water meters intended for measuring the volume of clean cold or hot water;

gas meters and volume converters;

electricity meters for consumption;

heat meters;

measuring systems for continuous and dynamic measurement of quantities of liquids except water;

self-adhesive balances;

Taxameter;

depletion (bodyed lengths and discharge measures);

measuring instruments for measuring length and combinations.

‘mechanistics’: any device or system with a measuring function, which in § 1(1). 1 is called;

"Participator": a unit referred to as such in the calibration legislation, belonging to a measuring device according to Section 1(1). 1 that works independently and

together with other sub-equipment with which it is compatible, or

together with a measuring device that is compatible

"legal metrology control": the control of measurement tasks for the application of a measuring device for reasons of public interest, public health, public security and order, environmental protection, the collection of taxes and levies, consumer protection and fair trade;

‘normative document’: a document with technical specifications drawn up by the International Organisation for the Law of Messrs (OIML);

"Processation on the market": any fee or free charge of a measuring device for sale or for use on the Union market in the context of a business activity;

"Market": the first provision of a measuring device on the Union market;

“In-use”: the first use of a measuring device intended for the end user;

‘producer’: any natural or legal person who manufactures or manufactures a measuring device and which markets that measuring device under its own name or trademark or enters into operation for its own purposes;

"authors": any natural or legal person established in the European Union who has been written by a manufacturer to perform certain tasks in his name;

“Introductory” means any natural or legal person established in the European Union who is placing a measuring device from a third country on the Union market;

" Dealers": any natural or legal person in the supply chain providing a measuring device on the market, with the exception of the manufacturer or the importer;

"economic actors": the manufacturer, the representative, the importer and the merchant;

‘technical specification’: a document that lays down the technical requirements that a measuring device must meet;

"harmonised standard": a harmonised standard within the meaning of Art. 2(1). (c) Council Directives 89/686/EEC and 93/15/EEC as well as Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council of 14/11/2012.

"Accreditation": an accreditation within the meaning of Art. 2 Z 10 of Council Regulation (EC) No 765/2008 on the rules for accreditation and market surveillance relating to the marketing of products and repealing Council Regulation (EEC) No 339/93, OJ No L 218 of 13.08.2008 p. 30;

National Accreditation Body: a national accreditation body within the meaning of Art. 2 Z 11 of Regulation (EC) No 765/2008;

"Conformity Assessment": the procedure for assessing whether the essential requirements of this Regulation have been met by a measuring device;

"Conformity Assessment Body": a body carrying out conformity assessment activities including calibrations, tests, certifications and inspections;

"recall": any measure aimed at restoring a measuring device already provided to the end user;

"Return": any measure to prevent a measuring device in the supply chain from being placed on the market;

"Union harmonisation legislation": European Union legislation harmonising the conditions for the marketing of products;

‘CE marking’: by which the manufacturer declares that the measuring device complies with the applicable requirements laid down in European Union harmonisation legislation on its attachment.

Prepare the EU declaration of conformity and technical documentation for national market surveillance authorities for a period of ten years from the placing on the market of the measuring device;

at a reasonable request of a competent national authority to provide all information and documents necessary to demonstrate the conformity of a measuring device to this authority;

cooperate at the request of the competent national authorities on all measures to eliminate the risks associated with measuring devices that are part of their field of responsibility.

of whom they have a measuring device;

they have delivered a measuring device.

Description of the metrological characteristics;

reproducing the measurement performance of the measuring instruments produced if these are properly adjusted with appropriate means for use;

integrity of the measuring device.

a general description of the measuring device;

design, production drawings and plans of components, construction groups, circuit boards, etc.;

Description of manufacturing processes to ensure uniform production;

where appropriate, a description of electronic components with drawings, charts, logic flow charts and general information on the software with an explanation of their characteristics and functioning;

descriptions and explanations necessary to understand the Z 2 to Z 4, including the functioning of the measuring device;

a list of harmonised standards and/or normative documents referred to in Section 12, which have been published in the Official Journal of the European Union;

a description of the solutions chosen to meet the essential requirements of this Regulation, in so far as the harmonised standards and/or normative documents referred to in Section 12 have not been applied, including a list of other relevant technical specifications;

the results of design calculations, tests, etc.;

where necessary, appropriate test results to demonstrate that the design and/or measuring instruments are used

comply with the requirements of this Regulation under the specified nominal operating conditions and in specified environmental disturbances;

comply with the specifications laid down in the calibration rules for the durability of gas, water and heat meters as well as measuring systems for liquids except water;

the EU design or EU design test certificates for measuring devices containing parts identical to those of the design.

not designer, manufacturer, supplier, installer, buyer, owner, user or maintenance operation of the measuring devices to be evaluated by them or representatives of any of these parties. This does not exclude the use of measuring devices already subject to conformity assessment, which are necessary for the operation of the conformity assessment body, or the use of such measuring instruments for personal use

neither directly involved in the design, manufacture or construction, marketing, installation, use or maintenance of these measuring instruments nor represent the parties involved in these activities. They may not deal with activities that may affect their independence in the assessment or integrity of conformity assessment measures for which they are notified. This is particularly true for consulting services.

the necessary staff with specialist knowledge and sufficient experience to perform the tasks of conformity assessment;

Descriptions of procedures in which conformity assessment is carried out to ensure the transparency and repeatability of these procedures. It has adequate instruments and appropriate procedures to distinguish between the tasks it performs as a notified body and other activities;

Procedures for carrying out activities taking due account of the size of a company in which it operates, its structure, the degree of complexity of the respective product technology and the fact that the production process is a mass production or serial production.

a solid technical and vocational training, covering all activities for conformity assessment in the area for which the conformity assessment body has been notified;

sufficient knowledge of the requirements associated with the evaluations to be carried out and the power to carry out such evaluations;

adequate knowledge and understanding of the essential requirements set out in Annex 1 and the relevant calibration requirements, the applicable harmonised standards and normative documents and the provisions of the European Union harmonisation legislation and national legislation;

the ability to produce certificates, protocols and reports as proof of carried out reviews.

They are accredited in accordance with Regulation (EC) No 765/2008;

the bodies and their employees are organisationally indefinite and have reporting procedures to ensure their impartiality that they prove to the national accreditation body;

neither the bodies nor their employees are responsible for the design, manufacture, supply, installation, operation or maintenance of the measuring instruments to be evaluated by them, or are going to work that could harm the independence of their judgment or their integrity in relation to the evaluation tasks;

the bodies provide their services exclusively for the company they belong to.

the measuring device does not meet the requirements set out in this Regulation regarding the aspects of public interest protection; or

the harmonised standards or normative documents, in which compliance is subject to a presumption of conformity according to Section 12, are inadequate.

the CE marking or the additional metrology marking was not respected by Art. 30 of Regulation (EC) No 765/2008 or of § 17 of this Regulation;

the CE marking or the additional metrology marking has not been applied;

the identification number of the notified body — if it was at the stage of manufacturing control — was appropriate or not appropriate for non-compliance with Section 17;

the EU declaration of conformity was not attached to the measuring device;

the EU declaration of conformity has not been properly issued;

the technical documents are either not available or not complete;

in § 6(2). 7 or § 8. 4 of these information is missing, incorrect or incomplete;

a different administrative requirement under § 6 or § 8 is not met.

serves as a basis for the price to be paid and

at least one of the parties affected by the measure is a consumer or another party that needs comparable protection, and

all parties concerned by the operation acknowledge the measurement result on the spot.

Error limits

Under nominal operating conditions and without the occurrence of a disturbance, the deviation of the measure may not exceed the extreme deviations approved in the relevant calibration rules ( error limits). Unless otherwise specified in the calibration rules, a limit of error is expressed as a two-sided value of the deviation from the true measurement value.

Under nominal operating conditions and in the event of a disturbance, the performance requirement for the device complies with the relevant calibration requirements. If the device is used in a continuous electromagnetic field, the permitted measurement properties must be within the limits of the error during the examination.

The manufacturer must specify the climatic, mechanical and electromagnetic environment conditions under which the device is to be used, as well as the power supply and other influence sizes that may affect its accuracy, taking into account the requirements set out in the relevant calibration rules.

Climate conditions

(a) the mechanical environment conditions are divided into classes M1 to M3 as follows:

In relation to mechanical environment conditions, the following influence sizes must be taken into account

vibration;

feeding.

(a) The electromagnetic environment conditions are divided into classes E1, E2 and E3, unless otherwise specified in the calibration legislation.

In relation to electromagnetic environment conditions, the following influence sizes must be taken into account

tension interruptions;

short-term voltage waste;

voltage transients in supply and/or signal lines;

charging static electricity;

electromagnetic HF fielder;

electromagnetic fields in supply and/or signal lines;

Strong voltages in supply and/or signal lines.

Other influence sizes to be taken into account where appropriate are:

voltage fluctuations;

fluctuations in network frequency;

mobile magnetic fields;

other sizes that can significantly affect the accuracy of the measuring device.

The following rules apply to the conduct of the tests under this Regulation:

Basic rules for examining and determining errors

Environment moistening

Depending on the climatic environment in which the measuring device is intended to be used, either a test can be carried out on wet heat and constant temperature (no condensation) or a check on wet heat and cyclical temperature change (replacement).

The test of wet heat and cyclical temperature change is appropriate if the retention is important or the intrusion of steam is accelerated by the respiratory effect. In terms of conditions in which it is necessary to achieve a free humidity, the test can be chosen for wet heat and constant temperature.

Reproducibility

Repeatability

Response threshold and sensitivity

Consistency

reliability

Aptitude

A measuring device may not have any characteristics that facilitate use in fraudulent intent and the possibility of unintended wrong-handling is minimised.

A measuring device must be suitable for the intended use, taking into account the practical conditions of use, and must not impose inappropriately high demands on the user to obtain a correct measurement result.

In the case of flows or flows outside the permitted area, the error of a measuring device for utility services must not have an excessive unilateral deviation.

If a measuring device is designed to measure measurements that are constant over time, the measuring device must be unsustainable or adequately react to small fluctuations in the measurement size.

A measuring device must be robust and the materials from which it exists must be suitable for the intended operating conditions.

A measuring device must be interpreted in such a way as to allow the measurement process to be controlled after the measuring device was placed on the market and put into operation. If necessary, the measuring device must have a specific equipment or software for this control. The test procedure must be described in the user manual.

Protection against counterfeiting

The metrological characteristics of a measuring device may not be influenced by the inclusion of another device, by the characteristics of the connected device or by the characteristics of a separated device which is in communication with the measuring device.

A building unit that is essential for the metrological characteristics must be interpreted in such a way that it can be secured. The safeguards provided must provide proof of any interference.

Software that is crucial for the metrological characteristics is to be labelled and secure. The identification of the software must be made available in a simple way by the measuring device. Any interference must be detectable over a reasonable period of time.

Measurement data, software that are essential for the metrological characteristics and measurable important parameters that are stored or transferred are adequately protected against accidental or intentional distortions.

In the case of display of measuring devices to measure supply services, the display of the total quantity of supply or the display of the display of visions for which the total quantity of supply can be derived and which, in whole or partly, serve as a basis for billing, cannot be resettled during the operation.

Information to be provided on the measuring device and to be processed

The following information is available on a measuring device:

Name of the manufacturer, registered trade name or registered trade mark

Details of measurement accuracy

Information on operating conditions

Measurement capacity

Area of measurement

Identity marking

Number of EU Model Testing Certificate or EU Design Testing Certificate

Information on whether or not additional installations providing measurement results comply with the provisions of this Regulation on statutory metrology control.

If a measuring device is too small or too sensitive to bear the necessary information, the packaging (where available) and the accompanying documentation to be created under this Regulation must be labelled accordingly.

The measuring device must have information about its functioning if this is not necessary due to the simplicity of the measuring device. This information must be easily understandable and, where appropriate, include:

nominal operating conditions

Class of mechanical and electromagnetic environment conditions

upper and lower temperature limit, condensing water formation possible or not possible, open or closed site

instructions for establishment, maintenance, repairs and admissibility

instructions to ensure a smooth operation and details of specific operating conditions

Conditions for compatibility with interfaces, sub-systems or measuring devices.

Individual operating instructions are not strictly necessary for groups of identical measuring devices used in the same place of use or for measuring devices to measure supply services.

Unless otherwise specified in the calibration legislation, the sub-section distance is 1 x 10n, 2 x 10n or 5 x 10n, with a total number or zero. The unit of measurement or its symbol is displayed in close proximity to the figure.

A unit of measure is marked with a nominal value or a scale and the unit used.

The units used and their symbols must comply with Community legislation on units of measurement and their symbols.

All markings and markings required by a requirement must be clear, unavoidable, clear and non-transferable.

Scoreboard of results

The display of the results is made in the form of an indicator of vision or a paper print.

The display of the results must be clearly and unambiguously, as well as with the necessary markings and markings to clarify the importance of the result. In normal operating conditions, a smooth reading of the results presented must be ensured. Additional advertisements are allowed if confusion with the display under the metrology control is excluded.

If the results are printed or recorded, the expression and the recording must be well read and unavoidable.

A measuring device used to manage a direct sale must be interpreted in such a way that the measurement result is displayed when the measuring device is determined by both parties. Insofar as this is of crucial importance in the case of direct sales, there is a need to provide evidence that is issued by periphery devices that do not meet the requirements of this Regulation to customers.

Measuring devices to measure supply services are, in any case, equipped with a view display under the metrology control which is accessible to consumers without tools. The display value of this Scoreboard is considered to be a measurement result, which is the basis for the price to be paid.

Further processing of data to complete the business process

A measuring device that does not serve to measure supplies must permanently record the measurement result and the information necessary to determine a particular transaction, if the measurement is not catching up and the measuring device is normally intended to be used in the absence of one of the parties.

In addition, a permanent detection of the measurement results and the information necessary to determine a particular transaction must be made available at the end of the measurement on request.

Conformity Assessment

Water meters that are intended to measure the volume of clean cold or hot water:

Gas meters and volume converters:

Electricity meters for use in household, commercial and light industry:

Heat meters:

Measurements for continuous and dynamic measurement of quantities of liquids except water:

Automatic scales:

For mechanical measuring devices:

For electromechanical measuring devices:

For electronic measuring devices or software measuring devices:

Taxameter:

Mass cartels:

embodies lengths:

Limits:

Measuring instruments for measuring length and their combinations:

For mechanical or electromechanical measuring devices:

For electronic measuring devices or measuring devices containing software:

The internal production control is the conformity assessment procedure in which the manufacturer meets the obligations set out in the Z 2, 3 and 4 and declares its sole responsibility that the measuring devices concerned meet the requirements of this Regulation.

Technical documents

Production

Conformity marking and EU declaration of conformity

The manufacturer brings the CE marking and the additional metrology marking to each measuring device which meets the applicable requirements of this Regulation.

The manufacturer makes a written EU declaration of conformity for a measuring device model and, together with the technical documentation after placing the measuring device on the market, it is ready for national authorities for ten years. From the EU declaration of conformity, it is necessary to identify which measuring device has been issued.

Representative

The internal production control, which is monitored at irregular intervals, is the conformity assessment procedure with which the manufacturer meets the obligations set out in the Z 2, 3, 4 and 5 and declares its own responsibility that the measuring devices concerned meet the requirements of this Regulation.

Technical documents

Production

Equipment tests

Conformity marking and EU declaration of conformity

The manufacturer shall bring the CE marking and the additional metrology marking to each device that meets the applicable requirements of this Regulation.

The manufacturer makes a written EU declaration of conformity for a device model and, together with the technical documentation after placing the device on the market, it is ready for national authorities for ten years. From the EU declaration of conformity, it is necessary to identify which device it has been issued.

Representative

The "EU Model Testing" is part of a conformity assessment procedure, where a notified body investigates and examines the technical design of a measuring device and cerifies that it meets the requirements of this Regulation.

An EU model test can be carried out on each of the following types:

examination of a design representative for the planned production of the complete measuring device (types);

assessing the suitability of the technical design of the measuring device on the basis of an examination of the technical documentation and additional evidence referred to in Z 3 and examination of samples of one or more important parts of the device representative for the planned production (combination of construction and design patterns);

Evaluation of the adequacy of the technical design of the device based on an examination of the technical documentation and additional evidence referred to in Z 3, without examination of a design (draft pattern).

The application for EU model testing must be submitted by the manufacturer at a single notified body of his choice.

name and address of the manufacturer and, if the application is submitted by the representative, his name and address;

a written statement that the same application has not been submitted to any other notified body;

the technical documents described in § 14. Based on the technical documentation, it must be possible to assess the conformity of the device with the applicable requirements of this Regulation; they must include appropriate risk analysis and evaluation. In the technical documents, the relevant requirements must be met and the design, manufacture and operation of the product must be recorded as far as they are relevant for the evaluation.

for the production concerned. The notified body may request additional samples if necessary to implement the audit programme;

the additional evidence for an appropriate solution by the technical design. In these additional evidence, all documents have to be noted, in particular when the relevant harmonised standards and/or normative documents have not been fully applied. The additional evidence includes, where necessary, the results of tests carried out by an appropriate laboratory of the manufacturer or by another testing laboratory on his behalf and under his responsibility in accordance with other relevant technical specifications.

The notified body has the following tasks:

examination of technical documentation and additional evidence to assess whether the technical design of the device is appropriate;

examine whether the model was manufactured in accordance with the technical documentation and determine which parts have been designed in accordance with the relevant harmonised standards and/or normative documents and which parts have been designed in accordance with other relevant technical specifications;

carry out or initiate appropriate investigations and tests to determine whether the solutions from the relevant harmonised standards and/or normative documents have been correctly applied, provided that the manufacturer has opted for their application;

carry out or initiate appropriate investigations and tests to determine whether the solutions chosen by the manufacturer, if it has not applied the solutions from the relevant harmonised standards and/or normative documents, have been achieved on the basis of other relevant technical specifications and meet the relevant essential requirements of this Regulation;

Agreement with the manufacturer where the investigations and tests are carried out.

examination of technical documentation and additional evidence to assess whether the technical design of the other parts of the measuring device is appropriate.

The notified body will prepare an audit report on the measures carried out under Z 4 and the results obtained. Without prejudice to its obligations to the notifying authorities, the notified body shall publish the content of this report or parts thereof only with the consent of the manufacturer.

If the design complies with the requirements of this Regulation applicable to the measuring device concerned, the notified body shall issue an EU test certificate to the manufacturer. This certificate contains the name and address of the manufacturer, the results of the examination, any conditions for its validity and the information necessary for the identification of the approved design. The EU model test certificate can be accompanied by one or more annexes.

the measurable characteristics of the design of the device;

the necessary measures to ensure the integrity of the device (monitoring, identification of the software, etc.);

other information necessary to identify the device and to monitor its external conformity with the type of construction;

any other specific information necessary to verify the characteristics of the equipment manufactured;

in the case of a partial device, all necessary information to ensure compatibility with other parts or measuring devices.

The notified body is constantly informed of all changes in the generally accepted state of technology; If these indicate that the approved design no longer complies with the applicable requirements of this Regulation, it decides whether such changes require further investigation. If this is the case, the notified body shall inform the manufacturer of it.

The manufacturer informs the notified body which has the technical documentation relating to the EU model test certificate of all changes to the approved construction patterns which may affect its conformity with the essential requirements of this Regulation or the conditions for the validity of this certificate. Such changes require an additional authorisation in the form of a supplement to the original EU model test certificate.

Each notified body shall inform its notifying authority of the EU type examination certificates and/or any additions to it which it has issued or withdrawn and, at regular intervals or upon request, send a list of all such certificates and/or additions to which it has refused, suspended or restricted to any other type.

The manufacturer holds a copy of the EU model test certificate with annexes and additions together with the technical documentation after placing the device for ten years.

The manufacturer’s representative may submit the application referred to in Z 3 and meet the obligations set out in the Z 8 and 10 if they are set on behalf.

Conformity with the type of construction based on an internal production control is part of a conformity assessment procedure where the manufacturer meets the obligations set out in the Z 2 and 3 and declares that the measuring devices in question conform to the type of construction described in the EU model test certificate and meet the requirements of this Regulation.

Production

Conformity marking and EU declaration of conformity

The manufacturer shall bring the CE marking and the additional metrology marking required by this Regulation to each individual device that conforms to the type described in the EU model test certificate.

The manufacturer makes a written EU declaration of conformity for each device model and, after placing the device on the market, it is ready for national authorities for ten years. From the EU declaration of conformity, it must be borne out of which device model it was issued.

Representative

Conformity with the type of construction on the basis of an internal production control with supervised product tests is irregularly the part of a conformity assessment procedure in which the manufacturer meets the obligations set out in the Z 2, 3 and 4 and declares its own responsibility that the measuring devices in question conform to the type of construction described in the EU model test certificate and meet the requirements of this Regulation.

Production

Equipment tests

Conformity marking and EU declaration of conformity

The manufacturer will bring the CE marking and the additional metrology marking to each measuring device that conforms to the type described in the EU Model Testing Certificate and meets the applicable requirements of this Regulation.

The manufacturer makes a written EU declaration of conformity for each device model and, after placing the device on the market, it is ready for national authorities for ten years. From the EU declaration of conformity, it must be borne out of which device model it was issued.

Representative

Conformity with the type of construction on the basis of quality assurance in relation to the production process is part of a conformity assessment procedure where the manufacturer meets the obligations set out in the Z 2 and 5 and declares its own responsibility that the measuring devices concerned conform to the type of construction described in the EU model test certificate and meet the requirements of this Regulation.

Production

Quality assurance system

The manufacturer applies to assessing its quality assurance system for the measuring devices concerned at a notified body of his choice.

name and address of the manufacturer and, if the application is submitted by the representative, his name and address;

a written statement that the same application has not been submitted to any other notified body;

all relevant information about the intended equipment category;

the documentation on the quality assurance system;

the technical documentation on the approved design and a copy of the EU model test certificate.

The quality assurance system ensures that the measuring devices conform to the type described in the EU model test certificate and with the requirements of this Regulation applicable to them.

quality objectives and organisational structure, responsibilities and powers of management in relation to product quality;

appropriate manufacturing, quality control and quality assurance techniques, applied procedures and planned systematic measures;

before, during and after production, investigations and tests, indicating their frequency;

quality-related records such as test reports, test and calibration data as well as reports on the qualification of employees in this area;

The means to monitor the achievement of required product quality and the effective functioning of the quality assurance system.

The notified body assesses the quality assurance system to determine whether it meets the requirements set out in Z 3.2.

The manufacturer undertakes to meet the obligations of the approved quality assurance system and to ensure that it is always properly and efficiently kept.

The manufacturer informs the notified body which has approved the quality assurance system of all planned changes to the quality assurance system.

Monitoring under the responsibility of the notified body

Monitoring should ensure that the manufacturer complies with the obligations of the approved quality assurance system.

The manufacturer grants the notified body access to the production, purchase, testing and storage facilities and makes all necessary documentation available, in particular:

the documentation on the quality assurance system;

quality-related records such as test reports, test and calibration data, as well as reports on the qualification of employees in this area.

The notified body regularly carries out audits to ensure that the manufacturer maintains and applies the quality assurance system, and submits an audit report to it.

In addition, the notified body may carry out unannounced visits to the manufacturer. During these visits, the notified body may, if necessary, carry out or carry out equipment tests to ensure the proper functioning of the quality assurance system. The notified body reports to the manufacturer a report on the visit and a review report in case of an examination.

Conformity marking and EU declaration of conformity

The manufacturer shall bring the CE marking, the additional metrology marking, in accordance with this Regulation and under the responsibility of the body notified in Z 3.1, to each measuring device that conforms to the type described in the EU Model Testing Certificate and meets the applicable requirements of this Regulation.

The manufacturer makes a written EU declaration of conformity for each device model and, after placing the device on the market, it is ready for national authorities for ten years. From the EU declaration of conformity, it must be borne out of which device model it was issued.

The manufacturer will provide the following documents for a period of ten years from placing the device on the market for the national authorities:

the documents in accordance with Z 3.1;

the information concerning the change in accordance with Z 3.5 in its approved form;

the decisions and reports of the notified body in accordance with the C 3.5, 4.3 and 4.4.

Each notified body shall inform its notifying authority of the authorisations of quality assurance systems that it has issued or withdrawn, and shall, at regular intervals or upon request, transmit to its notifying authority a list of all licences of quality assurance systems that it has refused, suspended or restricted to other types.

Representative

Quality assurance relating to the production process is the conformity assessment procedure in which the manufacturer meets the obligations set out in the Z 2, 4 and 7 and declares its own responsibility that the measuring devices concerned meet the requirements of this Regulation.

Technical documents

The manufacturer maintains the technical documentation for the national authorities for ten years after placing the device on the market.

Production

Quality assurance system

The manufacturer applies to assessing its quality assurance system for the measuring devices concerned at a notified body of his choice.

name and address of the manufacturer and, if the application is submitted by the representative, his name and address;

a written statement that the same application has not been submitted to any other notified body;

all relevant information about the intended equipment category;

the documentation on the quality assurance system;

the technical documents referred to in C 2.

The quality assurance system ensures that the measuring instruments comply with the requirements of this Regulation.

quality objectives and organisational structure, responsibilities and powers of management in relation to product quality;

appropriate manufacturing, quality control and quality assurance techniques, applied procedures and planned systematic measures;

before, during and after production, investigations and tests, indicating their frequency;

quality records such as test reports, test and calibration data, as well as reports on the qualification of staff employed in this area;

The means to monitor the achievement of the intended product quality and the effective functioning of the quality assurance system.

The notified body assesses the quality assurance system to determine whether it meets the requirements set out in Z 5.2.

The manufacturer undertakes to meet the obligations of the approved quality assurance system and to ensure that it is always properly and efficiently kept.

The manufacturer informs the notified body which has approved the quality assurance system of all planned changes to the quality assurance system.

Monitoring under the responsibility of the notified body

Monitoring should ensure that the manufacturer complies with the obligations of the approved quality assurance system.

The manufacturer grants the notified body access to the production, purchase, testing and storage facilities and makes all necessary documentation available, in particular:

the documentation on the quality assurance system;

the technical documents in accordance with Z 2;

quality-related records such as test reports, test and calibration data, as well as reports on the qualification of employees in this area.

The notified body regularly carries out audits to ensure that the manufacturer maintains and applies the quality assurance system, and submits an audit report to it.

In addition, the notified body may carry out unannounced visits to the manufacturer. During these visits, the notified body may, if necessary, carry out or carry out equipment tests to ensure the proper functioning of the quality assurance system. The notified body reports to the manufacturer a report on the visit and a review report in case of an examination.

Conformity marking and EU declaration of conformity

The manufacturer shall bring the CE marking, the additional metrology marking in accordance with this Regulation and under the responsibility of the body notified in Z 5.1.

The manufacturer makes a written EU declaration of conformity for each device model and, after placing the device on the market, it is ready for national authorities for ten years. From the EU declaration of conformity, it must be borne out of which device model it was issued.

The manufacturer will provide the following documents for a period of ten years from placing the device on the market for the national authorities:

the documents in accordance with Z 5.1;

the information concerning the change in accordance with Z 5.5 in its approved form;

the decisions and reports of the notified body in accordance with the CC 5.5, 6.3 and 6.4.

Each notified body shall inform its notifying authority of the authorisations of quality assurance systems that it has issued or withdrawn, and shall, at regular intervals or upon request, transmit to its notifying authority a list of all licences of quality assurance systems that it has refused, suspended or restricted to other types.

Representative

Conformity with the type of construction on the basis of quality assurance relating to the device is part of a conformity assessment procedure where the manufacturer meets the obligations set out in the Z 2 and 5 and declares its own responsibility that the measuring devices in question conform to the type of construction described in the EU model test certificate and meet the requirements of this Regulation.

Production

Quality assurance system

The manufacturer applies to assessing its quality assurance system for the measuring devices concerned at a notified body of his choice.

name and address of the manufacturer and, if the application is submitted by the representative, his name and address;

a written statement that the same application has not been submitted to any other notified body;

all relevant information about the intended equipment category;

the documentation on the quality assurance system;

the technical documentation on the approved design and a copy of the EU model test certificate.

The quality assurance system ensures that the measuring devices conform to the type described in the EU model test certificate and the requirements of this Regulation applicable to them.

quality objectives and organisational structure, responsibilities and powers of management in relation to product quality;

investigations and tests carried out after manufacture;

quality records such as test reports, test and calibration data, as well as reports on the qualification of staff employed in this area;

means to monitor the effective functioning of the quality assurance system.

The notified body assesses the quality assurance system to determine whether it meets the requirements set out in Z 3.2.

The manufacturer undertakes to meet the obligations of the approved quality assurance system and to ensure that it is always properly and efficiently kept.

The manufacturer informs the notified body which has approved the quality assurance system of all planned changes to the quality assurance system.

Monitoring under the responsibility of the notified body

Monitoring should ensure that the manufacturer complies with the obligations of the approved quality assurance system.

The manufacturer grants the notified body access to the production, purchase, testing and storage facilities and makes all necessary documentation available, in particular:

the documentation on the quality assurance system;

quality-related records such as test reports, test and calibration data, as well as reports on the qualification of employees in this area.

The notified body regularly carries out audits to ensure that the manufacturer maintains and applies the quality assurance system, and submits an audit report to it.

In addition, the notified body may carry out unannounced visits to the manufacturer. During these visits, the notified body may, if necessary, carry out or carry out equipment tests to ensure the proper functioning of the quality assurance system. The notified body reports to the manufacturer a report on the visit and a review report in case of an examination.

Conformity marking and EU declaration of conformity

The manufacturer shall bring the CE marking, the additional metrology marking required by this Regulation and under the responsibility of the body notified in Z 3.1, to each individual device that conforms to the type of construction described in the EU Model Testing Certificate and meets the applicable requirements of this Regulation.

The manufacturer makes a written EU declaration of conformity for each device model and, after placing the device on the market, it is ready for national authorities for ten years. From the EU declaration of conformity, it must be borne out of which device model it was issued.

The manufacturer will provide the following documents for a period of ten years from placing the device on the market for the national authorities:

the documents in accordance with Z 3.1;

the information concerning the change in accordance with Z 3.5 in its approved form;

the decisions and reports of the notified body in accordance with the C 3.5, 4.3 and 4.4.

Each notified body shall inform its notifying authority of the authorisations of quality assurance systems that it has issued or withdrawn, and shall, at regular intervals or upon request, transmit to its notifying authority a list of all licences of quality assurance systems that it has refused, suspended or restricted to other types.

Representative

The quality assurance of the withdrawal and testing of the equipment is the conformity assessment procedure in which the manufacturer meets the obligations set out in the Z 2, 4 and 7 and declares its own responsibility that the measuring devices concerned meet the requirements of this Regulation.

Technical documents

The manufacturer must keep the technical documentation available for the competent national authorities for ten years after placing the device on the market.

Production

Quality assurance system

The manufacturer applies to assessing its quality assurance system for the measuring devices concerned at a notified body of his choice.

name and address of the manufacturer and, if the application is submitted by the representative, his name and address;

a written statement that the same application has not been submitted to any other notified body;

all relevant information about the intended equipment category;

the documentation on the quality assurance system;

the technical documents referred to in C 2.

The quality assurance system ensures that the measuring instruments comply with the requirements of this Regulation.

quality objectives and organisational structure, responsibilities and powers of management in relation to product quality;

investigations and tests carried out after manufacture;

quality-related records such as test reports, test and calibration data as well as reports on the qualification of employees in this area;

means to monitor the effective functioning of the quality assurance system.

The notified body assesses the quality assurance system to determine whether it meets the requirements set out in Z 5.2.

The manufacturer undertakes to meet the obligations of the approved quality assurance system and to ensure that it is always properly and efficiently kept.

The manufacturer informs the notified body which has approved the quality assurance system of all planned changes to the quality assurance system.

Monitoring under the responsibility of the notified body

Monitoring should ensure that the manufacturer complies with the obligations of the approved quality assurance system.

The manufacturer grants the notified body access to the production, purchase, testing and storage facilities and makes all necessary documentation available, in particular:

the documentation on the quality assurance system;

the technical documents in accordance with Z 2;

quality-related records such as test reports, test and calibration data, as well as reports on the qualification of employees in this area.

The notified body regularly carries out audits to ensure that the manufacturer maintains and applies the quality assurance system, and submits an audit report to it.

In addition, the notified body may carry out unannounced visits to the manufacturer. During these visits, the notified body may, if necessary, carry out or carry out equipment tests to ensure the proper functioning of the quality assurance system. The notified body reports to the manufacturer a report on the visit and a review report in case of an examination.

Conformity marking and EU declaration of conformity

The manufacturer shall bring the CE marking, the additional metrology marking, in accordance with this Regulation and under the responsibility of the body notified in Z 5.1, to each measuring device that meets the relevant requirements of this Regulation.

The manufacturer makes a written EU declaration of conformity for each device model and, after placing the device on the market, it is ready for national authorities for ten years. From the EU declaration of conformity, it must be borne out of which device model it was issued.

The manufacturer will provide the following documents for a period of ten years from placing the device on the market for the national authorities:

the documents in accordance with Z 5.1,

the information concerning the change in accordance with Z 5.5 in its approved form;

the decisions and reports of the notified body in accordance with the CC 5.5, 6.3 and 6.4.

Each notified body shall inform its notifying authority of the authorisations of quality assurance systems that it has issued or withdrawn, and shall, at regular intervals or upon request, transmit to its notifying authority a list of all licences of quality assurance systems that it has refused, suspended or restricted to other types.

Representative

Conformity with the type of construction based on an examination of the products is part of a conformity assessment procedure where the manufacturer meets the obligations set out in the Z 2, 5.1 and 6 and declares on its own responsibility that the measuring devices subject to the provisions of Z 3 conform to the type described in the EU model test certificate and meet the requirements of this Regulation.

Production

Review

Verification of conformity by testing and testing every device

All measuring instruments are individually investigated and appropriate tests are carried out in accordance with the relevant harmonised standard/en and/or the normative documents and/or equivalent tests in accordance with other relevant technical specifications to verify their conformity with the approved type of construction as described in the EU model test certificate and the applicable requirements of this Regulation. In the absence of a harmonised standard or a normative document, the notified body will decide which tests will be carried out.

The notified body shall issue a certificate of conformity on the basis of these investigations and tests and, on each approved device, add its identification number to or transfer it under its responsibility. After placing the device on the market for ten years, the manufacturer is ready to accept the certificates of conformity.

Review of conformity with statistical means

The manufacturer shall take all necessary measures to ensure that the manufacturing process and its monitoring ensures the uniformity of all produced lots and submits its measuring instruments to be reviewed in uniform lots.

Each lot will be sampled according to Z 5.3. Each measuring device from a sample must be individually inspected and appropriate tests must be carried out in accordance with the relevant harmonised standard/en, and/or the normative document/documents and/or equivalent tests in accordance with other relevant technical specifications to ensure compliance with the type of construction described in the EU model test certificate and with the applicable requirements of this Regulation and to determine whether or not the batch is accepted. In the absence of such a harmonised standard or such a normative document, the notified body will decide on which tests will be carried out.

The statistical procedure must take into account the following points:

a normal quality level according to a 95% probability and a non-conformity rate of less than 1%;

a quality limit level according to a probability of 5% and a non-conformity rate of less than 7%.

If a lot is accepted, all measuring instruments of the Loses are considered to be approved, except the sample of depleted measuring devices with negative test results.

If a lot is rejected, the notified body shall take appropriate measures to prevent the lot being placed on the market. In case of frequent rejection of Losen, the notified body may suspend statistical control and take appropriate measures.

Conformity marking and EU declaration of conformity

The manufacturer shall bring the CE marking and the additional metrology marking required by this Regulation and, under the responsibility of the body notified in Z 3, the relevant specifications of this Regulation, the CE marking and the additional metrology marking required by this Regulation and, under the responsibility of the body notified in Z 3.

The manufacturer makes a written EU declaration of conformity for each device model and, after placing the device on the market, it is ready for national authorities for ten years. From the EU declaration of conformity, it must be borne out of which device model it was issued.

If the notified body votes, the manufacturer may, under the responsibility of this notified body, add the number of the notified body to the products during the manufacturing process.

Representative

Conformity on the basis of an examination of the products is the part of a conformity assessment procedure where the manufacturer meets the obligations set out in the Z 2, 3, 6.1 and 7 and declares, on its own responsibility, that the measuring devices subject to the provisions of C 4 satisfy the requirements of this Regulation.

Technical documents

Production

Review

Verification of conformity by testing and testing every device

All measuring instruments must be individually investigated and appropriate tests must be carried out in accordance with the relevant harmonised standards and/or normative documents, and/or equivalent tests according to other relevant technical specifications to ensure their conformity with the requirements applicable to them. In the absence of such a harmonised standard or such a normative document, the notified body will decide on which tests will be carried out.

The notified body shall issue a certificate of conformity on the basis of these investigations and tests and, on each approved device, add its identification number to or transfer it under its responsibility. The manufacturer maintains conformity certificates for the national authorities for ten years after placing the device on the market.

Review of conformity with statistical means

The manufacturer shall take all necessary measures to ensure that the manufacturing process ensures the uniformity of all produced lots and submits its measuring devices in uniform lots for verification.

Each lot will be sampled according to Z 6.4.

Each measuring device from a sample must be individually inspected and appropriate tests must be carried out in accordance with the relevant harmonised standards and/or normative documents and/or equivalent tests in accordance with other relevant technical specifications to ensure compliance with the applicable requirements of this Regulation and to determine whether the batch is accepted or rejected. In the absence of such a harmonised standard or such a normative document, the notified body will decide on which tests will be carried out.

The statistical procedure must take into account the following points:

a normal quality level according to a 95% probability and a non-conformity rate of less than 1%;

a quality limit level according to a probability of 5% and a non-conformity rate of less than 7%.

If a lot is accepted, all measuring instruments of the Loses are considered to be approved, except the sample of depleted measuring devices with negative test results.

Conformity marking and EU declaration of conformity

The manufacturer shall bring the CE marking and the additional metrology marking required by this Regulation to each measuring device corresponding to the applicable requirements of this Regulation and, under the responsibility of the body notified in Z 4, its identification number.

The manufacturer makes a written EU declaration of conformity for each device model and, after placing the device on the market, it is ready for national authorities for ten years. From the EU declaration of conformity, it must be borne out of which device model it was issued.

If the notified body votes, the manufacturer may, under the responsibility of this notified body, add the number of the notified body to the equipment during the manufacturing process.

Representative

Conformity based on a single test is the conformity assessment procedure by which the manufacturer meets the obligations set out in the Z 2, 3 and 5 and declares, on its own responsibility, that the measuring device subject to the provisions laid down in C 4 meets the requirements of this Regulation.

Technical documents

Production

Review

Conformity marking and EU declaration of conformity

The manufacturer shall bring the CE marking and the additional metrology marking required by the regulation and under the responsibility of the body notified in Z 4 of the above mentioned above.

The manufacturer makes a written EU declaration of conformity and maintains it for the national authorities for ten years after placing the device on the market. The Declaration of Conformity must indicate which device it has been issued.

Representative

Conformity based on a comprehensive quality assurance is the conformity assessment procedure with which the manufacturer meets the obligations set out in the Z 2 and 5 and declares its own responsibility that the measuring devices concerned meet the requirements of this Regulation.

Production

Quality assurance system

The manufacturer applies to assessing its quality assurance system for the measuring devices concerned at a notified body of his choice.

name and address of the manufacturer and, if the application is submitted by the representative, his name and address;

the technical documents described in § 14 for each type of measuring instrument to be produced, using these documents, it must be possible to assess the conformity of the device with the relevant requirements; they must include appropriate risk analysis and evaluation. The technical documentation must specify the applicable requirements and collect the design, manufacture and operation of the device as far as they are relevant for the evaluation.

the documentation on the quality system; and

a written statement that the same application has not been submitted to any other notified body.

The quality assurance system ensures that the measuring instruments comply with the requirements of this Regulation.

quality objectives as well as organisational structure, responsibilities and powers of management with regard to the quality of design and equipment;

technical design specifications, including the standards to be applied, and - if the relevant harmonised standards and/or normative documents are not fully applied - the means to ensure that the essential requirements of this Regulation applicable to the measuring instruments are met using other relevant technical specifications;

techniques to control the development and examination of the development results, procedures and systematic measures used in the development of the measuring devices belonging to the category concerned;

appropriate manufacturing, quality control and quality assurance techniques, applied procedures and planned systematic measures;

before, during and after production, investigations and tests, indicating their frequency;

quality records such as test reports, test and calibration data, as well as reports on the qualification of staff employed in this area;

means to monitor the achievement of the required quality of the design and device and the effective functioning of the quality assurance system.

The notified body assesses the quality assurance system to determine whether it meets the requirements set out in Z 3.2.

The manufacturer undertakes to meet the obligations of the approved quality assurance system and to ensure that it is always properly and efficiently kept.

The manufacturer informs the notified body which has approved the quality assurance system of all planned changes to the quality assurance system.

Monitoring under the responsibility of the notified body

Monitoring should ensure that the manufacturer complies with the obligations of the approved quality assurance system.

The manufacturer grants the notified body access to the development, production, purchase, testing and storage facilities and makes all necessary documentation available, in particular:

the documentation on the quality assurance system;

the quality-related records provided for in the development-related part of the quality assurance system, such as results of analyses, calculations, tests;

the quality-related records provided for in the production-related part of the quality assurance system, such as test reports, test and calibration data, as well as reports on the qualification of employees employed in this area.

The notified body regularly carries out audits to ensure that the manufacturer maintains and applies the quality assurance system and sends a corresponding audit report.

In addition, the notified body may carry out unannounced visits to the manufacturer. During these visits, the notified body may, if necessary, carry out tests on devices to ensure the proper functioning of the quality assurance system. The notified body reports to the manufacturer a report on the visit and a review report in case of an examination.

Conformity marking and EU declaration of conformity

The manufacturer shall bring the CE marking, the additional metrology marking in accordance with this Regulation and under the responsibility of the body notified in Z 3.1.

The manufacturer makes a written EU declaration of conformity for each device model and, after placing the device on the market, it is ready for national authorities for ten years. From the EU declaration of conformity, it must be borne out of which device model it was issued.

The manufacturer will provide the following documents for a period of ten years from placing the device on the market for the national authorities:

the technical documents referred to in Z 3.1;

the documentation on the quality assurance system in accordance with Z 3.1;

the information concerning the change in accordance with Z 3.5 in its approved form;

the decisions and reports of the notified body in accordance with the C 3.5, 4.3 and 4.4.

Each notified body shall inform its notifying authority of the authorisations of quality assurance systems that it has issued or withdrawn, and shall, at regular intervals or upon request, transmit to its notifying authority a list of all licences of quality assurance systems that it has refused, suspended or restricted to other types.

Representative

Conformity based on a comprehensive quality assurance with design testing is the conformity assessment procedure in which the manufacturer meets the obligations set out in the Z 2 and 6 and declares its own responsibility that the measuring devices concerned meet the requirements of the Regulation.

Production

Quality assurance system

The manufacturer applies to assessing its quality assurance system for the measuring devices concerned at a notified body of his choice.

name and address of the manufacturer and, if the application is submitted by the representative, his name and address;

all relevant information about the intended equipment category;

the documentation on the quality assurance system;

a written statement that the same application has not been submitted to any other notified body.

The quality assurance system ensures that the measuring instruments comply with the requirements of this Regulation.

quality objectives as well as organisational structure, responsibilities and powers of management with regard to the quality of design and equipment;

technical design specifications, including the standards to be applied, and - if the relevant harmonised standards and/or normative documents are not fully applied - the means to ensure that the essential requirements of this Regulation applicable to the measuring instruments are met using other relevant technical specifications;

techniques to control the development and examination of the development results, procedures and systematic measures used in the development of the measuring devices belonging to the category concerned;

appropriate manufacturing, quality control and quality assurance techniques, applied procedures and planned systematic measures;

before, during and after production, investigations and tests, indicating their frequency;

quality records such as test reports, test and calibration data, as well as reports on the qualification of staff employed in this area;

means to monitor the achievement of the required quality of the design and device and the effective functioning of the quality assurance system.

The notified body assesses the quality assurance system to determine whether it meets the requirements set out in Z 3.2. Each component of the quality assurance system, which meets the corresponding specifications of the relevant harmonised standard, is subject to compliance with these requirements.

The manufacturer undertakes to meet the obligations of the approved quality assurance system and to ensure that it is always properly and efficiently kept.

The manufacturer informs the notified body which has approved the quality assurance system of all planned changes to the quality assurance system.

Each notified body shall inform its notifying authority of the authorisations of quality assurance systems that it has issued or withdrawn, and shall, at regular intervals or upon request, transmit to its notifying authority a list of all licences of quality assurance systems that it has refused, suspended or restricted to other types.

Drafting

The manufacturer applied for the examination of the draft at the body notified in Z 3.1.

The application provides information on the design, manufacture and functioning of the device and allows an assessment of compliance with the applicable requirements of the Regulation.

Name and address of the manufacturer;

a written statement that the same application has not been submitted to any other notified body;

the technical documents described in § 14. Based on these documents, it must be possible to assess the conformity of the device with the relevant requirements; they must include appropriate risk analysis and evaluation. They cover the design and operation of the device as far as they are relevant for the evaluation.

the additional evidence for an appropriate solution by the technical design. These additional evidence contain a reference to all documents which have been used, in particular when the relevant harmonised standards and/or normative documents have not been fully applied, and, where appropriate, include the results of tests carried out in a suitable laboratory of the manufacturer or in his behalf and under his responsibility in another laboratory.

The notified body shall examine the application and issue an EU power test certificate to the manufacturer if the design meets the requirements of this Regulation applicable to the device. This certificate contains the name and address of the manufacturer, the results of the tests, any conditions for their validity and the necessary data for the identification of the approved design. This certificate may be accompanied by one or more annexes.

the metrological characteristics of the draft device;

the necessary measures to ensure the integrity of the devices (monitoring, identification of the software, etc.);

other information necessary to identify the device and to monitor its external conformity with the design;

any other specific information necessary to verify the characteristics of the equipment manufactured;

in the case of a partial device, all necessary information to ensure compatibility with other parts or measuring devices.

The notified body is constantly informed of all changes in the generally accepted state of technology; If these indicate that the approved design no longer complies with the applicable requirements of this Regulation, it decides whether such changes require further investigation. If this is the case, the notified body shall inform the manufacturer of it.

Each notified body shall inform its notifying authority of the EU's design tests certificates and/or any additions it has issued or withdrawn and, at regular intervals or upon request, send a list of all certificates and/or additions to which it has refused, suspended or restricted to any other type.

The manufacturer holds a copy of the EU design test certificate, its annexes and additions together with the technical documentation after placing the device for ten years.

Monitoring under the responsibility of the notified body

Monitoring should ensure that the manufacturer complies with the obligations of the approved quality assurance system.

The manufacturer grants the notified body access to the development, production, purchase, testing and storage facilities and makes all necessary documentation available, in particular:

the documentation on the quality assurance system;

quality-related records, such as results of analyses, calculations, tests, etc.;

quality-related records, such as test reports, test and calibration data, as well as reports on the qualifications of employees in this area, etc.

The notified body regularly carries out audits to ensure that the manufacturer maintains and applies the quality assurance system, and submits an audit report to it.

In addition, the notified body may carry out unannounced visits to the manufacturer. During these visits, the notified body may, if necessary, carry out tests on devices to ensure the proper functioning of the quality assurance system. The notified body reports to the manufacturer a report on the visit and a review report in case of an examination.

Conformity marking and EU declaration of conformity

The manufacturer shall bring the CE marking, the additional metrology marking in accordance with this Regulation and under the responsibility of the body notified in Z 3.1.

The manufacturer makes a written EU declaration of conformity for each device model and, after placing the device on the market, it is ready for national authorities for ten years. In the EU declaration of conformity, it must be specified for which device model it has been issued; The number of draft tests must also be added.

The manufacturer will provide the following documents for a period of ten years from placing the device on the market for the national authorities:

the documentation on the quality assurance system in accordance with Z 3.1;

the information concerning the change in accordance with Z 3.5 in its approved form;

the decisions and reports of the notified body in accordance with the C 3.5, 5.3 and 5.4.

Representative

Device model/equipment (product, type, batch or serial number):

Name and address of the manufacturer and, where appropriate, its representative:

The sole responsibility for the issue of this declaration of conformity is for the manufacturer.

The purpose of the statement (signment of the device for traceability; it may contain an image if necessary to identify the device):

The subject-matter of the declaration described above meets the relevant Union harmonisation legislation:

An indication of the relevant harmonised standards or normative documents which have been used or of the other normative documents or other technical specifications for which conformity is declared:

(if applicable:) The notified body (name, number) ... (description of its activity) ... and the following certificate:

Additional information:

the measuring instruments

no EC initial verification under Directive 2009/34/EC on common rules on measuring instruments and on measuring and testing procedures, OJ No L 106 of 28.04.2009 S. 7;

no CE marking on the basis of Directive 2014/31/EU on the approximation of the laws of the Member States relating to the provision of non-automatic balances on the market (recast), OJ No L 96 of 29/08/4 S. 107, may be obtained and not fall within the scope of this Directive;

not to obtain a CE marking on the basis of Directive 2014/32/EU on the harmonisation of the laws of the Member States relating to the provision of measuring instruments on the market (recast), OJ No L 96 of 29/08/4 S. 149, and not falling within the scope of this Directive; “