{
  "url": "https://openlegislation.uk/eu-directive-1998-79/annex-IV/division-3/division-3.2",
  "json_url": "https://openlegislation.uk/eu-directive-1998-79/annex-IV/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/IV/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 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 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 design and 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 design and of product, including control of devices which fail to conform;\n(c) the procedures for monitoring and verifying the design of the devices and in particular:\na general description of the device, including any variants planned,\nall documentation referred to in Annex III, section 3, indents 3 to 13,\nin the case of devices for self-testing, the information referred to in Annex III, section 6.1,\nthe techniques used to control and verify the design and the processes and systematic measures which will be used when the devices are being designed;\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 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(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.\nThe manufacturer shall carry out the required controls and tests according to the latest state of the art. The controls and tests shall cover the manufacturing process including the characterisation of the raw material and the individual devices or each batch of devices manufactured.\nIn testing the devices covered by Annex II, List A, the manufacturer shall take into account the most recent available information, in particular as regards the biological complexity and variability of the specimens to be tested with the in vitro device concerned.",
  "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/IV/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."
}