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The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995
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- UK Statutory Instruments
- 1995 No. 1671
- Regulation 9
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Amendment of regulation 8 of the principal Regulations
9. After paragraph (5) of regulation 8 of the principal Regulations (notified bodies) there shall be added the following paragraphs—
“(6) The Secretary of State may refuse to designate a body as a notified body, or may withdraw designation of a body as a notified body, if it fails to pay any fee or other charge in accordance with regulations made under section 56 of the Finance Act 1973(1) in connection with services provided by the Secretary of State in carrying out her functions for the purposes of the Directive.
(7) For the purpose of deciding whether or not a body is one in respect of which the conditions specified in Schedule 9 are fulfilled as respects the tasks which it carries out or is to carry out, the Secretary of State may arrange for the inspection of—
(a)any premises occupied, or plant or equipment used, in connection with the carrying out of any such task; or
(b)any premises occupied, or plant or equipment used, by a manufacturer where the body is a notified body undertaking any task in relation to that manufacturer,
and may take into account for the purposes of her decision any refusal of reasonable facilities for such inspection and the results of any such inspection.”.
(1)
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