EU In Vitro Diagnostic Regulation (IVDR)

The In Vitro Diagnostic Medical device directive has partially been replaced by the In Vitro Diagnostic Regulation. The transition period for regulation 2017/746 for IVD devices on the European market is postponed for some processes and some of the products but for other products it is required from 26th of May 2022. The new regulation will have a great impact on all device manufacturers, with stricter requirements on devices as well as on manufacturers’ QMS’s, throughout the product lifecycle.

QAdvis offers a 1-day course on the new regulation, to give you a basic understanding of the new requirements and help you get started on the transition project.