EUDAMED is the database, created by the European Commission, which aims to collect information related to medical devices marketed in Europe, according to the requirements of MDR 2017/745 and IVDR 2017/746, to improve transparency in information on these devices.
EUDAMED is structured around six interconnected modules, three of which are currently operational:
- Actor – user registration and management
- UDI database and registration of devices
- Certificates and Notified Bodies
- Clinical Investigation and performance studies
- Vigilance and post-market surveillance
- Market surveillance
The first Module “Actor Registration Module” (Actor (europa.eu)) has been operational since December 2020.
Which economic operators must register with EUDAMED?
- Manufacturers.
- Authorized Representatives.
- System and procedure pack producers.
- Importers.
Distributors do not need to register with EUDAMED.
For more information, you have this link from the European Commission that details the roles of the different economic agents: eudamed (europa.eu)
In addition, Importers are required to carry out verifications at EUDAMED:
- Verify that the medical device is registered (Article 13(4) MDR).
- Verify that the Manufacturer and the Authorised Representative have reported the necessary information to EUDAMED within two weeks of the product being placed on the market (except for made-to-measure products) and inform these agents when the information is incorrect or insufficient (Article 30(3) MDR/ Article 27(3) IVDR).
- Verify that their own registration information is complete, accurate and up to date with the periodicity indicated in Article 31(5) of the MDR/ Article 28(5) of the IVDR.
At Supplaffairs we can help you comply with EUDAMED registration obligations.
