EUDAMED Implementation 2026: Key Changes and National Adaptations

The EUDAMED Implementation 2026 will require mandatory use of four key modules in the European database on medical devices from 28 May 2026. These cover registration of economic operators, device registration via UDI, notified bodies and certificates, plus market surveillance, following earlier voluntary phases and prior INFARMED communications.

Mandatory Rollout of Core EUDAMED Modules

Four modules of the European database become compulsory on 28 May 2026. The change directly supports Regulations (EU) 2017/745 and 2017/746 and builds on voluntary availability of three modules since 2024.

National System Integration and Data Reuse

Portugal’s Sistema de Informação para Dispositivos Médicos is being aligned with EUDAMED Implementation 2026 to reuse data, cut duplication and simplify national notifications. The Nomenclatura Portuguesa de Dispositivos Médicos will be gradually replaced by the European Medical Device Nomenclature while preserving existing commercial and labelling records.

Technical Preparations and Temporary Downtime

Updates to the national platform will map Código de Dispositivo Médico entries to UDI-DI data and maintain access to certificates and documentation. The system will be unavailable between 26 and 28 May 2026 to finalise these links before resuming full operation alongside the European database.

Strengthened Surveillance and Reduced Burden

The unified platform improves traceability for authorities, notified bodies and sponsors while lowering administrative workload. Public information stays openly accessible and restricted sections remain available to authorised users, preserving INFARMED’s central role in market oversight and healthcare procurement.