Rimsys POV: new EUDAMED timeline

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:

5 modules (Actor, UDI & Device, Certificates, Market Surveillance and Vigilance) are planned to be ready for audit by Q2 2024. The audit for these 5 modules is foreseen to be completed by Q1 2025.
The development of the Clinical Investigation/Performance Studies (“CIPS”) module is intended to continue from Q2 2024 to Q3 2026. The above audit will then continue by assessing the CIPS module together with the other 5 modules.
The new target date for EUDAMED full functionality is Q2 2027 (best case scenario). Once it is declared fully functional, this triggers transition periods until the mandatory use of its modules, now foreseen as being: ‍

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.)

‍

Photo courtesy of the European Commission

Here is how Rimsys views the impact of this announcement for each stakeholder group:

Rimsys

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.

Industry

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

EU Commission

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

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.

‍

Bruce McKean is the Director of Regulatory at Rimsys and has more than 25 years of medical device industry experience as a regulatory professional specializing in quality and regulatory (Q&R) compliance, audits, design controls, and Q&R-related mergers and acquisitions. Before joining Rimsys, Bruce served as Director of Q&R at Philips, where he led numerous corporate-wide Q&R programs which included: Medical Device Single Audit Program (MDSAP) compliance initiative, mergers and acquisitions, industrial footprint transitions (site closures/moves), and EU Medical Device Regulations (EU MDR).

‍

* 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.

‍