Regulation 2 Amendment of regulation 2 of the principal Regulations

the words “, unless the context otherwise requires” are omitted;

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

after the definition of “Directive 2001/83”, there is inserted the following definitions—

““Directive 2003/12” means Commission Directive 2003/12 M1 of 3rd February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC M2 concerning medical devices;

F2...”;

in the definition of “the Medical Devices Directives”, after “Directive 93/42” there is inserted “ , read with Directive 2003/32 ”;

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

in the definition of “notified body”, for “Part V of” there is substituted “ Part V or ”; and

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .