The Danish Medicines Agency informs that Manufacturers of medical devices are to comply with the EU Central Management Committee (CMC) decision no. 3 on manufacturer address details on labelling by 1. September 2012.
Manufactuers are recommended to revise their labels and IFU according to the CMC decision as well as take int oconsidereation that the same details have to be provided for the address of the authorised representative.
http://www.cmc-md.eu/mediapool/97/978504/data/Decision_3_update-16thJuly.pdf