reg 5 Interpretation of Part II
(1) In this Part ...— “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— manufactured specifically in accordance with a written prescription of a registered medical practitioner, or other person authorised to write such a prescription by virtue of his professional qualification, which gives, under his responsibility, specific characteristics as to its design; and 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 ..., a reference to a numbered article or Annex is to the article or Annex of Directive 93/42 bearing that number.