{
  "url": "https://openlegislation.uk/eu-directive-1993-42/annex-I/division-II/division-13/division-13.3",
  "json_url": "https://openlegislation.uk/eu-directive-1993-42/annex-I/division-II/division-13/division-13.3.json",
  "legislation": "eudr/1993/42",
  "legislation_title": "Council Directive 93/42/EEC of 14 June 1993 concerning medical devices",
  "legislation_url": "https://openlegislation.uk/eu-directive-1993-42",
  "path": "annex/I/division/II/division/13/division/13.3",
  "kind": "division",
  "number": "13.3",
  "heading": null,
  "text": "The label must bear the following particulars:\n(a) the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community;\n(b) the details strictly necessary to identify the device and the contents of the packaging especially for the users;\n(c) where appropriate, the word ‘STERILE’;\n(d) where appropriate, the batch code, preceded by the word ‘LOT’, or the serial number;\n(e) where appropriate, an indication of the date by which the device should be used, in safety, expressed as the year and month;\n(f) where appropriate, an indication that the device is for single use. A manufacturer's indication of single use must be consistent across the Community;\n(g) if the device is costum-made, the words ‘custom-made device’;\n(h) if the device is intended for clinical investigations, the words ‘exclusively for clinical investigations’;\n(i) any special storage and/or handling conditions;\n(j) any special operating instructions;\n(k) any warnings and/or precautions to take;\n(l) year of manufacture for active devices other than those covered by (e). This indication may be included in the batch or serial number;\n(m) where applicable, method of sterilization;\n(n) in 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": "Substituted by Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma."
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Inserted by Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/1993/42/annex/I/division/II/division/13/division/13.3",
    "retrieved_at": "2026-11-01T15:23:18.816106+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."
}