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The DIRECTIVES and STANDARDS listed here may have been subsequently REVISED . You must refer to the CURRENT REVISION and AMENDMENTS if any.

Saturday, June 26, 2010


Current legislation

Medical Devices are regulated by three main Directives:
  • Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990) pdf [158 KB]
  • The Council Directive 93/42/EEC on Medical Devices (MDD) (1993) pdf [265 KB]
  • Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDMD) (1998) pdf [188 KB]


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