The Active Implantable Medical Devices Regulations 1992

Essential requirements for devices

3.—(1) All devices placed on the market or put into service must comply with the relevant essential requirements.

(2) In determining which are the relevant essential requirements for a device and whether or not the device complies with any of the relevant essential requirements, account shall be taken of its intended purpose.

(3) Any determination that a device complies with any of the essential requirements specified in paragraphs 1 to 5 of Schedule 2, and any evaluation of side effects or undesirable effects for the purposes of determining whether or not a device complies with any of the essential requirements, shall be based in particular on clinical data, the adequacy of which is based on the collation of scientific literature or the results of clinical investigations referred to in paragraph 1 of Schedule 3; and any determination as to whether or not a device complies with any other essential requirements may be based on such data.

(4) In the case of a device which has been put into service, the essential requirements specified in paragraphs 13, 14 and 15 of Schedule 2 are complied with only if the information and particulars referred to in those paragraphs are in English (whether or not they are also in another language).

(5) A device shall be treated as complying with an essential requirement if it conforms as respects that requirement to a relevant national Standard, unless there are reasonable grounds for suspecting that the device does not comply with that requirement.

(6) A device which is neither custom—made nor intended for clinical investigation and which bears the EC mark 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.

(7) A custom—made device in respect of which the conditions specified in Schedule 4 are satisfied and which is accompanied by the statement referred to in paragraph 1 of Schedule 4 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 device intended for clinical investigation in respect of which —

(a) notice has been given under regulation 7(1);

(b) no notice has been given under regulation 7(2) within the period of 60 days there referred to; and

(c) the conditions specified in Schedule 4 are satisfied,

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.