{
  "url": "https://openlegislation.uk/eu-regulation-2012-207/article-8",
  "json_url": "https://openlegislation.uk/eu-regulation-2012-207/article-8.json",
  "legislation": "eur/2012/207",
  "legislation_title": "Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2012-207",
  "path": "article/8",
  "kind": "article",
  "number": "8",
  "heading": null,
  "text": "Except for medical devices of Class I, as defined in Annex IX to Directive 93/42, the fulfilment of the obligations laid down in Articles 4 to 7 of this Regulation must be reviewed by an approved body during the applicable conformity assessment procedure for the medical device in question, as set out in Part 2 or Part 3 of the Medical Devices Regulations 2002. The review must be based on a specific sampling method adapted to the class and the complexity of the product.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Art. 8 substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 7"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2012/207/article/8",
    "retrieved_at": "2026-11-01T14:49:32.337958+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."
}