Amendment of regulation 3 of the principal Regulations
3. In regulation 3 of the principal Regulations (scope of the Regulations)—
(a)in paragraph (c), for “stable derivatives devices” substitute—
“—
(i)stable derivatives devices,
(ii)active implantable medical devices and accessories to such devices, and
(iii)in vitro diagnostic medical devices and accessories to such devices,”;
(b)in paragraph (d), at the end insert “, except for active implantable medical devices, in vitro diagnostic medical devices and accessories to such devices”; and
(c)for paragraph (e), substitute—
“(e)transplants or tissues or cells of animal origin, unless—
(i)a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue, or
(ii)a product is an active implantable medical device or an in vitro diagnostic medical device, or an accessory to such a device;”.