Overview

Companion diagnostics (also known as CDx) is a particular category of IVD devices, used to aid in the assessment of patients for whom a specific drug therapy is being considered. The IVDR has increased requirements for CDx.  Most CDx devices are now in risk Class C and require Notified Body oversight for placement on the market.

In addition, a Notified Body is required to consult the competent authority designated by the member states in accordance with Directive 2001/83/EC or the European Medicines Agency (EMA) as applicable, which results in a longer approval process.

Key takeaways and learning objectives

This webinar will update attendees on the latest BSI knowledge and best practise with regards to IVDR Companion Diagnostic conformity assessment. This will include:

• Classification
• Technical Documentation best practise
• Performance Evaluation best practise and common pitfalls
• EMA consultation process

Presenter information

Speaker - Dr Elizabeth Harrison – Global Head – IVD Medical Devices

Speaker - Elizabeth Linch - Technical Specialist and Scheme Manager – IVD