MHRA Guidance: Medical Device Stand-Alone Software (Including Apps), 3/14

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In March, 2014, the MHRA published this guidance on medical device stand-alone software, including apps, for people working in healthcare and companies developing devices.

This guidance aims to:

• Outline the UK’s current regulatory position on stand-alone software
• Explain what defines a medical device
• Help determine whether a stand-alone software or app is a medical device
• Provide information about the classification of medical devices and how to meet the medical device regulations