A mobile medical device is a mobile phone that has become a regulated medical device. Commonly done by installing dedicated software on the phone, a mobile app. The app could transform the mobile into a device or be an accessory to one.

An example is a mobile used to measure blood pressure, either by connecting a cuff directly or by indirectly controlling a blood pressure machine. Also, calculators for patient-specific doses, scores (eg Glasgow Comma Scale) or prognoses that aid a clinician in making a diagnosis or selecting a specific treatment for that patient are likely to be considered a mobile medical device.

Importantly, the FDA says: "Mobile apps may be subject to medical device regulation if they are intended for use in the diagnosis or the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man." Therefore, a mobile medical app like other medical devices may be classified by the FDA as class I (general controls), class II (general and special controls with premarket approval) or class III (general controls and premarket approval).

In Europe, medical devices may be classified as class I, class IIa, IIb and III, with class III covering the highest risk products. The higher the classification the greater the level of conformity assessment required by notified bodies.

Examples - mobile medical devices

Some examples of certified mobile medical devices are:

Mersey Burns A clinical tool for physicians and the first mobile app to be classified by the MHRA as a Class I medical device under the remit of the EU Medical Device Directive.

Withings Blood Pressure Monitor A blood pressure cuff that can be attached to and controlled by a mobile. Enabling users to graphically view their results and share results with doctors and personal health records. It is certified as a device by the European Commission, by the FDA (class II), in Canada (class 2) and in Australia and New Zealand (TGA class IIa).

AirStrip Solutions A suite of patient monitoring apps for healthcare professionals that are FDA cleared and received CE Mark certification for use in Europe earlier this year.

Mobile MIM A diagnostic radiology app for healthcare professionals, now cleared by the FDA as a Class I medical device. MIM was one of the first medical apps available in Apple’s AppStore but also the first to be pulled from the store because of regulatory concerns.

Care4today Treatment adherence app for US patients developed by Janssen, cleared as a Class I medical device by the FDA.

Examples - not mobile medical devices

The following apps are likely not to be considered as mobile medical devices:

• Reference information or educational materials, eg medical textbooks.
• Record keeping or trackers for general health and wellness, eg diet log with recipe suggestions.
• Automation of clinic operations, eg appointment reminders or billing transactions.
• General tools that are not intended for a medical application, eg magnifying, voice recording, note-taking.
• Electronic and personal health records.

Sources

MHRA's explanation of medical devices classification.

FDA draft guidance on mobile medical devices (or as PDF). Jul-11

EC guidelines on standalone software in healthcare. Jan-12

EU directive on medical devices (PDF). Jun-93

EC guidelines on medical devices (PDF). Jun-10

Thanks to Sally Leon for her help with this blog post.