2.Invasive devicesU.K.
2.1.Rule 5U.K.
[F1All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device or which are intended for connection to an active medical device in Class I:]
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).
are in Class I if they are intended for transient use,
are in Class IIa if they are intended for short-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity, in which case they are in Class I,
are in Class IIb if they are intended for long-term use, except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity and are not liable to be absorbed by the mucous membrane, in which case they are in Class IIa.
All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to an active medical device in Class IIa or a higher class, are in Class IIa.
[F12.2. Rule 6 U.K.
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.]
2.3.Rule 7U.K.
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.
2.4.Rule 8U.K.
All implantable devices and long-term surgically invasive devices are in Class IIb unless they are intended:
to be placed in the teeth, in which case they are in Class IIa,
to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are in Class III,
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 III.