Switzerland has revised its Therapeutic Products Act (TPA), Medical Device Ordinance (MedDO), and In Vitro Diagnostic Devices Ordinance (IvDO) and aligned them with the European Medical Device Regulation (MDR), establishing legal equality with the EU MDR & IVDR. According to article 51 of the Medical Device Ordinance and article 44 of the In Vitro Diagnostic Devices (IvDO), a foreign manufacturer can only place their products on the Swiss market when they have delegated a person based in Switzerland as its Authorized Representative (Swiss AR).

A Swiss AR must be a natural or legal person based in Switzerland and must have received and accepted a written mandate from the manufacturer.

Foreign manufacturers may choose to designate multiple Swiss ARs for their device portfolio. However, there shall be only one Swiss AR for all devices of the same generic device group, and for different generic groups, multiple Swiss ARs can be appointed.