{
  "url": "https://openlegislation.uk/medical-devices-amendment-regulations-2003/regulation-2",
  "json_url": "https://openlegislation.uk/medical-devices-amendment-regulations-2003/regulation-2.json",
  "legislation": "uksi/2003/1697",
  "legislation_title": "The Medical Devices (Amendment) Regulations 2003",
  "legislation_url": "https://openlegislation.uk/medical-devices-amendment-regulations-2003",
  "path": "regulation/2",
  "kind": "regulation",
  "number": "2",
  "heading": "Amendment of regulation 2 of the principal Regulations",
  "text": "In regulation 2(1) of the principal Regulations (interpretation)—\n(a) the words “, unless the context otherwise requires” are omitted;\n(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(c) after the definition of “Directive 2001/83”, there is inserted the following definitions—\n““Directive 2003/12” means Commission Directive 2003/12 of 3rd February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices;\n...”;\n(d) in the definition of “the Medical Devices Directives”, after “Directive 93/42” there is inserted “ , read with Directive 2003/32 ”;\n(e) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(f) in the definition of “notified body”, for “Part V of” there is substituted “ Part V or ”; and\n(g) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Reg. 2(b) revoked (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 21(a)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 2(c) revoked (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 21(a)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Reg. 2(e) revoked (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 21(a)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Reg. 2(g) revoked (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 21(a)"
    },
    {
      "type": "M",
      "label": "M1",
      "text": "OJ No. L 28, 4.2.2003, p.43."
    },
    {
      "type": "M",
      "label": "M2",
      "text": "OJ No. L 169, 12.7.1993, p.1; amended by Directive 98/79/EC (OJ No. L 331, 7.12.1998, p.1), Directive 2000/70/EC (OJ No. L 313, 13.12.2000, p.22) and Directive 2001/104/EC (OJ No. L 6, 10.1.2002, p.50)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2003/1697/regulation/2",
    "retrieved_at": "2026-10-29T06:16:48.278874+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."
}