{
  "url": "https://openlegislation.uk/eu-directive-1990-385/annex-2/division-3/division-3.1",
  "json_url": "https://openlegislation.uk/eu-directive-1990-385/annex-2/division-3/division-3.1.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/2/division/3/division/3.1",
  "kind": "division",
  "number": "3.1",
  "heading": null,
  "text": "The manufacturer shall make an application for evaluation of his quality system to a notified body.\nThe application shall include:\nall the appropriate items of information for the category of products manufacture of which is envisaged,\nthe quality-system documentation,\nan undertaking to fulfil the obligations arising from the quality system as approved,\nan undertaking to maintain the approved quality system in such a way that it remains adequate and efficacious,\nan undertaking by the manufacturer to institute and keep updated a post-marketing surveillance system including the provisions referred to in Annex 7. The undertaking shall include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:\n(i) any deterioration in the characteristics or performances, and any inaccuracies in the instruction leaflet for a device which might lead to or have led to the death of a patient or a deterioration in his state of health;\n(ii) any technical or medical reason resulting in withdrawal of a device from the market by the manufacturer.",
  "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/2/division/3/division/3.1",
    "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."
}