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Obligations for authorised representatives, importers and distributors

The Medical Devices Ordinance (MedDO; SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219) set out requirements and responsibilities for operators in the medical devices supply chain. The following Information sheet outlines the roles and obligations of the Swiss authorised representative, the importer and the distributor.

It also describes transitional provisions applicable to devices that are made available on the market in Switzerland. Due to the customs treaty between Switzerland and Liechtenstein, the terms “established in Switzerland” and “on the market in Switzerland” refer to the common market of Switzerland and Liechtenstein (customs union) if the devices are placed on the market based on MedDO/IvDO.