{
  "url": "https://openlegislation.uk/eu-regulation-2012-722/annex-I/division-2",
  "json_url": "https://openlegislation.uk/eu-regulation-2012-722/annex-I/division-2.json",
  "legislation": "eur/2012/722",
  "legislation_title": "Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2012-722",
  "path": "annex/I/division/2",
  "kind": "division",
  "number": "2",
  "heading": "EVALUATION BY APPROVED BODIES",
  "text": "For the medical devices referred to in Article 1(1), manufacturers must provide to the approved bodies referred to in Article 4 all relevant information to allow evaluation of their risk analysis and risk management strategy in accordance with Article 5(2).",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Annex 1 Section 2 heading substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 15(c)(i)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in Annex 1 s. 2 substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 15(c)(ii)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2012/722/annex/I/division/2",
    "retrieved_at": "2026-11-01T14:49:16.665664+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."
}