The course is aimed at importers and/or distributors involved in the regulation of medical devices under the Medical Device Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR).
The medical devices and in vitro diagnostics industry is subject to the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). This course provides you with insight and knowledge on, among other things, definitions and the requirements imposed on economic operators, such as verification and market surveillance.
After the training, you should have an increased knowledge of the importer's and distributor's responsibilities regarding e.g. contracts, document control, complaint handling and traceability.
