# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 2.4: Rule 8

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

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.

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/IX/division/III/division/2/division/2.4 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-IX/division-III/division-2/division-2.4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.