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

Documents

Guidance for manufacturers on reporting adverse incidents involving Software as a Medical Device under the vigilance system

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Details

This guidance provides information for manufacturers of Software as a Medical Device. It outlines events that may cause indirect harm and are therefore reportable.

It should be read in conjunction with the guidelines on a medical devices vigilance system MEDDEV 2.12/1 rev 8 which sets out the general adverse incident reporting obligations on all manufacturers of medical devices including software as a medical device.

Published 15 May 2023