# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 2.2: Rule 6

Extent: E+W+S+N.I.

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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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/IX/division/III/division/2/division/2.2 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-IX/division-III/division-2/division-2.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.