Unlocking Switzerland: Your Guide to the Swiss Authorised Representative Requirement

Medical Device Global Market Access · Oct 9, 2025 · 3m

This episode unpacks the essential requirements for placing medical devices on the Swiss market following the lapse of the EU-Switzerland Mutual Recognition Agreement. We explore the role and legal responsibilities of the mandatory Swiss Authorised Representative (CH REP), detail the past compliance deadlines for all device and IVD classes, and explain critical labeling and registration requirements with the Swiss authority, Swissmedic. Key Questions • Why is Switzerland now considered a 'third country' by the EU for medical devices? • What is a Swiss Authorised Representative (CH REP) and…