The growing role of EDC in clinical IVD studies for regulatory compliance
The role of EDC in IVD studies has been elevated since the EU’s new IVDR requirements took effect on May 26 2022. IVDR brings the regulatory compliance regime for In Vitro Diagnostics into allignment with MDR, which governs market access in the EU for all other medical devices. In summary, the new regulations mean a far more significant role for Notified Bodies (NBs) in providing statutory oversight of clinical studies designed to gain or maintain market access for In Vitro Diagnostic devices in the EU. More and better data will be required to gain market access in comparison to IVDD and crucially, there will also be far more exacting Post Market Surveillance data requirements in order to maintain market access in the EU for most exisiting products.
IVDR has acted as a catalyst to significantly increase the use of EDC in the support of studies designed to gain or retain market access in Europe.
Find out more about the impact of IVDR on regulatory clinical studies for In Vitro Diagnostics in the articles below.
