{
  "url": "https://openlegislation.uk/medical-devices-amendment-regulations-2012/regulation-2",
  "json_url": "https://openlegislation.uk/medical-devices-amendment-regulations-2012/regulation-2.json",
  "legislation": "uksi/2012/1426",
  "legislation_title": "The Medical Devices (Amendment) Regulations 2012",
  "legislation_url": "https://openlegislation.uk/medical-devices-amendment-regulations-2012",
  "path": "regulation/2",
  "kind": "regulation",
  "number": "2",
  "heading": "Amendment of the Medical Devices Regulations 2002",
  "text": "Regulation 2 (interpretation) of the Medical Devices Regulations 2002 is amended as follows:\n(a) in paragraph (1),\n(i) for the definition of “Directive 90/385”, substitute—\n““Directive 90/385” means Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of Member States relating to active implantable devices .”.\n(ii) For the definition of “Directive 93/42”, substitute—\n““Directive 93/42” means Council Directive 93/42/EEC of 14 June 1993 concerning medical devices .”.\n(iii) For the definition of “Directive 98/79”, substitute—\n““Directive 98/79” means Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in-vitro diagnostic medical devices .”.\n(b) after paragraph (1), insert—\n“(1A) In these Regulations, any reference to Annexes 1 to 7 to Directive 90/385, Annexes I to X to Directive 93/42 or Annex I to X to Directive 98/79 is to be construed as a reference to those Annexes as amended from time to time.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "M",
      "label": "M1",
      "text": "Directive 90/385/EEC as amended by Council Directive 93/43/EEC (OJ No.L.169, 12/7/1993, p.1), Council Directive 93/68/EEC (OJ No.L.220, 30.8.1993, p.1), Regulation (EC) No.1882/2003 (OJ No. L284, 31.10.2003, p.1) and Directive 2007/47/EC (OJ No. 1.247, 21.9.2007, p.21)."
    },
    {
      "type": "M",
      "label": "M2",
      "text": "Directive 93/42/EEC was 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), Directive 2001/104/EU (OJ No. L.6, 10.1.2002, p.50) and Directive 2007/47/EC (OJ No. L.247, 21.9.2007, p.21)."
    },
    {
      "type": "M",
      "label": "M3",
      "text": "Directive 98/79/EC was amended by Regulation (EC) No 1882/2003 (OJ No. L.284, 31.10.2003, p.1), Regulation (EC) No. 596/2009 (OJ No. L.188, 18.7.2009, p.14) and Directive 2011/100 (OJ No. L.341, 22.12.2011, p.50) and was corrected by Corrigendum (OJ No. L.22, 29.1.1999, p.75) and Corrigendum (OJ No. L.6, 10.1.2002, p.70)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1426/regulation/2",
    "retrieved_at": "2026-10-29T01:30:01.339222+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."
}