EU-MDR 2017/745 Review for Clinical Professionals

This comprehensive review of the EU-MDR 2017-745 focusses on the particular parts of the regulation that need understanding and compliance by clinical professionals during the planning, execution and archiving of clinical investigations whether pre- or post-market.

The course outlines the following regarding EU-MDR 2017-745:

• A thorough explanation of the requirements for clinical professionals in the relevant articles and Annexes 1 and 15
• Explains the importance of risk management prior to and throughout the clinical investigation
• Draws comparisons with the requirements of ISO 14155 latest version where applicable
• Provides an overview of the requirements for clinical investigation submissions to the competent authorities
• Provides a detailed explanation of documents required for submissions to the competent authorities.

Note: the course applies the requirements of EUDAMED as written in the EU-MDR. Due to the delay at the EU-Commission on implementing the EUDAMED data base, learners will need to be attentive to alternative reporting systems until EUDAMED will become fully applicable as described in the EU-MDR 2017-745.