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, in order to improve transparency in the information on these products.
EUDAMED is structured in 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 agents must register with EUDAMED?
- Manufacturers.
- Authorized Representatives.
- System and procedure pack producers.
- Importers.
Distributors should not 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 Authorized Representative have reported the necessary information in EUDAMED, within two weeks of the product’s introduction on the market (except for custom-made products) and inform these agents when the information is incorrect or insufficient (Article 30, paragraph 3 of the MDR/ Article 27, paragraph 3 of the 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.
From Supplaffairs we can help you to comply with your EUDAMED registration obligations.
