{
  "url": "https://openlegislation.uk/merchant-shipping-marine-equipment-regulations-1999/regulation-17",
  "json_url": "https://openlegislation.uk/merchant-shipping-marine-equipment-regulations-1999/regulation-17.json",
  "legislation": "uksi/1999/1957",
  "legislation_title": "The Merchant Shipping (Marine Equipment) Regulations 1999",
  "legislation_url": "https://openlegislation.uk/merchant-shipping-marine-equipment-regulations-1999",
  "path": "regulation/17",
  "kind": "regulation",
  "number": "17",
  "heading": "EC full quality assurance",
  "text": "(1) A manufacturer who decides, in accordance with regulation 11(1) above, to apply the EC full quality assurance procedure to equipment, may apply to any notified body for approval of his quality assurance system (in this regulation referred to as “the system”); and such an application shall be made in writing and shall include–\n(a) all relevant information for the equipment category envisaged; and\n(b) the documentation concerning the system.\n(2) On an application made to it under paragraph (1) above, the notified body shall evaluate the system to determine whether it satisfies the requirements referred to in paragraph 3.2, of the section entitled “Full-Quality Assurance (Module H)”, in Annex B of the Directive and set out in Merchant Shipping Notice MSN 1734 and, if the system implements the relevant harmonised standard, it shall be taken to satisfy the said requirements.\n(3) Paragraphs (3) to (15) of regulation 14 above shall apply in relation to a system which is the subject of an application under this regulation as they apply to the production quality assurance system and product quality assurance system under that regulation, as if for paragraph (12)(a) there were substituted the following:\n“(a) ensure and declare that the items of equipment concerned satisfy the applicable international standards;”.\n(4) In addition to the application under paragraph (1) above, the manufacturer shall apply to a notified body for an approval of the design of the equipment which is to be subject to the EC full quality assurance procedure.\n(5) An application under paragraph (4) above shall include all documentation necessary to enable the notified body to understand the design, manufacture and operation of the equipment and to assess its compliance with the applicable international standards; and in particular–\n(a) the technical design specifications, including standards, that have been applied to the design; and\n(b) the necessary supporting evidence, including the results of any tests carried out in an appropriate laboratory by the manufacturer, or on his behalf, for the adequacy of the technical design specifications, in particular where the standards specified in regulation 6 above have not been applied in full.\n(6) On an application made to it under paragraph (4) above, the notified body shall examine the design to determine whether it satisfies the applicable international standards.\n(7) Where a notified body is satisfied, after examining the design pursuant to paragraph (6) above, that the design satisfies the applicable international standards it shall issue to the manufacturer an EC design-examination certificate.\n(8) A certificate issued under paragraph (7) above shall include–\n(a) the conclusions of the examination;\n(b) the conditions of its validity;\n(c) the data necessary to identify the approved design; and\n(d) if relevant, a description of the equipment’s functioning.\n(9) Where the notified body is not satisfied as is mentioned in paragraph (7) above, it shall inform the manufacturer in writing–\n(a) of its decision to refuse to grant an approval in respect of the design; and\n(b) the conclusions of any examinations and the evaluation carried out by it.\n(10) If any modification is made to a design in respect of which an EC design-examination certificate has been issued, the applicant shall inform the notified body which issued the certificate.\n(11) If a modification such as is referred to in paragraph (10) above is such that it may affect the equipment’s compliance with the applicable international standards or any prescribed conditions for the use of the equipment, the notified body shall satisfy itself, by further examinations and tests if necessary, that the design as modified complies with the applicable international standards and, if so satisfied, shall–\n(a) approve the modifications to the design; and\n(b) issue an addition to the original EC design-examination certificate in respect thereof.\n(12) A notified body shall on request, provide flag member States and other notified bodies with all relevant information concerning–\n(a) EC design-examination certificates, and additions thereto, it has issued, including any it has withdrawn; and\n(b) EC design approvals, and additions thereto, it has granted, including any it has withdrawn.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1999/1957/regulation/17",
    "retrieved_at": "2026-10-29T10:17:54.681891+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."
}