Switzerland Proposes to Amend the Federal Act on Medicines and Medical Devices

The European Union has adopted two new regulations: one on medical devices, and the other on in-vitro diagnostic devices. It aims to improve the quality and safety of medical devices, to harmonize the implementation of legislation in the EU, and thereby increase the safety of patients. In the context of the partial revision of the Law on Therapeutic Products, the legislation relating to the regulation of medical devices has been redrafted and adapted to the new EU legislation.

partially revised law establishes, inter alia, the obligations for economic operators and the adapted requirements for medical devices, the conformity assessment procedure, and the registration and identification of products that must be brought into line with the corresponding EU provisions (the regulation on medical devices and the regulation on in- vitro diagnostic devices). In parallel, the legislation in force regarding medical devices has been reviewed in terms of existing measures, and adapted where necessary.

Draft Text 1 is available for download in the following languages: Deutch French Italian


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