Guidance

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.

From:
Medicines and Healthcare products Regulatory Agency
Published
15 May 2023
Last updated
15 January 2025 — See all updates

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Guidance for manufacturers on reporting adverse incidents involving software as a medical device under the vigilance system

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This guidance provides information for manufacturers of software as a medical device. It outlines events that may cause indirect harm and are therefore reportable.

You should read this in conjunction with the guidelines on medical devices post-market surveillance which sets out the general adverse incident reporting obligations on all manufacturers of medical devices including software as a medical device.

Updates to this page

Published 15 May 2023
Last updated 15 January 2025 + show all updates

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

  2. First published.

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