Eudamed: the Commission Publishes the Official Link

A fundamental element for achieving the objectives of the new regulation 2017/745 is the creation of a European database for medical devices.

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

The entire system revolves around 6 interconnected modules:

• Registration of economic operators (manufacturers, authorized representatives, importers, distributors)
• UDI and device registration
• 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 ensures that the public parts of Eudamed will be presented in an easy-to-use and consultable format.

Recently, on the European Commission’s website, the official link to the database was published: ec.europa.eu/tools/eudamed. However, as of today, the server responds with a 404 – The requested page does not exist.

The Publication Date

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

On April 23, 2020, the Council and Parliament adopted Regulation 2020/561 amending Regulation (EU) 2017/745 on medical devices regarding the dates of application of certain of its provisions. This regulation postpones the date of application of most provisions of the medical device regulation by one year, until May 26, 2021. (The new timeline).

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

If this is not the case, due to circumstances that could not have been reasonably foreseen, the obligations related to Eudamed will apply six months after the date of publication of the notice in the Official Journal of the European Union, following the assessment of Eudamed’s full functionality.