Unlocking Switzerland: Your Guide to the Swiss Authorised Representative Requirement

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 who is required to appoint one? • What are the specific legal responsibilities of a CH REP? • Have the compliance deadlines for appointing a CH REP for my device class already passed? • What specific information and symbols must be included on product labeling for the Swiss market? • What is the Swissdamed database and the CHRN registration number? • How does the Swiss regulatory framework differ from the EU MDR and IVDR? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.