Amendment of regulation 3(3)
This section has no associated Explanatory Memorandum
4. In regulation 3(3)—
(a)after sub-paragraph (a) insert—
““(aa)“after the definition of “active implantable medical device” insert—
“““approved body” is to be construed in accordance with regulation A45;”“;”;
(b)for sub-paragraph (c) substitute—
““(c)“omit the definition of “authorised representative”;”;
(c)after sub-paragraph (d) insert—
““(da)“omit the definition of “the Community”;”;
(d)in sub-paragraph (e) for “exit day” substitute “IP completion day”;
(e)in sub-paragraph (f) for “exit day” substitute “IP completion day”;
(f)in sub-paragraph (g) for “exit day” substitute “IP completion day”;
(g)after paragraph (j) insert—
(h)“(ja) omit the definition of “European Economic Area”;”;
(i)in sub-paragraph (l), for “the United Kingdom” substitute “Great Britain”;
(j)for sub-paragraph (q) substitute—
““(q)“omit the definition of “notified body”;”;
(k)in sub-paragraph (r)(i) for “United Kingdom” substitute “Great Britain”;
(l)in sub-paragraph (s) for “for “Community” substitute “United Kingdom”” substitute “for “the Community” substitute “Great Britain””;
(m)after sub-paragraph (u) insert—
““(ua)“after the definition of “third country conformity assessment body” insert—
“““UK marking” has the meaning given in Article 2(22) of Regulation “(EC) No 765/2008()“;”“;”;
(n)for sub-paragraph (v) substitute—
““(v)“omit the definition of “UK notified body”;”;
(o)in sub-paragraph (w) in the definition of “UK responsible person” inserted by sub-paragraph (w), after “established in” insert “any part of”.