Amendments to regulation 19B (obligations in Part II of these Regulations which are met by complying with obligations in Directive 93/42)6
1
Regulation 19B7 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).