{
  "url": "https://openlegislation.uk/eu-directive-1990-385/annex-1/division-II/division-8",
  "json_url": "https://openlegislation.uk/eu-directive-1990-385/annex-1/division-II/division-8.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/1/division/II/division/8",
  "kind": "division",
  "number": "8",
  "heading": null,
  "text": "Devices must be designed and manufactured in such a way as to remove or minimize as far as possible:\nthe risk of physical injury in connection with their physical, including dimensional, features,\nrisks connected with the use of energy sources with particular reference, where electricity is used, to insulation, leakage currents and overheating of the devices,\nrisks connected with reasonably foreseeable environmental conditions such as magnetic fields, external electrical influences, electrostatic discharge, pressure or variations in pressure and acceleration,\nrisks connected with medical treatment, in particular those resulting from the use of defibrillators or high-frequency surgical equipment,\nrisks connected with ionising radiation from radioactive substances included in the device, in compliance with the protection requirements laid down in Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation and Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure ,\nrisks which may arise where maintenance and calibration are impossible, including:\nexcessive increase of leakage currents,\nageing of the materials used,\nexcess heat generated by the device,\ndecreased accuracy of any measuring or control mechanism.",
  "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": "footnote",
      "label": "f1",
      "text": "OJ L 159, 29.6.1996, p. 1 ."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "OJ L 180, 9.7.1997, p. 22 ."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/1990/385/annex/1/division/II/division/8",
    "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."
}