The European Commission formally confirmed that EUDAMED, the European Database on Medical Devices, meets required functional specifications. The confirmation affects four key modules: Actor Registration, UDI/Device Registration, Notified Bodies & Certificates, and Market Surveillance. Starting 28 May 2026, use of these modules becomes mandatory for all manufacturers, importers, authorized representatives, and notified bodies operating in the EU.
This development marks a critical milestone in medical device regulation under EU MDR 2017/745 and IVDR 2017/746. Companies targeting the EU market must act now to align processes and maintain compliance.
What is EUDAMED?
EUDAMED is the central information system created by the European Commission to support regulatory oversight under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). It provides a comprehensive view of the lifecycle of medical devices and in‑vitro diagnostic devices in the EU. The system improves transparency for regulators, manufacturers, notified bodies, and the public.
EUDAMED consists of six modules:
- Actor Registration registers manufacturers, authorized representatives, and importers.
- UDI / Device Registration stores unique device identifiers and device metadata.
- Notified Bodies & Certificates tracks conformity assessments and certificates.
- Clinical Investigations & Performance Studies records study data.
- Vigilance & Post‑Market Surveillance manages adverse events and corrective actions.
- Market Surveillance supports monitoring and regulatory enforcement.
Until now, EUDAMED rollout was gradual. Some modules were optional while the full system awaited functional validation.
Formal Confirmation of EUDAMED Functionality
On 27 November 2025, the European Commission published Commission Decision (EU) 2025/2371 in the Official Journal. The decision confirms that the first four modules, Actor Registration, UDI / Device Registration, Notified Bodies & Certificates, and Market Surveillance, meet all required specifications.
A six-month transition period began immediately. From 28 May 2026, all relevant economic operators and notified bodies must use these modules to place devices on the EU market.
Key Deadlines and Obligations EUDAMED Functionality 2026
Operator | Obligation | Deadline |
Manufacturers (new MDR/IVDR devices) | Register devices in the UDI / Device module before placing on market | From 28 May 2026 |
Manufacturers (existing devices already on market) | Register devices in the UDI / Device module if they remain on market | By 27 November 2026 |
Notified Bodies | Upload certificates issued, amended, suspended, withdrawn, or refused | Start 28 May 2026; complete pre-existing certificate submissions by 28 May 2027 |
After 28 May 2026, national or regional registers will no longer meet regulatory requirements. EUDAMED will serve as the single official EU‑wide database for these four modules.
Modules Outside EUDAMED Mandatory Scope
The Clinical Investigations & Performance Studies module and the Vigilance & Post‑Market Surveillance module have not yet been declared fully functional. Regulators plan to release them in later phases. Until then, national systems remain in use for these functions under transitional provisions.
Mandatory use in May 2026 applies only to the four confirmed modules. Full EUDAMED‑wide implementation will follow the EU roadmap.
Implications for Industry
- Manufacturers and Importers: Device registration and UDI compliance become essential for market access.
- Notified Bodies: Internal processes must adapt to upload certificates and maintain accurate records in EUDAMED.
- Global Companies Exporting to EU: Delays in compliance may prevent devices from entering the EU market after 28 May 2026.
- Data Accuracy: Correct device classification, UDI, and EMDN codes are critical.
Benefits for Regulators
- EUDAMED provides a centralized database with harmonized and up-to-date information.
- Regulators gain stronger market surveillance capabilities and coordinated responses to recalls, safety notices, or withdrawals.
- Public transparency increases, improving patient safety and risk management across the device lifecycle.
Conclusion
The confirmation of functionality for EUDAMED’s first four modules represents a major step in EU medical device regulation. From 28 May 2026, medical device registration, UDI traceability, and certificate reporting become mandatory for all economic operators and notified bodies.
Manufacturers, importers, and regulatory affairs consultants must review processes, ensure data readiness, and align supply chain strategies to remain compliant. This development underscores the growing need for expert regulatory support in global medical device compliance.
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