Module 5 Presentations

16/07/2024

Medical Devices in Clinical Trials Focus on EU regulations for trials involving IVDs

Deepa Subramaniyan, Senior Clinical Trial Regulatory Lead Supported by Ruby Kansagra, Data and Content Lead

Produced by Roche Products Ltd

M-GB-00018492 Date of preparation: July 2024

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Medical devices: definition and types

Regulations and standards governing medical devices Device development pathway: where pre-market and post-market clinical studies fit Performance study and Clinical investigations : Roche submission experience New EU regulations: impacts on the clinical trials space Expected future developments: project on interplay of regulations and IT system deployment

Table of contents

M-GB-00018492 Date of preparation: July 2024

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