MetrD: Metrology Framework Directive (Directive 2009/34/EC), explained

MetrD in plain terms

Directive 2009/34/EC is the framework of the old-approach metrology system. It does not set requirements for any instrument itself: it lays down the two common procedures, EC pattern approval of an instrument type and EC initial verification of each instrument, and the signs and marks that show an instrument has passed them, and it leaves the measurement procedures, characteristics and technical requirements for each category to separate directives adopted under it (Art. 1(5)). In return, no Member State may prevent, prohibit or restrict the placing on the market or entry into service of an instrument or product bearing EC marks or signs affixed under those conditions, and Member States attach the same value to EC pattern approval and initial verification as to their own national measures (Art. 1(3) and Art. 1(4)).

The directive is a recast of Council Directive 71/316/EEC of 26 July 1971 and its amendments, adopted on 23 April 2009, published in OJ L 106 of 28 April 2009 and in force on 18 May 2009 (Art. 20 and Art. 21). Its one amendment is Regulation (EU) 2019/1243, which from 26 July 2019 replaced the committee procedure with delegated acts. The system it describes has, however, largely been dismantled around it: the instrument directives built on Directive 71/316/EEC were replaced by the Measuring Instruments Directive from 30 October 2006 and the remaining ones repealed by Directive 2011/17/EU by 1 December 2015, so today the framework matters for the reversed-epsilon sign on measuring container bottles, the small e on prepackages, the adaptation of the units of measurement directive, and for instruments still in service under old EC approvals.

Official text Read the consolidated text on EUR-Lex: Directive 2009/34/EC, consolidated 26 July 2019 (CELEX 02009L0034-20190726). The original act and its document information page carry the publication and entry-into-force dates.

Scope

The directive applies to instruments, meaning measuring instruments, components of measuring instruments, additional devices and measurement equipment; to units of measurement, the harmonisation of methods of measurement and metrological control and the means required to apply them; and to the prescription, methods of measurement, metrological control and marking of quantities of prepackaged products (Art. 1(1) and Art. 1(2)). For each of these, the separate directives specify the requirements and may fix the date on which national provisions are replaced by Community provisions (Art. 1(5) and Art. 1(6)).

Which separate directives still exist decides what the framework covers in practice. Directive 2004/22/EC repealed eleven instrument directives from 30 October 2006: gas meters, meters for liquids other than water and their ancillary equipment, material measures of length, cold-water meters as regards the MI-001 meters, continuous totalising weighing machines, electrical energy meters, taximeters, measuring systems for liquids other than water, automatic checkweighing and weight-grading machines and hot-water meters (Directive 2004/22/EC, Art. 22). Directive 2011/17/EU repealed the eight that remained: the calibration of the tanks of vessels from 1 July 2011, and weights of medium and above-medium accuracy, the standard mass of grain, cold-water meters, alcoholometers, alcohol tables and tyre pressure gauges from 1 December 2015; EC pattern approvals and certificates issued until 30 November 2015 under Directives 71/347/EEC, 75/33/EEC, 76/765/EEC and 86/217/EEC remain valid (Article 6(2)); weights conforming to Directives 71/317/EEC and 74/148/EEC could instead be subject to EC initial verification under Articles 8, 9 and 10 of this directive until 30 November 2025 (Article 6(3)), and Directive 76/766/EEC on alcohol tables has no transitional provision (Directive 2011/17/EU, Art. 1 to Art. 3 and Art. 6). The Measuring Instruments Directive 2014/32/EU now covers ten instrument categories, MI-001 to MI-010, with two more, EV charging and compressed gas dispenser measuring systems, added by Directive (EU) 2026/706 from 10 October 2028, and Directive 2014/31/EU covers all non-automatic weighing instruments; both use new-approach conformity assessment with CE marking and neither refers to EC pattern approval or EC initial verification (Directive 2014/32/EU, Art. 2(1) and Art. 7; Directive (EU) 2026/706, Art. 1 and Art. 3; Directive 2014/31/EU, Art. 1(1)).

What still refers to the framework are the products of Article 1(1)(b) and (c). Council Directive 75/107/EEC requires the manufacturer of a measuring container bottle to affix the sign of Article 6, the reversed epsilon, on his own responsibility (Directive 75/107/EEC, Annex I point 5). Council Directive 76/211/EEC takes the form of the small e on prepackages from the drawing in section 3 of Annex II and applies the prohibition of confusable marks and the in-service control article mutatis mutandis (Directive 76/211/EEC, Annex I points 3.3 and 6). Its own annexes no longer go through the framework: Regulation (EU) 2019/1243 replaced its Article 6 with a delegated-acts empowerment and inserted Article 6a, so from 26 July 2019 the Commission amends Annexes I and II of that directive directly. And Commission Directive (EU) 2019/1258, which aligned the SI base unit definitions in Directive 80/181/EEC with the 2018 decision of the General Conference on Weights and Measures, was adopted on the basis of Article 16 of this directive, whose recital describes it as the general framework for separate directives on units of measurement (Directive (EU) 2019/1258, citations and recital 2).

The duties fall on the manufacturer or his representative established within the Community, who alone may apply for EC pattern approval and who affixes the signs (Art. 2(4), Art. 4, Art. 6 and Art. 11); the metrological services of the Member States carry out the examinations and affix the verification marks (Art. 10 and Art. 13). Importers and distributors are addressed not by the directive but by Regulation (EU) 2019/1020, which lists it as point 28 of Annex I, and in Denmark by the product act as erhvervsdrivende (Regulation (EU) 2019/1020, Art. 3 and Annex I; lovbekendtgørelse 22 of 2026, § 4).

What you must do

EC pattern approval

Member States grant EC pattern approval in accordance with the directive and the relevant separate directive; the approval constitutes admission to EC initial verification and, where verification is not required, the authorisation to place the instruments on the market and put them into service, and a category exempted from approval by its separate directive goes directly to verification (Art. 2(1) and Art. 2(2)). An application may be made only by the manufacturer or his representative established within the Community, in one Member State only for one and the same instrument, in the official language of that Member State, with a copy sent simultaneously to all other Member States; it states the applicant’s name and address, the category, the intended use, the measurement characteristics and the type, and is accompanied in duplicate by descriptions of construction and operation, protecting arrangements, adjustment devices and the locations for verification marks and seals, drawings, a schematic diagram and any national approvals already granted (Art. 2(4) and Annex I points 1.1 to 1.4). The examination comprises a study of the documents and an examination of the measurement characteristics in the laboratories of the metrological service, in approved laboratories or at the place of manufacture, delivery or installation, or only of the documents where the characteristics are known in detail, and covers the entire performance of the instrument under normal conditions of use; the service may require standards, material and assisting personnel from the applicant and, in the cases the separate directives mention, the deposit of a sample instrument (Annex I points 2 and 4).

The Member State that carried out the examination draws up the EC pattern approval certificate and forwards it to the applicant, sending copies to the Commission and the other Member States, which may also obtain the examination reports (Art. 4 and Annex I point 5). Approval is valid for 10 years, extendable for successive periods of 10 years, with no limit on the number of instruments; it cannot be extended after an amendment or adaptation of the Community provisions under which it could no longer be granted, but continues to apply to instruments already in service (Art. 5(1)). Modifications or additions that influence or might influence measurement results or the prescribed conditions of use need additional approval from the granting Member State, or a new approval where the rules have changed (Art. 2(5)). Where a new technique not provided for in a separate directive is used, an approval with limited effect may be granted after consulting the other Member States, with limits on numbers, notification of installation places, restrictions on use and on the technique, for at most two years extendable by up to three (Art. 5(2)). The former Article 5(3) on adapting the annexes after such approvals was deleted by Regulation (EU) 2019/1243 because limited approvals no longer exist.

EC initial verification

EC initial verification is the examination of a new or reconditioned instrument and the confirmation of its conformity to the approved pattern and to the requirements of the directive and the separate directives, certified by the EC initial verification mark; it may be carried out by a method other than unit checking in the cases the separate directives specify (Art. 8(1) and Art. 8(2)). The metrological service determines whether the instrument belongs to a category exempt from pattern approval and satisfies the technical construction and functioning requirements, or has an approval and conforms to the approved pattern, and examines the metrological characteristics, the maximum permissible errors, the construction in so far as it guarantees that the characteristics will not deteriorate under normal conditions of use, and the presence of prescribed inscriptions and stamp plates (Art. 9). Verification is carried out in one stage for instruments that form a whole on leaving the factory and in two or more stages for instruments whose correct functioning depends on the conditions of installation or use, the last stage at the place of installation and the others at a place chosen by the service; outside the office the service may require standards, means, assisting personnel and a copy of the approval certificate (Annex II points 1 and 2). The Member State’s obligation to accept an instrument bearing the mark lasts until the end of the year following the year in which the mark was affixed, unless a separate directive provides longer (Art. 8(4)).

Signs and marks

The EC approval sign of Article 4 is a stylised letter epsilon containing, in its upper part, the distinguishing capital letters of the Member State that granted the approval and the last two digits of the year, and in its lower part an identification number assigned by the metrological service; the letter P of the same size before it marks a limited approval (Annex I points 3.1 and 3.2). Where a category meeting a separate directive does not require EC pattern approval, the manufacturer may affix on his own responsibility the special sign of Article 6, the same epsilon reversed symmetrically about a vertical axis and bearing no other indication unless a separate directive stipulates otherwise (Art. 6 and Annex I point 3.3). Where EC initial verification is not required, the manufacturer affixes the sign of Article 11, the approval sign inside a hexagon (Art. 11 and Annex I point 3.4). All signs affixed by the manufacturer must be at a visible point of each instrument and all ancillary equipment submitted for verification, legible and indelible (Annex I point 3.5). The final EC verification mark, affixed under the responsibility of the Member State when the instrument is completely verified, consists of two stamps: a lower-case letter e with the Member State letters and, where necessary, a territorial subdivision figure in the upper half and the identification number of the verifying agent or office in the lower half, and the last two digits of the year of verification in a hexagon; the partial verification mark is the first stamp alone and also serves as a seal, and the actual diameters of the circles described about the marks are 1.6 mm, 3.2 mm, 6.3 mm and 12.5 mm (Art. 10 and Annex II point 3). Member States must prevent the use of marks or inscriptions liable to be confused with the EC signs or marks, notify one another and the Commission of the services authorised to examine, certify and mark, and may require the prescribed inscriptions in their official language (Art. 12, Art. 13 and Art. 14). The country lists in Annex I point 3.1 and Annex II point 3.1.1.1 of the consolidated text run from B for Belgium to UK for the United Kingdom.

Withdrawal, control in service and decisions

The Member State that granted an EC pattern approval may withdraw it where the instruments do not conform to the approved pattern or the separate directive, where the metrological requirements of the certificate or the limits of a limited approval are not met, or where approval was granted improperly, and must withdraw it where instruments of the pattern reveal in service a defect of a general nature that makes them unsuitable for their intended use; it may then forbid the placing on the market and putting into service of the instruments until further notice, informing the other Member States and the Commission, and the same procedure applies to instruments exempt from EC initial verification whose manufacturer, after due warning, does not bring them into conformity (Art. 7). The separate directives specify the control requirements for instruments in service bearing EC signs or marks, in particular the maximum errors permitted in service, and less stringent national requirements for unmarked instruments may serve as criteria (Art. 15). Every decision refusing or withdrawing approval, refusing verification or prohibiting placing on the market or entry into service must state its reasons and be notified with the remedies and time limits available under national law (Art. 18).

Adaptation to technical progress

Since Regulation (EU) 2019/1243, the Commission is empowered to adopt delegated acts amending Annexes I and II to adapt them to technical progress (Art. 16). The power is conferred for five years from 26 July 2019 and tacitly extended for identical periods unless the European Parliament or the Council opposes no later than three months before the end of each period; it may be revoked at any time, the Commission consults Member States’ experts before adopting an act, and an act enters into force only if neither institution objects within three months, extendable by two (Art. 16a). The former Article 17 on the committee was deleted. The empowerment is also narrower than the one it replaced: until 26 July 2019 Article 16 covered ‘Annexes I and II to this Directive and the annexes to the separate Directives referred to in Article 1’, which is how the Commission adopted Directive (EU) 2019/1258 on the SI base units in Directive 80/181/EEC on 23 July 2019, three days before the change, under the committee procedure of the old Article 17; the new Article 16 reaches only Annexes I and II of this directive, and Member States had to apply Directive (EU) 2019/1258 from 13 June 2020.

Obligations by role

The manufacturer applies for approval, supplies the file, standards and samples, affixes the approval sign or the exemption signs, keeps the granting Member State informed of modifications, watches the 10-year validity, submits instruments for verification and brings non-conforming instruments into conformity when warned (Art. 2, Art. 4 to Art. 8 and Annex I). The authorised representative established in the Community may make the application in the manufacturer’s place and receives the certificate and any reasoned refusal (Art. 2(4), Art. 4 and Art. 18). Importers and distributors place on the market and make available only products whose EC signs or marks were properly affixed, and owe the market surveillance authorities the documents, supply-chain information and corrective action of Regulation (EU) 2019/1020 (Art. 1(3); Regulation (EU) 2019/1020, Art. 14 and Art. 16). Owners and users of instruments in service keep within the in-service requirements the separate directives or national rules specify (Art. 15).

Enforcement and penalties

The directive has no penalty article. Its enforcement is the administrative toolkit of Articles 7, 12 and 18: withdrawal of EC pattern approval, prohibition of the instruments until further notice, prevention of confusable marks, and reasoned decisions with national remedies. Since 16 July 2021 the directive is point 28 of Annex I to Regulation (EU) 2019/1020, so market surveillance authorities may require documents and supply-chain information, carry out inspections, order corrective action within a set period and prohibit, withdraw, recall or destroy non-compliant products (Regulation (EU) 2019/1020, Art. 14, Art. 16 and Art. 44). The directive is not among the acts listed in Annex II of that regulation, so the duty to lay down penalties under its Article 41 attaches through national law rather than to the directive itself.

In Denmark the directive is implemented by bekendtgørelse nr. 1139 af 15. december 2003 om EØF-typegodkendelse og -verifikation, issued by Sikkerhedsstyrelsen under lov om erhvervsfremme, in force since 1 January 2004 and amended by executive orders 161 of 5 March 2008 and 349 of 30 March 2010. Since the 2010 amendment, EØF-typegodkendelse is applied for at and granted by Sikkerhedsstyrelsen, which also authorises the laboratories that carry out EØF-førstegangsverifikation, on the basis that they hold the necessary accreditation from DANAK or from an equivalent accreditation body that is a signatory to the EA multilateral agreement on mutual recognition; the order mirrors the directive’s application file, 10-year validity, additional and limited approvals, exemption signs, verification stages and marks, subjects EC-marked instruments in service to the general Danish rules for instruments subject to control, lets decisions be brought before Sikkerhedsstyrelsen, and punishes with a fine the giving of incorrect or misleading information in connection with a decision and breaches of the marking, withdrawal and confusable-mark rules, with liability for companies (§§ 2, 3, 7, 12, 13, 15, 17 to 22 and 24). Since 1 July 2021 legal metrology falls under the product act, lov om produkter og markedsovervågning (lovbekendtgørelse nr. 22 af 8. januar 2026), which supplements Regulation (EU) 2019/1020, lists the directive on common provisions for measuring instruments and methods of metrological control in § 2, stk. 1, nr. 15, names Erhvervsstyrelsen as the control authority, lets it issue orders and prohibitions, including orders to the owner of an instrument used for a measurement on which a payment is based, and punishes with fines those who fail to give information or access or who disregard its decisions; because this directive is a product area within § 2, stk. 1, nr. 15, the penalty can rise to imprisonment of up to 2 years under aggravating circumstances, which § 37, stk. 2, defines as danger to safety or health, an accident causing serious injury or death, repetition after an earlier conviction for a similar breach, or a systematic breach committed for economic gain, with liability for companies (§ 1, § 2, § 9, § 14, § 16, § 16 a and § 37). Since January 2026 Sikkerhedsstyrelsen is the department Markedsovervågning of Erhvervsstyrelsen and carries out the same tasks as before.

How Conphora helps

Conphora keeps the metrology framework, the surviving separate directives, the MID and the NAWI Directive and the Danish executive orders in one place and tells you which regime your instrument or product is in, so that an old EC pattern approval, a reversed-epsilon bottle, an e-marked prepackage or a CE-marked meter is checked against the right rules. The platform tracks the validity of approvals and certificates, maps the signs and marks you use against the forms the annexes prescribe, and alerts you if the directive, the separate directives or the Danish rules change.

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Sources

• Directive 2009/34/EC relating to common provisions for both measuring instruments and methods of metrological control, consolidated text of 26 July 2019 (EUR-Lex)
• Directive 2009/34/EC as published in OJ L 106, 28 April 2009 (EUR-Lex)
• Document information, dates and relationships for CELEX 32009L0034 (EUR-Lex)
• Regulation (EU) 2019/1243 adapting acts providing for the regulatory procedure with scrutiny to Articles 290 and 291 TFEU (EUR-Lex)
• Directive 2011/17/EU repealing eight metrology directives adopted under Directive 71/316/EEC (EUR-Lex)
• Directive 2004/22/EC on measuring instruments, consolidated text of 1 December 2009 (EUR-Lex)
• Directive 2014/32/EU on measuring instruments, consolidated text of 27 January 2015 (EUR-Lex)
• Directive (EU) 2026/706 amending Directive 2014/32/EU (EUR-Lex)
• Directive 2014/31/EU on non-automatic weighing instruments (EUR-Lex)
• Commission Directive (EU) 2019/1258 amending the Annex to Directive 80/181/EEC as regards the definitions of SI base units (EUR-Lex)
• Council Directive 75/107/EEC on bottles used as measuring containers (EUR-Lex)
• Council Directive 76/211/EEC on the making-up by weight or by volume of certain prepackaged products, consolidated text of 26 July 2019 (EUR-Lex)
• Regulation (EU) 2019/1020 on market surveillance and compliance of products (EUR-Lex)
• Legal metrology (European Commission, DG GROW)
• Measuring and weighing instruments in the EU (European Commission, DG GROW)
• Bekendtgørelse nr. 1139 af 15. december 2003 om EØF-typegodkendelse og -verifikation (Retsinformation)
• Bekendtgørelse nr. 161 af 5. marts 2008 om ændring af bekendtgørelse om EØF-typegodkendelse og -verifikation (Retsinformation)
• Bekendtgørelse nr. 349 af 30. marts 2010 om ændring af bekendtgørelse om EØF-typegodkendelse og -verifikation (Retsinformation)
• Bekendtgørelse af lov om produkter og markedsovervågning, LBK nr. 22 af 8. januar 2026 (Retsinformation)
• Regler og bekendtgørelser for måling og vægt (Sikkerhedsstyrelsen)
• Legal måling og vejning (legal metrologi) (Sikkerhedsstyrelsen)
• Typegodkendelser, oversigt over nationale og EØF-typegodkendelser (Sikkerhedsstyrelsen)
• Sikkerhedsstyrelsen, en del af Erhvervsstyrelsen from January 2026 (Erhvervsstyrelsen)

This guide is for general information and is not legal advice.