Briefing: MDR To Bring Catastrophic Disruption to mHealth in 2020

On 26 May 2020, new European Union Medical Device Regulation (MDR) will come into force. Without action now, UK patients, NHS services and the UK’s medical tech industry will experience significant issues.

Today approximately 500 health apps require certification. In a move to build trust, the new requirements mean all of these, plus an additional 6,000 mHealth products will require classification. But there is only capacity in the system across Europe for 300 devices to be assessed each month (one notified body in Germany and another in Belgium).

Unaddressed, from May next year more than 6,000 health apps will be unable to get the appropriate CE mark, and so forced to be taken off the market. They will need to wait for assessment, many for more than 1.5 years.

This puts at risk:

Public Health – 66% of the UK public now use a mobile health app (1). Whilst the majority are general wellness related, 40% of apps help with condition management (2). Overnight, on 26 May, patients won’t be able to access these tools, for example:

  • GP at Hand – around 41,000 patients who have registered for this online GP consultation service will need to find another practice.
  • Changing Health – NHS England has partnered with Changing Health to roll out the largest ever roll out of free digital support for people diagnosed with Type 2 diabetes, which currently costs the NHS around £8.8 billion a year (3). Although proven to be more effective than face to face support(4), this programme will stop.
  • Brain in Hand – around 4,000 people with autism, a mental health condition, or learning difficulty using this on demand support system will be left without help; a quarter of these are students with a mental health condition attending university.

NHS services – apps deliver proven reductions in acute care utilisation across diabetes prevention, diabetes care, asthma, cardiac rehabilitation and pulmonary rehabilitation (2). In the clinical setting, apps have the potential to improve productivity as well as providing a method for managing confidential data. Around 50 NHS organisations have invested in building an app to address a real need; and NHS bodies have consulted in the development of almost a thousand apps.  NICE has built apps into patient pathways and GPs can now prescribe apps.

This investment and momentum towards the uptake of mHealth will stall.

UK Industry – Health apps represent the fastest growing segment in digital health.  The UK is well positioned to be the global leader of this market. The UK’s £250 million health app industry saw a 35% CAGR between from 2014 to 2018 (5).

Today, the average total cost for developing a health app to first release is £340,000. Only 32% of developers come from traditional healthcare stakeholders such as hospitals, health insurers and Pharma companies, who may be able to continue operations whilst usage waits for more than a year.  The vast majority come from technology and app developer companies, who do not have the finances to continue (6).