Amendment of regulation 15 of the principal Regulations

8.  In regulation 15 of the principal Regulations (procedure for custom-made general medical devices)—

(1) at the end of paragraph (c) omit “and”; and

(2) after paragraph (d) insert—

“;and

(e) ensures that the statement is passed on with the custom-made device so that it may be made available to the patient on request.”.