Companion Diagnostics under IVDR

In the existing EU regulatory framework, CDx devices are classified as ‘General IVDs’, requiring only self-declaration and limited regulatory oversight. The In-Vitro Diagnostic Regulation 2017/746 is accompanied by significant changes in the regulation of CDx devices, which will be classified as class C (the second highest risk classification) and will therefore require Notified Body oversight.

Owing to the unique nature of CDx devices, the IVDR also requires the consultation of the European Medicines Agency (EMA)/National Competent Authorities as part of the conformity assessment in addition to the role of the Notified Body.

This webinar reviews and summarises the requirements set out in the regulation for CDx devices. It also discusses the draft consultation process, which outlines the key steps and interactions between Manufacturer, Notified Body and EMA in the conformity assessment of CDx devices.


Date and time: Thursday, 20 May 2021, 11.30 am (CEST)

Your speakers: James Hewitt, IVD Product Expert

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