Health data analytics software might fall subject to medical devices regulation, says UK regulator

The confirmation was contained in updated guidance the regulator has issued on medical device stand-alone software, including apps (36-page / 860KB PDF). The guidance has been written to accord with current EU rules on medical devices, which are in the process of being reformed.

"MHRA do not generally regulate data, databases or analytical services, but if you are analysing or processing data for a medical purpose, then the software that you are using may be covered by the regulations (e.g. analysing imaging or genomic data to determine treatment)," the MHRA said.

Whether a device has a medical purpose is central to whether they should be classed as a medical device and subject to regulation.

In its guidance the MHRA said that "a medical purpose is determined by what the manufacturer states in the device’s labelling, instructions for use and any promotional materials".

Organisations that display disclaimers alongside products to state that they are not medical devices may nevertheless find that those products are subject to regulation as a medical device, it said.

"General disclaimers (for example ‘this product is not a medical device’) are not acceptable if medical claims are made or implied elsewhere in the product labelling or associated promotional literature," the regulator said.

It said that "the monitoring of general fitness, general health and general wellbeing is not usually considered to be a medical purpose".

In its guidance the MHRA also set out its views on when software is likely or unlikely to be considered as a device.

The MHRA said: "Software is unlikely to be a device if: it just reproduces a paper document in digital format; it is down to the health care professional to make the decisions based on the advice displayed; it just follows the path of a procedure/treatment - there are no decisions - may provide information; it has decision points, options may be explained but the health care professional decides which path to take; it offers lifestyle treatment choices only."

"Software is most likely to be a device if: it is linked to a specific medicine/device (is likely to be an accessory); it is intended to influence the actual treatment - dose, size of implant, time of treatment etc; it results in a diagnosis or prognosis - provides future risk of disease," it said.

The MHRA said some software could be considered as an "accessory" to a medical device and fall subject to regulation. This might include "software on a mobile device linked wirelessly to a monitoring device to record data", it said.

"The definition of 'accessory' requires that the accessory is specifically intended by the manufacturer of the accessory to be used together with a device," the MHRA said. "The intended use of the accessory must be such as to enable a device to be used in accordance with its intended use. Therefore a product can only become an accessory to a medical device if the manufacturer of such a product establishes an intended use in conjunction with one or several medical devices."

"Apps acting as accessories to physical medical devices such as in the measurement of temperature, heart rate, blood pressure and blood sugars could be a medical device as are programmers for prosthetics and active implanted devices. If an app is the only way of interacting with a physical device then it may be considered to be a component of the device e.g a physical clinical thermometer with no display that links to an app on a mobile device by wireless link. The app displays, stores and analyses the data," it said.