New regulatory roadmap ‘another important step’ towards helping medical device innovators navigate complex pathway

InnoScot Health is backing a new regulatory roadmap, calling it ‘another important step towards easier navigation of the pathway for getting medical device innovation safely into patients’ hands.’ 

The recently announced roadmap towards the future regulatory framework for medical devices from the Medicines and Healthcare products Regulatory Agency (MHRA) lays out the intended timelines for implementation of the UK’s future core regulations across the next two years. 

With the UK government planning to “ensure that there is a proportionate, phased approach to the implementation of the future regulatory framework,” the roadmap is designed to offer greater visibility and enhance the UK’s ability to benefit from rapidly advancing medical technology. 

The government also aims to “support system readiness and minimise the risk of supply disruption for UK patients” while helping businesses to plan out their regulatory approach in the early stages of the development process. 

Priority measures intended to protect patient safety and accessibility are expected to be implemented this year, with the core regulations of the new framework then planned to be in place by 2025. 

The plans are further designed to deliver greater alignment with international regulatory requirements, helping to ease the complexity of navigating post-Brexit processes while focusing on a more patient-centred approach that is agile and responsive to technological innovation, including cybersecurity requirements for software as a medical device including artificial intelligence (AI). 

Head of Regulatory Affairs at InnoScot Health, Elaine Gemmell (pictured above) said: “It is encouraging to see MHRA proactively sharing this information for better visibility of the planned UK process. It should help to clarify how and when closer alignment with EU requirements will achieve. 

The new roadmap represents another important step towards easier navigation of the regulatory pathway for getting medical device innovation safely into patients’ hands and for that, it is to be welcomed.”

She added: “Organisations innovating in increasingly technologically advanced medical devices should particularly stand to benefit from the foresight which this provides for their own regulatory planning. 

The roadmap can also help to heighten innovation and economic growth, while encouraging UK businesses to target global expansion. 

Progress is undoubtedly being made, but with so much to consider in this complex area, it remains beneficial to seek out the right advice and expertise in order to navigate the process successfully and ensure compliance.” 

Dr Laura Squire, the MHRA’s MedTech Regulatory Reform Lead and Chief Officer Healthcare, Quality and Access said: “The roadmap sets out how we will work with stakeholders including patients as the process moves forward, giving early sight of what is to come and giving us feedback about the guidance they will need, to ensure the successful implementation of these wide-ranging UK reforms.” 

The InnoScot Health team offers skilled regulatory experts, dispensing advice and support to healthcare innovators across Scotland, while facilitating and underlining the country’s reputation as a centre of excellence for medical device innovation. The organisation also operates an ISO 13485:2016 quality management system harmonised to the Medical Device Directive and Medical Device Regulation. 

With more than 20 years’ experience in medical device development, Elaine Gemmell – recently awarded the title of Honorary Professor in the School of Engineering and Physical Sciences at Heriot-Watt University – is a certified ISO 13485/ISO 9001 Lead Auditor and has experience of regulatory approval and CE marking for medical devices.