# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 1.4: Rule 4

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

All non-invasive devices which come into contact with injured skin:
are in Class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates,
are in Class IIb if they are intended to be used principally with wounds which have breached the dermis and can only heal by secondary intent,
are in Class IIa in all other cases, including devices principally intended to manage the micro-environment of a wound.

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/IX/division/III/division/1/division/1.4 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-IX/division-III/division-1/division-1.4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.