EUDAMED is the database developed by the European Commission for the registration of economic actors and their medical devices.
The system will be versatile:
- it will function as a registration system,
- a collaborative system,
- a notification system and
- a dissemination system (open to the public)
- and it will be interoperable.
EUDAMED database is a modular system
It will consist of six modules, but they are not yet ready. The first out of six, the actor registration module is now active since the December, 1st. The use of the actor registration module is not mandatory as long as EUDAMED is not fully functional. Only after completion of all modules, each economic actor – EU and non-EU manufacturers, authorised representatives, importers, etc.) must register as an actor in EUDAMED and provide the required information. A DECLARATION ON INFORMATION SECURITY RESPONSIBILITIES and, for Non-EU actors, an EUDAMED Mandate Summary document are required for the registration.
In addition to the Member State, Iceland, Liechtenstein and Norway have access to EUDAMED. UK, Switzerland and Turkey are currently not included, i.e. neither manufacturers from these countries can currently register nor do the authorities of these countries have access. However, we believe that future treaties will change this situation.
Manufacturers from other third countries initiate the registration via the respective EU Authorised Representatives. The single registration number (SRN) is also applied for within the actor registration module. The SRN ensures unique identification of economic actors across the EU (also outside EUDAMED). The MDCG 2020-15 position paper on the use of SRNs was published in August last year.
You can find more information and FAQs on the EU Commission’s website or by talking to BEO BERLIN’s consultants.