PART IU.K.Introductory Provisions Relating to all Medical Devices

Scope of these RegulationsE+W+S

3.  These Regulations shall not apply to—

(a)medicinal products governed by [F1the Human Medicines Regulations 2012] (including medicinal products derived from human blood or human plasma F2...);

(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 [F3—

(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 origin [F4, except for F5..., in vitro diagnostic medical devices and accessories to such devices] [F6save where medicinal products are incorporated as ancillary to the device];

[F7(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 F8... an in vitro diagnostic medical device, or an accessory to such a device;]

(f)cosmetic products governed by [F9Regulation (EC) 1223/2009 of the European Parliament and of the Council of 30th November 2009 on cosmetic products;] or

F10(g). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Scope of these RegulationsN.I.

3.  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 [F11—

(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 origin [F12, except for F13..., in vitro diagnostic medical devices and accessories to such devices] [F14save where medicinal products are incorporated as ancillary to the device];

[F15(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 F16... an in vitro diagnostic medical device, or an accessory to such a device;]

(f)cosmetic products governed by Council Directive 76/768/EEC F17, as amended F18; or

F19(g). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F17OJ No. L 262, 27.9.1976, p.169.

F18Council Directive 76/768/EEC was amended for the twenty-sixth time by Commission Directive 2000/41/EC (OJ No. L 145, 20.6.2000, p.25).