{
  "url": "https://openlegislation.uk/eu-regulation-2016-425/annex-VIII/division-CONFORMITY/division-3/division-3.5",
  "json_url": "https://openlegislation.uk/eu-regulation-2016-425/annex-VIII/division-CONFORMITY/division-3/division-3.5.json",
  "legislation": "eur/2016/425",
  "legislation_title": "Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2016-425",
  "path": "annex/VIII/division/CONFORMITY/division/3/division/3.5",
  "kind": "division",
  "number": "3.5",
  "heading": null,
  "text": "The manufacturer shall keep the approved body that has approved the quality system informed of any intended change to the quality system.\nThe approved body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.\nIt shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Word in Annex 8 para. 3.5 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(d); 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2016/425/annex/VIII/division/CONFORMITY/division/3/division/3.5",
    "retrieved_at": "2026-11-01T14:45:58.157392+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."
}