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 2003/12 M1 of 3rd February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EECM2 concerning medical devices;

“Directive 2003/32” means Commission Directive 2003/32 M3 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;