# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division: Rule 11

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

All active devices intended to administer and/or remove medicines, body liquids or other substances to or from the body are in Class IIa, unless this is done in a manner:
that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and 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/3/division/3.2/division/1 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-IX/division-III/division-3/division-3.2/division-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.