The European database EUDAMED (European Database on Medical Devices) has entered a decisive new phase.
With a decision adopted on 26 November 2025, the European Commission officially confirmed the full functionality of several EUDAMED modules, thereby triggering their mandatory use within a clearly defined timeline
This decision represents a major milestone in the operational implementation of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), with direct consequences for manufacturers, authorised representatives, importers, notified bodies and competent authorities across the European Union.
EUDAMED: regulatory background
EUDAMED is the central European database established under the MDR and IVDR.
Its objectives are to strengthen:
- traceability of medical devices through the UDI system (Unique Device Identification),
- transparency of the European market,
- post-market surveillance and vigilance,
- coordination between Member States.
The European Commission has consistently presented EUDAMED as a cornerstone of the new medical device regulatory framework, designed to replace fragmented national systems with a single, harmonised European infrastructure (European Commission – EUDAMED presentation).
EUDAMED European Commission.
The 26 November 2025 decision: a regulatory trigger
Until now, the use of EUDAMED relied largely on transitional mechanisms, pending official confirmation of its full functionality.
The European Commission decision of 26 November 2025 fundamentally changes this situation.
The Commission formally established that four EUDAMED modules are now fully functional, within the meaning of the MDR and IVDR
In accordance with the regulations, this confirmation automatically triggers the mandatory use of these modules from 28 May 2026.
This date is not arbitrary: it corresponds to the end of several transitional arrangements and marks the moment when EUDAMED becomes the primary regulatory entry point at EU level.
Which EUDAMED modules become mandatory?
From 28 May 2026, the use of the following four EUDAMED modules becomes mandatory for the relevant economic operators.
1. Registration of economic operators
Manufacturers, authorised representatives, importers (and, where applicable, distributors) must be registered in EUDAMED.
This registration is a prerequisite for obtaining the Single Registration Number (SRN), which is required to access other EUDAMED modules and to interact with notified bodies and competent authorities.
2. Device registration and UDI identifiers
Medical devices must be registered in EUDAMED with their UDI-DI identifiers, significantly reinforcing traceability across the European market.
Important clarification: authorised representatives and importers have read-only access to this module, while manufacturers remain responsible for data entry and maintenance.
3. Notified bodies and certificates
This module contains information on CE certificates issued for medical devices and on the notified bodies that issued them.
It allows authorities and stakeholders to quickly verify whether a medical device holds a valid certificate and complies with applicable regulatory requirements.
4. Market surveillance
The market surveillance module is designed to facilitate real-time information exchange between national competent authorities.
It includes data on:
- non-compliant devices,
- enforcement measures,
- inspections,
- outcomes of cooperation between Member States.
Information shared in this module may lead to coordinated regulatory actions at EU level.
What changes in practice for medical device stakeholders
With this decision, EUDAMED progressively moves from a “work in progress” tool to a mandatory regulatory system.
For economic operators, this implies in particular:
- rigorous structuring of regulatory data,
- alignment of internal processes with EUDAMED requirements,
- clear articulation between MDR / IVDR, UDI, vigilance and market surveillance,
- reinforced coordination with authorised representatives and notified bodies.
As national transitional systems are gradually phased out, EUDAMED becomes the single reference entry point at European level.
Anticipating EUDAMED compliance
Although the 28 May 2026 deadline may appear distant, achieving EUDAMED compliance requires significant preparation time:
- qualification and validation of regulatory data,
- clarification of roles and responsibilities,
- configuration of user access and governance,
- review of post-market obligations and data flows.
Delaying this preparation increases the risk of non-compliance, data inconsistencies and operational bottlenecks once EUDAMED becomes mandatory.
Conclusion – EUDAMED: a regulatory obligation to anticipate now
The European Commission decision of 26 November 2025 marks a structural milestone in the deployment of EUDAMED.
From 28 May 2026, the mandatory use of the first EUDAMED modules transforms the database into a central pillar of regulatory compliance for medical devices and in vitro diagnostic medical devices in Europe.
Beyond the formal obligation, EUDAMED imposes a more integrated and structured regulatory approach.
Management of economic operators, UDI traceability, notified body certificates, market surveillance and vigilance can no longer be addressed as separate topics. They are now part of a single, harmonised and interconnected European system.
For manufacturers, authorised representatives, importers and other stakeholders, the challenge is not only technical.
It also involves anticipating organisational impacts, securing regulatory data quality, and aligning internal processes with the requirements of MDR (EU) 2017/745 and IVDR (EU) 2017/746.
In this context, expert support from BluePharm can help secure EUDAMED compliance, identify gaps and structure a realistic and robust roadmap ahead of the 2026 deadline.
