The EU Commission has recently announced that the timeline for completing and implementing EUDAMED has shifted again. The new target date for full functionality is now Q2 2027.
The following information was provided during the Medical Devices Coordination Group (MDCG) EUDAMED WG meeting on 19 October:
Q4 2027 for mandatory use of Actor, Market Surveillance vigilance and CIPS modules
Q2 2029 for mandatory use of UDI & Device, Certificates modules (i.e. this date is when EUDAMED would need to be fully populated with device registrations, etc.)
Will continue to develop the UDI and PMS functionality regardless of the delay. We also recognize the potential impact to our capability to build solutions which are able to interact with EUDAMED in a machine to machine (M2M) capacity. UDI is front of mind as well as future interaction with the vigilance module. Any delays in the development of the requirements needed to establish M2M interaction with EUDAMED that have been caused by the shift will in turn delay our capability to establish these M2M connections.
Reluctance to submit data. There will be less urgency to implement/send data to EUDAMED because of uncertainties with the stability of it and potential rework due to changes within the modules. It is our opinion that industry will continue to monitor, and re-engage with a push Q4 2023 - Q1 2024
No impact, strongly recommends industry to submit data on a voluntary basis, do not wait. The commission position is that submitting data now will give companies an advantage by having their data in before the onslaught of the global medtech industry adding data and the ability to work with the commission resources if data submission issues occur. This is counter to the likely industry position described above.
Non-EU Countries: Delays in some countries that have not established UDI data submission. Some countries have delayed their implementation until EUDAMED is up and running. We will continue to monitor.
* Note - this article includes regulatory interpretations and opinions from the Rimsys team. We try to be as informative as possible, but this information isn’t intended to serve as a substitute for official guidance from regulatory authorities.