{
  "url": "https://openlegislation.uk/eu-directive-1990-385/annex-1/division-II/division-14/division-14.1",
  "json_url": "https://openlegislation.uk/eu-directive-1990-385/annex-1/division-II/division-14/division-14.1.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/1/division/II/division/14/division/14.1",
  "kind": "division",
  "number": "14.1",
  "heading": null,
  "text": "On the sterile pack:\nthe method of sterilization,\nan indication permitting this packaging to be recognized as such,\nthe name and address of the manufacturer,\na description of the device,\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.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/1990/385/annex/1/division/II/division/14/division/14.1",
    "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."
}