reg 9 Determining compliance of general 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) Where confirmation of conformity with the essential requirements must be based on clinical data, such data must be established in accordance with the requirements set out in Annex X. (3) In the case of a relevant device which is being or has been put into service— (a) the essential requirements specified in Sections 8.7 and 13 of Annex I with regard to information on the packaging and on any label are complied with only if such information is in English (whether or not it is also in another language and whether or not the device is for professional use); and (b) the essential requirements specified in Sections 11.4 and 13 of Annex I with regard to instructions for use are complied with only if— (i) such instructions are in English ... (ii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (4) A relevant device shall be treated as complying with an essential requirement if it conforms as respects that requirement to a relevant designated standard , unless there are reasonable grounds for suspecting that it does not comply with that requirement. (5) A custom-made device— (a) in respect of which the conditions specified in Annex VIII are satisfied; and (b) in the case of a Class IIa, Class IIb and Class III device, which is accompanied by the statement required by Section 1 of Annex VIII, shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements. (5A) When a custom-made device is supplied to a patient, the healthcare professional who writes the prescription for the custom-made device shall, in relation to each patient that they supply with such a device— (a) ensure that the patient is aware that they may request the statement containing the information required by Sections 1 and 2 of Annex VIII ; and (b) ensure that the statement containing the information required by Sections 1 and 2 of Annex VIII is made available to the patient on request. (6) Where, in accordance with Section 2.1 of Annex VIII, a manufacturer of a custom-made device, or their UK responsible person , has indicated that specified essential requirements have not been fully met, and has given proper grounds as to why they have not been fully met, those specified essential requirements are no longer to be treated as relevant essential requirements for that device. (7) A device intended for clinical investigation in respect of which— (a) the conditions specified in Annex VIII are satisfied; (b) notice has been given under regulation 16(1); and (c) either— (i) no notice has been given under regulation 16(4) within the period of 60 days there referred to, or (ii) notice has been given under regulation 16(5), shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements. (8) A single-use combination product shall be taken to comply with the relevant essential requirements if the medical device which forms part of that product only complies with the requirements set out in Annex I ... that relate to safety and performance, unless the medicinal product which forms part of that product is liable to act on the human body with action ancillary to that of the medical device, in which case the single-use combination product must comply with all the relevant essential requirements which apply to it. (9) Where a device is intended by the manufacturer to be used in conjunction with both the provisions in Regulation (EU) 2016/425 of the European Parliament and of the Council of 9th March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC and Directive 93/42, the relevant basic health and safety requirements of Regulation (EU) 2016/425 shall also be fulfilled.