The EU Commission announced that the timeline for completing and implementing EUDAMED has shifted out 1 year. The new timeline sets the release of all six modules in the second quarter of 2024 with mandatory use of the actors, vigilance, clinical investigation and performance studies, and post-market surveillance (PMS) modules in Q4 2024. Use of the UDI/device registration and notified-body certificate modules will be required in Q2 2026. Voluntary use of the actors, UDI/device registration, and notified-body certificate modules is still currently in effect.
Rimsys views the impact of this announcement for each stakeholder group as follows:
Rimsys will continue to develop the UDI and PMS functionality regardless of the delay. We also recognize that this delay may potentially impact our ability to build solutions which are capable of interacting with EUDAMED in a machine-to-machine (M2M) capacity. We have no plans to slow the development of our product, however, and we will continue to strive to deliver best-in-class functionality. Direct interaction with the UDI module remains a priority, along with future interaction with the vigilance module.
We suspect there will be hesitation to implement/submit data from medical device manufacturers and others in the industry, due to uncertainties with the stability and potential rework caused by subsequent changes within the modules. While the instinct to delay implementation is understandable (we suspect industry will continue to monitor progress and then re-engage with a push at the end of 2023/ beginning of 2024) we strongly recommend that companies do not relax their efforts due to the complexities in collecting, structuring, validating, and submitting all the required data. Do not underestimate the amount of time it will take to implement EUDAMED!
There is no change in the EU Commission’s strong recommendation that industry submit data on a voluntary basis as soon as they are able. The commission’s position is that submitting data now will give companies an advantage by allowing for time to work with the commission resources if data submission issues occur, before the onslaught of activity that is bound to occur as deadlines approach. This is counter to the likely industry position described above.
We expect further delays in some countries that have not yet fully established UDI data submission requirements. Some of these countries (i.e., Australia) have delayed their implementation until EUDAMED is up and running. We will continue to monitor the situation and will provide updates.
* 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.