OpenLegislation

Division 2.3 Rule 7

United Kingdom

Original text. Later amendments are not shown.

All surgically invasive devices intended for short-term use are in Class IIa unless they are intended:

  • F1either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,

  • or specifically for use in direct contact with the central nervous system, in which case they are in Class III,

  • or to supply energy in the form of ionizing radiation in which case they are in Class IIb,

  • or to have a biological effect or to be wholly or mainly absorbed in which case they are in Class III,

  • or to undergo chemical change in the body, except if the devices are placed in the teeth, or to administer medicines, in which case they are in Class IIb.

Annotations

Textual amendments

F1

Substituted by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance).