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    Clinical evidence for medical devices under the Regulation (EU) 2017/745

    According to the Regulation (EU) 2017/745, a clinical evaluation plan and a clinical evaluation report have to be provided for all medical devices. Under the new requirements, the state of the art, the data on equivalent devices and the scientific validity of clinical data for the device(s) under evaluation will be more critically assessed. Join this keynote to expand your knowledge on the regulation requirements for clinical data, the identification of clinical data sources, the choice between the equivalence and the clinical investigation routes as well as the selection of post-Market Clinical Follow-up (PMCF) activities.


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