CHAPTER 1
GENERAL PROVISIONS
Article 1
Subject matter
Article 2
Scope
Article 3
Optionality
Article 4
Definitions
Article 5
Applicability to sub-assemblies
Article 6
Essential requirements
Article 7
Making available on the market and putting into use
CHAPTER 2
OBLIGATIONS OF ECONOMIC OPERATORS
Article 8
Obligations of manufacturers
Article 9
Authorised representatives
Article 10
Obligations of importers
Article 11
Obligations of distributors
Article 12
Cases in which obligations of manufacturers apply to importers and distributors
Article 13
Identification of economic operators
CHAPTER 3
CONFORMITY OF MEASURING INSTRUMENTS
Article 14
Presumption of conformity of measuring instruments
Article 15
Publication of the references of normative documents
Article 16
Withdrawal of the references of normative documents
Article 17
Conformity assessment procedures
Article 18
Technical documentation
Article 19
EU declaration of conformity
Article 20
Conformity marking
Article 21
General principles of the CE marking and of the supplementary metrology marking
Article 22
Rules and conditions for affixing the CE marking and the supplementary metrology marking
CHAPTER 4
NOTIFICATION OF CONFORMITY ASSESSMENT BODIES
Article 23
Notification
Article 24
Notifying authorities
Article 25
Requirements relating to notifying authorities
Article 26
Information obligation on notifying authorities
Article 27
Requirements relating to notified bodies
Article 28
Presumption of conformity of notified bodies
Article 29
Subsidiaries of and subcontracting by notified bodies
Article 30
Accredited in-house bodies
Article 31
Application for notification
Article 32
Notification procedure
Article 33
Identification numbers and lists of notified bodies
Article 34
Changes to notifications
Article 35
Challenge of the competence of notified bodies
Article 36
Operational obligations of notified bodies
Article 37
Appeal against decisions of notified bodies
Article 38
Information obligation on notified bodies
Article 39
Exchange of experience
Article 40
Coordination of notified bodies
CHAPTER 5
UNION MARKET SURVEILLANCE, CONTROL OF MEASURING INSTRUMENTS ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE
Article 41
Union market surveillance and control of measuring instruments entering the Union market
Article 42
Procedure for dealing with measuring instruments presenting a risk at national level
Article 43
Union safeguard procedure
Article 44
Compliant measuring instruments which present a risk
Article 45
Formal non-compliance
CHAPTER 6
COMMITTEE AND DELEGATED ACTS
Article 46
Committee procedure
Article 47
Amendments of Annexes
Article 48
Exercise of the delegation
CHAPTER 7
TRANSITIONAL AND FINAL PROVISIONS
Article 49
Penalties
Article 50
Transitional provisions
Article 51
Transposition
Article 52
Repeal
Article 53
Entry into force and application
Article 54
Addressees
ANNEX I
ESSENTIAL 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 II
MODULE 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 III
WATER 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 IV
GAS METERS AND VOLUME CONVERSION DEVICES (MI-002)
DEFINITIONS
PART I
SPECIFIC REQUIREMENTS
1.
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 II
SPECIFIC REQUIREMENTS
7.
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 III
PUTTING INTO USE AND CONFORMITY ASSESSMENT
Putting into use
10.
Where a Member State imposes measurement of residential use, it...
CONFORMITY ASSESSMENT
ANNEX V
ACTIVE 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 VI
THERMAL 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 VII
MEASURING 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 VIII
AUTOMATIC WEIGHING INSTRUMENTS (MI-006)
DEFINITIONS
SPECIFIC REQUIREMENTS
CHAPTER I
Requirements 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 II
Automatic 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 III
Automatic 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 IV
Discontinuous 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 V
Continuous 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 VI
Automatic 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 IX
TAXIMETERS (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 X
MATERIAL MEASURES (MI-008)
CHAPTER I
Material 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 II
Capacity 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 XI
DIMENSIONAL 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 XII
EXHAUST 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 XIII
EU 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 XIV
PART A
PART B
ANNEX 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:
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.