{
  "url": "https://openlegislation.uk/eu-directive-1993-42/annex-IX/division-III/division-4/division-4.3",
  "json_url": "https://openlegislation.uk/eu-directive-1993-42/annex-IX/division-III/division-4/division-4.3.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/IX/division/III/division/4/division/4.3",
  "kind": "division",
  "number": "4.3",
  "heading": "Rule 15",
  "text": "All devices intended specifically to be used for disinfecting, cleaning, rinsing or, when appropriate, hydrating contact lenses are in Class IIb.\nAll devices intended specifically to be used for disinfecting medical devices are in Class IIa. Unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb.\nThis rule does not apply to products that are intended to clean medical devices other than contact lenses by means of physical action.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "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/1993/42/annex/IX/division/III/division/4/division/4.3",
    "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."
}