{
  "url": "https://openlegislation.uk/eu-regulation-2012-722/annex-I/division-2/division-2.1",
  "json_url": "https://openlegislation.uk/eu-regulation-2012-722/annex-I/division-2/division-2.1.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/division/2.1",
  "kind": "division",
  "number": "2.1",
  "heading": "Information of the Approved Body regarding changes and new information",
  "text": "Any change in relation to processes of sourcing, collection, handling, processing and inactivation or elimination and any new information on TSE risk collected by the manufacturer and relevant for the medical device that could modify the result of the manufacturer’s risk assessment must be transmitted to the approved body and, where applicable, needs to be approved by the approved body prior to its implementation.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Annex 1 s. 2.1 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(d)(i)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in Annex 1 s. 2.1 substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 15(d)(ii)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2012/722/annex/I/division/2/division/2.1",
    "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."
}