CH-REP for medical devices

Since the mutual recognition agreement between Switzerland and the European Union ceased to apply to medical devices, Switzerland counts as a separate market. Anyone placing devices there without a seat in the country needs an authorised representative based in Switzerland — the CH-REP. Their duties largely mirror those of the EU representative: keeping documentation available, acting as contact for Swissmedic, cooperating on incidents.

Added to this are obligations that are easily overlooked. The CH-REP's name and address belong on the labelling; instructions for use must be available in the national languages matching the distribution area; importers must also be named. A CE mark alone does not suffice — it is recognised, but it does not replace the Swiss formalities.

For manufacturers from Germany and Austria this is the most common stumbling block when crossing the border, and it usually surfaces only when a Swiss customer orders. The providers listed here take on the role, often together with registration, label review and vigilance reporting to Swissmedic.