As of 28 May 2026, it will be mandatory to use the first four modules of the European database on medical devices. This follows a decision published by the European Commission.
On 27 November 2025, the European Commission published Decision (EU) 2025/2371 confirming the functionality of the first four modules of EUDAMED, the European database on medical devices.
From 28 May 2026, use of the following modules will therefore be mandatory.
• Actor registration
• Unique device identification (UDI) and device registration
• Notified bodies and certificates
• Market surveillance
The other two modules (Vigilance and Post-Market Surveillance and Clinical Investigations and Performance Studies) are currently being developed and will be mandatory following a new publication in the Official Journal of the European Union (EU).
EUDAMED aims to increase transparency, improve access to information and facilitate coordination between Member States.
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Eudamed