# The Active Implantable Medical Devices Regulations 1992, Paragraph 2: Statement


(1) The particulars referred to in paragraph 1(1) for a custom-made device are—
(a) particulars allowing the device to be identified;
(b) a statement affirming that the device is intended for exclusive use by a particular patient, together with his name;
(c) the name of the registered medical practitioner who wrote the prescription and, if applicable, the name of the clinic concerned;
(d) the particular features of the device as described in the prescription;
(e) a statement affirming that the device complies with the essential requirements and, where applicable, indicating which relevant essential requirements have not been wholly complied with, together with the grounds for them not having been wholly complied with.
(2) The particulars referred to in paragraph 1(1) for a device intended for clinical investigation are—
(a) particulars allowing the device to be identified;
(b) a plan of the investigation, stating in particular the purpose, scope and number of the devices concerned, the terms of any opinion on the investigation given by a committee or other body which has considered the ethics of the investigation and a description of the precautions taken to protect the health and safety of the patient;
(c) the name of each registered medical practitioner and of each institution responsible for the investigation;
(d) each place, date of commencement and duration scheduled for the investigation;
(e) a statement affirming that the device complies with the relevant essential requirements apart from the aspects constituting the object of the investigations and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the patient.

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Source: https://www.legislation.gov.uk/uksi/1992/3146/schedule/4/paragraph/2 (the official version)
Page: https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-4/paragraph-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.