In-Vitro-Diagnostic (IVD)

With the passing of the European directive on in-vitro-diagnostic medical devices (IVDD 98/79/EC), the requirements of in-vitro-diagnostic medical devices are binding for all member states of the European Union. The directive includes product requirements, requirements on manufacture, placing the product on the market, as well as demands on safety and quality of the products.

The German Law on Medical Services (MPG) also applies in its 2nd Amendment (2. MPGÄG) to reagents and reagent products, calibrators and calibrating instruments as well as specimen receptacles intended by the manufacturer for the in-vitro examination of human tissue, blood or secretion specimens in order to provide information on the state of health of a patient.