ndatory Use of First Four EUDAMED Modules from 28 May 2026
To enhance transparency and safety in medical device regulation, the European Commission has confirmed that the first four modules of the European Database on Medical Devices (EUDAMED) will become mandatory for use starting 28 May 2026.
The announcement marks a major step in the transition of EUDAMED from its development phase to full regulatory operation, significantly affecting economic operators, notified bodies, and regulatory authorities involved in placing medical devices on the European market.
Official announcement:
https://health.ec.europa.eu/latest-updates/eudamed-four-first-modules-will-be-mandatory-use-28-may-2026-2025-11-27_en
I. Overview of EUDAMED
EUDAMED (European Database on Medical Devices) is a centralized database established under the Regulation (EU) 2017/745 (MDR).
The system is designed to:
- Improve market transparency
- Strengthen regulatory oversight
- Enhance traceability of medical devices
EUDAMED consists of several interconnected modules, each covering a specific area of the medical device regulatory framework.
II. Key Implementation Timeline
The transition to mandatory use follows a structured regulatory timeline:
- 26 November 2025
The European Commission adopted Commission Decision (EU) 2025/2371, confirming that the first four EUDAMED modules are fully functional. The decision was published in the Official Journal of the EU. - 28 May 2026
The four modules move from voluntary use to mandatory implementation.
From this date onward, all relevant stakeholders placing medical devices on the EU market must use these modules for registration and data submission.
For devices already on the market but not yet registered in the system, transitional deadlines (commonly extending to November 2026) may apply for completing registration to maintain compliance.
III. The Four Mandatory EUDAMED Modules
Starting 28 May 2026, the following four modules will become mandatory.
1. Actor Registration Module
This module registers all economic operators involved in the medical device supply chain, including:
- Manufacturers
- Authorized Representatives
- Importers
- System/Procedure Pack Producers
Once registered, each operator receives a Single Registration Number (SRN), which serves as the primary identification number for regulatory interactions and device submissions within the EU system.
2. UDI / Device Registration Module
This module records the Unique Device Identification (UDI) and essential product information.
It includes:
- Device identification data
- Risk classification
- Market placement information
All devices newly placed on the EU market after the mandatory date must be registered in this module before market placement.
UDI registration significantly improves device traceability, safety monitoring, and recall efficiency.
3. Notified Bodies & Certificates Module
This module allows EU Notified Bodies to upload conformity assessment results and certificates issued for medical devices.
Information that may be published includes:
- Certificate type
- Scope of certification
- Validity status
This mechanism increases transparency around conformity assessment activities and allows regulators and stakeholders to verify certificate status more easily.
4. Market Surveillance Module
The Market Surveillance module supports coordination among EU Member State authorities regarding regulatory enforcement activities.
It enables authorities to share:
- Inspection findings
- Regulatory actions
- Risk management information
Centralized data sharing helps regulators monitor device performance and respond more effectively to emerging safety risks.
IV. Regulatory Significance
Unified Regulatory Platform
EUDAMED provides a single EU-wide regulatory data platform, reducing duplication across national systems and improving regulatory efficiency.
Increased Transparency
Publicly accessible information—including device registrations, UDI data, and certificate status—enhances visibility for regulators, industry stakeholders, and the public.
Stronger Compliance Expectations
Manufacturers, authorized representatives, and importers must ensure that EUDAMED registration requirements are completed within the new timeline to avoid regulatory risks such as market access restrictions or enforcement actions.
V. Future Development
Following the mandatory implementation of the first four modules, additional EUDAMED modules remain under development, including:
- Vigilance / Post-Market Surveillance
- Clinical Investigations & Performance Studies
These modules are expected to become operational and mandatory in the coming years, further expanding EUDAMED’s coverage across the entire lifecycle of medical devices in the EU market.