MHRA: Common specification requirements for in vitro diagnostic devices (consultation closes at 11.59pm on 14 June 2024)

Summary

In vitro diagnostic (IVD) devices are used to examine samples taken from the human body and to diagnose and monitor health conditions. The Medicines and Healthcare products Regulatory Agency (MHRA) are seeking views on a new policy would require manufacturers to comply with additional measures for certain high risk IVDs, such as blood tests used to identify blood type before transfusions or tests which identify life-threatening diseases, introducing harmonised requirements for these products. The consultation closes at 11.59pm on 14 June 2024.