The Medical Devices Regulations 2002 No. 618

PART III U.K. Active Implantable Medical Devices

Interpretation of Part III U.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

F1 Words 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)

F2 Words 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)