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.
Learners having successfully completed this 3 part course will be able to:
- Apply the requirements of the EU-MDR 2017-745 in practice
- Understand the importance of the risk management process throughout the lifecycle of a medical device product
- Understand the relationship between the clinical investigation use of a device and target market use and design appropriate clinical investigations accordingly
Relate the requirements of EU-MDR 2017-745 to those of ISO 14155 latest version.
Clinical project managers, senior clinical research associates, clinical managers,
Understanding of the requirements of ISO 14155 latest version (see courses ISO 14155 in depth review)