Manufacturing conditions

The manufacture of IVD (In Vitro Diagnostic) medical devices must take place under controlled conditions that ensure the safety and effectiveness of the final product. Although Class A IVD devices (lowest risk according to the MDR/IVDR regulation) do not always require production in cleanroom conditions, they must still be manufactured in accordance with good manufacturing practice (GMP) and aseptic conditions if there is a risk of contamination that could affect the diagnostic result.