Insights
Medical Devices – Countdown to Mandatory Use of EUDAMED Modules Begins
On 27 November 2025, the European Commission published Decision (EU) 2025/2371 in the Official Journal of the European Union, officially confirming that the first four modules of the European Database on Medical Devices (EUDAMED) meet the required functional specifications.
The modules concerned are:
- Actor registration
- UDI/Device registration
- Certificates
- Market surveillance
As foreseen in Article 123(3)(d) of the Medical Devices Regulation (MDR), this decision triggers a six-month countdown: mandatory use of these EUDAMED modules will begin on 28 May 2026.
This milestone marks a critical step toward the full implementation of EUDAMED and represents a major advancement in transparency and traceability within the EU medical device sector. The mandatory activation of these modules will streamline data exchange among stakeholders and strengthen regulatory oversight.
Stakeholders are strongly encouraged to prepare for this transition by ensuring their systems and data are aligned with EUDAMED requirements.
RPN will provide any further update and is available to provide full support for Medical Devices registration in EUDAMED.