The Active Implantable Medical Devices Regulations 1992

Regulations 3(7) and (8), 6(2) and 7(1)

SCHEDULE 4 CONDITIONS RELATING TO DEVICES FOR SPECIAL PURPOSES (CORRESPONDING TO ANNEX 6 OF THE DIRECTIVE)

Statement

1.—(1) The manufacturer or his authorised representative shall draw up for custom-made devices or for devices intended for clinical investigation a written statement in English comprising the particulars specified in sub-paragraph (1) or (2) respectively of paragraph 2.

(2) The statement shall be signed by or on behalf of the manufacturer or by his authorised representative.

2.—(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.

Undertaking

3.  The manufacturer shall undertake to keep available for the Secretary of State—

(a) for custom-made devices, documentation in English enabling the design, manufacture and performances of the product, including the expected performances, to be understood, so as to allow conformity with the requirements of the Directive to be assessed;

(b) for devices intended for clinical investigation, that documentation and the following additional documentation in English:—

(i) a general description of the product,

(ii) design drawings, particulars of methods of manufacture, in particular as regards sterilisation, and diagrams of parts, sub-assemblies, circuits and similar items,

(iii) the descriptions and explanations necessary for the understanding of those drawings and diagrams and of the operation of the product,

(iv) a list of the relevant national Standards applied in full or in part, and a description of the measures taken to comply with the relevant essential requirements where those Standards have not been applied,

(v) the results of the design calculations, checks and technical tests carried out.