Custom—made devices

6.—(1) The manufacturer of a custom—made device shall —

(a) satisfy the conditions specified in Schedule 4 (as it applies to custom—made devices) before that device is placed on the market or put into service; and

(b) take all necessary measures to ensure that the manufacturing process ensures that the device manufactured to that process conforms to the documentation referred to in paragraph 3(a) of Schedule 4.

(2) The conditions specified in paragraph 1 of Schedule 4 may be satisfied by the manufacturer’s authorised representative, instead of by the manufacturer.