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

after “Directive 93/42” insert “as it had effect on 25 May 2021”;

omit “as amended from time to time”.

at the beginning insert “Subject to paragraph (3A),”;

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;”;

in sub-paragraph (f) for “draws up” substitute “has drawn up before 26 May 2021”.

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;”;

at the end of sub-paragraph (c) omit “and”;

at the end of sub-paragraph (d) for “English.” substitute “English; and”;

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).”.