{
  "url": "https://openlegislation.uk/eu-directive-2015-573/introduction",
  "json_url": "https://openlegislation.uk/eu-directive-2015-573/introduction.json",
  "legislation": "eudr/2015/573",
  "legislation_title": "Commission Delegated Directive (EU) 2015/573 of 30 January 2015 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in polyvinyl chloride sensors in in-vitro diagnostic medical devices (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2015-573",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Delegated Directive (EU) 2015/573\nof 30 January 2015\namending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in polyvinyl chloride sensors in in-vitro diagnostic medical devices\n(Text with EEA relevance)\nTHE EUROPEAN COMMISSION,\nHaving regard to the Treaty on the Functioning of the European Union,\nHaving regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment, and in particular Article 5(1)(a) thereof,\nWhereas:\n(1)\nDirective 2011/65/EU prohibits the use of lead in electrical and electronic equipment placed on the market.\n(2)\nBlood, body fluid and body gas analysers serve as a critical analytical instrument in many diagnostic and therapeutic procedures. Lead is required as a stabiliser in the processing of the PVC for the sensor cards. Although research of substitutes is ongoing, a suitable alternative is not yet available. The performance of tested alternatives both to lead in PVC and to PVC itself does not meet the specific technical requirements.\n(3)\nBoth the substitution of lead in PVC sensor cards for in-vitro diagnostic medical devices for blood, body fluid and body gas analysis and the elimination of lead via substitution of PVC in these applications are technically impracticable.\n(4)\nThe use of lead in PVC sensors for blood, body fluid and body gas analysis used in in-vitro diagnostic medical devices should therefore be exempted until 31 December 2018. In view of the innovation cycles for medical devices this is a short transition period which is unlikely to have adverse impacts on innovation.\n(5)\nDirective 2011/65/EU should therefore be amended accordingly,\nHAS ADOPTED THIS DIRECTIVE:",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ L 174, 1.7.2011, p. 88."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2015/573/introduction",
    "retrieved_at": "2026-11-01T15:21:39.808600+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."
}