- Understand why the MDR was established
- Understand the applicable regulatory framework for different research types
- Understand the impact of the MDR on medical device research, and how it differs from the Medical Device Directive it replaces
- Understand the clinical trial submission requirements and the assessment process
- Understand the safety and vigilance requirements
- Reference will be made to ISO 14155 and ISO13485 where applicable
Compliance with the Medical Device Regulation (MDR) is critical for those who take part in clinical trials with medical devices. This online course covers the areas of the MDR applicable to clinical research.
The MDR Course for Clinical Research is the self-paced online course solution for investigators and clinical research professionals who need to learn about the impact of the Medical Device Regulation to their research. Via an interactive storyline, you you will learn how to align your current research with the new requirements of the Medical Device Regulation.
The e-learning is the best choice for those who like the flexibility of online learning at their own pace and time. This course translates the MDR framework to the current practice in European research institutions and gives you the tools to directly implement the knowledge in your daily practice.
- EU MDR Certificate
- Efficient and interactive learning
- Easy accessible via smartphone, tablet or desktop
- Self-paced and modular
The course consists of 6 online course modules and represents a total workload of 4 hours. The modules are divided into chapters of 10 to 40 minutes. After you have completed the modules and the knowledge test of the MDR for Clinical Research course, you will receive an EU MDR Certificate.
All training courses include one-year access to the online training and updates.
Enroll now to get started with the online learning modules on your smartphone, tablet or desktop computer.
Module: The Basics
- Changes due to MDR
- The General Timelines
- Impact for you
Module: Scope of MDR
- Timelines in more detail
- Trial types and articles
- Requirements for submitting
- Before Starting the Trial
Module: Safety Reporting
Module: Modifications and End of Trial
- Temporary Hold or (Early) Termination of a Trial
Module: Vigilance Reporting
- Post Marketing Follow-up
Module: Knowledge Test
- Knowledge test of 25 questions
- Feedback per question (afterwards)
- 3 attempts
- Available in English and Dutch
- Online certificate with a score of 80 or higher