Course Description

EU-MDR 2017/745 Review for Clinical Professionals

Course Description:

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.

Learning Objectives:

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.

Who Should Enroll:

Clinical project managers, senior clinical research associates, clinical managers,

Prerequisite Knowledge/Requirements:

Understanding of the requirements of ISO 14155 latest version (see courses ISO 14155 in depth review)

Subject Matter Expert:
Danielle Giroud

80 min

Related resources:

Case studies:

Basic Account: € 234.00
Premium Account: € 176.00

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