical Devices.
On a similar note, although not confirmed yet, the EC has initiated another “corrigendum” to the MDR (UE) 2917/745 (the first one was published in May, 2019) requesting a four-year transition period for Class l devices that are up-classified under the MDR, like class Ir.
If approved by the European Parliament, this amendment would prevent an undersupply of class Ir Medical Devices (Class I devices represent 40% of all medical devices), allowing manufacturers four more years to achieve compliance and giving the few Notified Bodies designated under MDR a chance to focus on high-risk devices first.
