In-vitro diagnostics (IVD) is the analysis of medical samples, e.g. blood, urine or tissue from patients or healthy individuals. To ensure that only safe and functional IVD products (instruments and reagents) are sold in the European market, all manufacturers are required to conform to the IVD Directive (98/79/EC)1 requirements and also CE marked after 2003. CE (Conformité Européenne, meaning European Conformity) marking is a mandatory conformity marking for certain products sold within the European Economic Area (EEA) since 1985. Although similar regulations are found in the USA as implemented by the FDA, Europe places more emphasis on risk analysis than other regulated markets.
Taken together, analytical instruments and reagents with CE-IVD marking is the gold standard for IVD service provider nowadays. Most of the instruments and all of the reagent assay kits for pathogen detection used in our laboratory are certified with CE-IVD marking to ensure and maintain the high quality testing services and accurate result for clients.