Clariscience supports importers of medical devices and IVDs by guiding them in reading and interpreting the various requirements to be fulfilled in order to comply with legal obligations. The dedicated service for importers will allow the Company to adopt operating procedures in full compliance with Article 13 of the Medical Devices Regulation and the IVD Regulation and will ensure that all necessary import documents are present and compliant.
Upon request, Clariscience may also register the devices in the Database.
