SCHEDULE 2 Amendment of the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Substitution of regulation 4(8)

21.  For regulation 4(8) substitute—

“(8) In regulation 17(1) (manufacturers etc. and conformity assessment procedures for general medical devices)—

(a) for “his authorised representative” each time that those words occur substitute “their UK responsible person”;

(b) for each reference to “Directive 93/42” substitute “this Part”;

(c) omit paragraph (3).”.

(1)

There are amendments to regulation 17 which are not relevant to these Regulations.