Online workshop: Clinical evaluation of medical devices by literature

Clinical evaluation is mandatory for all medical devices under the MDR. An important part of the clinical evaluation is the thorough review and evaluation of published clinical data on your medical device and analogous devices. Conducting a systematic literature review helps support the intended use of your device and confirm its safety profile by demonstrating that it poses minimal risks or that its benefits outweigh the potential risks. A comprehensive analysis of published clinical data in peer-reviewed publications, medical guidelines and published reports can also show that your product is superior to existing alternatives. Therefore, a high-quality leterature review with pragmatic approach is needed to produce quality data output for your clinical evaluation report.

Intention

In this workshop you will learn the most important steps for preparing a clinical evaluation of a medical device based on a literature search.

The knowledge you acquire will empower you:

• check the adequacy of the literature gathering process for the preparation of a clinical evaluation of a medical device.
• optimise and justify the process of validation/selection of literature sources.
• prepare a clinical evaluation based on a literature search.