{
  "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-3",
  "json_url": "https://openlegislation.uk/eu-regulation-2020-1207/article-3.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/3",
  "kind": "article",
  "number": "3",
  "heading": "Contracting external reprocessors",
  "text": "1. If reprocessing is carried out by an external reprocessor, the health institution and the external reprocessor shall conclude a written contract.\n2. The contract shall include the following elements:\n(a) the attribution of tasks, obligations, and responsibilities of the two parties;\n(b) the arrangements for transition from one external reprocessor to another and responsibilities of the external reprocessor that is a party to the contract;\n(c) the requirements related to the qualification and expertise of the personnel participating in the reprocessing activities;\n(d) the requirements for the reprocessing, collection of information related to the reprocessed devices and information exchange between the health institution and the external reprocessor;\n(e) the requirement to ensure compatibility of the quality management systems (QMS) of the parties, as referred to in Article 21;\n(f) the procedure for monitoring of the quality of the reprocessing performed by the external reprocessor via on-site audit(s).",
  "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/3",
    "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."
}