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Content Type

Regulation and official guidance

Guidance: medical device stand-alone software including apps

Overview

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

Open Government Licence v3.0

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Key Information

Jurisdiction: UK - UK-wide

Name of organisation: Medicines and Healthcare products Regulatory Agency

Date published: 8 Aug 2014

Categorisation

Domain: Healthcare and medicine - Medical devices

Topic: Good practice for development and use, Safety

Type: Regulation and official guidance

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