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).