{
  "url": "https://openlegislation.uk/medical-devices-regulations-1994/regulation-27",
  "json_url": "https://openlegislation.uk/medical-devices-regulations-1994/regulation-27.json",
  "legislation": "uksi/1994/3017",
  "legislation_title": "The Medical Devices Regulations 1994",
  "legislation_url": "https://openlegislation.uk/medical-devices-regulations-1994",
  "path": "regulation/27",
  "kind": "regulation",
  "number": "27",
  "heading": "Amendment of the Electro-medical Equipment (EEC Requirements) Regulations 1988",
  "text": "(1) The Electro-medical Equipment (EEC Requirements) Regulations 1988 shall be amended in accordance with the following provisions of this regulation.\n(2) In regulation 2 (interpretation)—\n(a) for the definition of “the Directive” there shall be substituted the following definition—\n““the Directive” means Council Directive 84/539/EEC on the approximation of the laws of the member States relating to electro-medical equipment used in veterinary medicine;”;\n(b) in the definition of “electro-medical equipment” the words “human or” shall be omitted.\n(3) For regulation 3 (marking) there shall be substituted the following regulation—\n“3 A person shall be guilty of an offence where he supplies electro-medical equipment—\n(a) which does not comply with the technical requirements contained in Annex I to the Directive; and\n(i) which is marked with the reversed epsilon, (or with a mark so closely resembling it as to be taken to be the reversed epsilon), or\n(ii) to which a declaration has been applied; or\n(b) which is also a medical device for the purposes of the Medical Devices Regulations 1994 and which does not satisfy the essential requirements for that device specified in those Regulations.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "S.I. 1988/1586."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "OJ No. L 300, 19.11.84, p. 179, as amended by Council Directive 93/42/EEC (OJ No. L 169, 12.7.93, p. 1)."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "S.I. 1994/3017."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1994/3017/regulation/27",
    "retrieved_at": "2026-10-29T13:22:16.279438+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."
}