{
  "url": "https://openlegislation.uk/eu-directive-1993-42/annex-VIII/division-2/division-2.2",
  "json_url": "https://openlegislation.uk/eu-directive-1993-42/annex-VIII/division-2/division-2.2.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/2/division/2.2",
  "kind": "division",
  "number": "2.2",
  "heading": null,
  "text": "for devices intended for the clinical investigations covered by Annex X:\ndata allowing identification of the device in question,\nthe clinical investigation plan,\nthe investigator's brochure,\nthe confirmation of insurance of subjects,\nthe documents used to obtain informed consent,\na statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,\na statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,\nthe opinion of the ethics committee concerned and details of the aspects covered by its opinion,\nthe name of the medical practitioner or other authorized person and of the institution responsible for the investigations,\nthe place, starting date and scheduled duration for the investigations,\na statement that the device in question conforms to the essential requirements apart from the aspects covered by the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.",
  "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/VIII/division/2/division/2.2",
    "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."
}