[In vitro diagnostic medical devices--the legal context]

In vitro diagnostics is the basic principle of most laboratory activities. It influences three quarters of diagnostic decisions, affecting more than a half of direct costs of provided health care. Production, storing and distribution of in vitro diagnostic medical devices, as well as the laboratory diagnostic process itself (use of in vitro diagnostics) must strictly adhere to all legislative provisions relating to in vitro diagnostics. The article provides a detailed explanation of (i) Directive 98/79/CE on in vitro diagnostic medical devices, (ii) Act No. 22/1997 Coll. on technical requirements for products, (iii) Act No. 123/2000 Coll. on medical devices and (iv) Government Regulation No. 453/2004 on technical requirements for in vitro diagnostic medical devices.