Paragraph 21 Substitution of regulation 4(8)

For regulation 4(8) substitute—

“(8)

In regulation 17^f1 (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).”.