Regulation 6 Amendment of regulation 9 of the principal Regulations

after paragraph (5), insert—

“(5A)

When a custom-made device is supplied to a patient, the healthcare professional who writes the prescription for the custom-made device shall, in relation to each patient that they supply with such a device—

(a)

ensure that the patient is aware that they may request the statement containing the information required by Sections 1 and 2 of Annex VIII; and

(b)

ensure that the statement containing the information required by Sections 1 and 2 of Annex VIII is made available to the patient on request.”; and

after sub-paragraph (8) insert—

“(9)

Where a device is intended by the manufacturer to be used in conjunction with both the provisions in Council Directive 89/686/EEC on the approximation or the laws of the Member States relating to personal protective equipment^f1 and Directive 93/42, the relevant basic health and safety requirements of Directive 89/686/EEC shall also be fulfilled.”.