12.01.2021
To the attention of Romanian manufacturers of medical devices/authorised representatives/importers
Using the EUDAMED “actors” registration module and the single registration number (SRN)
The setup of a European database on medical devices (EUDAMED) is one of the key aspects of the new regulations on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746).
The EUDAMED will provide a real picture of the lifecycle of medical devices made available in the European Union (EU). It will integrate various electronic systems to collect and process information about medical devices and related companies (e.g. manufacturers). In this respect, the EUDAMED aims to increase overall transparency, including through better access to information for the public and healthcare professionals, and to strengthen coordination between the various EU Member States.
EUDAMED contains 6 modules, as follows:
1. Registration of the actors
2.unique device identification (UDI) and registration of medical devices,
3. notified bodies and issued certificates,
4. clinical investigations and performance studies,
5. vigilance
6. Market surveillance.
The actor registration module is active as of 1 December 2020. In accordance with Article 30 (1) of the MDR, the actor registration module must allow the creation of a single registration number (“SRN”) and the collection and processing of information necessary to identify the manufacturer (including producers of system/procedure packs) and , if applicable, of the authorised representative and importer. As such, the actor registration module is a prerequisite for the use of the other EUDAMED modules and facilitates a secure way of accessing the EUDAMED.
Actors involved in the EUDAMED are:
• Supervisory bodies
– The European Commission
– Competent Authorities (CAs), including designation authorities
– Notified Bodies (NB)
• Economic operators
– Manufacturers
– Manufacturers of systems and procedures packages
– Authorised representatives
– Importers
• Sponsors (clinical investigation financers)
Following the evaluation and approval of the request by the competent national authority in question (the NAMMDR), the EUDAMED generates the SRN of the economic operator to the competent national authority and transfers it to the requesting economic operator.
More information here: https://ec.europa.eu/health/md_eudamed/actors_registration_ro.
You can access the guide containing all the information needed to register actors in the Eudamed at:
https://ec.europa.eu/health/sites/health/files/md_eudamed/docs/md_user_guide_actor_module_en.pdf.