reg 33A Registration etc. of persons placing in vitro diagnostic medical devices on the market
(1) No person may place a relevant device on the market in accordance with this Part unless that person— (a) is established in Great Britain; and (b) has complied with paragraph (2). (2) A person who places a relevant device on the market complies with this paragraph if, before placing the relevant device on the market— (a) where— (i) that person is the manufacturer of that device and is based in Great Britain, the person informs the Secretary of State of the address of their registered place of business in Great Britain; (ii) that person is the manufacturer of that device and is based outside the United Kingdom, the manufacturer appoints a sole UK responsible person, and that UK responsible person provides the Secretary of State with written evidence that they have the manufacturer’s authority to act as their UK responsible person; or (iii) that person is not the manufacturer of the device, the address of that person’s registered place of business in Great Britain has been provided to the Secretary of State by the manufacturer or the UK responsible person; (b) that person supplies the Secretary of State with— (i) a description of the relevant device; and (ii) the relevant information in paragraph (4); and (c) that person pays to the Secretary of State the relevant fee in accordance with regulation 53. (2A) The person responsible for providing information in accordance with paragraph (2) must inform the Secretary of State of any changes to that information. (3) The UK responsible person appointed in accordance with paragraph (2)(a)(ii) must— (a) ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer; (b) keep available for inspection by the Secretary of State a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements; (c) in response to a request from the Secretary of State, provide the Secretary of State with all the information and documentation necessary to demonstrate the conformity of a device; (d) where they have samples of the device or access to the device, comply with any request from the Secretary of State to provide such samples or access; (e) where they have neither samples of the device nor access to the device, communicate to the manufacturer any request from the Secretary of State to provide such samples or access, and communicate to the Secretary of State whether the manufacturer intends to comply with that request; (f) cooperate with the Secretary of State on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices; (g) immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been appointed; (h) if the manufacturer acts contrary to its obligations under these Regulations— (i) terminate the legal relationship with the manufacturer; and (ii) inform the Secretary of State and, if applicable, the relevant approved body of that termination. (4) In this regulation “ relevant information ” means— (a) in relation to a new relevant device, a statement indicating that the device is a new relevant device; (b) if the device consists wholly or partly of reagents, reagent products or calibration and control materials, appropriate information in terms of common technological characteristics and analytes; (c) if the device does not wholly or partly consist of reagents, reagent products or calibration and control materials, the appropriate indications; (d) in relation to devices in a list in Annex II and devices for self-testing— (i) all data allowing for identification of such devices, the analytical and, where appropriate, diagnostic parameters as referred to in Section 3 of Part A of Annex 1; (ii) if requested by the Secretary of State, the labelling and instructions for use for when the device is placed on the market or put into service; (e) in relation to devices for performance evaluation which relate either to devices referred to in a list in Annex II or to devices for self-testing, all data allowing for identification of such devices, the analytical and where appropriate, diagnostic parameters as referred to in Section 3 of Part A of Annex I. (5) Within two years of the placing of a new relevant device on the market, the Secretary of State may, where the Secretary of State considers it justified, request a report relating to the experience gained with the device subsequent to it being placed on the market. (6) In this regulation a device is a “new relevant device” if— (a) there has been no such device continuously available on the United Kingdom or EEA market during the previous three years for the relevant analyte or other parameter; or (b) use of the device has involved analytical technology not continuously used in connection with a given analyte or other parameter on the United Kingdom or EEA market during the previous three years. (7) In paragraph (3)— (a) the references to “technical documentation” are to be construed in accordance with Annexes III to VIII; (b) the references to “declaration of conformity” are to be construed in accordance with Annexes III, IV, V and VII.