Switzerland · Swissmedic · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
2
2 requirements
Application fee
-
On a reasoned request, Swissmedic can allow a specific device to be placed on the market even though the required conformity assessment was not done, if its use is in the interest of public health or patient safety. In single cases, a health professional may also use a non-conforming device for a life-threatening condition without a permit, under strict conditions including informed consent. Urgent need for a specific device when no conforming device is available.
1. Reasoned request; 2. Agency decision.
Outcome: A permit for a specific device.
Legal basis: Medical Devices Ordinance (MepV) Article 22; Ordinance on In Vitro Diagnostic Medical Devices (IvDV) Article 18
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 Switzerland: Medical device conformity assessment and placing on the market, In vitro diagnostic device conformity assessment and placing on the market, Registration of device economic operators and products. See all routes on the Switzerland 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 (4 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.