S.L. 427.44 Art. 2009

This provision does not preclude a manufacturer from submitting an application for conformity assessment based on regulation 6(1)(b).

(h) Hip, knee and shoulder replacements that have been subject to a conformity assessment procedure pursuant to regulation 6(3)(b)(iii) before 1st September 2007 may be subject to a conformity assessment as Class III medical devices pursuant to regulation 6(1)(b)(i) or

(ii) before 1st September 2010. This provision does not preclude a manufacturer from submitting an application for conformity assessment based on regulation 6(1)(a).

(i) The placing on the market and the putting into service of hip, knee and shoulder replacements covered by a Decision in accordance with regulation 6(3)(a) issued before 1st September 2007 shall be accepted until 1st September 2009.

(j) The placing on the market of hip, knee and shoulder replacements which are covered by a Decision in accordance with regulation 6(3)(b)(iii) issued before 1st September 2007, shall be accepted until 1st September 2010 and permitted to be put into service beyond this date.