Module 19 2021

28/05/2021

Follow-on (2 nd generation) CDx

• CDx claiming to be equivalent to a CE-marked CDx (same population, specimen, drug, etc.) • Expected to select the same population for which efficacy and safety were demonstrated for corresponding drug in pivotal trial(s) • Bridging data may be used to demonstrate clinical performance • In lieu of new (interventional) clinical data • Use samples that are relevant and representative • Equivalence criteria should be pre-specified • Ensure that analytical validation is finalised prior to bridging • Devices authority needs to be notified of CDx bridging studies using left-over samples (no authorisation needed)

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Future UK IVD regulation

• MHRA is working to develop a robust, world-leading regulatory regime for medical devices that prioritises patient safety - to be in place from July 2023. • We are considering international standards and global harmonisation • We will engage with life sciences and healthcare sector stakeholders • We are identifying and prioritising elements of international best practice that promote public health and patient safety. • We plan to have a formal public consultation on future medical device regulation in Summer 2021 • We are keen to build on a range of expertise – please look out for more information and opportunities to engage on this topic on gov.uk in future.

The Organisation for Professionals in Regulatory Affairs

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