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"annex/VII/division/A/division/2", "kind": "division", "number": "2", "heading": "The technical file referred to in point 1 must be made available to the competent authorities of the Member States for at least 10 years following the date of manufacture of the machinery or, in the case of series manufacture, of the last unit produced.", "url": "https://openlegislation.uk/eu-directive-2006-42/annex-VII/division-A/division-2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/VII/division/A" }, { "path": "annex/VII/division/A/division/3", "kind": "division", "number": "3", "heading": null, "url": "https://openlegislation.uk/eu-directive-2006-42/annex-VII/division-A/division-3", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/VII/division/A" }, { "path": "annex/VII/division/B", "kind": "division", "number": "B", "heading": "Relevant technical documentation for partly completed machinery", "url": "https://openlegislation.uk/eu-directive-2006-42/annex-VII/division-B", 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"annex/IX", "kind": "annex", "number": "IX", "heading": "EC type-examination", "url": "https://openlegislation.uk/eu-directive-2006-42/annex-IX", "extent": "E+W+S+N.I.", "status": null, "parent": null }, { "path": "annex/IX/division/1", "kind": "division", "number": "1", "heading": null, "url": "https://openlegislation.uk/eu-directive-2006-42/annex-IX/division-1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/IX" }, { "path": "annex/IX/division/2", "kind": "division", "number": "2", "heading": "For each type, the application for an EC type-examination shall be submitted by the manufacturer or his authorised representative to a notified body of his choice.", "url": "https://openlegislation.uk/eu-directive-2006-42/annex-IX/division-2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/IX" }, { "path": "annex/IX/division/3", "kind": "division", "number": "3", "heading": "The notified body shall:", "url": "https://openlegislation.uk/eu-directive-2006-42/annex-IX/division-3", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/IX" }, { "path": "annex/IX/division/4", "kind": "division", "number": "4", "heading": "If the type satisfies the provisions of this Directive, the notified body shall issue the applicant with an EC type-examination certificate. The certificate shall include the name and address of the manufacturer and his authorised representative, the data necessary for identifying the approved type, the conclusions of the examination and the conditions to which its issue may be subject.", "url": "https://openlegislation.uk/eu-directive-2006-42/annex-IX/division-4", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/IX" }, { "path": "annex/IX/division/5", "kind": "division", "number": "5", "heading": null, "url": "https://openlegislation.uk/eu-directive-2006-42/annex-IX/division-5", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/IX" }, { "path": "annex/IX/division/6", "kind": "division", "number": "6", "heading": null, "url": "https://openlegislation.uk/eu-directive-2006-42/annex-IX/division-6", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/IX" }, { "path": "annex/IX/division/7", "kind": "division", "number": "7", "heading": null, "url": "https://openlegislation.uk/eu-directive-2006-42/annex-IX/division-7", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/IX" }, { "path": "annex/IX/division/8", "kind": "division", "number": "8", "heading": null, "url": "https://openlegislation.uk/eu-directive-2006-42/annex-IX/division-8", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/IX" }, { "path": "annex/IX/division/9", "kind": "division", "number": "9", "heading": null, "url": "https://openlegislation.uk/eu-directive-2006-42/annex-IX/division-9", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/IX" }, { "path": "annex/IX/division/9.1", "kind": "division", "number": "9.1", "heading": null, "url": "https://openlegislation.uk/eu-directive-2006-42/annex-IX/division-9.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/IX" }, { "path": "annex/IX/division/9.2", "kind": "division", "number": "9.2", "heading": null, "url": "https://openlegislation.uk/eu-directive-2006-42/annex-IX/division-9.2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/IX" }, { "path": "annex/IX/division/9.3", "kind": "division", "number": "9.3", "heading": "The manufacturer shall request from the notified body the review of the validity of the EC type-examination certificate every five years.", "url": "https://openlegislation.uk/eu-directive-2006-42/annex-IX/division-9.3", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/IX" }, { "path": "annex/IX/division/9.4", "kind": "division", "number": "9.4", "heading": null, "url": "https://openlegislation.uk/eu-directive-2006-42/annex-IX/division-9.4", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/IX" }, { "path": "annex/X", "kind": "annex", "number": "X", "heading": "Full quality assurance", "url": "https://openlegislation.uk/eu-directive-2006-42/annex-X", "extent": "E+W+S+N.I.", "status": null, "parent": null }, { "path": "annex/X/division/1", "kind": "division", "number": "1", "heading": null, "url": "https://openlegislation.uk/eu-directive-2006-42/annex-X/division-1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/X" }, { "path": "annex/X/division/2", "kind": "division", "number": "2", "heading": null, "url": "https://openlegislation.uk/eu-directive-2006-42/annex-X/division-2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/X" }, { "path": "annex/X/division/2.1", "kind": "division", "number": "2.1", "heading": "The manufacturer or his authorised representative shall lodge an application for assessment of his quality system to a notified body of his choice.", "url": "https://openlegislation.uk/eu-directive-2006-42/annex-X/division-2.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/X" }, { "path": "annex/X/division/2.2", "kind": "division", "number": "2.2", "heading": "The quality system must ensure conformity of the machinery with the provisions of this Directive. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner, in the form of measures, procedures and written instructions. The documentation on the quality system must permit a uniform interpretation of the procedural and quality measures, such as quality programmes, plans, manuals and records.", "url": "https://openlegislation.uk/eu-directive-2006-42/annex-X/division-2.2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/X" }, { "path": "annex/X/division/2.3", "kind": "division", "number": "2.3", "heading": "The notified body shall assess the quality system to determine whether it satisfies the requirements of point 2.2.", "url": "https://openlegislation.uk/eu-directive-2006-42/annex-X/division-2.3", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/X" }, { "path": "annex/X/division/2.4", "kind": "division", "number": "2.4", "heading": "The manufacturer shall undertake to fulfil the obligations arising from the quality system as approved and to ensure that it remains appropriate and effective.", "url": "https://openlegislation.uk/eu-directive-2006-42/annex-X/division-2.4", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/X" }, { "path": "annex/X/division/3", "kind": "division", "number": "3", "heading": null, "url": "https://openlegislation.uk/eu-directive-2006-42/annex-X/division-3", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/X" }, { "path": "annex/X/division/3.1", "kind": "division", "number": "3.1", "heading": null, "url": "https://openlegislation.uk/eu-directive-2006-42/annex-X/division-3.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/X" }, { "path": "annex/X/division/3.2", "kind": "division", "number": "3.2", "heading": "The manufacturer shall, for inspection purposes, allow the notified body access to the places of design, manufacture, inspection, testing and storage, and shall provide it with all necessary information, such as:", "url": "https://openlegislation.uk/eu-directive-2006-42/annex-X/division-3.2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/X" }, { "path": "annex/X/division/3.3", "kind": "division", "number": "3.3", "heading": null, "url": "https://openlegislation.uk/eu-directive-2006-42/annex-X/division-3.3", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/X" }, { "path": "annex/X/division/3.4", "kind": "division", "number": "3.4", "heading": "Moreover, the notified body may pay the manufacturer unannounced visits. The need for these additional visits and their frequency will be determined on the basis of a visit monitoring system managed by the notified body. In particular, the following factors will be taken into account in the visits monitoring system:", "url": "https://openlegislation.uk/eu-directive-2006-42/annex-X/division-3.4", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/X" }, { "path": "annex/X/division/4", "kind": "division", "number": "4", "heading": "The manufacturer or his authorised representative shall keep available for the national authorities, for a period of ten years from the last date of manufacture:", "url": "https://openlegislation.uk/eu-directive-2006-42/annex-X/division-4", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/X" }, { "path": "annex/XI", "kind": "annex", "number": "XI", "heading": "Minimum criteria to be taken into account by Member States for the notification of bodies", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": null }, { "path": "annex/XI/division/1", "kind": "division", "number": "1", "heading": null, "url": "https://openlegislation.uk/eu-directive-2006-42/annex-XI/division-1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/XI" }, { "path": "annex/XI/division/2", "kind": "division", "number": "2", "heading": null, "url": "https://openlegislation.uk/eu-directive-2006-42/annex-XI/division-2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/XI" }, { "path": "annex/XI/division/3", "kind": "division", "number": "3", "heading": null, "url": "https://openlegislation.uk/eu-directive-2006-42/annex-XI/division-3", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/XI" }, { "path": "annex/XI/division/4", "kind": "division", "number": "4", "heading": "The staff responsible for inspection shall have:", "url": "https://openlegislation.uk/eu-directive-2006-42/annex-XI/division-4", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/XI" }, { "path": "annex/XI/division/5", "kind": "division", "number": "5", "heading": null, "url": "https://openlegislation.uk/eu-directive-2006-42/annex-XI/division-5", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/XI" }, { "path": "annex/XI/division/6", "kind": "division", "number": "6", "heading": null, "url": "https://openlegislation.uk/eu-directive-2006-42/annex-XI/division-6", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/XI" }, { "path": "annex/XI/division/7", "kind": "division", "number": "7", "heading": null, "url": "https://openlegislation.uk/eu-directive-2006-42/annex-XI/division-7", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/XI" }, { "path": "annex/XI/division/8", "kind": "division", "number": "8", "heading": null, "url": "https://openlegislation.uk/eu-directive-2006-42/annex-XI/division-8", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/XI" }, { "path": "annex/XI/division/9", "kind": "division", "number": "9", "heading": null, "url": "https://openlegislation.uk/eu-directive-2006-42/annex-XI/division-9", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/XI" }, { "path": "annex/XII", "kind": "annex", "number": "XII", "heading": "Correlation table", "url": "https://openlegislation.uk/eu-directive-2006-42/annex-XII", "extent": "E+W+S+N.I.", "status": null, "parent": null } ], "outstanding_effects": [], "made_under": [], "changes_made_to": 0, "changes_made_to_url": "https://openlegislation.uk/eu-directive-2006-42/changes.json", "changes_made_by": 0, "changes_made_by_url": "https://openlegislation.uk/eu-directive-2006-42/changes/by-it.json", "instruments_made_under": 0, "instruments_made_under_url": "https://openlegislation.uk/eu-directive-2006-42/instruments.json", "provenance": { "source": "legislation.gov.uk", "source_url": "https://www.legislation.gov.uk/eudr/2006/42", "retrieved_at": "2026-11-01T15:22:36.910149+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." }