While FDA regulates Blood Establishment Computer Systems (BECS) as medical devices as well as regulating the blood establishments themselves, many other countries take a different approach.
According to the Danish Competent Authorities the European Union (EU) approach is that equipment for blood banks including transfusion and information systems with clinical data about the donors, blood type etc. is not categorized as Medical Devices and therefore not regulated by the Medical Device Directive (MDD). National legislation then regulates the issue. For Denmark, no rules exist except for general medical responsibility of the blood institution.