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GuidanceMHRA

Clinical trials that include an in vitro diagnostic device

Guidance on submitting an application for approval of a clinical trial that includes an in vitro diagnostic device.

First published: Sep 30, 2025Last updated: Mar 9, 2026Changes: 3

Latest change: Updated wording to align with current guidance on clinical trials that include an IVD.

The full document, source attachments, and change history are available on KeyPedia. Sign in to view.

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