reg 35 Determining compliance of in vitro diagnostic medical devices with relevant essential requirements
(1) In determining which are the relevant essential requirements for a particular relevant device, and whether or not it complies with any of the relevant essential requirements, account shall be taken of its intended purpose. (2) In order to meet the essential requirements set out in Section 8 of Part B of Annex I, the information to be provided under that Section must be in English ... . (3) A relevant device shall be presumed to comply with an essential requirement if it conforms as respects that requirement to a relevant designated standard . (4) A relevant device shall be treated as complying with an essential requirement in respect of which there is an applicable common technical specification only if it is in conformity with that specification or, if for duly justified reasons the manufacturer has not complied with that specification, an equivalent or higher specification.