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PART II
EEC PATTERN APPROVAL AND INITIAL VERIFICATION IN THE UNITED KINGDOM
EEC pattern approval 7. Regulation 8 to 11 of the 1988 Regulations (which contain provisions with respect to the grant, extension and revocation of EEC pattern approval), and Schedule 2 to those Regulations (which regulates the conduct in the United Kingdom of EEC pattern approval), shall apply in relation to the pattern approval of clinical thermometers to which these Regulations apply as they apply in relation to the pattern approval of instruments to which those Regulations apply as if in regulation 8 to 11 of, and Schedule 2 to, the 1988 Regulations for the words "Secretary of State" wherever they appear there were substituted the words "the approved body" and for the words "the relevant Directive" wherever they appear there were substituted the words "Council Directive No. 76/764/EEC on the approximation of the laws of the member States on clinical mercury-in-glass, maximum reading, thermometers, as amended by Council Directive No. 83/128/EEC and Commission Directive No. 84/414/EEC".
Application of signs of EEC pattern approval 8.(1) Where an EEC pattern approval (whether granted under these Regulations or by any member State other than the United Kingdom) is in force in respect of a pattern of clinical thermometer, the manufacturer shall cause one or other of the two signs of EEC pattern approval, or where the pattern approval is limited approval, one or other of the two signs of EEC limited pattern approval, to be affixed to clinical thermometers conforming to the approved pattern.
(2) Any sign affixed in accordance with this regulation shall be affixed at a visible point and shall be legible and indelible.
EEC initial verification 9.(1) An application for consideration of any clinical thermometer for EEC initial verification shall be made to an approved body together with such information as the approved body may reasonably require for the purposes of determining the application
(2) The approved body shall determine whether an EEC pattern approval is in force in respect of the clinical thermometer, and, if so, whether it conforms to the approved pattern and to the requirements of the Directive.
(3) Where the approved body is satisfied (a) that the clinical thermometer conforms to the requirements of the Directive; and
(b) that an EEC pattern approval is in force in respect of the clinical thermometer and that it conforms to the approved pattern, the approved body shall cause to be affixed to it one or other of the two United Kingdom marks of EEC initial verification.
(4) If the approved body refuses to cause any mark of EEC initial verification to be affixed it shall give to the applicant a statement in writing of its reasons for the refusal.
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