The use of the first four modules of EUDAMED in mandatory starting from May 28, 2026:
- Actor registration (economic operators)
- UDI and Devices Registration
- Notified bodies and certificates
- Market Surveillance
There is a transition period from Nov, 2025 to that date. But it is recommended to start using them to comply with the mandatory date.
EUDAMED is the European Medical Devices Database, the IT system established by EU MDR 2017/745 on medical devices and the Regulation 2017/746 on in vitro diagnosis. It consists of six modules. The other two are the following ones (Functionality confirmation pending):
- Clinicial investigations and performance studies.
- Vigilance and post-market surveillance.
The EUDAMED database has different access rights. There is information available to the public such as products placed on the market, economic operators, certificates issued by Notified Bodies, information related to clinical trials and safety or performance incidents. Futhermore, it allows for communications required by the MDR through this system for economic operators and greater interoperability between the Member States of the European Union.
References: – EUDAMED
