{
  "url": "https://openlegislation.uk/eu-directive-1990-385/annex-6/division-2/division-2.2",
  "json_url": "https://openlegislation.uk/eu-directive-1990-385/annex-6/division-2/division-2.2.json",
  "legislation": "eudr/1990/385",
  "legislation_title": "Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC)",
  "legislation_url": "https://openlegislation.uk/eu-directive-1990-385",
  "path": "annex/6/division/2/division/2.2",
  "kind": "division",
  "number": "2.2",
  "heading": null,
  "text": "For devices intended for clinical investigations covered in Annex 7:\ndata allowing the devices in question to be identified,\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 10 of Annex 1,\nthe opinion of the ethics committee concerned and details of the aspects covered by its opinion,\nthe name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,\nthe place, date of commencement and duration scheduled for the investigations,\na statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of 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)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/1990/385/annex/6/division/2/division/2.2",
    "retrieved_at": "2026-11-01T15:23:27.423975+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."
}