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Do you need an upgrade to MDR, MPDG and ISO 14155:2020 to your existing MPG certificate to continue or start your medical device trials? Would you like to deepen your knowledge? This Mastertrial MPDG/MDR update course is all online and is recognized by the Berlin Medical Association as CME continued education. Download the MDR/MPDG Update Course Brochure -
The purpose of this tutorial is to analyze the MDR provisions for adverse events recording and reporting to Competent Authorities. The topics addressed are: MDR references, Relevant definitions, Sponsor obligations in case of adverse events occurring during the clinical investigation and Regulatory comparison: MDD vs MDR.
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This tutorial aims to provide an overview of the MDR provisions related to the end of the clinical investigation, along with an outline of the MDR rules concerning the extraordinary events which could happen during the clinical investigation (substantial modifications, corrective measures, temporary halt, early termination).