6. MDR ADVERSE EVENT REPORTING IN CLINICAL INVESTIGATIONS

Clinical Trials for Medical Devices in Europe - The New MDR
Duration:  Unlimited
Cost:  49  EUR
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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.