MDSS News & Views

The European Commission released some updates regarding EUDAMED, the European Database on Medical Devices. These updates pertain to the responsibilities of economic operators.

The update on the EUDAMED - release notes, section 2.1, reflects Article 31 §5 from MDR (EU) 2017/745 and Article 28 §5 from IVDR (EU) 2017/746:

Not later than one year after submission of the information in accordance with paragraph 1, and every second year thereafter, the economic operator shall confirm the accuracy of the data. In the event of a failure to do so within six months of those deadlines, any Member State may take appropriate corrective measures within its territory until that economic operator complies with that obligation.

Additionally, it is crucial for all manufacturers to note the requirements stated in Article 31 §4 from MDR (EU) 2017/745 and Article 28 §4 from IVDR (EU) 2017/746:

Within one week of any change occurring in relation to the information referred to in paragraph 1 of this Article, the economic operator shall update the data in the electronic system referred to in Article 30.

For a detailed step-by-step explanation, we highly recommend referring to the video in section 2.1.7 of the Economic Operators - user guide, which provides a comprehensive guide. To access the video, click here. 

Should you have any further questions or require additional information, please do not hesitate to reach out to us.

MDSS offers personalized support for a seamless introduction to EUDAMED. Schedule your session here.

1.  Obtain the Actor ID / SRN

The economic operator will obtain a unique Actor ID/SRN for each actor role. If the economic operator has multiple roles, separated registration requests are required in order to obtain a different and specific Actor ID/SRN for each actor role.

What is an Actor ID / SRN ?

The Actor ID/SRN (Single Registration Number) uniquely identifies every economic operator in EUDAMED. The Actor ID/SRN is issued once the relevant competent authority has validated the Actor registration request.

 If the economic operator has multiple roles, separated registration requests are required in order to obtain a different and specific Actor ID/SRN for each actor role. 

2.  Validation Process

• The economic operator submits an actor registration request in EUDAMED.
• For non-EU manufacturers, its authorised representative verifies the registration
  request before passing it to the national competent authority for assessment.

Keep in mind that information provided during the Actor registration has to match with the signed Mandate with the authorised representative.

• The national competent authority issues the Actor ID/SRN (generated by EUDAMED)
  after approving the registration request.

EUDAMED notifies the Actor ID/SRN via email to the economic operator.