Statutory Instruments

European Communities (Medical Devices) Regulations 1994

The purpose of these Regulations is to give effect to Council Directive 9¾2/EEC of 14th June 1993 concerning medical devices (O.J No. L 169, 12.07.1993, p.1). The effect of these Regulations is:—

  • to lay down essential safety requirements which medical devices (hereinafter referred to as “devices”) must satisfy;
  •  to provide for the affixing of a CE marking to a device once its manufacturer has followed the conformity assessment procedures prescribed in these Regulations;
  • to prohibit the placing on the market or putting into service of a device, other than a device which is either custom-made or intended for clinical investigation, which does not bear the CE marking; and also prohibit the use of any mark which is likely to be confused with the CE marking,

and to set out all other associated matters arising from the provisions of the Directive.  View the SI here