{
  "url": "https://openlegislation.uk/draft-medical-devices-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-4",
  "json_url": "https://openlegislation.uk/draft-medical-devices-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-4.json",
  "legislation": "ukdsi/2020/9780348214956",
  "legislation_title": "The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020",
  "legislation_url": "https://openlegislation.uk/draft-medical-devices-amendment-etc-eu-exit-regulations-2020",
  "path": "schedule/2/paragraph/4",
  "kind": "paragraph",
  "number": "4",
  "heading": "Amendment of regulation 3(3)",
  "text": "In regulation 3(3)—\n(a) after sub-paragraph (a) insert—\n“(aa) after the definition of “active implantable medical device” insert—\n““approved body” is to be construed in accordance with regulation A45;”;”;\n(b) for sub-paragraph (c) substitute—\n“(c) omit the definition of “authorised representative”;”;\n(c) after sub-paragraph (d) insert—\n“(da) omit the definition of “the Community”;”;\n(d) in sub-paragraph (e) for “exit day” substitute “IP completion day”;\n(e) in sub-paragraph (f) for “exit day” substitute “IP completion day”;\n(f) in sub-paragraph (g) for “exit day” substitute “IP completion day”;\n(g) after paragraph (j) insert—\n(h) “(ja) omit the definition of “European Economic Area”;”;\n(i) in sub-paragraph (l), for “the United Kingdom” substitute “Great Britain”;\n(j) for sub-paragraph (q) substitute—\n“(q) omit the definition of “notified body”;”;\n(k) in sub-paragraph (r)(i) for “United Kingdom” substitute “Great Britain”;\n(l) in sub-paragraph (s) for “for “Community” substitute “United Kingdom”” substitute “for “the Community” substitute “Great Britain””;\n(m) after sub-paragraph (u) insert—\n“(ua) after the definition of “third country conformity assessment body” insert—\n““UK marking” has the meaning given in Article 2(22) of Regulation (EC) No 765/2008;”;”;\n(n) for sub-paragraph (v) substitute—\n“(v) omit the definition of “UK notified body”;”;\n(o) in sub-paragraph (w) in the definition of “UK responsible person” inserted by sub-paragraph (w), after “established in” insert “any part of”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Article 2(22) was inserted into Regulation (EC) No 765/2008 by paragraph 3 of Schedule 33 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696). This Regulation was incorporated into domestic law by section 3 of the European Union Withdrawal Act 2018 c. 16."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2020/9780348214956/schedule/2/paragraph/4",
    "retrieved_at": "2026-10-30T14:48:13.546182+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}