Clinipower Finland Ltd, an EU4MEDTECH project partner, attended the EUDAMED (European Database on Medical Devices) workshop organised by the European Commission on-site in Rome on 8 October 2025. The event was one of three workshops organised by the European Commission in 2025, aimed at supporting stakeholders in the roll-out of EUDAMED.
According to Commission Decision (EU) 2025/2371, published on 27 November 2025, the first four modules of the EUDAMED database (actor registration, UDI/device registration, notified bodies and certificates, and market surveillance) have been declared fully functional. Following this decision, the gradual roll-out of the database proceeds, with the mandatory use of these modules becoming applicable in all EU Member States on 28 May 2026 after a six-month transitional period. The two remaining modules, Vigilance and Post-Market Surveillance, and Clinical Investigations and Performance Studies, are currently under development and will be released when they are mandatory to use. They will be released directly as mandatory, with no period for voluntary use beforehand.
For further details on the decision and the status of EUDAMED from European Commission’s website: https://health.ec.europa.eu/medical-devices-eudamed/overview_en
Clinipower’s Participation in the Workshop
Clinipower participated in the workshop as part of the EU4MEDTECH project, in which Clinipower conducted a user experience study on EUDAMED as one sub-project. On-site attendance enabled deeper information gathering on EUDAMED’s modules, their functionalities, and the timelines for mandatory implementation across Europe. This supported the research objectives and helped ensure that the project’s outcomes remain up-to-date and relevant to MDR and IVDR requirements.
The workshop provided valuable information to stakeholders in preparation for the mandatory use of EUDAMED, and Clinipower’s representatives regarded the event as an excellent opportunity for networking and strengthening regulatory expertise.
What is EUDAMED?
EUDAMED is a centralised database for medical devices developed by the European Commission. It supports the implementation of the MDR and IVDR regulations by providing a unified European platform for the registration of medical devices. EUDAMED offers an up-to-date overview of the lifecycle of devices available in the EU, enhances transparency and coordination between member states, and assists economic operators, notified bodies, and authorities in complying with regulatory requirements.
EUDAMED consists of six modules, with the following readiness status:
- Actor registration: Available since December 2020.
- Unique Device Identifier (UDI)/Device registration: Available since October 2021.
- NBs and certificates: Available since October 2021, except for the inspection mechanism and the clinical evaluation consultation procedure (CECP) functions.
- Clinical investigations and performance studies: Not yet available.
- Vigilance and post-market surveillance: Not yet available.
- Market surveillance: Not yet available.
Except for Finland, the available modules are currently voluntary for economic operators in Europe. In Finland, the use of EUDAMED became mandatory in 2021: registration of MD and IVD operators starting from 26 May 2021, and registration of devices starting from 21 December 2021.
Workshop Content
The workshop provided a comprehensive overview of EUDAMED through five structured sessions. The first session introduced the MDR/IVDR regulations, described EUDAMED’s legal basis, obligations, and purposes, as well as the plan for its gradual roll-out. Additionally, the session outlined EUDAMED’s structure, which consists of six integrated modules. Key information sources were also highlighted, including official websites, information centres, and guidance documents.
The remaining sessions addressed EUDAMED’s functionalities on a module-by-module basis (Actors, UDI/Devices, NBs & Certificates, and Market Surveillance). They delved into each module’s purposes, scope, functionalities, and main business rules.
According to the plan presented at the workshop, the mandatory use of EUDAMED across Europe will become in the second quarter of 2026; a notice will be published in the Official Journal of the EU six months prior to this date.
