Swissmedic Mandate

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.

Under IVDO

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.