Why does a blood bank refrigerator need to be certified as a Medical Device?
In the European Union, any equipment used for the storage of blood intended for transfusion must be classified and certified as a medical device, in accordance with the Medical Device Regulation (MDR 2017/745) or the previous Medical Device Directive (MDD 93/42/EEC). This legal requirement ensures that blood bank refrigerators meet strict standards for temperature control, safety, traceability, and performance—essential factors for patient safety and regulatory compliance.
