Switzerland · Swissmedic · Diagnostics (IVD)
Review target
-
Not published
Legal time limit
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Not published
Steps
5
7 requirements
Application fee
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In vitro diagnostic devices, including diagnostic software, follow the EU IVDR rules as taken over in the Swiss ordinance. The manufacturer classifies the product in classes A to D, runs the conformity assessment with a performance evaluation, and declares conformity. Certificates from EU or EEA notified bodies are accepted. A manufacturer outside Switzerland needs a Swiss authorized representative. Placing an in vitro diagnostic device on the Swiss market.
1. Classify the device; 2. Conformity assessment and performance evaluation; 3. Declaration of conformity; 4. Register operators and the device; 5. Place on the market and monitor.
Yes. It relies on approvals from European Union (recognition).
Outcome: The device can be placed on the market. Certificates are valid for at most five years and can be renewed.
Legal basis: Therapeutic Products Act (HMG) Articles 45 to 47; Ordinance on In Vitro Diagnostic Medical Devices (IvDV), which refers to Regulation (EU) 2017/746 (EU IVDR)
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, Registration of device economic operators and products, Exceptional authorization of a device without conformity assessment. 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 (10 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.