{ "url": "https://openlegislation.uk/eu-directive-2014-31", "json_url": "https://openlegislation.uk/eu-directive-2014-31.json", "id": "eudr/2014/31", "title": "Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments (recast) (Text with EEA relevance)", "short_title": "Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments", "long_title": "Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments (recast) (Text with EEA relevance)", "citation": "EU Directive 2014/31", "type": "eudr", "year": "2014", "number": "31", "version": "current", "date": "2014-02-26", "revised": false, "valid_from": null, "extent": "E+W+S+N.I.", "unapplied_effects": 0, "provisions": [ { "path": "introduction", "kind": "introduction", "number": null, "heading": "Introductory text", "url": "https://openlegislation.uk/eu-directive-2014-31/introduction", "extent": "E+W+S+N.I.", "status": null, "parent": null }, { "path": "chapter/1", "kind": "chapter", "number": "1", "heading": "GENERAL PROVISIONS", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": null }, { "path": "article/1", "kind": "article", "number": "1", "heading": "Scope", "url": "https://openlegislation.uk/eu-directive-2014-31/article-1", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/1" }, { "path": "article/2", "kind": "article", "number": "2", "heading": "Definitions", "url": "https://openlegislation.uk/eu-directive-2014-31/article-2", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/1" }, { "path": "article/3", "kind": "article", "number": "3", "heading": "Making available on the market and putting into service", "url": "https://openlegislation.uk/eu-directive-2014-31/article-3", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/1" }, { "path": "article/4", "kind": "article", "number": "4", "heading": "Essential requirements", "url": "https://openlegislation.uk/eu-directive-2014-31/article-4", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/1" }, { "path": "article/5", "kind": "article", "number": "5", "heading": "Free movement of instruments", "url": "https://openlegislation.uk/eu-directive-2014-31/article-5", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/1" }, { "path": "chapter/2", "kind": "chapter", "number": "2", "heading": "OBLIGATIONS OF ECONOMIC OPERATORS", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": null }, { "path": "article/6", "kind": "article", "number": "6", "heading": "Obligations of manufacturers", "url": "https://openlegislation.uk/eu-directive-2014-31/article-6", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/2" }, { "path": "article/7", "kind": "article", "number": "7", "heading": "Authorised representatives", "url": "https://openlegislation.uk/eu-directive-2014-31/article-7", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/2" }, { "path": "article/8", "kind": "article", "number": "8", "heading": "Obligations of importers", "url": "https://openlegislation.uk/eu-directive-2014-31/article-8", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/2" }, { "path": "article/9", "kind": "article", "number": "9", "heading": "Obligations of distributors", "url": "https://openlegislation.uk/eu-directive-2014-31/article-9", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/2" }, { "path": "article/10", "kind": "article", "number": "10", "heading": "Cases in which obligations of manufacturers apply to importers and distributors", "url": "https://openlegislation.uk/eu-directive-2014-31/article-10", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/2" }, { "path": "article/11", "kind": "article", "number": "11", "heading": "Identification of economic operators", "url": "https://openlegislation.uk/eu-directive-2014-31/article-11", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/2" }, { "path": "chapter/3", "kind": "chapter", "number": "3", "heading": "CONFORMITY OF INSTRUMENTS", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": null }, { "path": "article/12", "kind": "article", "number": "12", "heading": "Presumption of conformity of instruments", "url": "https://openlegislation.uk/eu-directive-2014-31/article-12", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/3" }, { "path": "article/13", "kind": "article", "number": "13", "heading": "Conformity assessment procedures", "url": "https://openlegislation.uk/eu-directive-2014-31/article-13", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/3" }, { "path": "article/14", "kind": "article", "number": "14", "heading": "EU declaration of conformity", "url": "https://openlegislation.uk/eu-directive-2014-31/article-14", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/3" }, { "path": "article/15", "kind": "article", "number": "15", "heading": "Conformity marking", "url": "https://openlegislation.uk/eu-directive-2014-31/article-15", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/3" }, { "path": "article/16", "kind": "article", "number": "16", "heading": "General principles of the CE marking and of the supplementary metrology marking", "url": "https://openlegislation.uk/eu-directive-2014-31/article-16", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/3" }, { "path": "article/17", "kind": "article", "number": "17", "heading": "Rules and conditions for affixing the CE marking, the supplementary metrology marking and other markings", "url": "https://openlegislation.uk/eu-directive-2014-31/article-17", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/3" }, { "path": "article/18", "kind": "article", "number": "18", "heading": "Restrictive use symbol", "url": "https://openlegislation.uk/eu-directive-2014-31/article-18", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/3" }, { "path": "chapter/4", "kind": "chapter", "number": "4", "heading": "NOTIFICATION OF CONFORMITY ASSESSMENT BODIES", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": null }, { "path": "article/19", "kind": "article", "number": "19", "heading": "Notification", "url": "https://openlegislation.uk/eu-directive-2014-31/article-19", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/4" }, { "path": "article/20", "kind": "article", "number": "20", "heading": "Notifying authorities", "url": "https://openlegislation.uk/eu-directive-2014-31/article-20", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/4" }, { "path": "article/21", "kind": "article", "number": "21", "heading": "Requirements relating to notifying authorities", "url": "https://openlegislation.uk/eu-directive-2014-31/article-21", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/4" }, { "path": "article/22", "kind": "article", "number": "22", "heading": "Information obligation on notifying authorities", "url": "https://openlegislation.uk/eu-directive-2014-31/article-22", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/4" }, { "path": "article/23", "kind": "article", "number": "23", "heading": "Requirements relating to notified bodies", "url": "https://openlegislation.uk/eu-directive-2014-31/article-23", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/4" }, { "path": "article/24", "kind": "article", "number": "24", "heading": "Presumption of conformity of notified bodies", "url": "https://openlegislation.uk/eu-directive-2014-31/article-24", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/4" }, { "path": "article/25", "kind": "article", "number": "25", "heading": "Subsidiaries of and subcontracting by notified bodies", "url": "https://openlegislation.uk/eu-directive-2014-31/article-25", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/4" }, { "path": "article/26", "kind": "article", "number": "26", "heading": "Application for notification", "url": "https://openlegislation.uk/eu-directive-2014-31/article-26", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/4" }, { "path": "article/27", "kind": "article", "number": "27", "heading": "Notification procedure", "url": "https://openlegislation.uk/eu-directive-2014-31/article-27", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/4" }, { "path": "article/28", "kind": "article", "number": "28", "heading": "Identification numbers and lists of notified bodies", "url": "https://openlegislation.uk/eu-directive-2014-31/article-28", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/4" }, { "path": "article/29", "kind": "article", "number": "29", "heading": "Changes to notifications", "url": "https://openlegislation.uk/eu-directive-2014-31/article-29", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/4" }, { "path": "article/30", "kind": "article", "number": "30", "heading": "Challenge of the competence of notified bodies", "url": "https://openlegislation.uk/eu-directive-2014-31/article-30", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/4" }, { "path": "article/31", "kind": "article", "number": "31", "heading": "Operational obligations of notified bodies", "url": "https://openlegislation.uk/eu-directive-2014-31/article-31", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/4" }, { "path": "article/32", "kind": "article", "number": "32", "heading": "Appeal against decisions of notified bodies", "url": "https://openlegislation.uk/eu-directive-2014-31/article-32", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/4" }, { "path": "article/33", "kind": "article", "number": "33", "heading": "Information obligation on notified bodies", "url": "https://openlegislation.uk/eu-directive-2014-31/article-33", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/4" }, { "path": "article/34", "kind": "article", "number": "34", "heading": "Exchange of experience", "url": "https://openlegislation.uk/eu-directive-2014-31/article-34", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/4" }, { "path": "article/35", "kind": "article", "number": "35", "heading": "Coordination of notified bodies", "url": "https://openlegislation.uk/eu-directive-2014-31/article-35", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/4" }, { "path": "chapter/5", "kind": "chapter", "number": "5", "heading": "UNION MARKET SURVEILLANCE, CONTROL OF INSTRUMENTS ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": null }, { "path": "article/36", "kind": "article", "number": "36", "heading": "Union market surveillance and control of instruments entering the Union market", "url": "https://openlegislation.uk/eu-directive-2014-31/article-36", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/5" }, { "path": "article/37", "kind": "article", "number": "37", "heading": "Procedure for dealing with instruments presenting a risk at national level", "url": "https://openlegislation.uk/eu-directive-2014-31/article-37", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/5" }, { "path": "article/38", "kind": "article", "number": "38", "heading": "Union safeguard procedure", "url": "https://openlegislation.uk/eu-directive-2014-31/article-38", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/5" }, { "path": "article/39", "kind": "article", "number": "39", "heading": "Compliant instruments which present a risk", "url": "https://openlegislation.uk/eu-directive-2014-31/article-39", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/5" }, { "path": "article/40", "kind": "article", "number": "40", "heading": "Formal non-compliance", "url": "https://openlegislation.uk/eu-directive-2014-31/article-40", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/5" }, { "path": "chapter/6", "kind": "chapter", "number": "6", "heading": "COMMITTEE, TRANSITIONAL AND FINAL PROVISIONS", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": null }, { "path": "article/41", "kind": "article", "number": "41", "heading": "Committee procedure", "url": "https://openlegislation.uk/eu-directive-2014-31/article-41", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/6" }, { "path": "article/42", "kind": "article", "number": "42", "heading": "Penalties", "url": "https://openlegislation.uk/eu-directive-2014-31/article-42", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/6" }, { "path": "article/43", "kind": "article", "number": "43", "heading": "Transitional provisions", "url": "https://openlegislation.uk/eu-directive-2014-31/article-43", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/6" }, { "path": "article/44", "kind": "article", "number": "44", "heading": "Transposition", "url": "https://openlegislation.uk/eu-directive-2014-31/article-44", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/6" }, { "path": "article/45", "kind": "article", "number": "45", "heading": "Repeal", "url": "https://openlegislation.uk/eu-directive-2014-31/article-45", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/6" }, { "path": "article/46", "kind": "article", "number": "46", "heading": "Entry into force and application", "url": "https://openlegislation.uk/eu-directive-2014-31/article-46", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/6" }, { "path": "article/47", "kind": "article", "number": "47", "heading": "Addressees", "url": "https://openlegislation.uk/eu-directive-2014-31/article-47", "extent": "E+W+S+N.I.", "status": null, "parent": "chapter/6" }, { "path": "signature", "kind": "signature", "number": null, "heading": "Signature", "url": "https://openlegislation.uk/eu-directive-2014-31/signature", "extent": "E+W+S+N.I.", "status": null, "parent": null }, { "path": "annex/I", "kind": "annex", "number": "I", "heading": "ESSENTIAL REQUIREMENTS", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I", "extent": "E+W+S+N.I.", "status": null, "parent": null }, { "path": "annex/I/division/1", "kind": "division", "number": null, "heading": "Preliminary observation", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I" }, { "path": "annex/I/division/2", "kind": "division", "number": null, "heading": "Metrological requirements", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I" }, { "path": "annex/I/division/2/division/1", "kind": "division", "number": "1", "heading": "Units of mass", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-2/division-1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/2" }, { "path": "annex/I/division/2/division/2", "kind": "division", "number": "2", "heading": "Accuracy classes", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/2" }, { "path": "annex/I/division/2/division/2/division/2.1", "kind": "division", "number": "2.1", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-2/division-2/division-2.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/2/division/2" }, { "path": "annex/I/division/2/division/2/division/2.2", "kind": "division", "number": "2.2", "heading": "Scale intervals", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/2/division/2" }, { "path": "annex/I/division/2/division/2/division/2.2/division/2.2.1", "kind": "division", "number": "2.2.1", "heading": "The actual scale interval (d) and the verification scale interval (e) shall be in the form:", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-2/division-2/division-2.2/division-2.2.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/2/division/2/division/2.2" }, { "path": "annex/I/division/2/division/2/division/2.2/division/2.2.2", "kind": "division", "number": "2.2.2", "heading": "For all instruments other than those with auxiliary indicating devices:", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-2/division-2/division-2.2/division-2.2.2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/2/division/2/division/2.2" }, { "path": "annex/I/division/2/division/2/division/2.2/division/2.2.3", "kind": "division", "number": "2.2.3", "heading": "For instruments with auxiliary indicating devices the following conditions apply:", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-2/division-2/division-2.2/division-2.2.3", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/2/division/2/division/2.2" }, { "path": "annex/I/division/2/division/3", "kind": "division", "number": "3", "heading": "Classification", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/2" }, { "path": "annex/I/division/2/division/3/division/3.1", "kind": "division", "number": "3.1", "heading": "Instruments with one weighing range", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-2/division-3/division-3.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/2/division/3" }, { "path": "annex/I/division/2/division/3/division/3.2", "kind": "division", "number": "3.2", "heading": "Instruments with multiple weighing ranges", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-2/division-3/division-3.2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/2/division/3" }, { "path": "annex/I/division/2/division/3/division/3.3", "kind": "division", "number": "3.3", "heading": "Multi-interval instruments", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/2/division/3" }, { "path": "annex/I/division/2/division/3/division/3.3/division/3.3.1", "kind": "division", "number": "3.3.1", "heading": "Instruments with one weighing range may have several partial weighing ranges (multi-interval instruments).", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-2/division-3/division-3.3/division-3.3.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/2/division/3/division/3.3" }, { "path": "annex/I/division/2/division/3/division/3.3/division/3.3.2", "kind": "division", "number": "3.3.2", "heading": "Each partial weighing range i of multi-interval instruments is defined by:", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-2/division-3/division-3.3/division-3.3.2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/2/division/3/division/3.3" }, { "path": "annex/I/division/2/division/3/division/3.3/division/3.3.3", "kind": "division", "number": "3.3.3", "heading": "The partial weighing ranges are classified according to Table 2. All partial weighing ranges shall fall into the same accuracy class, that class being the instrument’s accuracy class.", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-2/division-3/division-3.3/division-3.3.3", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/2/division/3/division/3.3" }, { "path": "annex/I/division/2/division/4", "kind": "division", "number": "4", "heading": "Accuracy", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/2" }, { "path": "annex/I/division/2/division/4/division/4.1", "kind": "division", "number": "4.1", "heading": "On implementation of the procedures laid down in Article 13, the error of indication shall not exceed the maximum permissible error of indication as shown in Table 3. In the case of digital indication the error of indication shall be corrected for the rounding error.", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-2/division-4/division-4.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/2/division/4" }, { "path": "annex/I/division/2/division/4/division/4.2", "kind": "division", "number": "4.2", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-2/division-4/division-4.2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/2/division/4" }, { "path": "annex/I/division/2/division/5", "kind": "division", "number": "5", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-2/division-5", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/2" }, { "path": "annex/I/division/2/division/6", "kind": "division", "number": "6", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-2/division-6", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/2" }, { "path": "annex/I/division/2/division/7", "kind": "division", "number": "7", "heading": "Influence quantities and time", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/2" }, { "path": "annex/I/division/2/division/7/division/7.1", "kind": "division", "number": "7.1", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-2/division-7/division-7.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/2/division/7" }, { "path": "annex/I/division/2/division/7/division/7.2", "kind": "division", "number": "7.2", "heading": "The instruments shall meet the metrological requirements within the temperature range specified by the manufacturer. The value of this range shall be at least equal to:", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-2/division-7/division-7.2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/2/division/7" }, { "path": "annex/I/division/2/division/7/division/7.3", "kind": "division", "number": "7.3", "heading": "Instruments operated from a mains power supply shall meet the metrological requirements under conditions of power supply within the limits of normal fluctuation.", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-2/division-7/division-7.3", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/2/division/7" }, { "path": "annex/I/division/2/division/7/division/7.4", "kind": "division", "number": "7.4", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-2/division-7/division-7.4", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/2/division/7" }, { "path": "annex/I/division/2/division/7/division/7.5", "kind": "division", "number": "7.5", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-2/division-7/division-7.5", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/2/division/7" }, { "path": "annex/I/division/2/division/7/division/7.6", "kind": "division", "number": "7.6", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-2/division-7/division-7.6", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/2/division/7" }, { "path": "annex/I/division/3", "kind": "division", "number": null, "heading": "Design and construction", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I" }, { "path": "annex/I/division/3/division/8", "kind": "division", "number": "8", "heading": "General requirements", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/3" }, { "path": "annex/I/division/3/division/8/division/8.1", "kind": "division", "number": "8.1", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-3/division-8/division-8.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/3/division/8" }, { "path": "annex/I/division/3/division/8/division/8.2", "kind": "division", "number": "8.2", "heading": "When exposed to disturbances, electronic instruments shall not display the effects of significant faults, or shall automatically detect and indicate them.", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-3/division-8/division-8.2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/3/division/8" }, { "path": "annex/I/division/3/division/8/division/8.3", "kind": "division", "number": "8.3", "heading": "The requirements of points 8.1 and 8.2 shall be met on a lasting basis during a period of time that is normal in view of the intended use of such instruments.", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-3/division-8/division-8.3", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/3/division/8" }, { "path": "annex/I/division/3/division/8/division/8.4", "kind": "division", "number": "8.4", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-3/division-8/division-8.4", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/3/division/8" }, { "path": "annex/I/division/3/division/8/division/8.5", "kind": "division", "number": "8.5", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-3/division-8/division-8.5", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/3/division/8" }, { "path": "annex/I/division/3/division/8/division/8.6", "kind": "division", "number": "8.6", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-3/division-8/division-8.6", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/3/division/8" }, { "path": "annex/I/division/3/division/9", "kind": "division", "number": "9", "heading": "Indication of weighing results and other weight values", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-3/division-9", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/3" }, { "path": "annex/I/division/3/division/10", "kind": "division", "number": "10", "heading": "Printing of weighing results and other weight values", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-3/division-10", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/3" }, { "path": "annex/I/division/3/division/11", "kind": "division", "number": "11", "heading": "Levelling", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-3/division-11", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/3" }, { "path": "annex/I/division/3/division/12", "kind": "division", "number": "12", "heading": "Zeroing", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-3/division-12", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/3" }, { "path": "annex/I/division/3/division/13", "kind": "division", "number": "13", "heading": "Tare devices and preset tare devices", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-3/division-13", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/3" }, { "path": "annex/I/division/3/division/14", "kind": "division", "number": "14", "heading": "Instruments for direct sales to the public, with a maximum capacity not greater than 100 kg: additional requirements", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-3/division-14", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/3" }, { "path": "annex/I/division/3/division/15", "kind": "division", "number": "15", "heading": "Price labelling instruments", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-I/division-3/division-15", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/I/division/3" }, { "path": "annex/II", "kind": "annex", "number": "II", "heading": "CONFORMITY ASSESSMENT PROCEDURES", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": null }, { "path": "annex/II/division/1", "kind": "division", "number": "1", "heading": "Module B: EU-type examination", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II" }, { "path": "annex/II/division/1/division/1.1", "kind": "division", "number": "1.1", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-1/division-1.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/1" }, { "path": "annex/II/division/1/division/1.2", "kind": "division", "number": "1.2", "heading": "EU-type examination may be carried out in any of the following manners:", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-1/division-1.2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/1" }, { "path": "annex/II/division/1/division/1.3", "kind": "division", "number": "1.3", "heading": "The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice.", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-1/division-1.3", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/1" }, { "path": "annex/II/division/1/division/1.4", "kind": "division", "number": "1.4", "heading": "The notified body shall:", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-1/division-1.4", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/1" }, { "path": "annex/II/division/1/division/1.5", "kind": "division", "number": "1.5", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-1/division-1.5", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/1" }, { "path": "annex/II/division/1/division/1.6", "kind": "division", "number": "1.6", "heading": "Where the type meets the requirements of this Directive, that apply to the instrument concerned, the notified body shall issue an EU-type examination certificate to the manufacturer. That certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The EU-type examination certificate may have one or more annexes attached.", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-1/division-1.6", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/1" }, { "path": "annex/II/division/1/division/1.7", "kind": "division", "number": "1.7", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-1/division-1.7", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/1" }, { "path": "annex/II/division/1/division/1.8", "kind": "division", "number": "1.8", "heading": "Each notified body shall inform its notifying authority concerning the EU-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted.", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-1/division-1.8", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/1" }, { "path": "annex/II/division/1/division/1.9", "kind": "division", "number": "1.9", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-1/division-1.9", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/1" }, { "path": "annex/II/division/1/division/1.10", "kind": "division", "number": "1.10", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-1/division-1.10", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/1" }, { "path": "annex/II/division/2", "kind": "division", "number": "2", "heading": "Module D: Conformity to type based on quality assurance of the production process", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II" }, { "path": "annex/II/division/2/division/2.1", "kind": "division", "number": "2.1", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-2/division-2.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/2" }, { "path": "annex/II/division/2/division/2.2", "kind": "division", "number": "2.2", "heading": "Manufacturing", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-2/division-2.2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/2" }, { "path": "annex/II/division/2/division/2.3", "kind": "division", "number": "2.3", "heading": "Quality system", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/2" }, { "path": "annex/II/division/2/division/2.3/division/2.3.1", "kind": "division", "number": "2.3.1", "heading": "The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the instruments concerned.", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-2/division-2.3/division-2.3.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/2/division/2.3" }, { "path": "annex/II/division/2/division/2.3/division/2.3.2", "kind": "division", "number": "2.3.2", "heading": "The quality system shall ensure that the instruments are in conformity with the type described in the EU-type examination certificate and comply with the requirements of this Directive that apply to them.", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-2/division-2.3/division-2.3.2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/2/division/2.3" }, { "path": "annex/II/division/2/division/2.3/division/2.3.3", "kind": "division", "number": "2.3.3", "heading": "The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 2.3.2.", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-2/division-2.3/division-2.3.3", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/2/division/2.3" }, { "path": "annex/II/division/2/division/2.3/division/2.3.4", "kind": "division", "number": "2.3.4", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-2/division-2.3/division-2.3.4", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/2/division/2.3" }, { "path": "annex/II/division/2/division/2.3/division/2.3.5", "kind": "division", "number": "2.3.5", "heading": "The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-2/division-2.3/division-2.3.5", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/2/division/2.3" }, { "path": "annex/II/division/2/division/2.4", "kind": "division", "number": "2.4", "heading": "Surveillance under the responsibility of the notified body", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/2" }, { "path": "annex/II/division/2/division/2.4/division/2.4.1", "kind": "division", "number": "2.4.1", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-2/division-2.4/division-2.4.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/2/division/2.4" }, { "path": "annex/II/division/2/division/2.4/division/2.4.2", "kind": "division", "number": "2.4.2", "heading": "The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-2/division-2.4/division-2.4.2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/2/division/2.4" }, { "path": "annex/II/division/2/division/2.4/division/2.4.3", "kind": "division", "number": "2.4.3", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-2/division-2.4/division-2.4.3", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/2/division/2.4" }, { "path": "annex/II/division/2/division/2.4/division/2.4.4", "kind": "division", "number": "2.4.4", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-2/division-2.4/division-2.4.4", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/2/division/2.4" }, { "path": "annex/II/division/2/division/2.5", "kind": "division", "number": "2.5", "heading": "Conformity marking and EU declaration of conformity", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/2" }, { "path": "annex/II/division/2/division/2.5/division/2.5.1", "kind": "division", "number": "2.5.1", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-2/division-2.5/division-2.5.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/2/division/2.5" }, { "path": "annex/II/division/2/division/2.5/division/2.5.2", "kind": "division", "number": "2.5.2", "heading": "The manufacturer shall draw up a written EU declaration of conformity for each instrument model and keep it at the disposal of the national authorities for 10 years after the instrument has been placed on the market. The EU declaration of conformity shall identify the instrument model for which it has been drawn up.", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-2/division-2.5/division-2.5.2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/2/division/2.5" }, { "path": "annex/II/division/2/division/2.6", "kind": "division", "number": "2.6", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-2/division-2.6", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/2" }, { "path": "annex/II/division/2/division/2.7", "kind": "division", "number": "2.7", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-2/division-2.7", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/2" }, { "path": "annex/II/division/2/division/2.8", "kind": "division", "number": "2.8", "heading": "Authorised representative", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-2/division-2.8", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/2" }, { "path": "annex/II/division/3", "kind": "division", "number": "3", "heading": "Module D1: Quality assurance of the production process", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II" }, { "path": "annex/II/division/3/division/3.1", "kind": "division", "number": "3.1", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-3/division-3.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/3" }, { "path": "annex/II/division/3/division/3.2", "kind": "division", "number": "3.2", "heading": "Technical documentation", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-3/division-3.2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/3" }, { "path": "annex/II/division/3/division/3.3", "kind": "division", "number": "3.3", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-3/division-3.3", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/3" }, { "path": "annex/II/division/3/division/3.4", "kind": "division", "number": "3.4", "heading": "Manufacturing", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-3/division-3.4", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/3" }, { "path": "annex/II/division/3/division/3.5", "kind": "division", "number": "3.5", "heading": "Quality system", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/3" }, { "path": "annex/II/division/3/division/3.5/division/3.5.1", "kind": "division", "number": "3.5.1", "heading": "The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the instruments concerned.", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-3/division-3.5/division-3.5.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/3/division/3.5" }, { "path": "annex/II/division/3/division/3.5/division/3.5.2", "kind": "division", "number": "3.5.2", "heading": "The quality system shall ensure compliance of the instruments with the requirements of this Directive that apply to them.", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-3/division-3.5/division-3.5.2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/3/division/3.5" }, { "path": "annex/II/division/3/division/3.5/division/3.5.3", "kind": "division", "number": "3.5.3", "heading": "The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.5.2.", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-3/division-3.5/division-3.5.3", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/3/division/3.5" }, { "path": "annex/II/division/3/division/3.5/division/3.5.4", "kind": "division", "number": "3.5.4", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-3/division-3.5/division-3.5.4", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/3/division/3.5" }, { "path": "annex/II/division/3/division/3.5/division/3.5.5", "kind": "division", "number": "3.5.5", "heading": "The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-3/division-3.5/division-3.5.5", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/3/division/3.5" }, { "path": "annex/II/division/3/division/3.6", "kind": "division", "number": "3.6", "heading": "Surveillance under the responsibility of the notified body", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/3" }, { "path": "annex/II/division/3/division/3.6/division/3.6.1", "kind": "division", "number": "3.6.1", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-3/division-3.6/division-3.6.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/3/division/3.6" }, { "path": "annex/II/division/3/division/3.6/division/3.6.2", "kind": "division", "number": "3.6.2", "heading": "The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-3/division-3.6/division-3.6.2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/3/division/3.6" }, { "path": "annex/II/division/3/division/3.6/division/3.6.3", "kind": "division", "number": "3.6.3", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-3/division-3.6/division-3.6.3", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/3/division/3.6" }, { "path": "annex/II/division/3/division/3.6/division/3.6.4", "kind": "division", "number": "3.6.4", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-3/division-3.6/division-3.6.4", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/3/division/3.6" }, { "path": "annex/II/division/3/division/3.7", "kind": "division", "number": "3.7", "heading": "Conformity marking and EU declaration of conformity", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/3" }, { "path": "annex/II/division/3/division/3.7/division/3.7.1", "kind": "division", "number": "3.7.1", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-3/division-3.7/division-3.7.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/3/division/3.7" }, { "path": "annex/II/division/3/division/3.7/division/3.7.2", "kind": "division", "number": "3.7.2", "heading": "The manufacturer shall draw up a written EU declaration of conformity for each instrument model and keep it at the disposal of the national authorities for 10 years after the instrument has been placed on the market. The EU declaration of conformity shall identify the instrument model for which it has been drawn up.", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-3/division-3.7/division-3.7.2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/3/division/3.7" }, { "path": "annex/II/division/3/division/3.8", "kind": "division", "number": "3.8", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-3/division-3.8", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/3" }, { "path": "annex/II/division/3/division/3.9", "kind": "division", "number": "3.9", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-3/division-3.9", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/3" }, { "path": "annex/II/division/3/division/3.10", "kind": "division", "number": "3.10", "heading": "Authorised representative", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-3/division-3.10", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/3" }, { "path": "annex/II/division/4", "kind": "division", "number": "4", "heading": "Module F: Conformity to type based on product verification", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II" }, { "path": "annex/II/division/4/division/4.1", "kind": "division", "number": "4.1", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-4/division-4.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/4" }, { "path": "annex/II/division/4/division/4.2", "kind": "division", "number": "4.2", "heading": "Manufacturing", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-4/division-4.2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/4" }, { "path": "annex/II/division/4/division/4.3", "kind": "division", "number": "4.3", "heading": "Verification", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-4/division-4.3", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/4" }, { "path": "annex/II/division/4/division/4.4", "kind": "division", "number": "4.4", "heading": "Verification of conformity by examination and testing of every instrument", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/4" }, { "path": "annex/II/division/4/division/4.4/division/4.4.1", "kind": "division", "number": "4.4.1", "heading": "All instruments shall be individually examined and appropriate tests set out in the relevant harmonised standard(s), and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify conformity with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Directive.", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-4/division-4.4/division-4.4.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/4/division/4.4" }, { "path": "annex/II/division/4/division/4.4/division/4.4.2", "kind": "division", "number": "4.4.2", "heading": "The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved instrument or have it affixed under its responsibility.", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-4/division-4.4/division-4.4.2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/4/division/4.4" }, { "path": "annex/II/division/4/division/4.5", "kind": "division", "number": "4.5", "heading": "Conformity marking and EU declaration of conformity", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/4" }, { "path": "annex/II/division/4/division/4.5/division/4.5.1", "kind": "division", "number": "4.5.1", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-4/division-4.5/division-4.5.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/4/division/4.5" }, { "path": "annex/II/division/4/division/4.5/division/4.5.2", "kind": "division", "number": "4.5.2", "heading": "The manufacturer shall draw up a written EU declaration of conformity for each instrument model and keep it at the disposal of the national authorities, for 10 years after the instrument has been placed on the market. The EU declaration of conformity shall identify the instrument model for which it has been drawn up.", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-4/division-4.5/division-4.5.2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/4/division/4.5" }, { "path": "annex/II/division/4/division/4.6", "kind": "division", "number": "4.6", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-4/division-4.6", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/4" }, { "path": "annex/II/division/4/division/4.7", "kind": "division", "number": "4.7", "heading": "Authorised representative", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-4/division-4.7", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/4" }, { "path": "annex/II/division/5", "kind": "division", "number": "5", "heading": "Module F1: Conformity based on product verification", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II" }, { "path": "annex/II/division/5/division/5.1", "kind": "division", "number": "5.1", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-5/division-5.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/5" }, { "path": "annex/II/division/5/division/5.2", "kind": "division", "number": "5.2", "heading": "Technical documentation", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/5" }, { "path": "annex/II/division/5/division/5.2/division/5.2.1", "kind": "division", "number": "5.2.1", "heading": "The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the instrument’s conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the instrument. The technical documentation shall, wherever applicable, contain at least the following elements:", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-5/division-5.2/division-5.2.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/5/division/5.2" }, { "path": "annex/II/division/5/division/5.2/division/5.2.2", "kind": "division", "number": "5.2.2", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-5/division-5.2/division-5.2.2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/5/division/5.2" }, { "path": "annex/II/division/5/division/5.3", "kind": "division", "number": "5.3", "heading": "Manufacturing", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-5/division-5.3", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/5" }, { "path": "annex/II/division/5/division/5.4", "kind": "division", "number": "5.4", "heading": "Verification", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-5/division-5.4", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/5" }, { "path": "annex/II/division/5/division/5.5", "kind": "division", "number": "5.5", "heading": "Verification of conformity by examination and testing of every instrument", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/5" }, { "path": "annex/II/division/5/division/5.5/division/5.5.1", "kind": "division", "number": "5.5.1", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-5/division-5.5/division-5.5.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/5/division/5.5" }, { "path": "annex/II/division/5/division/5.5/division/5.5.2", "kind": "division", "number": "5.5.2", "heading": "The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved instrument or have it affixed under its responsibility.", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-5/division-5.5/division-5.5.2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/5/division/5.5" }, { "path": "annex/II/division/5/division/5.6", "kind": "division", "number": "5.6", "heading": "Conformity marking and EU declaration of conformity", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/5" }, { "path": "annex/II/division/5/division/5.6/division/5.6.1", "kind": "division", "number": "5.6.1", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-5/division-5.6/division-5.6.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/5/division/5.6" }, { "path": "annex/II/division/5/division/5.6/division/5.6.2", "kind": "division", "number": "5.6.2", "heading": "The manufacturer shall draw up a written EU declaration of conformity for each instrument model and keep it at the disposal of the national authorities for 10 years after the instrument has been placed on the market. The EU declaration of conformity shall identify the instrument model for which it has been drawn up.", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-5/division-5.6/division-5.6.2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/5/division/5.6" }, { "path": "annex/II/division/5/division/5.7", "kind": "division", "number": "5.7", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-5/division-5.7", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/5" }, { "path": "annex/II/division/5/division/5.8", "kind": "division", "number": "5.8", "heading": "Authorised representative", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-5/division-5.8", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/5" }, { "path": "annex/II/division/6", "kind": "division", "number": "6", "heading": "Module G: Conformity based on unit verification", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II" }, { "path": "annex/II/division/6/division/6.1", "kind": "division", "number": "6.1", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-6/division-6.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/6" }, { "path": "annex/II/division/6/division/6.2", "kind": "division", "number": "6.2", "heading": "Technical documentation", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/6" }, { "path": "annex/II/division/6/division/6.2/division/6.2.1", "kind": "division", "number": "6.2.1", "heading": "The manufacturer shall establish the technical documentation and make it available to the notified body referred to in point 6.4. The documentation shall make it possible to assess the instrument’s conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the instrument. The technical documentation shall, wherever applicable, contain at least the following elements:", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-6/division-6.2/division-6.2.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/6/division/6.2" }, { "path": "annex/II/division/6/division/6.2/division/6.2.2", "kind": "division", "number": "6.2.2", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-6/division-6.2/division-6.2.2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/6/division/6.2" }, { "path": "annex/II/division/6/division/6.3", "kind": "division", "number": "6.3", "heading": "Manufacturing", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-6/division-6.3", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/6" }, { "path": "annex/II/division/6/division/6.4", "kind": "division", "number": "6.4", "heading": "Verification", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-6/division-6.4", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/6" }, { "path": "annex/II/division/6/division/6.5", "kind": "division", "number": "6.5", "heading": "Conformity marking and EU declaration of conformity", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/6" }, { "path": "annex/II/division/6/division/6.5/division/6.5.1", "kind": "division", "number": "6.5.1", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-6/division-6.5/division-6.5.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/6/division/6.5" }, { "path": "annex/II/division/6/division/6.5/division/6.5.2", "kind": "division", "number": "6.5.2", "heading": "The manufacturer shall draw up a written EU declaration of conformity and keep it at the disposal of the national authorities for 10 years after the instrument has been placed on the market. The EU declaration of conformity shall identify the instrument for which it has been drawn up.", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-6/division-6.5/division-6.5.2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/6/division/6.5" }, { "path": "annex/II/division/6/division/6.6", "kind": "division", "number": "6.6", "heading": "Authorised representative", "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-6/division-6.6", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/6" }, { "path": "annex/II/division/7", "kind": "division", "number": "7", "heading": "Common provisions", "url": null, "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II" }, { "path": "annex/II/division/7/division/7.1", "kind": "division", "number": "7.1", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-7/division-7.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/7" }, { "path": "annex/II/division/7/division/7.2", "kind": "division", "number": "7.2", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-7/division-7.2", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/7" }, { "path": "annex/II/division/7/division/7.2.1", "kind": "division", "number": "7.2.1", "heading": null, "url": "https://openlegislation.uk/eu-directive-2014-31/annex-II/division-7/division-7.2.1", "extent": "E+W+S+N.I.", "status": null, "parent": "annex/II/division/7" }, { "path": "annex/II/division/7/division/7.2.2", "kind": "division", "number": "7.2.2", "heading": "The party which has carried out the first stage of the procedure shall issue for each of the instruments a certificate containing the data necessary for identification of the instrument and specifying the examinations and tests that have been carried out.", "url": 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