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Amendment of regulation 4 of the principal RegulationsU.K.

3.  In regulation 4 of the principal Regulations (transitional provisions)—

(a)after paragraph (4) there is inserted the following paragraph—

(5) Regulation 13(4) shall not be applied before 1st March 2004 in respect of breast implants which—

(a)bore a CE marking before 1st September 2003; and

(b)satisfy the requirements in respect of relevant devices falling within Class IIb set out in regulation 13(3).; and

(b)after paragraph (5) there shall be added the following paragraph—

(6) Regulation 19A shall not be applied before 1st October 2004 in respect of a device placed on the market before 1st April 2004..