{
  "url": "https://openlegislation.uk/eu-directive-1990-385/annex-6/division-2/division-2.1",
  "json_url": "https://openlegislation.uk/eu-directive-1990-385/annex-6/division-2/division-2.1.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/2.1",
  "kind": "division",
  "number": "2.1",
  "heading": null,
  "text": "For custom-made devices:\nthe name and address of the manufacturer,\nthe information necessary for the identification of the product in question,\na statement affirming that the device is intended for exclusive use by a particular patient, together with his name,\nthe name of the duly qualified medical practitioner who drew up the prescription and, if applicable, the name of the clinic concerned,\nthe specific characteristics of the product revealed by the prescription,\na statement affirming that the device complies with the essential requirements given in Annex 1 and, where applicable, indicating which essential requirements have not been wholly met, together with the grounds.",
  "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/2.1",
    "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."
}