OJ C 181, 21.6.2012, p. 105.

Position of the European Parliament of 5 February 2014 (not yet published in the Official Journal) and decision of the Council of 20 February 2014.

OJ L 135, 30.4.2004, p. 1.

See Annex XIV, Part A.

OJ L 218, 13.8.2008, p. 30.

OJ L 218, 13.8.2008, p. 82.

OJ L 390, 31.12.2004, p. 24.

OJ L 316, 14.11.2012, p. 12.

OJ L 55, 28.2.2011, p. 13.

http://www.legislation.gov.uk/eudr/2014/32/contentsDirective 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) (Text with EEA relevance)Directive 2014/32/EU of the European Parliament and of the CouncilDirective 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) (Text with EEA relevance)2021-02-17King's Printer of Acts of Parliamenthttps://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02014L0032-20150127texttext/xmlen2015-01-27CHAPTER 1 GENERAL PROVISIONS Article 1Subject matterArticle 2ScopeArticle 3OptionalityArticle 4DefinitionsArticle 5Applicability to sub-assembliesArticle 6Essential requirementsArticle 7Making available on the market and putting into useCHAPTER 2 OBLIGATIONS OF ECONOMIC OPERATORS Article 8Obligations of manufacturersArticle 9Authorised representativesArticle 10Obligations of importersArticle 11Obligations of distributorsArticle 12Cases in which obligations of manufacturers apply to importers and distributorsArticle 13Identification of economic operatorsCHAPTER 3 CONFORMITY OF MEASURING INSTRUMENTS Article 14Presumption of conformity of measuring instrumentsArticle 15Publication of the references of normative documentsArticle 16Withdrawal of the references of normative documentsArticle 17Conformity assessment proceduresArticle 18Technical documentationArticle 19EU declaration of conformityArticle 20Conformity markingArticle 21General principles of the CE marking and of the supplementary metrology markingArticle 22Rules and conditions for affixing the CE marking and the supplementary metrology markingCHAPTER 4 NOTIFICATION OF CONFORMITY ASSESSMENT BODIES Article 23NotificationArticle 24Notifying authoritiesArticle 25Requirements relating to notifying authoritiesArticle 26Information obligation on notifying authoritiesArticle 27Requirements relating to notified bodiesArticle 28Presumption of conformity of notified bodiesArticle 29Subsidiaries of and subcontracting by notified bodiesArticle 30Accredited in-house bodiesArticle 31Application for notificationArticle 32Notification procedureArticle 33Identification numbers and lists of notified bodiesArticle 34Changes to notificationsArticle 35Challenge of the competence of notified bodiesArticle 36Operational obligations of notified bodiesArticle 37Appeal against decisions of notified bodiesArticle 38Information obligation on notified bodiesArticle 39Exchange of experienceArticle 40Coordination of notified bodiesCHAPTER 5 UNION MARKET SURVEILLANCE, CONTROL OF MEASURING INSTRUMENTS ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE Article 41Union market surveillance and control of measuring instruments entering the Union marketArticle 42Procedure for dealing with measuring instruments presenting a risk at national levelArticle 43Union safeguard procedureArticle 44Compliant measuring instruments which present a riskArticle 45Formal non-complianceCHAPTER 6 COMMITTEE AND DELEGATED ACTS Article 46Committee procedureArticle 47Amendments of AnnexesArticle 48Exercise of the delegationCHAPTER 7 TRANSITIONAL AND FINAL PROVISIONS Article 49PenaltiesArticle 50Transitional provisionsArticle 51TranspositionArticle 52RepealArticle 53Entry into force and applicationArticle 54AddresseesANNEX IESSENTIAL REQUIREMENTS DEFINITIONS ESSENTIAL REQUIREMENTS 1.Allowable Errors 1.1.Under rated operating conditions and in the absence of a...1.2.Under rated operating conditions and in the presence of a...1.3.The manufacturer shall specify the climatic, mechanical and electromagnetic environments...1.3.1.Climatic environments 1.3.2.Mechanical environments are classified into classes M1 to M3 as...1.3.3.Electromagnetic environments are classified into classes E1, E2 or E3...1.3.4.Other influence quantities to be considered, where appropriate, are: 1.4.When carrying out the tests as envisaged in this Directive,...1.4.1.Basic rules for testing and the determination of errors 1.4.2.Ambient humidity 2.Reproducibility 3.Repeatability 4.Discrimination and Sensitivity 5.Durability 6.Reliability 7.Suitability 7.1.A measuring instrument shall have no feature likely to facilitate...7.2.A measuring instrument shall be suitable for its intended use...7.3.The errors of a utility measuring instrument at flows or...7.4.Where a measuring instrument is designed for the measurement of...7.5.A measuring instrument shall be robust and its materials of...7.6.A measuring instrument shall be designed so as to allow...8.Protection against corruption 8.1.The metrological characteristics of a measuring instrument shall not be...8.2.A hardware component that is critical for metrological characteristics shall...8.3.Software that is critical for metrological characteristics shall be identified...8.4.Measurement data, software that is critical for measurement characteristics and...8.5.For utility measuring instruments the display of the total quantity...9.Information to be borne by and to accompany the instrument...9.1.A measuring instrument shall bear the following inscriptions: 9.2.An instrument of dimensions too small or of too sensitive...9.3.The instrument shall be accompanied by information on its operation,...9.4.Groups of identical measuring instruments used in the same location...9.5.Unless specified otherwise in an instrument-specific annex, the scale interval...9.6.A material measure shall be marked with a nominal value...9.7.The units of measurement used and their symbols shall be...9.8.All marks and inscriptions required under any requirement shall be...10.Indication of result 10.1.Indication of the result shall be by means of a...10.2.The indication of any result shall be clear and unambiguous...10.3.In the case of hard copy the print or record...10.4.A measuring instrument for direct sales trading transactions shall be...10.5.Whether or not a measuring instrument intended for utility measurement...11.Further processing of data to conclude the trading transaction 11.1.A measuring instrument other than a utility measuring instrument shall...11.2.Additionally, a durable proof of the measurement result and the...12.Conformity evaluation ANNEX IIMODULE A:INTERNAL PRODUCTION CONTROL 1.‘Internal production control’ is the conformity assessment procedure whereby the...2.Technical documentation 3.Manufacturing 4.Conformity marking and EU declaration of conformity 4.1.The manufacturer shall affix the CE marking and the supplementary...4.2.The manufacturer shall draw up a written EU declaration of...5.Authorised representative MODULE A2:INTERNAL PRODUCTION CONTROL PLUS SUPERVISED INSTRUMENT CHECKS AT RANDOM INTERVALS...1.Internal production control plus supervised instrument checks at random intervals...2.Technical documentation 3.Manufacturing 4.Instrument checks 5.Conformity marking and EU declaration of conformity 5.1.The manufacturer shall affix the CE marking and the supplementary...5.2.The manufacturer shall draw up a written EU declaration of...6.Authorised representative MODULE B:EU- TYPE EXAMINATION 1.‘EU-type examination’ is the part of a conformity assessment procedure...2.EU-type examination may be carried out in either of the...3.The manufacturer shall lodge an application for EU-type examination with...4.The notified body shall: 5.The notified body shall draw up an evaluation report that...6.Where the type meets the requirements of this Directive, the...7.The notified body shall keep itself apprised of any changes...8.The manufacturer shall inform the notified body that holds the...9.Each notified body shall inform its notifying authority concerning the...10.The manufacturer shall keep a copy of the EU-type examination...11.The manufacturer’s authorised representative may lodge the application referred to...MODULE C:CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL 1.Conformity to type based on internal production control is the...2.Manufacturing 3.Conformity marking and EU declaration of conformity 3.1.The manufacturer shall affix the CE marking and the supplementary...3.2.The manufacturer shall draw up a written EU declaration of...4.Authorised representative MODULE C2:CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED...1.Conformity to type based on internal production control plus supervised...2.Manufacturing 3.Instrument checks 4.Conformity marking and EU declaration of conformity 4.1.The manufacturer shall affix the CE marking, and the supplementary...4.2.The manufacturer shall draw up a written EU declaration of...5.Authorised representative MODULE D:CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION...1.Conformity to type based on quality assurance of the production...2.Manufacturing 3.Quality system 3.1.The manufacturer shall lodge an application for assessment of his...3.2.The quality system shall ensure that the measuring instruments are...3.3.The notified body shall assess the quality system to determine...3.4.The manufacturer shall undertake to fulfil the obligations arising out...3.5.The manufacturer shall keep the notified body that has approved...4.Surveillance under the responsibility of the notified body 4.1.The purpose of surveillance is to make sure that the...4.2.The manufacturer shall, for assessment purposes, allow the notified body...4.3.The notified body shall carry out periodic audits to make...4.4.In addition, the notified body may pay unexpected visits to...5.Conformity marking and EU declaration of conformity 5.1.The manufacturer shall affix the CE marking and the supplementary...5.2.The manufacturer shall draw up a written EU declaration of...6.The manufacturer shall, for a period ending 10 years after...7.Each notified body shall inform its notifying authority of quality...8.Authorised representative MODULE D1:QUALITY ASSURANCE OF THE PRODUCTION PROCESS 1.Quality assurance of the production process is the conformity assessment...2.Technical documentation 3.The manufacturer shall keep the technical documentation at the disposal...4.Manufacturing 5.Quality system 5.1.The manufacturer shall lodge an application for assessment of his...5.2.The quality system shall ensure compliance of the measuring instruments...5.3.The notified body shall assess the quality system to determine...5.4.The manufacturer shall undertake to fulfil the obligations arising out...5.5.The manufacturer shall keep the notified body that has approved...6.Surveillance under the responsibility of the notified body 6.1.The purpose of surveillance is to make sure that the...6.2.The manufacturer shall, for assessment purposes, allow the notified body...6.3.The notified body shall carry out periodic audits to make...6.4.In addition, the notified body may pay unexpected visits to...7.Conformity marking and EU declaration of conformity 7.1.The manufacturer shall affix the CE marking, the supplementary metrology...7.2.The manufacturer shall draw up a written EU declaration of...8.The manufacturer shall, for a period ending 10 years after...9.Each notified body shall inform its notifying authority of quality...10.Authorised representative MODULE E:CONFORMITY TO TYPE BASED ON INSTRUMENT QUALITY ASSURANCE 1.Conformity to type based on instrument quality assurance is that...2.Manufacturing 3.Quality system 3.1.The manufacturer shall lodge an application for assessment of his...3.2.The quality system shall ensure compliance of the measuring instruments...3.3.The notified body shall assess the quality system to determine...3.4.The manufacturer shall undertake to fulfil the obligations arising out...3.5.The manufacturer shall keep the notified body that has approved...4.Surveillance under the responsibility of the notified body 4.1.The purpose of surveillance is to make sure that the...4.2.The manufacturer shall, for assessment purposes, allow the notified body...4.3.The notified body shall carry out periodic audits to make...4.4.In addition, the notified body may pay unexpected visits to...5.Conformity marking and EU declaration of conformity 5.1.The manufacturer shall affix the CE marking, the supplementary metrology...5.2.The manufacturer shall draw up a written EU declaration of...6.The manufacturer shall, for a period ending 10 years after...7.Each notified body shall inform its notifying authority of quality...8.Authorised representative MODULE E1:QUALITY ASSURANCE OF FINAL INSTRUMENT INSPECTION AND TESTING 1.Quality assurance of final instrument inspection and testing is the...2.Technical documentation 3.The manufacturer shall keep the technical documentation at the disposal...4.Manufacturing 5.Quality system 5.1.The manufacturer shall lodge an application for assessment of his...5.2.The quality system shall ensure compliance of the measuring instruments...5.3.The notified body shall assess the quality system to determine...5.4.The manufacturer shall undertake to fulfil the obligations arising out...5.5.The manufacturer shall keep the notified body that has approved...6.Surveillance under the responsibility of the notified body 6.1.The purpose of surveillance is to make sure that the...6.2.The manufacturer shall, for assessment purposes, allow the notified body...6.3.The notified body shall carry out periodic audits to make...6.4.In addition, the notified body may pay unexpected visits to...7.Conformity marking and EU declaration of conformity 7.1.The manufacturer shall affix the CE marking, the supplementary metrology...7.2.The manufacturer shall draw up a written EU declaration of...8.The manufacturer shall, for a period ending 10 years after...9.Each notified body shall inform its notifying authority of quality...10.Authorised representative MODULE F:CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION 1.Conformity to type based on product verification is the part...2.Manufacturing 3.Verification 4.Verification of conformity by examination and testing of every instrument...4.1.All measuring instruments shall be individually examined and appropriate tests...4.2.The notified body shall issue a certificate of conformity in...5.Statistical verification of conformity 5.1.The manufacturer shall take all measures necessary so that the...5.2.A random sample shall be taken from each lot according...5.3.The statistical procedure shall meet the following requirements: 5.4.If a lot is accepted, all measuring instruments of the...5.5.If a lot is rejected, the notified body shall take...6.Conformity marking and EU declaration of conformity 6.1.The manufacturer shall affix the CE marking and the supplementary...6.2.The manufacturer shall draw up a written EU declaration of...7.If the notified body agrees and under its responsibility, the...8.Authorised representative MODULE F1:CONFORMITY BASED ON PRODUCT VERIFICATION 1.Conformity based on product verification is the conformity assessment procedure...2.Technical documentation 3.Manufacturing 4.Verification 5.Verification of conformity by examination and testing of every instrument...5.1.All measuring instruments shall be individually examined and appropriate tests,...5.2.The notified body shall issue a certificate of conformity in...6.Statistical verification of conformity 6.1.The manufacturer shall take all measures necessary so that the...6.2.A random sample shall be taken from each lot according...6.3.All measuring instruments in the sample shall be individually examined...6.4.The statistical procedure shall meet the following requirements: 6.5.If a lot is accepted, all measuring instruments of the...7.Conformity marking and EU declaration of conformity 7.1.The manufacturer shall affix the CE marking and the supplementary...7.2.The manufacturer shall draw up a written EU declaration of...8.If the notified body agrees and under its responsibility, the...9.Authorised representative MODULE G:CONFORMITY BASED ON UNIT VERIFICATION 1.Conformity based on unit verification is the conformity assessment procedure...2.Technical documentation 3.Manufacturing 4.Verification 5.Conformity marking and EU declaration of conformity 5.1.The manufacturer shall affix the CE marking and the supplementary...5.2.The manufacturer shall draw up a written EU declaration of...6.Authorised representative MODULE H:CONFORMITY BASED ON FULL QUALITY ASSURANCE 1.Conformity based on full quality assurance is the conformity assessment...2.Manufacturing 3.Quality system 3.1.The manufacturer shall lodge an application for assessment of his...3.2.The quality system shall ensure compliance of the measuring instruments...3.3.The notified body shall assess the quality system to determine...3.4.The manufacturer shall undertake to fulfil the obligations arising out...3.5.The manufacturer shall keep the notified body that has approved...4.Surveillance under the responsibility of the notified body 4.1.The purpose of surveillance is to make sure that the...4.2.The manufacturer shall, for assessment purposes, allow the notified body...4.3.The notified body shall carry out periodic audits to make...4.4.In addition, the notified body may pay unexpected visits to...5.Conformity marking and EU declaration of conformity 5.1.The manufacturer shall affix the CE marking, the supplementary metrology...5.2.The manufacturer shall draw up a written EU declaration of...6.The manufacturer shall, for a period ending 10 years after...7.Each notified body shall inform its notifying authority of quality...8.Authorised representative MODULE H1:CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION 1.Conformity based on full quality assurance plus design examination is...2.Manufacturing 3.Quality system 3.1.The manufacturer shall lodge an application for assessment of the...3.2.The quality system shall ensure compliance of the measuring instruments...3.3.The notified body shall assess the quality system to determine...3.4.The manufacturer shall undertake to fulfil the obligations arising out...3.5.The manufacturer shall keep the notified body that has approved...3.6.Each notified body shall inform its notifying authority of quality...4.Design examination 4.1.The manufacturer shall lodge an application for examination of the...4.2.The application shall make it possible to understand the design,...4.3.The notified body shall examine the application, and where the...4.4.The notified body shall keep itself apprised of any changes...4.5.Each notified body shall inform its notifying authority of the...4.6.The manufacturer shall keep a copy of the EU design...5.Surveillance under the responsibility of the notified body 5.1.The purpose of surveillance is to make sure that the...5.2.The manufacturer shall, for assessment purposes, allow the notified body...5.3.The notified body shall carry out periodic audits to make...5.4.In addition, the notified body may pay unexpected visits to...6.Conformity marking and EU declaration of conformity 6.1.The manufacturer shall affix the CE marking and the supplementary...6.2.The manufacturer shall draw up a written EU declaration of...7.The manufacturer shall, for a period ending 10 years after...8.Authorised representative ANNEX IIIWATER METERS (MI-001) DEFINITIONS SPECIFIC REQUIREMENTS Rated Operating Conditions MPE 5.The MPE, positive or negative, on volumes delivered at flowrates...6.The MPE, positive or negative, on volumes delivered at flowrates...Permissible Effect of Disturbances 7.1.Electromagnetic immunity 7.1.1.The effect of an electromagnetic disturbance on a water meter...7.1.2.After undergoing an electromagnetic disturbance the water meter shall: 7.1.3.The critical change value is the smaller of the two...7.2.Durability Suitability 8.1.The meter shall be able to be installed to operate...8.2.The manufacturer shall specify whether the meter is designed to...Units of Measurement 9.Metered volume shall be displayed in cubic metres. Putting into Use 10.The Member State shall ensure that the requirements under points...CONFORMITY ASSESSMENT ANNEX IVGAS METERS AND VOLUME CONVERSION DEVICES (MI-002) DEFINITIONS PART ISPECIFIC REQUIREMENTS1.Rated operating conditions 1.1.The flowrate range of the gas shall fulfil at least...1.2.The temperature range of the gas, with a minimum range...1.3.The fuel/gas related conditions 1.4.A minimum temperature range of 50 °C for the climatic...1.5.The nominal value of the AC voltage supply and/or the...2.Maximum permissible error (MPEs) 2.1.Gas meter indicating the volume at metering conditions or mass...2.2.For a gas meter with temperature conversion, which only indicates...3.Permissible effect of disturbances 3.1.Electromagnetic immunity 3.1.1.The effect of an electromagnetic disturbance on a gas meter...3.1.2.After undergoing a disturbance, the gas meter shall: 3.1.3.The critical change value is the smaller of the two...3.2.Effect of upstream-downstream flow disturbances 4.Durability 4.1.Class 1,5 meters 4.1.1.The variation of the measurement result after the durability test...4.1.2.The error of indication after the durability test shall not...4.2.Class 1,0 meters 4.2.1.The variation of the measurement result after the durability test...4.2.2.The error of indication after the durability test shall not...5.Suitability 5.1.A gas meter powered from the mains (AC or DC)...5.2.A dedicated power source shall have a lifetime of at...5.3.An indicating device shall have a sufficient number of digits...5.4.The gas meter shall be able to be installed to...5.5.The gas meter shall have a test element, which shall...5.6.The gas meter shall respect the MPE in any flow...6.Units PART IISPECIFIC REQUIREMENTS7.Base conditions for converted quantities 8.MPE Note: 9.Suitability 9.1.An electronic conversion device shall be capable of detecting when...9.2.An electronic conversion device shall be capable to display all...PART IIIPUTTING INTO USE AND CONFORMITY ASSESSMENTPutting into use 10.Where a Member State imposes measurement of residential use, it...CONFORMITY ASSESSMENT ANNEX VACTIVE ELECTRICAL ENERGY METERS (MI-003) Note: DEFINITIONS SPECIFIC REQUIREMENTS 1.Accuracy 2.Rated operating conditions 3.MPEs 4.Permissible effect of disturbances 4.1.General 4.2.Effect of disturbances of long duration 4.3.Permissible effect of transient electromagnetic phenomena 4.3.1.The effect of an electromagnetic disturbance on an electrical energy...4.3.2.For overcurrent the critical change value is 1,5 %. 5.Suitability 5.1.Below the rated operating voltage the positive error of the...5.2.The display of the total energy shall have a sufficient...5.3.In the event of loss of electricity in the circuit,...5.4.Running with no load 5.5.Starting 6.Units 7.Putting into use (a)Where a Member State imposes measurement of residential use, it...(b)Where a Member State imposes measurement of commercial and/or light...(c)The Member State shall ensure that the current range be...CONFORMITY ASSESSMENT ANNEX VITHERMAL ENERGY METERS (MI-004) DEFINITIONS SPECIFIC REQUIREMENTS 1.Rated operating conditions 2.Accuracy classes 3.MPEs applicable to complete thermal energy meters 4.Permissible influences of electromagnetic disturbances 4.1.The instrument shall not be influenced by static magnetic fields...4.2.The influence of an electromagnetic disturbance shall be such that...4.3.The critical change value for a complete thermal energy meter...5.Durability 6.Inscriptions on a thermal energy meter 7.Sub-assemblies 7.1.The relative MPE of the flow sensor, expressed in %,...7.2.The relative MPE of the temperature sensor pair, expressed in...7.3.The relative MPE of the calculator, expressed in %: 7.4.The critical change value for a sub-assembly of a thermal...7.5.Inscriptions on the sub-assemblies PUTTING INTO USE 8.Where a Member State imposes measurement of residential use, it...CONFORMITY ASSESSMENT ANNEX VIIMEASURING SYSTEMS FOR THE CONTINUOUS AND DYNAMIC MEASUREMENT OF QUANTITIES...DEFINITIONS SPECIFIC REQUIREMENTS 1.Rated operating conditions 1.1.The flowrate range 1.2.The properties of the liquid to be measured by the...1.3.The nominal value of the AC voltage supply and/or limits...1.4.The base conditions for converted values. Note: 2.Accuracy classification and maximum permissible errors (MPEs) 2.1.For quantities equal to or greater than 2 litres the...2.2.For quantities less than two litres the MPE on indications...2.3.However, no matter what the measured quantity may be, the...2.4.1.For minimum measured quantities greater than or equal to 2...2.4.2.For minimum measured quantities of less than two litres, the...2.5.Converted indication 2.6.Conversion devices (a)Calculator (b)Associated measuring instruments (c)Accuracy for calculating function 2.7.The requirement (a) in point 2.6 applies to any calculation,...2.8.The measuring system shall not exploit the MPEs or systematically...3.Maximum permissible effect of disturbances 3.1.The effect of an electromagnetic disturbance on a measuring system...3.2.The critical change value is the greater of MPE/5 for...4.Durability 5.Suitability 5.1.For any measured quantity relating to the same measurement, the...5.2.It shall not be possible to divert the measured quantity...5.3.Any percentage of air or gas not easily detectable in...5.4.Instruments for direct sales 5.4.1.A measuring system for direct sales shall be provided with...5.4.2.The display of the quantity on which the transaction is...5.4.3.Measuring systems for direct sales shall be interruptible. 5.4.4.Any percentage of air or gas in the liquid shall...5.5.Fuel Dispensers 5.5.1.Displays on fuel dispensers shall not be capable of being...5.5.2.The start of a new measurement shall be inhibited until...5.5.3.Where a measuring system is fitted with a price display,...6.Power supply failure 7.Putting into use 8.Units of measurement CONFORMITY ASSESSMENT ANNEX VIIIAUTOMATIC WEIGHING INSTRUMENTS (MI-006) DEFINITIONS SPECIFIC REQUIREMENTS CHAPTER IRequirements common to all types of automatic weighing instruments 1.Rated Operating Conditions 2.Permissible effect of disturbances — Electromagnetic environment 3.Suitability 3.1.Means shall be provided to limit the effects of tilt,...3.2.Adequate material handling facilities shall be provided to enable the...3.3.Any operator control interface shall be clear and effective. 3.4.The integrity of the display (where present) shall be verifiable...3.5.Adequate zero setting capability shall be provided to enable the...3.6.Any result outside the measurement range shall be identified as...4.Conformity assessment CHAPTER IIAutomatic Catchweighers 1.Accuracy Classes 1.1.Instruments are divided into primary categories designated by: 1.2.These primary categories are further divided into four accuracy classes:...2.Category X Instruments 2.1.Category X applies to instruments used to check prepackages made...2.2.The accuracy classes are supplemented by a factor (x) that...3.Category Y Instruments 4.MPE 4.1.Mean error Category X/MPE Category Y instruments 4.2.Standard deviation 4.3.Verification scale interval — single interval instruments 4.4.Verification scale interval — multi-interval instruments 5.Measurement Range 6.Dynamic Setting 6.1.The dynamic setting facility shall operate within a load range...6.2.When fitted, a dynamic setting facility that compensates for the...7.Performance Under Influence Factors And Electromagnetic Disturbances 7.1.The MPEs due to influence factors are: 7.1.1.For category X instruments: 7.1.2.For category Y instruments 7.2.The critical change value due to a disturbance is one...7.3.Temperature range: CHAPTER IIIAutomatic Gravimetric Filling Instruments 1.Accuracy classes 1.1.The manufacturer shall specify both the reference accuracy class Ref(x)...1.2.An instrument type is designated a reference accuracy class, Ref(x),...1.3.The reference accuracy class, Ref(x) is applicable for static loads....1.4.For the operational accuracy class X(x), X is a regime...2.MPE 2.1.Static weighing error 2.1.1.For static loads under rated operating conditions, the MPE for...2.1.2.For instruments where the fill may be made up from...2.2.Deviation from average fill Note: 2.3.Error relative to pre-set value (setting error) 3.Performance Under Influence Factor And Electromagnetic Disturbance 3.1.The MPE due to influence factors shall be as specified...3.2.The critical change value due to a disturbance is a...3.3.The manufacturer shall specify the value of the rated minimum...CHAPTER IVDiscontinuous Totalisers 1.Accuracy Classes 2.MPEs 3.Totalisation scale interval 4.Minimum Totalised Load (Σmin) 5.Zero Setting 6.Operator Interface 7.Printout 8.Performance under influence factors and electromagnetic disturbances 8.1.The MPEs due to influence factors shall be as specified...8.2.The critical change value due to a disturbance is one...CHAPTER VContinuous Totalisers 1.Accuracy classes 2.Measurement Range 2.1.The manufacturer shall specify the measurement range, the ratio between...2.2.The minimum totalised load Σmin shall not be less than...3.MPE 4.Speed of the belt 5.General Totalisation Device 6.Performance under influence factors and electromagnetic disturbances 6.1.The MPE due to influence factor, for a load not...6.2.The critical change value due to a disturbance shall be...CHAPTER VIAutomatic Rail Weighbridges 1.Accuracy classes 2.MPE 2.1.The MPEs for weighing-in-motion of a single wagon or a...2.2.The MPEs for the weight of coupled or uncoupled wagons...2.3.The MPEs for the weight of train weighing-in-motion shall be...2.4.When weighing coupled wagons; the errors of not more than...3.Scale interval (d) 4.Measurement range 4.1.The minimum capacity shall not be less than 1 t,...4.2.The minimum wagon weight shall not be less than 50...5.Performance under influence factor and electromagnetic disturbance 5.1.The MPE due to an influence factor shall be as...5.2.The critical change value due to a disturbance is one...ANNEX IXTAXIMETERS (MI-007) DEFINITIONS Taximeter Fare Cross-over speed Normal calculation mode S (single application of tariff) Normal calculation mode D (double application of tariff) Operating position DESIGN REQUIREMENTS 1.The taximeter shall be designed to calculate the distance and...2.The taximeter shall be designed to calculate and display the...3.A taximeter shall be able to apply the normal calculation...4.A taximeter shall be able to supply the following data...5.If relevant, it shall be possible to adjust a taximeter...RATED OPERATING CONDITIONS 6.1.The mechanical environment class that applies is M3. 6.2.The manufacturer shall specify the rated operating conditions for the...MAXIMUM PERMISSIBLE ERRORS (MPEs) 7.The MPE, excluding any errors due to application of the...PERMISSIBLE EFFECT OF DISTURBANCES 8.Electromagnetic immunity 8.1.The electromagnetic class that applies is E3. 8.2.The MPE laid down in point 7 shall also be...POWER SUPPLY FAILURE 9.In case of a reduction of the voltage supply to...OTHER REQUIREMENTS 10.The conditions for the compatibility between the taximeter and the...11.If there is a supplement charge for an extra service,...12.If the fare is calculated according to calculation mode D...13.All values displayed for the passenger shall be suitably identified....14.1.If the fare to be paid or the measures to...14.2.The securing possibilities available in a taximeter shall be such...14.3.The provisions in point 8.3 of Annex I apply also...15.1.A taximeter shall be fitted with non-resettable totalisers for all...15.2.If disconnected from power, a taximeter shall allow the totalised...15.3.Adequate measures shall be taken to prevent the display of...16.Automatic change of tariffs is allowed due to the: 17.If properties of the taxi are important for the correctness...18.For the purpose of testing after installation, the taximeter shall...19.A taximeter and its installation instructions specified by the manufacturer...20.The general essential requirement dealing with fraudulent use shall be...21.A taximeter shall be designed so that it can respect...22.The taximeter shall be equipped with a real-timeclock by means...23.The values of distance travelled and time elapsed, when displayed...CONFORMITY ASSESSMENT ANNEX XMATERIAL MEASURES (MI-008)CHAPTER IMaterial measures of length DEFINITIONS SPECIFIC REQUIREMENTS Reference Conditions 1.1.For tapes of length equal to or greater than 5...1.2.The reference temperature is 20 °C unless otherwise specified by...MPEs 2.The MPE, positive or negative in mm, between two non-consecutive...Materials 3.1.Materials used for material measures shall be such that length...3.2.Measures made from material whose dimensions may alter materially when...Markings 4.The nominal value shall be marked on the measure. Millimetre...CONFORMITY ASSESSMENT CHAPTER IICapacity serving measures DEFINITIONS SPECIFIC REQUIREMENTS 1.Reference Conditions 1.1.Temperature: the reference temperature for measurement of capacity is 20...1.2.Position for correct indication: free standing on a level surface....2.MPEs 3.Materials 4.Shape 4.1.Transfer measures shall be designed so that a change of...4.2.Transfer measures shall be designed so that the complete discharge...5.Marking 5.1.The nominal capacity declared shall be clearly and indelibly marked...5.2.Capacity serving measures may also be marked with up to...5.3.All filling marks shall be sufficiently clear and durable to...CONFORMITY ASSESSMENT ANNEX XIDIMENSIONAL MEASURING INSTRUMENTS (MI-009) DEFINITIONS CHAPTER I Requirements common to all dimensional measuring instruments Electromagnetic immunity 1.The effect of an electromagnetic disturbance on a dimensional measuring...2.The critical change value is equal to one scale interval....CONFORMITY ASSESSMENT CHAPTER II Length measuring instruments Characteristics of the product to be measured 1.Textiles are characterised by the characteristic factor K. This factor...Operating conditions 2.1.Range 2.2.Where the measured object is not transported by the measuring...2.3.If the measurement result depends on the thickness, the surface...MPEs 3.Instrument Other requirements 4.The instruments must ensure that the product is measured unstretched...CHAPTER III Area measuring instruments Operating conditions 1.1.Range 1.2.Condition of the product MPEs 2.Instrument Other requirements 3.Presentation of the product 4.Scale interval CHAPTER IV Multidimensional measuring instruments Operating conditions 1.1.Range 1.2.Minimum dimension 1.3.Speed of the product MPE 2.Instrument: ANNEX XIIEXHAUST GAS ANALYSERS (MI-010) DEFINITIONS SPECIFIC REQUIREMENTS Instrument Classes 1.Two classes (0 and I) are being defined for exhaust...Rated operating conditions 2.The values of the operating conditions shall be specified by...Maximum permissible errors (MPEs) 3.The MPEs are defined as follows: Permissible effect of disturbances 4.For each of the volume fractions measured by the instrument,...5.The effect of an electromagnetic disturbance shall be such that:...Other requirements 6.The resolution shall be equal to or of one order...7.The standard deviation of 20 measurements shall not be greater...8.For measuring CO, CO2 and HC, the instrument, including the...9.The components in the exhaust gas, other than the components...10.An exhaust gas analyser shall have an adjustment facility that...11.For automatic or semi-automatic adjustment facilities, the instrument shall be...12.An exhaust gas analyser shall detect hydrocarbon residues in the...13.An exhaust gas analyser shall have a device for automatically...14.If the exhaust gas analyser is capable to operate with...CONFORMITY ASSESSMENT ANNEX XIIIEU DECLARATION OF CONFORMITY (No XXXX) 1.Instrument model/Instrument (product, type, batch or serial number): 2.Name and address of the manufacturer and, where applicable, his...3.This declaration of conformity is issued under the sole responsibility...4.Object of the declaration (identification of instrument allowing traceability; it...5.The object of the declaration described above is in conformity...6.References to the relevant harmonised standards or normative documents used...7.Where applicable, the notified body … (name, number) performed …...8.Additional information: ANNEX XIVPART APART BANNEX XV

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)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee,

Acting in accordance with the ordinary legislative procedure,

Whereas:

(1)

Directive 2004/22/EC of the European Parliament and of the Council of 31 March 2004 on measuring instruments has been substantially amended. Since further amendments are to be made, that Directive should be recast in the interests of clarity.

(2)

Regulation (EC) No 765/2008 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 lays down rules on the accreditation of conformity assessment bodies, provides a framework for the market surveillance of products and for controls on products from third countries, and lays down the general principles of the CE marking.

(3)

Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products lays 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. Directive 2004/22/EC should be adapted to that Decision.

(4)

This Directive covers measuring instruments which are new to the Union market when they are placed on the market; that is to say they are either new measuring instruments made by a manufacturer established in the Union or measuring instruments, whether new or second-hand, imported from a third country.

(5)

Correct and traceable measuring instruments can be used for a variety of measurement tasks. Those responding to reasons of public interest, public health, safety and order, protection of the environment and the consumer, of levying taxes and duties and of fair trading, which directly and indirectly affect the daily life of citizens in many ways, may require the use of legally controlled measuring instruments.

(6)

This Directive should apply to all forms of supply, including distance selling.

(7)

Legal metrological control should not lead to barriers to the free movement of measuring instruments. The applicable provisions should be the same in all Member States and proof of conformity should be accepted throughout the Union.

(8)

Legal metrological control requires conformity with specified performance requirements. The performance requirements that the measuring instruments must meet should provide a high level of protection. The conformity assessment should provide a high level of confidence.

(9)

Member States should as a general rule prescribe legal metrological control. Where legal metrological control is prescribed, only measuring instruments complying with common performance requirements should be used.

(10)

The principle of optionality introduced by Directive 2004/22/EC allows Member States to exercise their right to decide whether or not to prescribe the use of the measuring instruments covered by this Directive.

(11)

National specifications concerning the appropriate national requirements for use should not interfere with the provisions of this Directive on ‘putting into use’.

(12)

The performance of certain measuring instruments is particularly sensitive to the environment, in particular the electromagnetic environment. Immunity of measuring instruments to electromagnetic interference should form an integral part of this Directive and the immunity requirements of Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility should therefore not apply.

(13)

In order to ensure the free circulation of measuring instruments in the Union, Member States should not impede the placing on the market and/or putting into use of measuring instruments that carry the CE marking and supplementary metrology marking in accordance with the provisions of this Directive.

(14)

Member States should take appropriate action to prevent non-complying measuring instruments from being placed on the market and/or put into use. Adequate cooperation between the competent authorities of the Member States is therefore necessary to ensure a Union-wide effect of this objective.

(15)

Economic operators should be responsible for the compliance of measuring instruments with this Directive, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of the aspects of public interest covered by this Directive, and also to guarantee fair competition on the Union market.

(16)

All economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that they make available on the market only measuring instruments which are in conformity with this Directive. It is necessary to provide for a clear and proportionate distribution of obligations which correspond to the role of each economic operator in the supply and distribution chain.

(17)

In order to facilitate communication between economic operators, market surveillance authorities and consumers, Member States should encourage economic operators to include a website address in addition to the postal address.

(18)

The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the conformity assessment procedure. Conformity assessment should therefore remain solely the obligation of the manufacturer.

(19)

It is necessary to ensure that measuring instruments from third countries entering the Union market comply with this Directive, and in particular that the appropriate conformity assessment procedures have been carried out by manufacturers with regard to those measuring instruments. Provision should therefore be made for importers to make sure that the measuring instruments they place on the market comply with the requirements of this Directive and that they do not place on the market measuring instruments which do not comply with such requirements or present a risk. Provision should also be made for importers to make sure that conformity assessment procedures have been carried out and that marking of measuring instruments and documentation drawn up by manufacturers are available for inspection by the competent national authorities.

(20)

When placing a measuring instrument on the market, every importer should indicate on the measuring instrument his name, registered trade name or registered trade mark and the postal address at which he can be contacted. Exceptions should be provided for in cases where the size or nature of the measuring instrument does not allow it. This includes cases where the importer would have to open the packaging to put his name and address on the measuring instrument.

(21)

The distributor makes a measuring instrument available on the market after it has been placed on the market by the manufacturer or the importer. The distributor should act with due care to ensure that its handling of the measuring instrument does not adversely affect the compliance of that instrument with this Directive.

(22)

Any economic operator that either places a measuring instrument on the market under his own name or trade mark or modifies a measuring instrument in such a way that compliance with of this Directive may be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer.

(23)

Distributors and importers, being close to the market place, should be involved in market surveillance tasks carried out by competent national authorities, and should be prepared to participate actively, providing those authorities with all necessary information relating to the measuring instrument concerned.

(24)

Ensuring traceability of a measuring instrument throughout the whole supply chain helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates market surveillance authorities’ task of tracing economic operators who made non-compliant measuring instruments available on the market. When keeping the information required under this Directive for the identification of other economic operators, economic operators should not be required to update such information in respect of other economic operators who have either supplied them with a measuring instrument or to whom they have supplied a measuring instrument.

(25)

This Directive should be limited to the expression of essential requirements that do not impede technical progress, preferably performance requirements. In order to facilitate conformity assessment with those requirements it is necessary to provide for a presumption of conformity for measuring instruments which are in conformity with harmonised standards that are adopted in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European Standardisation for the purpose of expressing detailed technical specifications of those requirements.

(26)

Regulation (EU) No 1025/2012 provides for a procedure for objections to harmonised standards where those standards do not entirely satisfy the requirements of this Directive.

(27)

The technical and performance specifications of internationally agreed normative documents may also comply, in part or in full, with the essential requirements laid down by this Directive. In those cases the use of these internationally agreed normative documents should be allowed as an alternative to the use of harmonised standards and, under specific conditions, give rise to a presumption of conformity.

(28)

Conformity with the essential requirements laid down by this Directive can also be provided by specifications that are not supplied by a harmonised standard or an internationally agreed normative document. The use of harmonised standards or internationally agreed normative documents should therefore be optional.

(29)

In order to enable economic operators to demonstrate and the competent authorities to ensure that measuring instruments made available on the market comply with the essential requirements, it is necessary to provide for conformity assessment procedures. Decision No 768/2008/EC establishes modules for conformity assessment procedures, from the least to the most stringent, in proportion to the level of risk involved and the level of safety required. In order to ensure inter-sectoral coherence and to avoid ad-hoc variants, conformity assessment procedures should be chosen from among those modules. However, it is necessary to adapt those modules in order to reflect specific aspects of metrological control.

(30)

The conformity assessment of sub-assemblies should be carried out in accordance with this Directive. If sub-assemblies are made available on the market separately and independently of an instrument, their conformity assessment should be undertaken independently of the instrument concerned.

(31)

The state of the art in measurement technology is subject to constant evolution which may lead to changes in the needs for conformity assessments. Therefore, for each category of measuring instrument and, where appropriate, sub-assemblies, there should be an appropriate procedure or a choice between different procedures of equivalent stringency.

(32)

Manufacturers should draw up an EU declaration of conformity to provide information required under this Directive on the conformity of a measuring instrument with this Directive and with other relevant Union harmonisation legislation.

(33)

To ensure effective access to information for market surveillance purposes, the information required to identify all applicable Union acts should be available in a single EU declaration of conformity. In order to reduce the administrative burden on economic operators, that single EU declaration of conformity may be a dossier made up of relevant individual declarations of conformity.

(34)

The CE marking and the supplementary metrology marking, indicating the conformity of a measuring instrument, are the visible consequence of a whole process comprising conformity assessment in a broad sense. General principles governing the CE marking and its relationship to other markings are set out in Regulation (EC) No 765/2008. Rules governing the affixing of the CE marking and the supplementary metrology marking should be laid down in this Directive.

(35)

In order to take account of differences in climatic conditions or of different levels of consumer protection that may apply at national level, it is necessary to establish environmental or accuracy classes as essential requirements.

(36)

Certain conformity assessment procedures set out in this Directive require the intervention of conformity assessment bodies, which are notified by the Member States to the Commission.

(37)

Experience has shown that the criteria set out in Directive 2004/22/EC that conformity assessment bodies have to fulfil to be notified to the Commission are not sufficient to ensure a uniformly high level of performance of notified bodies throughout the Union. It is, however, essential that all notified bodies perform their functions to the same level and under conditions of fair competition. That requires the setting of obligatory requirements for conformity assessment bodies wishing to be notified in order to provide conformity assessment services.

(38)

If a conformity assessment body demonstrates conformity with the criteria laid down in harmonised standards it should be presumed to comply with the corresponding requirements set out in this Directive.

(39)

In order to ensure a consistent level of quality in the performance of conformity assessment of measuring instruments, it is also necessary to set requirements for notifying authorities and other bodies involved in the assessment, notification and monitoring of notified bodies.

(40)

The system set out in this Directive should be complemented by the accreditation system provided for in Regulation (EC) No 765/2008. Since accreditation is an essential means of verifying the competence of conformity assessment bodies, it should also be used for the purposes of notification.

(41)

Transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring the necessary level of confidence in certificates of conformity, should be considered by the national public authorities throughout the Union as the preferred means of demonstrating the technical competence of conformity assessment bodies. However, national authorities may consider that they possess the appropriate means of carrying out that evaluation themselves. In such cases, in order to ensure the appropriate level of credibility of evaluations carried out by other national authorities, they should provide the Commission and the other Member States with the necessary documentary evidence demonstrating the compliance of the conformity assessment bodies evaluated with the relevant regulatory requirements.

(42)

Conformity assessment bodies frequently subcontract parts of their activities linked to the assessment of conformity or have recourse to a subsidiary. In order to safeguard the level of protection required for the measuring instruments to be placed on the market, it is essential that conformity assessment subcontractors and subsidiaries fulfil the same requirements as notified bodies in relation to the performance of conformity assessment tasks. Therefore, it is important that the assessment of the competence and the performance of bodies to be notified and the monitoring of bodies already notified cover also activities carried out by subcontractors and subsidiaries.

(43)

It is necessary to increase the efficiency and transparency of the notification procedure and, in particular, to adapt it to new technologies so as to enable online notification.

(44)

Since notified bodies may offer their services throughout the Union, it is appropriate to give the other Member States and the Commission the opportunity to raise objections concerning a notified body. It is therefore important to provide for a period during which any doubts or concerns as to the competence of conformity assessment bodies can be clarified before they start operating as notified bodies.

(45)

In the interests of competitiveness, it is crucial that notified bodies apply the conformity assessment procedures without creating unnecessary burdens for economic operators. For the same reason, and to ensure equal treatment of economic operators, consistency in the technical application of the conformity assessment procedures needs to be ensured. That can best be achieved through appropriate coordination and cooperation between notified bodies.

(46)

In order to ensure legal certainty, it is necessary to clarify that rules on Union market surveillance and control of products entering the Union market provided for in Regulation (EC) No 765/2008 apply to measuring instruments covered by this Directive. This Directive should not prevent Member States from choosing the competent authorities to carry out those tasks.

(47)

Member States should take all appropriate measures to ensure that measuring instruments may be placed on the market only if, when properly stored and used for their intended purpose, or under conditions of use which can be reasonably foreseen, they do not endanger the health and safety of persons. Measuring instruments should be considered as non-compliant with the essential requirements laid down in this Directive only under conditions of use which can be reasonably foreseen, that is when such use could result from lawful and readily predictable human behaviour.

(48)

Directive 2004/22/EC already provides for a safeguard procedure allowing the Commission to examine the justification for a measure taken by a Member State against measuring instruments it considers to be non-compliant. In order to increase transparency and to reduce processing time, it is necessary to improve the existing safeguard procedure, with the view to making it more efficient and drawing on the expertise available in Member States.

(49)

The existing system should be supplemented by a procedure under which interested parties are informed of measures intended to be taken with regard to measuring instruments presenting a risk to aspects of public interest protection covered by this Directive. It should also allow market surveillance authorities, in cooperation with the relevant economic operators, to act at an early stage in respect of such measuring instruments.

(50)

Where the Member States and the Commission agree as to the justification of a measure taken by a Member State, no further involvement of the Commission should be required, except where non-compliance can be attributed to shortcomings of a harmonised standard or a normative document.

(51)

In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers.

(52)

The advisory procedure should be used for the adoption of implementing acts requesting the notifying Member State to take the necessary corrective measures in respect of notified bodies that do not meet or no longer meet the requirements for their notification.

(53)

The advisory procedure should also be used for the adoption of implementing acts with respect to the objections to the internationally agreed normative documents whose references have not yet been published in the Official Journal of the European Union, given that the relevant document has not yet led to the presumption of conformity with the applicable essential requirements.

(54)

The examination procedure should be used for the adoption of implementing acts with respect to the objections to the internationally agreed normative documents whose references were already published in the Official Journal of the European Union and which a Member State or the Commission considers justified, given that such acts could have consequences on the presumption of conformity with the applicable essential requirements.

(55)

The examination procedure should also be used for the adoption of implementing acts with respect to compliant measuring instruments which present a risk to the health or safety of persons or to other aspects of public interest protection.

(56)

In line with established practice, the committee set up by this Directive can play a useful role in examining matters concerning the application of this Directive raised either by its chair or by a representative of a Member State in accordance with its rules of procedure.

(57)

When matters relating to this Directive, other than its implementation or infringements, are being examined, i.e. in a Commission expert group, the European Parliament should in line with existing practice receive full information and documentation and, where appropriate, an invitation to attend such meetings.

(58)

The Commission should, by means of implementing acts and, given their special nature, acting without the application of Regulation (EU) No 182/2011, determine whether measures taken by Member States in respect of non-compliant measuring instruments are justified or not.

(59)

In order to take into account the developments in the measurement technology, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amendments to the instrument-specific Annexes. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.

(60)

Member States should lay down rules on penalties applicable to infringements of the provisions of national law adopted pursuant to this Directive and ensure that those rules are enforced. The penalties provided for should be effective, proportionate and dissuasive.

(61)

It is necessary to provide for reasonable transitional arrangements that allow the making available on the market and putting into use, without the need to comply with further product requirements, of measuring instruments that have already been placed on the market in accordance with Directive 2004/22/EC before the date of application of national measures transposing this Directive. Distributors should therefore be able to supply measuring instruments that have been placed on the market, namely stock that is already in the distribution chain, before the date of application of national measures transposing this Directive.

(62)

Since the objective of this Directive, namely to ensure that measuring instruments on the market fulfil the requirements providing for a high level of protection of the public interests covered by this Directive while guaranteeing the functioning of the internal market cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.

(63)

The obligation to transpose this Directive into national law should be confined to those provisions which represent a substantive amendment as compared to the earlier Directive. The obligation to transpose the provisions which are unchanged arises under the earlier Directive.

(64)

This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law and the dates of application of the Directives set out in Annex XIV, Part B,

HAVE ADOPTED THIS DIRECTIVE:

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<notes source="#source">
<note class="footnote" eId="f00001">
<p>
<ref href="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.C_.2012.181.01.0105.01.ENG">OJ C 181, 21.6.2012, p. 105</ref>
.
</p>
</note>
<note class="footnote" eId="f00002">
<p>Position of the European Parliament of 5 February 2014 (not yet published in the Official Journal) and decision of the Council of 20 February 2014.</p>
</note>
<note class="footnote" eId="f00003">
<p>
<ref href="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2004.135.01.0001.01.ENG">OJ L 135, 30.4.2004, p. 1</ref>
.
</p>
</note>
<note class="footnote" eId="f00004">
<p>See Annex XIV, Part A.</p>
</note>
<note class="footnote" eId="f00005">
<p>
<ref href="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2008.218.01.0030.01.ENG">OJ L 218, 13.8.2008, p. 30</ref>
.
</p>
</note>
<note class="footnote" eId="f00006">
<p>
<ref href="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2008.218.01.0082.01.ENG">OJ L 218, 13.8.2008, p. 82</ref>
.
</p>
</note>
<note class="footnote" eId="f00007">
<p>
<ref href="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2004.390.01.0024.01.ENG">OJ L 390, 31.12.2004, p. 24</ref>
.
</p>
</note>
<note class="footnote" eId="f00008">
<p>
<ref href="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2012.316.01.0012.01.ENG">OJ L 316, 14.11.2012, p. 12</ref>
.
</p>
</note>
<note class="footnote" eId="f00009">
<p>
<ref href="https://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2011.055.01.0013.01.ENG">OJ L 55, 28.2.2011, p. 13</ref>
.
</p>
</note>
</notes>
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<toc>
<inline name="tocNum">CHAPTER 1</inline>
<inline name="tocHeading"> GENERAL PROVISIONS </inline>
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<inline name="tocNum">Article 1</inline>
<inline name="tocHeading">Subject matter</inline>
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<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/2" level="1" class="item" period="#period1">
<inline name="tocNum">Article 2</inline>
<inline name="tocHeading">Scope</inline>
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<inline name="tocNum">Article 3</inline>
<inline name="tocHeading">Optionality</inline>
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<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/4" level="1" class="item" period="#period1">
<inline name="tocNum">Article 4</inline>
<inline name="tocHeading">Definitions</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/5" level="1" class="item" period="#period1">
<inline name="tocNum">Article 5</inline>
<inline name="tocHeading">Applicability to sub-assemblies</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/6" level="1" class="item" period="#period1">
<inline name="tocNum">Article 6</inline>
<inline name="tocHeading">Essential requirements</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/7" level="1" class="item" period="#period1">
<inline name="tocNum">Article 7</inline>
<inline name="tocHeading">Making available on the market and putting into use</inline>
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<inline name="tocNum">CHAPTER 2</inline>
<inline name="tocHeading"> OBLIGATIONS OF ECONOMIC OPERATORS </inline>
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<inline name="tocNum">Article 8</inline>
<inline name="tocHeading">Obligations of manufacturers</inline>
</tocItem>
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<inline name="tocNum">Article 9</inline>
<inline name="tocHeading">Authorised representatives</inline>
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<inline name="tocNum">Article 10</inline>
<inline name="tocHeading">Obligations of importers</inline>
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<inline name="tocNum">Article 11</inline>
<inline name="tocHeading">Obligations of distributors</inline>
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<inline name="tocNum">Article 12</inline>
<inline name="tocHeading">Cases in which obligations of manufacturers apply to importers and distributors</inline>
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<inline name="tocNum">Article 13</inline>
<inline name="tocHeading">Identification of economic operators</inline>
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<inline name="tocNum">CHAPTER 3</inline>
<inline name="tocHeading"> CONFORMITY OF MEASURING INSTRUMENTS </inline>
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<inline name="tocNum">Article 14</inline>
<inline name="tocHeading">Presumption of conformity of measuring instruments</inline>
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<inline name="tocNum">Article 15</inline>
<inline name="tocHeading">Publication of the references of normative documents</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/16" level="1" class="item" period="#period1">
<inline name="tocNum">Article 16</inline>
<inline name="tocHeading">Withdrawal of the references of normative documents</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/17" level="1" class="item" period="#period1">
<inline name="tocNum">Article 17</inline>
<inline name="tocHeading">Conformity assessment procedures</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/18" level="1" class="item" period="#period1">
<inline name="tocNum">Article 18</inline>
<inline name="tocHeading">Technical documentation</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/19" level="1" class="item" period="#period1">
<inline name="tocNum">Article 19</inline>
<inline name="tocHeading">EU declaration of conformity</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/20" level="1" class="item" period="#period1">
<inline name="tocNum">Article 20</inline>
<inline name="tocHeading">Conformity marking</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/21" level="1" class="item" period="#period1">
<inline name="tocNum">Article 21</inline>
<inline name="tocHeading">General principles of the CE marking and of the supplementary metrology marking</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/22" level="1" class="item" period="#period1">
<inline name="tocNum">Article 22</inline>
<inline name="tocHeading">Rules and conditions for affixing the CE marking and the supplementary metrology marking</inline>
</tocItem>
<inline name="tocNum">CHAPTER 4</inline>
<inline name="tocHeading"> NOTIFICATION OF CONFORMITY ASSESSMENT BODIES </inline>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/23" level="1" class="item" period="#period1">
<inline name="tocNum">Article 23</inline>
<inline name="tocHeading">Notification</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/24" level="1" class="item" period="#period1">
<inline name="tocNum">Article 24</inline>
<inline name="tocHeading">Notifying authorities</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/25" level="1" class="item" period="#period1">
<inline name="tocNum">Article 25</inline>
<inline name="tocHeading">Requirements relating to notifying authorities</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/26" level="1" class="item" period="#period1">
<inline name="tocNum">Article 26</inline>
<inline name="tocHeading">Information obligation on notifying authorities</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/27" level="1" class="item" period="#period1">
<inline name="tocNum">Article 27</inline>
<inline name="tocHeading">Requirements relating to notified bodies</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/28" level="1" class="item" period="#period1">
<inline name="tocNum">Article 28</inline>
<inline name="tocHeading">Presumption of conformity of notified bodies</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/29" level="1" class="item" period="#period1">
<inline name="tocNum">Article 29</inline>
<inline name="tocHeading">Subsidiaries of and subcontracting by notified bodies</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/30" level="1" class="item" period="#period2">
<inline name="tocNum">Article 30</inline>
<inline name="tocHeading">Accredited in-house bodies</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/31" level="1" class="item" period="#period1">
<inline name="tocNum">Article 31</inline>
<inline name="tocHeading">Application for notification</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/32" level="1" class="item" period="#period1">
<inline name="tocNum">Article 32</inline>
<inline name="tocHeading">Notification procedure</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/33" level="1" class="item" period="#period1">
<inline name="tocNum">Article 33</inline>
<inline name="tocHeading">Identification numbers and lists of notified bodies</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/34" level="1" class="item" period="#period1">
<inline name="tocNum">Article 34</inline>
<inline name="tocHeading">Changes to notifications</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/35" level="1" class="item" period="#period1">
<inline name="tocNum">Article 35</inline>
<inline name="tocHeading">Challenge of the competence of notified bodies</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/36" level="1" class="item" period="#period1">
<inline name="tocNum">Article 36</inline>
<inline name="tocHeading">Operational obligations of notified bodies</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/37" level="1" class="item" period="#period1">
<inline name="tocNum">Article 37</inline>
<inline name="tocHeading">Appeal against decisions of notified bodies</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/38" level="1" class="item" period="#period1">
<inline name="tocNum">Article 38</inline>
<inline name="tocHeading">Information obligation on notified bodies</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/39" level="1" class="item" period="#period1">
<inline name="tocNum">Article 39</inline>
<inline name="tocHeading">Exchange of experience</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/40" level="1" class="item" period="#period1">
<inline name="tocNum">Article 40</inline>
<inline name="tocHeading">Coordination of notified bodies</inline>
</tocItem>
<inline name="tocNum">CHAPTER 5</inline>
<inline name="tocHeading"> UNION MARKET SURVEILLANCE, CONTROL OF MEASURING INSTRUMENTS ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE </inline>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/41" level="1" class="item" period="#period1">
<inline name="tocNum">Article 41</inline>
<inline name="tocHeading">Union market surveillance and control of measuring instruments entering the Union market</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/42" level="1" class="item" period="#period1">
<inline name="tocNum">Article 42</inline>
<inline name="tocHeading">Procedure for dealing with measuring instruments presenting a risk at national level</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/43" level="1" class="item" period="#period1">
<inline name="tocNum">Article 43</inline>
<inline name="tocHeading">Union safeguard procedure</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/44" level="1" class="item" period="#period1">
<inline name="tocNum">Article 44</inline>
<inline name="tocHeading">Compliant measuring instruments which present a risk</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/45" level="1" class="item" period="#period1">
<inline name="tocNum">Article 45</inline>
<inline name="tocHeading">Formal non-compliance</inline>
</tocItem>
<inline name="tocNum">CHAPTER 6</inline>
<inline name="tocHeading"> COMMITTEE AND DELEGATED ACTS </inline>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/46" level="1" class="item" period="#period1">
<inline name="tocNum">Article 46</inline>
<inline name="tocHeading">Committee procedure</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/47" level="1" class="item" period="#period1">
<inline name="tocNum">Article 47</inline>
<inline name="tocHeading">Amendments of Annexes</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/48" level="1" class="item" period="#period1">
<inline name="tocNum">Article 48</inline>
<inline name="tocHeading">Exercise of the delegation</inline>
</tocItem>
<inline name="tocNum">CHAPTER 7</inline>
<inline name="tocHeading"> TRANSITIONAL AND FINAL PROVISIONS </inline>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/49" level="1" class="item" period="#period1">
<inline name="tocNum">Article 49</inline>
<inline name="tocHeading">Penalties</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/50" level="1" class="item" period="#period1">
<inline name="tocNum">Article 50</inline>
<inline name="tocHeading">Transitional provisions</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/51" level="1" class="item" period="#period1">
<inline name="tocNum">Article 51</inline>
<inline name="tocHeading">Transposition</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/52" level="1" class="item" period="#period1">
<inline name="tocNum">Article 52</inline>
<inline name="tocHeading">Repeal</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/53" level="1" class="item" period="#period1">
<inline name="tocNum">Article 53</inline>
<inline name="tocHeading">Entry into force and application</inline>
</tocItem>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/article/54" level="1" class="item" period="#period1">
<inline name="tocNum">Article 54</inline>
<inline name="tocHeading">Addressees</inline>
</tocItem>
<tocItem href="" level="1" class="schedules" period="#period2"/>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/annex/I" level="2" class="schedule" period="#period1">
<inline name="tocNum">ANNEX I</inline>
</tocItem>
<inline name="tocHeading">ESSENTIAL REQUIREMENTS </inline>
<inline name="tocHeading">DEFINITIONS </inline>
<inline name="tocHeading">ESSENTIAL REQUIREMENTS </inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Allowable Errors </inline>
<inline name="tocNum">1.1.</inline>
<inline name="tocHeading">Under rated operating conditions and in the absence of a...</inline>
<inline name="tocNum">1.2.</inline>
<inline name="tocHeading">Under rated operating conditions and in the presence of a...</inline>
<inline name="tocNum">1.3.</inline>
<inline name="tocHeading">The manufacturer shall specify the climatic, mechanical and electromagnetic environments...</inline>
<inline name="tocNum">1.3.1.</inline>
<inline name="tocHeading">Climatic environments </inline>
<inline name="tocNum">1.3.2.</inline>
<inline name="tocHeading">Mechanical environments are classified into classes M1 to M3 as...</inline>
<inline name="tocNum">1.3.3.</inline>
<inline name="tocHeading">Electromagnetic environments are classified into classes E1, E2 or E3...</inline>
<inline name="tocNum">1.3.4.</inline>
<inline name="tocHeading">Other influence quantities to be considered, where appropriate, are: </inline>
<inline name="tocNum">1.4.</inline>
<inline name="tocHeading">When carrying out the tests as envisaged in this Directive,...</inline>
<inline name="tocNum">1.4.1.</inline>
<inline name="tocHeading">Basic rules for testing and the determination of errors </inline>
<inline name="tocNum">1.4.2.</inline>
<inline name="tocHeading">Ambient humidity </inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">Reproducibility </inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">Repeatability </inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">Discrimination and Sensitivity </inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">Durability </inline>
<inline name="tocNum">6.</inline>
<inline name="tocHeading">Reliability </inline>
<inline name="tocNum">7.</inline>
<inline name="tocHeading">Suitability </inline>
<inline name="tocNum">7.1.</inline>
<inline name="tocHeading">A measuring instrument shall have no feature likely to facilitate...</inline>
<inline name="tocNum">7.2.</inline>
<inline name="tocHeading">A measuring instrument shall be suitable for its intended use...</inline>
<inline name="tocNum">7.3.</inline>
<inline name="tocHeading">The errors of a utility measuring instrument at flows or...</inline>
<inline name="tocNum">7.4.</inline>
<inline name="tocHeading">Where a measuring instrument is designed for the measurement of...</inline>
<inline name="tocNum">7.5.</inline>
<inline name="tocHeading">A measuring instrument shall be robust and its materials of...</inline>
<inline name="tocNum">7.6.</inline>
<inline name="tocHeading">A measuring instrument shall be designed so as to allow...</inline>
<inline name="tocNum">8.</inline>
<inline name="tocHeading">Protection against corruption </inline>
<inline name="tocNum">8.1.</inline>
<inline name="tocHeading">The metrological characteristics of a measuring instrument shall not be...</inline>
<inline name="tocNum">8.2.</inline>
<inline name="tocHeading">A hardware component that is critical for metrological characteristics shall...</inline>
<inline name="tocNum">8.3.</inline>
<inline name="tocHeading">Software that is critical for metrological characteristics shall be identified...</inline>
<inline name="tocNum">8.4.</inline>
<inline name="tocHeading">Measurement data, software that is critical for measurement characteristics and...</inline>
<inline name="tocNum">8.5.</inline>
<inline name="tocHeading">For utility measuring instruments the display of the total quantity...</inline>
<inline name="tocNum">9.</inline>
<inline name="tocHeading">Information to be borne by and to accompany the instrument...</inline>
<inline name="tocNum">9.1.</inline>
<inline name="tocHeading">A measuring instrument shall bear the following inscriptions: </inline>
<inline name="tocNum">9.2.</inline>
<inline name="tocHeading">An instrument of dimensions too small or of too sensitive...</inline>
<inline name="tocNum">9.3.</inline>
<inline name="tocHeading">The instrument shall be accompanied by information on its operation,...</inline>
<inline name="tocNum">9.4.</inline>
<inline name="tocHeading">Groups of identical measuring instruments used in the same location...</inline>
<inline name="tocNum">9.5.</inline>
<inline name="tocHeading">Unless specified otherwise in an instrument-specific annex, the scale interval...</inline>
<inline name="tocNum">9.6.</inline>
<inline name="tocHeading">A material measure shall be marked with a nominal value...</inline>
<inline name="tocNum">9.7.</inline>
<inline name="tocHeading">The units of measurement used and their symbols shall be...</inline>
<inline name="tocNum">9.8.</inline>
<inline name="tocHeading">All marks and inscriptions required under any requirement shall be...</inline>
<inline name="tocNum">10.</inline>
<inline name="tocHeading">Indication of result </inline>
<inline name="tocNum">10.1.</inline>
<inline name="tocHeading">Indication of the result shall be by means of a...</inline>
<inline name="tocNum">10.2.</inline>
<inline name="tocHeading">The indication of any result shall be clear and unambiguous...</inline>
<inline name="tocNum">10.3.</inline>
<inline name="tocHeading">In the case of hard copy the print or record...</inline>
<inline name="tocNum">10.4.</inline>
<inline name="tocHeading">A measuring instrument for direct sales trading transactions shall be...</inline>
<inline name="tocNum">10.5.</inline>
<inline name="tocHeading">Whether or not a measuring instrument intended for utility measurement...</inline>
<inline name="tocNum">11.</inline>
<inline name="tocHeading">Further processing of data to conclude the trading transaction </inline>
<inline name="tocNum">11.1.</inline>
<inline name="tocHeading">A measuring instrument other than a utility measuring instrument shall...</inline>
<inline name="tocNum">11.2.</inline>
<inline name="tocHeading">Additionally, a durable proof of the measurement result and the...</inline>
<inline name="tocNum">12.</inline>
<inline name="tocHeading">Conformity evaluation </inline>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/annex/II" level="2" class="schedule" period="#period1">
<inline name="tocNum">ANNEX II</inline>
</tocItem>
<inline name="tocNum">MODULE A:</inline>
<inline name="tocHeading">INTERNAL PRODUCTION CONTROL </inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">‘Internal production control’ is the conformity assessment procedure whereby the...</inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">Technical documentation </inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">Manufacturing </inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">Conformity marking and EU declaration of conformity </inline>
<inline name="tocNum">4.1.</inline>
<inline name="tocHeading">The manufacturer shall affix the CE marking and the supplementary...</inline>
<inline name="tocNum">4.2.</inline>
<inline name="tocHeading">The manufacturer shall draw up a written EU declaration of...</inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">Authorised representative </inline>
<inline name="tocNum">MODULE A2:</inline>
<inline name="tocHeading">INTERNAL PRODUCTION CONTROL PLUS SUPERVISED INSTRUMENT CHECKS AT RANDOM INTERVALS...</inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Internal production control plus supervised instrument checks at random intervals...</inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">Technical documentation </inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">Manufacturing </inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">Instrument checks </inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">Conformity marking and EU declaration of conformity </inline>
<inline name="tocNum">5.1.</inline>
<inline name="tocHeading">The manufacturer shall affix the CE marking and the supplementary...</inline>
<inline name="tocNum">5.2.</inline>
<inline name="tocHeading">The manufacturer shall draw up a written EU declaration of...</inline>
<inline name="tocNum">6.</inline>
<inline name="tocHeading">Authorised representative </inline>
<inline name="tocNum">MODULE B:</inline>
<inline name="tocHeading">EU- TYPE EXAMINATION </inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">‘EU-type examination’ is the part of a conformity assessment procedure...</inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">EU-type examination may be carried out in either of the...</inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">The manufacturer shall lodge an application for EU-type examination with...</inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">The notified body shall: </inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">The notified body shall draw up an evaluation report that...</inline>
<inline name="tocNum">6.</inline>
<inline name="tocHeading">Where the type meets the requirements of this Directive, the...</inline>
<inline name="tocNum">7.</inline>
<inline name="tocHeading">The notified body shall keep itself apprised of any changes...</inline>
<inline name="tocNum">8.</inline>
<inline name="tocHeading">The manufacturer shall inform the notified body that holds the...</inline>
<inline name="tocNum">9.</inline>
<inline name="tocHeading">Each notified body shall inform its notifying authority concerning the...</inline>
<inline name="tocNum">10.</inline>
<inline name="tocHeading">The manufacturer shall keep a copy of the EU-type examination...</inline>
<inline name="tocNum">11.</inline>
<inline name="tocHeading">The manufacturer’s authorised representative may lodge the application referred to...</inline>
<inline name="tocNum">MODULE C:</inline>
<inline name="tocHeading">CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL </inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Conformity to type based on internal production control is the...</inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">Manufacturing </inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">Conformity marking and EU declaration of conformity </inline>
<inline name="tocNum">3.1.</inline>
<inline name="tocHeading">The manufacturer shall affix the CE marking and the supplementary...</inline>
<inline name="tocNum">3.2.</inline>
<inline name="tocHeading">The manufacturer shall draw up a written EU declaration of...</inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">Authorised representative </inline>
<inline name="tocNum">MODULE C2:</inline>
<inline name="tocHeading">CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED...</inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Conformity to type based on internal production control plus supervised...</inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">Manufacturing </inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">Instrument checks </inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">Conformity marking and EU declaration of conformity </inline>
<inline name="tocNum">4.1.</inline>
<inline name="tocHeading">The manufacturer shall affix the CE marking, and the supplementary...</inline>
<inline name="tocNum">4.2.</inline>
<inline name="tocHeading">The manufacturer shall draw up a written EU declaration of...</inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">Authorised representative </inline>
<inline name="tocNum">MODULE D:</inline>
<inline name="tocHeading">CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION...</inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Conformity to type based on quality assurance of the production...</inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">Manufacturing </inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">Quality system </inline>
<inline name="tocNum">3.1.</inline>
<inline name="tocHeading">The manufacturer shall lodge an application for assessment of his...</inline>
<inline name="tocNum">3.2.</inline>
<inline name="tocHeading">The quality system shall ensure that the measuring instruments are...</inline>
<inline name="tocNum">3.3.</inline>
<inline name="tocHeading">The notified body shall assess the quality system to determine...</inline>
<inline name="tocNum">3.4.</inline>
<inline name="tocHeading">The manufacturer shall undertake to fulfil the obligations arising out...</inline>
<inline name="tocNum">3.5.</inline>
<inline name="tocHeading">The manufacturer shall keep the notified body that has approved...</inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">Surveillance under the responsibility of the notified body </inline>
<inline name="tocNum">4.1.</inline>
<inline name="tocHeading">The purpose of surveillance is to make sure that the...</inline>
<inline name="tocNum">4.2.</inline>
<inline name="tocHeading">The manufacturer shall, for assessment purposes, allow the notified body...</inline>
<inline name="tocNum">4.3.</inline>
<inline name="tocHeading">The notified body shall carry out periodic audits to make...</inline>
<inline name="tocNum">4.4.</inline>
<inline name="tocHeading">In addition, the notified body may pay unexpected visits to...</inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">Conformity marking and EU declaration of conformity </inline>
<inline name="tocNum">5.1.</inline>
<inline name="tocHeading">The manufacturer shall affix the CE marking and the supplementary...</inline>
<inline name="tocNum">5.2.</inline>
<inline name="tocHeading">The manufacturer shall draw up a written EU declaration of...</inline>
<inline name="tocNum">6.</inline>
<inline name="tocHeading">The manufacturer shall, for a period ending 10 years after...</inline>
<inline name="tocNum">7.</inline>
<inline name="tocHeading">Each notified body shall inform its notifying authority of quality...</inline>
<inline name="tocNum">8.</inline>
<inline name="tocHeading">Authorised representative </inline>
<inline name="tocNum">MODULE D1:</inline>
<inline name="tocHeading">QUALITY ASSURANCE OF THE PRODUCTION PROCESS </inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Quality assurance of the production process is the conformity assessment...</inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">Technical documentation </inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">The manufacturer shall keep the technical documentation at the disposal...</inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">Manufacturing </inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">Quality system </inline>
<inline name="tocNum">5.1.</inline>
<inline name="tocHeading">The manufacturer shall lodge an application for assessment of his...</inline>
<inline name="tocNum">5.2.</inline>
<inline name="tocHeading">The quality system shall ensure compliance of the measuring instruments...</inline>
<inline name="tocNum">5.3.</inline>
<inline name="tocHeading">The notified body shall assess the quality system to determine...</inline>
<inline name="tocNum">5.4.</inline>
<inline name="tocHeading">The manufacturer shall undertake to fulfil the obligations arising out...</inline>
<inline name="tocNum">5.5.</inline>
<inline name="tocHeading">The manufacturer shall keep the notified body that has approved...</inline>
<inline name="tocNum">6.</inline>
<inline name="tocHeading">Surveillance under the responsibility of the notified body </inline>
<inline name="tocNum">6.1.</inline>
<inline name="tocHeading">The purpose of surveillance is to make sure that the...</inline>
<inline name="tocNum">6.2.</inline>
<inline name="tocHeading">The manufacturer shall, for assessment purposes, allow the notified body...</inline>
<inline name="tocNum">6.3.</inline>
<inline name="tocHeading">The notified body shall carry out periodic audits to make...</inline>
<inline name="tocNum">6.4.</inline>
<inline name="tocHeading">In addition, the notified body may pay unexpected visits to...</inline>
<inline name="tocNum">7.</inline>
<inline name="tocHeading">Conformity marking and EU declaration of conformity </inline>
<inline name="tocNum">7.1.</inline>
<inline name="tocHeading">The manufacturer shall affix the CE marking, the supplementary metrology...</inline>
<inline name="tocNum">7.2.</inline>
<inline name="tocHeading">The manufacturer shall draw up a written EU declaration of...</inline>
<inline name="tocNum">8.</inline>
<inline name="tocHeading">The manufacturer shall, for a period ending 10 years after...</inline>
<inline name="tocNum">9.</inline>
<inline name="tocHeading">Each notified body shall inform its notifying authority of quality...</inline>
<inline name="tocNum">10.</inline>
<inline name="tocHeading">Authorised representative </inline>
<inline name="tocNum">MODULE E:</inline>
<inline name="tocHeading">CONFORMITY TO TYPE BASED ON INSTRUMENT QUALITY ASSURANCE </inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Conformity to type based on instrument quality assurance is that...</inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">Manufacturing </inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">Quality system </inline>
<inline name="tocNum">3.1.</inline>
<inline name="tocHeading">The manufacturer shall lodge an application for assessment of his...</inline>
<inline name="tocNum">3.2.</inline>
<inline name="tocHeading">The quality system shall ensure compliance of the measuring instruments...</inline>
<inline name="tocNum">3.3.</inline>
<inline name="tocHeading">The notified body shall assess the quality system to determine...</inline>
<inline name="tocNum">3.4.</inline>
<inline name="tocHeading">The manufacturer shall undertake to fulfil the obligations arising out...</inline>
<inline name="tocNum">3.5.</inline>
<inline name="tocHeading">The manufacturer shall keep the notified body that has approved...</inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">Surveillance under the responsibility of the notified body </inline>
<inline name="tocNum">4.1.</inline>
<inline name="tocHeading">The purpose of surveillance is to make sure that the...</inline>
<inline name="tocNum">4.2.</inline>
<inline name="tocHeading">The manufacturer shall, for assessment purposes, allow the notified body...</inline>
<inline name="tocNum">4.3.</inline>
<inline name="tocHeading">The notified body shall carry out periodic audits to make...</inline>
<inline name="tocNum">4.4.</inline>
<inline name="tocHeading">In addition, the notified body may pay unexpected visits to...</inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">Conformity marking and EU declaration of conformity </inline>
<inline name="tocNum">5.1.</inline>
<inline name="tocHeading">The manufacturer shall affix the CE marking, the supplementary metrology...</inline>
<inline name="tocNum">5.2.</inline>
<inline name="tocHeading">The manufacturer shall draw up a written EU declaration of...</inline>
<inline name="tocNum">6.</inline>
<inline name="tocHeading">The manufacturer shall, for a period ending 10 years after...</inline>
<inline name="tocNum">7.</inline>
<inline name="tocHeading">Each notified body shall inform its notifying authority of quality...</inline>
<inline name="tocNum">8.</inline>
<inline name="tocHeading">Authorised representative </inline>
<inline name="tocNum">MODULE E1:</inline>
<inline name="tocHeading">QUALITY ASSURANCE OF FINAL INSTRUMENT INSPECTION AND TESTING </inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Quality assurance of final instrument inspection and testing is the...</inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">Technical documentation </inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">The manufacturer shall keep the technical documentation at the disposal...</inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">Manufacturing </inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">Quality system </inline>
<inline name="tocNum">5.1.</inline>
<inline name="tocHeading">The manufacturer shall lodge an application for assessment of his...</inline>
<inline name="tocNum">5.2.</inline>
<inline name="tocHeading">The quality system shall ensure compliance of the measuring instruments...</inline>
<inline name="tocNum">5.3.</inline>
<inline name="tocHeading">The notified body shall assess the quality system to determine...</inline>
<inline name="tocNum">5.4.</inline>
<inline name="tocHeading">The manufacturer shall undertake to fulfil the obligations arising out...</inline>
<inline name="tocNum">5.5.</inline>
<inline name="tocHeading">The manufacturer shall keep the notified body that has approved...</inline>
<inline name="tocNum">6.</inline>
<inline name="tocHeading">Surveillance under the responsibility of the notified body </inline>
<inline name="tocNum">6.1.</inline>
<inline name="tocHeading">The purpose of surveillance is to make sure that the...</inline>
<inline name="tocNum">6.2.</inline>
<inline name="tocHeading">The manufacturer shall, for assessment purposes, allow the notified body...</inline>
<inline name="tocNum">6.3.</inline>
<inline name="tocHeading">The notified body shall carry out periodic audits to make...</inline>
<inline name="tocNum">6.4.</inline>
<inline name="tocHeading">In addition, the notified body may pay unexpected visits to...</inline>
<inline name="tocNum">7.</inline>
<inline name="tocHeading">Conformity marking and EU declaration of conformity </inline>
<inline name="tocNum">7.1.</inline>
<inline name="tocHeading">The manufacturer shall affix the CE marking, the supplementary metrology...</inline>
<inline name="tocNum">7.2.</inline>
<inline name="tocHeading">The manufacturer shall draw up a written EU declaration of...</inline>
<inline name="tocNum">8.</inline>
<inline name="tocHeading">The manufacturer shall, for a period ending 10 years after...</inline>
<inline name="tocNum">9.</inline>
<inline name="tocHeading">Each notified body shall inform its notifying authority of quality...</inline>
<inline name="tocNum">10.</inline>
<inline name="tocHeading">Authorised representative </inline>
<inline name="tocNum">MODULE F:</inline>
<inline name="tocHeading">CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION </inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Conformity to type based on product verification is the part...</inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">Manufacturing </inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">Verification </inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">Verification of conformity by examination and testing of every instrument...</inline>
<inline name="tocNum">4.1.</inline>
<inline name="tocHeading">All measuring instruments shall be individually examined and appropriate tests...</inline>
<inline name="tocNum">4.2.</inline>
<inline name="tocHeading">The notified body shall issue a certificate of conformity in...</inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">Statistical verification of conformity </inline>
<inline name="tocNum">5.1.</inline>
<inline name="tocHeading">The manufacturer shall take all measures necessary so that the...</inline>
<inline name="tocNum">5.2.</inline>
<inline name="tocHeading">A random sample shall be taken from each lot according...</inline>
<inline name="tocNum">5.3.</inline>
<inline name="tocHeading">The statistical procedure shall meet the following requirements: </inline>
<inline name="tocNum">5.4.</inline>
<inline name="tocHeading">If a lot is accepted, all measuring instruments of the...</inline>
<inline name="tocNum">5.5.</inline>
<inline name="tocHeading">If a lot is rejected, the notified body shall take...</inline>
<inline name="tocNum">6.</inline>
<inline name="tocHeading">Conformity marking and EU declaration of conformity </inline>
<inline name="tocNum">6.1.</inline>
<inline name="tocHeading">The manufacturer shall affix the CE marking and the supplementary...</inline>
<inline name="tocNum">6.2.</inline>
<inline name="tocHeading">The manufacturer shall draw up a written EU declaration of...</inline>
<inline name="tocNum">7.</inline>
<inline name="tocHeading">If the notified body agrees and under its responsibility, the...</inline>
<inline name="tocNum">8.</inline>
<inline name="tocHeading">Authorised representative </inline>
<inline name="tocNum">MODULE F1:</inline>
<inline name="tocHeading">CONFORMITY BASED ON PRODUCT VERIFICATION </inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Conformity based on product verification is the conformity assessment procedure...</inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">Technical documentation </inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">Manufacturing </inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">Verification </inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">Verification of conformity by examination and testing of every instrument...</inline>
<inline name="tocNum">5.1.</inline>
<inline name="tocHeading">All measuring instruments shall be individually examined and appropriate tests,...</inline>
<inline name="tocNum">5.2.</inline>
<inline name="tocHeading">The notified body shall issue a certificate of conformity in...</inline>
<inline name="tocNum">6.</inline>
<inline name="tocHeading">Statistical verification of conformity </inline>
<inline name="tocNum">6.1.</inline>
<inline name="tocHeading">The manufacturer shall take all measures necessary so that the...</inline>
<inline name="tocNum">6.2.</inline>
<inline name="tocHeading">A random sample shall be taken from each lot according...</inline>
<inline name="tocNum">6.3.</inline>
<inline name="tocHeading">All measuring instruments in the sample shall be individually examined...</inline>
<inline name="tocNum">6.4.</inline>
<inline name="tocHeading">The statistical procedure shall meet the following requirements: </inline>
<inline name="tocNum">6.5.</inline>
<inline name="tocHeading">If a lot is accepted, all measuring instruments of the...</inline>
<inline name="tocNum">7.</inline>
<inline name="tocHeading">Conformity marking and EU declaration of conformity </inline>
<inline name="tocNum">7.1.</inline>
<inline name="tocHeading">The manufacturer shall affix the CE marking and the supplementary...</inline>
<inline name="tocNum">7.2.</inline>
<inline name="tocHeading">The manufacturer shall draw up a written EU declaration of...</inline>
<inline name="tocNum">8.</inline>
<inline name="tocHeading">If the notified body agrees and under its responsibility, the...</inline>
<inline name="tocNum">9.</inline>
<inline name="tocHeading">Authorised representative </inline>
<inline name="tocNum">MODULE G:</inline>
<inline name="tocHeading">CONFORMITY BASED ON UNIT VERIFICATION </inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Conformity based on unit verification is the conformity assessment procedure...</inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">Technical documentation </inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">Manufacturing </inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">Verification </inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">Conformity marking and EU declaration of conformity </inline>
<inline name="tocNum">5.1.</inline>
<inline name="tocHeading">The manufacturer shall affix the CE marking and the supplementary...</inline>
<inline name="tocNum">5.2.</inline>
<inline name="tocHeading">The manufacturer shall draw up a written EU declaration of...</inline>
<inline name="tocNum">6.</inline>
<inline name="tocHeading">Authorised representative </inline>
<inline name="tocNum">MODULE H:</inline>
<inline name="tocHeading">CONFORMITY BASED ON FULL QUALITY ASSURANCE </inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Conformity based on full quality assurance is the conformity assessment...</inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">Manufacturing </inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">Quality system </inline>
<inline name="tocNum">3.1.</inline>
<inline name="tocHeading">The manufacturer shall lodge an application for assessment of his...</inline>
<inline name="tocNum">3.2.</inline>
<inline name="tocHeading">The quality system shall ensure compliance of the measuring instruments...</inline>
<inline name="tocNum">3.3.</inline>
<inline name="tocHeading">The notified body shall assess the quality system to determine...</inline>
<inline name="tocNum">3.4.</inline>
<inline name="tocHeading">The manufacturer shall undertake to fulfil the obligations arising out...</inline>
<inline name="tocNum">3.5.</inline>
<inline name="tocHeading">The manufacturer shall keep the notified body that has approved...</inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">Surveillance under the responsibility of the notified body </inline>
<inline name="tocNum">4.1.</inline>
<inline name="tocHeading">The purpose of surveillance is to make sure that the...</inline>
<inline name="tocNum">4.2.</inline>
<inline name="tocHeading">The manufacturer shall, for assessment purposes, allow the notified body...</inline>
<inline name="tocNum">4.3.</inline>
<inline name="tocHeading">The notified body shall carry out periodic audits to make...</inline>
<inline name="tocNum">4.4.</inline>
<inline name="tocHeading">In addition, the notified body may pay unexpected visits to...</inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">Conformity marking and EU declaration of conformity </inline>
<inline name="tocNum">5.1.</inline>
<inline name="tocHeading">The manufacturer shall affix the CE marking, the supplementary metrology...</inline>
<inline name="tocNum">5.2.</inline>
<inline name="tocHeading">The manufacturer shall draw up a written EU declaration of...</inline>
<inline name="tocNum">6.</inline>
<inline name="tocHeading">The manufacturer shall, for a period ending 10 years after...</inline>
<inline name="tocNum">7.</inline>
<inline name="tocHeading">Each notified body shall inform its notifying authority of quality...</inline>
<inline name="tocNum">8.</inline>
<inline name="tocHeading">Authorised representative </inline>
<inline name="tocNum">MODULE H1:</inline>
<inline name="tocHeading">CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION </inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Conformity based on full quality assurance plus design examination is...</inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">Manufacturing </inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">Quality system </inline>
<inline name="tocNum">3.1.</inline>
<inline name="tocHeading">The manufacturer shall lodge an application for assessment of the...</inline>
<inline name="tocNum">3.2.</inline>
<inline name="tocHeading">The quality system shall ensure compliance of the measuring instruments...</inline>
<inline name="tocNum">3.3.</inline>
<inline name="tocHeading">The notified body shall assess the quality system to determine...</inline>
<inline name="tocNum">3.4.</inline>
<inline name="tocHeading">The manufacturer shall undertake to fulfil the obligations arising out...</inline>
<inline name="tocNum">3.5.</inline>
<inline name="tocHeading">The manufacturer shall keep the notified body that has approved...</inline>
<inline name="tocNum">3.6.</inline>
<inline name="tocHeading">Each notified body shall inform its notifying authority of quality...</inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">Design examination </inline>
<inline name="tocNum">4.1.</inline>
<inline name="tocHeading">The manufacturer shall lodge an application for examination of the...</inline>
<inline name="tocNum">4.2.</inline>
<inline name="tocHeading">The application shall make it possible to understand the design,...</inline>
<inline name="tocNum">4.3.</inline>
<inline name="tocHeading">The notified body shall examine the application, and where the...</inline>
<inline name="tocNum">4.4.</inline>
<inline name="tocHeading">The notified body shall keep itself apprised of any changes...</inline>
<inline name="tocNum">4.5.</inline>
<inline name="tocHeading">Each notified body shall inform its notifying authority of the...</inline>
<inline name="tocNum">4.6.</inline>
<inline name="tocHeading">The manufacturer shall keep a copy of the EU design...</inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">Surveillance under the responsibility of the notified body </inline>
<inline name="tocNum">5.1.</inline>
<inline name="tocHeading">The purpose of surveillance is to make sure that the...</inline>
<inline name="tocNum">5.2.</inline>
<inline name="tocHeading">The manufacturer shall, for assessment purposes, allow the notified body...</inline>
<inline name="tocNum">5.3.</inline>
<inline name="tocHeading">The notified body shall carry out periodic audits to make...</inline>
<inline name="tocNum">5.4.</inline>
<inline name="tocHeading">In addition, the notified body may pay unexpected visits to...</inline>
<inline name="tocNum">6.</inline>
<inline name="tocHeading">Conformity marking and EU declaration of conformity </inline>
<inline name="tocNum">6.1.</inline>
<inline name="tocHeading">The manufacturer shall affix the CE marking and the supplementary...</inline>
<inline name="tocNum">6.2.</inline>
<inline name="tocHeading">The manufacturer shall draw up a written EU declaration of...</inline>
<inline name="tocNum">7.</inline>
<inline name="tocHeading">The manufacturer shall, for a period ending 10 years after...</inline>
<inline name="tocNum">8.</inline>
<inline name="tocHeading">Authorised representative </inline>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/annex/III" level="2" class="schedule" period="#period2">
<inline name="tocNum">ANNEX III</inline>
</tocItem>
<inline name="tocHeading">WATER METERS (MI-001) </inline>
<inline name="tocHeading">DEFINITIONS </inline>
<inline name="tocHeading">SPECIFIC REQUIREMENTS </inline>
<inline name="tocHeading">Rated Operating Conditions </inline>
<inline name="tocHeading">MPE </inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">The MPE, positive or negative, on volumes delivered at flowrates...</inline>
<inline name="tocNum">6.</inline>
<inline name="tocHeading">The MPE, positive or negative, on volumes delivered at flowrates...</inline>
<inline name="tocHeading">Permissible Effect of Disturbances </inline>
<inline name="tocNum">7.1.</inline>
<inline name="tocHeading">Electromagnetic immunity </inline>
<inline name="tocNum">7.1.1.</inline>
<inline name="tocHeading">The effect of an electromagnetic disturbance on a water meter...</inline>
<inline name="tocNum">7.1.2.</inline>
<inline name="tocHeading">After undergoing an electromagnetic disturbance the water meter shall: </inline>
<inline name="tocNum">7.1.3.</inline>
<inline name="tocHeading">The critical change value is the smaller of the two...</inline>
<inline name="tocNum">7.2.</inline>
<inline name="tocHeading">Durability </inline>
<inline name="tocHeading">Suitability </inline>
<inline name="tocNum">8.1.</inline>
<inline name="tocHeading">The meter shall be able to be installed to operate...</inline>
<inline name="tocNum">8.2.</inline>
<inline name="tocHeading">The manufacturer shall specify whether the meter is designed to...</inline>
<inline name="tocHeading">Units of Measurement </inline>
<inline name="tocNum">9.</inline>
<inline name="tocHeading">Metered volume shall be displayed in cubic metres. </inline>
<inline name="tocHeading">Putting into Use </inline>
<inline name="tocNum">10.</inline>
<inline name="tocHeading">The Member State shall ensure that the requirements under points...</inline>
<inline name="tocHeading">CONFORMITY ASSESSMENT </inline>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/annex/IV" level="2" class="schedule" period="#period2">
<inline name="tocNum">ANNEX IV</inline>
</tocItem>
<inline name="tocHeading">GAS METERS AND VOLUME CONVERSION DEVICES (MI-002) </inline>
<inline name="tocHeading">DEFINITIONS </inline>
<inline name="tocNum">PART I</inline>
<inline name="tocHeading">SPECIFIC REQUIREMENTS</inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Rated operating conditions </inline>
<inline name="tocNum">1.1.</inline>
<inline name="tocHeading">The flowrate range of the gas shall fulfil at least...</inline>
<inline name="tocNum">1.2.</inline>
<inline name="tocHeading">The temperature range of the gas, with a minimum range...</inline>
<inline name="tocNum">1.3.</inline>
<inline name="tocHeading">The fuel/gas related conditions </inline>
<inline name="tocNum">1.4.</inline>
<inline name="tocHeading">A minimum temperature range of 50 °C for the climatic...</inline>
<inline name="tocNum">1.5.</inline>
<inline name="tocHeading">The nominal value of the AC voltage supply and/or the...</inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">Maximum permissible error (MPEs) </inline>
<inline name="tocNum">2.1.</inline>
<inline name="tocHeading">Gas meter indicating the volume at metering conditions or mass...</inline>
<inline name="tocNum">2.2.</inline>
<inline name="tocHeading">For a gas meter with temperature conversion, which only indicates...</inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">Permissible effect of disturbances </inline>
<inline name="tocNum">3.1.</inline>
<inline name="tocHeading">Electromagnetic immunity </inline>
<inline name="tocNum">3.1.1.</inline>
<inline name="tocHeading">The effect of an electromagnetic disturbance on a gas meter...</inline>
<inline name="tocNum">3.1.2.</inline>
<inline name="tocHeading">After undergoing a disturbance, the gas meter shall: </inline>
<inline name="tocNum">3.1.3.</inline>
<inline name="tocHeading">The critical change value is the smaller of the two...</inline>
<inline name="tocNum">3.2.</inline>
<inline name="tocHeading">Effect of upstream-downstream flow disturbances </inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">Durability </inline>
<inline name="tocNum">4.1.</inline>
<inline name="tocHeading">Class 1,5 meters </inline>
<inline name="tocNum">4.1.1.</inline>
<inline name="tocHeading">The variation of the measurement result after the durability test...</inline>
<inline name="tocNum">4.1.2.</inline>
<inline name="tocHeading">The error of indication after the durability test shall not...</inline>
<inline name="tocNum">4.2.</inline>
<inline name="tocHeading">Class 1,0 meters </inline>
<inline name="tocNum">4.2.1.</inline>
<inline name="tocHeading">The variation of the measurement result after the durability test...</inline>
<inline name="tocNum">4.2.2.</inline>
<inline name="tocHeading">The error of indication after the durability test shall not...</inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">Suitability </inline>
<inline name="tocNum">5.1.</inline>
<inline name="tocHeading">A gas meter powered from the mains (AC or DC)...</inline>
<inline name="tocNum">5.2.</inline>
<inline name="tocHeading">A dedicated power source shall have a lifetime of at...</inline>
<inline name="tocNum">5.3.</inline>
<inline name="tocHeading">An indicating device shall have a sufficient number of digits...</inline>
<inline name="tocNum">5.4.</inline>
<inline name="tocHeading">The gas meter shall be able to be installed to...</inline>
<inline name="tocNum">5.5.</inline>
<inline name="tocHeading">The gas meter shall have a test element, which shall...</inline>
<inline name="tocNum">5.6.</inline>
<inline name="tocHeading">The gas meter shall respect the MPE in any flow...</inline>
<inline name="tocNum">6.</inline>
<inline name="tocHeading">Units </inline>
<inline name="tocNum">PART II</inline>
<inline name="tocHeading">SPECIFIC REQUIREMENTS</inline>
<inline name="tocNum">7.</inline>
<inline name="tocHeading">Base conditions for converted quantities </inline>
<inline name="tocNum">8.</inline>
<inline name="tocHeading">MPE </inline>
<inline name="tocHeading">Note: </inline>
<inline name="tocHeading"/>
<inline name="tocHeading"/>
<inline name="tocNum">9.</inline>
<inline name="tocHeading">Suitability </inline>
<inline name="tocNum">9.1.</inline>
<inline name="tocHeading">An electronic conversion device shall be capable of detecting when...</inline>
<inline name="tocNum">9.2.</inline>
<inline name="tocHeading">An electronic conversion device shall be capable to display all...</inline>
<inline name="tocNum">PART III</inline>
<inline name="tocHeading">PUTTING INTO USE AND CONFORMITY ASSESSMENT</inline>
<inline name="tocHeading">Putting into use </inline>
<inline name="tocNum">10.</inline>
<inline name="tocHeading">Where a Member State imposes measurement of residential use, it...</inline>
<inline name="tocHeading">CONFORMITY ASSESSMENT </inline>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/annex/V" level="2" class="schedule" period="#period1">
<inline name="tocNum">ANNEX V</inline>
</tocItem>
<inline name="tocHeading">ACTIVE ELECTRICAL ENERGY METERS (MI-003) </inline>
<inline name="tocHeading">Note: </inline>
<inline name="tocHeading">DEFINITIONS </inline>
<inline name="tocHeading">SPECIFIC REQUIREMENTS </inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Accuracy </inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">Rated operating conditions </inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">MPEs </inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">Permissible effect of disturbances </inline>
<inline name="tocNum">4.1.</inline>
<inline name="tocHeading">General </inline>
<inline name="tocNum">4.2.</inline>
<inline name="tocHeading">Effect of disturbances of long duration </inline>
<inline name="tocNum">4.3.</inline>
<inline name="tocHeading">Permissible effect of transient electromagnetic phenomena </inline>
<inline name="tocNum">4.3.1.</inline>
<inline name="tocHeading">The effect of an electromagnetic disturbance on an electrical energy...</inline>
<inline name="tocNum">4.3.2.</inline>
<inline name="tocHeading">For overcurrent the critical change value is 1,5 %. </inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">Suitability </inline>
<inline name="tocNum">5.1.</inline>
<inline name="tocHeading">Below the rated operating voltage the positive error of the...</inline>
<inline name="tocNum">5.2.</inline>
<inline name="tocHeading">The display of the total energy shall have a sufficient...</inline>
<inline name="tocNum">5.3.</inline>
<inline name="tocHeading">In the event of loss of electricity in the circuit,...</inline>
<inline name="tocNum">5.4.</inline>
<inline name="tocHeading">Running with no load </inline>
<inline name="tocNum">5.5.</inline>
<inline name="tocHeading">Starting </inline>
<inline name="tocNum">6.</inline>
<inline name="tocHeading">Units </inline>
<inline name="tocNum">7.</inline>
<inline name="tocHeading">Putting into use </inline>
<inline name="tocNum">(a)</inline>
<inline name="tocHeading">Where a Member State imposes measurement of residential use, it...</inline>
<inline name="tocNum">(b)</inline>
<inline name="tocHeading">Where a Member State imposes measurement of commercial and/or light...</inline>
<inline name="tocNum">(c)</inline>
<inline name="tocHeading">The Member State shall ensure that the current range be...</inline>
<inline name="tocHeading">CONFORMITY ASSESSMENT </inline>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/annex/VI" level="2" class="schedule" period="#period2">
<inline name="tocNum">ANNEX VI</inline>
</tocItem>
<inline name="tocHeading">THERMAL ENERGY METERS (MI-004) </inline>
<inline name="tocHeading">DEFINITIONS </inline>
<inline name="tocHeading">SPECIFIC REQUIREMENTS </inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Rated operating conditions </inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">Accuracy classes </inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">MPEs applicable to complete thermal energy meters </inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">Permissible influences of electromagnetic disturbances </inline>
<inline name="tocNum">4.1.</inline>
<inline name="tocHeading">The instrument shall not be influenced by static magnetic fields...</inline>
<inline name="tocNum">4.2.</inline>
<inline name="tocHeading">The influence of an electromagnetic disturbance shall be such that...</inline>
<inline name="tocNum">4.3.</inline>
<inline name="tocHeading">The critical change value for a complete thermal energy meter...</inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">Durability </inline>
<inline name="tocNum">6.</inline>
<inline name="tocHeading">Inscriptions on a thermal energy meter </inline>
<inline name="tocNum">7.</inline>
<inline name="tocHeading">Sub-assemblies </inline>
<inline name="tocNum">7.1.</inline>
<inline name="tocHeading">The relative MPE of the flow sensor, expressed in %,...</inline>
<inline name="tocNum">7.2.</inline>
<inline name="tocHeading">The relative MPE of the temperature sensor pair, expressed in...</inline>
<inline name="tocNum">7.3.</inline>
<inline name="tocHeading">The relative MPE of the calculator, expressed in %: </inline>
<inline name="tocNum">7.4.</inline>
<inline name="tocHeading">The critical change value for a sub-assembly of a thermal...</inline>
<inline name="tocNum">7.5.</inline>
<inline name="tocHeading">Inscriptions on the sub-assemblies </inline>
<inline name="tocHeading">PUTTING INTO USE </inline>
<inline name="tocNum">8.</inline>
<inline name="tocHeading">Where a Member State imposes measurement of residential use, it...</inline>
<inline name="tocHeading">CONFORMITY ASSESSMENT </inline>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/annex/VII" level="2" class="schedule" period="#period1">
<inline name="tocNum">ANNEX VII</inline>
</tocItem>
<inline name="tocHeading">MEASURING SYSTEMS FOR THE CONTINUOUS AND DYNAMIC MEASUREMENT OF QUANTITIES...</inline>
<inline name="tocHeading">DEFINITIONS </inline>
<inline name="tocHeading">SPECIFIC REQUIREMENTS </inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Rated operating conditions </inline>
<inline name="tocNum">1.1.</inline>
<inline name="tocHeading">The flowrate range </inline>
<inline name="tocNum">1.2.</inline>
<inline name="tocHeading">The properties of the liquid to be measured by the...</inline>
<inline name="tocNum">1.3.</inline>
<inline name="tocHeading">The nominal value of the AC voltage supply and/or limits...</inline>
<inline name="tocNum">1.4.</inline>
<inline name="tocHeading">The base conditions for converted values. </inline>
<inline name="tocHeading">Note: </inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">Accuracy classification and maximum permissible errors (MPEs) </inline>
<inline name="tocNum">2.1.</inline>
<inline name="tocHeading">For quantities equal to or greater than 2 litres the...</inline>
<inline name="tocNum">2.2.</inline>
<inline name="tocHeading">For quantities less than two litres the MPE on indications...</inline>
<inline name="tocNum">2.3.</inline>
<inline name="tocHeading">However, no matter what the measured quantity may be, the...</inline>
<inline name="tocNum">2.4.1.</inline>
<inline name="tocHeading">For minimum measured quantities greater than or equal to 2...</inline>
<inline name="tocNum">2.4.2.</inline>
<inline name="tocHeading">For minimum measured quantities of less than two litres, the...</inline>
<inline name="tocNum">2.5.</inline>
<inline name="tocHeading">Converted indication </inline>
<inline name="tocNum">2.6.</inline>
<inline name="tocHeading">Conversion devices </inline>
<inline name="tocNum">(a)</inline>
<inline name="tocHeading">Calculator </inline>
<inline name="tocNum">(b)</inline>
<inline name="tocHeading">Associated measuring instruments </inline>
<inline name="tocNum">(c)</inline>
<inline name="tocHeading">Accuracy for calculating function </inline>
<inline name="tocNum">2.7.</inline>
<inline name="tocHeading">The requirement (a) in point 2.6 applies to any calculation,...</inline>
<inline name="tocNum">2.8.</inline>
<inline name="tocHeading">The measuring system shall not exploit the MPEs or systematically...</inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">Maximum permissible effect of disturbances </inline>
<inline name="tocNum">3.1.</inline>
<inline name="tocHeading">The effect of an electromagnetic disturbance on a measuring system...</inline>
<inline name="tocNum">3.2.</inline>
<inline name="tocHeading">The critical change value is the greater of MPE/5 for...</inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">Durability </inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">Suitability </inline>
<inline name="tocNum">5.1.</inline>
<inline name="tocHeading">For any measured quantity relating to the same measurement, the...</inline>
<inline name="tocNum">5.2.</inline>
<inline name="tocHeading">It shall not be possible to divert the measured quantity...</inline>
<inline name="tocNum">5.3.</inline>
<inline name="tocHeading">Any percentage of air or gas not easily detectable in...</inline>
<inline name="tocNum">5.4.</inline>
<inline name="tocHeading">Instruments for direct sales </inline>
<inline name="tocNum">5.4.1.</inline>
<inline name="tocHeading">A measuring system for direct sales shall be provided with...</inline>
<inline name="tocNum">5.4.2.</inline>
<inline name="tocHeading">The display of the quantity on which the transaction is...</inline>
<inline name="tocNum">5.4.3.</inline>
<inline name="tocHeading">Measuring systems for direct sales shall be interruptible. </inline>
<inline name="tocNum">5.4.4.</inline>
<inline name="tocHeading">Any percentage of air or gas in the liquid shall...</inline>
<inline name="tocNum">5.5.</inline>
<inline name="tocHeading">Fuel Dispensers </inline>
<inline name="tocNum">5.5.1.</inline>
<inline name="tocHeading">Displays on fuel dispensers shall not be capable of being...</inline>
<inline name="tocNum">5.5.2.</inline>
<inline name="tocHeading">The start of a new measurement shall be inhibited until...</inline>
<inline name="tocNum">5.5.3.</inline>
<inline name="tocHeading">Where a measuring system is fitted with a price display,...</inline>
<inline name="tocNum">6.</inline>
<inline name="tocHeading">Power supply failure </inline>
<inline name="tocNum">7.</inline>
<inline name="tocHeading">Putting into use </inline>
<inline name="tocNum">8.</inline>
<inline name="tocHeading">Units of measurement </inline>
<inline name="tocHeading">CONFORMITY ASSESSMENT </inline>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/annex/VIII" level="2" class="schedule" period="#period1">
<inline name="tocNum">ANNEX VIII</inline>
</tocItem>
<inline name="tocHeading">AUTOMATIC WEIGHING INSTRUMENTS (MI-006) </inline>
<inline name="tocHeading">DEFINITIONS </inline>
<inline name="tocHeading">SPECIFIC REQUIREMENTS </inline>
<inline name="tocNum">CHAPTER I</inline>
<inline name="tocHeading">Requirements common to all types of automatic weighing instruments </inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Rated Operating Conditions </inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">Permissible effect of disturbances — Electromagnetic environment </inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">Suitability </inline>
<inline name="tocNum">3.1.</inline>
<inline name="tocHeading">Means shall be provided to limit the effects of tilt,...</inline>
<inline name="tocNum">3.2.</inline>
<inline name="tocHeading">Adequate material handling facilities shall be provided to enable the...</inline>
<inline name="tocNum">3.3.</inline>
<inline name="tocHeading">Any operator control interface shall be clear and effective. </inline>
<inline name="tocNum">3.4.</inline>
<inline name="tocHeading">The integrity of the display (where present) shall be verifiable...</inline>
<inline name="tocNum">3.5.</inline>
<inline name="tocHeading">Adequate zero setting capability shall be provided to enable the...</inline>
<inline name="tocNum">3.6.</inline>
<inline name="tocHeading">Any result outside the measurement range shall be identified as...</inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">Conformity assessment </inline>
<inline name="tocNum">CHAPTER II</inline>
<inline name="tocHeading">Automatic Catchweighers </inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Accuracy Classes </inline>
<inline name="tocNum">1.1.</inline>
<inline name="tocHeading">Instruments are divided into primary categories designated by: </inline>
<inline name="tocNum">1.2.</inline>
<inline name="tocHeading">These primary categories are further divided into four accuracy classes:...</inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">Category X Instruments </inline>
<inline name="tocNum">2.1.</inline>
<inline name="tocHeading">Category X applies to instruments used to check prepackages made...</inline>
<inline name="tocNum">2.2.</inline>
<inline name="tocHeading">The accuracy classes are supplemented by a factor (x) that...</inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">Category Y Instruments </inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">MPE </inline>
<inline name="tocNum">4.1.</inline>
<inline name="tocHeading">Mean error Category X/MPE Category Y instruments </inline>
<inline name="tocNum">4.2.</inline>
<inline name="tocHeading">Standard deviation </inline>
<inline name="tocNum">4.3.</inline>
<inline name="tocHeading">Verification scale interval — single interval instruments </inline>
<inline name="tocNum">4.4.</inline>
<inline name="tocHeading">Verification scale interval — multi-interval instruments </inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">Measurement Range </inline>
<inline name="tocNum">6.</inline>
<inline name="tocHeading">Dynamic Setting </inline>
<inline name="tocNum">6.1.</inline>
<inline name="tocHeading">The dynamic setting facility shall operate within a load range...</inline>
<inline name="tocNum">6.2.</inline>
<inline name="tocHeading">When fitted, a dynamic setting facility that compensates for the...</inline>
<inline name="tocNum">7.</inline>
<inline name="tocHeading">Performance Under Influence Factors And Electromagnetic Disturbances </inline>
<inline name="tocNum">7.1.</inline>
<inline name="tocHeading">The MPEs due to influence factors are: </inline>
<inline name="tocNum">7.1.1.</inline>
<inline name="tocHeading">For category X instruments: </inline>
<inline name="tocNum">7.1.2.</inline>
<inline name="tocHeading">For category Y instruments </inline>
<inline name="tocNum">7.2.</inline>
<inline name="tocHeading">The critical change value due to a disturbance is one...</inline>
<inline name="tocNum">7.3.</inline>
<inline name="tocHeading">Temperature range: </inline>
<inline name="tocNum">CHAPTER III</inline>
<inline name="tocHeading">Automatic Gravimetric Filling Instruments </inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Accuracy classes </inline>
<inline name="tocNum">1.1.</inline>
<inline name="tocHeading">The manufacturer shall specify both the reference accuracy class Ref(x)...</inline>
<inline name="tocNum">1.2.</inline>
<inline name="tocHeading">An instrument type is designated a reference accuracy class, Ref(x),...</inline>
<inline name="tocNum">1.3.</inline>
<inline name="tocHeading">The reference accuracy class, Ref(x) is applicable for static loads....</inline>
<inline name="tocNum">1.4.</inline>
<inline name="tocHeading">For the operational accuracy class X(x), X is a regime...</inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">MPE </inline>
<inline name="tocNum">2.1.</inline>
<inline name="tocHeading">Static weighing error </inline>
<inline name="tocNum">2.1.1.</inline>
<inline name="tocHeading">For static loads under rated operating conditions, the MPE for...</inline>
<inline name="tocNum">2.1.2.</inline>
<inline name="tocHeading">For instruments where the fill may be made up from...</inline>
<inline name="tocNum">2.2.</inline>
<inline name="tocHeading">Deviation from average fill </inline>
<inline name="tocHeading">Note: </inline>
<inline name="tocNum">2.3.</inline>
<inline name="tocHeading">Error relative to pre-set value (setting error) </inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">Performance Under Influence Factor And Electromagnetic Disturbance </inline>
<inline name="tocNum">3.1.</inline>
<inline name="tocHeading">The MPE due to influence factors shall be as specified...</inline>
<inline name="tocNum">3.2.</inline>
<inline name="tocHeading">The critical change value due to a disturbance is a...</inline>
<inline name="tocNum">3.3.</inline>
<inline name="tocHeading">The manufacturer shall specify the value of the rated minimum...</inline>
<inline name="tocNum">CHAPTER IV</inline>
<inline name="tocHeading">Discontinuous Totalisers </inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Accuracy Classes </inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">MPEs </inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">Totalisation scale interval </inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">Minimum Totalised Load (Σmin) </inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">Zero Setting </inline>
<inline name="tocNum">6.</inline>
<inline name="tocHeading">Operator Interface </inline>
<inline name="tocNum">7.</inline>
<inline name="tocHeading">Printout </inline>
<inline name="tocNum">8.</inline>
<inline name="tocHeading">Performance under influence factors and electromagnetic disturbances </inline>
<inline name="tocNum">8.1.</inline>
<inline name="tocHeading">The MPEs due to influence factors shall be as specified...</inline>
<inline name="tocNum">8.2.</inline>
<inline name="tocHeading">The critical change value due to a disturbance is one...</inline>
<inline name="tocNum">CHAPTER V</inline>
<inline name="tocHeading">Continuous Totalisers </inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Accuracy classes </inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">Measurement Range </inline>
<inline name="tocNum">2.1.</inline>
<inline name="tocHeading">The manufacturer shall specify the measurement range, the ratio between...</inline>
<inline name="tocNum">2.2.</inline>
<inline name="tocHeading">The minimum totalised load Σmin shall not be less than...</inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">MPE </inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">Speed of the belt </inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">General Totalisation Device </inline>
<inline name="tocNum">6.</inline>
<inline name="tocHeading">Performance under influence factors and electromagnetic disturbances </inline>
<inline name="tocNum">6.1.</inline>
<inline name="tocHeading">The MPE due to influence factor, for a load not...</inline>
<inline name="tocNum">6.2.</inline>
<inline name="tocHeading">The critical change value due to a disturbance shall be...</inline>
<inline name="tocNum">CHAPTER VI</inline>
<inline name="tocHeading">Automatic Rail Weighbridges </inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Accuracy classes </inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">MPE </inline>
<inline name="tocNum">2.1.</inline>
<inline name="tocHeading">The MPEs for weighing-in-motion of a single wagon or a...</inline>
<inline name="tocNum">2.2.</inline>
<inline name="tocHeading">The MPEs for the weight of coupled or uncoupled wagons...</inline>
<inline name="tocNum">2.3.</inline>
<inline name="tocHeading">The MPEs for the weight of train weighing-in-motion shall be...</inline>
<inline name="tocNum">2.4.</inline>
<inline name="tocHeading">When weighing coupled wagons; the errors of not more than...</inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">Scale interval (d) </inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">Measurement range </inline>
<inline name="tocNum">4.1.</inline>
<inline name="tocHeading">The minimum capacity shall not be less than 1 t,...</inline>
<inline name="tocNum">4.2.</inline>
<inline name="tocHeading">The minimum wagon weight shall not be less than 50...</inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">Performance under influence factor and electromagnetic disturbance </inline>
<inline name="tocNum">5.1.</inline>
<inline name="tocHeading">The MPE due to an influence factor shall be as...</inline>
<inline name="tocNum">5.2.</inline>
<inline name="tocHeading">The critical change value due to a disturbance is one...</inline>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/annex/IX" level="2" class="schedule" period="#period1">
<inline name="tocNum">ANNEX IX</inline>
</tocItem>
<inline name="tocHeading">TAXIMETERS (MI-007) </inline>
<inline name="tocHeading">DEFINITIONS </inline>
<inline name="tocHeading">Taximeter </inline>
<inline name="tocHeading">Fare </inline>
<inline name="tocHeading">Cross-over speed </inline>
<inline name="tocHeading">Normal calculation mode S (single application of tariff) </inline>
<inline name="tocHeading">Normal calculation mode D (double application of tariff) </inline>
<inline name="tocHeading">Operating position </inline>
<inline name="tocHeading">DESIGN REQUIREMENTS </inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">The taximeter shall be designed to calculate the distance and...</inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">The taximeter shall be designed to calculate and display the...</inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">A taximeter shall be able to apply the normal calculation...</inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">A taximeter shall be able to supply the following data...</inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">If relevant, it shall be possible to adjust a taximeter...</inline>
<inline name="tocHeading">RATED OPERATING CONDITIONS </inline>
<inline name="tocNum">6.1.</inline>
<inline name="tocHeading">The mechanical environment class that applies is M3. </inline>
<inline name="tocNum">6.2.</inline>
<inline name="tocHeading">The manufacturer shall specify the rated operating conditions for the...</inline>
<inline name="tocHeading">MAXIMUM PERMISSIBLE ERRORS (MPEs) </inline>
<inline name="tocNum">7.</inline>
<inline name="tocHeading">The MPE, excluding any errors due to application of the...</inline>
<inline name="tocHeading">PERMISSIBLE EFFECT OF DISTURBANCES </inline>
<inline name="tocNum">8.</inline>
<inline name="tocHeading">Electromagnetic immunity </inline>
<inline name="tocNum">8.1.</inline>
<inline name="tocHeading">The electromagnetic class that applies is E3. </inline>
<inline name="tocNum">8.2.</inline>
<inline name="tocHeading">The MPE laid down in point 7 shall also be...</inline>
<inline name="tocHeading">POWER SUPPLY FAILURE </inline>
<inline name="tocNum">9.</inline>
<inline name="tocHeading">In case of a reduction of the voltage supply to...</inline>
<inline name="tocHeading">OTHER REQUIREMENTS </inline>
<inline name="tocNum">10.</inline>
<inline name="tocHeading">The conditions for the compatibility between the taximeter and the...</inline>
<inline name="tocNum">11.</inline>
<inline name="tocHeading">If there is a supplement charge for an extra service,...</inline>
<inline name="tocNum">12.</inline>
<inline name="tocHeading">If the fare is calculated according to calculation mode D...</inline>
<inline name="tocNum">13.</inline>
<inline name="tocHeading">All values displayed for the passenger shall be suitably identified....</inline>
<inline name="tocNum">14.1.</inline>
<inline name="tocHeading">If the fare to be paid or the measures to...</inline>
<inline name="tocNum">14.2.</inline>
<inline name="tocHeading">The securing possibilities available in a taximeter shall be such...</inline>
<inline name="tocNum">14.3.</inline>
<inline name="tocHeading">The provisions in point 8.3 of Annex I apply also...</inline>
<inline name="tocNum">15.1.</inline>
<inline name="tocHeading">A taximeter shall be fitted with non-resettable totalisers for all...</inline>
<inline name="tocNum">15.2.</inline>
<inline name="tocHeading">If disconnected from power, a taximeter shall allow the totalised...</inline>
<inline name="tocNum">15.3.</inline>
<inline name="tocHeading">Adequate measures shall be taken to prevent the display of...</inline>
<inline name="tocNum">16.</inline>
<inline name="tocHeading">Automatic change of tariffs is allowed due to the: </inline>
<inline name="tocNum">17.</inline>
<inline name="tocHeading">If properties of the taxi are important for the correctness...</inline>
<inline name="tocNum">18.</inline>
<inline name="tocHeading">For the purpose of testing after installation, the taximeter shall...</inline>
<inline name="tocNum">19.</inline>
<inline name="tocHeading">A taximeter and its installation instructions specified by the manufacturer...</inline>
<inline name="tocNum">20.</inline>
<inline name="tocHeading">The general essential requirement dealing with fraudulent use shall be...</inline>
<inline name="tocNum">21.</inline>
<inline name="tocHeading">A taximeter shall be designed so that it can respect...</inline>
<inline name="tocNum">22.</inline>
<inline name="tocHeading">The taximeter shall be equipped with a real-timeclock by means...</inline>
<inline name="tocNum">23.</inline>
<inline name="tocHeading">The values of distance travelled and time elapsed, when displayed...</inline>
<inline name="tocHeading">CONFORMITY ASSESSMENT </inline>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/annex/X" level="2" class="schedule" period="#period1">
<inline name="tocNum">ANNEX X</inline>
<inline name="tocHeading">MATERIAL MEASURES (MI-008)</inline>
</tocItem>
<inline name="tocNum">CHAPTER I</inline>
<inline name="tocHeading">Material measures of length </inline>
<inline name="tocHeading">DEFINITIONS </inline>
<inline name="tocHeading">SPECIFIC REQUIREMENTS </inline>
<inline name="tocHeading">Reference Conditions </inline>
<inline name="tocNum">1.1.</inline>
<inline name="tocHeading">For tapes of length equal to or greater than 5...</inline>
<inline name="tocNum">1.2.</inline>
<inline name="tocHeading">The reference temperature is 20 °C unless otherwise specified by...</inline>
<inline name="tocHeading">MPEs </inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">The MPE, positive or negative in mm, between two non-consecutive...</inline>
<inline name="tocHeading">Materials </inline>
<inline name="tocNum">3.1.</inline>
<inline name="tocHeading">Materials used for material measures shall be such that length...</inline>
<inline name="tocNum">3.2.</inline>
<inline name="tocHeading">Measures made from material whose dimensions may alter materially when...</inline>
<inline name="tocHeading">Markings </inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">The nominal value shall be marked on the measure. Millimetre...</inline>
<inline name="tocHeading">CONFORMITY ASSESSMENT </inline>
<inline name="tocNum">CHAPTER II</inline>
<inline name="tocHeading">Capacity serving measures </inline>
<inline name="tocHeading">DEFINITIONS </inline>
<inline name="tocHeading">SPECIFIC REQUIREMENTS </inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Reference Conditions </inline>
<inline name="tocNum">1.1.</inline>
<inline name="tocHeading">Temperature: the reference temperature for measurement of capacity is 20...</inline>
<inline name="tocNum">1.2.</inline>
<inline name="tocHeading">Position for correct indication: free standing on a level surface....</inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">MPEs </inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">Materials </inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">Shape </inline>
<inline name="tocNum">4.1.</inline>
<inline name="tocHeading">Transfer measures shall be designed so that a change of...</inline>
<inline name="tocNum">4.2.</inline>
<inline name="tocHeading">Transfer measures shall be designed so that the complete discharge...</inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">Marking </inline>
<inline name="tocNum">5.1.</inline>
<inline name="tocHeading">The nominal capacity declared shall be clearly and indelibly marked...</inline>
<inline name="tocNum">5.2.</inline>
<inline name="tocHeading">Capacity serving measures may also be marked with up to...</inline>
<inline name="tocNum">5.3.</inline>
<inline name="tocHeading">All filling marks shall be sufficiently clear and durable to...</inline>
<inline name="tocHeading">CONFORMITY ASSESSMENT </inline>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/annex/XI" level="2" class="schedule" period="#period1">
<inline name="tocNum">ANNEX XI</inline>
</tocItem>
<inline name="tocHeading">DIMENSIONAL MEASURING INSTRUMENTS (MI-009) </inline>
<inline name="tocHeading">DEFINITIONS </inline>
<inline name="tocNum">CHAPTER I</inline>
<inline name="tocHeading"> Requirements common to all dimensional measuring instruments </inline>
<inline name="tocHeading">Electromagnetic immunity </inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">The effect of an electromagnetic disturbance on a dimensional measuring...</inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">The critical change value is equal to one scale interval....</inline>
<inline name="tocHeading">CONFORMITY ASSESSMENT </inline>
<inline name="tocNum">CHAPTER II</inline>
<inline name="tocHeading"> Length measuring instruments </inline>
<inline name="tocHeading">Characteristics of the product to be measured </inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Textiles are characterised by the characteristic factor K. This factor...</inline>
<inline name="tocHeading">Operating conditions </inline>
<inline name="tocNum">2.1.</inline>
<inline name="tocHeading">Range </inline>
<inline name="tocNum">2.2.</inline>
<inline name="tocHeading">Where the measured object is not transported by the measuring...</inline>
<inline name="tocNum">2.3.</inline>
<inline name="tocHeading">If the measurement result depends on the thickness, the surface...</inline>
<inline name="tocHeading">MPEs </inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">Instrument </inline>
<inline name="tocHeading">Other requirements </inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">The instruments must ensure that the product is measured unstretched...</inline>
<inline name="tocNum">CHAPTER III</inline>
<inline name="tocHeading"> Area measuring instruments </inline>
<inline name="tocHeading">Operating conditions </inline>
<inline name="tocNum">1.1.</inline>
<inline name="tocHeading">Range </inline>
<inline name="tocNum">1.2.</inline>
<inline name="tocHeading">Condition of the product </inline>
<inline name="tocHeading">MPEs </inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">Instrument </inline>
<inline name="tocHeading">Other requirements </inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">Presentation of the product </inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">Scale interval </inline>
<inline name="tocNum">CHAPTER IV</inline>
<inline name="tocHeading"> Multidimensional measuring instruments </inline>
<inline name="tocHeading">Operating conditions </inline>
<inline name="tocNum">1.1.</inline>
<inline name="tocHeading">Range </inline>
<inline name="tocNum">1.2.</inline>
<inline name="tocHeading">Minimum dimension </inline>
<inline name="tocNum">1.3.</inline>
<inline name="tocHeading">Speed of the product </inline>
<inline name="tocHeading">MPE </inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">Instrument: </inline>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/annex/XII" level="2" class="schedule" period="#period1">
<inline name="tocNum">ANNEX XII</inline>
</tocItem>
<inline name="tocHeading">EXHAUST GAS ANALYSERS (MI-010) </inline>
<inline name="tocHeading">DEFINITIONS </inline>
<inline name="tocHeading">SPECIFIC REQUIREMENTS </inline>
<inline name="tocHeading">Instrument Classes </inline>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Two classes (0 and I) are being defined for exhaust...</inline>
<inline name="tocHeading">Rated operating conditions </inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">The values of the operating conditions shall be specified by...</inline>
<inline name="tocHeading">Maximum permissible errors (MPEs) </inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">The MPEs are defined as follows: </inline>
<inline name="tocHeading">Permissible effect of disturbances </inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">For each of the volume fractions measured by the instrument,...</inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">The effect of an electromagnetic disturbance shall be such that:...</inline>
<inline name="tocHeading">Other requirements </inline>
<inline name="tocNum">6.</inline>
<inline name="tocHeading">The resolution shall be equal to or of one order...</inline>
<inline name="tocNum">7.</inline>
<inline name="tocHeading">The standard deviation of 20 measurements shall not be greater...</inline>
<inline name="tocNum">8.</inline>
<inline name="tocHeading">For measuring CO, CO2 and HC, the instrument, including the...</inline>
<inline name="tocNum">9.</inline>
<inline name="tocHeading">The components in the exhaust gas, other than the components...</inline>
<inline name="tocNum">10.</inline>
<inline name="tocHeading">An exhaust gas analyser shall have an adjustment facility that...</inline>
<inline name="tocNum">11.</inline>
<inline name="tocHeading">For automatic or semi-automatic adjustment facilities, the instrument shall be...</inline>
<inline name="tocNum">12.</inline>
<inline name="tocHeading">An exhaust gas analyser shall detect hydrocarbon residues in the...</inline>
<inline name="tocNum">13.</inline>
<inline name="tocHeading">An exhaust gas analyser shall have a device for automatically...</inline>
<inline name="tocNum">14.</inline>
<inline name="tocHeading">If the exhaust gas analyser is capable to operate with...</inline>
<inline name="tocHeading">CONFORMITY ASSESSMENT </inline>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/annex/XIII" level="2" class="schedule" period="#period1">
<inline name="tocNum">ANNEX XIII</inline>
<inline name="tocHeading">EU DECLARATION OF CONFORMITY (No XXXX) </inline>
</tocItem>
<inline name="tocNum">1.</inline>
<inline name="tocHeading">Instrument model/Instrument (product, type, batch or serial number): </inline>
<inline name="tocNum">2.</inline>
<inline name="tocHeading">Name and address of the manufacturer and, where applicable, his...</inline>
<inline name="tocNum">3.</inline>
<inline name="tocHeading">This declaration of conformity is issued under the sole responsibility...</inline>
<inline name="tocNum">4.</inline>
<inline name="tocHeading">Object of the declaration (identification of instrument allowing traceability; it...</inline>
<inline name="tocNum">5.</inline>
<inline name="tocHeading">The object of the declaration described above is in conformity...</inline>
<inline name="tocNum">6.</inline>
<inline name="tocHeading">References to the relevant harmonised standards or normative documents used...</inline>
<inline name="tocNum">7.</inline>
<inline name="tocHeading">Where applicable, the notified body … (name, number) performed …...</inline>
<inline name="tocNum">8.</inline>
<inline name="tocHeading">Additional information: </inline>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/annex/XIV" level="2" class="schedule" period="#period1">
<inline name="tocNum">ANNEX XIV</inline>
</tocItem>
<inline name="tocNum">PART A</inline>
<inline name="tocHeading"/>
<inline name="tocNum">PART B</inline>
<inline name="tocHeading"/>
<tocItem href="http://www.legislation.gov.uk/eudr/2014/32/annex/XV" level="2" class="schedule" period="#period1">
<inline name="tocNum">ANNEX XV</inline>
</tocItem>
</toc>
</coverPage>
<preface>
<longTitle>
<p>
<inline name="uppercase">Directive</inline>
2014/32/EU
<inline name="uppercase">of the European Parliament and of the Council</inline>
</p>
<p>of 26 February 2014</p>
<p>on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments (recast)</p>
<p>(Text with EEA relevance)</p>
</longTitle>
</preface>
<preamble>
<p>THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,</p>
<p>Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,</p>
<p>Having regard to the proposal from the European Commission,</p>
<p>After transmission of the draft legislative act to the national parliaments,</p>
<p>
Having regard to the opinion of the European Economic and Social Committee
<noteRef href="#f00001" class="footnote" marker="1"/>
,
</p>
<p>
Acting in accordance with the ordinary legislative procedure
<noteRef href="#f00002" class="footnote" marker="2"/>
,
</p>
<p>Whereas:</p>
<tblock>
<num>(1)</num>
<p>
Directive 2004/22/EC of the European Parliament and of the Council of 31 March 2004 on measuring instruments
<noteRef href="#f00003" class="footnote" marker="3"/>
has been substantially amended
<noteRef href="#f00004" class="footnote" marker="4"/>
. Since further amendments are to be made, that Directive should be recast in the interests of clarity.
</p>
</tblock>
<tblock>
<num>(2)</num>
<p>
Regulation (EC) No 765/2008 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
<noteRef href="#f00005" class="footnote" marker="5"/>
lays down rules on the accreditation of conformity assessment bodies, provides a framework for the market surveillance of products and for controls on products from third countries, and lays down the general principles of the CE marking.
</p>
</tblock>
<tblock>
<num>(3)</num>
<p>
Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products
<noteRef href="#f00006" class="footnote" marker="6"/>
lays 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. Directive 2004/22/EC should be adapted to that Decision.
</p>
</tblock>
<tblock>
<num>(4)</num>
<p>This Directive covers measuring instruments which are new to the Union market when they are placed on the market; that is to say they are either new measuring instruments made by a manufacturer established in the Union or measuring instruments, whether new or second-hand, imported from a third country.</p>
</tblock>
<tblock>
<num>(5)</num>
<p>Correct and traceable measuring instruments can be used for a variety of measurement tasks. Those responding to reasons of public interest, public health, safety and order, protection of the environment and the consumer, of levying taxes and duties and of fair trading, which directly and indirectly affect the daily life of citizens in many ways, may require the use of legally controlled measuring instruments.</p>
</tblock>
<tblock>
<num>(6)</num>
<p>This Directive should apply to all forms of supply, including distance selling.</p>
</tblock>
<tblock>
<num>(7)</num>
<p>Legal metrological control should not lead to barriers to the free movement of measuring instruments. The applicable provisions should be the same in all Member States and proof of conformity should be accepted throughout the Union.</p>
</tblock>
<tblock>
<num>(8)</num>
<p>Legal metrological control requires conformity with specified performance requirements. The performance requirements that the measuring instruments must meet should provide a high level of protection. The conformity assessment should provide a high level of confidence.</p>
</tblock>
<tblock>
<num>(9)</num>
<p>Member States should as a general rule prescribe legal metrological control. Where legal metrological control is prescribed, only measuring instruments complying with common performance requirements should be used.</p>
</tblock>
<tblock>
<num>(10)</num>
<p>The principle of optionality introduced by Directive 2004/22/EC allows Member States to exercise their right to decide whether or not to prescribe the use of the measuring instruments covered by this Directive.</p>
</tblock>
<tblock>
<num>(11)</num>
<p>National specifications concerning the appropriate national requirements for use should not interfere with the provisions of this Directive on ‘putting into use’.</p>
</tblock>
<tblock>
<num>(12)</num>
<p>
The performance of certain measuring instruments is particularly sensitive to the environment, in particular the electromagnetic environment. Immunity of measuring instruments to electromagnetic interference should form an integral part of this Directive and the immunity requirements of Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility
<noteRef href="#f00007" class="footnote" marker="7"/>
should therefore not apply.
</p>
</tblock>
<tblock>
<num>(13)</num>
<p>In order to ensure the free circulation of measuring instruments in the Union, Member States should not impede the placing on the market and/or putting into use of measuring instruments that carry the CE marking and supplementary metrology marking in accordance with the provisions of this Directive.</p>
</tblock>
<tblock>
<num>(14)</num>
<p>Member States should take appropriate action to prevent non-complying measuring instruments from being placed on the market and/or put into use. Adequate cooperation between the competent authorities of the Member States is therefore necessary to ensure a Union-wide effect of this objective.</p>
</tblock>
<tblock>
<num>(15)</num>
<p>Economic operators should be responsible for the compliance of measuring instruments with this Directive, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of the aspects of public interest covered by this Directive, and also to guarantee fair competition on the Union market.</p>
</tblock>
<tblock>
<num>(16)</num>
<p>All economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that they make available on the market only measuring instruments which are in conformity with this Directive. It is necessary to provide for a clear and proportionate distribution of obligations which correspond to the role of each economic operator in the supply and distribution chain.</p>
</tblock>
<tblock>
<num>(17)</num>
<p>In order to facilitate communication between economic operators, market surveillance authorities and consumers, Member States should encourage economic operators to include a website address in addition to the postal address.</p>
</tblock>
<tblock>
<num>(18)</num>
<p>The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the conformity assessment procedure. Conformity assessment should therefore remain solely the obligation of the manufacturer.</p>
</tblock>
<tblock>
<num>(19)</num>
<p>It is necessary to ensure that measuring instruments from third countries entering the Union market comply with this Directive, and in particular that the appropriate conformity assessment procedures have been carried out by manufacturers with regard to those measuring instruments. Provision should therefore be made for importers to make sure that the measuring instruments they place on the market comply with the requirements of this Directive and that they do not place on the market measuring instruments which do not comply with such requirements or present a risk. Provision should also be made for importers to make sure that conformity assessment procedures have been carried out and that marking of measuring instruments and documentation drawn up by manufacturers are available for inspection by the competent national authorities.</p>
</tblock>
<tblock>
<num>(20)</num>
<p>When placing a measuring instrument on the market, every importer should indicate on the measuring instrument his name, registered trade name or registered trade mark and the postal address at which he can be contacted. Exceptions should be provided for in cases where the size or nature of the measuring instrument does not allow it. This includes cases where the importer would have to open the packaging to put his name and address on the measuring instrument.</p>
</tblock>
<tblock>
<num>(21)</num>
<p>The distributor makes a measuring instrument available on the market after it has been placed on the market by the manufacturer or the importer. The distributor should act with due care to ensure that its handling of the measuring instrument does not adversely affect the compliance of that instrument with this Directive.</p>
</tblock>
<tblock>
<num>(22)</num>
<p>Any economic operator that either places a measuring instrument on the market under his own name or trade mark or modifies a measuring instrument in such a way that compliance with of this Directive may be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer.</p>
</tblock>
<tblock>
<num>(23)</num>
<p>Distributors and importers, being close to the market place, should be involved in market surveillance tasks carried out by competent national authorities, and should be prepared to participate actively, providing those authorities with all necessary information relating to the measuring instrument concerned.</p>
</tblock>
<tblock>
<num>(24)</num>
<p>Ensuring traceability of a measuring instrument throughout the whole supply chain helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates market surveillance authorities’ task of tracing economic operators who made non-compliant measuring instruments available on the market. When keeping the information required under this Directive for the identification of other economic operators, economic operators should not be required to update such information in respect of other economic operators who have either supplied them with a measuring instrument or to whom they have supplied a measuring instrument.</p>
</tblock>
<tblock>
<num>(25)</num>
<p>
This Directive should be limited to the expression of essential requirements that do not impede technical progress, preferably performance requirements. In order to facilitate conformity assessment with those requirements it is necessary to provide for a presumption of conformity for measuring instruments which are in conformity with harmonised standards that are adopted in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European Standardisation
<noteRef href="#f00008" class="footnote" marker="8"/>
for the purpose of expressing detailed technical specifications of those requirements.
</p>
</tblock>
<tblock>
<num>(26)</num>
<p>Regulation (EU) No 1025/2012 provides for a procedure for objections to harmonised standards where those standards do not entirely satisfy the requirements of this Directive.</p>
</tblock>
<tblock>
<num>(27)</num>
<p>The technical and performance specifications of internationally agreed normative documents may also comply, in part or in full, with the essential requirements laid down by this Directive. In those cases the use of these internationally agreed normative documents should be allowed as an alternative to the use of harmonised standards and, under specific conditions, give rise to a presumption of conformity.</p>
</tblock>
<tblock>
<num>(28)</num>
<p>Conformity with the essential requirements laid down by this Directive can also be provided by specifications that are not supplied by a harmonised standard or an internationally agreed normative document. The use of harmonised standards or internationally agreed normative documents should therefore be optional.</p>
</tblock>
<tblock>
<num>(29)</num>
<p>In order to enable economic operators to demonstrate and the competent authorities to ensure that measuring instruments made available on the market comply with the essential requirements, it is necessary to provide for conformity assessment procedures. Decision No 768/2008/EC establishes modules for conformity assessment procedures, from the least to the most stringent, in proportion to the level of risk involved and the level of safety required. In order to ensure inter-sectoral coherence and to avoid ad-hoc variants, conformity assessment procedures should be chosen from among those modules. However, it is necessary to adapt those modules in order to reflect specific aspects of metrological control.</p>
</tblock>
<tblock>
<num>(30)</num>
<p>The conformity assessment of sub-assemblies should be carried out in accordance with this Directive. If sub-assemblies are made available on the market separately and independently of an instrument, their conformity assessment should be undertaken independently of the instrument concerned.</p>
</tblock>
<tblock>
<num>(31)</num>
<p>The state of the art in measurement technology is subject to constant evolution which may lead to changes in the needs for conformity assessments. Therefore, for each category of measuring instrument and, where appropriate, sub-assemblies, there should be an appropriate procedure or a choice between different procedures of equivalent stringency.</p>
</tblock>
<tblock>
<num>(32)</num>
<p>Manufacturers should draw up an EU declaration of conformity to provide information required under this Directive on the conformity of a measuring instrument with this Directive and with other relevant Union harmonisation legislation.</p>
</tblock>
<tblock>
<num>(33)</num>
<p>To ensure effective access to information for market surveillance purposes, the information required to identify all applicable Union acts should be available in a single EU declaration of conformity. In order to reduce the administrative burden on economic operators, that single EU declaration of conformity may be a dossier made up of relevant individual declarations of conformity.</p>
</tblock>
<tblock>
<num>(34)</num>
<p>The CE marking and the supplementary metrology marking, indicating the conformity of a measuring instrument, are the visible consequence of a whole process comprising conformity assessment in a broad sense. General principles governing the CE marking and its relationship to other markings are set out in Regulation (EC) No 765/2008. Rules governing the affixing of the CE marking and the supplementary metrology marking should be laid down in this Directive.</p>
</tblock>
<tblock>
<num>(35)</num>
<p>In order to take account of differences in climatic conditions or of different levels of consumer protection that may apply at national level, it is necessary to establish environmental or accuracy classes as essential requirements.</p>
</tblock>
<tblock>
<num>(36)</num>
<p>Certain conformity assessment procedures set out in this Directive require the intervention of conformity assessment bodies, which are notified by the Member States to the Commission.</p>
</tblock>
<tblock>
<num>(37)</num>
<p>Experience has shown that the criteria set out in Directive 2004/22/EC that conformity assessment bodies have to fulfil to be notified to the Commission are not sufficient to ensure a uniformly high level of performance of notified bodies throughout the Union. It is, however, essential that all notified bodies perform their functions to the same level and under conditions of fair competition. That requires the setting of obligatory requirements for conformity assessment bodies wishing to be notified in order to provide conformity assessment services.</p>
</tblock>
<tblock>
<num>(38)</num>
<p>If a conformity assessment body demonstrates conformity with the criteria laid down in harmonised standards it should be presumed to comply with the corresponding requirements set out in this Directive.</p>
</tblock>
<tblock>
<num>(39)</num>
<p>In order to ensure a consistent level of quality in the performance of conformity assessment of measuring instruments, it is also necessary to set requirements for notifying authorities and other bodies involved in the assessment, notification and monitoring of notified bodies.</p>
</tblock>
<tblock>
<num>(40)</num>
<p>The system set out in this Directive should be complemented by the accreditation system provided for in Regulation (EC) No 765/2008. Since accreditation is an essential means of verifying the competence of conformity assessment bodies, it should also be used for the purposes of notification.</p>
</tblock>
<tblock>
<num>(41)</num>
<p>Transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring the necessary level of confidence in certificates of conformity, should be considered by the national public authorities throughout the Union as the preferred means of demonstrating the technical competence of conformity assessment bodies. However, national authorities may consider that they possess the appropriate means of carrying out that evaluation themselves. In such cases, in order to ensure the appropriate level of credibility of evaluations carried out by other national authorities, they should provide the Commission and the other Member States with the necessary documentary evidence demonstrating the compliance of the conformity assessment bodies evaluated with the relevant regulatory requirements.</p>
</tblock>
<tblock>
<num>(42)</num>
<p>Conformity assessment bodies frequently subcontract parts of their activities linked to the assessment of conformity or have recourse to a subsidiary. In order to safeguard the level of protection required for the measuring instruments to be placed on the market, it is essential that conformity assessment subcontractors and subsidiaries fulfil the same requirements as notified bodies in relation to the performance of conformity assessment tasks. Therefore, it is important that the assessment of the competence and the performance of bodies to be notified and the monitoring of bodies already notified cover also activities carried out by subcontractors and subsidiaries.</p>
</tblock>
<tblock>
<num>(43)</num>
<p>It is necessary to increase the efficiency and transparency of the notification procedure and, in particular, to adapt it to new technologies so as to enable online notification.</p>
</tblock>
<tblock>
<num>(44)</num>
<p>Since notified bodies may offer their services throughout the Union, it is appropriate to give the other Member States and the Commission the opportunity to raise objections concerning a notified body. It is therefore important to provide for a period during which any doubts or concerns as to the competence of conformity assessment bodies can be clarified before they start operating as notified bodies.</p>
</tblock>
<tblock>
<num>(45)</num>
<p>In the interests of competitiveness, it is crucial that notified bodies apply the conformity assessment procedures without creating unnecessary burdens for economic operators. For the same reason, and to ensure equal treatment of economic operators, consistency in the technical application of the conformity assessment procedures needs to be ensured. That can best be achieved through appropriate coordination and cooperation between notified bodies.</p>
</tblock>
<tblock>
<num>(46)</num>
<p>In order to ensure legal certainty, it is necessary to clarify that rules on Union market surveillance and control of products entering the Union market provided for in Regulation (EC) No 765/2008 apply to measuring instruments covered by this Directive. This Directive should not prevent Member States from choosing the competent authorities to carry out those tasks.</p>
</tblock>
<tblock>
<num>(47)</num>
<p>Member States should take all appropriate measures to ensure that measuring instruments may be placed on the market only if, when properly stored and used for their intended purpose, or under conditions of use which can be reasonably foreseen, they do not endanger the health and safety of persons. Measuring instruments should be considered as non-compliant with the essential requirements laid down in this Directive only under conditions of use which can be reasonably foreseen, that is when such use could result from lawful and readily predictable human behaviour.</p>
</tblock>
<tblock>
<num>(48)</num>
<p>Directive 2004/22/EC already provides for a safeguard procedure allowing the Commission to examine the justification for a measure taken by a Member State against measuring instruments it considers to be non-compliant. In order to increase transparency and to reduce processing time, it is necessary to improve the existing safeguard procedure, with the view to making it more efficient and drawing on the expertise available in Member States.</p>
</tblock>
<tblock>
<num>(49)</num>
<p>The existing system should be supplemented by a procedure under which interested parties are informed of measures intended to be taken with regard to measuring instruments presenting a risk to aspects of public interest protection covered by this Directive. It should also allow market surveillance authorities, in cooperation with the relevant economic operators, to act at an early stage in respect of such measuring instruments.</p>
</tblock>
<tblock>
<num>(50)</num>
<p>Where the Member States and the Commission agree as to the justification of a measure taken by a Member State, no further involvement of the Commission should be required, except where non-compliance can be attributed to shortcomings of a harmonised standard or a normative document.</p>
</tblock>
<tblock>
<num>(51)</num>
<p>
In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers
<noteRef href="#f00009" class="footnote" marker="9"/>
.
</p>
</tblock>
<tblock>
<num>(52)</num>
<p>The advisory procedure should be used for the adoption of implementing acts requesting the notifying Member State to take the necessary corrective measures in respect of notified bodies that do not meet or no longer meet the requirements for their notification.</p>
</tblock>
<tblock>
<num>(53)</num>
<p>
The advisory procedure should also be used for the adoption of implementing acts with respect to the objections to the internationally agreed normative documents whose references have not yet been published in the
<em>Official Journal of the European Union</em>
, given that the relevant document has not yet led to the presumption of conformity with the applicable essential requirements.
</p>
</tblock>
<tblock>
<num>(54)</num>
<p>
The examination procedure should be used for the adoption of implementing acts with respect to the objections to the internationally agreed normative documents whose references were already published in the
<em>Official Journal of the European Union</em>
and which a Member State or the Commission considers justified, given that such acts could have consequences on the presumption of conformity with the applicable essential requirements.
</p>
</tblock>
<tblock>
<num>(55)</num>
<p>The examination procedure should also be used for the adoption of implementing acts with respect to compliant measuring instruments which present a risk to the health or safety of persons or to other aspects of public interest protection.</p>
</tblock>
<tblock>
<num>(56)</num>
<p>In line with established practice, the committee set up by this Directive can play a useful role in examining matters concerning the application of this Directive raised either by its chair or by a representative of a Member State in accordance with its rules of procedure.</p>
</tblock>
<tblock>
<num>(57)</num>
<p>When matters relating to this Directive, other than its implementation or infringements, are being examined, i.e. in a Commission expert group, the European Parliament should in line with existing practice receive full information and documentation and, where appropriate, an invitation to attend such meetings.</p>
</tblock>
<tblock>
<num>(58)</num>
<p>The Commission should, by means of implementing acts and, given their special nature, acting without the application of Regulation (EU) No 182/2011, determine whether measures taken by Member States in respect of non-compliant measuring instruments are justified or not.</p>
</tblock>
<tblock>
<num>(59)</num>
<p>In order to take into account the developments in the measurement technology, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amendments to the instrument-specific Annexes. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.</p>
</tblock>
<tblock>
<num>(60)</num>
<p>Member States should lay down rules on penalties applicable to infringements of the provisions of national law adopted pursuant to this Directive and ensure that those rules are enforced. The penalties provided for should be effective, proportionate and dissuasive.</p>
</tblock>
<tblock>
<num>(61)</num>
<p>It is necessary to provide for reasonable transitional arrangements that allow the making available on the market and putting into use, without the need to comply with further product requirements, of measuring instruments that have already been placed on the market in accordance with Directive 2004/22/EC before the date of application of national measures transposing this Directive. Distributors should therefore be able to supply measuring instruments that have been placed on the market, namely stock that is already in the distribution chain, before the date of application of national measures transposing this Directive.</p>
</tblock>
<tblock>
<num>(62)</num>
<p>Since the objective of this Directive, namely to ensure that measuring instruments on the market fulfil the requirements providing for a high level of protection of the public interests covered by this Directive while guaranteeing the functioning of the internal market cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.</p>
</tblock>
<tblock>
<num>(63)</num>
<p>The obligation to transpose this Directive into national law should be confined to those provisions which represent a substantive amendment as compared to the earlier Directive. The obligation to transpose the provisions which are unchanged arises under the earlier Directive.</p>
</tblock>
<tblock>
<num>(64)</num>
<p>This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law and the dates of application of the Directives set out in Annex XIV, Part B,</p>
</tblock>
<p>HAVE ADOPTED THIS DIRECTIVE:</p>
</preamble>
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