Amendment of regulation 9 of the principal Regulations6
In regulation 9 of the principal Regulations (determining compliance of general medical devices with relevant essential requirements)—
a
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.
b
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 equipment7 and Directive 93/42, the relevant basic health and safety requirements of Directive 89/686/EEC shall also be fulfilled.