PART IIntroductory Provisions Relating to all Medical Devices

F1Transitional provisions for hip, knee and shoulder replacements4A

1

This regulation applies to hip, knee or shoulder replacements.

2

Regulation 13(4) shall not apply in respect of a replacement—

a

whose manufacturer or his authorised representative has before 1st September 2007—

i

fulfilled the applicable obligations imposed by Annex II, excluding Section 4 of that Annex,

ii

declared, in accordance with a declaration of conformity procedure set out in that Annex, that the device meets the provisions of Directive 93/42 which apply to it, and

iii

ensured that the device meets the provisions of Directive 93/42 which apply to it; and

b

in respect of which an examination under Section 4 of Annex II has been carried out and an EC design-examination certificate under that Section has been issued before 1st September 2009.

3

Regulation 13(4) shall not apply before 1st September 2009 in respect of a replacement—

a

whose manufacturer or his authorised representative has—

i

fulfilled the applicable obligations imposed by Annex II, excluding Section 4 of that Annex,

ii

declared, in accordance with a declaration of conformity procedure set out in that Annex, that the device meets the provisions of Directive 93/42 which apply to it, and

iii

ensured that the device meets the provisions of Directive 93/42 which apply to it; and

b

which is covered by the decision of a notified body issued in accordance with Section 3.3 or 3.4 of Annex II before 1st September 2007.

4

Regulation 13(4) shall not apply before 1st September 2010 in respect of replacement—

a

whose manufacturer or his authorised representative has—

i

fulfilled the applicable obligations imposed by Annex III together with Annex VI,

ii

declared, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of Directive 93/42 which apply to it, and

iii

ensured that the device meets the provisions of Directive 93/42 which apply to it; and

b

which is covered by the decision of a notified body issued in accordance with Section 3.3 or 3.4 of Annex VI before 1st September 2007.

5

Regulation 13(4) shall not apply in respect of a replacement which—

a

satisfies the conditions set out in paragraph (4)(a) and (b);

b

has been placed on the market before 1st September 2010; and

b

is put into service on or after that date.