Interpretation of Part IIIU.K.
20.—(1) In this PartF1...—
“custom-made device” means an active implantable medical device that is—
(a)manufactured specifically in accordance with a medical specialist’s written prescription which gives, under his responsibility, specific characteristics as to its design; and
(b)intended to be used only for a particular patient; and
“relevant device” shall be construed in accordance with regulation 21.
(2) In this PartF1..., a reference to a numbered F2... Annex is to the F2... Annex of Directive 90/385 bearing that number.
Textual Amendments
F1Words in reg. 20(1)(2) omitted (1.9.2003) by virtue of The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 10(a)
F2Words in reg. 20(2) omitted (1.9.2003) by virtue of The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 10(b)