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The Medical Devices Regulations 2002

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This is the original version (as it was originally made).

Interpretation of Part III

20.—(1) In this Part, unless the context otherwise requires—

  • “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 Part, unless the context otherwise requires, a reference to a numbered article or Annex is to the article or Annex of Directive 90/385 bearing that number.

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