PART IIIU.K.Active Implantable Medical Devices

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)