Since the gradual implementation of Regulation (EU) 2017/745 (MDR), the European database EUDAMED has become an increasingly operational tool for structuring transparency, traceability, and monitoring of medical devices. In 2026, certain EUDAMED modules reach a significant milestone: data entry and maintenance are no longer just a "project" task but a compliance process to be managed continuously.
A Shift in Nature: From "Filling In" to "Maintaining Consistency"
EUDAMED is not just a simple registry. The database is built with interconnected modules designed to support regulatory uses (identification, traceability, certificates, clinical investigations, vigilance, market surveillance, etc.) as the modules are progressively deployed.
For manufacturers, the main challenge is not just filling in fields but ensuring that the declared data are:
- accurate and complete,
- up to date,
- traceable (who changed what, why, and when),
- consistent with source elements of the documentation system (technical file, labeling/IFU, clinical strategy, PMS, etc.), even if these documents are not fully "deposited" in EUDAMED.
Concrete Obligations in 2026
The MDR does not set a single calendar frequency for updates "every X days/weeks" for EUDAMED. However, it imposes a continuous compliance obligation: whenever a relevant change occurs, the affected data must be updated without undue delay. This is precisely what transforms EUDAMED into an operational daily issue.
In 2026, a key milestone to integrate into planning is the start of the obligation for certain uses/modules once the functionality has been officially notified and the associated regulatory deadlines have passed. For example, MDCG positions indicate a start date of May 28, 2026, for the mandatory use of the UDI/Devices module (as part of the gradual deployment).
What This Means in Practice for RA/QA Teams
In many SMEs and mid-sized companies, EUDAMED updates still rely on manual sequences: information extraction, re-entry, and occasional checks before audits or inspections. This operational mode exposes them to recurring risks:
- transcription errors,
- partial updates (one source updated, another forgotten),
- divergences between versions,
- insufficient traceability of modifications.
As data and document volumes increase, the challenge shifts: the burden is not so much the act of declaration but the ability to demonstrate, over time, the reliability and consistency of the information.
Towards Industrialized Verification (Without Automating Regulatory Decisions)
In this context, a recurring need arises: to make consistency checks more reliable and faster (source comparison, gap detection, identification of missing information), while keeping decision-making and validation at the expert level.
This is the logic behind emerging tooling approaches: automation of repetitive verifications, generation of discrepancy lists, and traceability of performed checks to facilitate internal reviews and exchanges with third parties.
Conclusion
In 2026, EUDAMED is not "just another form." The gradual deployment and the mandatory nature of certain modules make data consistency an issue of continuous control. Manufacturers who structure a robust process (data governance, traceability, consistency checks) reduce the risk of discrepancies and gain peace of mind during regulatory reviews.