SCHEDULE 2Amendment of the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
Substitution of regulation 4(8)21
For regulation 4(8) substitute—
8
In regulation 179 (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).