IVD Clinical Performance Studies for FDA & EU
At present, the regulatory discussion pretty much focuses on MDR Regulation (EU) 2017/745 on medical devices. However, it seems the impact of Regulation (EU) 2017/746 on in vitro medical devices (IVDR) on the industry is expected to be much more intense. With the updated in vitro diagnostic medical devices (IVD) classification, at least 80% of IVDs will be moving under Notified Body scrutiny, compared to 20% previously. Therefore, most manufacturers should now be gearing up to shift from self-certification to notified body oversight as IVDR will be fully enforceable on May 2022.
According to the IVDR, clinical evidence must support the intended purpose of the device as stated by the manufacturer and be based on a continuous process of performance evaluation, following a performance evaluation plan.
The performance evaluation reports should demonstrate the following elements:
- Scientific validity
- Analytical performance
- Clinical performance