The Active Implantable Medical Devices Regulations 1992

EC mark

4.—(1) Except as provided by paragraph (2), every device placed on the market or put into service shall bear the EC mark (affixed following a procedure mentioned in regulation 5, whether carried out in the United Kingdom or elsewhere) in a visible, legible and indelible form —

(a) on the sterile pack;

(b) on any sales packaging; and

(c) on the instruction leaflet,

and the mark shall in each case be accompanied by the relevant notified body logo for that device.

(2) Paragraph (1) does not apply to a device which is custom—made or intended for clinical investigation, and such devices shall not bear the EC mark.

(3) No device placed on the market or put into service shall bear (whether on its pack, sales packaging or instruction leaflet or elsewhere) a mark which is likely to be confused with the EC mark.