{
  "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-22",
  "json_url": "https://openlegislation.uk/eu-regulation-2020-1207/article-22.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/22",
  "kind": "article",
  "number": "22",
  "heading": "Annual audit",
  "text": "1. Reprocessors shall undertake at least one annual independent external audit of the reprocessing activities. The audit report shall be made available to the notified body competent for the certification of the reprocessor pursuant to Article 17(5) of Regulation (EU) 2017/745 and, upon request, to the competent authority of the Member State where the reprocessor is established.\n2. The reprocessing processes and the QMS shall be revised, as needed, on the basis of the results of the independent external audit.\n3. The audit report and the documentation related to the eventual follow up actions shall be kept for a period of five years.",
  "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/22",
    "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."
}