7. In regulation 4T(1) (references in other legislation to Directives 90/385, 93/42 and 98/79)—
(a)in paragraph (2)—
(i)omit sub-paragraph (b),
(ii)at the end of the paragraph insert—
“(c)the reference to the expression “Directive 93/42/EEC” is to be construed, to the extent necessary for the practical application of that expression, as a reference also or instead to Part II of the Medical Devices Regulations 2002;
(d)the references to “paragraph 4.3 of Annex II to Directive 93/42/EEC” and “paragraph 5 of Annex III to Directive 93/42/EEC” are to be construed, to the extent necessary for the practical application of those provisions, as references also or instead to those paragraphs and those Annexes as they applied immediately before IP completion day and as modified by Schedule 2A.”;
(b)in paragraph (4)(a), omit “or in accordance with Schedule 9”.
Inserted by S.I. 2019/971 (as amended by S.I. 2020/1478).