Amendment of regulation 2 of the principal Regulations2
In regulation 2(1) of the principal Regulations (interpretation)—
a
the words “, unless the context otherwise requires” are omitted;
b
after the definition of “active implantable device”, there is inserted the following definition—
“animal” means any animal from a bovine, ovine or caprine species, as well as deer, elk, mink and cats;
c
after the definition of “Directive 2001/83”, there is inserted the following definitions—
“Directive 2003/12” means Commission Directive 2003/125 of 3rd February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC6 concerning medical devices;
“Directive 2003/32” means Commission Directive 2003/327 of 23rd April 2003 on medical devices manufactured utilising tissues of animal origin;
d
in the definition of “the Medical Devices Directives”, after “Directive 93/42” there is inserted “, read with Directive 2003/32”;
e
after the definition of “national standard”, there is inserted the following definition—
“non-viable” means having no potential for metabolism or multiplication;
f
in the definition of “notified body”, for “Part V of” there is substituted “Part V or”; and
g
after the definition of “third country conformity assessment body”, there is inserted the following definition—
“tissue” means an organisation of cells and/or extra-cellular constituents;