The Medical Devices Regulations 1994

CE marking

6.—(1) Except as provided by paragraph (2), every device placed on the market shall bear the CE marking (affixed following a procedure mentioned in regulation 7, 8, 9, 10 or 11, whether carried out in the United Kingdom or elsewhere) in a visible, legible and indelible form—

(a) on the device or its sterile pack, where practicable and appropriate;

(b) on the instructions for use; and

(c) where applicable, on the sales packaging,

and, where relevant, the marking shall be accompanied by the relevant notified body identification number.

(2) Paragraph (1) shall not apply to a device which is custom-made or intended for clinical investigation.

(3) No device shall bear a mark or inscription which is likely to mislead third parties with regard to the meaning or the graphics of the CE marking.

(4) Any other mark may be affixed to a device, its packaging or accompanying instruction leaflet, provided that the visibility and legibility of the CE marking are not thereby reduced.

(5) Where a device comes within the scope of a directive other than the Directive and that other directive provides for the affixing of the CE marking, the CE marking shall not be affixed unless the relevant requirements of that other directive are also satisfied.

(6) Where a directive other than the Directive permits a manufacturer to choose which arrangements to apply during a transitional period, the CE marking shall indicate that the device fulfils only the provisions of those directives applied by the manufacturer.

(7) In a case falling within paragraph (6), particulars of the directives applied by the manufacturer, as published in the Official Journal of the European Communities, shall be given in the documents, notices or instructions required by the directives and accompanying the device.