EUDAMED (European Database on Medical Devices) is a database containing comprehensive information on medical devices in Europe. It is administered by the European Commission and serves as a tool for monitoring and inspection of medical devices. This database was created with the aim of increasing the safety and health protection of patients, healthcare professionals and the general public.
The main features and functions of EUDAMED are:
1. *Registration of Medical Devices:* Manufacturers and authorized representatives provide relevant information by registering the medical devices they place on the market with EUDAMED.
2. *Event Reporting:* Adverse events and safety-related information about the device are reported to EUDAMED. This can help authorities react quickly and take appropriate action.
3. *Conformity Evaluation:* Includes evaluations and results of medical devices by conformity assessment bodies.
4. *Clinical Trials:* Information and results of clinical trials conducted for medical devices can be found on EUDAMED.
5. *Market Surveillance:* Authorities may use EUDAMED to monitor the safe possession and use of medical devices on the market.
6. *Transparency:* EUDAMED contains some information that is available to the public, which enables consumers and healthcare professionals to obtain information about medical devices.
With the new Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) adopted in 2017, the scope and functionality of EUDAMED has been expanded. The purpose of these regulations is to provide a higher level of transparency and standardization in the monitoring and inspection of medical devices.