{
  "url": "https://openlegislation.uk/eu-directive-1993-42/annex-V/division-3/division-3.2",
  "json_url": "https://openlegislation.uk/eu-directive-1993-42/annex-V/division-3/division-3.2.json",
  "legislation": "eudr/1993/42",
  "legislation_title": "Council Directive 93/42/EEC of 14 June 1993 concerning medical devices",
  "legislation_url": "https://openlegislation.uk/eu-directive-1993-42",
  "path": "annex/V/division/3/division/3.2",
  "kind": "division",
  "number": "3.2",
  "heading": null,
  "text": "Application of the quality system must ensure that the products conform to the type described in the EC type-examination certificate.\nAll the elements, requirements and provisions adopted by the manufacturer for his quality system must be documented in a systematic and orderly manner in the form of written policy statements and procedures. This quality system documentation must permit uniform interpretation of the quality policy and procedures such as quality programmes, plans, manuals and records.\nIt must include in particular an adequate description of:\n(a) the manufacturer's quality objectives;\n(b) the organization of the business and in particular:\nthe organizational structures, the responsibilities of the managerial staff and their organizational authority where manufacture of the products is concerned,\nthe methods of monitoring the efficient operation of the quality system and in particular its ability to achieve the desired quality of product, including control of products which fail to conform,\nwhere the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;\n(c) the inspection and quality assurance techniques at the manufacturing stage and in particular:\nthe processes and procedures which will be used, particularly as regards sterilization, purchasing and the relevant documents,\nthe product identification procedures drawn up and kept up to date from drawings, specifications or other relevant documents at every stage of manufacture;\n(d) the appropriate tests and trials to be carried out before, during and after manufacture, the frequency with which they will take place, and the test equipment used; it must be possible adequately to trace back the calibration of the test equipment.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Substituted by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Inserted by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/1993/42/annex/V/division/3/division/3.2",
    "retrieved_at": "2026-11-01T15:23:18.816106+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."
}