{
  "url": "https://openlegislation.uk/draft-human-medicines-and-medical-devices-amendment-etc-eu-exit-regulations-2019/schedule-2/paragraph-9",
  "json_url": "https://openlegislation.uk/draft-human-medicines-and-medical-devices-amendment-etc-eu-exit-regulations-2019/schedule-2/paragraph-9.json",
  "legislation": "ukdsi/2019/9780111189092",
  "legislation_title": "The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019",
  "legislation_url": "https://openlegislation.uk/draft-human-medicines-and-medical-devices-amendment-etc-eu-exit-regulations-2019",
  "path": "schedule/2/paragraph/9",
  "kind": "paragraph",
  "number": "9",
  "heading": "Amendment of regulation 10 (insertion of Part VIII into the 2002 Regulations)",
  "text": "(1) Regulation 10 is amended as follows.\n(2) In inserted regulation 75 of the 2002 Regulations (common specifications)—\n(a) in paragraph (3), before “Manufacturers” insert “Subject to paragraph (7),”;\n(b) after paragraph (6), insert—\n“(7) Manufacturers of devices which fall within the groups of products listed in Schedule 16 must comply with the relevant CS for those products.”.\n(3) In inserted regulation 93 of the 2002 Regulations (registration of devices) after paragraph (3), insert—\n“(4) The manufacturer must keep the information provided in accordance with paragraph (1) updated.”.\n(4) In inserted regulation 119 of the 2002 Regulations (recording and reporting adverse events that occur during clinical investigations), in paragraph (6) before “This regulation” insert “Unless a causal relationship has been established between the serious adverse event and the preceding investigational procedure,”.\n(5) In inserted regulation 124 of the 2002 Regulations (periodic safety update report), in paragraph (5), for “paragraph 12(2)” substitute “paragraph 2”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2019/9780111189092/schedule/2/paragraph/9",
    "retrieved_at": "2026-10-30T14:59:28.001075+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."
}