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.
Documents
Details
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聽guidance on post market surveillance聽which sets out the general adverse incident reporting obligations on all manufacturers of medical devices including software as a medical device.聽
The aim of this guidance is to complement the requirements of聽. You should read it in conjunction with this regulation. Device-specific guidance does not replace or extend these requirements.
Updates to this page
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Updated to reflect the laying of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.
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First published.