{
  "url": "https://openlegislation.uk/medical-devices-regulations-1994/regulation-5",
  "json_url": "https://openlegislation.uk/medical-devices-regulations-1994/regulation-5.json",
  "legislation": "uksi/1994/3017",
  "legislation_title": "The Medical Devices Regulations 1994",
  "legislation_url": "https://openlegislation.uk/medical-devices-regulations-1994",
  "path": "regulation/5",
  "kind": "regulation",
  "number": "5",
  "heading": "Essential requirements for devices",
  "text": "(1) Subject to paragraph (2), all devices placed on the market or put into service must comply with the relevant essential requirements.\n(2) The devices mentioned in regulation 3(3) which are placed on the market or put into service must comply with such of the relevant essential requirements as relate to safety or performance.\n(3) In determining which are the relevant essential requirements for a device and whether or not the device complies with any of the relevant essential requirements account shall be taken of its intended purpose.\n(4) Where confirmation of conformity with the essential requirements must be based on clinical data, such data must be established in accordance with the requirements set out in Annex X.\n(5) In the case of a device which has been put into service—\n(a) the essential requirements specified in Sections 8.7 and 13 of Annex I with regard to information on the packaging and on any label are complied with only if such information is in English (whether or not it is also in another language and whether or not the device is for professional use); and\n(b) the essential requirements specified in Sections 11.4 and 13 of Annex I with regard to instructions for use are complied with only if such instructions are in English or another Community language.\n(6) Where the instructions for use referred to in paragraph (5)(b) are not in English, any packaging, label or promotional literature must carry a clear statement in English stating the language in which the instructions are given.\n(7) A device shall be treated as complying with an essential requirement if it conforms as respects that requirement to a relevant national Standard unless there are reasonable grounds for suspecting that the device does not comply with that requirement.\n(8) A device which is neither custom-made nor intended for clinical investigation and which bears the CE marking shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.\n(9) A custom-made device in respect of which the conditions specified in Annex VIII are satisfied, and in the case of a Class IIa, Class IIb and Class III device, which is accompanied by the statement required by Section 1 of Annex VIII, shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.\n(10) A device intended for clinical investigation in respect of which—\n(a) notice has been given under regulation 16(1);\n(b) the conditions specified in Annex VIII are satisfied; and\n(c) either—\n(i) no notice has been given under regulation 16(2) within the period of 60 days there referred to, or\n(ii) notice has been given under regulation 16(3),\nshall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1994/3017/regulation/5",
    "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."
}