European Commission confirms phased mandatory roll-out of Eudamed modules for medical devices
Published on 11th June 2025
New timeline from Stuttgart workshop details compliance deadlines for medical device and diagnostics companies under updated framework
The European Database on Medical Devices (Eudamed) is transitioning to a phased implementation model following useful updates from the European Commission’s Stuttgart workshop in May 2025. This shift, enabled by recent regulation (EU) 2024/1860, replaces the previous all-or-nothing approach with a module-by-module activation system.
The new framework prioritises functionality audits and staggered compliance deadlines, offering medical device and diagnostics businesses clearer planning parameters, while maintaining the system’s core objectives of transparency and traceability.
Regulatory context and Eudamed framework
Eudamed's legal foundation stems from the EU's Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). Although they are currently being reviewed at EU level as part of a targeted evaluation, the regulations are applicable since May 2021 (MDR) and May 2022 (IVDR), and introduced extended transitional periods for legacy devices certified under previous directives. The 2024 amendment specifically enables individual Eudamed modules to become mandatory once independently audited and declared functional, bypassing the previous requirement for full system completion.
The system comprises six, interconnected modules:
- Actor registration
- UDI/device registration
- Notified bodies and certificates
- Clinical investigations and performance studies
- Vigilance and post-market surveillance
- Market surveillance
Each module supports specific compliance obligations, from economic-actor registration (the actor module) to post-market surveillance reporting (the vigilance module), with data accessibility split between public interfaces and restricted portals for authorised users.
Key timeline clarifications
A recent Stuttgart workshop held by the Commission provided critical implementation details, including a draft timeline assuming the first Official Journal of the European Union (OJEU) functionality notice in July 2025.
Under this schedule, actor registration, UDI/Device registration, and notified bodies/certificates modules – currently voluntary – could become mandatory by the first quarter of 2026. Remaining modules (Vigilance, Clinical investigations, Market surveillance) would then follow individual audit completions.
A six-month transition period begins upon OJEU publication for each module, after which non-compliance may carry regulatory consequences.
For example, new devices entering the EU market post-mandatory UDI/device module activation will require registration before market placement. Legacy devices already on the market will need to complete UDI/device registration within 12 months of the relevant OJEU notice. Notified bodies have 18 months to register pre-mandatory certificates for MDR or IVDR-compliant devices.
Strategic implications
Manufacturers and authorised representatives are encouraged to prioritise data standardisation and system integration to meet staggered deadlines. The Commission mandates UDI/device registration for legacy devices if identical MDR/IVDR devices (matching UDI-DI/catalogue numbers) exist, creating dual compliance tracks.
Notified bodies face compressed timelines for certificate registration, particularly for decisions impacting pre-mandatory certificates. Proactive collaboration with manufacturers on data alignment may help mitigate bottlenecks.
Non-EU manufacturers will require robust coordination with EU representatives to ensure timely actor registration and device data submissions, as non-compliance could risk market access disruptions.
The Commission’s onboarding strategy includes further hybrid workshops in Rome (October 2025) and Brussels (December 2025), complemented by targeted training materials and video tutorials.
Osborne Clarke Comment
The Stuttgart workshop outcomes mark a watershed in Eudamed implementation, replacing uncertainty with a structured compliance pathway. While the phased approach reduces systemic risk, businesses may wish to consider proactive strategies to navigate overlapping deadlines and evolving guidance. Many businesses are now considering how best to prepare for the phased introduction of Eudamed’s modules.
It may be helpful to keep a close watch on the publication of OJEU notices, as these will mark the start of each six-month transition period for the relevant module. Reviewing and updating internal data processes – particularly those related to device identification, clinical investigations, and post-market surveillance – can support readiness as new requirements come into force. Participation in the Commission’s ongoing workshops and training sessions, as well as making use of the Eudamed information centre, Playground, for testing, may also prove valuable for teams seeking to familiarise themselves with the system’s functionalities. For organisations operating from outside the EU, ensuring good communication and data flow with EU-based representatives and importers will help to smooth the registration process and avoid unnecessary delays.
