{
  "url": "https://openlegislation.uk/eu-directive-1993-42/annex-II/division-3/division-3.2",
  "json_url": "https://openlegislation.uk/eu-directive-1993-42/annex-II/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/II/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 provisions of this Directive which apply to them at every stage, from design to final inspection. All 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 policies and procedures such as quality programmes, quality plans, quality manuals and quality records.\nIt shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).\nIt shall 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 quality of design and 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 design and of product, including control of products which fail to conform,\nwhere the design, manufacture and/or final inspection and testing of the products, or elements thereof, is 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 procedures for monitoring and verifying the design of the products, including the corresponding documentation, and in particular:\na general description of the product, including any variants planned, and its intended use(s),\nthe design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,\nthe techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,\nif the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,\na statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,\na statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC ,\nthe solutions adopted as referred to in Annex I, Chapter I, Section 2,\nthe pre-clinical evaluation,\nthe clinical evaluation referred to in Annex X,\nthe draft label and, where appropriate, instructions for use;\n(d) 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(e) the appropriate tests and trials which will 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 to trace back the calibration of the test equipment adequately.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "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)."
    },
    {
      "type": "F",
      "label": "F2",
      "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": "footnote",
      "label": "f1",
      "text": "Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin ( OJ L 105, 26.4.2003, p. 18 )."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/1993/42/annex/II/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."
}