Overview

In the complex world of medical device regulation, understanding and complying with the EU Medical Device Regulation (MDR 2017/745) is essential for maintaining product quality, ensuring patient safety, and achieving market access in the European Union. Manufacturers must navigate new requirements for technical documentation, risk management, device classification, and post-market surveillance, making MDR compliance both challenging and critical.

This live-online EU MDR Training for Medical Device Manufacturers provides an interactive, instructor-led learning experience where you can engage in real-time with expert instructors and industry peers. Unlike self-paced courses, this format allows for live discussions, Q&A sessions, and collaborative exercises, giving you the confidence and competence to apply MDR requirements effectively in your organization.

Recognized by Exemplar Global, this course equips you with the knowledge, tools, and strategies needed to navigate MDR compliance, including:

• A complete overview of the EU MDR, including implementation timelines and paths to CE marking
• In-depth exploration of the articles and annexes most relevant to manufacturers
• Practical guidance on preparing technical documentation and conducting gap assessments
• Understanding the impact of MDR requirements across the device lifecycle, from design and development to post-market surveillance

Through daily quizzes, practical tools, and interactive workshops on device classification, compliance scenarios, and real-world implementation examples, you’ll gain actionable skills that can be applied immediately. The live-online format fosters collaboration with other quality and regulatory professionals and ensures personalized guidance from expert instructors.

By the end of this training, you will leave with the confidence to lead your organization toward MDR compliance, navigate complex regulatory requirements, and avoid common pitfalls, all while earning a registered Exemplar Global certificate that validates your mastery of the course material.

Quizzes, Tools, Workshops

This is not a sit-and-listen course, and you will actively apply what you learn every day. Short quizzes help you confirm your understanding of key MDR concepts, while hands-on reviews of essential tools guide you through practical compliance steps.

You will explore resources such as the EU MDR Gap Analysis Checklist, GSPR Conformity Checklist, Technical Documentation Checklist, and comparison tools for ISO 13485:2016 and ISO 14971:2012 requirements.

To bring it all together, you will take part in interactive workshops focused on Device Classification, Compliance Scenarios, and real-world implementation exercises. You will leave ready to apply MDR principles in your own organization.

Who Should Attend

• Auditors performing MDR or Quality/Regulatory System audits
• Professionals guiding their organizations toward MDR compliance
• Individuals who are frequently audited under MDR requirements
• Quality & Regulatory Directors and Managers
• Design and Process Engineers
• ISO Coordinators
• Laboratory Professionals
• Risk Managers
• Manufacturing Managers and Supervisors
• Anyone looking to improve their organization’s quality management system