Provisional text
OPINION OF ADVOCATE GENERAL
BIONDI
delivered on 7 May 2026 (1)
Case C‑238/25
Land Nordrhein-Westfalen
v
Bizerba,
other party:
Vertreterin des Bundesinteresses beim Bundesverwaltungsgericht
(Request for a preliminary ruling from the Bundesverwaltungsgericht (Federal Administrative Court, Germany))
( Reference for a preliminary ruling – Approximation of laws – Directive 2014/31/EU – Non-automatic weighing instruments – Device that records a weighing result without printing or independently displaying it – Concept of ‘non-automatic weighing instrument’ – Essential requirements – Indication of the mass value – Normal conditions of use – Additional requirements for direct sales to the public – Harmonised standards – EN 45501:2015 – CE marking and supplementary metrology marking – Eligibility requirements )
I.      Introduction
1.        The present case requires the Court to clarify the scope of Directive 2014/31/EU, (2) in particular, whether a device which determines the mass of a body, records the weighing result and transmits it to an external display device may constitute a non-automatic weighing instrument and, if so, under what conditions it may satisfy the essential requirements laid down by the directive for such instruments and bear the CE marking and the supplementary metrology marking. It also provides the Court with an opportunity to clarify the relationship between the provisions of a harmonisation directive and the technical standards adopted within its scope.
II.    The main proceedings and the questions referred for a preliminary ruling
2.        Bizerba SE & Co. KG (‘Bizerba’) manufactures the CS 300 model, a device which determines mass and which is integrated into the point-of-sale (POS) systems of other manufacturers for use in the retail trade and enables weighing during the checkout process (‘the CS 300 model’). Weighing results are recorded by weighing software which forwards the data to the POS computer via a data interface. The weighing values are visible to users and customers on the POS system monitor via a software model licensed by Bizerba. The CS 300 model does not have its own display.
3.         In 2016, the Physikalisch-Technische Bundesanstalt (National Metrology Institute, Germany; ‘the National Metrology Institute’) had initially issued an EC type-approval certificate valid until March 2019 for the ‘non-automatic price-computing weighing instrument for direct sales to the public’ type designation ‘CS300 …’. Consequently, Bizerba had issued an EU declaration of conformity. On expiry of the EU type-approval certificate, the National Metrology Institute issued an EU type-examination certificate valid until November 2028. (3)
4.        The Regierungspräsidium Tübingen (Regional Council of Tübingen, Germany), in its capacity as a recognised conformity assessment body, certified the quality assurance system submitted by Bizerba in accordance with Directive 2014/31. With that recognition, Bizerba was authorised to affix the metrology marking in accordance with Module D (4) contained in Annex II to Directive 2014/31. With reference to the EU type-approval certificate issued by the National Metrology Institute and the quality assurance system certified by the Regierungspräsidium Tübingen (Regional Council of Tübingen), in 2020 Bizerba issued an EU declaration of conformity for the model CS 300. After completion of the manufacturing process, Bizerba affixes to the CS 300 model a label indicating, inter alia, the CE marking and the supplementary metrology marking prior to its delivery to POS system manufacturers and, consequently, prior to its placing on the market.
5.        Following an inspection in February 2019 at a retail outlet, the supervisory authority of the Land Nordrhein-Westfalen (Land of North Rhine-Westphalia, Germany; ‘the Land’) concluded that the device could not bear that marking prior to its integration into a POS system equipped with its own display. By decision of 31 January 2020, it therefore prohibited Bizerba from marketing in that Land devices bearing the CE marking and/or the supplementary metrology marking affixed prior to such integration.
6.        Following the annulment of that decision by the Verwaltungsgericht Köln (Administrative Court, Cologne, Germany) and the confirmation of that outcome by the Oberverwaltungsgericht Nordrhein-Westfalen (Higher Administrative Court, North Rhine-Westphalia, Germany), the Bundesverwaltungsgericht (Federal Administrative Court, Germany) stayed the proceedings and referred the following question to the Court of Justice for a preliminary ruling:
‘Does a measuring instrument also constitute a non-automatic weighing instrument within the meaning of points 1 and 2 of Article 2 of Directive [2014/31] if the weighing result is not printed or visibly displayed, but merely recorded?’
7.        Written observations were submitted by Bizerba, the Land, the German, Greek and Austrian Governments, and the European Commission; all parties and interveners attended the hearing on 12 February 2026.
III. The legal context
A.      Directive 2014/31
8.        Article 1 of Directive 2014/31, entitled ‘Scope’, provides as follows:
‘1. This Directive shall apply to all non-automatic weighing instruments.
2. For the purposes of this Directive, the following categories of use of non-automatic weighing instruments shall be distinguished:
…
(f) determination of price on the basis of mass for the purposes of direct sales to the public and the making-up of prepackages’.
9.        Article 2 of Directive 2014/31, entitled ‘Definitions’, provides as follows in points 1 and 2:
‘(1) “weighing instrument” means a measuring instrument serving to determine the mass of a body by using the action of gravity on that body. A weighing instrument may also serve to determine other mass-related magnitudes, quantities, parameters or characteristics;
(2) “non-automatic weighing instrument” or “instrument” means a weighing instrument requiring the intervention of an operator during weighing;
…
(11) “harmonised standard” means harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012”. (5)
10.      Article 4 of that directive, entitled ‘Essential requirements’, provides as follows:
‘Instruments used or intended to be used for the applications listed in points (a) to (f) of Article 1(2) shall satisfy the essential requirements set out in Annex I.
Where the instrument includes, or is connected to, devices which are not used or intended to be used for the applications listed in points (a) to (f) of Article 1(2), such devices shall not be subject to those essential requirements.’
11.      Article 6 of that directive, entitled ‘Obligations of manufacturers’, provides as follows, in paragraph 2:
‘2.      For the instruments intended to be used for the applications listed in points (a) to (f) of Article 1(2), manufacturers shall draw up the technical documentation referred to in Annex II and carry out the relevant conformity assessment procedure referred to in Article 13 or have it carried out.
Where compliance of an instrument intended to be used for the applications listed in points (a) to (f) of Article 1(2) with the applicable requirements has been demonstrated by that conformity assessment procedure, manufacturers shall draw up an EU declaration of conformity and affix the CE marking and the supplementary metrology marking.’
12.      Article 17, entitled ‘Rules and conditions for affixing the CE marking, the supplementary metrology marking and other markings’ provides as follows in paragraphs 1 and 2:
‘1.      The CE marking and the supplementary metrology marking shall be affixed visibly, legibly and indelibly to the instrument or to its data plate.
2.      The CE marking and the supplementary metrology marking shall be affixed before the instrument is placed on the market.’
13.      Annex I to that directive, entitled ‘Essential requirements’, provides as follows:
‘The terminology used is that of the International Organisation of Legal Metrology.
Preliminary observation
Where an instrument includes, or is connected to, more than one indicating or printing device used for the applications listed in points (a) to (f) of Article 1(2), those devices which repeat the results of the weighing operation and which cannot influence the correct functioning of the instrument shall not be subject to the essential requirements if the weighing results are printed or recorded correctly and indelibly by a part of the instrument which meets the essential requirements and the results are accessible to both parties concerned by the measurement. However, in the case of instruments used for direct sales to the public, display and printing devices for the vendor and the customer must fulfil the essential requirements.
Metrological requirements
…
Design and construction
8.      General requirements
8.1.      Design and construction of the instruments shall be such that the instruments will preserve their metrological qualities when properly used and installed and when used in an environment for which they are intended. The value of the mass must be indicated.
…
9.      Indication of weighing results and other weight values
The indication of the weighing results and other weight values shall be accurate, unambiguous and non-misleading and the indicating device shall permit easy reading of the indication under normal conditions of use.
…
14.      Instruments for direct sales to the public, with a maximum capacity not greater than 100 kg: additional requirements
Instruments for direct sale to the public shall show all essential information about the weighing operation and, in the case of price-indicating instruments, shall clearly show the customer the price calculation of the product to be purchased.
…
Price-computing instruments shall display the essential indications long enough for the customer to read them properly.
…
Instruments shall bear no characteristics that can cause, directly or indirectly, indications the interpretation of which is not easy or straightforward.
…
Instruments similar to those normally used for direct sales to the public which do not satisfy the requirements of this Section must carry near to the display the indelible marking “Not to be used for direct sale to the public”.’
B.      Harmonised standard EN 45501:2015
14.      The relevant harmonised standard (6) is EN 45501:2015 ‘Metrological aspects of non-automatic weighing instruments’. It distinguishes, from a technical standpoint, between different components of the instrument and defines, amongst other things, the ‘weighing module’ as a part of the instrument that does not have its own means of displaying the result. (7)
15.      References to the standard EN 45501:2015 are made in the Commission communication in the framework of the implementation of Directive 2009/23/EC (8) of the European Parliament and of the Council of 23 April 2009 on non-automatic weighing instruments. (9) Annex ZZ of the harmonised standard EN 45501:2015 identifies the provisions of the standard capable of establishing the presumption of conformity within the meaning of Article 12 of Directive 2014/31. (10)
16.      Point 4.13.6 of that harmonised standard, entitled ‘Visibility’ provides as follows: ‘all primary indications (4.13.1 […]) shall be indicated clearly and simultaneously to both the vendor and the customer. If this is not possible with one display device two sets are necessary, one set each for the vendor and the customer’. However, that point is not among the provisions cited in Annex ZZ.
C.      German law
17.      German law has implemented the Directive, in essence, through the Mess- und Eichgesetz (Mess EG) (11) and the Mess- und Eichverordnung (MessEV), (12) which make the placing on the market of measuring instruments subject to compliance with the essential requirements, as attested by a conformity assessment and the prescribed marking, and confer the relevant powers of intervention on the supervisory authorities.
IV.    Analysis
18.      It is perhaps worth first considering the complex regulatory framework of the case at hand: on the one hand, the primary legislation, represented by Directive 2014/31; on the other, a set of general provisions supplemented and clarified by secondary sources, consisting of a series of harmonised standards.
19.      The growing importance of those instruments within the European Union’s governance system is now widely recognised. Indeed, the Court has affirmed their importance, whilst highlighting some of the vulnerabilities that still characterise the current framework. In the James Elliott Construction judgment (13) and, more recently, in the Public.Resource.Org judgment, (14) the Court emphasised that harmonised standards form an integral part of the EU legal order and are therefore subject to the fundamental principles of that order, such as legal certainty and respect for the rule of law.
20.      Harmonised standards, which are largely modelled on international standards, were not however designed to fully meet these objectives. They are drawn up by European standardisation bodies (15) on a mandate from the Commission, through complex adoption processes involving multiple stakeholders. They usually consist of technical provisions structured across multiple levels and, as their adoption is often an extremely lengthy process, they struggle to keep up with technological developments. (16)
21.      Far from being an abstract debate, this is in fact a very concrete issue, as compliance with harmonised standards is de facto mandatory. Indeed, alignment with these standards creates a presumption of compliance with EU law. Therefore, non-compliance has serious repercussions for manufacturers, which must demonstrate compliance with the essential requirements through often technically complex and costly alternative means.
22.      As the case at hand amply demonstrates, the complexity and multiplicity of regulatory references pose significant challenges for both national authorities and private operators. In this context, the need to ensure, on the one hand, respect for the fundamental EU principles and, on the other, the full protection of the rights of individuals and businesses, in my view, requires that the answers to be provided to the national court follow the path laid down by the Court in the James Elliott Construction and Public.Resource.Org cases.
23.      I therefore deem it preferable to develop this analysis not through the traditional prism of the hierarchical relationship between sources, but in the light of a uniform interpretation of those sources.
24.      In this context, it is also useful to emphasise a further element of complexity. The common framework for the marketing of products (‘the common framework’) established by Decision No 768/2008/EC of the European Parliament and of the Council (17) and by Regulation (EC) No 765/2008 (18) on accreditation and market surveillance laid down common principles and reference provisions intended to apply across sectoral legislation in order to provide a coherent basis for revision or recasts of that legislation.
25.      It has replaced the approach of detailed technical harmonisation with a two-tier model: the legislature sets out essential requirements in functional terms, without imposing specific technical solutions; European standardisation bodies acting on a mandate from the Commission (19) draw up harmonised technical standards specifying the technical solutions designed to meet those requirements.
26.      Directive 2014/31, which replaced the earlier Directive 2009/23, was adapted to that model, by setting out the essential requirements in Annex I and the conformity assessment procedures in Annex II.
27.      The decision to formulate the essential requirements in functional terms – without reference to specific technical solutions – reflects the principle of technological neutrality (20) and entails that the essential requirements must be interpreted independently, taking into account their wording and the objectives of the Directive, and not in the light of the technical solutions currently covered by the harmonised standards. (21)
28.      The system established by Directive 2014/31 therefore distinguishes between the essential requirements laid down by the EU legislature and the technical solutions developed by European standardisation bodies, compliance with which may give rise to a presumption of conformity with the requirements they cover.
29.      As noted in point 14 of the present Opinion, instruments that comply with harmonised standards, the details of which have been published in the Official Journal of the European Union, (22) indeed enjoy a presumption of conformity pursuant to Article 12 of the Directive. However, such standards may not alter or restrict the scope of the provisions of the Directive.
30.      In the event that an instrument is not fully in conformity with a harmonised standard, conformity may be established by one of the assessment procedures provided for in Article 13 of Directive 2014/31.
31.      That said, I note that, although the referring court formally asks the Court only about the concept of non-automatic weighing instruments within the meaning of points 1 and 2 of Article 2 of Directive 2014/31, it is apparent from the order for reference that that court also has doubts concerning the conformity of the device with the essential requirements set out in Annex I and, consequently, the lawfulness of affixing the CE marking and the supplementary metrology marking prior to its integration into the POS system.
32.      In order to provide the referring court with a useful answer, the Court should therefore examine not only whether such a device falls within the definition of a non-automatic weighing instrument, but also under what conditions it can satisfy the essential requirements laid down in Article 4 of that directive and defined in Annex I thereto and bear the prescribed marking when the weighing result is displayed via a connected external device.
A.      The definition of a non-automatic weighing instrument
33.      Before examining the substance of the matter, it is necessary to clarify the role of the harmonised standard EN 45501:2015 within the framework of Directive 2014/31.
34.      Within the scheme of that directive, the essential requirements are laid down by the EU legislature, whilst compliance with harmonised standards may form the basis of a presumption of conformity with the requirements covered by those standards. It follows that the harmonised standard may provide useful technical guidance, but it cannot either amend or restrict the scope of the provisions of the Directive.
35.      Consequently, the fact that standard EN 45501:2015 classifies the CS 300 model, from a technical point of view, as a ‘weighing module’ is not, in itself, sufficient to rule out that it may fall within the definition of non-automatic weighing instrument within the meaning of points 1 and 2 of Article 2 of Directive 2014/31. That matter must first be resolved in the light of the wording, structure and aim of the Directive. (23)
36.      Furthermore, the presumption of conformity linked to compliance with harmonised standard EN 45501:2015 applies only within the limits of the provisions of that standard referred to in Annex ZZ. Provisions not included in that annex, such as point 4.13.6, may be taken into account as part of the technical context, but do not, in and of themselves, give rise to the presumption provided for in Article 12 of Directive 2014/31.
37.      The definition of ‘weighing instrument’ in point 1 of Article 2 of Directive 2014/31 is built around the function of ‘determining … mass’. That expression is neutral with regard to the manner in which the result is communicated to users. Mass is ‘determined’ at the moment it is measured and recorded, regardless of whether the value can be read immediately: such determination logically and functionally precedes the reading and does not presuppose it.
38.      Similarly, the definition of ‘non-automatic weighing instrument’ in point 2 of Article 2 of that directive (24) contains no reference to a display. Since the CS 300 requires the intervention of an operator – a fact which is not disputed – that instrument satisfies that definition.
39.      Moreover, in the judgment in Marhon, albeit delivered in a different context, the Court clarified that the scope of Directive 2014/31 must be interpreted broadly and that points 1 and 2 of Article 2 of that directive defines the concept of ‘non-automatic weighing instrument’ by referring to the function performed by such instruments, without taking into consideration the manner in which they are used or the areas in which they are used. (25)
40.      In the case at hand, therefore, it is necessary to start from the statutory definition of the instrument, without attaching any decisive importance to technical elements not referred to in that definition.
41.      The structure of Directive 2014/31 confirms such interpretation. The legislature has used the term ‘visible’ or ‘visibly’ only in contexts where it intended to impose that requirement expressly, for example in Article 17(1) regarding the visibility of the CE marking and the supplementary metrology marking and in Article 18 regarding the restrictive use symbol. (26) The absence of such a term in point 8.1 of Annex I to that directive is not coincidental: the legislature used the passive form ‘must be indicated’ without specifying that the indication must come directly from the device or that it must be visible at all times during the product’s lifetime.
42.      The preliminary observation in Annex I expressly covers the case where the instrument ‘includes, or is connected to, more than one indicating or printing device’. By treating the two situations (‘includes’ and ‘is connected to’) as equivalent, the observation demonstrates that the legislature has taken into account situations in which the display is not incorporated into the instrument. Connection to an external device does not constitute an exception, but a solution that is expressly provided for; the preliminary observation contained in Annex I, referred to in point 13 of the present Opinion (‘the preliminary observation’) does not require that every instrument include at least one display amongst its components, but refers to the case where an instrument ‘includes’ or ‘is connected’ to multiple devices.
43.      Point 8.3 of Annex I provides that ‘digital electronic devices shall always exercise adequate control of the correct operation of the measuring process’, thereby presupposing the existence of a connected indicating device but without specifying whether it must be physically incorporated. Similarly, point 5 of Annex I, in requiring that weighing results be reproducible by ‘the other indicating devices used’, presupposes an indicating device but does not require that it be integrated.
44.      Point 14 of Annex I to Directive 2014/31 does not lead to a different conclusion. Admittedly, it presupposes that, in direct sales to the public, the essential indications are displayed to the purchaser in a clear and sufficiently comprehensible manner. However, that provision concerns the manner in which the instrument must operate under its normal conditions of use.
45.      In an integrable weighing module, those conditions are met when the weighing module is integrated into the POS system provided and the result is displayed on the terminal intended for the seller and the customer. Point 14 does not, therefore, require that the display device be incorporated into the module, but requires that it form part of an instrument as a whole whose conformity has been assessed.
46.      The second sentence of the preliminary observation to Annex I of Directive 2014/13 confirms that interpretation, as it requires that, in direct sales to the public, display and printing devices for vendors and customers must fulfil the essential requirements. However, it does not require that such devices be necessarily incorporated into the metrological module.
47.      Nor does the reference, in point 14 to that annex, to the wording ‘not to be used for direct sale to the public’ to be affixed ‘near to the display’ imply that the display must be part of the weighing module; it merely presupposes the existence of a display in the actual configuration of the instrument.
48.      The German, Greek and Austrian Governments argue that allowing a non-automatic weighing instrument without its own display would undermine the protection of the public against incorrect weighing results and make conformity checks more burdensome. These observations merit attention, but I do not think they are decisive.
49.      The objective of protecting the public does not require that protection be achieved by incorporating a display into the module, but rather that, under normal conditions of use, the weighing result be made accessible and verifiable in a clear and non-misleading manner. An external device, provided it is included in the configuration covered by the conformity assessment, can satisfy this requirement in an equivalent manner.
50.      As regards conformity verifications, the manufacturer must describe in detail, in the EU-type examination certificate and in the technical file, the permitted configurations, the conditions for integration and the verification procedures. The issue raised therefore concerns the quality of the technical documentation and the conformity assessment, not the eligibility in principle of the integrable weighing module.
51.      Following the reasoning of some of the intervening parties who submitted observations to the Court,
a structural requirement would be introduced by way of interpretation – that of the display being incorporated in the same module – which is not provided for in the Directive. In my view, this would be contrary to the principle of technological neutrality derived from the common framework. (27) The legislation must neither favour nor exclude specific technical solutions, leaving the choice of means to the manufacturer, provided that the functional requirements are fulfilled.
52.      The analogy, drawn by Bizerba at the hearing, with the structure of a computer – in which the monitor may be built-in (as in a laptop) or external, without this affecting the classification of the device – illustrates a general principle: the function does not depend on the physical location of the component that performs it, but on the ability of the system as a whole to produce the expected result. In the case of a weighing instrument, the expected result is the determination and indication of mass; whether the indication appears on a built-in display or on a connected terminal does not alter the functional nature of the instrument.
53.      It must also be considered, from the point of view of practical consequences, that devices similar to the CS 300 model have been marketed and used in retail outlets – integrated into POS systems – for over twenty years, as confirmed by Bizerba at the hearing without being contradicted.
54.       The answer to the question whether the instrument in the case at hand cannot simply be certified as a ‘weighing module’ rather than a ‘weighing instrument’ raised by the Court at the hearing, underscores the practical relevance of the difference in classification. As Bizerba asserts, classification as a mere module would prevent manufacturers of POS systems from integrating the device without themselves assuming the role of manufacturers of the final instrument, with the consequent obligations regarding conformity assessment. This would result in a significant barrier to the circulation of modular solutions within the single market, contrary to the objectives of facilitating trade and technological neutrality pursued by the common framework, (28) as well as, ultimately, to the very purpose of Directive 2014/31 of ensuring that such instruments meet the essential requirements.
55.      I therefore consider that points 1 and 2 of Article 2 of Directive 2014/31 must be interpreted as meaning that an instrument which determines the mass of a body, records the result of the weighing, transmits it to a connected external display device and requires the intervention of an operator during the weighing may constitute a non-automatic weighing instrument, even if it does not autonomously print or display the results of the weighing.
B.      Compliance with the essential requirements
56.      Point 8.1 of Annex I to Directive 2014/31 requires that the mass value be indicated; however, it does not prescribe a specific technical solution for such indication.
57.      Similarly, point 9 of that annex requires that the indication be easily legible under normal conditions of use. If the device is designed from the outset to operate as part of an integrable weighing module, these conditions are met at the point of sale once the module is integrated into the POS system provided.
58.      For instruments intended for direct sale to the public, the same applies with regard to point 14 of Annex I: when the weighing result is displayed on an external terminal, compliance with the essential requirements must be verified not only for the weighing module itself, but for the combination comprising that module and the display device. It follows that a device without its own display, designed to operate within an integrable weighing module in which the mass value is displayed via a connected external device, may satisfy the essential requirements set out in points 8.1, 9 and, where applicable, 14 of Annex I, provided such external device forms part of the instrument’s configuration whose conformity has been assessed.
C.      CE marking and metrology marking: conditions and timing of affixing
59.      It remains to be determined whether the CE marking and the supplementary metrology marking may be affixed prior to the physical integration of the module into the POS system. In this regard, the assessment must be performed not merely on the actual sequence of operations, but on the subject matter of the conformity assessment.
60.      If that assessment has covered not only the module considered in isolation, but the entire instrument as defined in the EU type-examination certificate and the technical file, including the permitted configurations for connection to the display device – there is, in principle, no obstacle to affixing the marking to the module prior to its final integration.
61.      Conversely, such marking would not comply with the Directive if it purported to certify the conformity of the module irrespective of any subsequent configuration, or in relation to configurations not covered by the conformity assessment.
62.      The German Government stated at the hearing that it does not, in principle, dispute the eligibility of modular weighing instruments equipped with an external display device, even if housed in a separate casing. More specifically, the dispute concerns the timing of the marking: according to the Federal Republic of Germany, it cannot be applied before the ‘weighing module and display unit’ are assembled, as it is only at that stage that the conformity of the entire instrument can be verified, including the accuracy of the signal transmission to the display.
63.      The concerns expressed by the German Government are not
devoid of technical foundation. As highlighted at the hearing, even when the weighing module is functioning correctly, a fault in the signal transmission – for example, a wiring error – could result in an incorrect display of the result on the POS terminal. It is precisely this risk that justifies the requirement that the conformity assessment cover the combination ‘module + type of POS system/display device’ in the configurations covered by the EU type-examination certificate. It is not sufficient to verify the operation of the module in isolation; rather, it must be ensured that the result is correctly transmitted and displayed in the intended configuration.
64.      It will therefore be for the referring court to verify whether, in the specific case, the marking affixed to the device actually corresponds to a conformity assessment concerning the relevant integrated configuration.
65.      If that were not the case, it would not be a question of abstractly rejecting the admissibility of an integrable weighing module, but of noting a lack of conformity of the marking in the present case.
66.      Ultimately, Directive 2014/31 does not prescribe a specific technical design for the instrument, but requires that the essential requirements be met in a verifiable manner in the instrument as a whole, as intended for use.
67.      The decisive factor is therefore not the absence of a display incorporated into the module, but the fact that the indication function is ensured, under normal conditions of use, by an external device included in the configuration covered by the conformity assessment.
68.      Under the same conditions, the CE marking and the supplementary metrology marking may be affixed prior to the physical integration of the module, provided that they cannot certify the conformity of configurations other than those actually considered in the conformity assessment.
V.      Conclusion
69.      In the light of the analysis carried out, I propose that the Court should respond as follows to the question raised by the Bundesverwaltungsgericht (Federal Administrative Court, Germany):
1.      Points 1 and 2 of Article 2 of 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
must be interpreted as meaning that an instrument which determines the mass of a body by means of the action of gravity, records the result of the weighing, transmits it to a connected external display device and requires the intervention of an operator during the weighing process may constitute a ‘non-automatic weighing instrument’, even if it does not autonomously print or display the results of weighing.
2.      Article 4 of Directive 2014/31/EU, read in conjunction with the preliminary observation in Annex I to that Directive and points 8.1, 9 and 14 of that annex, as well as Article 6(2) and Article 17
must be interpreted as meaning that such a device may satisfy the essential requirements of the Directive where the indication function is ensured, under normal conditions of use, by an external display forming part of the instrument as a whole covered by a conformity assessment;
for instruments intended for direct sale to the public, the external display device is not exempt from the essential requirements, but must constitute an integral part of those instruments for the purposes of the relevant conformity verification;
the CE marking and the supplementary metrology marking may be affixed to the module prior to its physical integration only if the conformity assessment has already covered the instrument as a whole in the configurations covered by the EU-type examination certificate and the technical file; it is for the referring court to verify whether that is indeed the case here.
1      Original language: Italian.
2      Directive 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 (OJ 2014 L 96, p. 107).
3      The EU type-examination certificate attests, on the part of the competent body, that a representative sample of the product meets the applicable essential requirements and forms the basis for the subsequent declaration of conformity. See Annex II to Directive 2014/31, module B.
4      Module D is the conformity assessment procedure based on the quality assurance of the production process.
5      Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC,
98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ 2012 L 316, p. 12).
6      See point 9 of the present Opinion.
7      See point T.2.2.7 of the harmonised standard EN 45501:2015, entitled
‘Weighing module’ which is worded as follows: ‘Part of the weighing instrument that comprises all mechanical and electronic devices (i.e. load receptor, load-transmitting device, load cell, and analog data processing device or digital data processing device) but not having the means to display the weighing result. It may optionally have devices for further processing (digital) data and operating the instrument’.
8      For the sake of completeness, Directive 2009/23/EC (OJ 2009 L 122, p. 6) was repealed by Directive 2014/31.
9      OJ 2015 C 300, p. 3. Inter alia, as noted in that communication, ‘Standards are adopted by the European standardisation organisations in English (CEN and Cenelec also publish in French and German). …’
10      Article 12 of Directive 2014/31, entitled ‘Presumption of conformity of instruments’, provides as follows: ‘Instruments which are in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the essential requirements set out in Annex I covered by those standards or parts thereof’.
11      Law on the placing on the market and making available on the market of measuring instruments, their use and calibration, as well as prepackaged goods, of 25 July 2013 (BGBl. 2013 I, p. 2722).
12      Law on the placing on the market and making available on the market of measuring instruments, as well as their use and calibration, of 11 December 2014 (BGBl. I, pp. 2010, 2011).
13      Judgment of 27 October 2016, James Elliott Construction (C‑613/14, EU:C:2016:821, paragraphs 38 to 40).
14      Judgment of 5 March 2024, Public.Resource.Org and Right to Know v Commission and Others (C‑588/21 P, EU:C:2024:201, paragraph 70).
15      The European standardisation bodies are officially recognised by Regulation No 1025/2012. They are the European Committee for Standardisation (‘CEN’), the European Committee for Electrotechnical Standardization (‘CENELEC’) and the European Telecommunications Standards Institute (‘ETSI’).
16      These are well-known concerns. Indeed, the European Union institutions are fully aware of the need to rethink the foundations of this EU governance model. See https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14511-Standardisation-Regulation-revision_en.
17      Decision of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ 2008 L 218, p. 82).
18      Regulation of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ 2008 L 218, p. 30).
19      This is done by means of a formal act whereby the Commission mandates a standards body to draw up a technical standard designed to cover the essential requirements of a specific directive.
20      See judgment of 20 June 2024, GEMA (C‑135/23, EU:C:2024:526), in which the Court ruled that under the principle of technological neutrality, ‘the law must specify the rights and obligations of persons in a generic manner, so as not to favour the use of one technology to the detriment of another’ (paragraph 37).
21      See, to that effect, Commission notice The ‘Blue Guide’ on the implementation of EU product rules 2022 (OJ 2022 C 247, p. 1., point 1.1).
22      Such as harmonised standard EN 45501:2015, see footnote 9 above.
23      According to settled case-law, when interpreting a provision of EU law, account must be taken not only of its wording but also of its context and the objectives pursued by the legislation of which it forms part. See judgment of 4 July 2024, Marhon (C‑283/23, EU:C:2024:569, paragraph 26).
24      See point 9 of the present Opinion for the definition of ‘non-automatic weighing instrument’.
25      See judgment of 4 July 2024, Marhon (C‑283/23, EU:C:2024:569, paragraphs 27 and 30).
26      The restrictive use symbol is specified in point 3 of Annex III to Directive 2014/31.
27      See point 27 of the present Opinion.
28      See point 24 of the present Opinion.