[Home](/)/[Resources](/resources)/UK Software as Medical Device SaMDMHRAAI as Medical Device # Software as a Medical Device (SaMD) UK: MHRA Guidance and Registration Mobile health apps, clinical decision support tools, and AI-based diagnostic software can all qualify as medical devices in the UK — triggering MHRA registration, clinical evaluation, and Approved Body requirements. The line between a regulated SaMD and an unregulated wellness app depends on intended purpose, clinical claims, and the significance of the clinical decision the software makes. Copy Link[Share on WhatsApp](https://wa.me/?text=https%3A%2F%2Fkrono-labs.com%2Fguides%2Fuk-software-medical-device) ## Is your software a medical device? ### Does the software have a medical purpose? Software is a medical device if it has a medical purpose — intended to diagnose, prevent, monitor, treat, or alleviate a disease, injury, or disability. A general wellness app tracking steps is not a medical device. An app that suggests insulin dosage adjustments based on glucose readings is. ### Is the software standalone or embedded? Standalone software (an app, a cloud-based diagnostic tool, a clinical decision support system) can itself be a medical device. Embedded software that controls a medical device hardware is regulated as part of that device. Both can require registration. ### Does the software make clinical decisions? Software that simply displays data from another device is lower risk than software that performs analysis, generates clinical recommendations, or makes autonomous decisions. The higher the clinical significance of the software's output, the higher the regulatory classification. ### MHRA definition: IVD software? Software intended for IVD purposes (e.g., analysing genetic data for disease risk, interpreting PCR results) may be classified as an in-vitro diagnostic medical device under UK IVDR rather than UK MDR. The classification determines which regulatory framework and which Approved Body review applies. ## SaMD classification and registration requirements ### Not a medical device (wellness) **Examples:** Step counter, sleep tracker (no clinical claims), general healthy eating app, fitness log **Registration:** No MHRA registration required ### Class I SaMD **Examples:** Software that retrieves or stores medical records; non-diagnostic lifestyle management tools with general health purpose **Registration:** MHRA registration required; self-assessment ### Class IIa SaMD **Examples:** Software providing decision support based on patient-specific data for non-serious conditions; telehealth monitoring software **Registration:** MHRA registration + UK Approved Body involvement ### Class IIb SaMD **Examples:** Clinical decision support for serious conditions (e.g., oncology treatment planning aids, cardiac monitoring interpretation) **Registration:** MHRA registration + UK Approved Body conformity assessment including CER review ### Class III SaMD **Examples:** Software making automated clinical decisions for life-threatening conditions; AI-based diagnostic imaging analysis for cancer **Registration:** MHRA registration + full UK Approved Body review including clinical evaluation and PMCF ## Key MHRA SaMD guidance points MHRA published 'Software and AI as a Medical Device' guidance in 2024 — read the current version on the MHRA website before classifying your SaMD. MHRA's AI as a Medical Device (AIaMD) guidance specifically addresses machine learning and AI-based SaMD — including continuously learning systems that may change their outputs over time. The MHRA Pre-Submission Service allows companies to request MHRA feedback on device classification or proposed clinical evidence approach before formal registration — valuable for novel SaMD. International Artificial Intelligence Consortium (IMDRF) SaMD guidance documents are referenced by MHRA as a framework for SaMD risk categorisation. ## Learn this properly, not just for one product In-depth courses and books that teach the process — not a one-off answer you'll need to look up again next time. [Start the course — $149](/courses/09-ukca-marking-for-electronics-products)See your free roadmap [Prefer to read? Get the book — $24.99](/books/09-ukca-marking-for-electronics-products) ## Frequently asked questions ### Is a mobile app that helps patients manage a chronic condition a medical device in the UK? It depends entirely on the specific functionality and claims. A diabetes management app that simply logs blood glucose readings (data storage/retrieval) is likely Class I. An app that provides insulin dosage recommendations based on logged readings is making clinical decisions and would be classified significantly higher — potentially Class IIb or III. The MHRA has specifically stated that apps making clinical recommendations for serious conditions are medical devices and require registration. If in doubt, use the MHRA's Software Decision Tool or request a Pre-Submission meeting. ### Do wellness apps with optional 'health insights' features need MHRA registration? MHRA focuses on the medical purpose claim — not just what the software can do, but what it is intended and marketed to do. A wellness app that incidentally provides 'health insights' based on user data may qualify as a medical device if those insights are presented as health or medical information rather than general lifestyle guidance. MHRA guidance is clear that the intended purpose (as stated in the instructions for use and marketing materials) determines classification. Many app developers have restructured their feature descriptions and disclaimers specifically to position features as general wellness rather than medical diagnosis or treatment. 🇬🇧 UK roadmap for medical devices Every standard, document, and test that applies — free, no account required. See your free roadmap[ Want an expert to take medical devices through 🇬🇧 UK compliance for you? One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts. See compliance services](/services) Learn this properly In-depth course that teaches the full process, not just this one answer. [Start the course — $149](/courses/09-ukca-marking-for-electronics-products)[Prefer to read? Get the book — $24.99](/books/09-ukca-marking-for-electronics-products) Related guides * [UK Medical Device Clinical EvaluationComplete guide to UK medical device clinical evaluation requirements under MHRA regulations: what clinical evaluation must demo…](/guides/uk-medical-device-clinical-evaluation) * [UK In-Vitro Diagnostic DevicesComplete guide to UK In-Vitro Diagnostic Medical Device Regulations 2022 for Great Britain: IVDR classification (A, B, C, D), M…](/guides/uk-medical-devices-ivd) * [UK AI and Product RegulationComplete guide to UK AI regulation for product manufacturers: current UK AI governance framework, AI Safety Institute, interact…](/guides/uk-ai-product-regulation) * [UK PSTI Act Cybersecurity RequirementsComplete guide to UK PSTI Act 2022 cybersecurity requirements: which connected products are in scope, the three mandatory minim…](/guides/uk-psti-cyber-requirements) Educational resource only. MHRA SaMD guidance is updated regularly. Always verify current classification and registration requirements on the MHRA website.