{
  "url": "https://openlegislation.uk/draft-medical-devices-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-14",
  "json_url": "https://openlegislation.uk/draft-medical-devices-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-14.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/14",
  "kind": "paragraph",
  "number": "14",
  "heading": "Insertion of regulation 4(6A)",
  "text": "After regulation 4(6) insert—\n“(6A) In regulation 10 (CE marking of general medical devices)—\n(a) in the heading for “CE Marking” substitute “UK marking”;\n(b) in paragraph (1)—\n(i) in the opening words for “CE marking” substitute “UK marking”;\n(ii) in sub-paragraph (a) for “Annex XII” substitute “Annex 2 of Regulation (EC) No 765/2008 ” ;\n(iii) in sub-paragraph (c) for “notified body” substitute “approved body”;\n(c) in paragraph (2)—\n(i) in the opening words for “CE marking” substitute “UK marking”;\n(ii) in sub-paragraph (a) for “Annex XII” substitute “Annex 2 of Regulation (EC) No 765/2008”;\n(iii) in sub-paragraph (c) for “notified body” substitute “approved body”;\n(d) in paragraph (3)—\n(i) in the words before sub-paragraph (a), for “a CE marking, meeting the requirements set out in Annex XII” substitute “a UK marking meeting the requirements of Annex 2 of Regulation (EC) No 765/2008”;\n(ii) in the words following sub-paragraph (b)—\n(aa) for “CE marking” substitute “UK marking”;\n(bb) for “notified body” substitute “approved body”;\n(e) in paragraph (4)—\n(i) in the words before sub-paragraph (a), for “a CE marking, meeting the requirements set out in Annex XII” substitute “a UK marking meeting the requirements of Annex 2 of Regulation (EC) No 765/2008”;\n(ii) in the words following sub-paragraph (b)—\n(aa) for “CE marking” substitute “UK marking”;\n(bb) for “notified body” substitute “approved body”;\n(f) in paragraph (5) in the words after sub-paragraph (c), for both references to “CE marking” substitute “UK marking”.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Annex 2 was inserted by paragraph 39 of Schedule 33 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 S.I. 2019/696."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2020/9780348214956/schedule/2/paragraph/14",
    "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."
}