# 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

> The Medicines and Healthcare products Regulatory Agency (MHRA) provides this guidance for manufacturers of software as a medical device (SaMD). It clarifies the reporting requirements for events that may lead to indirect harm, such as diagnostic errors or treatment delays caused by software malfunctions. This guidance functions within the regulatory framework of SI 2024 No. 1368 and complements general post-market surveillance obligations. While this specific document does not stem from an inspection of a single company or list specific violations, it addresses industry-wide compliance issues regarding the failure to report non-physical harm. Manufacturers must read this in conjunction with broader adverse incident reporting regulations to ensure comprehensive safety monitoring. Required actions for SaMD companies include the implementation of rigorous post-market surveillance systems capable of identifying and reporting software-specific risks. This approach ensures that all potential patient safety issues, whether direct or indirect, are communicated to the regulatory authorities as mandated by UK law. By adhering to these standards, manufacturers fulfill their legal obligations to maintain device safety throughout the product lifecycle, preventing the escalation of software-related risks into serious clinical incidents.

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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)