This interactive webinar is developed to help in vitro diagnostic medical device manufacturers understand the basics of the impact of the new In vitro diagnostic regulation (IVDR), the most relevant changes against the directive and how it will impact to either medical devices already in the market and new medical devices.
The In Vitro Diagnostics Regulation (EU) 2017/746 entered into force on May 26th, 2017 as the replacement of Directive on In Vitro Diagnostic Medical Devices (98/79/EC). This regulation will be fully applicable from May 26th, 2022, with the aim to increase safety and efficiency in the EU medical device market. Within the key changes expected, there is a product scope expansion as IVD and a reclassification of these devices according to their risk. In addition, the clinical evidence to demonstrate clinical benefit and safety will be rigorously evaluated according risk class. This new regulatory framework causes a burden for IVD manufacturers, who will have to address the new requirements to maintain their already marketed products or to place their new IVDs on the market. To know which will be the impact of the new regulation and the main new requirements to comply with will be key to assure continuity in European market.