Clinical Evaluation under EU MDR 2017/745
You will leave this e-learning course with the following key benefits:
- Describe the new and key requirements and expectations for Clinical Evaluation under the EU MDR
- Illustrate how to plan and implement the process for Clinical Evaluation
- Understand key concepts like the State-of-the-Art (SOTA), Clinical evaluation Plan (CEP), Clinical Development Plan (CDP) and Clinical Evaluation Report (CER)
- Define the literature search process
The Clinical Evaluation course is designed for employees of a medical device manufacturer, specifically for those working in quality assurance or regulatory affairs, and service providers to the industry.
Key requirements and expectations for Clinical Evaluation under the EU MDR
- Evolution of Clinical Evaluation
- Purpose of Clinical Evaluation
- Understand how to plan and implement the Clinical Evaluation Process
- Overview of concepts:
- State-of-the-art (STOA)
- Clinical Evaluation Plan (CEP)
- Clinical Development Plan (CDP)
- Clinical Evaluation Report (CER)
- Conducting literature search
The Clinical Evaluation course is part of a modular concept under the MDR Expert Certification Program. The Clinical Evaluation of medical devices is a critical element of the European CE marking regulation. Through this self-paced course learners will gain an understanding of the key requirements including planning and implementation for Clinical Evaluation under EU MDR. Join us in a transformative journey!
This training course provides a foundational on the topic.
Self-paced training: access 24/7 to the course during 12 months at your own rhythm.
The e-learning course employs a variety of training tools such-as content-embedded assessment, and other interactive exercises to enhance the learning experience. Easily accessible via your preferred choice of device, the course allows you to log in and learn whenever, wherever.
The cumulative duration of the programme is 90 minutes, after which you will be required to pass a final assessment to receive your internationally recognised e-certificate.
There are no formal prerequisites for this self-paced training.
Learning Path:
This learning path is designed to build comprehensive knowledge of clinical evaluation requirements for medical devices under the European Medical Device Regulation (EU MDR 2017/745).
Participants begin with a self-paced web-based training course, Clinical Evaluation under EU MDR 2017/745, that introduces the fundamental concepts, regulatory expectations, and key principles of clinical evaluation. This flexible online module provides a solid foundation and prepares learners for more in-depth study.
The next step is the Clinical Evaluation of Medical Devices – Foundation Course, an instructor-led classroom training that expands on the core concepts and practical application of clinical evaluation processes. Learners gain a deeper understanding of regulatory requirements, clinical evidence, and documentation expectations while benefiting from expert guidance and interactive discussions.
The learning journey culminates with the Clinical Evaluation of Medical Devices under EU MDR – Advanced Course. This classroom-based course is intended for professionals who already understand the fundamentals and want to develop advanced expertise in planning, preparing, reviewing, and maintaining clinical evaluations under EU MDR. Together, these three courses provide a structured progression from foundational knowledge to advanced competency, helping professionals confidently navigate clinical evaluation requirements throughout the medical device lifecycle.
System requirements
Supported browsers include:
- Chrome
- Safari
- Edge
- Firefox
Additional requirements include:
- A high-speed internet connection will provide best results.
- An email address is required to register for courses.
- Microsoft Media Player or equivalent is needed to play audio and video files.
What is included with the course?
Each course will include access to e-learning content, quizzes, and proof of completion. Additional resources may also be included, and this will vary by course.
Can I pause the course and log in to it anytime?
Certainly. The course allows the learner to take a break and return to it within the defined access period (typically 365 days).
Are there any quizzes in the middle of the course?
Our e-learning courses are designed to promote interaction between learner and content and often include quizzes. Quizzes are designed to help understand where successful learning has been achieved, and where opportunities for additional review exist.
Can I get a refund if I cancel my enrollment?
Refunds cannot be provided once a course is activated. Please be sure to review course information prior to activation.
What happens if I don’t finish the course within the access period?
The standard access period is 365 days to allow sufficient time to complete your course.
If you have questions, or require assistance, you may reach us at [email protected]
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