The European Commission organized a hybrid workshop in Stuttgart on May 21, 2025, to support the integration of all relevant stakeholders into EUDAMED. The workshop provided an overview of the obligations under the Medical Devices and Medical Devices for In Vitro Diagnostic Use Regulations, as well as practical guidance on using the platform.
An overview of the scheduled release dates for the feature announcements, as well as the deadlines for mandatory use of the six modules, is available below:
- Module: Stakeholders
Estimated dates for the publication of the functionality notice: July 2025
Estimated dates for mandatory use: January 2026
This module is the foundation for all use of EUDAMED. It enables the registration of economic operators (manufacturers, authorized representatives, importers) and the assignment of a Single Registration Number (SRN) to them.
- Module: UDI/Devices
Estimated dates for the publication of the functionality notice: July 2025
Estimated dates for mandatory use: January 2026
This module covers the registration of devices by manufacturers in two categories:
1/ Legacy devices, or DM or DMDIV devices, that comply with the directives and were placed on the market before the regulations took effect.
2/ Medical devices that comply with the RDM or RDMDIV. (Each device must be associated with a Basic UDI-DI and may be registered manually or via an M2M exchange.)
Device Registration Requirements:
New DM/DMDIV devices must be registered before they are first placed on the market after the module’s mandatory implementation date. (Effective January 2026, if the notice is published in July 2025).
For devices already on the market, registration is mandatory within 12 months of the publication of the notice in the Official Journal of the European Union. (Effective July 2026, if the notice is published in July 2025.)
- Module: Notified Bodies and Certificates
Estimated dates for the publication of the functionality notice: July 2025
Estimated dates for mandatory use: January 2026
This module centralizes certificates issued, denied, or revoked by notified bodies. It also includes SS(C)Ps (Summaries of Safety and Clinical Performance) and clinical evaluation consultation procedures (CECPs).
Certificate Registration Requirements: Certificates issued after the mandatory effective date must be registered immediately. Certificates issued before the mandatory effective date must be registered within 18 months.
- Module: Market Surveillance
Estimated dates for the publication of the functionality notice: July 2025
Estimated dates for mandatory use: January 2026
This module is intended for competent authorities only and includes:
- Annual and quadrennial monitoring reports.
- Final inspection reports.
- Information on devices that pose an unacceptable risk or are noncompliant.
- Preventive measures.
It enables enhanced traceability of the measures taken and facilitates the sharing of information among Member States, the European Commission, and notified bodies.
- Module: Vigilance
Estimated dates for publication of the functionality notice: Audit in progress / December 2025
Estimated dates for mandatory use: July 2026
This module allows you to submit:
- incident reports (MIR).
- security corrective actions (FSCA).
- periodic safety update reports (PSURs).
Manufacturers, authorized representatives, and competent authorities are required to submit this information through EUDAMED. Once published, some of this data will become publicly available, helping to enhance transparency and market surveillance.
The audit of the “vigilance” module is scheduled for 2025. Since its implementation is contingent on the publication of the functionality notice in the Official Journal of the European Union (OJEU) at the end of the year, followed by a 6-month transition period, mandatory use is expected to begin in mid-2026.
- Module: Clinical Investigations / Performance Studies
Estimated dates for publishing the feature announcement: Currently in development
Estimated dates for mandatory use: 2026 or 2027
This module allows you to:
- management of the full lifecycle of clinical investigations and performance studies
- the submission of initial notifications, substantial amendments, end-of-study reports, and summaries of results.
Developers and the relevant authorities are the key stakeholders involved in this module, which will enable them to interact directly.
This module is still under development. Depending on the progress of the audit and the publication of the notice in the Official Journal of the European Union, its mandatory use is expected to take effect in 2026 or 2027.
For more details on Eudamed, please refer to the following presentations:
Introduction and Regulatory Framework for the European Database on Medical Devices (EUDAMED)