The Medical Devices Regulation (MDR) is the medical device regulation - the legislation setting out the requirements that manufacturers must meet in order to market medical devices in the European Union. It affects all manufacturers, importers, distributors and representatives of medical devices within the EU. The MDR focuses on the safety and performance of medical devices, focusing on the requirements for placing them on the market.
The In Vitro Diagnostic Regulation (IVDR) describes the requirements that manufacturers must meet in order to sell IVDR devices within the EU. IVDR training courses will introduce you to the requirements of IVDR.
Do you want to comply with both legislation and customer requirements? Then BSI's MDR & IVDR training courses are suitable for you.