{
  "url": "https://openlegislation.uk/medical-devices-northern-ireland-protocol-regulations-2021/regulation-3",
  "json_url": "https://openlegislation.uk/medical-devices-northern-ireland-protocol-regulations-2021/regulation-3.json",
  "legislation": "uksi/2021/905",
  "legislation_title": "The Medical Devices (Northern Ireland Protocol) Regulations 2021",
  "legislation_url": "https://openlegislation.uk/medical-devices-northern-ireland-protocol-regulations-2021",
  "path": "regulation/3",
  "kind": "regulation",
  "number": "3",
  "heading": "Interpretation",
  "text": "(1) In these Regulations—\n“Regulation (EU) 2017/745” means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5th 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;\n“Regulation (EU) 2017/746” means 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“ethics committee” means a research ethics committee recognised or established by, or on behalf of, the Scottish Ministers, the Welsh Ministers, the Department of Health in Northern Ireland or the Health Research Authority.\n“Institute” means the charitable organisation with registered number 803725 and known as the Chartered Institute of Arbitrators;\n“UK(NI) indication” means the marking in the form set out in Schedule 1 to the Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020.\n(2) Unless otherwise defined in these Regulations—\n(a) terms used in Parts 2 and 3 have the same meaning as in Regulation (EU) 2017/745;\n(b) terms used in Parts 2A and 3A have the same meaning as in Regulation (EU) 2017/746.\n(3) In these Regulations, a reference to an Article or an Annex is—\n(a) in Parts 2 and 3, a reference to an Article or an Annex of Regulation (EU) 2017/745;\n(b) in Parts 2A and 3A, a reference to an Article or an Annex of Regulation (EU) 2017/746.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 3(1) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 29(a)(i)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 3(1) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 29(a)(ii)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Reg. 3(2) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 29(b)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Reg. 3(3) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 29(c)"
    },
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 3 in force at 27.7.2021, see reg. 1(2)"
    },
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ No. L 117, 05.05.2017, p. 1., amended by Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020, OJ No. L 130, 24.04.2020, p.18."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "The Health Research Authority is established by section 109 of the Care Act 2014 (c.23)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2021/905/regulation/3",
    "retrieved_at": "2026-10-28T22:10:11.075057+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."
}