UNITED KINGDOM: Stand-alone software and medical applications guidance

On June 20, 2018 the Medicines & Healthcare products Regulatory Agency (MHRA) published a guidance in order to provide clarifications on which applications and stand-alone software are included in the definition of medical devices and IVDs, as well as the related regulations. The “Medical device stand-alone software including apps (including IVDMDs)” guidance shall be used in synergy with MEDDEV 2.1./6.

If a software has a medical intended use – for example, if it is used for prevention, diagnosis, monitoring of a disease, injury or disability – according to the aforementioned guidance the software is classified as a medical device.

Although used for medical purposes, the software and/or applications that monitor fitness activity/health/well-being or used for the patient’s medical education or to store and transmit medical data without modification are not classified as medical devices.

For more information:

https://www.gov.uk/government/publications/medical-devices-software-applications-apps

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