Amendment of regulation 4 of the principal Regulations3
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).
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.