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    Medical devices

    Clinical evaluation of medical devices according to MDR & MEDDEV 2.7/1 Rev. 4

    A one-day intensive training about all related matters regarding the preparation of a clinical evaluation for a medical device including a workshop.

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    Topics

    • Medical Device Regulation 2017/745 (MDR), MDCG documents, and MEDDEV 2.7/1 rev. 4
    • Basics of clinical evaluation, clinical data, as well as the relationship between PMS/PMCF and clinical evaluation (CEP, CER)
    • Structure and content of a CEP and CER, clinical evaluation process, required documents and data, as well as equivalent, similar and benchmark devices
    • Different ways of clinical evaluation, evidence-based medicine, different types of scientific publications, dealing with problematic data, and problem areas: too much or too little clinical data
    • PMS and PMCF, CAPA, clinical evaluation update, and risk/benefit ratio
    • Clinical evaluation workshop: Literature research, evaluation of literature, and dealing with problem areas

    Target group

    People working in clinical research, safety reporting, regulatory affairs, and quality management.

    Objectives

    After the course, participants will:
    • Be familiar with the specific regulatory requirements for clinical investigations with medical devices
    • Be able to develop a clinical investigation plan and synopsis
    • Understand which ethical, scientific and quality aspects need to be considered, including what problems may arise and how they can be solved
    • Be equipped to plan, conduct and evaluate a clinical investigation with a medical device and understand the relevant regulatory requirements