--- title: "AI/ML-Enabled Medical Device, Definition | MedTech Terms" description: "Medical device that uses artificial intelligence or machine learning to perform its intended use. Plain-English Software & AI definition for MedTech teams, with" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ai-ml-device#term", "name": "AI/ML-Enabled Medical Device", "description": "An AI/ML-enabled device incorporates models that learn patterns from data to provide diagnostic, predictive, monitoring, or therapeutic functions. 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Regulators scrutinize the quality, representativeness, and governance of data used for training, testing, and validating AI/ML models to prevent biases and ensure reliable performance." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Software & AI](/terms?cat=Software%20%26%20AI) 6. / 7. AI/ML-Enabled Medical Device [All terms](/terms) Software & AI [AI / ML in Devices](/ecosystems/ai-ml)[Software Lifecycle](/ecosystems/software-lifecycle) # AI/ML-Enabled Medical Device Medical device that uses artificial intelligence or machine learning to perform its intended use. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition An AI/ML-enabled device incorporates models that learn patterns from data to provide diagnostic, predictive, monitoring, or therapeutic functions. FDA maintains a public list of AI/ML-enabled devices that have been authorized. What the regulation says AI/ML-enabled medical devices are regulated based on their [intended use](/terms/intended-use) and risk classification, similar to other medical devices. The FDA, for example, provides guidance on " [Clinical Decision Support](/terms/cds) Software" and "Artificial Intelligence/Machine Learning (AI/ML)-Based [Software as a Medical Device](/terms/samd) (SaMD)" to clarify regulatory expectations for these technologies. Key considerations include data management, algorithm transparency, validation, and performance monitoring, as described in documents like the [IMDRF](/terms/imdrf) "Software as a Medical Device (SaMD): Key Definitions" guidance. ## What this means in practice Most authorized AI devices today are 'locked' - the model weights do not change post-deployment. Adaptive systems require a [Predetermined Change Control Plan](/terms/ai-ml-pccp) (PCCP) to enable continued learning while maintaining oversight. ## Examples - An AI/ML-enabled diagnostic device uses a locked algorithm trained on a large dataset of medical images to identify anomalies, requiring no post-market model updates. - An adaptive AI/ML therapeutic device for personalized drug dosing continuously learns from a patient's physiological data to adjust treatment, operating under an FDA-approved Predetermined Change Control Plan (PCCP). - A predictive AI/ML monitoring device analyzes continuous patient data streams to forecast potential adverse events, necessitating regular performance monitoring and validation to ensure accuracy. Common pitfalls - • Failing to establish a robust data management plan for training and validation data can lead to biased or ineffective AI/ML models. - • Assuming that an AI/ML model’s performance in a controlled development environment will perfectly translate to real-world clinical settings is a common misconception. - • Neglecting to implement a post-market surveillance strategy for AI/ML performance can result in undetected degradation or errors over time. - • Underestimating the cybersecurity risks associated with AI/ML models, including data poisoning or adversarial attacks, can compromise device safety and effectiveness. - • Not adequately documenting the AI/ML model’s design, development, and validation processes can lead to difficulties in demonstrating regulatory compliance. ## Frequently asked questions What is the primary regulatory concern for AI/ML-enabled medical devices? The primary regulatory concern is ensuring the safety and effectiveness of the device, particularly given the dynamic and data-driven nature of AI/ML models. Regulators focus on robust validation, risk management, and [post-market surveillance](/terms/post-market-surveillance). How does "locked" AI/ML differ from "adaptive" AI/ML in a regulatory context? What role does data play in the regulation of AI/ML devices? ## Cross-references ### Governed by Regulations or standards this term must comply with. - [ Good Machine Learning Practice(GMLP) ](/terms/good-machine-learning-practice) - [ EU AI Act Most medical AI is high-risk under the AI Act. ](/terms/eu-ai-act) ### Uses Concepts or artefacts this term builds on. - [ Predetermined Change Control Plan(PCCP) ](/terms/ai-ml-pccp) - [ Model Card ](/terms/model-card) ### See also Closely related context worth reading. - [ Total Product Lifecycle(TPLC) ](/terms/tplc) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Software & AI Predetermined Change Control Plan(PCCP) FDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices. ](/terms/ai-ml-pccp)[ Software & AI Good Machine Learning Practice(GMLP) Guiding principles for the development of AI/ML-enabled medical devices. ](/terms/good-machine-learning-practice)[ Software & AI Software as a Medical Device(SaMD) Software intended for medical purposes that performs without being part of a hardware device. ](/terms/samd)[ Software & AI Total Product Lifecycle(TPLC) FDA framework integrating premarket and post-market oversight across a device's life. ](/terms/tplc) ### AI/ML Devices Deep Dive · From this learning path [ Software & AI Explainability and Interpretability Methods (SHAP, saliency maps, prototype explanations) that help users understand why a model made a given prediction. ](/terms/explainability?from=ai-ml-devices-deep-dive)[ Software & AI Foundation Model (Healthcare) Large pretrained model adaptable to many downstream clinical tasks via fine-tuning or prompting. ](/terms/foundation-model-health?from=ai-ml-devices-deep-dive)[ Software & AI Generative AI in Medical Devices Devices that use LLMs or diffusion models to generate text, images, or recommendations within a clinical workflow. ](/terms/generative-ai-devices?from=ai-ml-devices-deep-dive)[ Software & AI Model Card Structured documentation of a machine learning model's intended use, performance, and limitations. ](/terms/model-card?from=ai-ml-devices-deep-dive) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [AI/ML Devices Deep Dive](/paths/ai-ml-devices-deep-dive)Lesson 1 of 9 Ecosystems (2) - [AI / ML in Devices](/ecosystems/ai-ml) - [Software Lifecycle](/ecosystems/software-lifecycle) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 2 MDCG· 1 1. [1 FDA AI/ML-Enabled Device List Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices) 2. [2 MDCG Software Guidance Verified MDCG · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en) 3. [3 FDA - Software as a Medical Device (SaMD) Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Building software-as-a-medical-device? We help SaMD and AI/ML device teams meet IEC 62304 and the FDA's evolving expectations for software cybersecurity. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Software & AI Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=ai-ml-device) Learn in 60 seconds Card Lesson Quiz Medical device that uses artificial intelligence or machine learning to perform its intended use. - · Most authorized AI devices today are 'locked' - the model weights do not change post-deployment. - · Adaptive systems require a Predetermined Change Control Plan (PCCP) to enable continued learning while maintaining oversight. - · FDA maintains a public list of AI/ML-enabled devices that have been authorized. Remember this Watch out: Failing to establish a robust data management plan for training and validation data can lead to biased or ineffective AI/ML models. Related terms - [Good Machine Learning Practice(GMLP) ](/terms/good-machine-learning-practice) - [Predetermined Change Control Plan(PCCP) ](/terms/ai-ml-pccp) - [Software as a Medical Device(SaMD) ](/terms/samd) - [Total Product Lifecycle(TPLC) ](/terms/tplc) You may also need Auto-suggested from Software & AI and shared keywords. - [Medical Device Data System(MDDS) ](/terms/mdds) - [MLOps for Medical Devices(MLOps) ](/terms/mlops-medical-device) - [Model Card ](/terms/model-card) - [Algorithm Change Protocol(ACP) ](/terms/algorithm-change-protocol) - [Locked vs. Adaptive Algorithm ](/terms/locked-vs-adaptive) - [EU AI Act ](/terms/eu-ai-act) [All Software & AI terms](/terms?cat=Software%20%26%20AI) From the Blue Goat network Related resources and services on this topic. - [ AI SaMD Insights How AI is changing SaMD - risk, regulation, and good machine-learning practice. ](https://ai-samd.com) - [ Med Device Cyber Podcast Conversations with medical device cybersecurity practitioners. ](https://mdcpodcast.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. A community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com)