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6.—(1) Regulation 19B(1) is amended as follows.
(2) In paragraph (1)(a)—
(a)after “Directive 93/42” insert “as it had effect on 25 May 2021”;
(b)omit “as amended from time to time”.
(3) In paragraph (3)—
(a)at the beginning insert “Subject to paragraph (3A),”;
(b)after sub-paragraph (b) insert—
“(ba)ensures that any certificate issued by a notified body in connection with that conformity assessment procedure is valid by virtue of Article 120(2) of Regulation (EU) 2017/745;”;
(c)in sub-paragraph (f) for “draws up” substitute “has drawn up before 26 May 2021”.
(4) After paragraph (3) insert—
“(3A) Paragraph (3) only applies to a class I device under the Directive if—
(a)the conformity assessment procedure under Article 11 required the involvement of a notified body; or
(b)the conformity assessment procedure for that device under Article 52 of Regulation (EU) 2017/745 would require the involvement of a notified body (if it were to be assessed under that regulation).”.
(5) In paragraph (7)—
(a)after sub-paragraph (b) insert—
“(ba)ensures that any certificate in relation to the system or procedure pack or a device within it that was issued by a notified body under the Directive is valid by virtue of Article 120(2) of Regulation (EU) 2017/745;
(bb)ensures that the declarations required by Article 12 were drawn up before 26 May 2021;”;
(b)at the end of sub-paragraph (c) omit “and”;
(c)at the end of sub-paragraph (d) for “English.” substitute “English; and”;
(d)after sub-paragraph (d) insert—
“(e)ensures that the system or procedure pack does not contain a class I device under the Directive for which—
(i)the conformity assessment procedure under Article 11 did not require the involvement of a notified body; and
(ii)the conformity assessment procedure under Article 52 of Regulation (EU) 2017/745 would not require the involvement of a notifed body (if it were to be assessed under that regulation).”.
Regulation 19B was inserted by S.I. 2019/791.
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