# The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020, Paragraph 4: Amendment of regulation 3(3)


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”.

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Source: https://www.legislation.gov.uk/ukdsi/2020/9780348214956/schedule/2/paragraph/4 (the official version)
Page: https://openlegislation.uk/draft-medical-devices-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.