OpenLegislation

Division 2.2 Rule 6F1

United Kingdom

Original text. Later amendments are not shown.

All surgically invasive devices intended for transient use are in Class IIa unless they are:

  • intended 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,

  • reusable surgical instruments, in which case they are in Class I,

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

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

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

  • intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, 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).