{
  "url": "https://openlegislation.uk/eu-directive-1990-385/annex-1/division-II/division-14/division-14.2",
  "json_url": "https://openlegislation.uk/eu-directive-1990-385/annex-1/division-II/division-14/division-14.2.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/1/division/II/division/14/division/14.2",
  "kind": "division",
  "number": "14.2",
  "heading": null,
  "text": "On the sales packaging:\nthe name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,\na description of the device,\nthe purpose of the device,\nthe relevant characteristics for its use,\nif the device is intended for clinical investigations, the words: ‘exclusively for clinical investigations’,\nif the device is custom-made, the words: ‘custom-made device’,\na declaration that the implantable device is in a sterile condition,\nthe month and year of manufacture,\nan indication of the time limit for implanting a device safely,\nthe conditions for transporting and staring the device,\nin the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.",
  "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/1990/385/annex/1/division/II/division/14/division/14.2",
    "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."
}