Artificial Intelligence and Medical Devices — Understanding the European Regulatory Framework

About This Course

Artificial Intelligence (AI) is transforming modern healthcare. From clinical decision support systems to diagnostic imaging and predictive analytics, AI-based technologies are becoming an integral part of medical devices and healthcare delivery. These innovations bring major benefits in accuracy, efficiency, and patient outcomes — but they also raise new regulatory, technical, and ethical challenges.

This course provides a structured introduction to how AI systems are regulated within the European Union when used in medical applications. It explores the main principles of the Medical Device Regulation (EU MDR 2017/745) and the EU Artificial Intelligence Act, focusing on their interplay and shared objectives of safety, transparency, and accountability. Learners will understand how to determine when an AI system qualifies as a medical device, how it should be classified, and what documentation and conformity assessment procedures are required.

Throughout the course, participants will engage with real-world examples, short quizzes, and reflective discussions to explore how regulation and ethics guide the full lifecycle of AI in healthcare — from design and validation to post-market monitoring. The course is intended for innovators, regulators, clinicians, and professionals who aim to apply or supervise the responsible use of AI in medical settings.

Requirements

No specific technical background is required. A general understanding of Artificial Intelligence concepts and basic familiarity with healthcare systems will help but is not mandatory.

All key terms, frameworks, and regulatory concepts are explained within the course to ensure accessibility for participants from diverse professional backgrounds.

Course Staff:

Francis Destin

Chief Operating Officer/ HealthAI Navigator Project Lead

Francis Destin is an expert in AI strategy, digital transformation, and data governance for health technologies. With extensive experience in operational leadership and regulatory innovation, he leads initiatives supporting the safe and responsible implementation of AI in healthcare.

Frequently Asked Questions

What web browser should I use?

The N edX platform works best with current versions of Chrome, Edge, Firefox, or Safari. Please refer to the official list of supported browsers for the most up-to-date information.

Is this course certified?

Yes. Learners who complete all sections and achieve a score of at least 70% on the final quiz will automatically receive a digital certificate through the platform’s credential system.

How long does the course take?

This is a self-paced course designed to be completed in approximately two hours.

Can I use this course for professional training?

Yes. The content aligns with EU frameworks for AI and medical device regulation and can serve as part of continuing professional development in digital health or regulatory science.