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The opportunities and challenges of navigating Europe’s new regulatory environment

Experts from Scottish Health Innovations Ltd (SHIL) and The Digital Health & Care Innovation Centre (DHI) give us their professional opinion on European regulations

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Health tech Europe regulations

Experts from Scottish Health Innovations Ltd (SHIL) and The Digital Health & Care Innovation Centre (DHI) discuss how they are navigating a new regulatory environment in Europe with a new partnership to help MedTech developers 

The opportunities that the National Health Service (NHS) recovery plan presents over the next five years and the ongoing requirement for a wealth of tech and apps means that there has never been a more exciting time to be a healthcare innovator in the UK.

As we emerge from the COVID-19 pandemic Graham Watson, SHIL executive chair, explains that “innovative medical devices and diagnostics continue to play a heightened role in quickly delivering new products that have, and will continue to benefit, the NHS, the economy, and above all, patients.

“The medical device industry has seen unprecedented growth over the course of the pandemic,” Mr Watson continues. “Regulators have been more flexible against a backdrop of fast-changing advances in science and technology, and the regulatory landscape has continued to evolve due to Medical Device Regulation (MDR) implementation and the fallout from Brexit.”
Nevertheless, this evolution has produced a complex, multi-faceted scenario.

Europe and the UK

Indeed, in the face of a new MDR coming into force across Europe, earlier this year the UK chose to retain pre-existing rules while also introducing mechanisms to allow it to draw up separate rulings for the sector in the future.

With that in mind, consultation on future medical device regulation in the UK is now underway and will conclude this month prior to implementation in 2023. This is expected to result in more stringent regulation, with “the prospect of a standardisation of procedure to be particularly welcomed,” says Elaine Gemmell, head of regulatory affairs at SHIL.

In its own words, the Medicines and Healthcare products Regulatory Agency (MHRA) is working to develop a “world-leading future regime for medical devices that prioritises patient safety while fostering innovation.”

Undoubtedly then, it is vital that innovators now have a strong understanding of the processes involved when developing compliant devices for healthcare settings.

In addition to COVID-19 treatment needs, telehealth and digital solutions have of course been of paramount importance with many people unable to see their doctors in person.

This has served to bolster demand for medical device innovation to meet the immediate requirements of patients and doctors alike – and “it seems likely that demand for these remote services will continue, as will the need for the software and devices, that make them possible,” explains Mr Watson.

Before the pandemic, there was a movement towards increased governance around this heightened innovation. Now, however, far-reaching new regulations are having a significant impact on everyone involved with medical devices – from their manufacture to their use.

A strong understanding of regulatory compliance must therefore be closely intertwined when attempting to harness the true potential of new innovations early on in the development process.

“Innovators have to be supported in their grassroots understanding of what is required of them from a compliance point of view,” adds Mrs Gemmell.

“This will ensure that good practice is inherent in product development strategies and many of the criteria in the specification will have already been met when products are initially presented for assessment.”

Essentially though, while digital and data-driven health and care technologies have the potential to deliver huge benefits, the adoption of promising technologies must be approached responsibly and transparently with trust and the NHS’s reputation for delivering safe and ethical care consistently upheld.

There are inherent dangers in the increasing use of data-driven technologies, whether it is accountability, safety, fairness, or bias – the latter particularly if it benefits some groups while excluding others.

Mr Watson affirms that “equity must remain foregrounded.

“Likewise, privacy and rights must be carefully safeguarded with those affected by new innovations kept properly informed on how and when data involving them is shared.”

European skill

In turn, it means real demand for new skills in this area and across many areas of the industry for the foreseeable future, and the need for regulatory expertise is expected to remain high with the SHIL team expanding.

With these new regulatory demands in mind, SHIL and the DHI have partnered in a forward-thinking and first-for-Scotland initiative that delivers a unique and growing suite of UK Conformity Assessed (UKCA) marked decision support tools.
UKCA marking is required for all medical devices. The tools developed through this partnership embed validated evidence in digital tools and systems in daily use by health and social care staff.

These have been created amid wider issues in navigating UKCA and other marking requirements and they provide assistance to developers looking to overcome the challenges of navigating the regulatory process.

As a legal requirement before placing devices on the market, the UKCA mark means staff can use the tools with full confidence that all clinical safety, quality, and regulatory standards have been met.

Created through the ‘Right Decision Service’ – a Once for Scotland platform delivered by DHI to build national decision support solutions, they help drive consistent, evidence-based practice across health and social care in Scotland.

“This collaboration between DHI and SHIL extends the reach of the Right Decision Service into frontline practice and further strengthens its impact on patient and service outcomes,” says Dr Ann Wales, Programme Lead for Knowledge and Decision Support in DHI.

“It has opened up new ways of delivering best evidence direct to point of care through digital tools that meet the highest standards of clinical safety and quality.

“We especially appreciate SHIL’s willingness to take the manufacturer role and their expertise in regulatory requirements. These have been key enablers for the decision support programme delivering software as medical devices.”

To date, the collaboration has registered Class 1 UKCA marking for decision support tools including:

  • Centor and Feverpain for assessing the risk of bacterial infection and benefits of antibiotic prescribing in sore throat
  • The 4AT tool for more timely identification and management of delirium
  • Asthma Control Questionnaire 5 (ACQ 5) for determining the effectiveness of asthma control
  • Risk Score for Exacerbation of Asthma for determining the risk of asthma exacerbation within 6 months
  • Management of lower urinary tract infection in women under 65 years, based on SIGN Guideline 160
  • The Malnutrition Universal Screening Tool (MUST) for assessing the risk of malnutrition. Uniquely, the DHI-SHIL MUST tool adjusts the risk assessment automatically for the presence of oedema and amputation.

DHI and SHIL have also registered Class 1 UKCA marking for RESTORE2 (Recognise Early Soft Signs, Take Observations, Respond Escalate) for early detection of deterioration in care home residents, and timely, appropriate escalation reducing avoidable referrals and emergency admissions.

UKCA marking is in the pipeline for high risk prescribing alerts embedded in primary care electronic health record systems, based on the NHS Scotland polypharmacy guidance (currently being piloted in two NHS Boards); assessment and management of lower urinary tract infection for people over 65; assessment and management of acute coronary syndrome in Emergency Departments; and vital signs and sepsis assessment in paediatric unscheduled care.

Clinician feedback

Feedback from clinicians has been overwhelmingly positive. Speaking of the 4AT tool which assesses the likelihood of delirium, Professor Alasdair MacLullich, Professor in Geriatric Medicine and consultant in NHS Lothian, comments that “the 4AT calculator is a game-changing clinical calculator tool. Its ease of use reduces barriers to appropriate consideration and testing for delirium, and the ready availability of a mobile-based app will facilitate its use in every patient encounter.”
A key feature of the DHI/SHIL suite of tools is the ability to be re-used and embedded in multiple applications for use by different audiences in different contexts.

For example, the 4AT tool is embedded in a primary care remote consultation toolkit, a care home decision support application and the SIGN decision support service.

“We are proud to have partnered with DHI on these tools. Many of them are in wide use across health and social care but for the first time UKCA marking gives the SHIL/DHI versions a hallmark of quality and clinical safety,” Mrs Gemmell explains.
Mrs Gemmell continues by stressing the importance of this partnership as “it means that staff can use the tools with full confidence and without the concern of personal liability for clinical error associated with the use of non-UKCA marked tools.

“As they have been developed to standards and processes that comply with 93/42/EEC Medical Device Directive and 2017 /745 Medical Device Regulation, we are future-proofing the tools against potential changes in medical device regulation in the UK.”
Chief Executive Officer of DHI, Professor George Crooks OBE adds: “This effective collaboration supports and benefits not only those delivering health and care but also those requiring health and care services.

“It demonstrates why Scotland is an ideal place for businesses to come to if they wish to innovate and develop next-generation tools and services. Organisations like DHI and SHIL are part of a national ecosystem that is designed to support the evolution and delivery of health and care services that are fit for the 21st century, encouraging entrepreneurship and innovation while ensuring that quality and safety are at the centre of all we do.”

DHI provides knowledge management and clinical evaluation expertise. It manages co-design and usability testing with health and social care staff.

SHIL provides a wealth of regulatory expertise and experience in applying the Medical Devices Directive and Medical Device Regulations. It holds ISO 13485 certification for quality management and takes the role of manufacturer of these decision support tools as medical devices.

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