{
  "url": "https://openlegislation.uk/eu-directive-1993-42/annex-VIII/division-3/division-3.1",
  "json_url": "https://openlegislation.uk/eu-directive-1993-42/annex-VIII/division-3/division-3.1.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/VIII/division/3/division/3.1",
  "kind": "division",
  "number": "3.1",
  "heading": null,
  "text": "For custom-made devices, documentation, indicating manufacturing site(s) and allowing an understanding of the design, manufacture and performances of the product, including the expected performances, so as to allow assessment of conformity with the requirements of this Directive.\nThe manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which are manufactured in accordance with the documentation mentioned in the first paragraph;",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "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)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/1993/42/annex/VIII/division/3/division/3.1",
    "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."
}