Division 1.4 Rule 4

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.