{
  "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-6",
  "json_url": "https://openlegislation.uk/eu-regulation-2020-1207/article-6.json",
  "legislation": "eur/2020/1207",
  "legislation_title": "Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use devices (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2020-1207",
  "path": "article/6",
  "kind": "article",
  "number": "6",
  "heading": "Original intended purpose and monitoring of changes made by the manufacturer of the original single-use device",
  "text": "1. Reprocessors shall not change the original intended purpose of the single-use device as indicated in its instructions for use.\n2. Reprocessors shall establish a monitoring process to verify the following:\n(a) that the single-use device is not withdrawn from the market;\n(b) that the certificate of conformity of the single-use device has not been suspended, withdrawn or is not subject to restrictions;\n(c) the use of the single-use device is not subject to restrictions for safety reasons based on the information referred to in Article 5(3), (b) and (c);\nThe reprocessors shall also identify any change made by the manufacturer to components, materials, intended purpose or specifications of the single-use device that may have an impact on the reprocessing. Reprocessors shall assess the significance of these changes for the appropriateness of reprocessing. If a change has a detrimental effect on the reprocessed single-use device, reprocessing shall be discontinued or the reprocessing process shall be modified to adapt to the change made to the single-use device.",
  "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/eur/2020/1207/article/6",
    "retrieved_at": "2026-11-01T14:42:28.241115+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."
}