The first EUDAMED module, launched on 1 December 2020, is the electronic operator registration system. All economic operators (EU and non-EU manufacturers, authorized persons, systems & procedure pack kit producers, importers) must register with EUDAMED and provide the necessary information.
Economic operator registration process (excluding non-EU manufacturers)
- Sending the application for registration – electronically
- Assessment of the registration by the competent authority
- Approval of registration – assignment of Single Registration Number
- In case of non-approval by the relevant competent person
- Invitation to complete the application and then approve the registration (point 3)
- Rejection of the application for registration
For non-EU manfacturers, the procedure will be slightly different. Before the application is assessed by the competent authority, it will be necessary to verify the application by an authorized person. The authorized person must therefore already be registered with EUDAMED prior to this process.
Single Registration Number (SRN)
It uniquely identifies each economic operator in EUDAMED. SRN is issued as soon as the competent authority confirms the application for registration of the economic operator. Please note that the economic operator must register separately for each notified activity. Therefore, if the economic operator is both a manufacturer and an importer of medical devices, he will be assigned two registration numbers.
More information
The functionalities are launched for persons established in the EU (Iceland, Liechtenstein and Norway) and non-EU manufacturers having authorized persons in the EU (Iceland, Liechtenstein and Norway). For persons from other countries, the possibility of registration will be launched at a later stage (this also applies to persons established in Turkey and the United Kingdom).
Although registration in EUDAMED will be mandatory, registration is not currently required until EUDAMED is fully operational and other modules are launched (a brief overview of the modules is given in our previous news, European Databank on Medical Devices – EUDAMED). It is therefore possible that registration in national systems is still required.
If the economic operator already wants to register at the moment, he can use the services of MeDeCorp s.r.o., which will guide you through the registration process. What are the exact requirements for the registration of an economic operator, what are the necessary documents required and further detailed information about EUDAMED will be described in the next update.
Our services
If you need help to become familiar with the complex and changing issues of medical device legislation, do not hesitate to contact us by email: medecorp@medecorp.cz or via the Internet form at www.medecorp.cz. We will also be happy to help you, for example, with the placing of a medical device on the market, the creation of technical documentation or the comprehensive provision of regulatory affairs in your company. You can also find a list of services offered on our website.