Introduction to the EU Medical Device Regulation (MDR 2017/745)

This 1 day introductory course provides a practical and accessible overview of the MDR—ideal for professionals who need a solid foundation without diving into technical complexity. Participants will gain clarity on regulatory expectations, roles and responsibilities, and the steps required for conformity.

Why This Course?

The EU Medical Device Regulation (MDR 2017/745) sets a significantly higher standard for safety, performance, documentation, and post-market surveillance requirements for medical devices in the European Union. Organizations that design, manufacture, distribute, or work with medical devices must understand the MDR to remain compliant, avoid costly delays, and ensure patient safety.

Contents of the Course

The course covers on a high level all the essential MDR topics needed to understand the regulation’s structure, scope, and implications, including:

• Overview of the MDR (EU 2017/745)
  Structure, purpose, transition timelines.
  Harmonized standards and best practice documents
• Classification of Medical Devices
  Rules, examples, and implications for conformity assessment.
• Key MDR Requirements
  
  • General Safety & Performance Requirements (GSPRs)
  • Technical documentation
  • Clinical evaluation, post-market clinical follow-up (PMCF) and clinical evidence
  • Risk management system
  • Post Market Surveillance system
• Roles and Responsibilities
  Manufacturers, authorized representatives, importers, distributors, Person Responsible for Regulatory Compliance (PRRC).
• Conformity Assessment Routes & CE Marking
  Notified Bodies, required documentation, and certification processes.
• Vigilance
  Reporting, trend analysis, and timelines.

Learning Objectives

After completing the course, participants will be able to:

• Understand the purpose, structure, and key requirements of the MDR.
• Identify the roles and responsibilities of different economic operators.
• Recognize the classification rules and understand their impact on regulatory obligations.
• Describe the essential requirements for technical documentation and clinical evaluation.
• Outline the steps involved in conformity assessment and CE marking.
• Understand the fundamentals of post-market surveillance and vigilance requirements.
• Assess how the MDR affects their own organization and daily work.

Who should attend

This course is designed for professionals who need a practical introduction to MDR, including:

• Quality assurance and regulatory affairs beginners
• R&D and engineering staff new to regulatory requirements
• Product managers and project managers
• Anyone seeking a foundational understanding of EU medical device regulations