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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.


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


  • Optimization of your search term strategy
  • Identification of relevant publications
  • Reasons for inclusion and exclusion of published data/notes/articles/reports
  • Evaluation and weighting of clinical data
  • Effective summarization of data
  • Use of multiple data sources
  • Documentation of references


Examples of best practice, exchange of experiences, work on concrete practical examples.

Course and materials will be in English language.

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.

The online workshop will take place in a live online e-classroom and will be divided into three parts with breaks in between.  Up to two days before the implementation, registered participants will receive a link to the online training. Participants need a computer with a microphone and a camera, as well as access to a reliably functioning internet connection to participate in online training without interruption.

Additional information: Bojan Varga, phone: +386 1 477 81 08, e-mail:

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