Switzerland Medical Device Registration Overview
The Mutual Recognition Agreement (MRA) facilitated bilateral trade between Switzerland & the EU, avoiding technical barriers that lapsed on May 26, 2021. The Medical Device Regulation (EU 2017/745) replacing the MDD (93/42/EEC) and AIMDD (90/385/EEC) has come into effect from May 26, 2021. The Swissmedic’s revised Medical Device Ordinance (MedDO) and In Vitro Diagnostic Medical Devices (IVDO) also came into force on May 26, 2021, and May 26, 2022, respectively.
Under the Swiss MedDO and IVDO, Swissmedic mandated the non-Swiss manufacturers located outside Switzerland and without any local business offices to appoint a Swiss Authorized Representative (CH-REP) or Swiss AR or Swiss Rep on their behalf as a pre-requisite for Switzerland medical device registration and to launch their device in Switzerland.