{
  "url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-5/paragraph-3",
  "json_url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-5/paragraph-3.json",
  "legislation": "uksi/1992/3146",
  "legislation_title": "The Active Implantable Medical Devices Regulations 1992",
  "legislation_url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992",
  "path": "schedule/5/paragraph/3",
  "kind": "paragraph",
  "number": "3",
  "heading": "Approval and evaluation of quality system",
  "text": "(1) Approval of a quality system shall not be given unless the conditions specified in subparagraphs (2) to (4) are fulfilled.\n(2) The application of the quality system must ensure that the devices conform to the provisions of the Directive which apply to them at every stage, from design to final controls.\n(3) All the elements, requirements and provisions adopted by the manufacturer for his quality system shall be documented in a systematic and orderly manner in the form of written policies and procedures, and the documentation must make possible a uniform interpretation of the policies and procedures as to quality such as those programmes, plans, manuals and records which relate to quality.\n(4) The documentation referred to in sub-paragraph (3) shall include in particular an adequate description of—\n(a) the manufacturer’s objectives as to quality;\n(b) the organisation of the business and in particular—\n(i) the organisational structure of the organisation and the responsibilities and degrees of authority of the managerial staff, where quality of design and manufacture of devices is concerned;\n(ii) the methods of monitoring the efficient operation of the quality system and in particular its ability to achieve the desired quality of the design and of the devices, including control of devices which do not conform to harmonised Standards;\n(c) the procedures for monitoring and verifying the design of the products and in particular—\n(i) the design specifications, including the standards which will be applied and a description of the solutions adopted to fulfil the relevant essential requirements when the relevant national Standards are not applied in full;\n(ii) the techniques of control and verification of the design, and the processes and systematic actions which will be used when the devices are being designed;\n(d) the techniques of control and of quality assurance at the manufacturing stage and in particular:\n(i) the processes and procedures which will be used, particularly as regards sterilization, purchasing and the relevant documents,\n(ii) product-identification procedures drawn up and kept up to date from drawings, specifications or other relevant documents at every stage of manufacture;\n(e) the appropriate tests and trials which will be effected before, during and after production, the frequency with which they will take place, and the equipment used for testing.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [
    {
      "type": "amended",
      "affecting": "uksi/1995/1671",
      "affecting_title": "The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995"
    },
    {
      "type": "amended",
      "affecting": "uksi/1995/1671",
      "affecting_title": "The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995"
    },
    {
      "type": "substituted",
      "affecting": "uksi/1995/1671",
      "affecting_title": "The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995"
    },
    {
      "type": "added",
      "affecting": "uksi/1995/1671",
      "affecting_title": "The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995"
    }
  ],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1992/3146/schedule/5/paragraph/3",
    "retrieved_at": "2026-10-29T14:09:16.889291+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."
}