Reporting adverse incidents involving Software as a Medical Device under the vigilance system

Name: Reporting adverse incidents involving Software as a Medical Device under the vigilance system
Creator: Medicines and Healthcare products Regulatory Agency
License: https://www.nationalarchives.gov.uk/doc/open-government-licence/version/2/
Keywords: adverse-incidents,events,guidances,incidents,manufacturers,medical-devices,reporting,samd,software,software-as-a-medical-device,vigilance

Information

Original link

Type

Guidance

Regulated products

Medical Devices

Topics

Health And Social Care

Published

May 15, 2023

Last updated

May 15, 2023

Description

Information for manufacturers of Software as a Medical Device, detailing events that may cause indirect harm and are therefore reportable.

Organization

Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧

Country / Region

United Kingdom

License

Open Government Licence 2.0 (United Kingdom)

Feedback

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1 Main file

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

Updated on May 15, 2023

html

URL: https://www.gov.uk/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
Permalink: https://data.openrid.co/en/datasets/r/417d5e9e-928c-456d-a0a6-487c7dfb695e
MIME Type: text/html

Created on: May 15, 2023
Modified on: May 15, 2023