It may seem obvious that patient safety and evidence of efficacy should be the greatest priorities for healthcare, but this isn’t always the case. While the world of pharmaceuticals is heavily regulated, less attention has traditionally been paid to medical devices, including software.

Healthcare has undergone a huge transformation in recent years and we are seeing a growing number of digital health apps, including our own Huma software. These digital platforms, usually known as software as a medical device (SaMD) or medical device software (MDSW), should also be properly regulated to ensure patient safety and provide devices that healthcare providers can trust. But right now, this isn’t the case. Just 7% of digital health ventures produce clinical trial data, and fewer than one in 10 digital health ventures make regulatory filings.¹ A lack of oversight and regulation is bad for providers and patients, and for the sector as a whole - unsafe products risk a public or regulatory backlash against all digital platforms. 

It is relatively easy to see how proper clinical trials and regulation can be put in place for devices such as implants and pacemakers. But in such a fast-moving world as digital health, where there are many claims made that aren’t always backed up by robust evidence,² what does this kind of regulatory oversight mean and how can it be done? 

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What is Class IIb certification?

The MDR classification system is a legal framework put in place by the EU in May 2021 to reflect the potential risk of medical devices and improve regulation.³ For digital health products, the classification system works on two axes (see table 1):

• The significance of the information and the impact on patients - low (informs clinical management), medium (drives clinical management) and high (directly diagnoses or treats a disease)
• The state of the patient – non-serious (not life-threatening/not progressing fast), serious (if not properly treated promptly then condition could progress), and critical (life-threatening)

Huma’s remote patient monitoring (RPM) software platform collects data about patients’ health conditions via an app. Our platform enables clinicians to use this information to remotely monitor patients in any setting and, most importantly, help improve patient care.

We were not content to make digital health monitoring software that was restricted only to specific patient groups or diseases, or would only be suitable for mildly ill patients and would no longer be useful if they progressed to a more severe state.

We decided to aim for Class IIb certification as it falls in the sweet spot of covering the widest range of patients, short of the most critically ill, and offering the most useful insights to drive clinical decision-making. 

Our challenge was to achieve it.
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Our journey to EU MDR Class IIb certification

The journey to achieving EU MDR Class IIb began back in October 2021. I joined Huma at this time to set up the quality control systems that would provide the level of evidence required for certification.

To obtain the EU MDR Class IIb mark, all our data needed to be thoroughly reviewed by an independent external body. Only once we’d shown the appropriate evidence for product safety and patient benefits, did we finally get awarded the certification.

There was an amazing sense of collaboration and everyone was working together tirelessly, day and night, to get the job done. There was seemingly endless document writing, reviewing, editing and collation, and it was an extremely thorough and intense process.

Throughout, the team has been outstanding - we just put our heads down and worked hard on getting it all together. I am so proud of what we have managed to do and the evidence we’ve pulled together to prove that our platform truly does what we claim.
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What does this mean for Huma and our users?

We are thrilled to be the first health tech company with a EU MDR Class IIb certified disease agnostic RPM software platform, meeting the newest regulations and highest levels of patient safety in the EU and UK. Achieving external validation for this was no simple feat, as the bar for approval is set very high.

Our platform is able to monitor patients of all ages with any condition - including infants and pregnant people - and can connect with a range of external devices, such as heart rate or blood sugar monitors. 

Patients can feel confident they are in safe hands knowing that our product has been thoroughly vetted for efficacy and safety. Importantly, they can trust that the data they enter is properly guarded and that the software is appropriately flagging anything abnormal to clinicians.

Healthcare providers can also rest assured that our platform is proven to be safe with robust clinical evidence, and that it is certified from non-serious illness to life-threatening progression, right up to the hospital or ambulance door. 

Now we’ve gained EU MDR Class IIb certification for our digital health platform, we have to keep it. The world is watching us, and we have to maintain our commitment to ensuring patient safety. 

Moving forward, we’ll continue to build a solid evidence base for our digital platforms. It’s the right thing to do and it’s what we believe will bring the promise of the digital healthcare revolution to fruition, supporting healthcare providers and bringing genuine benefits and improved outcomes to patients.