6. MDR ADVERSE EVENT REPORTING IN CLINICAL INVESTIGATIONS
Clinical Trials for Medical Devices in Europe - The New MDRDuration: Unlimited
Cost: 49 EUR
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.
