{
  "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-5",
  "json_url": "https://openlegislation.uk/eu-regulation-2020-1207/article-5.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/5",
  "kind": "article",
  "number": "5",
  "heading": "Preliminary assessment of the suitability of a single-use device for reprocessing",
  "text": "1. Before deciding to start reprocessing a single-use device, or requesting an external reprocessor to do so, the health institution shall assess if the single-use device is suitable for reprocessing.\n2. For the purposes of paragraph 1, the health institution shall analyse whether the safety and performance of the single-use device once reprocessed will be equivalent to the original single-use device.\n3. When assessing the suitability of a single-use device for reprocessing the health institution, where applicable, shall:\n(a) verify that the single-use device is CE marked;\n(b) verify that the single-use device has not been withdrawn from the market and its certificate of conformity has not been suspended, withdrawn or subject to restrictions;\n(c) verify if the use of the single-use device has been subject to restrictions for safety reasons as indicated in the field safety notices;\n(d) conduct an analysis of the properties of the single-use device, taking into account all available documentation and information on the single-use device to ensure sufficient understanding and know-how on design, constructional properties, material characteristics, functional properties, and other risks factors related to the reprocessing of the single-use device, including its previous use.\nWhere applicable, when carrying out an assessment in accordance with the first subparagraph, the health institution shall consult an external reprocessor and rely on its operational support in accordance with the contract referred to in Article 3.\nFor the purpose of points (b) and (c), the health institution shall verify the information in the European Database on Medical Devices (EUDAMED). Until EUDAMED is fully functional, the health institution shall verify the information in accordance with the provisions on exchange of information referred to in Article 123(3)(d) of Regulation (EU) 2017/745.\nWhere the information cannot be obtained in accordance with the third subparagraph, the health institution shall verify the information on the website of the manufacturer or of its authorised representative.\nFor the purpose of point (d), the health institution shall review the information referred to in point (p) of Section 23.4 of Chapter III of Annex I to Regulation (EU) 2017/745 and all other relevant documentation and information in the public domain.\n4. The decision of the health institution concerning the suitability of a single-use device for reprocessing shall be based on a written positive opinion provided by the person responsible for reprocessing. Single-use device shall not be reprocessed if the person responsible for reprocessing has provided a negative opinion on the suitability of the single-use device for reprocessing.",
  "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/5",
    "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."
}