Dive Brief:

• The European Commission is aiming to have a fully functional version of the Eudamed medical device database available in the second quarter of 2024.
• Originally scheduled to launch in 2020, the database, a key part of the new regulations, suffered delays and is now in a staggered rollout. While some modules are already available, European officials expect it to take almost another two years to finalize the rest of the system.
• Once Eudamed is fully functional, the industry will have six or 24 months before it is mandatory to use the system. The longer transition period applies to the unique device identifier (UDI)/device and notified body certificate modules.

Dive Insight:

Eudamed is a database that will register every medical device authorized to be used across the 27-member European Union, and allow national medical regulators and device makers to know of authorized use of devices, safety issues, recalls and new regulations.

The European Commission says that the goals of the database are to increase transparency about the regulation of devices, including increasing access to information for the public and healthcare providers, and to help enhance coordination between the member states of the EU.

Eudamed had been scheduled to go live in May 2020, the original date of application for the Medical Devices Regulation. Late in 2019, the Commission delayed the launch by two years and then outlined a phased rollout, with the actor registration module going live in December 2020 followed by the modules for UDI/device registration and notified bodies and certificates in October 2021.

Going into 2022, the Commission said the remaining modules would be released when the database was fully functional, without committing to a timeline. The Commission has now published a timeline. 

The centerpiece of the timeline is the release of all six Eudamed modules in the second quarter of 2024, four years after their originally targeted launch date. To hit that target, the project team will need to meet a series of other milestones. The Commission expects minimum viable product development on all six modules to end in the fourth quarter of 2023, enabling an independent audit to be conducted early in 2024. 

If the project hits those targets, the Medical Devices Coordination Group will review the audit results in the second quarter of 2024 to enable the release of all six modules later in the quarter. Requirements related to the actors, vigilance, clinical investigation and performance studies and market surveillance modules will become mandatory six months after the release of the system.

The Commission has proposed a longer, 24-month transition period for UDI/device registration and notified-body certificate modules, meaning use of the full system will become mandatory in the second quarter of 2026, six years after the originally targeted launch.

This article was updated to reflect that the transition timeline after Eudamed takes effect is six or 24 months, not a range as previously stated.