We welcome you to our compact and practical eLearning course MDR Express.
This course provides non-EU medical device manufacturers with a concise introduction to the European Medical Device Regulation (MDR 2017/745). You will gain an understanding of the key regulatory requirements for placing medical devices on the European market, including CE marking, manufacturer obligations, quality and risk management, technical documentation, clinical evaluation, post-market surveillance, and vigilance.
MDR Express is designed to give you a clear overview of the most important MDR concepts and processes without requiring extensive prior knowledge. It is the ideal starting point for organizations that want to understand the European regulatory framework and their responsibilities as medical device manufacturers.
Why should you choose our eLearning course?
- Focused MDR overview: Gain a structured understanding of the most important MDR requirements relevant to manufacturers entering or operating in the European market.
- Designed for non-EU manufacturers: Learn the key regulatory expectations and responsibilities when placing medical devices on the EU market.
- Flexible eLearning: Learn at your own pace and from any location. Our online learning environment allows you to fit training into your schedule.
- Interactive learning experience: Videos, practical examples, storytelling, and quizzes help transform complex regulatory requirements into understandable and engaging content.
- Certificate of completion: Upon successful completion of the course, you will receive a certificate confirming your participation and newly acquired MDR knowledge.
- Content
- Introduction and course overview
- Legal framework of the MDR
- CE marking and conformity assessment
- Intended purpose and device classification
- Declaration of Conformity
- General obligations of manufacturers
- Quality Management System (QMS)
- Risk Management System
- Technical Documentation and its key elements
- General Safety and Performance Requirements (GSPR)
- Product verification and validation
- Post-Market Surveillance (PMS)
- Summary of Safety and Clinical Performance (SSCP)
- Clinical Evaluation under the MDR
- Vigilance requirements
- Person Responsible for Regulatory Compliance (PRRC)
- EUDAMED
- Final quiz
Note on your personal learning environment
After registration, you will receive access to our Learning Management System (LMS), allowing you to complete the training whenever it suits you. Upon successful completion of the eLearning course, you will receive a certificate of completion.
- How you benefit
- Practical MDR knowledge: Understand the essential requirements for medical device manufacturers under the European MDR.
- Regulatory awareness: Learn how the various MDR elements interact and contribute to market access and compliance.
- Flexible learning: Complete the training at your own pace and according to your individual schedule.
- Improved market readiness: Gain the knowledge needed to navigate MDR requirements more confidently and efficiently.
- Professional development: Demonstrate your understanding of European medical device regulations with an official course certificate.
- Methods
Trainer input, real-life review scenarios, case studies, practical exercises, and interactive learning elements.
- Target Audience
- Non-EU medical device manufacturers
- Regulatory Affairs professionals
- Quality Management professionals
- Product managers and project managers
- Start-ups planning market entry into the European Union
- Employees seeking a practical introduction to MDR requirements
