Reference, Calibration and Referral Laboratories - A Look at Current European Provisions and Beyond

European Union (EU) regulations on in vitro diagnostics (IVD) and on serious cross-border threats to health provide for the establishment of European Reference Laboratories (EURLs) and their harmonisation and cooperation with National Reference Laboratories (NRLs). While the EURLs under the IVD Regulation will be operational by 1 October 2024, the EURLs under the Regulation on serious cross-border threats to health will be operational by January 2025. Although NRLs may have been operating for a long time on the basis of national legislation, they should now cooperate with each other and with EURLs in a network of centres of excellence for the authorisation and post-market surveillance of IVDs and for the epidemiological surveillance and control of communicable diseases. The term "reference laboratory" has long been used colloquially to refer to many kinds of laboratories, regardless of their tasks, competencies, responsibilities and designation. To clarify the roles and functioning of EURLs and NRLs, we evaluated the relevant current EU provisions and compared the findings with those of reference laboratories designated by other organisations, calibration (reference) laboratories and referral laboratories, which are simply referred to as "reference laboratories".