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

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/1127ca30-c2c7-4645-9bcc-01d1731b2b38
Type: Guidance
Published: May 14, 2023
Updated: January 15, 2025

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

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## Content

This document provides guidance for manufacturers of software as a medical device. It outlines events that may cause indirect harm and are therefore reportable. Read it in conjunction with the guidance on post market surveillance which sets out the general adverse incident reporting obligations on all manufacturers of medical devices including software as a medical device. The aim of this guidance is to complement the requirements of SI 2024 No. 1368 . You should read it in conjunction with this regulation. Device-specific guidance does not replace or extend these requirements.

## Attachments

- [Guidance for manufacturers on reporting adverse incidents involving software as a medical device under the vigilance system](/government/publications/reporting-adverse-incidents-involving-software-as-a-medical-device-under-the-vigilance-system/guidance-for-manufacturers-on-reporting-adverse-incidents-involving-software-as-a-medical-device-under-the-vigilance-system)