Due to the lapsed Mutual Recognition Agreement (MRA) with Europe, Switzerland is a ‘third country’ related to medical devices. Swissmedic, therefore, instituted its own importer requirements.
A transition period is implemented for importers to identify themselves with MDD/AIMDD legacy devices. However, no such transition period is granted for MDR CE Marked devices and Swiss importers must identify themselves immediately. The importer may be identified on the device, the packaging, or in a document accompanying the device.