Icelandic Medicines Agency
European database - EUDAMED
The European database on medical devices, also known as EUDAMED, is operated by the European Union. The Icelandic Medicines Agency (IMA) is responsible, among other things, for verifying the legitimacy of Icelandic actors in the database.
The European Commission manages EUDAMED. Its purpose is to keep track of the registration and traceability of medical devices on the European market. This is provided for in the medical device regulations, Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).
Role and objectives of the database
EUDAMED holds the registration of manufacturers, importers, authorised representatives, notified bodies and sponsors of clinical investigations of medical devices. Through this registration they fulfil the information obligations laid down in the regulations.
The objective of EUDAMED is to increase transparency, including by improving access to information for the general public and healthcare professionals, and to strengthen coordination and cooperation between Member States. EUDAMED enables the general public to obtain information on medical devices on the market, their economic operators and the certificates issued for the devices. The database will also contain information on clinical investigations of medical devices, for the information of users.
The EUDAMED database is made up of six modules:
Registration of economic operators, i.e. manufacturers, importers, authorised representatives and notified bodies (distributors do not register in EUDAMED but with IMA -
Unique device identifier (UDI) and device registration
Notified bodies and certificates
Clinical investigations and performance studies
Post-market surveillance
Market surveillance
The database also makes it easier for the competent authorities and the European Commission to carry out their tasks, i.e. market surveillance and other matters relating to the regulations concerned.
Four of six modules now in operation
As of 28 May 2026, four of the six modules had been put into use, and their use is mandatory. They are:
Registration of economic operators
UDI registration and device registration
Notified bodies and certificates
Market surveillance
The modules for clinical investigations and performance studies, and for post-market surveillance, are still under development. An announcement will be made when they are put into use
Registration of actors in the database
First go to MDR-Eudamed – Welcome to EUDAMED – European Database on Medical Devices and click "Create your EU account"
Once the account is ready and you have logged in, two tabs appear. Select the blue tab labelled "Actor registration"
Once the account has been created, the requested information about the company can be entered. This information is then sent for validation.
IMA will then receive a notification that an actor registration is awaiting its approval. IMA's experts review and verify the information and approve it if there are no comments. This generates a single registration number (SRN), which IMA sends to the actor concerned together with confirmation of the registration.