PART II U.K. General Medical Devices

Interpretation of Part II U.K.

5.—(1) In this Part F1 ...—

• “accessory” means an article which, whilst not being a medical device, is intended specifically by its manufacturer to be used together with a medical device to enable it to be used in accordance with the use of the medical device intended by its manufacturer;

• “custom-made device” means a relevant device that is—

  (a)

  manufactured specifically in accordance with a written prescription of a duly qualified medical practitioner or a professional user which gives, under his responsibility, specific characteristics as to its design; and

  (b)

  intended for the sole use of a particular patient,

  but does not include a mass-produced product which needs to be adapted to meet the specific requirements of the medical practitioner or professional user;

• “relevant device” shall be construed in accordance with regulation 6;

• “single-use combination product” means a product which comprises a medical device and medicinal product forming a single integral product which is intended exclusively for use in the given combination and which is not reusable; and

• “system or procedure pack” has the same meaning as in article 12 of Directive 93/42.

(2) In this Part F1 ..., a reference to a numbered article or Annex is to the article or Annex of Directive 93/42 bearing that number.

Textual Amendments

F1 Words in reg. 5(1)(2) omitted (1.9.2003) by virtue of The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 4