The creation of a European database of medical devices is essential to achieve the objectives of the new regulation 2017/745.

Eudamed will improve the transparency and coordination of information on devices on the market in the EU market. It will work as a system for registration, collaboration, notification and dissemination (open to the public).

The entire system revolves around 6 interconnected modules:

• Registration of economic operators (manufacturers, agents, importers, distributors)
• Registration of UDIs and devices
• Notified bodies and certificates
• Clinical investigations and performance studies
• Vigilance and post-market surveillance
• Market surveillance

THE OFFICIAL LINK, BUT IT’S STILL A 404

The site will be open to the public and the Commission guarantees that the parts of Eudamed accessible to the public will be presented in a format that is simple to use and easy to consult.

The official link to the database was recently published on the website of the European Commission: ec.europa.eu/tools/eudamed. The server currently still responds however with the message 404 — The requested page does not exist.

THE DATE OF PUBLICATION

The regulation associated with “circumstances that could not have been reasonably foreseen”, a failure to publish by Eudamed on 26 May 2020.
It is difficult to better describe the current health situation. However, it was a pity that already at the beginning of the year, before the emergency, it was known that this date would not have been met.

On 23 April 2020, the Council and Parliament adopted Regulation 2020/561 which amends Regulation (EU) 2017/745 on medical devices with regard to dates of application of some of its provisions. This regulation postponed the date of application of most of the provisions of the Medical Devices Regulation by one year, to 26 May 2021. (The new timeline).

Consequently, the presumed publication date of Eudamed, which will be accessible at the official link, is 26 May 2021.

If this were not the case, due to circumstances that could not reasonably be foreseen, the obligations relating to Eudamed will apply six months after the date of publication of the notice in the European Official Journal, following evaluation of the full functionality of Eudamed.