{
  "url": "https://openlegislation.uk/eu-regulation-2020-1207",
  "json_url": "https://openlegislation.uk/eu-regulation-2020-1207.json",
  "id": "eur/2020/1207",
  "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)",
  "short_title": "Regulation (EU) 2020/1207 laying down rules for the application of Regulation (EU) 2017/745 of the European…",
  "long_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)",
  "citation": "EU Regulation 2020/1207",
  "type": "eur",
  "year": "2020",
  "number": "1207",
  "version": "current",
  "date": "2020-08-19",
  "revised": false,
  "valid_from": null,
  "extent": "E+W+S+N.I.",
  "unapplied_effects": 0,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/eu-regulation-2020-1207/introduction",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "chapter/I",
      "kind": "chapter",
      "number": "I",
      "heading": "SUBJECT MATTER AND DEFINITIONS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/1",
      "kind": "article",
      "number": "1",
      "heading": "Subject matter",
      "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/I"
    },
    {
      "path": "article/2",
      "kind": "article",
      "number": "2",
      "heading": "Definitions",
      "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/I"
    },
    {
      "path": "chapter/II",
      "kind": "chapter",
      "number": "II",
      "heading": "ORGANISATION OF REPROCESSING AND RISK MANAGEMENT",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/3",
      "kind": "article",
      "number": "3",
      "heading": "Contracting external reprocessors",
      "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/4",
      "kind": "article",
      "number": "4",
      "heading": "Staff, premises and equipment",
      "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/5",
      "kind": "article",
      "number": "5",
      "heading": "Preliminary assessment of the suitability of a single-use device for reprocessing",
      "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "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",
      "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/7",
      "kind": "article",
      "number": "7",
      "heading": "Determination of reprocessing cycle",
      "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/8",
      "kind": "article",
      "number": "8",
      "heading": "Maximum number of reprocessing cycles",
      "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/9",
      "kind": "article",
      "number": "9",
      "heading": "Technical documentation",
      "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-9",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "chapter/III",
      "kind": "chapter",
      "number": "III",
      "heading": "PROCEDURES AND STEPS OF THE REPROCESSING CYCLE",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/10",
      "kind": "article",
      "number": "10",
      "heading": "Establishment of procedures",
      "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-10",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/11",
      "kind": "article",
      "number": "11",
      "heading": "Steps of the reprocessing cycle",
      "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-11",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/12",
      "kind": "article",
      "number": "12",
      "heading": "Pre-treatment at the point of use and transportation",
      "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-12",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/13",
      "kind": "article",
      "number": "13",
      "heading": "Preparation before cleaning",
      "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-13",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/14",
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      "heading": "Cleaning",
      "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-14",
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      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/15",
      "kind": "article",
      "number": "15",
      "heading": "Thermal disinfection",
      "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-15",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/16",
      "kind": "article",
      "number": "16",
      "heading": "Chemical disinfection",
      "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-16",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/17",
      "kind": "article",
      "number": "17",
      "heading": "Drying",
      "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-17",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/18",
      "kind": "article",
      "number": "18",
      "heading": "Inspection, maintenance, repair and functionality testing",
      "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-18",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/19",
      "kind": "article",
      "number": "19",
      "heading": "Packaging",
      "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-19",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/20",
      "kind": "article",
      "number": "20",
      "heading": "Labelling and provision of instructions for use",
      "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-20",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "chapter/IV",
      "kind": "chapter",
      "number": "IV",
      "heading": "QUALITY MANAGEMENT SYSTEM, ANNUAL AUDIT AND REPORTING OF INCIDENTS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/21",
      "kind": "article",
      "number": "21",
      "heading": "Quality management system",
      "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-21",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "article/22",
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      "number": "22",
      "heading": "Annual audit",
      "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-22",
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      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "article/23",
      "kind": "article",
      "number": "23",
      "heading": "Reporting of incidents",
      "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-23",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "chapter/V",
      "kind": "chapter",
      "number": "V",
      "heading": "TRACEABILITY OF SINGLE-USE DEVICE AND FINAL PROVISIONS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/24",
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      "number": "24",
      "heading": "Tracking of reprocessing cycles",
      "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-24",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/V"
    },
    {
      "path": "article/25",
      "kind": "article",
      "number": "25",
      "heading": "Records",
      "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-25",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/V"
    },
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      "path": "article/26",
      "kind": "article",
      "number": "26",
      "heading": "Entry into force and application",
      "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-26",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/V"
    },
    {
      "path": "signature",
      "kind": "signature",
      "number": null,
      "heading": "Signature",
      "url": "https://openlegislation.uk/eu-regulation-2020-1207/signature",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    }
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