{
  "url": "https://openlegislation.uk/eu-regulation-2013-920/article-5",
  "json_url": "https://openlegislation.uk/eu-regulation-2013-920/article-5.json",
  "legislation": "eur/2013/920",
  "legislation_title": "Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2013-920",
  "path": "article/5",
  "kind": "article",
  "number": "5",
  "heading": "Surveillance and monitoring",
  "text": "1. For the purpose of surveillance, the Secretary of State shall assess an appropriate number of approved body’s reviews of the manufacturer’s clinical evaluations and shall carry out an appropriate number of file reviews, surveillance on-site assessments and observed audits at the following intervals:\n(a) at least every 12 months for approved bodies with more than 100 clients;\n(b) at least every 18 months for all other approved bodies.\nThat designating authority shall, in particular, examine changes which have occurred since the last assessment and the work the approved body has performed since that assessment.\nBy way of derogation from the first and second subparagraphs, in exceptional circumstances relating to the COVID-19 pandemic that temporarily prevent the designating authority of a Member State from carrying out surveillance on-site assessments or observed audits, it shall carry out any measures to ensure an adequate level of surveillance that remain possible under those circumstances in addition to the assessment of an appropriate number of the approved body’s reviews of the manufacturer’s technical documentation, including clinical evaluations. The Secretary of State shall examine changes to the organisational and general requirements set out in Annex II that have occurred since the last on-site assessment and the activities the approved body has performed thereafter.\n2. Surveillance and monitoring conducted by the Secretary of State shall appropriately address subsidiaries.\n3. The Secretary of State shall continuously monitor that body to ensure ongoing compliance with the applicable requirements. The Secretary of State shall provide for a systematic follow-up of complaints, vigilance reports and other information, including from outside the United Kingdom, which might indicate the non-fulfilment of the obligations by an approved body or its deviation from common or best practice.\nIn addition to surveillance or renewal on-site assessments, the Secretary of State shall initiate unannounced or short-notice on-site assessments if those on-site assessments are needed to verify compliance.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Art. 5(1) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 26(a)(ii)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Word in Art. 5(1) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 26(a)(i)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Inserted by Commission Implementing Regulation (EU) 2020/666 of 18 May 2020 amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Words in Art. 5(1) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 26(a)(iii)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Words in Art. 5(2) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 26(b)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Words in Art. 5(3) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 26(c)(i)"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Words in Art. 5(3) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 26(c)(ii)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2013/920/article/5",
    "retrieved_at": "2026-11-01T14:48:24.338131+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."
}