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Essentials of EU Medical Device Regulation (EU MDR – Regulation 2017/745) Course & Certification
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1 x Essentials of EU Medical Device Regulation (EU MDR – Regulation 2017/745)
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Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
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The course content has been developed to ensure that you comply with GDP legislation through the application of learning outcomes. The course is written by Louise Handy, who is a past chairperson of the Research Quality Association (RQA
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About
Essentials of EU Medical Device Regulation (EU MDR – Regulation 2017/745) is a foundational program designed to help professionals understand the European regulatory framework governing medical devices. The course provides a practical overview of the key requirements introduced by EU MDR, including device classification, technical documentation, clinical evaluation, post-market surveillance, economic operator responsibilities, and regulatory reporting obligations.
This Essentials of EU Medical Device Regulation (EU MDR – Regulation 2017/745) Course & Certification provides structured training on the transition from the former Medical Device Directives to the MDR framework, helping learners understand compliance requirements for placing and maintaining medical devices on the European market. Upon completion, participants receive certification demonstrating competency in the fundamental principles and requirements of EU MDR 2017/745.
Who Should Enrol?
- Medical Device Regulatory Affairs, Quality Assurance, and Compliance Professionals.
- Medical Device Manufacturers, Product Development Teams, and Quality Management Personnel.
- Authorized Representatives, Importers, Distributors, and Other Economic Operators involved in the EU market.
- Clinical Affairs, Post-Market Surveillance, and Regulatory Strategy Professionals.
- Entry-level professionals and consultants seeking certification and foundational knowledge of EU MDR 2017/745 compliance.
What you will learn
Understand the evolution of European medical device regulations, key MDR concepts, terminology, and major regulatory changes introduced by EU MDR 2017/745.
Learn the essential MDR requirements relating to device classification, technical documentation, clinical evaluation, post-market surveillance, and routes to market.
Develop knowledge of the roles and responsibilities of manufacturers, authorized representatives, importers, distributors, and other economic operators.
Gain expertise in regulatory reporting requirements, including Unique Device Identification (UDI), EUDAMED, and device traceability obligations.
Course Syllabus
- Learning Outcomes
- The Three European Directives on Medical Devices
- Key Regulatory Changes in the European Market
- Terms and Definitions
- Publication of the EU MDR and Key Highlights
- Lesson Summary
- Learning Outcomes
- Technical Documentation & Post-Market Surveillance
- Classification of Devices & Route to Market
- Economic Operators & Clinical Evaluation
- Lesson Summary – A quick wrap-up of the essential points covered.
- Learning Outcomes
- Unique Device Identifier (UDI)
- European Database on Medical Devices (EUDAMED)
- Lesson Summary – A quick wrap-up of the essential points covered.
- 📘 Bonus: Essentials of EU Medical Device Regulation eBook (Free with purchase)
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Frequently Asked Questions
Our EU MDR (Medical Device Regulation) course is designed to provide a comprehensive understanding of the regulatory framework governing medical devices within the European Union. This training helps learners navigate the complex requirements of the EU MDR and ensures compliance throughout the device lifecycle.
Understand the structure, scope, and intent of the EU MDR. Learn about classification rules and conformity assessment pathways.Explore enhanced requirements for clinical evidence and post-market surveillance. Gain clarity on roles and responsibilities of manufacturers, importers,distributors, and authorised representatives. Understand Unique Device Identification (UDI), technical documentation, and GSPR (General Safety & Performance Requirements).Identify major changes from MDD to MDR and their impact on existing medical devices.
Regulatory Affairs professionals Quality Assurance teams Clinical Research and Clinical Evaluation personnel Medical Device Manufacturers Importers, distributors, and authorised representatives Anyone seeking a detailed and practical understanding of EU MDR compliance
Updated content aligned with the latest EU MDR regulatory expectations Clear, structured explanations designed for all experience levels Suitable for organisations aiming to strengthen compliance across teams Developed by regulatory experts with extensive industry experience
Upon successful completion, learners receive a Certificate of Achievement, validating their understanding of EU MDR requirements and readiness tocontribute to regulatory compliance activities.
