{
  "url": "https://openlegislation.uk/medical-devices-amendment-regulations-2013/regulation-2",
  "json_url": "https://openlegislation.uk/medical-devices-amendment-regulations-2013/regulation-2.json",
  "legislation": "uksi/2013/2327",
  "legislation_title": "The Medical Devices (Amendment) Regulations 2013",
  "legislation_url": "https://openlegislation.uk/medical-devices-amendment-regulations-2013",
  "path": "regulation/2",
  "kind": "regulation",
  "number": "2",
  "heading": "Amendment of regulation 2 of the 2002 Regulations",
  "text": "(1) Regulation 2 of the 2002 Regulations (interpretation) is amended as follows.\n(2) In paragraph (1) omit the following definitions—\n(a) “animal”;\n(b) “Directive 2003/32”;\n(c) “EEA State”;\n(d) “non-viable”; and\n(e) “tissue”.\n(3) In paragraph (1) for the definition of “European Economic Area” substitute—\n““European Economic Area” means the European Economic Area created by the EEA Agreement;”.\n(4) In paragraph (1) in the definition of “the Medical Devices Directives” for “read with Directive 2003/32” substitute “both read with Regulation (EU) No 207/2012 and Regulation (EU) No 722/2012”.\n(5) In paragraph (1) after the definition of “putting into service” insert the following definitions—\n““Regulation (EU) No 207/2012” means Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices;\n“Regulation (EU) No 722/2012” means Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin;”.\n(6) After paragraph (1A) insert the following paragraph—\n“(1B) In these Regulations, any reference to Annex 1 to Directive 90/385 or to Annex I to Directive 93/42 is to that Annex read with Regulation (EU) No 207/2012.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ No L 72, 10.3.2012, p.28."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "OJ No L 212, 9.8.2012, p.3."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2013/2327/regulation/2",
    "retrieved_at": "2026-10-29T00:41:18.815669+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."
}