The Conference is designed to address the most challenging and perplexing aspects of planning and conducting medical device and IVD clinical studies in accordance with the requirements of the European Medical Device Regulation (MDR, 2017/745) and the In Vitro Diagnostic Regulation (IVDR, 2017/746).
Highly experienced and accomplished experts will share their knowledge and practical advice regarding the design, conduct and regulation of medical device and IVD clinical studies, including best practices and mistakes to avoid. Every effort will be made to provide practical, usable information to help attendees understand what must be done, but also avoid errors that will increase costs and extend timescales.
The Conference will be of interest to all who are involved in planning, designing, conducting, sponsoring, evaluating or assisting in medical device or IVD clinical study-related activities.
Topics to be covered during the conference:
- Regulatory authority view of the new clinical study regulations
- Notified Body procedures related to the evaluation of clinical investigations
- Newly developed European guidance documents important for European clinical study conduct
- International standards for conducting medical device and IVD studies: revised ISO 14155 and ISO 20916:2019
- Quality system concepts in clinical study planning, management, and regulatory compliance
- 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
- PMCF investigations, regulatory requirements and practical considerations
- New medical device clinical safety reporting requirements
- Investigator-initiated studies, new requirements, new considerations
- Effective compliance with clinical study-related European privacy requirements
- Manufacturer best practices for working with CRO’s