- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (a wnaed Fel)
Dyma’r fersiwn wreiddiol (fel y’i gwnaed yn wreiddiol).
2. 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(1) of 3rd February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC(2) concerning medical devices;
“Directive 2003/32” means Commission Directive 2003/32(3) 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;”.
OJ No. L 28, 4.2.2003, p.43.
OJ No. L 169, 12.7.1993, p.1; amended by Directive 98/79/EC (OJ No. L 331, 7.12.1998, p.1), Directive 2000/70/EC (OJ No. L 313, 13.12.2000, p.22) and Directive 2001/104/EC (OJ No. L 6, 10.1.2002, p.50).
OJ No. L 105, 26.4.2003, p.18.
Y Diweddaraf sydd Ar Gael (diwygiedig):Y fersiwn ddiweddaraf sydd ar gael o’r ddeddfwriaeth yn cynnwys newidiadau a wnaed gan ddeddfwriaeth ddilynol ac wedi eu gweithredu gan ein tîm golygyddol. Gellir gweld y newidiadau nad ydym wedi eu gweithredu i’r testun eto yn yr ardal ‘Newidiadau i Ddeddfwriaeth’.
Gwreiddiol (Fel y’i Deddfwyd neu y’i Gwnaed): Mae'r wreiddiol fersiwn y ddeddfwriaeth fel ag yr oedd pan gafodd ei deddfu neu eu gwneud. Ni wnaed unrhyw newidiadau i’r testun.
Gallwch wneud defnydd o ddogfennau atodol hanfodol a gwybodaeth ar gyfer yr eitem ddeddfwriaeth o’r tab hwn. Yn ddibynnol ar yr eitem ddeddfwriaeth sydd i’w gweld, gallai hyn gynnwys:
Defnyddiwch y ddewislen hon i agor dogfennau hanfodol sy’n cyd-fynd â’r ddeddfwriaeth a gwybodaeth am yr eitem hon o ddeddfwriaeth. Gan ddibynnu ar yr eitem o ddeddfwriaeth sy’n cael ei gweld gall hyn gynnwys:
liciwch ‘Gweld Mwy’ neu ddewis ‘Rhagor o Adnoddau’ am wybodaeth ychwanegol gan gynnwys