European Union Medical Device Regulation 745 (EU MDR)
You will leave this e-learning course with the following key benefits:
- Understand the basic requirements of EU MDR 745 for Medical Devices other than IVDs
- Discover about the European Parliament and the Council on medical devices
- List the regulations for medical devices exercised by the European Parliament under EU MDR
- Learn about different chapters and the articles covered in EU MDR 745
Who Should Attend?
This 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.
Course Agenda
- Introduction and Need of EU Under MDR-745
- The European Parliament and The Council on Medical Devices
- Inputs for Medical Devices with Nanomaterials
- Responsibility of Distributors and Manufacturers
- Chapters, Articles, and Annexures
- EUDAMED: Introduction, Purpose, Elements
- Key Roles of Notified Bodies & Classification of Devices
- Clinical Evaluation and Investigations
- PMS System, Periodic Safety Update Report (PSUR)
- Market Surveillance, MDCG
Course Description
EU MDR 745 course helps you understand the new and key requirements and expectations set by the Medical Device Regulation (MDR EU 2017/745). It covers how to achieve compliance with stringent standards for safety, efficacy, and quality, essential for medical devices' market approval. We will also discuss the necessary steps for regulatory compliance, including planning and implementing compliance processes, reporting systems, and integrating these with an existing Quality Management System (QMS). Real-world examples and scenarios will be provided to illustrate the practical application of EU MDR 745 standards.
Benefits
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.
Methodology
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.
Learning Assessments
The cumulative duration of the programme is 60 minutes, after which you will be required to pass a final assessment to receive your internationally recognised e-certificate.
FAQs
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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