Updated: 18th June 2026
Reviewed by: David Small BSc (Hons), MSc, MTOPRA (Founder & CEO)
What Does EUDAMED Stand For?
EUDAMED stands for the European Database on Medical Devices. It was established by the European Commission to support the implementation of the MDR and IVDR by creating a central platform for regulatory information relating to medical devices and IVDs.
The database aims to increase transparency for authorities, economic operators, healthcare professionals, and the public while improving coordination between Member States.
New to the EU MDR?
EUDAMED is a key component of the EU MDR, helping improve transparency, device registration and traceability across Europe. For a complete overview of Regulation (EU) 2017/745, including classification, Article 10 obligations, GSPRs, technical documentation, UDI and CE marking requirements, explore our EU MDR for Beginners Guide.
Working with In Vitro Diagnostic Medical Devices?
EUDAMED also plays a central role in the implementation of the In Vitro Diagnostic Medical Device Regulation (IVDR), supporting device registration, transparency and regulatory oversight. For a complete overview of Regulation (EU) 2017/746, including classification, Article 10 obligations, Performance Evaluation, Technical Documentation, UDI and conformity assessment requirements, explore our IVDR for Beginners Guide.
Why Was EUDAMED Created?
EUDAMED was developed by the European Commission to improve transparency, traceability and coordination within the European medical device sector. The database supports the objectives of the MDR and IVDR by providing a central platform for regulatory information relating to medical devices and in vitro diagnostic medical devices.
Prior to the introduction of EUDAMED, information was often fragmented across Member States, making it more difficult to share safety information and coordinate regulatory activities. EUDAMED aims to improve access to information, strengthen market surveillance and enhance patient safety across the European Union.
The Six EUDAMED Modules
EUDAMED consists of six interconnected modules that support different aspects of regulatory compliance and post-market oversight.
1. Actor Registration Module
Registers manufacturers, authorised representatives, importers and system or procedure pack producers, assigning each economic operator a Single Registration Number (SRN) used throughout EUDAMED.
2. UDI and Device Registration Module
Stores information relating to Basic UDI-DIs, UDI-DIs, device models and associated product information, supporting consistent identification and traceability throughout the supply chain.
3. Notified Bodies and Certificates Module
Contains information on designated notified bodies, issued certificates, certificate amendments, suspensions, withdrawals and restrictions, improving transparency for regulators and manufacturers.
4. Clinical Investigations and Performance Studies Module
Supports the submission and management of clinical investigations and performance studies, allowing competent authorities to oversee studies conducted within the European Union.
5. Vigilance and Post-Market Surveillance Module
Facilitates the reporting and management of serious incidents, field safety corrective actions and trend reporting, helping authorities identify emerging safety concerns more quickly.
6. Market Surveillance Module
Enables competent authorities to share surveillance activities, enforcement actions and regulatory decisions across Member States, improving coordination and patient safety.
EUDAMED Today
Since 28 May 2026, EUDAMED has moved from a voluntary database towards becoming an integral part of regulatory compliance under the EU MDR and IVDR. The first four modules—Actor Registration, UDI and Device Registration, Notified Bodies and Certificates, and Market Surveillance—are now mandatory, while the Clinical Investigations/Performance Studies and Vigilance modules will become mandatory once they are declared fully functional by the European Commission.
Rather than acting as a simple registration database, EUDAMED now forms part of the regulatory infrastructure supporting medical device traceability, market oversight and communication between manufacturers, notified bodies, competent authorities and other economic operators. As additional modules become mandatory, EUDAMED will continue to develop into a comprehensive lifecycle management system for medical devices placed on the European market.
Which EUDAMED Modules Are Now Mandatory?
EUDAMED is becoming an increasingly important part of EU MDR and IVDR compliance. For a detailed explanation of the modules that became mandatory from May 2026, the applicable transition arrangements and the practical steps manufacturers should take, read our EUDAMED Mandatory from May 2026 Guide.
Benefits of EUDAMED
EUDAMED provides several benefits for manufacturers, competent authorities, healthcare professionals and patients, including:
- Improved transparency throughout the medical device lifecycle.
- Enhanced traceability through device registration and UDI information.
- More effective vigilance and post-market surveillance activities.
- Better coordination between competent authorities across Member States.
- Increased access to regulatory information for stakeholders and the public.
- Stronger protection of patient health and safety.
Beyond improving transparency, EUDAMED also supports greater regulatory consistency across Europe by providing a shared source of information for competent authorities, notified bodies and economic operators. The system helps reduce duplicated regulatory activities, strengthens collaboration between Member States and provides manufacturers with a more streamlined approach to managing regulatory information throughout the product lifecycle.
How Do UDI and EUDAMED Work Together?
EUDAMED uses Unique Device Identification data to strengthen medical device traceability throughout the European market. Learn how Basic UDI-DI, UDI-DI and device registration work together to support regulatory oversight, post-market surveillance, recalls and patient safety in our guide to UDI and EUDAMED traceability.
In Summary
EUDAMED represents one of the most significant developments introduced by the EU MDR and IVDR, providing a centralised platform for medical device registration, traceability and regulatory oversight. As additional modules continue to become fully operational, manufacturers will increasingly rely on EUDAMED to manage regulatory information throughout the device lifecycle.
Understanding how the database operates, how it interacts with UDI and what information must be maintained within the system is becoming an essential part of achieving and maintaining compliance with European medical device legislation.
Frequently Asked Questions About EUDAMED
Yes. Following the publication of Regulation (EU) 2024/1860, certain EUDAMED modules will become mandatory according to phased implementation timelines beginning in 2026. Economic operators should prepare for the progressive mandatory use of the database and ensure their registration and device information are maintained.
Manufacturers, authorised representatives and importers placing devices on the EU market are generally required to register in EUDAMED and obtain a Single Registration Number (SRN). Additional obligations may apply depending on the role of the economic operator and the applicable regulations.
An SRN (Single Registration Number) is a unique identifier issued through EUDAMED to economic operators. It is used to facilitate regulatory interactions and identify organisations throughout the medical device lifecycle.
Yes. UK manufacturers placing medical devices or IVDs on the EU market under the MDR or IVDR must comply with applicable EUDAMED requirements, typically through their EU Authorised Representative. Compliance obligations will depend on the manufacturer's market access strategy and device classification.
EUDAMED improves transparency, traceability and coordination across the European medical device sector. It helps strengthen market surveillance, supports vigilance activities, enhances regulatory oversight and provides greater access to information for authorities, healthcare professionals and the public.
References
This guide is based on the following legislation and official regulatory guidance relating to EUDAMED (the European Database on Medical Devices) and its implementation under Regulation (EU) 2017/745 (MDR).
| Organisation | Reference | Why it's relevant |
|---|---|---|
| European Union | Regulation (EU) 2017/745 on Medical Devices (MDR) | Establishes the legal framework for EUDAMED, including the regulatory requirements for economic operator registration, UDI/device registration, certificates, vigilance and market surveillance. |
| European Commission | EUDAMED Overview | Provides the European Commission's official overview of EUDAMED, explaining its purpose, architecture, implementation timeline and the six interconnected modules supporting the lifecycle of medical devices within the European Union. |
| European Commission | UDI/Device Registration in EUDAMED | Explains the requirements for registering medical devices and Unique Device Identifiers (UDIs) within EUDAMED, including legacy device registration and the use of the European Medical Device Nomenclature (EMDN). |
| European Commission | EUDAMED Information Centre | Provides official user guidance, documentation, onboarding materials, FAQs and technical information to help economic operators use the EUDAMED platform effectively. |
| European Commission | Unique Device Identifier (UDI) | Explains the European Commission's Unique Device Identification (UDI) system, which underpins device traceability and is closely integrated with EUDAMED registration requirements. |
EUDAMED continues to evolve as additional modules become fully operational and regulatory requirements develop. Manufacturers and other economic operators should always consult the latest published legislation and official European Commission guidance when registering devices, maintaining regulatory data and meeting MDR obligations.
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