What is EUDAMED
EUDAMED is the unified information system of the European Union for medical devices and organisations that are involved in the placement and circulation of medical devices on the EU market. Registration in the Eudamed system is a requirement of EU Regulation MDR 2017/745 (Articles 29-31 para. 4) and EU Regulation IVDR 2017/746 (Articles 26-28 para. 3).
The system consists of six modules with the following functions:
- Registration of economic operators
- Registration of medical devices
- Notified bodies and certificates
- Clinical investigations
- Post-market surveillance and reporting of adverse events
- Oversight of regulatory authorities over the circulation of medical devices
Relevant information is entered into each of the specified modules on the EUDAMED portal.
Who needs to register in EUDAMED
Registration in EUDAMED is mandatory for:
- Authorised Representatives
- Manufacturers of medical devices, including legal manufacturers and repackagers
- Importers of medical devices
As for the registration of manufacturers in EUDAMED, it is important to note that every manufacturer, regardless of their location - within or outside the European Union, must register in this system. In the case of a manufacturer located outside the EU, it is crucial that their authorised representative is already registered in the system at the time of registration. Otherwise, registration of a manufacturer from outside the EU in EUDAMED will not be possible.
If a company performs multiple functions at once (for example, acting as both a manufacturer and an authorised representative), they must register in each of these roles.
Distributors of medical products are not obligated to register in the EUDAMED system. However, if a distributor simultaneously serves as an authorised representative or importer, which is quite common, they should register in EUDAMED according to the role they perform.
What documents are needed for manufacturer registration in EUDAMED
Only two documents are required for registration in the system:
- Declaration on information security responsibilities - a statement that the manufacturer is responsible for the information provided and its management.
- Mandate Summary document - a document describing the rights and responsibilities with which the manufacturer empowers its authorised representative.
Result of registration in EUDAMED: SRN - Single Registration Number
After completing all stages of registration on the EUDAMED portal, the European manufacturer receives a Single Registration Number, often referred to as SRN. This number serves as the primary identifier for the manufacturer of medical devices in the European Union. It is indicated in the technical documentation, used for reporting adverse events, as well as in trade and procurement processes, among many other situations.
If the manufacturer is located outside the EU, after filling out all the necessary forms on the EUDAMED portal, their authorised representative submits an application on their behalf. The manufacturer receives their SRN only after this application is approved by the authorised representative.
If an economic operator registers in multiple capacities (for example, as a manufacturer and an authorised representative), they are assigned a separate SRN for each of these roles.
