Swissmedic, in compliance with the Swiss Medical Device Ordinance (MedDO) and In Vitro Diagnostic Medical Devices (IVDO), has made it mandatory to appoint a CH-REP/Swiss Responsible Person, if the device product (MD/IVD/AIMD) manufacturer is not based in Switzerland.
Role of Swiss AR/CH-REP
The Swiss AR shall register medical devices with Swissmedic on behalf of the manufacturer, ensure conformity of the device, respond to any queries from Swissmedic and carry out Post-Marketing Surveillance (PMS) activities.
Eligibility for being a Swiss AR
Any legal entity, individual, or organization with a registered office in Switzerland can act as a Swiss agent for foreign manufacturers.
Timelines for Appointing a Swiss AR
Foreign manufacturers other than the EU/EEA countries must appoint a Swiss AR, which was set as mandatory by May 26, 2021. The EEA and the EU-based countries have various grace periods for different risk classes of the devices till July 31, 2022.
Foreign manufacturers other than EU/EEA countries must appoint a Swiss AR as per the IVDO by May 26, 2022. The EU/EEA IVD manufacturers have been given grace periods for different risk classes of the IVDs.