European Union Medical Device Regulation 2017/745: Technical Documentation (2 hours)

This course provides a greater understanding of the key requirements outlined in the EU MDR for medical device technical documentation. Learners will be able to conceptualize the regulatory requirements and the Notified Body expectation for technical documentation, helping to reduce unnecessary delays to the certification process. The content in this course supports the creation of compliant and Notified Body-friendly technical documentation.

Key learning objectives:

By the end of this course, you should be able to:

• Recognize the documentation requirements of different regulatory bodies
• Identify the required elements to compile technical documentation
• Explain the European Conformity Assessment Procedure (CAP)
• Identify the purpose and benefits of technical documentation
• Recognize how to draft basic structured documentation
• Explain the importance of Annexes I–III