IVDR Regulation (2017/746) IVDR Regulation defines an IVD Device as "any medical device that is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the analysis of

CE Marking The manufacturer certifies that their product complies with the General Safety and Performance Requirements of the applicable European Regulation by applying the CE Mark. Once a product has received the CE Marking, it can travel freely within the European Union and the European Free Trade Association (EFTA)

The IVDR CE Marking / In Vitro Diagnostic Regulation (EU) 2017/746 is the new EU legislation applicable to in vitro diagnostic (IVD) medical devices.

CE Mark for medical device stands for Conformité Européenne and this is a legal requirement to place the medical device on the market in Europe.