Updated EUDAMED roadmap projects mandatory use of some processes as early as December 2025

A quick history of the still incomplete EUDAMED database

• EUDAMED “is the IT system developed by the European Commission (EC) to implement Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).” Article 33 of both regulations outlines “the setting up, maintenance and management of the future EUDAMED by the Commission,” in conjunction with the Medical Device Coordination Group (MDCG), consisting of one member each from each of the EU Member States and chaired by the EC.
• The first version EUDAMED was conceived in 1998 as a “ European databank,” included in the publication of the original In Vitro Diagnostic Devices Directive (IVDD), Directive 98/79/EC. It also contained a clause expanding use to non-IVD medical devices. This database was not publicly accessible, but instead the information was available only to Competent Authorities (CAs) in E.U. countries and Notified Bodies (NBs). This database was created to share post-market surveillance information across E.U. countries and contained information about medical devices, the registration of manufacturers, authorized representatives, certificates, vigilance information and clinical investigation data.
• The publication of the MDR and IVDR reset the purpose of EUDAMED. Many portions of the database are, or are planned to be, publicly available. Article 33 of the MDR and IVDR outlines the intentions for the revised EUDAMED database as part of a wider transparency effort for competent authorities, users and patients of medical devices and diagnostics.
• The plan is for EUDAMED to contain six modules that are released over time, some of which will be publicly available, and other parts available to regulators only. The modules include electronic systems for actor registration; Unique Device Identifier (UDI) and devices registration; Notified Body and certificates; clinical investigations and performance studies; vigilance and post-market surveillance; and market surveillance.
• To date, three of the six modules are available publicly for voluntary use. The Commission released the first module (actor registration) in late 2020. The device and UDI registration module came out in October 2021, as did the module on Notified Bodies and certificates, save for certain clinical functionality. According to Article 34 of the MDR (prior to the latest amendment), the database should have been ready by the time the MDR’s date of application came around, in May 2021. But since then, development has had multiple delays, which are generally blamed on the pandemic, personnel and support of the active portions of the database. Another notable challenge has been development of the clinical investigation and performance study module (CI/PS). Ultimately, this module will interact with CTIS, the drug clinical trial information system.

The last roadmap, released last year in November, reflected some of those delays but was still struggling with the requirement that all of the modules need to be complete and audited before use of any could become mandatory.

• The preceding version of the EUDAMED roadmap, released late in 2023, showed milestones through 2029 for each of the six modules – actor, devices, certificates, market surveillance, vigilance and CI/PS. According to that version of the plan, the actor and market surveillance modules would be complete as of Q4 2023, the certificates module by Q1 2024, the device and vigilance modules by the end of Q2 2024, and the CI/PS module estimated to be ready for Q3 2026.
• The independent auditing schedule showed publication of full functionality in mid-2027. The first five modules would be audited between Q2 2024 and Q1 2025 and the CI/PS module between Q4 2026 and Q1 2027, with publication of complete functionality occurring by the end of Q2 2027.
• When usage would have become mandatory: For all modules save devices and certificates, mandatory usage would have begun six months after the announcement of full functionality (Q4 2027); mandatory verification of the data entry by manufacturers for the devices and certificates module would be required 18 months after the announcement – by the end of Q2 2029.
• Regulators were concerned about that timeline, in part because of concerns around device availability due to the cost and time to implement the regulations. EUDAMED, the database designed for the purpose, would be the best place to track device registration (or lack thereof). But if usage weren’t mandatory until halfway through 2029, which is five years from now, it won’t be useful for tracking this for some time. While the commission is trying to track device availability other ways, these are voluntary and thus an incomplete picture of the landscape. Notably, Parliament suggested a phased rollout of EUDAMED at the EPSCO (Employment, Social Policy, Health and Consumer Affairs Council) meeting in late November 2023.
• The Commission agreed, proposed an amendment to the MDR and IVDR to do just that, and that amendment became law this week. European regulators amended the MDR and the IVDR in several ways, one of which was to allow EUDAMED to be rolled out in a phased manner. Once a module’s development is completed, that module can be audited and the Commission can announce its readiness. After the announcement, stakeholders will have six months to begin mandatory usage, per MDR Article 123(d). The one exception is approval of clinical investigations and performance studies conducted in multiple member states using the coordinated procedure described in MDR Article 78/IVDR Article 74. In this case, member states will have five years after the notification that the clinical module is ready to be required to use it, though they can begin sooner on a voluntary basis as soon as six months after the announcement. [ Read AgencyIQ’s complete analysis of the regulation amendments here.]

This week, in response to the recent amendment to the regulations, the Commission released an updated roadmap reflecting a phased rollout for the EUDAMED database

• In response to the MDR/IVDR amendment, the new roadmap introduced a “current plan” for the gradual rollout of EUDAMED modules. Even though three modules (actors registration, device registration and UDI, and Notified Bodies and certificates) have been in voluntary use for several years the new roadmap shows publication of the notices for these modules in the Official Journal of the E.U. (OJEU) around July 2025. This will include notices for four modules: actor registration, UDI/device registration, Notified Body and certificates, and market surveillance. The announcement that the vigilance module is ready is projected for January 2026. During this same time, work will continue to develop the CI/PS module.
• Mandatory use for some of the modules comes sooner. For the four modules planned to be announced in 2025 noted above, their use would become mandatory at the end of 2025 and mandatory use of the vigilance module would begin around July 2026.
• There’s a notable absence from this roadmap. The roadmap covers a four-year period, from 2024 to 2027, but nowhere in that period is there any indication of an audit or announcement of full functionality for the CI/PS module, though it implies that development on that module will continue to mid-2026.

Analysis:

• The updated EUDAMED plan and roadmap reflects the recent amendments to the MDR and IVDR. Because the amendment removed the requirement that EUDAMED use can only become mandatory when the entire database has been completed and audited, the new roadmap reflects a phased approach to mandatory use of certain modules. The use of four modules is projected to become mandatory by the end of 2025 – the actor and device registration modules, Notified Bodies and certificates and market surveillance. Mandatory vigilance reporting in EUDAMED would, under this timeline, be mandatory by July 2026. This means manufacturers will need to be registered in the database, have those processes in place and are up to date on registration requirements by those dates – they will not have until 2029 or beyond for registering devices and logging vigilance cases.
• But missing from that plan is any mention of the clinical module. Medical Device Coordination Group meetings have talked about the challenges in completing the development of this module, as it includes clinical investigation and performance study applications by manufacturers, as well as public information about clinical and performance studies. Because this also includes device studies that involve drug products, for instance when diagnostics are part of a drug trial, this has complicated development of what was already a complex and ambitious EUDAMED module. Importantly, the use of EUDAMED for coordinated assessment of clinical and performance study investigations that take place in multiple member states has been pushed back five years, to give member states time to put processes in place.

To contact the author of this item, please email Corey Jaseph ( cjaseph@agencyiq.com).
To contact the editor of this item, please email Laura DiAngelo ( ldiangelo@agencyiq.com).

Key Documents and Dates

• News announcement – Updated Timeline – Current planning for gradual roll out and modules’ functionality view, published July 10, 2024.
• Direct link to EUDAMED roadmap.
• EUDAMED Roadmap Backup