The Medical Devices Fees Regulations 1995

means a device as defined in the 1992 Regulations;

means an application for designation as a notified body under regulation 8(1) of the 1992 Regulations or regulation 17(1) of the 1994 Regulations;

means a device as defined in the 1994 Regulations;

means a Class I device, a Class IIa device or a Class IIb device other than an implantable or long term invasive device;

means a Class IIb implantable or long term invasive device, a Class III device or an active implantable device;

means a period of three and a half hours;

means an extension— (a) to add or substitute tasks relating to: (a) active implantable devices in addition to or in substitution of tasks relating to other devices, or (ii) devices which are materially different in technology from devices in connection with which they have already been designated tasks having regard to the risk they pose to the health and safety of patients and the skills needed to assess those risks, (b) to add or substitute tasks relating to the procedures specified in Annex 3 or 4 of the 1990 Directive or Annex III or IV of the 1993 Directive in addition to or in substitution of tasks relating to procedures specified in Annex 2 or 5 of the 1990 Directive or Annex II, V or VI of the 1993 Directive or vice versa, (c) to add or substitute tasks in relation to the procedures specified in Annex 3 of the 1990 Directive or Annex III of the 1993 Directive in addition to or in substitution of tasks relating to the procedures specified in Annex 4 of the 1990 Directive or Annex IV of the 1993 Directive, (d) to add or substitute tasks relating to the procedures specified in Annex 2 of the 1990 Directive or Annex II of the 1993 Directive in addition to o

means notice to the Secretary of State under regulation 7(1) of the 1992 Regulations or regulation 16(1) of the 1994 Regulations of the making available of a device for clinical investigation;

means Council Directive 90/385/EEC on the approximation of the laws of Member States relating to active implantable medical devices as amended by the 1993 Directive and by Council Directive 93/68/EEC;

means the Active Implantable Medical Devices Regulations 1992;

means Council Directive 93/42/EEC concerning medical devices;

means the Medical Devices Regulations 1994;

means the table set out in the Schedule to these Regulations;