The EU Commission has recently announced the most current timeline for completing and implementing EUDAMED based on amendment 2024/1860 to the regulations allowing the release of individual EUDAMED modules once declared fully functional. The new target date for the first mandatory application of functional EUDAMED modules is Q1 2026. The Vigilance module is expected to be mandatory beginning in Q3 2026 with full EUDAMED functionality planned for Q2 2027.

The following information was provided by the European Commission as of October 2024:

• The Actor, UDI & Devices, Certificates, and Market Surveillance modules are planned to be ready for audit by Q3 2024. The independent Minimum Viable Product (MVP) audit is intended to assess and confirm functionality and interconnectivity of the EUDAMED modules that are deemed audit ready.  This audit is foreseen to be completed by Q2 2025.

• The target date for mandatory application of EUDAMED modules declared fully functional is Q1 2026. Mandatory use of each module is to commence six (6) months after the module is declared fully functional through the independent audit and publication in the Official Journal of the European Union (OJEU).

• The Actor, UDI & Devices, Certificates, and Market Surveillance modules are expected to be mandatory beginning in Q1 2026.

• The Vigilance module will not be part of the Q1 2026 mandatory application of EUDAMED. We believe that the audit of this module will be postponed by a few months. This delay will also likely impact the present mandatory application date of Q3 2026.

• The development of the Clinical Investigation/Performance Studies (“CI/PS”) module is intended to continue through Q4 2026.  An audit to assess the CI/PS module together with the other five (5) modules will be completed once the CI/PS MVP has been developed.
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Photo courtesy of the European Commission

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

Rimsys 

UDI is front of mind as well as future interaction with the Vigilance module. There is no change to our current plans as Rimsys will continue to develop UDI and Post Market Surveillance functionality regardless of the updated target dates. We also recognize the potential impact to establish data transfer (DTX) capabilities to interact with EUDAMED in a machine-to-machine (M2M) capacity. With the publication of the final requirements needed for M2M DTX to EUDAMED expected in Q4 2024, Rimsys will finalize our connection and deliver M2M capabilities as part of the EUDAMED solution.

Industry/customer

Since the commission has made multiple updates to EUDAMED timelines, we expect industry will have some reluctance to accept the new target dates. As a result, this could delay re-engagement with EUDAMED preparations. However, we do not expect the commission to push these updated timelines. Manufacturers that don’t have a plan to submit data to EUDAMED by Q2 next year will have significant challenges to overcome in order to meet these deadlines. Rimsys recommends taking steps to organize regulatory data now and in order to submit early to all available EUDAMED modules.

EU Commission

The commission strongly recommends industry continues to establish your solution and to submit data on a voluntary basis. Do not wait. The commission’s position is that submitting data early will give companies an advantage by having their data in before the onslaught of the entire global medtech industry adding data at the time EUDAMED becomes mandatory. These companies will also have the ability to work with the commission resources if data submission issues occur.

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* 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.

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