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.
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
The Actor Registration Module is used by manufacturers, authorised representatives, importers and other economic operators to register within EUDAMED and obtain a Single Registration Number (SRN). The SRN serves as a unique identifier throughout regulatory interactions within the European Union.
2. UDI and Device Registration Module
The UDI and Device Registration Module stores device registration information and Unique Device Identification (UDI) data. This module improves traceability throughout the supply chain and helps authorities identify devices placed on the EU market.
3. Notified Bodies and Certificates Module
This module contains information relating to notified bodies and certificates issued under the MDR and IVDR. It enhances transparency by providing visibility of certification activities and the status of issued certificates.
4. Clinical Investigations and Performance Studies Module
The Clinical Investigations and Performance Studies Module supports the submission, assessment and management of clinical investigations for medical devices and performance studies for IVDs. It facilitates communication between sponsors, competent authorities and ethics committees.
5. Vigilance and Post-Market Surveillance Module
This module facilitates the reporting and management of serious incidents, field safety corrective actions (FSCAs), trend reporting and vigilance activities. It supports the ongoing monitoring of device safety and performance after market placement.
6. Market Surveillance Module
The Market Surveillance Module supports cooperation between competent authorities across the EU. It enables the sharing of information relating to market surveillance activities, inspections and corrective actions to help protect public health and patient safety.
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.
Related EUDAMED Resources
To learn more about EUDAMED implementation and compliance requirements, read the following guides:
- EUDAMED Mandatory from May 2026: What Manufacturers Need to Know
https://patientguard.com/eudamed-mandatory-from-may-2026-what-you-need-to-know-3/ - EUDAMED Implementation Timeline and Transition Period
https://patientguard.com/transition-period-eudamed/ - UDI and EUDAMED Strengthen Medical Device Traceability https://patientguard.com/udi-and-eudamed-strengthen-medical-device-traceability/
EUDAMED System
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.
Patient Guards Recent Posts
Predetermined Change Control Plans (PCCPs): The Future of Agile Compliance for Medical Device Software
Learn how PCCPs help medical device software manufacturers manage updates, support AI systems, and enable agile compliance under evolving MDR and UKCA frameworks.
The AI Act Omnibus Explained: What the 2026 EU Rules Mean for Medical Device and IVD Manufacturers
Discover how the EU AI Act Omnibus affects AI medical devices and IVD manufacturers. Learn about the No Duplication principle, transparency rules, key 2026 and 2028 deadlines, and how MDR and IVDR compliance are converging with AI regulation.
Post-Deadline Reality Check: I’ve Submitted My IVDR Class C – Now What?
Submitted your IVDR Class C application? Learn what happens next, common causes of delays, review timelines, and why the September 2026 contract deadline is critical for maintaining EU market access.
Patient Guards Related Services
Patient Guards Regulatory Tools
Need Training?
Do you need training on Quality Management Systems or EU MDR/ EU IVDR? then check out our training courses.
