{
  "url": "https://openlegislation.uk/eu-directive-1993-42/annex-IV/division-4",
  "json_url": "https://openlegislation.uk/eu-directive-1993-42/annex-IV/division-4.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/IV/division/4",
  "kind": "division",
  "number": "4",
  "heading": null,
  "text": "The notified body must carry out the appropriate examinations and tests in order to verify the conformity of the product with the requirements of the Directive either by examining and testing every product as specified in Section 5 or by examining and testing products on a statistical basis as specified in Section 6, as the manufacturer decides.\nThe aforementioned checks do not apply to those aspects of the manufacturing process designed to secure sterility.",
  "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/1993/42/annex/IV/division/4",
    "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."
}