{
  "url": "https://openlegislation.uk/eu-directive-1998-79/annex-VI/division-6/division-6.3",
  "json_url": "https://openlegislation.uk/eu-directive-1998-79/annex-VI/division-6/division-6.3.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/VI/division/6/division/6.3",
  "kind": "division",
  "number": "6.3",
  "heading": null,
  "text": "Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling scheme will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.",
  "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/VI/division/6/division/6.3",
    "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."
}