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Council Directive 93/42/EECShow full title

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

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Changes over time for: Division 2.2.

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[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.]

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