Medical Device Regulation (MDR) – Technical Documentation

This training is intended for newcomers, engineers and consultants in the medical device industry as well as experts and executive personnel seeking to update their knowledge and for personnel in charge of regulatory affairs and quality management.

• Newcomer to the medical device industry
• Specialists and executives who want to update their knowledge
• Manager Regulatory Affairs
• Quality Management Representative
• Engineers in the medical device industry
• Consultant in the medical device industry

• Product Verification and Validation
  
  • Specific requirements on Product Verification and Validation
  • Specific requirements on Pre-Clinical Data
  • Specific requirements on Additional Information required in Specific Cases
• Post-Market-Requirements
  • Requirement PMS (Post-Market Surveillance) for the Technical Documentation – Annex III
  • Specific requirements on “The Post-Market Surveillance Plan”
  • Further requirements not included in Annex II and III
• Technical Documentation Guidance for Manufacturers
• Notified Body Involvement in Technical Documentation Assessment

According to the European Medical Device Regulation (EU) 2017/745 (MDR), manufacturers of medical devices must prepare Technical Documentation for their devices. Technical documentation is a compilation of all relevant information about a medical device. It must be kept up to date by the manufacturer throughout the product life cycle.

The main task of the technical documentation for medical devices according to MDR is to prove to the manufacturer that a medical device meets the general safety and performance requirements (GSPR). The essential elements include certain criteria set out in Annexes II and III of the MDR for Post-Market Surveillance (PMS). There is also a clear requirement that the technical documentation must be clear, clear, unambiguous and easily searchable.

As a manufacturer, familiarize yourself with the basic requirements of the technical documentation for medical devices according to MDR. You will get a compact overview of the requirements for the content and the structure.

No special knowledge is required for this course. The relevant basics will be covered as part of the training. The learning modules are equally suitable for beginners and for deepening knowledge.

Know and understand the structure and requirements of Technical Documentation.

Participants who successfully complete the training course will receive a Certificate of Participation from the TÜV SÜD Academy.

System requirements

Supported browsers include:

• Chrome
• Safari
• Internet Explorer
• 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.
• Flash Player is used for content and interactive learning. If necessary, download and install Flash Player to ensure proper operation of course content.

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]

To learn more about TÜV SÜD, please click here.