Market surveillance of medical devices

Anyone placing medical devices on the market in Switzerland must guarantee the conformity of the products. The Agency is responsible for carrying out the state control tasks in this area.

By carrying out monitoring within the framework of market surveillance, the Agency ensures that the medical devices placed on the market, the corresponding procedures for placing them on the market, and the product observation and handling satisfy the requirements of the Medical Devices Ordinance. Specifically, the Agency receives suspicion reports and carries out follow-up checks in the form of random tests or inspections.

If products do not conform, the Agency enforces the necessary corrective actions to restore the correct status and conformity of the medical devices (enforcement). These actions are selected based on risk and the proportionality principle. Their implementation is monitored.
The Agency works closely with cantonal enforcement authorities and the relevant competent authorities of the contracting states (EU, EFTA states and Turkey).