Course overview

EU MDR Essentials for AI Medical Devices: Classification & CE Marking (2-Hour Crash Course)

A practical introduction to the EU Medical Device Regulation covering device classification, the CE marking pathway, the role of notified bodies, and key AI regulatory considerations including the EU AI Act.

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Course Description

This 2-hour crash course introduces the key principles of the EU Medical Device Regulation (EU MDR) as they apply to AI-enabled and software-based medical devices. Participants will learn the fundamentals of device classification, the CE marking process, and the role of notified bodies, along with important regulatory considerations for AI in medical devices and the emerging EU AI Act. The course provides a clear and practical overview of how to navigate the European regulatory framework for AI medical technologies.

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— What's included

What You’ll Learn (Course Outcomes)

Understand EU MDR for AI Medical Devices

  • Learn the core principles of the EU Medical Device Regulation (MDR).
  • Understand how AI and software-based medical devices are regulated in the EU.

Learn Device Classification and the CE Marking Process

  • Understand how medical devices and AI software are classified under EU MDR.
  • Learn the key steps required to obtain CE marking and place a device on the EU market.

Navigate Key Regulatory Requirements

  • Understand the role of Notified Bodies and conformity assessment. Explore important considerations for AI medical devices and the EU AI Act.
  • Prepare for submission and compliance in real-world product development.
  • Earn a certificate to demonstrate knowledge in this emerging field.

Course Lessons

Why choose RegTech Institute

At RegTech Institute we make online learning easy. Our only concern is your education. Build your future right here.

Comprehensive EU MDR & AI Regulatory Training

Gain a clear understanding of EU MDR requirements for AI and software-based medical devices, including classification, CE marking, and emerging AI regulatory considerations in Europe.

Practical and Self-Paced Learning

Learn through short video lessons, real-world examples, and quizzes designed to help you understand MDR requirements for AI medical devices at your own pace.

Certification Upon Completion

Receive a certificate of completion demonstrating your knowledge of EU MDR and regulatory considerations for AI medical devices.

Who should Enrol

  • AI developers and engineers building software or AI solutions for healthcare and medical devices.
  • Health tech entrepreneurs and start up founders developing AI-enabled medical technologies.
  • Regulatory affairs and quality professionals seeking a practical overview of EU MDR requirements for AI medical devices.
  • Medical device manufacturers exploring AI integration and the pathway to CE marking.
  • Legal, compliance, and policy professionals working on AI and healthcare regulation.
Lesson series

Ready to Dive In?

Take the first step toward understanding EU MDR classification, CE marking, and regulatory requirements for AI-enabled medical devices.

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