Technology
classification rule 11, which will lower risk class for many SaMDs. The UK is currently following classification rules defined at Brexit. Here more SaMD devices fall under class I than in the EU and while new requirements will be introduced in 2026, there is a concentrated effort towards simplification. The MHRA has also provided a Software and AI Change Programme Roadmap which builds upon wider reforms for medical devices and provides guidance for programmes to ensure regulatory requirements for software and AI are clear and patients are protected. MHRA guidelines on identification of an SaMD are a case in point. Despite this, there has been increased
scrutiny around devices such as ambient scribes, and the opportunity may be closing. In short, depending on the status of the
device SaMD, the UK and US currently offer simpler routes to market but the EU is taking steps to lessen the burden in the future unlocking a profitable market. Regulatory strategies will need to adapt to changing requirements. Keeping pace with regulatory and
technological change is one of the most persistent challenges in medical device development. Falling behind risks costly delays, failed submissions, and recalls which no business can afford. Yet maintaining every required specialism in-house is unrealistic, even for well- resourced teams: the different specialisms are many and even within those roles, experience applying technology to the medical sector is still scarce. In an evolving new environment, partnering with specialists in areas like AI development, SaMD regulation, cybersecurity, and UI design means accessing current expertise
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without expanding headcount. These specialists will have made it their business to stay ahead of change, so device manufacturers can remain focused on building effective, compliant products that protect patients.
References 1. Fortune Business Insights. AI in Healthcare Market Size, Share & Industry Analysis, By Platform (Solutions and Services), By Application (Robot-Assisted Surgery, Virtual Nursing Assistant, Administrative Workflow Assistance, Clinical Trials, Diagnostics, and Others), By End-user (Hospitals & Clinics, Pharmaceutical & Biotechnology Companies, Contract Research Organization (CRO), and Others), and Regional Forecasts, 2026-2034 [online]. Fortune Business Insights; 2026. Available from: https://www.
fortunebusinessinsights.com/industry- reports/artificial-intelligence-in-healthcare- market-100534
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2. FDA, Deciding When to Submit a 510(k) for a Change to an Existing Device [online]. FDA; 2024. Available from:
https://www.fda.gov/ media/99785/download
3. Anthropic, Alignment faking in large language models [online]. Anthopic; 2024. Available from:
https://www.anthropic.com/research/ alignment-faking
Ruaidhrí Primrose Jonathan Ripley Download the white paper:
Smart Code, Safe Care: Navigating AI Acceleration in Regulated Medical Devices’
Jonathan Ripley is the Managing Director at IMed Group. An expert in Quality Management and Regulatory Affairs with a robust background spanning over a decade in the IVD and Medical Device industries, Jonathan holds a degree in Microbiology from Kings College and has extensive experience in Pharmaceuticals, Defence, and Medical Devices. Specialising in GxP systems, Jonathan has managed ISO 13485:2016 and ISO 9001:2015 QMS certified systems. His regulatory expertise encompasses RT-PCR, immunoassays, and immunochromatographic technologies, as well as developing manufacturing capabilities and guiding clients through global regulatory landscapes, including the UK, EU, and US markets. Jonathan is dedicated to fostering growth and innovation, as well as building strong teams, leveraging knowledge and skills from his time in multiple industries. He is currently focused on helping build IMed Consultancy into a place that delivers value and expert services to clients and where people love to work.
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Ruaidhrí Primrose is a Director at Firefinch Software. A seasoned technology leader with a background in software development and a deep passion for the life sciences sector, Ruaidhrí Primrose has built a career at the intersection of software engineering and scientific innovation, with experience spanning cloud and on-premise solution design, technical architecture, and team leadership. Ruaidhrí joined Firefinch Software as a
Director in 2019, helping to grow the Edinburgh- based agency into a trusted partner for life science, medtech, and biotech organisations ranging from early-stage university spinouts to established multinationals. With his help, Firefinch has developed a reputation for combining deep scientific domain knowledge with rigorous software delivery, helping clients build and ship compliant software products for the UK, EU, and US markets, including the rapidly evolving space of AI-enabled medical devices. Beyond his work at Firefinch, Ruaidhrí is an active contributor to Scotland’s life sciences and technology communities. He leads Firefinch’s work with Converge, supporting the next generation of science and technology entrepreneurs, and participates in forums championing digital innovation in healthcare. He is committed to building an organisation where expertise, collaboration, and client outcomes go hand in hand.
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