Our services
CH REPRESENTATION
In Switzerland, a legal person who receives and accepts a written mandate from a manufacturer located in another country to act on the manufacturer's behalf in relation to specified tasks in accordance with MedDO/IvDO is commonly referred to as an "authorized representative" or "mandated representative." This individual or entity assumes responsibilities on behalf of the manufacturer, ensuring compliance with relevant regulations and facilitating tasks outlined in the Medical Devices Ordinance (MedDO) and In Vitro Diagnostic Devices Ordinance (IvDO) in Switzerland.
Medical device and in vitro diagnostic (IVD) manufacturers without a registered office in Switzerland must now appoint a local Swiss Authorized Representative (CH-REP). If you are an IVD and/or medical device (MD) manufacturer located outside Switzerland and plan to sell your products in the Swiss market, it is mandatory to have a Swiss Authorized Representative.
- Verify the Swiss declaration of conformity and technical documentation.
- Verify labeling, instructions for use (IFU), and ensure that a Unique Device Identifier (UDI) has been assigned.
- Confirm that the manufacturer is properly identified on the documentation.
- Verify compliance with Swiss storage and transportation requirements.
- Inform the manufacturer promptly if a device poses a serious risk or is not in conformity with regulations.
- Check that devices have been appropriately registered with Swissmedic.
- Report any serious incidents or risks to Swissmedic as required.
- Cooperate with Swissmedic in implementing preventive and corrective actions when necessary.
- EEA States include the member states of the EU, Iceland, Norway, and Liechtenstein. However, the timelines specified apply only to EU states, Norway, and Iceland. Due to the customs treaty between Switzerland and Liechtenstein, a manufacturer in Liechtenstein is not obligated to designate an Authorized Representative in Switzerland.
- Nevertheless, all foreign manufacturers are required to appoint a Swiss authorized representative.
