Reporting Adverse Incidents Involving Software as a Medical Device under the Vigilance System

Open Menu

HOME
SERVICES
WHO WE ARE
PARTNERSHIPS
RESOURCES
CAREER OPPORTUNITIES
CONTACT

You are here: Home > News > Reporting Adverse Incidents Involving Software as a Medical Device under the Vigilance System

Reporting Adverse Incidents Involving Software as a Medical Device under the Vigilance System

15 May 2023 – the UK MHRA published guidance on reporting adverse incidents involving software as a medical device.

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