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The Medical Devices (Amendment) Regulations 2008
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- UK Statutory Instruments
- 2008 No. 2936
- Regulation 6
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Amendment of regulation 9 of the principal Regulations
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6. 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.”; and
(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 equipment(1) and Directive 93/42, the relevant basic health and safety requirements of Directive 89/686/EEC shall also be fulfilled.”.
(1)
OJ No. L 399, 30.12.1989, p.18; as last amended by Regulation (EC) No. 1882/2003 (OJ No. L 284, 31.10.2003, p.1).
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