Medical devices: software applications (apps)

Name: Medical devices: software applications (apps)
Creator: Medicines and Healthcare products Regulatory Agency
License: https://www.nationalarchives.gov.uk/doc/open-government-licence/version/2/
Keywords: appendixes,applications,guidances,medical-devices,notification,safety,software

Information

Original link

Type

Guidance

Regulated products

Medical Devices

Topics

Health And Social Care

Published

August 8, 2014

Last updated

July 1, 2023

Description

Information on when software applications are considered to be a medical device and how they are regulated.

Organization

Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧

Country / Region

United Kingdom

License

Open Government Licence 2.0 (United Kingdom)

Feedback

Suggest an improvement to this page

5 Main files

Medical device stand-alone software including apps (including IVDMDs)

Updated on July 1, 2023

pdf

URL: https://assets.publishing.service.gov.uk/media/64a7d22d7a4c230013bba33c/Medical_device_stand-alone_software_including_apps__including_IVDMDs_.pdf
Permalink: https://data.openrid.co/en/datasets/r/03eaff32-5cea-4eee-80b7-7ae2618cc55f
MIME Type: application/pdf

Created on: August 8, 2014
Modified on: July 1, 2023

Appendix 1 - symptom checkers

Updated on July 1, 2023

pdf

URL: https://assets.publishing.service.gov.uk/media/64a7d235c531eb000c650051/Appendix_1_-_symptom_checkers.pdf
Permalink: https://data.openrid.co/en/datasets/r/ee303a00-2de9-491d-9e6a-878bcdc4415a
MIME Type: application/pdf

Created on: August 8, 2014
Modified on: July 1, 2023

Appendix 2 - clinical calculators

Updated on July 1, 2023

pdf

URL: https://assets.publishing.service.gov.uk/media/64a7d23c7a4c230013bba33e/Appendix_2_-_clinical_calculators.pdf
Permalink: https://data.openrid.co/en/datasets/r/4498aebf-e735-4ddd-861b-4f97d02f2a7b
MIME Type: application/pdf

Created on: August 8, 2014
Modified on: July 1, 2023

Appendix 3 - ‘drives or influences the use of a device’

Updated on July 1, 2023

pdf

URL: https://assets.publishing.service.gov.uk/media/64a7d247c531eb000c650053/Appendix_3_-__drives_or_influences_the_use_of_a_device_.pdf
Permalink: https://data.openrid.co/en/datasets/r/7a909b21-3c28-40ee-a6f2-24fc4f1aff7f
MIME Type: application/pdf

Created on: August 8, 2014
Modified on: July 1, 2023

Appendix 4 – Field Safety Warnings and End-of-Life notification

Updated on July 1, 2023

pdf

URL: https://assets.publishing.service.gov.uk/media/64a7d2507a4c230013bba33f/Appendix_4___Field_Safety_Warnings_and_End-of-Life_notification.pdf
Permalink: https://data.openrid.co/en/datasets/r/0e5b155e-69c7-48e9-80c1-b67fa537acfb
MIME Type: application/pdf

Created on: August 8, 2014
Modified on: July 1, 2023

Medical devices: software applications (apps)

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Type

Regulated products

Topics

Published

Last updated

Description

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