Latest update, February 2025: The audit of the Vigilance module has begun; the initial review of the module has already been completed and is expected to continue through October. A final report is expected between October and November 2025.

Its mandatory use is scheduled for the first half of 2026.

As a reminder, the four modules (Actors, Devices, Certificates, Market Surveillance) will be mandatory in January 2026.

The IC/PS module is still under development

Learn more

Linked news

The European Commission has released a new update to its study on the availability of medical devices in Europe

21 Jul 2026 Read more

Reusable Surgical Instruments and EU Regulation 2017/745

21 Jul 2026 Read more

Biological Evaluation of Medical Devices

21 Jul 2026 Read more
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