Safety Reporting in Medical Devices Trials


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.

Learning objectives

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
Intended audience

Fundamental Level
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.

Zuzanna Kwade
Zuzanna Kwade is clinical post-market surveillance team lead at Agfa Healthcare. She is an active member of COCIR, the European Trade Association representing the medical imaging, radiotherapy, health ICT and electro-medical industries and represents COCIR in clinical evaluation of software task force at European level. Zuzanna has over 10 years of hands-on experience in clinical safety management in pharma and medical device studies. She holds a PhD in molecular biology.