Since the Medical Devices law came into effect in July 1999, surgical covers and surgical protective clothing have been classified as class I medical devices. In order to prove that basic requirements of the law have been complied with, they must bear the CE mark. In the event that a label, which is for instance attached to a surgical drape, could lead to application problems in the operating theatre, a labelling on the offer, order confirmation, delivery note and / or invoice is sufficient. The certification process necessary for the CE-declaration of conformity must be performed by the manufacturer prior to market entry.
