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Regulation 20 Interpretation of Part III

United Kingdom

(1)

In this PartF1...—

  • “custom-made device” means an active implantable medical device that is—

    1. (a)

      manufactured specifically in accordance with a medical specialist’s written prescription which gives, under his responsibility, specific characteristics as to its design; and

    2. (b)

      intended to be used only for a particular patient; and

  • “relevant device” shall be construed in accordance with regulation 21.

(2)

In this Part..., a reference to a numbered F2... Annex is to the ... Annex of Directive 90/385 bearing that number.

Annotations

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)