Substitution of regulation 4(8)
This section has no associated Explanatory Memorandum
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.