In Vitro Diagnostic Medical Device Regulation

IVDR stands for In Vitro Diagnostic Regulation.

IVDR is a risk-based approach to classify device with increased notified body and competent authority controls. The Regulation identifies four risk classes:

·       Class A (lowest risk),

·       Class B,

·       Class C, and

·       Class D (highest risk)

The In Vitro Diagnostic Medical Device Regulation has progressively roll out from May 26 ,2022. The IVDR strengthens the existing regulatory framework providing a 5-year transition period.