Paragraph 4 Amendment of regulation 3(3)

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;”;”;

for sub-paragraph (c) substitute—

“(c)

omit the definition of “authorised representative”;”;

after sub-paragraph (d) insert—

“(da)

omit the definition of “the Community”;”;

in sub-paragraph (e) for “exit day” substitute “IP completion day”;

in sub-paragraph (f) for “exit day” substitute “IP completion day”;

in sub-paragraph (g) for “exit day” substitute “IP completion day”;

after paragraph (j) insert—

“(ja) omit the definition of “European Economic Area”;”;

in sub-paragraph (l), for “the United Kingdom” substitute “Great Britain”;

for sub-paragraph (q) substitute—

“(q)

omit the definition of “notified body”;”;

in sub-paragraph (r)(i) for “United Kingdom” substitute “Great Britain”;

in sub-paragraph (s) for “for “Community” substitute “United Kingdom”” substitute “for “the Community” substitute “Great Britain””;

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^f1;”;”;

for sub-paragraph (v) substitute—

“(v)

omit the definition of “UK notified body”;”;

in sub-paragraph (w) in the definition of “UK responsible person” inserted by sub-paragraph (w), after “established in” insert “any part of”.