The Medical and Healthcare products Regulatory Agency (the “MHRA”) has recently published updated guidance on medical device stand-alone software, including apps, in the context of the Medical Devices Directive (93/42/EEC) and In Vitro Diagnostics Directive (98/79/EC).
Health apps have surged in popularity and are in everyday use for the purposes of, for example, counting steps, tracking diet and exercise, monitoring heart rate and other health measures and assisting healthcare professionals in prescribing treatment. The updated guidance is intended to assist app developers and manufacturers of medical devices in assessing whether their app is a medical device and to ensure they comply with the relevant regulatory regime.
An app will be classified as a medical device under EU legislation if it has as its intended purposes one or more of the “medical purpose(s)” set out in the relevant EU directive. The updated guidance from the MHRA seeks to provide clarity on what is meant by this. The MHRA’s approach is that the app must be linked to a specific disease, injury or handicap in order to fall within one of the medical purposes. This means that some of the more generic wellbeing and health monitoring apps are now less likely to fall to be regulated as medical devices.
The guidance also seeks to provide guidance on complying with the regulatory regime, should an app fall within the definition of a medical device. Before a device can be placed on the market, a manufacturer must be able to demonstrate that it meets all of the applicable “essential requirements” and these are highlighted in the guidance.
The guidance is likely to prove useful to app developers and medical device manufacturers, however it relates to the current EU legislation relating to medical devices. The new EU Medical Devices Regulation and EU In Vitro Diagnostics Regulation, replacing the current directives, are expected to be adopted this year and come into force over the following three to five year period. The guidance will then need to be updated to reflect the new regime.
Do not hesitate to speak with your usual S&B contact if you would like to discuss any aspect of the guidance or the EU medical devices regulatory regime.