With the newly published Regulations entering into force on the 25th of May, it is now essential to understand the importance of the Eudamed (European Database on Medical Devices) in the European medical device regulatory system. Previously accessible solely to Competent Authorities and the European Commission, the new database aims not only at providing a wider accessibility, but also more information and of higher quality, such as traceability of medical devices, information on conformity assessment procedures, certificates, incidents and clinical studies.
More information for “everyone”
Besides the Member States and the European Commission, the new Eudamed will now be available to several different users – Notified Bodies, economic operators, sponsors and the public – with each user having access to different levels of information (MDR Article 33 paragraph 4).
The final objective is a bigger transparency on which medical devices are being distributed and where, as well as who is responsible for them. Another purpose for such changes is a better coordination between the manufacturers and operators of medical devices, Notified Bodies, Member States and the European Commission.
New Features and more information
The new Eudamed will now comprise more electronic systems/databases and features such as:
- Unique Device Identification database
- Registration of economic operators
- Registration of devices
- Notified Bodies accreditation (replacing Nando)
- Performance studies
- Vigilance and post-market surveillance
- Compatibility with national databases allowing for the import and export of information
It is expected to be fully functional by the 25th of March 2020.
If you wish to know more about the new role of Eudamed, please do not hesitate to contact us. Obelis Expert Consultants, having nearly 30 years of experience with EU Regulations, will gladly answer any question you may have.