Introduction to the New Performance Evaluation Requirements Mandated Under the IVDR (2017/746)

Understand where, when and how performance evaluation should be undertaken during the life cycle of an IVD device under the IVDR (2017/746).

The EU In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746, came into force in May 2017, with an initial transition period of five years, and an intention to strengthen the current approval system for in vitro diagnostics in Europe through an evidenced based Notified Body review system. A key area of change is the minimisation of self-certification, and the introduction of mandatory documentation for the planning and reporting of the manufacturer’s clinical evidence to demonstrate the safety and effectiveness of the IVD device under evaluation.

This training will provide attendees with a holistic high-level view of performance evaluation, how it sits within the wider Regulation, the vital issues your organisation needs to understand to produce the relevant evidence within the terms of the new Regulation, the importance of establishing the cross-functional team needed within your organization to meet this new and demanding regulation and the role and interaction with the new Notified Bodies. It will then go on to consider the complex implications of the Regulation for overlap with the Clinical Trial Regulation (CTR) 536/2014 and Medical Device Regulation (MDR) 2017/745.

IVDeology and Management Forum have developed this training programme to provide detailed knowledge and understanding of the heavily updated area of performance evaluation within this vital new regulation and its opportunities and threats for your business.