In August 2020, the Medical Device Coordination Group (MDCG) announced that the economic operator registration or actor registration module will be available as of December 1, 2020. This module will serve to obtain the Single Registration Number (SRN), which is a prerequisite to get access to other EUDAMED 3 core functions. EUDAMED 3 will be a central tool for the implementation of the medical devices and in vitro medical devices regulations (MDR and IVDR).
Just recently, the European Commission has published a new website (link further below) with a number of brief guidance documents including a user guide and a helpful video to generally explain the registration process.
Please find below an overview of some essential points:
- Manufacturers must set up an EU Login account
- Manufacturers will be guided through a number of screens and prompted to provide general company and contact information. In this context, manufacturers will also be prompted to upload an organization identification document.
- Manufacturers will be required to identify the Authorized Representative and upload the belonging mandate summary document form. The latter is available on the website for download. The entire process may only be completed when the Authorized Representative is already registered in EUDAMED and a valid MDR/ IVDR mandate is in place.
- Manufacturers are prompted to add the details on the Person Responsible for Regulatory Compliance (PRRC).
- The details of the contact person will be taken for the first user, who in turn will be the Local Actor Administrator (LAA). The website also includes a brief overview of the different possible profiles.
- The LAA must sign and upload a declaration on information security, which is also available on the website.
- Once the manufacturer has submitted its registration request, the Authorized Representative and finally the competent authority will verify the request. Upon completion, the SRN is assigned.
Our team will do its best to provide you with all the information you need. Please have a look at the website to make yourself familiar with the new registration process.
What has not been clarified yet is to what extent the actor registration process can be completely or partially delegated to a third party.
Please note also that the MDR requires all economic operators to register themselves in EUDAMED 3 as of May 26, 2021. This, however, is true under the condition that the database is fully operational. As a result, until further notice, the registration remains voluntarily. We would nonetheless suggest to initiate the registration process as soon as possible!
Source: European Commission
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