In Vitro Diagnostic Medical Device

IVDI In-vitro diagnostic medical device For performance evaluation... 

The size of laboratory medicine has become quite considerable, comprising tens of thousands of laboratories in Europe alone not counting near -patient examination sites in clinical departments, hospital wards, and general practitioners offices. The expenses for all these activities are around one-twentieth of the costs of health services in industrialized countries, and the global market of in vitro diagnostic medical devices is now about 25 thousand million a year. 

ISO/TC 212/WG2 N65 prEN 17511 (2000) In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Metro-logical traceability of values assigned to calibrators and control material. ISO/CEN, Geneva, Switzerland EU Lex Directive 98/79 EC (1998)... 

On in vitro diagnostic medical devices. Official JL 331 1 37 Thomas L (1998) Labor und Diagnose. TH-Books, Frankfurt, Germany Jacobs DS, De Mott WR, Grady HJ, Horvat RT, Huestis DW, Kasten BL (1996) Laboratory test handbook. Lexi-Comp, Hudson, USA http //www.bipm.org/enus/ 2 Committees/JCTLM.shtml... 

EN ISO 17511, In vitro diagnostic medical devices Metrological trace-ability of values assigned to calibrators and control materials... 

Part 800 In vitro diagnostics/medical devices Part 1270 Tissue regulations... 

ISO 15193—Bioanalytical procedures ISO 15193 2009 In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin— Requirements for content and presentation of reference measurement procedures... 

Many organizations have been involved in developing a traceable accuracy base for analytes of clinical interest (see Chapter 14). A driver for current efforts to develop such a base is the European Directive 98/79/EC on in vitro diagnostic medical devices (www.ce-mark.com/ivd.pdf), which requires that The traceability of values assigned to calibrators and/or control materials must be assured through available reference measurement procedures and/or available reference materials of a higher order. ... 

In vitro diagnostic medical devices- information supplied by the manufacturer with in vitro diagnostic reagents for stdning in biology... 

European Council (1998) Directive 98/79/EC of 27 October 1998 on in vitro diagnostic medical devices. 

ISO 17511 2003 Metrological Traceability for in Vitro Diagnostic Medical Devices (Date Accessed 3 November 2013) Available from http //www.iso.org/. 

EEC concerns medical devices, and Directive 98/79/EC of 27 October 1998 specifically covers in vitro diagnostic medical devices. EU Directives define a medical device as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings. Devices are to be used for the purpose of ... 

Figure 4 Calibration hierarchy and metrological traceability to SI (The terms and definitions taken from ISO 17511 2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials.) (Reproduced with permission from International Organization for standardization, ISO. This standard can be obtained from any ISO member and from the website, www.iso.org ISO.)...

ISO 17511 (2003) In vitro Diagnostic Medical Devices -Measurement of Quantities in Biological Samples -Metrological Traceability of Values Assigned to Calibrators and Control Materials. Geneva International Organization for Standardization. 

ISO 23640 In vitro diagnostic medical devices—evaluation of stability of in vitro diagnostic reagents... 

In 2012, a European harmonized version of this standard was adopted by European Committee for Standardization as EN ISO 14971 2012. This version is harmonized with respect to the three European directives associated with MDs Medical Devices Directive 93/42/EEC, In Vitro Diagnostic Medical Device Directive 98/79/EC, and Active Implantable Medical Device Directive 90/385/EEC. This was done to address the presumed compliance with the three directives that is obtained through notified body certification audits and regulatory submissions that claim compliance to this standard. 

For the purpose of improving safety and efficacy, there are three Specific Product Safety Directives for active implantable medical devices, for other medical devices, and for in-vitro diagnostic medical devices. There is also a General Product Safety Directive, intended for "all medical devices that are supplied in the course of a commercial activity for use by consumers" to which none of the three Specific Product Safety Directives can be applied. 

Medical Device Directive 98/79/EC (1998) In vitro diagnostic medical devices. http //ec. europa.eu/growth/single-markel/european-standards/harmonised-standards/iv-diagnostic-medi cal-devices/index en.htm... 

---