# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 2.1: Rule 5

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

All 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:
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.

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/IX/division/III/division/2/division/2.1 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-IX/division-III/division-2/division-2.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.