This course provides an essential overview of the adverse event reporting requirements and good practice during medical device clinical investigations and post-market clinical follow-up (PMCF) studies. The course will concentrate mostly on the existing European Medical Device Directive with some references to the Medical Device Regulations (MDR). It will provide a good introduction to safety management in medical device clinical studies and serve as an update for those with experience who need to keep abreast of the regulatory changes and the methods of handling adverse events during the study period. It will also provide an overview on the new requirements regarding periodic safety update reports (PSURs) and the summary of safety and clinical performance.
By the end of this TRIUM Training you should be able to:
- Conduct safety reporting in medical devices
- Explain how the new MDR will impact medical device safety reporting activities
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.