{ "$schema": "https://www.conphora.com/schemas/regulation-page.json", "code": "NAWI", "locale": "en", "url": "https://www.conphora.com/regulations/nawi/", "json": "https://www.conphora.com/regulations/nawi.json", "summaryPdf": "https://www.conphora.com/regulations/nawi/summary.pdf", "dateModified": "2026-09-12", "regulation": { "code": "NAWI", "name": "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)", "shortName": "Non-automatic Weighing Instruments Directive", "reference": "Directive 2014/31/EU", "celex": "32014L0031", "eurlex": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031", "actType": "Directive", "category": "Measuring Instruments", "inForce": "2014-04-18", "appliesFrom": "2016-04-20", "changing": false, "video": "regulation-nawi" }, "answer": "The Non-automatic Weighing Instruments Directive requires operator-assisted weighing instruments used for legally controlled purposes to meet accuracy classes I to IIII, pass notified-body assessment and carry the CE and metrology markings, binding manufacturers, importers and distributors. It has applied since 20 April 2016, replacing Directive 2009/23/EC, and has never been amended.", "description": "NAWI guide: the Non-automatic Weighing Instruments Directive, the six legally controlled uses from shop scales to patient scales, accuracy classes I to IIII, the notified-body conformity modules, the CE marking with the supplementary metrology marking, key dates and how to comply.", "enforcedBy": "National market surveillance authorities enforce the national laws transposing the directive; Article 36 still cites Article 15(3) and Articles 16 to 29 of Regulation (EC) No 765/2008, read as Regulation (EU) 2019/1020 since 16 July 2021, whose Annex I lists the directive as point 50 and whose Article 4 requires an economic operator established in the Union for every instrument placed on the market. In Denmark the directive is implemented by executive order nr. 773 of 1 June 2022 on making non-automatic weighing instruments available on the market, issued under the product act (lov om produkter og markedsovervågning), which lists the directive in section 2 as point 13 and names Erhvervsstyrelsen as the control authority; the tasks are carried out by Sikkerhedsstyrelsen, since January 2026 the department Markedsovervågning of Erhvervsstyrelsen, which also designates the Danish notified bodies, and executive order nr. 591 of 29 May 2018 binds the undertaking that has a weighing instrument at its disposal and uses it for one of those purposes — the vægtejer — to accuracy classes, self-checks and reverification, while section 16 a of the product act reaches any instrument owner, natural or legal person. The toolkit is corrective action within a set period, prohibition or restriction of the making available, withdrawal or recall, orders to end formal non-compliance such as a missing CE or metrology marking, inscription, declaration or technical documentation, orders to the owner of an instrument used for payment-based weighing, and national penalties that must be effective, proportionate and dissuasive and may include criminal penalties for serious infringements.", "keyDates": [ { "date": "1993-01-01", "label": "Council Directive 90/384/EEC on non-automatic weighing instruments applies, with a ten-year transition for instruments conforming to the rules in force before that date; Directive 93/68/EEC's marking arrangements followed from 1 January 1995", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Annex V, Part B" }, { "date": "2009-06-05", "label": "Directive 2009/23/EC, the codification of Directive 90/384/EEC, enters into force; it is the act Directive 2014/31/EU recasts and repeals", "source": "https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32009L0023 · document information (dates); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · recital 1 and footnote 3" }, { "date": "2014-02-26", "label": "Directive 2014/31/EU adopted by the European Parliament and the Council as a recast of Directive 2009/23/EC aligned with the New Legislative Framework", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · title and signature block after Art. 47" }, { "date": "2014-04-18", "label": "Entry into force, the twentieth day after publication in OJ L 96 of 29 March 2014", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 46" }, { "date": "2016-04-19", "label": "Deadline for Member States to adopt and publish the laws transposing points (3) to (19) of Article 2, Articles 6 to 17, Articles 19 to 43 and Annexes II, III and IV", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 44(1)" }, { "date": "2016-04-20", "label": "National measures apply; Article 1, points (1) and (2) of Article 2, Articles 3, 4, 5 and 18 and Annexes I, V and VI apply directly; Directive 2009/23/EC repealed; instruments conforming to it and placed on the market before this date may still be made available and put into service, and its certificates remain valid", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 43, Art. 44(1), Art. 45 and Art. 46" }, { "date": "2018-07-01", "label": "Danish executive order nr. 591 of 29 May 2018 on the use of non-automatic weighing instruments in force: undertakings that use an instrument for one of the six legal purposes must use the prescribed accuracy class, run a traceable self-check against an in-service tolerance of twice the tolerance at placing on the market and have the instrument reverified by an accredited firm when its seal is broken", "source": "https://www.retsinformation.dk/eli/lta/2018/591 · § 1, § 3 to § 8 and § 13" }, { "date": "2021-07-01", "label": "Legal metrology, including non-automatic weighing instruments, falls under the Danish product act (lov om produkter og markedsovervågning)", "source": "https://www.sik.dk/erhverv/produkter/maaling-og-vaegt-metrologi/love-og-regler-0/regler-og-bekendtgoerelser-maaling-og-vaegt; https://www.retsinformation.dk/eli/lta/2026/22 · § 2, stk. 1, nr. 13" }, { "date": "2021-07-16", "label": "Regulation (EU) 2019/1020 applies: it replaces the market surveillance articles of Regulation (EC) No 765/2008 that Article 36 cites, lists the directive as point 50 of its Annex I and, under Article 4, requires an economic operator established in the Union for every non-automatic weighing instrument placed on the market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32019R1020 · Art. 4(5), Art. 39, Art. 44 and Annex I point 50" }, { "date": "2022-07-01", "label": "Danish executive order nr. 773 of 1 June 2022 on making non-automatic weighing instruments available on the market in force, replacing order nr. 1381 of 25 November 2016; it repeats the seven categories of use, the operator duties, the modules, the markings and the notified-body designation by Sikkerhedsstyrelsen", "source": "https://www.retsinformation.dk/eli/lta/2022/773 · § 2, § 34, § 35, § 41, § 56 and § 57" }, { "date": "2026-01-01", "label": "Sikkerhedsstyrelsen becomes the department Markedsovervågning of Erhvervsstyrelsen and continues the same tasks, including the control of weighing instruments and the designation of notified bodies", "source": "https://erhvervsstyrelsen.dk/sikkerhedsstyrelsen-en-del-af-erhvervsstyrelsen; https://www.retsinformation.dk/eli/lta/2026/22 · § 9" } ], "scope": { "appliesTo": [ "All non-automatic weighing instruments, that is weighing instruments requiring the intervention of an operator during weighing, such as shop and counter scales, platform and pallet scales, weighbridges, laboratory balances, patient scales and price-labelling scales", "Instruments used or intended for the six legally controlled purposes of Article 1(2)(a) to (f): mass for commercial transactions; mass for calculating a toll, tariff, tax, bonus, penalty, remuneration, indemnity or similar payment; mass for the application of laws or regulations or for an expert opinion in court proceedings; mass in medical practice for weighing patients for monitoring, diagnosis and treatment; mass for making up medicines on prescription in a pharmacy and in analyses in medical and pharmaceutical laboratories; and price on the basis of mass for direct sales to the public and the making-up of prepackages", "Instruments for all other applications, Article 1(2)(g): they need only the manufacturer's name and the maximum capacity, must not carry the conformity marking, and their makers, importers and distributors keep the identification and address duties", "The economic operators in the chain: manufacturers, authorised representatives, importers and distributors" ], "derived": [ "Only instruments used or intended for the purposes in Article 1(2)(a) to (f) must satisfy the Annex I essential requirements; devices included in or connected to such an instrument that are not used for those purposes are not subject to them, and carry the restrictive use symbol, a black capital M on a red square of at least 25 mm by 25 mm with two crossed diagonals (Art. 4, Art. 6(5), Art. 18 and Annex III, point 3)", "Instruments may not be put into service for the purposes in Article 1(2)(a) to (f) unless they meet the directive, and must continue to conform once in service; in Denmark executive order nr. 591/2018 makes the using undertaking responsible for accuracy class, self-check and reverification (Art. 3(2) and (3); executive order nr. 591/2018, § 3 to § 8)", "Automatic weighing instruments, which weigh without operator intervention, are outside the directive; they are MI-006 under the Measuring Instruments Directive 2014/32/EU (Art. 2, point (2); Directive 2014/32/EU, Art. 2(1))", "Instruments conforming to harmonised standards whose references are published in the Official Journal are presumed to meet the essential requirements those standards cover; the Commission publishes the list of harmonised standards under the directive and works with WELMEC on guidance (Art. 12; European Commission, measuring and weighing instruments page)", "An importer or distributor that sells under its own name or trade mark, or modifies an instrument already placed on the market in a way that may affect compliance, is treated as the manufacturer (Art. 10)", "Instruments similar to those used for direct sales to the public that do not satisfy the additional requirements for such instruments must carry the indelible marking 'Not to be used for direct sale to the public' near the display (Annex I, point 14)" ], "categories": [ { "id": "retail-scales", "label": "Shop, counter or price-computing scales used for direct sales to the public" }, { "id": "commercial-transaction-scales", "label": "Platform, pallet, crane or weighbridge scales used to determine mass for commercial transactions" }, { "id": "toll-tax-legal-scales", "label": "Scales used for tolls, tariffs, taxes, bonuses, penalties or similar payments, or for applying laws or court expertise" }, { "id": "medical-scales", "label": "Patient scales used in medical practice for monitoring, diagnosis and treatment" }, { "id": "pharmacy-laboratory-scales", "label": "Balances for making up prescription medicines in a pharmacy or for analyses in medical and pharmaceutical laboratories" }, { "id": "prepackage-scales", "label": "Non-automatic scales used to make up prepackages" }, { "id": "non-legal-use-scales", "label": "Scales for any other use only, such as kitchen, bathroom, luggage, postal-estimate or industrial process scales not used for payment or legal purposes" }, { "id": "connected-non-legal-devices", "label": "Printer, display or other device included in or connected to a legally used scale but not used for the legal purpose" }, { "id": "automatic-weighing-instruments", "label": "Automatic weighing instruments that weigh without an operator, such as checkweighers, filling machines and belt weighers" }, { "id": "pre-2016-instruments", "label": "Instrument conforming to Directive 2009/23/EC and placed on the market before 20 April 2016" } ], "roles": [ { "id": "manufacturer", "label": "Manufacturer (including brand owners)", "definition": "Any natural or legal person who manufactures an instrument or has an instrument designed or manufactured, and markets that instrument under his name or trade mark; an importer or distributor that places an instrument on the market under its own name or trade mark or modifies an instrument in a way that may affect compliance is treated as the manufacturer.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 2, point (5), and Art. 10" }, { "id": "other", "label": "Authorised representative", "definition": "Any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks; the duty to design and manufacture to the essential requirements and the duty to draw up the technical documentation cannot form part of the mandate.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 2, point (6), and Art. 7(1)" }, { "id": "importer", "label": "Importer", "definition": "Any natural or legal person established within the Union who places an instrument from a third country on the Union market.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 2, point (7)" }, { "id": "distributor", "label": "Distributor (wholesaler, retailer or dealer supplying scales)", "definition": "Any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes an instrument available on the market.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 2, point (8)" } ], "rules": [ { "categories": [ "automatic-weighing-instruments" ], "roles": [ "*" ], "size": "any", "result": "out-of-scope", "note": "The directive covers only instruments that require the intervention of an operator during weighing; an instrument that weighs without an operator is an automatic weighing instrument, defined as MI-006 in Annex VIII of the Measuring Instruments Directive 2014/32/EU, which has its own conformity assessment and metrology marking rules.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 1(1) and Art. 2, point (2); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0032 · Art. 2(1)" }, { "categories": [ "retail-scales", "commercial-transaction-scales", "toll-tax-legal-scales", "medical-scales", "pharmacy-laboratory-scales", "prepackage-scales" ], "roles": [ "manufacturer", "importer", "distributor", "other" ], "size": "any", "result": "in-scope", "note": "An instrument used or intended for one of the six purposes in Article 1(2)(a) to (f) must satisfy the Annex I essential requirements, go through EU-type examination with module D or F, module D1 or F1 for purely mechanical non-spring instruments, or unit verification under module G with a notified body, and carry the CE marking, the supplementary metrology marking, the notified body number and the Annex III point 1 inscriptions before it is placed on the market; the duties fall on the manufacturer, authorised representative, importer and distributor and contain no company-size threshold. In Denmark executive order nr. 773/2022 repeats these duties and the owner must keep the instrument in legal use verified under executive order nr. 591/2018.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 1(2), Art. 3, Art. 4, Art. 6, Art. 8, Art. 9, Art. 13, Art. 15 and Annex III, point 1; https://www.retsinformation.dk/eli/lta/2022/773 · § 2, § 34 and § 35; https://www.retsinformation.dk/eli/lta/2018/591 · § 3" }, { "categories": [ "non-legal-use-scales" ], "roles": [ "manufacturer", "importer", "distributor", "other" ], "size": "any", "result": "depends", "note": "The directive applies to all non-automatic weighing instruments, but an instrument not intended for the purposes in Article 1(2)(a) to (f) is not subject to the essential requirements, the conformity assessment or the CE and metrology markings, which it must not bear; it must carry the manufacturer's name, registered trade name or registered trade mark and the maximum capacity in the form Max, together with the manufacturer's and importer's name and postal contact address; Annex III point 2 requires nothing else for such instruments, so the type, batch or serial number that Article 6(5) calls for is satisfied by those inscriptions. Importers and distributors must check that the manufacturer applied them. If the same model is sold or installed for a legal purpose, the full regime applies, so the intended use decides.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 1(2)(g), Art. 4, Art. 6(5) and (6), Art. 8(2), Art. 9(2) and Annex III, point 2" }, { "categories": [ "connected-non-legal-devices" ], "roles": [ "manufacturer", "importer", "distributor", "other" ], "size": "any", "result": "depends", "note": "Where a legally used instrument includes or is connected to devices not used for the legal purpose, those devices are not subject to the essential requirements, but the manufacturer must affix the restrictive use symbol, a black capital M on a red square of at least 25 mm by 25 mm crossed by two diagonals, to each of them; a repeating display or printer that cannot influence the result is likewise outside the essential requirements if a conforming part of the instrument records the result correctly, except that for direct sales to the public the vendor's and customer's display and printing devices must conform.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 4, Art. 6(5), Art. 18, Annex I, preliminary observation, and Annex III, point 3" }, { "categories": [ "pre-2016-instruments" ], "roles": [ "*" ], "size": "any", "result": "depends", "note": "Instruments covered by Directive 2009/23/EC, in conformity with it and placed on the market before 20 April 2016 may still be made available and put into service, and certificates issued under that directive remain valid; in Denmark the same rule is repeated in executive order nr. 773/2022 for instruments meeting the 2003 control order. A modified instrument needs a new conformity assessment and declaration under the current directive. New production must meet Directive 2014/31/EU.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 43; https://www.retsinformation.dk/eli/lta/2022/773 · § 57; https://www.sik.dk/erhverv/produkter/maaling-vaegt-og-e-maerkning-metrologi/spoergsmaal-og-svar/spoergsmaal-og-svar-om-direktiv-om-ikke-automatiske-vaegte-nawi" }, { "categories": [ "*" ], "roles": [ "*" ], "size": "any", "result": "depends", "note": "Whether the full regime applies turns on whether the instrument needs an operator during weighing, whether it is used or intended for one of the six purposes in Article 1(2)(a) to (f), when it was placed on the market and which role the operator holds.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 1, Art. 2, Art. 4 and Art. 43" } ] }, "obligations": { "manufacturer": [ { "text": "Design and manufacture instruments intended for the six legal purposes to the essential requirements of Annex I: legal units of mass, an accuracy class I, II, III or IIII with the verification scale interval, minimum capacity and number of verification scale intervals of Table 1, errors within the maximum permissible errors of Table 3, repeatable and reproducible results, insensitivity to tilt, the specified temperature range, correct behaviour on power fluctuation and disturbances, no features that facilitate fraud, correct indication and printing, levelling, zeroing and tare devices, and the extra rules for instruments for direct sales to the public and price labelling.", "id": "nawi-mfr-design-manufacture-instruments", "kind": "evidence", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 4, Art. 6(1) and Annex I, points 1 to 15" }, { "text": "Draw up the Annex II technical documentation, which must allow the conformity to be assessed and include an adequate analysis and assessment of the risks, a general description, design and manufacturing drawings, the explanations needed to understand them, the list of harmonised standards applied in full or in part or the solutions adopted instead, design calculations, examinations and test reports, and carry out or have carried out the Article 13 conformity assessment procedure.", "id": "nawi-mfr-draw-annex-technical", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "technical-documentation", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 6(2) and Annex II, point 1.3" }, { "text": "Carry out an adequate analysis and assessment of the risks of the instrument and include it in the technical documentation.", "id": "nawi-mfr-carry-out-risk-analysis", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "risk-analysis", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 6(2) and Annex II, point 1.3" }, { "text": "Draw up the Annex II technical documentation: a general description, design and manufacturing drawings with explanations, the harmonised standards applied or the solutions adopted instead, design calculations, examinations and test reports.", "id": "nawi-mfr-draw-technical-documentation", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "technical-documentation", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 6(2) and Annex II, point 1.3" }, { "text": "Carry out, or have carried out, the Article 13 conformity assessment procedure for instruments intended for a legal purpose.", "id": "nawi-mfr-carry-out-conformity-assessment", "kind": "procedure", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 6(2) and Art. 13" }, { "text": "Choose EU-type examination (module B) followed by conformity to type based on quality assurance of the production process (module D) or on product verification (module F), or conformity based on unit verification (module G); module B is not compulsory for instruments that use no electronic device and whose load-measuring device does not use a spring to balance the load, which then follow module D1 or F1. In Denmark the notified body must be designated by Sikkerhedsstyrelsen or by another Member State.", "id": "nawi-mfr-choose-eu-type-examination", "kind": "decision", "level": "company", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 13 and Annex II; https://www.retsinformation.dk/eli/lta/2022/773 · § 34 and § 35" }, { "text": "Draw up the EU declaration of conformity per the Annex IV model, containing the elements of the modules used, continuously updated, translated into the languages the Member State requires and, where several Union acts apply, as a single declaration covering them all, and affix the CE marking and the supplementary metrology marking before placing the instrument on the market; in Denmark the declaration must be in Danish or English.", "id": "nawi-mfr-draw-declaration-conformity", "kind": "evidence", "level": "product-market", "timing": "before-market", "sharedKey": "declaration-of-conformity", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 6(2), Art. 14, Art. 15 and Art. 17(2); https://www.retsinformation.dk/eli/lta/2022/773 · § 37" }, { "text": "Draw up the EU declaration of conformity per the Annex IV model with the elements of the modules used, kept continuously updated, translated into the languages the Member State requires (in Denmark Danish or English) and, where several Union acts apply, as a single declaration.", "id": "nawi-mfr-draw-eu-declaration", "kind": "evidence", "level": "product-market", "timing": "before-market", "sharedKey": "declaration-of-conformity", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 6(2) and Art. 14; https://www.retsinformation.dk/eli/lta/2022/773 · § 37" }, { "text": "Affix the CE marking and the supplementary metrology marking, the capital letter M and the last two digits of the year of affixing in a rectangle of the CE marking's height, visibly, legibly and indelibly to the instrument or its data plate, the metrology marking immediately after the CE marking and both followed by the identification number of the notified body involved in production control, affixed by the body or under its instructions.", "id": "nawi-mfr-affix-marking-supplementary", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "ce-marking", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 16 and Art. 17" }, { "text": "Apply the Annex III inscriptions: for legally used instruments the EU-type examination certificate number where appropriate, your name or trade mark, the accuracy class in an oval, Max, Min, e, the type, batch or serial number and where applicable d, T, dT, Lim, temperature limits and the load-receptor ratio, with Max, Min, e and d also near the display; for other instruments only your name or trade mark and Max, without the conformity marking; and the restrictive use symbol on connected devices not used for the legal purpose.", "id": "nawi-mfr-apply-annex-iii", "kind": "data", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 6(5), Art. 18 and Annex III" }, { "text": "Keep the technical documentation and the EU declaration of conformity for 10 years after the instrument was placed on the market, keep series production in conformity, taking account of changes in design and in the standards referenced, and where the risks warrant it sample-test marketed instruments, investigate and keep a register of complaints, non-conforming instruments and recalls, and keep distributors informed.", "id": "nawi-mfr-keep-technical-documentation", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 6(3) and Art. 6(4)" }, { "text": "Keep the technical documentation and the EU declaration of conformity for 10 years after the instrument was placed on the market.", "id": "nawi-mfr-keep-documentation-years", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 6(3)" }, { "text": "Keep series production in conformity, taking account of changes in design or characteristics and in the harmonised standards referenced.", "id": "nawi-mfr-maintain-series-conformity", "kind": "standing", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 6(4)" }, { "text": "Where the risks warrant it, sample-test marketed instruments, investigate complaints, keep a register of complaints, non-conforming instruments and recalls, and keep distributors informed of that monitoring.", "id": "nawi-mfr-sample-test-register", "kind": "standing", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 6(4)" }, { "text": "Mark your name, registered trade name or trade mark and a single postal contact address on the instrument, supply legally used instruments with instructions and information in a language the Member State determines, and if an instrument you placed on the market does not conform, immediately bring it into conformity, withdraw or recall it, inform the competent authorities where it presents a risk, provide conformity documentation on reasoned request, cooperate on risk-elimination measures and identify your suppliers and customers for 10 years.", "id": "nawi-mfr-mark-name-registered", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "identification-and-address", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 6(6) to Art. 6(9) and Art. 11" }, { "text": "Mark your name, registered trade name or trade mark and a single postal contact address on the instrument.", "id": "nawi-mfr-mark-name-address", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "identification-and-address", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 6(6)" }, { "text": "Supply legally used instruments with instructions and information in a language the Member State determines.", "id": "nawi-mfr-supply-instructions", "kind": "evidence", "level": "product-market", "timing": "before-market", "sharedKey": "instructions-and-safety-information", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 6(7)" }, { "text": "If an instrument you placed on the market does not conform, immediately bring it into conformity, withdraw or recall it, and where it presents a risk inform the competent national authorities of the Member States concerned.", "id": "nawi-mfr-take-corrective-measures", "kind": "submission", "level": "product", "timing": "on-event", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 6(8)" }, { "text": "On a reasoned request, provide the authority with the information and documentation demonstrating conformity in a language it understands, and cooperate on measures to eliminate the risks posed by the instruments.", "id": "nawi-mfr-provide-information-request", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 6(9)" }, { "text": "Be able to identify, for 10 years after each supply, the economic operators that supplied you and the economic operators you supplied.", "id": "nawi-mfr-identify-suppliers-customers", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "record-keeping-10y", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 11" } ], "other": [ { "text": "Act under a written mandate that at least lets you keep the EU declaration of conformity and the technical documentation at the disposal of the national market surveillance authorities for 10 years after the instrument was placed on the market, provide conformity information and documentation on reasoned request, and cooperate with the authorities on risk-elimination measures for the instruments in your mandate.", "id": "nawi-oth-act-written-mandate", "kind": "evidence", "level": "company", "timing": "before-market", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 7(2)" }, { "text": "Act only under a written mandate from the manufacturer that sets out the tasks you perform on its behalf.", "id": "nawi-oth-hold-written-mandate", "kind": "evidence", "level": "company", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 7(1) and Art. 7(2)" }, { "text": "Keep the EU declaration of conformity and the technical documentation at the disposal of the national market surveillance authorities for 10 years after the instrument was placed on the market.", "id": "nawi-oth-keep-documentation-years", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 7(2)(a)" }, { "text": "On a reasoned request, provide the authority with the information and documentation demonstrating conformity, and cooperate with it on measures to eliminate the risks of the instruments covered by your mandate.", "id": "nawi-oth-provide-information-request", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 7(2)(b) and Art. 7(2)(c)" }, { "text": "Do not take over the manufacturer's duty to design and manufacture to the essential requirements or to draw up the technical documentation; those cannot form part of the mandate.", "id": "nawi-oth-take-manufacturers-duty", "kind": "status", "level": "company", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 7(1)" }, { "text": "Where the notified body instructs it, affix its identification number after the CE and metrology markings on the manufacturer's behalf, and be able to identify the economic operators that supplied you and that you supplied for 10 years.", "id": "nawi-oth-affix-identification-number", "kind": "mark", "level": "product", "timing": "before-market", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 11 and Art. 17(4)" }, { "text": "Where the notified body instructs it, affix its identification number after the CE and metrology markings on the manufacturer's behalf.", "id": "nawi-oth-affix-notified-body-number", "kind": "mark", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 17(4)" }, { "text": "Be able to identify, for 10 years after each supply, the economic operators that supplied you and the economic operators you supplied.", "id": "nawi-oth-identify-suppliers-customers", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "record-keeping-10y", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 11" }, { "text": "Where the manufacturer is outside the Union and no importer exists, you may be the economic operator established in the Union that Regulation (EU) 2019/1020 requires for every non-automatic weighing instrument placed on the market, verifying the declaration and documentation, informing the authorities of risks and cooperating on corrective action.", "id": "nawi-oth-economic-operator-established", "kind": "verification", "level": "product", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32019R1020 · Art. 4(1) to Art. 4(5)" } ], "importer": [ { "text": "Place only compliant instruments on the market, and before placing a legally used instrument on the market check that the manufacturer carried out the Article 13 conformity assessment, drew up the technical documentation, affixed the CE marking and the supplementary metrology marking, supplied the required documents and applied the identification and address markings; hold back instruments you believe do not meet Annex I and inform the manufacturer and the market surveillance authorities where they present a risk. For instruments not intended for a legal purpose, check the identification and address markings.", "id": "nawi-imp-place-compliant-instruments", "kind": "verification", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 8(1) and Art. 8(2)" }, { "text": "Indicate your name, registered trade name or trade mark and a postal contact address on the instrument or, where that requires opening the packaging, on the packaging and in an accompanying document, in a language end users and the authorities understand.", "id": "nawi-imp-indicate-name-registered", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "identification-and-address", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 8(3)" }, { "text": "Ensure legally used instruments are accompanied by instructions and information in a language the Member State determines, in Denmark Danish or English, and keep storage and transport conditions from jeopardising compliance with Annex I while the instrument is under your responsibility.", "id": "nawi-imp-ensure-legally-used", "kind": "verification", "level": "product-market", "timing": "before-market", "sharedKey": "instructions-and-safety-information", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 8(4) and Art. 8(5); https://www.retsinformation.dk/eli/lta/2022/773 · § 20, stk. 2, nr. 3" }, { "text": "Ensure legally used instruments are accompanied by instructions and information in a language the Member State determines, in Denmark Danish or English.", "id": "nawi-imp-ensure-instructions-accompany", "kind": "verification", "level": "product-market", "timing": "before-market", "sharedKey": "instructions-and-safety-information", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 8(4); https://www.retsinformation.dk/eli/lta/2022/773 · § 20, stk. 2, nr. 3" }, { "text": "While an instrument is under your responsibility, keep storage and transport conditions from jeopardising its compliance with Annex I.", "id": "nawi-imp-ensure-storage-transport", "kind": "standing", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 8(5)" }, { "text": "Where the risks warrant it, sample-test marketed instruments, investigate and keep a register of complaints, non-conforming instruments and recalls, and keep distributors informed.", "id": "nawi-imp-sample-test-marketed-instruments", "kind": "standing", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 8(6)" }, { "text": "If an instrument you placed on the market does not conform, immediately take corrective measures, withdraw or recall it, and where it presents a risk inform the competent national authorities of the Member States concerned with details of the non-compliance and the corrective measures.", "id": "nawi-imp-immediately-take-corrective", "kind": "submission", "level": "product", "timing": "on-event", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 8(7)" }, { "text": "Keep a copy of the EU declaration of conformity of legally used instruments at the disposal of the market surveillance authorities for 10 years and ensure the technical documentation can be made available on request; provide conformity information on reasoned request in a language the authority understands, cooperate on risk-elimination measures and identify suppliers and customers for 10 years.", "id": "nawi-imp-keep-copy-declaration", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 8(8), Art. 8(9) and Art. 11" }, { "text": "Keep a copy of the EU declaration of conformity of legally used instruments at the disposal of the market surveillance authorities for 10 years, and ensure the technical documentation can be made available on request.", "id": "nawi-imp-keep-declaration-copy", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 8(8)" }, { "text": "On a reasoned request, provide the authority with the information and documentation demonstrating conformity in a language it understands, and cooperate on measures to eliminate the risks posed by the instruments.", "id": "nawi-imp-provide-information-request", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 8(9)" }, { "text": "Be able to identify, for 10 years after each supply, the economic operators that supplied you and the economic operators you supplied.", "id": "nawi-imp-identify-suppliers-customers", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "record-keeping-10y", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 11" }, { "text": "If you place an instrument on the market under your own name or trade mark, or modify an instrument already placed on the market in a way that may affect compliance, you carry the manufacturer's obligations under Article 6.", "id": "nawi-imp-modify-instrument-already", "kind": "status", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 10" } ], "distributor": [ { "text": "Act with due care and, before making a legally used instrument available, verify that it bears the CE marking and the supplementary metrology marking, is accompanied by the required documents and by instructions and information in a language end users in the Member State understand, and that the manufacturer and importer applied their identification and address markings; hold back instruments you believe do not meet Annex I and inform the manufacturer or importer and the market surveillance authorities where they present a risk. For instruments not intended for a legal purpose, verify the identification and address markings.", "id": "nawi-dist-act-due-care", "kind": "verification", "level": "product-market", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 9(1) and Art. 9(2)" }, { "text": "Keep storage and transport conditions from jeopardising compliance with Annex I while a legally used instrument is under your responsibility.", "id": "nawi-dist-keep-storage-transport", "kind": "standing", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 9(3)" }, { "text": "If an instrument you made available does not conform, make sure corrective measures are taken to bring it into conformity, withdraw or recall it, and where it presents a risk immediately inform the competent national authorities of the Member States concerned.", "id": "nawi-dist-make-sure-corrective", "kind": "submission", "level": "product", "timing": "on-event", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 9(4)" }, { "text": "On reasoned request, provide the information and documentation demonstrating conformity, cooperate on risk-elimination measures, and identify the economic operators that supplied you and that you supplied for 10 years.", "id": "nawi-dist-provide-information-documentation", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 9(5) and Art. 11" }, { "text": "On a reasoned request, provide the authority with the information and documentation demonstrating conformity in a language it understands, and cooperate on measures to eliminate the risks posed by the instruments.", "id": "nawi-dist-provide-information-request", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 9(5)" }, { "text": "Be able to identify, for 10 years after each supply, the economic operators that supplied you and the economic operators you supplied.", "id": "nawi-dist-identify-suppliers-customers", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "record-keeping-10y", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 11" }, { "text": "If you sell under your own name or trade mark or modify an instrument in a way that may affect compliance, you take on the manufacturer's obligations; in Denmark an instrument used for weighing on which payment is based must also meet the rules in the hands of the undertaking that uses it, which must use the prescribed accuracy class, self-check it and have it reverified, and can be ordered to bring it into conformity or forbidden to use it.", "id": "nawi-dist-take-manufacturers-obligations", "kind": "status", "level": "product", "timing": "before-market", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 10; https://www.retsinformation.dk/eli/lta/2018/591 · § 3 to § 8; https://www.retsinformation.dk/eli/lta/2026/22 · § 16 a" }, { "text": "If you make an instrument available under your own name or trade mark, or modify one in a way that may affect compliance, you take on the manufacturer's obligations under Article 6.", "id": "nawi-dist-own-name-manufacturer", "kind": "status", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 10" } ] }, "requirements": [ { "id": "nawi-mfr-design-manufacture-instruments", "role": "manufacturer", "kind": "evidence", "level": "product", "timing": "before-market", "text": "Design and manufacture instruments intended for the six legal purposes to the essential requirements of Annex I: legal units of mass, an accuracy class I, II, III or IIII with the verification scale interval, minimum capacity and number of verification scale intervals of Table 1, errors within the maximum permissible errors of Table 3, repeatable and reproducible results, insensitivity to tilt, the specified temperature range, correct behaviour on power fluctuation and disturbances, no features that facilitate fraud, correct indication and printing, levelling, zeroing and tare devices, and the extra rules for instruments for direct sales to the public and price labelling.", "article": "Art. 4, Art. 6(1) and Annex I, points 1 to 15", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-mfr-draw-annex-technical", "role": "manufacturer", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "technical-documentation", "retired": "2026-09-24", "text": "Draw up the Annex II technical documentation, which must allow the conformity to be assessed and include an adequate analysis and assessment of the risks, a general description, design and manufacturing drawings, the explanations needed to understand them, the list of harmonised standards applied in full or in part or the solutions adopted instead, design calculations, examinations and test reports, and carry out or have carried out the Article 13 conformity assessment procedure.", "article": "Art. 6(2) and Annex II, point 1.3", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-mfr-carry-out-risk-analysis", "role": "manufacturer", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "risk-analysis", "text": "Carry out an adequate analysis and assessment of the risks of the instrument and include it in the technical documentation.", "article": "Art. 6(2) and Annex II, point 1.3", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-mfr-draw-technical-documentation", "role": "manufacturer", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "technical-documentation", "text": "Draw up the Annex II technical documentation: a general description, design and manufacturing drawings with explanations, the harmonised standards applied or the solutions adopted instead, design calculations, examinations and test reports.", "article": "Art. 6(2) and Annex II, point 1.3", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-mfr-carry-out-conformity-assessment", "role": "manufacturer", "kind": "procedure", "level": "product", "timing": "before-market", "text": "Carry out, or have carried out, the Article 13 conformity assessment procedure for instruments intended for a legal purpose.", "article": "Art. 6(2) and Art. 13", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-mfr-choose-eu-type-examination", "role": "manufacturer", "kind": "decision", "level": "company", "timing": "before-market", "text": "Choose EU-type examination (module B) followed by conformity to type based on quality assurance of the production process (module D) or on product verification (module F), or conformity based on unit verification (module G); module B is not compulsory for instruments that use no electronic device and whose load-measuring device does not use a spring to balance the load, which then follow module D1 or F1. In Denmark the notified body must be designated by Sikkerhedsstyrelsen or by another Member State.", "article": "Art. 13 and Annex II; https://www.retsinformation.dk/eli/lta/2022/773 · § 34 and § 35", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-mfr-draw-declaration-conformity", "role": "manufacturer", "kind": "evidence", "level": "product-market", "timing": "before-market", "sharedKey": "declaration-of-conformity", "retired": "2026-09-24", "text": "Draw up the EU declaration of conformity per the Annex IV model, containing the elements of the modules used, continuously updated, translated into the languages the Member State requires and, where several Union acts apply, as a single declaration covering them all, and affix the CE marking and the supplementary metrology marking before placing the instrument on the market; in Denmark the declaration must be in Danish or English.", "article": "Art. 6(2), Art. 14, Art. 15 and Art. 17(2); https://www.retsinformation.dk/eli/lta/2022/773 · § 37", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-mfr-draw-eu-declaration", "role": "manufacturer", "kind": "evidence", "level": "product-market", "timing": "before-market", "sharedKey": "declaration-of-conformity", "text": "Draw up the EU declaration of conformity per the Annex IV model with the elements of the modules used, kept continuously updated, translated into the languages the Member State requires (in Denmark Danish or English) and, where several Union acts apply, as a single declaration.", "article": "Art. 6(2) and Art. 14; https://www.retsinformation.dk/eli/lta/2022/773 · § 37", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-mfr-affix-marking-supplementary", "role": "manufacturer", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "ce-marking", "text": "Affix the CE marking and the supplementary metrology marking, the capital letter M and the last two digits of the year of affixing in a rectangle of the CE marking's height, visibly, legibly and indelibly to the instrument or its data plate, the metrology marking immediately after the CE marking and both followed by the identification number of the notified body involved in production control, affixed by the body or under its instructions.", "article": "Art. 16 and Art. 17", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-mfr-apply-annex-iii", "role": "manufacturer", "kind": "data", "level": "product", "timing": "before-market", "text": "Apply the Annex III inscriptions: for legally used instruments the EU-type examination certificate number where appropriate, your name or trade mark, the accuracy class in an oval, Max, Min, e, the type, batch or serial number and where applicable d, T, dT, Lim, temperature limits and the load-receptor ratio, with Max, Min, e and d also near the display; for other instruments only your name or trade mark and Max, without the conformity marking; and the restrictive use symbol on connected devices not used for the legal purpose.", "article": "Art. 6(5), Art. 18 and Annex III", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-mfr-keep-technical-documentation", "role": "manufacturer", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "retired": "2026-09-24", "text": "Keep the technical documentation and the EU declaration of conformity for 10 years after the instrument was placed on the market, keep series production in conformity, taking account of changes in design and in the standards referenced, and where the risks warrant it sample-test marketed instruments, investigate and keep a register of complaints, non-conforming instruments and recalls, and keep distributors informed.", "article": "Art. 6(3) and Art. 6(4)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-mfr-keep-documentation-years", "role": "manufacturer", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "text": "Keep the technical documentation and the EU declaration of conformity for 10 years after the instrument was placed on the market.", "article": "Art. 6(3)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-mfr-maintain-series-conformity", "role": "manufacturer", "kind": "standing", "level": "company", "timing": "ongoing", "text": "Keep series production in conformity, taking account of changes in design or characteristics and in the harmonised standards referenced.", "article": "Art. 6(4)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-mfr-sample-test-register", "role": "manufacturer", "kind": "standing", "level": "company", "timing": "ongoing", "text": "Where the risks warrant it, sample-test marketed instruments, investigate complaints, keep a register of complaints, non-conforming instruments and recalls, and keep distributors informed of that monitoring.", "article": "Art. 6(4)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-mfr-mark-name-registered", "role": "manufacturer", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "identification-and-address", "retired": "2026-09-24", "text": "Mark your name, registered trade name or trade mark and a single postal contact address on the instrument, supply legally used instruments with instructions and information in a language the Member State determines, and if an instrument you placed on the market does not conform, immediately bring it into conformity, withdraw or recall it, inform the competent authorities where it presents a risk, provide conformity documentation on reasoned request, cooperate on risk-elimination measures and identify your suppliers and customers for 10 years.", "article": "Art. 6(6) to Art. 6(9) and Art. 11", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-mfr-mark-name-address", "role": "manufacturer", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "identification-and-address", "text": "Mark your name, registered trade name or trade mark and a single postal contact address on the instrument.", "article": "Art. 6(6)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-mfr-supply-instructions", "role": "manufacturer", "kind": "evidence", "level": "product-market", "timing": "before-market", "sharedKey": "instructions-and-safety-information", "text": "Supply legally used instruments with instructions and information in a language the Member State determines.", "article": "Art. 6(7)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-mfr-take-corrective-measures", "role": "manufacturer", "kind": "submission", "level": "product", "timing": "on-event", "text": "If an instrument you placed on the market does not conform, immediately bring it into conformity, withdraw or recall it, and where it presents a risk inform the competent national authorities of the Member States concerned.", "article": "Art. 6(8)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-mfr-provide-information-request", "role": "manufacturer", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "text": "On a reasoned request, provide the authority with the information and documentation demonstrating conformity in a language it understands, and cooperate on measures to eliminate the risks posed by the instruments.", "article": "Art. 6(9)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-mfr-identify-suppliers-customers", "role": "manufacturer", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "record-keeping-10y", "text": "Be able to identify, for 10 years after each supply, the economic operators that supplied you and the economic operators you supplied.", "article": "Art. 11", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-oth-act-written-mandate", "role": "other", "kind": "evidence", "level": "company", "timing": "before-market", "retired": "2026-09-24", "text": "Act under a written mandate that at least lets you keep the EU declaration of conformity and the technical documentation at the disposal of the national market surveillance authorities for 10 years after the instrument was placed on the market, provide conformity information and documentation on reasoned request, and cooperate with the authorities on risk-elimination measures for the instruments in your mandate.", "article": "Art. 7(2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-oth-hold-written-mandate", "role": "other", "kind": "evidence", "level": "company", "timing": "before-market", "text": "Act only under a written mandate from the manufacturer that sets out the tasks you perform on its behalf.", "article": "Art. 7(1) and Art. 7(2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-oth-keep-documentation-years", "role": "other", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "text": "Keep the EU declaration of conformity and the technical documentation at the disposal of the national market surveillance authorities for 10 years after the instrument was placed on the market.", "article": "Art. 7(2)(a)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-oth-provide-information-request", "role": "other", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "text": "On a reasoned request, provide the authority with the information and documentation demonstrating conformity, and cooperate with it on measures to eliminate the risks of the instruments covered by your mandate.", "article": "Art. 7(2)(b) and Art. 7(2)(c)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-oth-take-manufacturers-duty", "role": "other", "kind": "status", "level": "company", "timing": "before-market", "text": "Do not take over the manufacturer's duty to design and manufacture to the essential requirements or to draw up the technical documentation; those cannot form part of the mandate.", "article": "Art. 7(1)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-oth-affix-identification-number", "role": "other", "kind": "mark", "level": "product", "timing": "before-market", "retired": "2026-09-24", "text": "Where the notified body instructs it, affix its identification number after the CE and metrology markings on the manufacturer's behalf, and be able to identify the economic operators that supplied you and that you supplied for 10 years.", "article": "Art. 11 and Art. 17(4)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-oth-affix-notified-body-number", "role": "other", "kind": "mark", "level": "product", "timing": "before-market", "text": "Where the notified body instructs it, affix its identification number after the CE and metrology markings on the manufacturer's behalf.", "article": "Art. 17(4)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-oth-identify-suppliers-customers", "role": "other", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "record-keeping-10y", "text": "Be able to identify, for 10 years after each supply, the economic operators that supplied you and the economic operators you supplied.", "article": "Art. 11", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-oth-economic-operator-established", "role": "other", "kind": "verification", "level": "product", "timing": "ongoing", "text": "Where the manufacturer is outside the Union and no importer exists, you may be the economic operator established in the Union that Regulation (EU) 2019/1020 requires for every non-automatic weighing instrument placed on the market, verifying the declaration and documentation, informing the authorities of risks and cooperating on corrective action.", "article": "Art. 4(1) to Art. 4(5)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32019R1020" }, { "id": "nawi-imp-place-compliant-instruments", "role": "importer", "kind": "verification", "level": "product", "timing": "before-market", "text": "Place only compliant instruments on the market, and before placing a legally used instrument on the market check that the manufacturer carried out the Article 13 conformity assessment, drew up the technical documentation, affixed the CE marking and the supplementary metrology marking, supplied the required documents and applied the identification and address markings; hold back instruments you believe do not meet Annex I and inform the manufacturer and the market surveillance authorities where they present a risk. For instruments not intended for a legal purpose, check the identification and address markings.", "article": "Art. 8(1) and Art. 8(2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-imp-indicate-name-registered", "role": "importer", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "identification-and-address", "text": "Indicate your name, registered trade name or trade mark and a postal contact address on the instrument or, where that requires opening the packaging, on the packaging and in an accompanying document, in a language end users and the authorities understand.", "article": "Art. 8(3)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-imp-ensure-legally-used", "role": "importer", "kind": "verification", "level": "product-market", "timing": "before-market", "sharedKey": "instructions-and-safety-information", "retired": "2026-09-24", "text": "Ensure legally used instruments are accompanied by instructions and information in a language the Member State determines, in Denmark Danish or English, and keep storage and transport conditions from jeopardising compliance with Annex I while the instrument is under your responsibility.", "article": "Art. 8(4) and Art. 8(5); https://www.retsinformation.dk/eli/lta/2022/773 · § 20, stk. 2, nr. 3", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-imp-ensure-instructions-accompany", "role": "importer", "kind": "verification", "level": "product-market", "timing": "before-market", "sharedKey": "instructions-and-safety-information", "text": "Ensure legally used instruments are accompanied by instructions and information in a language the Member State determines, in Denmark Danish or English.", "article": "Art. 8(4); https://www.retsinformation.dk/eli/lta/2022/773 · § 20, stk. 2, nr. 3", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-imp-ensure-storage-transport", "role": "importer", "kind": "standing", "level": "company", "timing": "ongoing", "text": "While an instrument is under your responsibility, keep storage and transport conditions from jeopardising its compliance with Annex I.", "article": "Art. 8(5)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-imp-sample-test-marketed-instruments", "role": "importer", "kind": "standing", "level": "company", "timing": "ongoing", "text": "Where the risks warrant it, sample-test marketed instruments, investigate and keep a register of complaints, non-conforming instruments and recalls, and keep distributors informed.", "article": "Art. 8(6)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-imp-immediately-take-corrective", "role": "importer", "kind": "submission", "level": "product", "timing": "on-event", "text": "If an instrument you placed on the market does not conform, immediately take corrective measures, withdraw or recall it, and where it presents a risk inform the competent national authorities of the Member States concerned with details of the non-compliance and the corrective measures.", "article": "Art. 8(7)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-imp-keep-copy-declaration", "role": "importer", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "retired": "2026-09-24", "text": "Keep a copy of the EU declaration of conformity of legally used instruments at the disposal of the market surveillance authorities for 10 years and ensure the technical documentation can be made available on request; provide conformity information on reasoned request in a language the authority understands, cooperate on risk-elimination measures and identify suppliers and customers for 10 years.", "article": "Art. 8(8), Art. 8(9) and Art. 11", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-imp-keep-declaration-copy", "role": "importer", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "record-keeping-10y", "text": "Keep a copy of the EU declaration of conformity of legally used instruments at the disposal of the market surveillance authorities for 10 years, and ensure the technical documentation can be made available on request.", "article": "Art. 8(8)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-imp-provide-information-request", "role": "importer", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "text": "On a reasoned request, provide the authority with the information and documentation demonstrating conformity in a language it understands, and cooperate on measures to eliminate the risks posed by the instruments.", "article": "Art. 8(9)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-imp-identify-suppliers-customers", "role": "importer", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "record-keeping-10y", "text": "Be able to identify, for 10 years after each supply, the economic operators that supplied you and the economic operators you supplied.", "article": "Art. 11", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-imp-modify-instrument-already", "role": "importer", "kind": "status", "level": "product", "timing": "before-market", "text": "If you place an instrument on the market under your own name or trade mark, or modify an instrument already placed on the market in a way that may affect compliance, you carry the manufacturer's obligations under Article 6.", "article": "Art. 10", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-dist-act-due-care", "role": "distributor", "kind": "verification", "level": "product-market", "timing": "before-market", "text": "Act with due care and, before making a legally used instrument available, verify that it bears the CE marking and the supplementary metrology marking, is accompanied by the required documents and by instructions and information in a language end users in the Member State understand, and that the manufacturer and importer applied their identification and address markings; hold back instruments you believe do not meet Annex I and inform the manufacturer or importer and the market surveillance authorities where they present a risk. For instruments not intended for a legal purpose, verify the identification and address markings.", "article": "Art. 9(1) and Art. 9(2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-dist-keep-storage-transport", "role": "distributor", "kind": "standing", "level": "company", "timing": "ongoing", "text": "Keep storage and transport conditions from jeopardising compliance with Annex I while a legally used instrument is under your responsibility.", "article": "Art. 9(3)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-dist-make-sure-corrective", "role": "distributor", "kind": "submission", "level": "product", "timing": "on-event", "text": "If an instrument you made available does not conform, make sure corrective measures are taken to bring it into conformity, withdraw or recall it, and where it presents a risk immediately inform the competent national authorities of the Member States concerned.", "article": "Art. 9(4)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-dist-provide-information-documentation", "role": "distributor", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "retired": "2026-09-24", "text": "On reasoned request, provide the information and documentation demonstrating conformity, cooperate on risk-elimination measures, and identify the economic operators that supplied you and that you supplied for 10 years.", "article": "Art. 9(5) and Art. 11", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-dist-provide-information-request", "role": "distributor", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "text": "On a reasoned request, provide the authority with the information and documentation demonstrating conformity in a language it understands, and cooperate on measures to eliminate the risks posed by the instruments.", "article": "Art. 9(5)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-dist-identify-suppliers-customers", "role": "distributor", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "record-keeping-10y", "text": "Be able to identify, for 10 years after each supply, the economic operators that supplied you and the economic operators you supplied.", "article": "Art. 11", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-dist-take-manufacturers-obligations", "role": "distributor", "kind": "status", "level": "product", "timing": "before-market", "retired": "2026-09-24", "text": "If you sell under your own name or trade mark or modify an instrument in a way that may affect compliance, you take on the manufacturer's obligations; in Denmark an instrument used for weighing on which payment is based must also meet the rules in the hands of the undertaking that uses it, which must use the prescribed accuracy class, self-check it and have it reverified, and can be ordered to bring it into conformity or forbidden to use it.", "article": "Art. 10; https://www.retsinformation.dk/eli/lta/2018/591 · § 3 to § 8; https://www.retsinformation.dk/eli/lta/2026/22 · § 16 a", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "id": "nawi-dist-own-name-manufacturer", "role": "distributor", "kind": "status", "level": "product", "timing": "before-market", "text": "If you make an instrument available under your own name or trade mark, or modify one in a way that may affect compliance, you take on the manufacturer's obligations under Article 6.", "article": "Art. 10", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" } ], "requirementsHash": "397cddfea9e68441", "penalties": { "text": "Member States lay down the rules on penalties for infringements by economic operators of their national transposing laws and enforce them; the penalties must be effective, proportionate and dissuasive and may include criminal penalties for serious infringements. Market surveillance authorities evaluate instruments that present a risk to the public interests the directive protects, require corrective action, withdrawal or recall within a period commensurate with the risk, inform the notified body, and if the operator fails to act prohibit or restrict the making available, withdraw or recall the instrument and notify the Commission and the other Member States; compliant instruments that still present a risk can be treated the same way. Formal non-compliance, such as a missing or wrongly affixed CE marking or supplementary metrology marking, missing Annex III inscriptions, a missing notified body number, a missing or incorrect EU declaration of conformity, missing or incomplete technical documentation or missing manufacturer or importer identification, must be ended and otherwise leads to restriction, prohibition, withdrawal or recall. Since 16 July 2021 the surveillance powers come from Regulation (EU) 2019/1020, whose authorities can demand documents and supply-chain information, inspect and check products, require corrective action, prohibit the making available and have instruments withdrawn, recalled or destroyed. In Denmark, executive order nr. 773 of 1 June 2022 lets Sikkerhedsstyrelsen order formal non-compliance corrected within a deadline and then order withdrawal, recall or a sales ban under the product act, and punishes with a fine the placing on the market of non-conforming instruments, missing documentation, markings, instructions, notifications, mandates and use of a body not designated by Sikkerhedsstyrelsen or another Member State, with imprisonment of up to 2 years in aggravating circumstances; executive order nr. 591 of 29 May 2018 fines the owner who uses an unmarked instrument, the wrong accuracy class or no self-check or reverification for a legal purpose; and the product act adds orders to warn users, stop marketing, remedy, stop sales, withdraw, recall or destroy, prohibitions, orders to the owner of an instrument used for payment-based weighing, and fines, rising to imprisonment of up to 2 years in aggravating circumstances, for breaches of the act, of Regulation (EU) 2019/1020 Article 4 and of the authority's decisions. Since January 2026 Sikkerhedsstyrelsen is the department Markedsovervågning of Erhvervsstyrelsen.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 36, Art. 37, Art. 39, Art. 40 and Art. 42; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32019R1020 · Art. 14, Art. 16, Art. 39 and Annex I point 50; https://www.retsinformation.dk/eli/lta/2022/773 · § 54 and § 55; https://www.retsinformation.dk/eli/lta/2018/591 · § 12; https://www.retsinformation.dk/eli/lta/2026/22 · § 2, stk. 1, nr. 13, § 9, § 14, § 16, § 16 a and § 37; https://erhvervsstyrelsen.dk/sikkerhedsstyrelsen-en-del-af-erhvervsstyrelsen" }, "checklist": [ "Confirm the instrument is non-automatic, that is it needs an operator during weighing; an instrument that weighs without one falls under the Measuring Instruments Directive as MI-006 instead (Article 2, point (2)).", "Decide which of the seven categories of use in Article 1(2) the instrument is intended for; only the six purposes in points (a) to (f) trigger the essential requirements, the conformity assessment and the CE and metrology markings (Articles 1(2) and 4).", "Decide your role for each product, remembering that selling under your own brand or modifying an instrument makes you the manufacturer (Article 2, point (5), and Article 10).", "Select the accuracy class I, II, III or IIII and the verification scale interval, minimum capacity and number of verification scale intervals from Annex I Table 1, and design to the maximum permissible errors of Table 3 and the direct-sales rules of point 14 where relevant (Annex I, points 2, 4 and 14).", "Apply the harmonised standards listed in the Official Journal under the directive, or document the solutions used instead (Article 12 and Annex II, point 1.3(c)(iv)).", "Choose the module route, B + D, B + F, D1 or F1 for mechanical non-spring instruments, or G, and engage a notified body listed by the Commission; in Denmark one designated by Sikkerhedsstyrelsen or another Member State (Article 13, Annex II and executive order nr. 773/2022 § 34).", "Compile the technical documentation with the risk analysis, drawings, standards list, calculations and test reports, and keep it with the declaration for 10 years (Article 6(3) and Annex II, point 1.3).", "Draw up the Annex IV EU declaration of conformity, as a single declaration where other Union acts also apply, translated as the Member States require (Article 14).", "Affix the CE marking, the supplementary metrology marking M with the two-digit year in a rectangle, the notified body number and the Annex III inscriptions before placing on the market, and the restrictive use symbol on connected non-legal devices (Articles 16, 17 and 18 and Annex III).", "Set up the corrective-action and notification procedure, 10-year supplier and customer traceability and, where the risks warrant it, sample testing and a complaints register (Articles 6(4), 6(8), 8(6), 8(7), 9(4) and 11)." ], "faq": [ { "q": "When did the Non-automatic Weighing Instruments Directive 2014/31/EU start to apply?", "a": "The recast directive was adopted on 26 February 2014, published in the Official Journal on 29 March 2014 and entered into force on 18 April 2014. Member States had to transpose it by 19 April 2016 and apply their measures from 20 April 2016, when Article 1, the first two definitions, Articles 3, 4, 5 and 18 and Annexes I, V and VI also took effect and Directive 2009/23/EC was repealed. Instruments conforming to the old directive and placed on the market before 20 April 2016 may still be made available and put into service, and certificates issued under it remain valid. The directive has not been amended since.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 43, Art. 44, Art. 45 and Art. 46; https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32014L0031" }, { "q": "Which scales need the CE marking and the M metrology marking?", "a": "Non-automatic weighing instruments used or intended for the six purposes in Article 1(2)(a) to (f): mass for commercial transactions; mass for calculating a toll, tariff, tax, bonus, penalty, remuneration, indemnity or similar payment; mass for the application of laws or regulations or for court expertise; weighing patients in medical practice for monitoring, diagnosis and treatment; making up medicines on prescription in a pharmacy and analyses in medical and pharmaceutical laboratories; and price on the basis of mass for direct sales to the public and the making-up of prepackages. Instruments for any other use, point (g), must not bear the conformity marking and need only the manufacturer's name or trade mark and the maximum capacity.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 1(2), Art. 4, Art. 15 and Annex III, points 1 and 2" }, { "q": "What are the accuracy classes I, II, III and IIII?", "a": "Annex I defines four accuracy classes: I special, II high, III medium and IIII ordinary. Each is set by the verification scale interval e, the minimum capacity and the number of verification scale intervals in Table 1: class I has e of at least 0,001 g, a minimum capacity of 100 e and at least 50 000 intervals; class II covers e from 0,001 g to 0,05 g with 20 e and 100 to 100 000 intervals, or e of at least 0,1 g with 50 e and 5 000 to 100 000 intervals; class III covers e from 0,1 g to 2 g with 20 e and 100 to 10 000 intervals, or e of at least 5 g with 20 e and 500 to 10 000 intervals; class IIII has e of at least 5 g, 10 e and 100 to 1 000 intervals. The maximum permissible error is 0,5 e, 1,0 e or 1,5 e depending on the load, and twice that in service. In Denmark the using undertaking must use class I, II or III for legal weighing, class I or II for precious metals, and may use class IIII for bulk goods, transport fees and vehicle weighing for fines.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Annex I, points 2 and 4; https://www.retsinformation.dk/eli/lta/2018/591 · § 4" }, { "q": "Do I need a notified body under the NAWI Directive?", "a": "Yes for every instrument intended for a legal purpose. The manufacturer chooses EU-type examination (module B) followed by conformity to type based on quality assurance of the production process (module D) or on product verification (module F), or conformity based on unit verification (module G). Module B is not compulsory for instruments that use no electronic device and whose load-measuring device does not use a spring to balance the load; those use quality assurance of the production process (module D1) or product verification (module F1) instead, still with a notified body. The Commission notes that the directive requires notified bodies for most products in its scope, and in Denmark the body must be designated by Sikkerhedsstyrelsen or by another Member State.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 13 and Annex II; https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/legal-metrology/measuring-weighing-instruments-eu_en; https://www.retsinformation.dk/eli/lta/2022/773 · § 34" }, { "q": "What is the supplementary metrology marking?", "a": "The capital letter M and the last two digits of the year of its affixing, surrounded by a rectangle whose height equals the height of the CE marking. It follows the same general principles as the CE marking, is affixed visibly, legibly and indelibly to the instrument or its data plate before placing on the market, immediately after the CE marking, and both are followed by the identification number of the notified body involved in production control, affixed by the body or under its instructions; other marks indicating a special risk or use may follow. Devices connected to a legal instrument but not used for the legal purpose carry the restrictive use symbol instead, a black M on a red square crossed by two diagonals.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 16, Art. 17, Art. 18 and Annex III, point 3" }, { "q": "Can a scale certified under the old Directive 2009/23/EC still be sold?", "a": "Instruments covered by Directive 2009/23/EC, in conformity with it and placed on the market before 20 April 2016 may still be made available and put into service, and certificates issued under it are valid under the current directive. Sikkerhedsstyrelsen adds that such instruments may keep the old green M marking and need no manufacturer's address, that a declaration referring only to Directive 2009/23/EC must be reissued under Directive 2014/31/EU while keeping the old type-examination certificate, and that a modified instrument needs a new conformity assessment and declaration under the current directive, with the person modifying it treated as the manufacturer.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 10 and Art. 43; https://www.sik.dk/erhverv/produkter/maaling-vaegt-og-e-maerkning-metrologi/spoergsmaal-og-svar/spoergsmaal-og-svar-om-direktiv-om-ikke-automatiske-vaegte-nawi" }, { "q": "Who enforces the NAWI Directive in Denmark and what applies to a scale in use?", "a": "The product act lists the directive in section 2 as point 13 and names Erhvervsstyrelsen as the control authority; the tasks are carried out by Sikkerhedsstyrelsen, since January 2026 the department Markedsovervågning of Erhvervsstyrelsen, which also designates the Danish notified bodies under executive order nr. 773/2022. Once a scale is in legal use, executive order nr. 591/2018 requires the using undertaking to use an instrument marked under order nr. 773/2022 in the prescribed accuracy class, to run a metrologically traceable self-check against an in-service tolerance of twice the tolerance at placing on the market, to stop using the scale and have it reverified by a DANAK-accredited or equivalent firm when its seal is broken, and to use it only in the range in which it was reverified; the authority can order the owner to bring an instrument used for payment into conformity or forbid its use, and breaches are fined.", "source": "https://www.retsinformation.dk/eli/lta/2026/22 · § 2, stk. 1, nr. 13, § 9 and § 16 a; https://www.retsinformation.dk/eli/lta/2022/773 · § 41; https://www.retsinformation.dk/eli/lta/2018/591 · § 3 to § 8 and § 12; https://erhvervsstyrelsen.dk/sikkerhedsstyrelsen-en-del-af-erhvervsstyrelsen" }, { "q": "How long must I keep the technical documentation and traceability records?", "a": "Manufacturers keep the technical documentation and the EU declaration of conformity of legally used instruments for 10 years after the instrument was placed on the market, authorised representatives keep both at the disposal of the authorities for the same period, and importers keep a copy of the declaration for 10 years and ensure the documentation can be produced. All economic operators must be able to identify who supplied them and whom they supplied for 10 years after the supply.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 6(3), Art. 7(2), Art. 8(8) and Art. 11" } ], "changelog": [ { "date": "2026-09-12", "kind": "guidance", "title": "Guide rebuilt on the SPEC-62 model from the directive text", "summary": "The guide was rewritten from the text of Directive 2014/31/EU, Regulation (EU) 2019/1020, the Danish executive orders nr. 773/2022 and nr. 591/2018, the product act and Sikkerhedsstyrelsen's NAWI questions and answers: the seven categories of use, the Annex I class tables, the exact module routes and the Annex III inscriptions replace the earlier summary, the earlier claim of a type-examination-free route for class III and IIII instruments is corrected to the module D1 and F1 rule for instruments without electronic devices or a spring, the Danish owner duties and enforcement basis are now sourced, Sikkerhedsstyrelsen is placed within Erhvervsstyrelsen since January 2026, and the market surveillance reference is read as Regulation (EU) 2019/1020.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 1, Art. 13, Art. 36 and Annexes I to III" }, { "date": "2022-07-01", "kind": "applies", "title": "Danish executive order nr. 773/2022 on making non-automatic weighing instruments available in force", "summary": "The order issued under the product act replaces order nr. 1381 of 25 November 2016, repeats the seven categories of use, the operator duties, the module routes, the CE and metrology markings and the designation of notified bodies by Sikkerhedsstyrelsen, and keeps the 20 April 2016 transition for instruments meeting the 2003 control order and for certificates under Directive 2009/23/EC.", "source": "https://www.retsinformation.dk/eli/lta/2022/773 · § 2, § 34, § 35, § 41, § 56 and § 57" }, { "date": "2021-07-16", "kind": "applies", "title": "Regulation (EU) 2019/1020 replaces the market surveillance articles of Regulation (EC) No 765/2008", "summary": "Articles 15 to 29 of Regulation (EC) No 765/2008, which Article 36 of the directive cites, are replaced and the directive is listed as point 50 of Annex I to Regulation (EU) 2019/1020; its Article 4 requires an economic operator established in the Union for every non-automatic weighing instrument placed on the market.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32019R1020 · Art. 4(5), Art. 39, Art. 44 and Annex I point 50" }, { "date": "2016-04-20", "kind": "applies", "title": "Directive 2014/31/EU applies; Directive 2009/23/EC repealed", "summary": "Member States apply their transposing measures from 20 April 2016, Article 1, the first two definitions, Articles 3, 4, 5 and 18 and Annexes I, V and VI apply from the same date and Directive 2009/23/EC is repealed; instruments conforming to the old directive and placed on the market before 20 April 2016 may still be made available and put into service, and its certificates remain valid.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 43, Art. 44, Art. 45 and Art. 46" }, { "date": "2014-04-18", "kind": "in-force", "title": "Directive 2014/31/EU enters into force", "summary": "Adopted on 26 February 2014 as a recast of Directive 2009/23/EC aligned with the New Legislative Framework and published in OJ L 96 on 29 March 2014, the directive entered into force on the twentieth day after publication; Member States had until 19 April 2016 to transpose it.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031 · Art. 44(1) and Art. 46" } ], "sources": [ { "label": "Directive 2014/31/EU on non-automatic weighing instruments as published in OJ L 96, 29 March 2014 (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031" }, { "label": "Document information, dates, corrigenda and relationships for CELEX 32014L0031 (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32014L0031" }, { "label": "Directive 2009/23/EC on non-automatic weighing instruments, repealed from 20 April 2016 (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32009L0023" }, { "label": "Directive 2014/32/EU on measuring instruments, which covers automatic weighing instruments (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0032" }, { "label": "Regulation (EU) 2019/1020 on market surveillance and compliance of products (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32019R1020" }, { "label": "Legal metrology (European Commission, DG GROW)", "url": "https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/legal-metrology_en" }, { "label": "Measuring and weighing instruments in the EU, with the WELMEC guides and harmonised standards under the NAWID (European Commission, DG GROW)", "url": "https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/legal-metrology/measuring-weighing-instruments-eu_en" }, { "label": "Bekendtgørelse nr. 773 af 1. juni 2022 om tilgængeliggørelse på markedet af ikke-automatiske vægte (Retsinformation)", "url": "https://www.retsinformation.dk/eli/lta/2022/773" }, { "label": "Bekendtgørelse nr. 591 af 29. maj 2018 om anvendelse af ikke-automatiske vægte (Retsinformation)", "url": "https://www.retsinformation.dk/eli/lta/2018/591" }, { "label": "Bekendtgørelse af lov om produkter og markedsovervågning, LBK nr. 22 af 8. januar 2026 (Retsinformation)", "url": "https://www.retsinformation.dk/eli/lta/2026/22" }, { "label": "Regler og bekendtgørelser for måling og vægt (Sikkerhedsstyrelsen)", "url": "https://www.sik.dk/erhverv/produkter/maaling-og-vaegt-metrologi/love-og-regler-0/regler-og-bekendtgoerelser-maaling-og-vaegt" }, { "label": "Spørgsmål og svar om direktiv om ikke-automatiske vægte (NAWI) (Sikkerhedsstyrelsen)", "url": "https://www.sik.dk/erhverv/produkter/maaling-vaegt-og-e-maerkning-metrologi/spoergsmaal-og-svar/spoergsmaal-og-svar-om-direktiv-om-ikke-automatiske-vaegte-nawi" }, { "label": "Vejledning for ikke-automatiske vægte (NAWI) i brug (Sikkerhedsstyrelsen)", "url": "https://www.sik.dk/erhverv/produkter/maaling-og-vaegt-metrologi/vejledninger/vejledning-ikke-automatiske-vaegte-nawi-brug" }, { "label": "Legal måling og vejning (legal metrologi) (Sikkerhedsstyrelsen)", "url": "https://www.sik.dk/erhverv/produkter/maaling-og-vaegt-metrologi/vejledninger/legal-maaling-og-vejning-legal-metrologi" }, { "label": "Sikkerhedsstyrelsen, en del af Erhvervsstyrelsen from January 2026 (Erhvervsstyrelsen)", "url": "https://erhvervsstyrelsen.dk/sikkerhedsstyrelsen-en-del-af-erhvervsstyrelsen" } ], "reviewer": { "name": "Conphora compliance team", "role": "Compliance editors, Conphora" }, "reviewedAt": "2026-09-24", "nextReview": "2027-03-12", "links": { "tools": [], "courses": [], "related": { "en": "/regulations/nawi/", "dk": "/dk/eu-regulativer/nawi/" } } }