What is EUDAMED?
The Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostics Regulation (EU) 2017/746 (IVDR) introduced the requirement for a comprehensive electronic database known as the European Database for Medical Devices (EUDAMED). This platform developed by the European Commission is designed to improve transparency, accessibility, and traceability of medical devices and IVDs in the EU market. The EUDAMED system will be used by Economic Operators, Notified Bodies, Member State authorities, healthcare professionals, and even the public to access critical device information.
EUDAMED is structured into six core modules:
- Actor Registration
- Unique Device Identification (UDI) and Device Registration
- Notified Bodies and Certificates
- Clinical Investigations and Performance Studies
- Vigilance and Post-Market Surveillance
- Market Surveillance
The first three modules (Actor Registration, UDI & Device Registration, and Notified Bodies & Certificates) are already live for voluntary use. However, Actor and UDI registration could become mandatory in late 2025, which means device manufacturers who are not already using EUDAMED should start establishing a procedure for building this registration into their Quality Management System (QMS) processes.
How to register your company in EUDAMED
Manufacturers (EU and non-EU), along with System/Procedure Pack Producers (SPPP), Authorized Representatives (AR), and Importers are required to register as an Actor in EUDAMED. To register using the Actor module, you must create an EU login account in EUDAMED and provide basic information about your company, such as address and contact information. You must also name key regulatory personnel, including your AR if you are not based in the EU. This includes naming your Person Responsible for Regulatory Compliance (PRRC).
On submission, your Actor registration will route to your AR or your Competent Authority for review and approval, based on your location in the respective EU Member state. Once approved, you will receive a Single Registration Number (SRN), and your company will be published in the EUDAMED Public Database.
How to register your device in EUDAMED
All medical devices and IVDs that are CE Marked must be registered in EUDAMED, including self-certifying devices (class I medical devices, class A IVDs or legacy devices). To register a device or IVD using the UDI/Devices module, you will need to supply detailed information about your device, including:
- UDI (Basic UDI, UDI-DI, and UDI-PI)
- Name of UDI-issuing body
- Device Reference / Catalogue number
- European Medical Device Nomenclature (EMDN) Code
- Device trade name or model name
- Device classification
- Device description and characteristics (single use, sterility, storage conditions, warnings)
- Device information for presence of human or animal tissues and cells or their derivatives
- All EU Member States where the device is made available
Device information in the UDI module is publicly accessible. Changes to key device information or characteristics can require a new UDI and updated registration in EUDAMED.
