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When is wearable technology considered a medical device?

Posted on 02 November 2020

In recent years, the wearable technology sector has boomed, particularly in fitness wearables and medical health trackers.

As wearable technology and the algorithmic software underpinning the technology becomes increasingly advanced, there are plenty of exciting opportunities for inventors, producers, manufacturers, software developers and, importantly, end-users. For example, recent wearable technology developments show it is possible to:

  1. identify early-stage breast cancer using a smart bra containing sensors that analyse breast tissue;
  2. engineer waterproof micro-sensors that monitor the chemical composition of sweat particles and inform athletes how to replenish hydration levels after exercise;
  3. monitor glucose levels via a watch/bracelet or implantable sensor, helping those with diabetes to more efficiently manage their blood sugar levels;
  4. measure and analyse athletes' movements using GPS technology in a vest comprising a accelerometer, gyroscope and magnetometer.

However, the rise of wearable technology comes with regulatory risks whether in relation to data privacy, under competition law, or by straying into the categorisation of medical devices. Companies involved in the development of wearable technology should be alive to what "medical devices" are and the regulatory regime underpinning them, so that they can understand when wearable technology crosses the line into medical devices and avoid running foul of a developing area of law.

What are "medical devices"?

Currently, devices in the EU, including the UK, are regulated by three EU Directives relating to medical devices, in vitro diagnostic medical devices and active implantable medical devices (with modernising EU Regulations due to take effect in 2021-2022). Under the Medical Devices Directive, a medical device is "any instrument, apparatus, appliance, software, material or other article used alone or combined for humans" to either:

  1. diagnose, prevent, monitor, treat or alleviate disease, an injury or handicap;
  2. investigate, replace or modify the anatomy or a physiological process; and/or
  3. control conception.

Whilst a broad definition, in essence, a medical device needs to have a medical purpose, meaning it should work in a way that is metabolic, immunological or pharmacological.

Within this definition of medical devices, there are three categories of medical devices:

  1. general medical devices (e.g. x-ray equipment, ECG monitors);
  2. in vitro diagnostic medical devices (these analyse blood and body tissue, such as a finger prick glucose tests and pregnancy tests); and
  3. active implantable medical devices (bodily implants, such as glucose sensors and cardiac pacemakers).

However, the delineation of what is and what is not a medical device is not a straightforward task, and although the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has published some useful guidance, which is of assistance for stakeholders when considering this critical point, it does not cover all possible use cases.

When is wearable tech a "medical device"?

A wearable or implantable product that plainly alleviates disease, such as a pacemaker, is clearly a medical device. However, it is not simply the product in and of itself that could be a "medical device", but also the related software that works in conjunction with the product and allows it to fulfil its function. Software is not defined by the Medical Devices Directive, but the scope of the regime is clarified by the EU Medical Devices Regulation: software includes both algorithms and 'mobile computing platforms' (i.e. apps). Whilst this Regulation does not have force in the EU yet and won't have force in the UK after Brexit, it is likely that the UK will adopt similar provisions confirming the scope of "software" as a medical device. As a result, a product that does not appear to have a medical purpose could be a medical device simply because the algorithm underpinning it and/or the end-user app has a medical purpose.

To help clarify matters, under EU guidance, certain types of software, even when used for a medical purpose, will not be classed as a medical device. This includes software with the following functions:

  • Neutral assistance with medical decision-making (e.g. by providing reference information and recommending lifestyle treatment choices or referral advice).
  • Patient or professional medical education.
  • Monitoring of fitness, health or wellbeing.
  • Administrative functions such as booking appointments and requesting prescriptions.

The line between an application that has or does not have a medical purpose is becoming increasingly blurred. For instance, an app that syncs to a wearable device and monitors fitness, health or wellbeing generally, rather than for a specific disease, is not considered a medical device, even though monitoring and improving general fitness and health will contribute to preventing disease and may flag symptoms that allow a disease to be diagnosed.

Developers of technology should be particularly aware of the first exclusion above, assistance with decision-making: an app that neutrally provides reference information to help a physician make a medical decision is not a medical device, however software can easily stray into including automated decision making processes (e.g. based on machine learning). Such automated processes, where they do not involve a medical professional's intervention in the diagnosis or determination of a treatment plan, amounts to a medical purpose and the device would be subject to medical device regulation. A prime example would be fertility trackers, which typically incorporate a wearable device that measures certain physiological metrics daily and applies these to an algorithm in order to predict the user's fertility and make recommendations on how to avoid or encourage conception (e.g. the Ava bracelet). Since the purpose of the device is to control conception, and it incorporates software that does not simply "assist" with decision making by providing a physician with reference information (but instead makes recommendations directly to the user), it is classed as a medical device.

Products and applications will have a spectrum of functionality, and this gives rise to a grey area when considering whether a particular device is a medical device or not. When considering the legal framework that applies to an application that performs in the health and fitness space, stakeholders must ask:

  • Is the wearable technology's primary purpose medical?
  • If so, what function does it perform within the definition of "medical devices"?
  • If it is a multi-purpose device, can the medical purpose of the product or its software be considered its primary purpose or ancillary?
  • Is the application an excluded type of software?

What is the current and future UK legal regime for "medical devices"?

With the end of the Brexit transition period approaching, the legal position in relation to regulation of "medical devices" in the UK has been clarified in recent MHRA guidance. The legal position and changes are discussed in greater detail here. In summary, with effect from 1 January 2021:

  • All medical devices and in vitro diagnostic medical devices (IVDs) to be placed on the GB market (England, Scotland and Wales) after 1 January 2021 will need to be registered with the MHRA, with either a UK Conformity Assessed (UKCA) or CE mark (there are grace periods for certain products and different rules relating to Northern Ireland);
  • UKCA mark must be used from 1 July 2023 for devices placed on the GB market;
  • the existing regulatory regime will continue to apply until amended (including by powers being created under The Medicines and Medical Devices Bill which is working its way through the Parliamentary process); and
  • the EU Medical Devices Regulation and the EU in vitro Diagnostic Medical Devices Regulation, which are intended to modernise the EU regime and will take full effect within the EU in 2021-2022, will not apply in the UK.

Given that the distinction between wearable technology and medical devices is becoming increasingly blurred as technological capabilities continue to expand, there are both great opportunities and regulatory risks for those involved in the space.

For any new device, it is important to consider the current and possible applications of the product and software carefully, in the context of the applicable regulatory framework and guidance provided by the regulators.

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