EUDAMED Mandatory Timeline: Essential Insights from the Brussels Workshop

EUDAMED Mandatory Timeline: Essential Insights from the Brussels Workshop

The European Commission’s recent workshop in Brussels confirmed a pivotal shift for medical device regulation in Europe. Following Commission Decision 2025/2371, EUDAMED has met its functional specifications, triggering the countdown for mandatory compliance under MDR Article 123.

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Critical Deadlines

The transition to mandatory usage follows a tiered schedule. Organizations must be ready for the following dates:

• 28 May 2026: Modules for Actors, Devices, and Market Surveillance become fully mandatory.
• 28 May 2027: The Certificates module becomes mandatory. However, any certificate issued after May 2026 must be entered into the system immediately.

The Registration Hierarchy

Registration in EUDAMED must follow a strict, logical sequence. You cannot skip steps:

1. Actors: Register the organization and legal entities.
2. Devices: Register product data and UDI-DI.
3. Certificates: Link approved certificates to registered devices.
4. Vigilance: Enter incident reports and safety data.

Actor Registration and Management

To access EUDAMED, users must first establish an EU Login. Every actor is required to appoint at least two Local Actor Administrators (LAA).

• LAA Role: The only users authorized to change organizational data.
• LUA Role: Local User Administrators can be appointed by the LAA to manage general user roles and access permissions.

Playground vs. Production

EUDAMED operates in two distinct environments:

• Playground: Used strictly for training and testing procedures. Data entered here is fictional and cannot be transferred to the live system.
• Production: The live environment for real regulatory data. While drafts can be saved, once a record is confirmed, it is final. Corrections usually require a new version or a formal deletion request via the EUDAMED Desk.

Devices and Market Surveillance

• Basic UDI-DI: This serves as the identifier for a device family. Manufacturers can link multiple UDI-DIs to a single Basic UDI-DI, but legacy devices are limited to a one-to-one link between EUDAMED DI and ID.
• Market Surveillance Triggers: The module is primarily for authorities and notified bodies. Triggers for procedures include Manufacturer Incident Reports, FSCAs, and complaints. Notably, PSURs and trend reports are currently excluded as triggers.

Next Steps: Manufacturers should immediately begin training in the Playground environment, appoint their LAAs, and prepare their internal procedures for device data entry before the May 2026 deadline.