News about GMP/cGMP

23.10.2020

EC: New webpage to Actor Registration Module for EUDAMED

The European Commission announces that the EUDAMED Actor Registration Module  will go live on 1 December 2020. Meanwhile a website has been set up to explain all the necessary steps to register  for access to EUDAMED and the following modules.

EUDAMED is the IT system developed by the EC to implement the two EU medical devices regulations 2017/745 (MDR) and  2017/746 (IVDR).

The "Actor Registration Module" is the first of six EUDAMED modules to be published before 22 May 2020. The website provides information on how to apply for a Single Registration Number (SRN) and explains which documents to submit for a registration request. A 60-page user guide is available to all economic operators. Additionally, infographics and videos clearly illustrate

  • the actor roles
  • what is meant by an SRN
  • the actor registration request process
  • the role of manufacturers, authorised representatives, packaging manufacturers and importers of medical devices, both EU and non-EU
  • the validation process to obtain an SRN from the authority.

Source:

European Commission, webpage



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