EUDAMED Is Now Mandatory: What Changes for Medical Device Manufacturers and Importers?

Published by Passarini Group | Regulatory Affairs & International Market

As of May 28, 2026, the European medical device sector has undergone a significant structural transformation: four modules of EUDAMED—the European Database on Medical Devices—have become mandatory across the European Union. If your company manufactures, imports, or distributes medical devices within the European market, this article is essential for maintaining regulatory compliance.

What Is EUDAMED?

EUDAMED is the information system developed by the European Commission to implement Regulations (EU) 2017/745 (MDR—Medical Device Regulation) and (EU) 2017/746 (IVDR—In Vitro Diagnostic Regulation). It functions as a large, centralized database designed to bring greater transparency, traceability, and safety to the lifecycle of medical devices available in the European market.

In practical terms, EUDAMED centralizes information within a single European system regarding who manufactures and imports devices, which products are on the market, which certificates have been issued, and what actions are being taken by surveillance authorities. Once fully operational, the platform will also include data on clinical investigations and post-market surveillance.

The Regulatory Landmark: How Did We Get Here?

The mandatory enforcement of the first four modules was triggered by the publication of the European Commission’s Decision (EU) 2025/2371 in the Official Journal of the European Union on November 27, 2025. This decision confirmed that these modules had successfully passed an independent audit and were technically ready for operation.

Based on Regulation (EU) 2024/1860, this publication initiated a six-month transitional period—which expired on May 28, 2026, the date from which their use became strictly mandatory.

Which Modules Are Now Mandatory?

EUDAMED is structured into six interconnected modules. The first four are now mandatory:

1. Actor Registration (Economic Operators) — Mandatory since 05/28/2026 Manufacturers, authorized representatives, importers, and producers of systems or procedure packs must be registered in this module.

2. UDI / Device Registration — Mandatory since 05/28/2026 For new devices placed on the European market under the MDR/IVDR, registration in the UDI/Device module must be considered an essential step prior to making the product available on the market, as applicable.

3. Notified Bodies and Certificates — Mandatory since 05/28/2026 Centralizes information regarding certifications issued by responsible notified bodies across the EU.

4. Market Surveillance — Mandatory since 05/28/2026 (for Competent Authorities and the European Commission)

The remaining two modules—Clinical Investigations and Performance Studies and Post-Market Surveillance—are still under development. A critical feature to note: there will be no voluntary period before they become mandatory.

What Changes in Portugal: Integration with the SIDM

For companies operating in the Portuguese market, the operationalization of EUDAMED is accompanied by an important update to the SIDM—the Medical Device Information System (Sistema de Informação para Dispositivos Médicos), managed by INFARMED.

The SIDM has been adapted to link directly with the European database, aiming to achieve clear goals: streamline processes, prevent duplicate registrations, and reduce the administrative burden on companies.

What changes in practice?

• Existing registrations in the SIDM must be updated to align with the information made available in EUDAMED. The system will provide functionalities to speed up this update, allowing the mapping between the device’s CDM (Medical Device Code) and its respective UDI-DI registered in EUDAMED—thereby preserving the documentation already residing in the system.

• Adoption of the EMDN (European Medical Device Nomenclature): EUDAMED utilizes a standardized European nomenclature. The SIDM will transition to it gradually, phasing out the NPDM (Portuguese Medical Device Nomenclature) for new registrations and updates to existing entries. Consequently, the respective CDMs will be created or updated.

• A faster, more transparent notification process: Reusing information across systems eliminates red tape and creates a more efficient regulatory flow.

The SIDM Is Not Disappearing

It is crucial to clarify: the SIDM maintains its relevant role at the national level, addressing specific requirements that extend beyond EUDAMED’s European scope, such as:

• Supporting national market surveillance;

• Procurement within the scope of the SNS (National Health Service);

• Issuing Free Sale Certificates (FSC).