Over the past decade, governments across the world have scrambled to devise regulations that keep up with the advances being made in technology. In June 2023, the UK’s Medicines Healthcare Products Regulatory Agency (MHRA) updated its guidelines on the “Software and AI as a Medical Device Change Programme” to revise the regulatory scope for medical devices. This across the software as a medical device lifecycle, from qualification and classification to requirements that apply both pre- and post-market by 2024 when the UK will see the release of its first formal legislation on software as a medical device (SaMD) and AI as a medical device (AIaMD).
Whilst traditional medical device companies have become accustomed to working with the medical device regulations and have built legal and compliance teams to ensure they stay within the rules, for those companies in the broader technology space moving into the realm of health care for the first time, this may be unfamiliar territory. As medical device regulation begins to impact those companies that sit outside of the traditional healthcare setting, now is the time to act and ensure they are prepared for forthcoming regulatory changes and equipped to influence them.
What is a medical device?
The World Health Organisation defines a medical device as “any instrument, apparatus, implement, machine, appliance, implant, reagent for in- vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose.” Variations on this definition are used in many countries.
The new concept of medical devices now includes a range of items which sit outside the traditional realm of health care, such as those that use software, AI and machine learning. These modern devices potentially have an important role to play in improving population health, but for regulators, it is challenging to keep up with the explosion of innovative products entering the market.
What is the line between wearables and medical devices?
At present, a device for gathering data—for example, something which measures heart rate or motion—does not usually constitute a medical device in itself. However, as soon as this device is used to perform a medical assessment it may fall within a medical device regulatory framework (depending on the country in which it is authorised for sale), opening businesses up to entirely new areas of complexity and by extension potential regulation.
Digital technology has become embedded into everyday lives with consumers using their phones, watches and other wearable trackers to log their food intake, exercise, contraception, mental health, menstrual cycles and more. For many people, these devices are not medical, but part of general well-being. But the challenge for start-ups as well as established tech companies entering the health and wellness space is to decipher at what point a product will be defined as a medical device. The distinction is becoming more blurred and increasingly difficult to navigate.
As an, more than a quarter of UK adults own an exercise tracker of some kind, with a third of those wearing their trackers every day to capture their levels of health and fitness. At present these types of trackers are unlikely to fall under the regulations for medical devices, instead remaining outside the MHRA’s control. However, the UK Government’s recently published “plan for digital health and social care” set out an ambitious vision for transforming the sector with digital technology, stating that by March 2025, patients will be able to link wearable devices and other health-related data to their “online NHS profile.” This is likely to further complicate the distinction between a general wearable item and a medical device. And is only one example of a growing problem likely to hit the industry.
As more innovative solutions for health care services are developed—such as AI-powered questionnaires for patients to submit following procedures—providers need to be aware of applicable regulations and understand the current and future legislative landscapes.
What’s next for manufacturers?
Over the coming years, companies operating in the UK will be required to ensure that their products comply with new regulations, with many ill-prepared for the time and resources needed to gather evidence and file reports to enable their items to qualify as medical devices.
As regulators try to keep pace with the explosion of technological innovation and create new legislation to protect consumers, manufacturers must ensure that they know what is coming and are able to provide evidence of how their technology works. Whether a company is a start-up with limited resources or an established technology supplier looking to enter a new sector, having access to expertise will be vital. Policy and communications experts that can help these companies navigate the changing regulatory landscape in whichever territory they intend to operate and advise on when and how they can influence the market, will be key for success.