{
  "url": "https://openlegislation.uk/eu-regulation-2016-425/article-19",
  "json_url": "https://openlegislation.uk/eu-regulation-2016-425/article-19.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": "article/19",
  "kind": "article",
  "number": "19",
  "heading": "Conformity assessment procedures",
  "text": "The conformity assessment procedures to be followed for each of the risk categories set out in Annex I are as follows:\n(a)Category I: internal production control (module A) set out in Annex IV;\n(b)Category II: ... type-examination (module B) set out in Annex V, followed by conformity to type based on internal production control (module C) set out in Annex VI;\n(c)Category III: ... type-examination (module B) set out in Annex V, and either of the following:\n(i)conformity to type based on internal production control plus supervised product checks at random intervals (module C2) set out in Annex VII;\n(ii)conformity to type based on quality assurance of the production process (module D) set out in Annex VIII.\nBy way of derogation, for PPE produced as a single unit to fit an individual user and classified according to Category III, the procedure referred to in point (b) may be followed.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Word in Art. 19(b) omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(17); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Word in Art. 19(c) omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(17); 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/article/19",
    "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."
}