In Vitro Diagnostic Medical Device Directive

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. 

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)... 

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. ... 

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

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 ... 

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... 

Community-wide regulation of medical devices commenced with the introduction of Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices. Two further base directives followed that cover all other medical devices The Medical Devices Directive 93/42/EEC and The In Vitro Diagnostics Directive 98/79/EC. All three base directives are similar in content and structure. However, it should be noted that, in addition to dealing with the particular subject matter, the Medical Devices Directive and the In Vitro Diagnostics Directive also contained amendments to the previous device directives. The Medical Devices Directive amended articles in the Active Implantable Medical Devices Directive, while the In Vitro Diagnostics Directive amended articles in the Medical Devices Directive. 

Studies to investigate the safety and effectiveness of In Vitro Diagnostic (IVD) medical devices under intended use conditions are conducted as performance evaluations. They are considered to present less risk than clinical investigations since, by their nature, studies involving IVDs cannot have any direct impact on the health and safety of trial subjects. 

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