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Clara Fargo
EBMT Clinical Research Quality Assurance Coordinator
I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...
Essentials of EU Medical Device Regulation (EU MDR – Regulation 2017/745)
4.7
★★★★★
97% Recommended
Updated 2025
3 hours
88 active users
3 points
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1 x Essentials of EU Medical Device Regulation (EU MDR – Regulation 2017/745)
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Each course includes:
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.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with any legislative changes in GDP as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
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
This course offers a detailed explanation of the EU MDR (Regulation (EU) 2017/745), focusing on the key regulatory changes, responsibilities of manufacturers and stakeholders, documentation requirements, and conformity assessment routes. It is suitable for individuals involved in regulatory affairs, quality assurance, clinical evaluation, medical device development, and compliance functions.
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.
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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.
