France · National Agency for the Safety of Medicines and Health Products · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
3 requirements
Application fee
-
In exceptional cases the ANSM can allow the use of a device without a CE mark in the interest of public health. A request can cover one patient or be global. The patient benefit must be significant, and safety and performance data and the lack of an alternative weigh heavily. The patient is informed and consents. A device without CE marking needed for a patient or group of patients, when no alternative exists.
1. Request; 2. Case-by-case review; 3. Reasoned decision.
Outcome: A reasoned decision; global derogations are listed by the ANSM.
Legal basis: Article 59 of the Regulation
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in France: National declarations for medical devices, Early coverage for digital medical devices. See all routes on the France page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (8 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.