Switzerland – Medical device direct imports to users in Switzerland

The concept of “importation” can be seen from various perspectives. Someone may physically transport a product across a border, which is addressed from a logistics perspective. Next is the perspective of taxes and customs, whereby someone takes care of paperwork and possible taxes and duties. There is also the regulatory perspective, which is represented by the European Medical Devices Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR), but which was introduced in the European Union several years ago by Decision 768/2008