The Commission has come to the conclusion that that it will only be possible to make EUDAMED operational once the entire system and its different modules have achieved full functionality and have been subject to an independent audit. Therefore, EUDAMED’s launch will be done together for medical and in-vitro diagnostic medical devices, at the original date foreseen for in-vitro medical devices i.e. May 2022.
EUDAMED will contain different modules on actors, UDI and devices, notified bodies and certificates, vigilance, clinical investigations and performance studies and market surveillance.
The date of application of the MDR remains May 2020 and that of IVDR remains May 2022.
The delay will give companies more time to prepare their systems and populate the database once it goes live. It also gives additional time to the European Commission to finish the various EUDAMED modules.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.