Regulation 4A Transitional provisions for hip, knee and shoulder replacementsF1

(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.

Annotations

Textual amendments

F1: Reg. 4A inserted (1.9.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(b), 4