Multiplex in vitro diagnostic (IVD) devices concurrently detect two or more targets/markers. Multiplex IVDs are sold as one device with their sole intended purpose.
They may be intended to detect dozens of targets/markers, such as allergies or microorganisms. Due to the possibly high number of targets/markers in the intended purpose, assessing the Technical Documentation and #clinicaldata to support the detection of each target/marker is problematic.
Due to the potentially large number of targets/markers, a risk-based sampling approach should be considered. In these cases, the notified body review should focus on the multiplex IVD device’s detection technology.
Choosing which marker data to review, using a risk-based approach. Based on targets/markers there may be different classifications; the #IVDR highest-class markers should be reviewed first. Multiple deficiencies during the initial review may cause the notified body to sample additional analytes or update the sampling plan during the certification cycle.
- Class C and B markers/targets can be sampled using the risk-based approach.
- All class D marker documentation will be reviewed.
The Notified Body Conformity assessment documentation should include the approach and rationale used to assess the Technical Documentation.