PART IIntroductory Provisions Relating to all Medical Devices

Scope of these Regulations3

These Regulations shall not apply to—

a

medicinal products governed by Directive 2001/83 (including medicinal products derived from human blood or human plasma governed by Title X of Directive 2001/83);

b

human blood, human blood products, plasma or blood cells of human origin;

c

devices that incorporate, at the time of placing on the market, human blood, blood products, plasma or blood cells of human origin, except for F1—

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,;

d

transplants or tissues or cells of human origin or products incorporating or derived from tissues or cells of human originF2, except for active implantable medical devices, in vitro diagnostic medical devices and accessories to such devices;

F3e

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;

f

cosmetic products governed by Council Directive 76/768/EECM1, as amended M2; or

g

products whose principal intended purpose is such that they fall under Council Directive 89/686/EEC on the approximation of the laws of the Member States relating to personal protective equipment M3, as amended M4.