This module is the first of the six EUDAMED modules to be released and is key to accessing and using EUDAMED. Registration will allow economic operators to obtain their Single Registration Number (SRN) for each role they play. Registration in EUDAMED is only required for Manufacturers, Authorised Representatives and Importers as per Article 31 of the MDR 2017/745/ Article 28 of the IVDR 2017/746. 

The module also features a publicly accessible and searchable database of registered economic operators and competent authorities that allows users to obtain information about the actors and that provides information about the entities, such as contact information and identification. For manufacturers it will also provide information about the companies’ Person(s) Responsible for Regulatory Compliance (PRRC).

The Actor Module can be accessed here.

The Public version of the database can be accessed here.

What does this mean for you?

If you are a Medical Device or IVD Manufacturer, Authorised Representative and/or Importer, you can now register in EUDAMED and obtain your Single Registration Number (SRN) for each role you play.

Qarad EC-REP is also registered in EUDAMED as Authorized Representative.
Click here for more information about our AR services

 

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