02. September 2021
Why do we need a Swiss Authorized Representative (Swiss AR)?
Health Tech Cluster Switzerland’s event “Why do we need a Swiss Authorized Representative (Swiss AR)?” last week showed that interest remains high.
Our three Key Take Aways:
- The swissmedic sheet clearly lays out the two fundamental levels: Physical product responsibility – manufacturer, importer, distributor; Formal and safety concerns – CH REP.
- The role of the importer is significantly enhanced in the logistics chain, as he ensures that only products that comply with the MepV are placed on the market.
- Contrary to all expectations, swissmedic does not specify the location of the “Person Responsible for Regulatory Compliance”. The decisive factor is that he or she is able to exercise the responsibility in accordance with the legal requirements
Many thanks again to Stefan Leuthold for inviting Ulrike Neuberger. It was a pleasure to organize the event together with Beni Hirt and Michael Maier!
If you have any further questions, please feel free to contact us!