{
  "url": "https://openlegislation.uk/eu-regulation-2012-722/annex-I/division-2/division-2.2",
  "json_url": "https://openlegislation.uk/eu-regulation-2012-722/annex-I/division-2/division-2.2.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/division/2.2",
  "kind": "division",
  "number": "2.2",
  "heading": "Renewal of certificates",
  "text": "In the context of its decision regarding the extension for a further period of maximum five years of a design-examination certificate or a type-examination certificate in accordance with regulation 18(3) or regulation 31(3) of the Medical Devices Regulations 2002, respectively, the approved body shall review for the purpose of this Regulation at least the following aspects:\n(a)updated justification for the use of animal tissue or derivative, including a comparison with lower risk tissues or synthetic alternatives;\n(b)updated risk analysis;\n(c)updated clinical evaluation;\n(d)updated test data and/or rationales, for example in relation to the current harmonised standards;\n(e)identification of any changes made since the issue of the original certificate (or last renewal) that could impact the TSE risk;\n(f)evidence that the design dossier remains state of the art in relation to TSE risks.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Word in Annex 1 s. 2.2 substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 15(e)(i)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in Annex 1 s. 2.2 substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 15(e)(ii)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in Annex 1 s. 2.2 substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 15(e)(iii)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2012/722/annex/I/division/2/division/2.2",
    "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."
}