Medical Devices Vigilance regulations in Switzerland

Swissmedic is the central Swiss supervisory authority for therapeutic products. It is a public service organization of the federal government with headquarters in Bern.

Its core competence includes

• licensing medicines
• granting authorizations to manufacture and distribute wholesale, and inspecting facilities
• monitoring medicines and medical devices already on the market
• controlling the traffic of narcotics
• laboratory testing of medicine quality
• drafting laws and standards

Medical devices Vigilance:

In order to monitor medical devices already on the market, manufacturers and distributors placing medical devices on the Swiss market are required to report all serious incidents and recalls that are carried out for safety reasons.

• The European guidelines on vigilance to report procedure applies also in Switzerland. MEDDEV 2.12/1.
• Incidents: people responsible for the product on the market, should report incidences to Swissmed. An information sheet from Swissmedic describes the legal obligations and the reporting procedure for serious incidents.
• Recalls: In case of recall of a product from market, Swissmedic should be informed.

To get more information about Vigilance procedure in Switzerland, take a look at the following link:

Vigilance: reporting serious incidents with medical devices