{
  "url": "https://openlegislation.uk/personal-protective-equipment-enforcement-regulations-2018/regulation-2B",
  "json_url": "https://openlegislation.uk/personal-protective-equipment-enforcement-regulations-2018/regulation-2B.json",
  "legislation": "uksi/2018/390",
  "legislation_title": "The Personal Protective Equipment (Enforcement) Regulations 2018",
  "legislation_url": "https://openlegislation.uk/personal-protective-equipment-enforcement-regulations-2018",
  "path": "regulation/2B",
  "kind": "regulation",
  "number": "2B",
  "heading": "Conformity assessment procedure obligation which is met by complying with Regulation 2016/425 (pre-exit)",
  "text": "(1) Paragraph (2) applies where—\n(a) PPE is classified under Article 18 of Regulation 2016/425 (pre-exit) as falling within risk category II or risk category III, as set out in Annex I to Regulation 2016/425 (pre-exit); and\n(b) prior to manufacture of that PPE, the manufacturer ensures that the conformity assessment procedure set out in Annex V to Regulation 2016/425 (pre-exit), and referred to in Article 19(b) and (c) of Regulation 2016/425 (pre-exit) as EU type-examination, has been carried out in accordance with Article 19(b) or (c).\n(2) Where this paragraph applies—\n(a) the requirement in Article 19(b) or (c) to follow the conformity assessment procedure referred to in those provisions as type-examination, and set out in Annex V, is to be treated as being satisfied;\n(b) any reference to “conformity assessment procedure” in Articles 8(2) and 10(2) is to be read as including the conformity assessment procedure referred to in Article 19(b) and (c) of Regulation 2016/425 (pre-exit) as EU type-examination;\n(c) any reference to “technical documentation” in Articles 8(2), 8(3), 10(2) and 10(8) is to be read as including the technical documentation relating to the design of the PPE as referred to in Annex V to Regulation 2016/425 (pre-exit).",
  "extent": "E+W+S",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Regs. 2A, 2B inserted (E.W.S.) (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. 1(4) (as amended by S.I. 2020/676, regs. 1(1), 2, 3); 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2018/390/regulation/2B",
    "retrieved_at": "2026-10-28T22:59:52.654684+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."
}