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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 7
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Amendment of regulation 7 of the principal Regulations
7.—(1) Regulation 7 of the principal Regulations (clinical investigations) shall be amended in accordance with the following provisions of this regulation.
(2) In paragraph (2) for the words “relating to the health or safety of patients, users or others” there shall be substituted the words “of public health or public policy”.
(3) After paragraph (2) there shall be inserted the following paragraph—
“(2A) Where the relevant ethics committee has issued a favourable opinion on a programme of clinical investigation, the Secretary of State may give written notice to the manufacturer or his authorised representative within 60 days of the giving of notice under paragraph (1) that devices may be made available for the purposes of those investigations at any time after the giving of notice under that paragraph.”.
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