{
  "url": "https://openlegislation.uk/eu-directive-1998-79/annex-VII/division-3/division-3.2",
  "json_url": "https://openlegislation.uk/eu-directive-1998-79/annex-VII/division-3/division-3.2.json",
  "legislation": "eudr/1998/79",
  "legislation_title": "Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices",
  "legislation_url": "https://openlegislation.uk/eu-directive-1998-79",
  "path": "annex/VII/division/3/division/3.2",
  "kind": "division",
  "number": "3.2",
  "heading": null,
  "text": "Application of the quality system must ensure that the devices 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 organisation of the business and in particular:\nthe organisational structures, the responsibilities of the managerial staff and their organisational authority where quality of manufacture of the devices 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 devices which fail to conform;\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 sterilisation,\nthe procedures in relation to purchasing,\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 to trace back the calibration.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/1998/79/annex/VII/division/3/division/3.2",
    "retrieved_at": "2026-11-01T15:23:06.143766+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."
}