{
  "url": "https://openlegislation.uk/eu-directive-1993-42/annex-VII/division-3",
  "json_url": "https://openlegislation.uk/eu-directive-1993-42/annex-VII/division-3.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/VII/division/3",
  "kind": "division",
  "number": "3",
  "heading": null,
  "text": "The technical documentation must allow assessment of the conformity of the product with the requirements of the Directive. It must include in particular:\na general description of the product, including any variants planned and its intended use(s),\ndesign drawings, methods of manufacture envisaged and diagrams of components, sub-assemblies, circuits, etc.,\nthe descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operations of the product,\nthe results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive if the standards referred to in Article 5 have not been applied in full,\nin the case of products placed on the market in a sterile condition, description of the methods used and the validation report,\nthe results of the design calculations and of the inspections carried out, etc.; if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,\nthe solutions adopted as referred to in Annex I, Chapter I, Section 2,\nthe pre-clinical evaluation,\nthe clinical evaluation in accordance with Annex X,\nthe label and instructions for use.",
  "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)."
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Inserted 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/VII/division/3",
    "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."
}