{
  "url": "https://openlegislation.uk/eu-regulation-2020-1207/article-21",
  "json_url": "https://openlegislation.uk/eu-regulation-2020-1207/article-21.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/21",
  "kind": "article",
  "number": "21",
  "heading": "Quality management system",
  "text": "1. Reprocessors shall establish, document, implement, and maintain a QMS for the reprocessing activities.\n2. The QMS shall ensure that requirements set out in this Regulation and requirements applicable to reprocessing set out in Regulation (EU) 2017/745 are complied with.\n3. The QMS shall cover the organisation of all steps of reprocessing and shall address at least the following aspects:\n(a) strategy for regulatory compliance;\n(b) procedures for each step of the reprocessing cycle;\n(c) description of the responsibilities, of the personnel involved in reprocessing (tasks, qualification, training and continuous training), and description of the premises;\n(d) establishment and maintenance of the technical documentation referred to in Article 9;\n(e) control of documents and communications concerning the reprocessing activities;\n(f) control of records concerning the reprocessing activities;\n(g) reporting of incidents and management of corrective and preventive actions and verification of their effectiveness;\n(h) risk management;\n(i) traceability system, including procedures for disposing or returning to the external reprocessor reprocessed single-use devices that do not belong to the health institution;\n(j) internal and external audits;\n(k) contract conditions with external entities participating in the reprocessing activities.",
  "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/21",
    "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."
}