Topics

  • Competent authority views on managing MDR clinical study applications
  • Competent authority update on preparation for IVDR study applications
  • Notified Body assessment of clinical study strategies
  • Industry view on implementation of MDR and IVDR clinical study requirements
  • International standard for conducting medical device studies: ISO 14155:2020
  • International standard for conducting IVD clinical performance studies: ISO 20916:2019
  • Clinical Investigation Plans that meet regulatory and operational requirements
  • Key statistical elements of a successful clinical study
  • Critical considerations in site selection and subject enrollment
  • New medical device clinical safety reporting requirements
  • MDR requirements on sponsor GCP audits and how to conduct them
  • Aligning clinical investigations and risk management for MDR compliance
  • Effective compliance with clinical study-related European privacy requirements
  • Remote conduct of clinical studies: digital tools and key concepts
  • PMCF investigations, regulatory requirements and practical considerations
Broadcast Timezone CET

The conference will be broadcast at Central European Time (CET).  Please refer to the program on the virtual conference platform for the final timings of each presentation and the LIVE Q&A’s.