Liquid Handling

CE MarkingTechnical InformationIVD DirectiveIVD Directive of EUOn December 7th, 1998, the EUdirective for "In-vitro-DiagnosticMedical Devices" (IVD Directive)was published in the Official Journalof the European Communities andbecame effective since June 7th,2000.How to define In-Vitro-DiagnosticMedical Devices (IVD)?An "In-Vitro-Diagnostic Medical Device"is any medical device used in-vitro for theexamination of specimens, including bloodandtissue donations, derived from thehuman body.IVD can be a reagent, calibrator, controlmaterial, kit, instrument, apparatus,equipment, system, or specimen receptacles,intended by the manufacturer tobe specifically used for in-vitro diagnosticexamination. IVD are mainly used to provideinformation■ concerning a physiological orpathological state■ concerning a congenital abnormality■ to monitor therapeutic measures.What is a Medical Device?The definition of a "Medical Device" includesany instrument, apparatus, appliance,material or other article, includingthe software necessary for its proper application,intended by the manufacturer to beused for human beings for the purpose of:■ diagnosis, prevention, monitoring, treatmentor alleviation of disease, injury orhandicap■ investigation, replacement or modificationof the anatomy or of a physiologicalprocess■ control of conception.Excluded are pharmacological or immunologicalmeans, which are regulated byappropriate drug laws.CE MarkingThe CE mark is the official marking requiredby the European Community. It shows theuser, that this product fulfills all essentialsafety and environmental requirements asdefined in the so-called European Directives.The manufacturer marks the instrumentand produces a declaration of conformitydescribing the instruments' fulfillmentwith the guidelines and technical requirements.BRAND medical products are all includedin the class of in-vitro diagnostic (IVD)devices. This includes, for example:– blood counting chambers– haemacytometer cover glasses– disposable capillary pipettes– micro haematocrit capillaries– haematocrit sealing compound– sample cups for analyzers– urine beaker– feces container– cryogenic tubes– pipette tips– PD-Tips– Transferpette ® microliter pipettes– HandyStep ® repetitive pipettes330info@brand.de