Measuring Instruments [EU]

Table of Contents

Measuring instruments

This Directive ensures the free movement of measuring instruments in the internal market. It guarantees, through the use of CE marking, a high level of confidence through essential specifications which are applicable in all Member States.

Directive 2004/22/EC of the European Parliament and of the Council of 31 March 2004 on measuring instruments.

Summary

Scope. The directive applies to the measuring instruments defined in the Annexes to the directive:

water meters;
gas meters and volume conversion devices
active electrical energy meters;
heat meters;
measuring systems for continuous and dynamic measurement of quantities of liquids other then water;
automatic weighing instruments;
taximeters;
material measures;
dimensional measuring instruments;
exhaust gas analysers.

It establishes the essential requirements that the measuring instruments will have to satisfy if they are subject to legal metrological control in a Member State, and the conformity assessment that they have to undergo prior to their placing on the market and putting into use.

Definitions

The directive provides definitions for a “measuring instrument”, “sub-assembly” and “legal metrological control”.

Essential requirements. The essential requirements are defined in the Annexes to the directive. Annex I establishes the essential requirements which must be met by all measuring instruments, whilst the specific annexes describe the particular requirements which are applicable to the instruments in question.

Conformity marking. The conformity of a measuring instrument with the Directive is indicated by the ” CE” conformity marking and the supplementary metrology marking (specified in Article 17).

Placing on the market. Member States shall not impede the placing on the market and putting into use of any measuring instrument that carries the CE conformity marking and supplementary metrology marking.

Assessment of conformity. The assessment of conformity should be carried out by the application, at the choice of the manufacturer, of one of the conformity assessment procedures listed in the specific annex concerning that instrument. The conformity assessment modules which make up the procedures are set out in the Annexes.

Technical documentation. The technical documentation clearly describes the design, manufacturing and operation of the measuring instrument. It should allow for the conformity assessment to be measured against the appropriate provisions of the Directive.

Notification. Member States should notify to the other Member States and the Commission the bodies which they have designated to carry out the tasks pertaining to the conformity assessment. The Commission then publishes the list of bodies notified.

Presumption of conformity. Member States should presume that an instrument conforms with the essential requirements if it complies with the national standards implementing the European harmonised standards in question. The references for these standards are published in the Official Journal of the European Union.

Market surveillance. The Member States should monitor their markets and take all appropriate measures to prevent the placing on the market or use of instruments which do not comply. Moreover, Member States should help each other fulfil their obligations regarding market surveillance, in particular by the exchange of information between the competent authorities. A safeguard clause ensures that a measuring instrument bearing the ‘CE’ marking can be withdrawn from the market if it is established that the instrument does not meet all the essential requirements of the above-mentioned Directive.

Committee. The Commission shall be assisted by a Committee whose tasks will be defined by the Directive.

Repeal of previous directives.

This Directive repeals these directives:

Directive 71/318/EEC (gas meters);
Directive 71/319/EEC (meters for liquids other than water)
Directive 71/348/EEC (meters for liquids other than water – ancillary equipment);
Directive 73/362/EEC (material measures of length);
Directive 75/33/EEC (cold water meters);
Directive 75/410/EEC (continuous totalising weighing machines);
Directive 76/891/EEC (electrical energy meters);
Directive 77/95/EEC (taximeters);
Directive 77/313/EEC (measuring systems for liquids other than water);
Directive 78/1031/EEC (automatic checkweighing and weight grading machines);
Directive 79/830/EEC (hot-water meters).

Directive 75/33/EEC (cold water meters) is a special case as it has only been partially repealed for meters defined in Annex MI-001 of the new Directive (for clean water meters, for example in residential areas, commercial or light industrial use).

Transposal into national law by the Member States. The Member States should transpose the above-mentioned Directive into national law before 30 April 2006. These measures will be applied from 30 October 2006. Transitional measures can be applied to instruments which comply with the rules which are applicable before 30 October 2006 for a maximum period of 10 years.

Review clause. Before 30 April 2011 the Commission will produce a report on the implementation of the Directive and will propose amendments if necessary.

References

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Directive 2004/22/EC [adoption: codecision COD/2000/0233]	30.04.2004	30.04.2006	OJ L 135 of 30.04.2004

EU rules ensuring that non-automatic weighing instruments are accurate

Directive 2014/31/EU relating to non-automatic weighing instruments

It lays down uniform, EU-wide rules on the sale and putting into service of non-automatic weighing instruments (NAWIs)*. NAWIs are important for trade, consumers and industry as they ensure the accuracy of measurements and help the transparency and fairness of commercial transactions.

It aims to:

establish the essential requirements that NAWIs have to satisfy;
introduce simpler, clearer and more-consistent rules, thus ensuring traceability;
reduce administrative burdens for manufacturers, importers and distributors;
ensure that instruments compliant with the essential requirements can circulate freely within the EU.

Benefits should include:

compliant and more accurate NAWIs on the EU market and increased levels of public trust in them;
fewer non-compliant instruments and distortions of competition on the market arising from different enforcement practices;
protection of the public from wrong measurements;
increased room for technological innovation, by adopting a modern regulatory approach.
The directive recasts and repeals Directive 2009/23/EC.

Key Points

The directive brings the NAWI legislation into line with the EU’s ‘new legislative framework’. This framework comprises 2 complementary texts:

Regulation (EC) No 765/2008 on accreditation and market surveillance; and
Decision No 768/2008/EC on uniform conditions for the marketing of safe products in the EU (conformity marking).

Scope

The directive applies to all NAWIs that are new to the EU market when they are placed on that market or put into service, that is that they are:
new NAWIs made by a manufacturer established in the EU; or
NAWIs imported from a non-EU country, whether they are new or second hand.
The directive applies to all forms of supply of NAWIs, including distance selling.

The directive distinguishes the following categories of use of NAWIs for determination of weight for:
commercial transactions;
the calculation of a toll, tariff, tax, bonus, penalty, remuneration, indemnity or similar type of payment;
the application of laws or regulations or for an expert opinion given in court proceedings;
the practice of medicine for weighing patients for the purposes of monitoring, diagnosis and medical treatment;
preparing medicines on prescription in a pharmacy and determining weight in analyses carried out in medical and pharmaceutical laboratories;
the purposes of direct sales to the public and the preparation of pre-packages.

Responsibilities of manufacturers, importers and distributors

Manufacturers must ensure that:

all NAWIs on sale in the EU bear the conformity marking consisting of the European conformity (CE) marking plus the supplementary metrology (M) marking, with the last two digits of the year of its affixing and the accredited notified body* number(s), indicating that they meet all the essential requirements set out in Annex I to the directive;
they lodge an application for EU-type examination with a single notified body of their choice in line with Annex II to the directive on conformity assessment procedures;
they conduct a risk and conformity assessment and draw up technical documentation for the NAWI before affixing the CE + M markings (see Annex III to the directive);
they (and if they appoint an authorised representative*) keep the technical documentation and the EU declaration of conformity (as set out in Annex IV to the directive) for 10 years after the NAWI has been placed on the market;
they indicate on the NAWI their name, registered trade name or registered trade mark and the postal address where they can be contacted to ensure traceability;
in the event they believe that NAWIs they have placed on the market do not conform, take corrective measures to bring them into conformity, withdraw or recall them;
instructions and information accompanying the NAWI are written in language easily understood by its end users and that they, as well as any labelling, are clear and understandable.

Importers must ensure that:

NAWIs they place on the market comply with the essential requirements;
manufacturers have carried out conformity assessments correctly and inform the market-surveillance authority if they consider that

the NAWIs do not comply;
they indicate on the NAWI their name, registered trade name or registered trade mark and the postal address where they can be contacted;
marking of NAWIs and documentation drawn up by manufacturers are available for inspection by the competent authorities.

Distributors must ensure that:

NAWIs under their responsibility, their storage or transport conditions do not place at risk the instruments’ compliance with the essential requirements;
NAWIs bear the necessary markings;
in the event they believe that NAWIs they have made available on the market do not conform, take corrective measures to bring them into conformity, withdraw or recall them.

In addition, the directive:

introduces requirements for notifying authorities and the procedures for notification;
specifies how national authorities that monitor safety must identify and prevent the import from non-EU countries of NAWIs that endanger the health and safety of persons;
includes rules on penalties for infringements by manufacturers, importers and distributors which may include criminal penalties in serious cases.

Application & Background

Directive 2014/31/EU revised and replaced Directive 2002/95/EC and had to be applied in the EU countries as of 20 April 2016.

For more information, see:

Legal metrology (European Commission).

KEY TERMS

Non-automatic weighing instrument: a weighing instrument requiring human intervention during weighing.
Notified body: an independent organisation designated by an EU country to assess the conformity of certain products before they are placed on the market. It carries out tasks related to conformity-assessment procedures set out in the relevant legislation, when the intervention of an external authority is required.
Authorised representative: any individual or organisation established in the EU with a written mandate from a manufacturer to act on their behalf.

MAIN DOCUMENT

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) (OJ L 96, 29.3.2014, pp. 107-148)

EU rules ensuring that measuring instruments are accurate

Directive 2014/32/EU relating to measuring instruments

It lays down uniform, EU-wide rules on the sale and putting into use of measuring instruments (MIs). MIs are important for trade, consumers and industry as they ensure the accuracy of measurements and help the transparency and fairness of commercial transactions.

It aims to:

establish the essential requirements that instruments or systems with a measurement function have to satisfy;
introduce simpler, clearer and more-consistent rules and ensure traceability;
reduce administrative burdens for manufacturers, importers and distributors;
ensure that instruments compliant with the essential requirements can circulate freely within the EU.

Benefits should include:

compliant and more-accurate measuring instruments on the EU market and increased levels of public trust in them;
fewer non-compliant instruments and distortions of competition on the market arising from different enforcement practices;
protection of the public from wrong measurements;
increased room for technological innovation, by adopting a modern regulatory approach.

The directive recasts and repeals Directive 2004/22/EC.

Key Points

The directive brings the MI legislation into line with the EU’s ‘new legislative framework’. This framework comprises 2 complementary texts:

Regulation (EC) No 765/2008 on accreditation and market surveillance; and
Decision No 768/2008/EC on uniform conditions for the marketing of safe products in the EU (conformity marking).
Scope

Legally controlled measuring instruments are used for a variety of measurement tasks in the areas of public health and safety and of fair trading. The directive applies to:

utility meters (water meters, gas meters and volume-conversion devices*, active electrical energy meters and thermal energy meters);
measuring systems for the continuous and dynamic measurement of quantities of liquids other than water (e.g. petrol pumps);
automatic weighing instruments (e.g. rail weighbridges or automatic packaging lines);
taximeters;
material measures and dimensional measuring instruments (e.g. for metalworking or woodworking); and
exhaust gas analysers (e.g. to check engine performance).
The directive applies to all MIs that are new to the EU market when they are placed on that market or put into use, that is that they are:

new MIs made by a manufacturer established in the EU; or
MIs imported from a non-EU country, whether they are new or second hand.
It applies to all forms of supply of MIs, including distance selling.

Responsibilities of manufacturers, importers and distributors

Manufacturers must ensure that:

all MIs on sale in the EU bear the conformity marking consisting of the European conformity (CE) marking plus the supplementary metrology (M) marking, with the last two digits of the year of its affixing and the notified body* number(s), indicating that they meet all the essential requirements of EU legislation (set out in Annex I of the directive and in the relevant instrument-specific annexes);
they conduct a risk and conformity assessment and draw up technical documentation for the MI before affixing the CE + M markings (see Annex II of the directive);
they (and if they appoint an authorised representative*) keep the technical documentation and the EU declaration of conformity (as set out in Annex II of the directive) for 10 years after the MI has been placed on the market;
they indicate on the MI their name, registered trade name or registered trade mark and the postal address where they can be contacted to ensure traceability;
in the event they believe that MIs they have placed on the market do not conform, take corrective measures to bring them into conformity, withdraw or recall them;
instructions and information accompanying the MI are written in a language easily understood by its end users and that they, as well as any labelling, are clear and understandable.

Importers must ensure that:

MIs they place on the market comply with the essential requirements;
manufacturers have carried out conformity assessments correctly and inform the market surveillance authority if they consider that the MIs do not comply;
they indicate on the MI their name, registered trade name or registered trade mark and the postal address where they can be contacted;
marking of MIs and documentation drawn up by manufacturers are available for inspection by the competent authorities.

Distributors must ensure that:

MIs under their responsibility, or MIs’ storage or transport conditions do not place at risk their compliance with the essential requirements;
MIs bear the necessary markings;
in the event they believe that MIs they have made available on the market do not conform, take corrective measures to bring them into conformity, withdraw or recall them.

In addition, the directive:

introduces requirements for notifying authorities and the procedures for notification of conformity assessment bodies;
specifies how national market surveillance authorities must identify and prevent the sale of MIs which present a risk to aspects of public interest protection, including their import from non-EU countries;
includes rules on penalties for infringements by manufacturers, importers and distributors which may include criminal penalties in serious cases.

Application & Background

Directive 2014/32/EU revised and replaced Directive 2004/22/EC and had to be applied in the EU countries as of 20 April 2016.

BACKGROUND

For more information, see:

Legal metrology (European Commission).
KEY TERMS

Volume-conversion device: a device used to convert the measurement flow, temperature, pressure and gas composition under operating conditions into base conditions.
Notified body: an independent organisation designated by an EU country to assess the conformity of certain products before they are placed on the market. It carries out tasks related to conformity assessment procedures set out in the relevant legislation, when the intervention of an external authority is required.

Authorised representative: any individual or organisation established in the EU with a written mandate from a manufacturer to act on their behalf.

MAIN DOCUMENT

Directive 2014/32/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 measuring instruments (recast) (OJ L 96, 29.3.2014, pp. 149-250)

Successive amendments to Directive 2014/32/EU have been incorporated into the original document. This consolidated version is of documentary value only.

Measuring Instruments [EU]