Stricter obligations to act for distributors of medical devices
Following an increasing number of devastating incidents in the past in connection with defective medical devices - such as leaking silicone breast implants and faulty hip prostheses - the control mechanisms for such medical devices are being tightened throughout Europe. Switzerland also gradually revised its medical device law from 1 August 2021 in close alignment with the EU provisions.
The revision of medical device law aims to improve the quality and safety of medical devices and thus patient safety. To this end, the regulatory requirements for the actors involved are being tightened considerably.
Switzerland is thus adapting its legal basis for medical devices to developments in the EU. In doing so, it is ensuring that Swiss patients can also benefit from the intended improvements in patient safety as well as from the new transparency of information on medical devices.
In this document you will find more detailed information on the revision and its effects:
Summary of general changes to the revised medical device legislation
Overview of the target groups affected
Obligations to act for manufacturers, distributors, importers and healthcare facilities