{
  "url": "https://openlegislation.uk/human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-2",
  "json_url": "https://openlegislation.uk/human-tissue-quality-and-safety-for-human-application-regulations-2007/regulation-2.json",
  "legislation": "uksi/2007/1523",
  "legislation_title": "The Human Tissue (Quality and Safety for Human Application) Regulations 2007",
  "legislation_url": "https://openlegislation.uk/human-tissue-quality-and-safety-for-human-application-regulations-2007",
  "path": "regulation/2",
  "kind": "regulation",
  "number": "2",
  "heading": "Extent and application",
  "text": "(1) These Regulations extend to England and Wales and Northern Ireland.\n(2) Parts 1 to 5 and 7 of, and the Schedules to, these Regulations also extend to Scotland.\n(3) These Regulations shall not apply in relation to the processing, preservation, storage, distribution, import from third countries and export from the United Kingdom of tissue or cells for use in manufactured products, including medical devices, to the extent that such activities are regulated by—\n(a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(b) the Human Medicines Regulations 2012;\n(c) the Medical Devices Regulations 2002, ...\n(d) the Medicines for Human Use (Clinical Trials) Regulations 2004 , ...\n(e) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC , or\n(f) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.\n(4) Paragraph (3) does not limit the application of the amendments made by Part 6 of these Regulations.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 2(3) substituted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (S.I. 2018/335), regs. 1(2)(3), 2(1)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 2(3) substituted (31.12.2020) by The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/481), regs. 1, 3(1A) (as inserted by S.I. 2020/1306, regs. 1, 3); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Reg. 2(3)(a) omitted (14.8.2012) by virtue of The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 92(a) (with Sch. 32)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Reg. 2(3)(b) substituted (14.8.2012) by The Human Medicines Regulations 2012 (S.I. 2012/1916), reg. 1(2), Sch. 34 para. 92(b) (with Sch. 32)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Word in reg. 2(3)(c) omitted (27.7.2021) by virtue of The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 39(a)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Reg. 2(3)(e) and word inserted (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 39(b)"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Word in reg. 2(3)(d) omitted (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 21(a)"
    },
    {
      "type": "F",
      "label": "F8",
      "text": "Reg. 2(3)(f) and word inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 21(b)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2007/1523/regulation/2",
    "retrieved_at": "2026-10-29T03:52:01.998683+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."
}