Use of Structured Dialogs to Navigate the CDx Consultation and Clinical Aspects of IVDR
Time: 1:25 pm
day: Day 3 Track C
Details:
- MDCG (2022-14) encourages IVD Manufacturers and Notified Bodies to have ‘structured dialogs’ between the partners to enhance the efficiency and predictability of the IVDR certification process.
- These dialogs, which can occur prior to and during the conformity assessment can be highly beneficial in:
- Identifying general clinical requirements of the IVDR
- Planning and ensuring clinical evidence is prepared adequately for the EMA CDx Consultation process
- Can help Manufacturers gain a better understanding of how they need to proceed for bringing a device (e.g., LDT) to market under the Regulation.
