Strategic Regulatory Partner for Success in Switzerland

Switzerland holds a leading position in medical technology innovation. Following its departure from the EU’s single market, it established its own regulatory framework – the Medical Device Ordinance (MedDO) and In Vitro Diagnostic Devices Ordinance (IVDO). While initially modeled after EU Directives, both ordinances have since been updated to align with the European Union Medical Devices Regulation (EU MDR) 2017/745 and In Vitro Diagnostic Devices Regulation (IVDR) 2017/746. The MedDO became effective on May 26, 2021, and the IVDO followed on May 26, 2022. For compliance with Swiss registration requirements, foreign medical device manufacturers are required to appoint a Swiss Authorised Representative (CH-REP).