SAVE-THE-DATE - IVDR & analytical performance testing requirements
IVDR – State-of-the-art requirements for analytical performance testing
In May 2017, the European In Vitro Diagnostic Medical Device Regulation (IVDR) entered into force and replaces after a 5 year transition period which will end May, 2022 the In Vitro Diagnostic Medical Devices Directive. This has major implications on most in vitro diagnostic devices (IVDs) in development and those currently on the market as they have to be re-certified. Furthermore, this affects also called laboratory developed tests (i.e. devices manufactured and used only within health institutions) are now included in the IVDR requirements.
Goal of this event is to inform manufacturers and users of IVDs about these implications and to give insight into the current situation on the IVDR and related ISO standards and CEN Technical Specifications. Special emphasis will be put on the issues scientific validity and requirements for analytical performance testing, including pre-analytical requirements, and clinical performance testing.