New UK Post-Market Surveillance Requirements
16 May 2023Swiss Importer Identified with MDD/AIMDD
16 May 2023Due to the lapsed Mutual Recognition Agreement (MRA) with Europe, Switzerland is a ‘third country’ related to IVDs. Swissmedic, therefore, instituted its own importer requirements.
Swiss importers must identify themselves immediately for IVD devices. The importer may be identified on the device, the packaging, or in a document accompanying the device.