reg 32 Interpretation of Part IV
(1) In this Part ...— “accessory” means an article intended specifically by its manufacturer to be used together with an in vitro diagnostic medical device to enable that device to be used in accordance with its intended purpose, which is not— itself an in vitro diagnostic medical device; an invasive sampling medical device; or a medical device which is directly applied to the human body for the purpose of obtaining a specimen; “calibration and control material” means any substance, material or article intended by its manufacturer either to establish measurement relationships or to verify the performance characteristics of a relevant device in conjunction with the intended use of that device; “common technical specification” means a technical specification set out in the Annex to Commission Decision 2002/364/EC (as retained under section 3 of the European Union Withdrawal Act 2018 and modified under section 8 of that Act) for a relevant device referred to in a list in Annex II; “device for self-testing” means an in vitro diagnostic medical device which is intended by its manufacturer to be able to be used by a member of the public in a home environment; and “relevant device” shall be construed in accordance with regulation 33(1); (2) In this Part ..., a reference to a numbered article or Annex is to the article or Annex of Directive 98/79 bearing that number.