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GuidanceMHRA

Reporting adverse incidents involving software as a medical device under the vigilance system

Information for manufacturers of software as a medical device, detailing events that may cause indirect harm and are therefore reportable.

First published: May 14, 2023Last updated: Jan 15, 2025Changes: 2

Latest change: Updated to reflect the laying of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.

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