2016 Meter Regulation And Amendment Of The Regulation On Mutual Recognition In The Field Of Measurement And Calibration System, Dispensing Vascular Regulation, The Calibration Accreditation Regulation And...

Original Language Title: Messgeräteverordnung 2016 und Änderung der Verordnung über die gegenseitige Anerkennung auf dem Gebiet des Maß- und Eichwesens, der Schankgefäßeverordnung, der Eich-Zulassungsverordnung und der ...

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31. Regulation of the Federal Minister for Science, Research and Economy, which is to adopt a Regulation on measuring instruments (Measuring Equipment Regulation 2016) and the Regulation on mutual recognition in the field of measurement and calibration, which Rules on the purchase of vessels, the calibration authorisation regulation and the regulation on the recognition of verification of oak tests.

Table of Contents

Article 1

Measuring Equipment Regulation 2016

Article 2

Amendment of the Regulation on Mutual Recognition in the field of measurement and calibration

Article 3

Changing the Schankvascular Order

Article 4

Amendment of the calibration approval decree

Article 5

Amendment of the Regulation on the Recognition of Oak tests

Article 1

Regulation of the Federal Minister for Science, Research and the Economy on Measuring Instruments (Measuring Equipment Ordinance 2016)

On the basis of § 18 Z 4 of the Measure and Verification Act (MEG), BGBl. No 152/1950, as last amended by the Federal Law BGBl.  I No 148/2015 shall be prescribed:

Scope

§ 1. (1) This Regulation lays down the requirements for the first-time placing on the market and/or for the initial entry into service of the measuring instruments listed below for the first time Measurement tasks must be complied with, provided they are subject to the calibration obligation:

1.

Water meters designed for volume measurement of clean cold water or hot water;

2.

Gas meter and quantity conversion;

3.

Power meter for power consumption;

4.

Heat meter;

5.

Measuring systems for the continuous and dynamic measurement of quantities of liquids other than Water;

6.

Self-acting scales;

7.

Taxameter;

8.

Measure embodied (embodied length dimensions and dimensions);

9.

Measuring devices for measurement of lengths and their combinations.

(2) If the conformity of a measuring instrument within the scope of this Regulation is established, these measuring instruments shall be deemed to be the first and shall be used within the scope of the provisions of the measure and calibration law and/or ready.

§ 2. The measuring instruments according to § 1 (1) are subject to the requirements of the electromagnetic interference immunity within the meaning of Article 2 (3) of Directive 2014 /30/EU on the harmonisation of the Legislation of the Member States relating to electromagnetic compatibility (recast), OJ L 327, 28. No.  OJ L 96, 29.03.2014 p. 79

Definitions

§ 3. For the purposes of this Regulation, the term:

1.

"Measuring Device": any device or system with a measurement function referred to in Section 1 (1);

2.

"Subdevice": an assembly called as such in the calibration rules, belonging to a Measuring device according to § 1 (1), which works independently and

a)

together with other devices that it is compatible with, or

)

together with a measuring device that is compatible with it

is a meter;

3.

"Legal metrological control": the control of the scope of the application Measuring equipment for reasons of public interest, public health, public safety and order, environmental protection, the levying of taxes and charges, consumer protection and fair trade Measurement tasks;

4.

"Normative Document": a document with technical specifications that is provided by the International Organization for the legal metrology (OIML);

5.

"Providing on the market": any delivery of a meter to the market for payment or free of charge. Distribution or use on the Union market in the context of a business activity;

6.

"Placing on the market": the first-time provision of a measuring device on the Union market;

7.

"Start-up": the first use of a meter for the end user for the intended purpose;

8.

"Manufacturer": any natural or legal person who makes a measuring instrument or develop or manufacture the measuring instrument under its own name or trademark, or put it into service for its own purposes;

9.

"Plenipotentiary": any natural or legal entity established in the European Union A person who has been instructed in writing by a manufacturer to carry out certain tasks on his behalf;

10.

"importer": any natural or legal person resident in the European Union who Placing a measuring instrument from a third country on the Union market;

11.

"Dealer": any natural or legal person in the supply chain who is a meter on the market, with the exception of the manufacturer or the importer;

12.

"Economic agents": the manufacturer, the authorized agent, the importer, and the dealer;

13.

"Technical Specification": a document in which the technical requirements are required , to which a measuring instrument must be sufficient;

14.

"harmonized standard": a harmonised standard within the meaning of Article 2 (1) lit.  (c) of Regulation (EU) No 1025/2012 on European standardisation, amending Council Directives 89 /686/EEC and 93 /15/EEC and Directives 94 /9/EC, 94 /25/EC, 95 /16/EC, 97 /23/EC, 98 /34/EC, 2004 /22/EC, 2007 /23/EC, 2009 /23/EC and 2009 /105/EC of the European Parliament and Council and repealing Council Decision 87 /95/EEC and Decision No 1673 /2006/EC of the European Parliament and of the Council, OJ L 136, 31.5.2002, p. No.  OJ L 316, 14.11.2012 p. 12;

15.

"Accreditation": an accreditation within the meaning of Art. 2 Z 10 of 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 L 327, 31.12.1993, p. No.  OJ L 218, 13.08.2008 p. 30;

16.

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

17.

"Conformity Assessment": the procedure for evaluating whether the essential requirements of these Regulation to a measuring instrument has been fulfilled;

18.

"Conformance assessment body": a body that has conformity assessment activities including calibrations, audits, certifications, and inspections;

19.

"Call back": any measure that already has the effect of returning one of the end-user ,

20.

"Withdrawal": any measure to prevent a supply chain from being used measuring device is provided on the market;

21.

"Union Harmonization Law": European Union legislation on Harmonisation of the conditions for the marketing of products;

22.

"CE Marking": Marking by which the manufacturer declares that the measuring device is the shall comply with the requirements laid down in harmonisation legislation of the European Union concerning its affixing.

Applicability of the Provisions to Subdevices

§ 4. Where essential requirements for subdevices are laid down in the oak regulations of the Federal Office of Eich-und Vermessungswesen, hereinafter referred to as "calibration regulations", the following shall apply: the provisions of this Regulation relating to such sub-devices. Subdevices and measuring instruments can be evaluated independently and separately for the purpose of determining conformity.

Essential Requirements

§ 5. (1) A gauge must meet the essential requirements set out in Annex 1 and meet the requirements of the corresponding calibration requirements.

(2) The information provided for in Annex 1 and in the calibration rules shall be provided in German.

(3) The conformity of a measuring instrument with the essential requirements shall be assessed in accordance with § 13.

Obligations of manufacturers

§ 6. (1) Manufacturers shall ensure that measuring instruments which they place on the market and/or put into service and are to be used within the scope of the provisions of the MEG, in accordance with the have been designed and manufactured in accordance with the essential requirements of Annex 1 and the corresponding calibration requirements.

(2) The manufacturers shall draw up the technical documentation in accordance with § 14 and carry out the relevant conformity assessment procedure in accordance with § 13, or have it carried out. Where this conformity assessment procedure has demonstrated that a measuring instrument complies with the applicable requirements of this Regulation and the calibration requirements, the manufacturers shall draw up an EU declaration of conformity and bring the CE marking as well as the additional metrology marking according to § 16.

(3) Manufacturers shall keep the technical documentation and the EU declaration of conformity after the measuring instrument has been placed on the market for a period of ten years.

(4) Manufacturers shall ensure, by means of appropriate procedures, that conformity with this Regulation is always ensured in the case of series production. Changes to the design of the measuring instrument or its characteristics, as well as modifications to the harmonised standards, normative documents or other technical specifications referred to in the declaration of conformity of a measuring instrument, shall be subject to the following: shall be taken into account.

(5) In the event that this is considered to be appropriate with regard to the performance of a measuring instrument, manufacturers shall take samples of measuring instruments available on the market, carry out tests and, if necessary, carry out tests a list of complaints, non-compliant measuring instruments and the recalls of measuring instruments, and keep distributors informed of this monitoring.

(6) Manufacturers shall ensure that measuring instruments which they have placed on the market carry a type, batch or serial number or other identification mark for their identification, or, if this is due to the size of the measuring instruments, or the nature of the measuring instrument, it is not possible to provide the necessary information in the documents accompanying the measuring instrument and, where appropriate, on the packaging in accordance with Annex 1 Z 9.2.

(7) Manufacturers shall indicate on the measuring instrument their name, registered trade name or registered trade mark and the postal address under which they can be reached, or, where this is not possible, in the documents attached to the measuring instrument and, where appropriate, on the packaging referred to in Annex 1, Z. 9.2. The address refers to a one-stop shop where the manufacturer can be reached. The contact details are to be stated in German.

(8) Manufacturers shall ensure that the measuring instrument placed on the market is accompanied by a copy of the EU declaration of conformity, the operating instructions and the information referred to in Annex 1, Z 9.3, which shall be published in the of the German language. These operating instructions and information, as well as all markings, must be clear, understandable and clear.

(9) Manufacturers who are of the opinion or have reason to believe that a measuring instrument placed on the market is not in conformity with the requirements of this Regulation or the calibration requirements shall be taken without delay the corrective measures necessary to ensure the conformity of this measuring instrument or, where appropriate, to withdraw it or recall it. In addition, where risks are associated with the measuring device, manufacturers shall immediately inform the competent national authorities of the Member States of the European Union in which they have provided the measuring instrument on the market, and detailed information, in particular on the non-compliance and the corrective measures taken. As the competent authorities in Austria, the Federal Ministry of Science, Research and the Economy and the calibration authorities are to be informed.

(10) The manufacturers shall provide the Federal Minister of Science, Research and the Economy and the Verification Authorities with all the information and documents required for the proof of conformity of the Measuring instruments with this Regulation are required, in paper form or by electronic means in German. They shall cooperate with those authorities, at their request, in all measures to prevent risks associated with measuring instruments which have placed them on the market.

Authorized

§ 7. (1) A manufacturer may nominate an authorised representative in writing. The obligations pursuant to § 6 (1) and the obligation to draw up the technical documentation pursuant to § 6 (2) are not part of the mandate of an authorized representative.

(2) An authorized representative shall carry out the tasks defined on behalf of the manufacturer. The contract shall allow the authorised representative to carry out at least the following tasks:

a)

The EU declaration of conformity and the technical documentation for the national Market surveillance authorities for a period of ten years from the date of placing the measuring instrument on the market;

)

On a well-founded request from a competent national authority, issue all information and documents required to demonstrate the conformity of a measuring instrument to that authority;

)

at the request of the competent national authorities to cooperate in all actions for waste management of the risks associated with measuring devices that are part of their role.

Obligations of the importer

§ 8. (1) The importer only has to place conformable measuring instruments on the market.

(2) Before placing a measuring instrument on the market and/or putting it into service, the importer shall ensure that the conformity assessment procedure referred to in § 13 has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the measuring instrument is marked with the CE marking and the additional metrology marking, that the EU declaration of conformity and the necessary information are required. The manufacturer has complied with the requirements of Section 6 (6) and (7).

(3) If a importer considers or has reason to believe that a measuring instrument does not meet the essential requirements of Annex 1 and the calibration requirements, it shall not place this meter on the market until the end of the period of time. or put into service when the measuring instrument is in conformity. If a risk is associated with the measuring instrument, the importer shall inform the manufacturer and the Federal Ministry of Science, Research and the Economy as well as the calibration authorities thereof.

(4) The importer shall indicate on the measuring instrument its name, its registered trade name or registered trade mark and the postal address to which it may be contacted, or, if this is not possible, in the documents attached to the measuring instrument and, where appropriate, on the packaging referred to in Annex 1, Z. 9.2. The contact details are to be installed in German.

(5) The importer shall ensure that the measuring instrument is accompanied by the operating instructions and the information referred to in Annex 1, Z 9.3, in German.

(6) As long as a measuring instrument is in its responsibility, the importer shall ensure that the conditions of its storage or transport are in accordance with the essential requirements of Annex 1 and of the calibration rules.

(7) In the event that this is considered to be appropriate with regard to the performance of a measuring instrument, the importer shall take samples of measuring instruments provided on the market, carry out tests and, if necessary, carry out tests a list of complaints, non-compliant measuring instruments and the recalls of measuring instruments, and keep distributors informed of this monitoring.

(8) A importer who considers or has reason to believe that a measuring instrument placed on the market is not in conformity with the requirements of this Regulation shall immediately take the necessary measures to ensure that: Corrective measures to establish the conformity of this measuring instrument or to withdraw it or recall it if necessary. In addition, in cases where risks are associated with the measuring device, the importer shall immediately inform the competent national authorities of the Member States of the European Union in which they have provided the measuring instrument on the market, and detailed information, in particular on the non-compliance and the corrective measures taken. As the competent authorities in Austria, the Federal Ministry of Science, Research and the Economy and the calibration authorities are to be informed.

(9) After placing the measuring instrument on the market, the importer shall keep a copy of the EU declaration of conformity to the market surveillance authorities for a period of ten years and shall ensure that they are accompanied by the technical documentation on request.

(10) The importer shall provide the Federal Minister of Science, Research and the Economy and the Verification Authorities with all the information and documents required for the proof of conformity of the Measuring instruments with this Regulation are required, in paper form or by electronic means in German. They shall cooperate with those authorities, at their request, in all measures to prevent risks associated with measuring instruments which have placed them on the market.

Obligations of traders

§ 9. (1) The dealers shall take into account the requirements of this Regulation and the calibration rules with due diligence if they provide a measuring instrument on the market and/or in Operation.

(2) Before they provide and/or operate a measuring instrument on the market, dealers shall verify that the measuring instrument is marked with the CE marking and the additional metrology marking, whether the measuring instrument is fitted with the CE marking and the additional metrology marking. EU declaration of conformity, the required documents and instructions and the other information in German language listed in Annex 1, Z 9.3, and whether the manufacturer and the importer meet the requirements of § 6 (6) and (7) and in accordance with Section 8 (4).

(3) If a trader is of the opinion or has reason to believe that a measuring instrument does not comply with the essential requirements of Annex 1 and the corresponding calibration requirements, he shall make this measuring instrument is only available on the market or does not take it into service until its conformity is established. If a risk is associated with the measuring instrument, the dealer also informs the manufacturer or the importer, as well as the Federal Ministry of Science, Research and Economy, as well as the calibration authorities.

(4) As long as a measuring instrument is in its responsibility, dealers shall ensure that the conditions of its storage or transport are in accordance with the essential requirements of Annex 1 and of the Do not interfere with the calibration rules.

(5) Traders who are of the opinion or have reason to believe that a measuring instrument supplied or put into service on the market is not in conformity with this Regulation or the calibration requirements; ensure that the necessary corrective measures are taken to ensure the conformity of this measuring instrument, to withdraw it if necessary or to recall it. In addition, if risks are associated with the measuring device, dealers shall immediately inform the competent national authorities of the Member States of the European Union in which they have provided the measuring instrument on the market, and detailed information, in particular on the non-compliance and the corrective measures taken. As the competent authorities in Austria, the Federal Ministry of Science, Research and the Economy and the calibration authorities are to be informed.

(6) The dealers shall provide the Federal Minister of Science, Research and the Economy and the Verification Authorities with all the information and documents necessary for the proof of conformity of a Measuring equipment is required, in paper form or by electronic means. They shall cooperate with those authorities at their request for any risk-taking measures associated with products that they have provided on the market.

Circumstances in which the manufacturer's obligations are also applicable to importer and trader

§ 10. A importer or distributor shall be deemed to be a manufacturer for the purposes of this Regulation and shall be subject to the obligations of a manufacturer in accordance with § 6, if he/she is a measuring instrument under his own name or its own trade mark, or modifies a measuring instrument already on the market in such a way that conformity with this Regulation or the calibration rules may be affected.

Identification of economic operators

§ 11. (1) The economic actors call the Federal Ministry of Science, Research and Economy and the calibration authorities at the request of the economic operators,

a)

of which they have purchased a meter;

)

to which they have delivered a meter.

(2) The economic operators must be able to provide the information according to paragraph 1 10 years from the point of reference of the measuring instrument as well as ten years from the date of submission of the measuring instrument.

Compliance of measuring devices

§ 12. (1) Compliance with harmonized standards or parts of which the references have been published in the Official Journal of the European Union shall be subject to conformity with the essential requirements set out in Annex 1 and the corresponding calibration requirements covered by the relevant standards or parts thereof.

(2) In the case of measuring instruments which are in conformity with parts of normative documents the list of which has been published in the Official Journal of the European Union, conformity with the essential requirements shall be met in accordance with Annex 1 and the corresponding calibration rules covered by these parts of the normative documents.

(3) A manufacturer may opt for a technical solution which complies with the essential requirements set out in Annex 1 and the corresponding calibration requirements. In addition, in order to benefit from the presumption of conformity, it must correctly apply solutions which are listed in either the relevant harmonised standards or in the normative documents referred to in paragraphs 1 and 2.

(4) It is possible to assume compliance with the respective test requirements in accordance with § 14 (3) Z 9 if the relevant test programme has been carried out in accordance with the relevant documents referred to in paragraphs 1 to 3 above and the test results ensure compliance with the essential requirements.

Conformity Assessment Procedures

§ 13. (1) The assessment of the conformity of a measuring instrument with the appropriate requirements in accordance with § 5 shall be carried out in accordance with a conformity assessment procedure to be selected by the manufacturer, which shall be used in the following: Annex 2.

(2) If a body notified in accordance with section 18 becomes active, records and correspondence relating to the conformity assessment procedures carried out shall be either in German or in another one from that point of view. to write a recognized language.

Technical documentation

§ 14. (1) The technical documentation shall indicate the design, manufacture and operation of the measuring instrument and the assessment of its conformity with the relevant Enable the requirements of this Regulation.

(2) The technical documentation must be sufficiently detailed to meet the requirements for the following:

1.

Description of metrology features;

2.

Reproducibility of the metrological performance of the measurement devices manufactured when they are appropriate means are properly adjusted for this purpose;

3.

The integrity of the meter.

(3) Where this is relevant for the evaluation and identification of the equipment type and/or the measuring instrument, the technical documentation shall contain, in addition to the content referred to in paragraph 2, the following:

1.

a general description of the meter;

2.

Drafts, manufacturing drawings and plans of components, assemblies, circuits, etc.;

3.

Description of manufacturing techniques that ensure consistent production ;

4.

If necessary, a description of the electronic components with drawings, diagrams, Logic flow diagrams and general information about the software with an explanation of its characteristics and how it works;

5.

Descriptions and explanations required to understand the Z 2 through Z 4 including the mode of operation of the measuring instrument;

6.

a list of harmonized standards referred to in § 12, all or part of the harmonised standards, and/or Normative documents whose references have been published in the Official Journal of the European Union;

7.

a description of the selected requirements of this Regulation to meet the essential requirements of this Regulation. solutions where the harmonized standards and/or normative documents referred to in § 12 have not been applied, including a list of other relevant technical specifications;

8.

the results of design calculations, checks, and so on;

9.

If necessary, appropriate test results that provide proof that the Construction patterns and/or measuring instruments

a)

under the specified nominal operating conditions and under predetermined environmental conditions meet the requirements of this Regulation;

)

the specifications for the resistance of gas, water, and water, as defined in the calibration rules. and heat meters, as well as measuring systems for liquids other than water;

10.

EU design or EU design audit certificates for measuring devices that contain parts that that are identical to the design.

(4) The manufacturer must indicate where seals and markings are to be made.

(5) The manufacturer shall specify the conditions applicable to compatibility with interfaces and subdevices.

EU Declaration of Conformity

§ 15. (1) The EU declaration of conformity states that compliance with the essential requirements set out in Annex 1 and the corresponding calibration requirements has been demonstrated.

(2) The EU declaration of conformity corresponds in its structure to the specimen in Annex 4, contains the elements specified in the relevant modules in Annex 3 and shall be kept up to date. The manufacturer may, on a voluntary basis, allocate a number to the declaration of conformity. It is to be written in German language if the measuring instrument is placed on the market or provided in Austria.

(3) A measuring instrument is subject to several European Union legislative acts, each of which requires an EU declaration of conformity, only one EU declaration of conformity shall be drawn up for all acts of the European Union European Union. This declaration shall state the acts of the European Union concerned, together with its reference, in the Official Journal of the European Union.

(4) With the exhibition of the EU Declaration of Conformity, the manufacturer shall assume responsibility for ensuring that the measuring instrument meets the requirements of this Regulation.

Conformity Marking

§ 16. (1) The conformity of a measuring instrument with the provisions of this Regulation shall be determined by the "CE" marking in accordance with para. 2 and the additional metrology marking in accordance with paragraph 3 on the Meter specified.

(2) The CE marking shall be governed by the general principles laid down in Article 30 in conjunction with Annex II to Regulation (EC) No 765/2008.

(3) The additional metrology marking shall consist of the letter "M" and the last two digits of the year in which the marking was affixed, framed by a rectangle. The height of the rectangle corresponds to the height of the CE marking.

(4) The additional metrology marking shall be governed by the general principles laid down in Article 30 of Regulation (EC) No 765/2008.

Affixing the CE marking and the additional metrology marking

§ 17. (1) The CE marking and the additional metrology marking shall be displayed in a legible, legible and permanent way on the measuring instrument or its data plaque. If the type of measuring instrument does not permit or does not justify it, it shall be affixed to the accompanying documents and, where appropriate, to the packaging.

(2) If a measuring instrument consists of a series of cooperating devices which are not part-devices, the CE marking and the additional metrology marking shall be affixed to the main device.

(3) The CE marking and the additional metrology marking shall be affixed prior to placing the measuring instrument on the market.

(4) The CE marking and the additional metrology marking may be affixed to the device during manufacture, if justified.

(5) The additional metrology marking is immediately behind the CE mark. The identification number of the notified body shall be behind the CE marking and the additional metrology marking, if this body has been involved in the production control referred to in Annex 3.

(6) The identification number of the notified body must be affixed either by the body itself or by its instructions by the manufacturer or his authorised representative.

(7) The identification number of the competent notified body must be affixed permanently or in such a way that it cannot be removed undamaged.

(8) Behind the CE marking, the additional metrology marking and, where applicable, the identification number of the notified body, may be another sign which may be of particular risk or use

Notification

§ 18. (1) The notification of positions shall be made by the procedure in accordance with § § 18a to 18d MEG.

(2) The identification number issued by the European Commission to the notified body shall be used by the notified body for all activities carried out under this Regulation.

Requirements for notified bodies

§ 19. (1) A conformity assessment body has to comply with the requirements of para. 2 to 15 for the purposes of the notification.

(2) Any legal person or registered partnership may be notified as a conformity assessment body in compliance with the conditions laid down in this Regulation.

(3) A conformity assessment body must be an independent third party who is not connected to the device or the measuring instrument which it assesses. A body belonging to a trade association or professional association and assesses the measuring instruments whose design, manufacture, supply, assembly, use or maintenance are involved in companies represented by that association, on the condition that their independence and the absence of any conflicts of interest have been proved to be such an independent third party.

(4) A conformity assessment body, its top management level and the staff responsible for compliance with conformity assessment tasks.

1.

not designer, manufacturer, supplier, installer, buyer, owner, user, or Maintenance operation of the measuring instruments or representatives of one of these parties to be evaluated. This does not preclude the use of measuring instruments already subjected to conformity assessment, which are necessary for the activities of the conformity assessment body, or the use of such measuring instruments for personal use.

2.

neither directly related to design, manufacture, or construction, marketing, installation, use, or maintenance of these measuring instruments, or of the parties involved in these activities. They shall not deal with activities which could affect their independence in the assessment or their integrity in relation to the conformity assessment measures for which they are notified. This is especially true for consulting services.

The possibility of exchange of technical information between the manufacturer and the conformity assessment body is not excluded in any way.

(5) The conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not respect the confidentiality, objectivity or impartiality of their conformity assessment activities

(6) The conformity assessment bodies and their staff have the conformity assessment activities with the greatest possible degree of professionalism and the professional competence required in the area concerned. , they shall not be subject to any form of influence, in particular of a financial nature, which could have an impact on their assessment or the results of their conformity assessment work, and in particular by persons or groups of persons , which have an interest in the outcome of these activities.

(7) A conformity assessment body must be in a position to perform all conformity assessment tasks which it is entitled to, in accordance with Annex 3 and for which it has been notified, whether those tasks are carried out by: the place itself, on its behalf, or under its responsibility.

(8) A conformity assessment body shall, at any time, have the following information for each conformity assessment procedure and for each type and category of measuring equipment for which it has been notified:

1.

The required staff with expertise and sufficient experience to complete the to perform the tasks of conformity assessment;

2.

Descriptions of procedures according to which the conformity assessment is performed in order to to ensure transparency and the repeatability of these procedures. It shall have adequate instruments and appropriate procedures to distinguish between the tasks which it takes as a notified body and other activities;

3.

Procedure for performing activities with due regard to the size of a Company, the industry 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 series production.

(9) A conformity assessment body must have the necessary means to carry out the technical and administrative tasks involved in conformity assessment and access to all required equipment or facilities.

(10) The staff responsible for carrying out the tasks of conformity assessment must have:

1.

A solid technical and vocational training system that provides all the activities for conformity assessment in the Area for which the conformity assessment body has been notified;

2.

a sufficient knowledge of the requirements associated with the assessments to be performed and the appropriate power to carry out such assessments;

3.

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

4.

The ability to create certificates, logs, and reports as evidence of Assessments carried out.

(11) The impartiality of the conformity assessment bodies, their highest levels of management and the staff responsible for the performance of conformity assessment tasks shall be guaranteed.

(12) The remuneration of the highest level of management and the staff responsible for the performance of conformity assessment tasks shall not be based on the number of assessments carried out or the results of such assessments. .

(13) The conformity assessment body shall take out liability insurance provided that the liability is not taken over by the Republic of Austria.

(14) Information obtained by the staff of a conformity assessment body in the performance of its tasks in accordance with Annex 3 under this Regulation shall be subject to professional secrecy except in relation to: the competent authorities of the Member State of the European Union in which they carry out their activities. Property rights are protected.

(15) The conformity assessment bodies shall participate in the relevant standardisation activities and the activities of the coordination group of notified bodies within the framework of the relevant standardisation activities and activities of the coordination group. European Union harmonisation legislation has been set up, or has to ensure that the staff responsible for compliance with the conformity assessment tasks are informed, and shall apply the information provided by that group developed administrative decisions and documents as general guidelines.

Conformance presumption in notified bodies

§ 20. A conformity assessment body shall comply with the criteria of the relevant harmonised standards or parts thereof, the references of which shall be published in the Official Journal of the European Communities. Union may be presumed to comply with the requirements of § 19, in so far as the applicable harmonised standards cover these requirements.

Branch companies of notified bodies and subcontracting

§ 21. (1) The notified body shall assign or transfer to a subcontractor certain tasks associated with the conformity assessment, and it shall have ensure that the subcontractor or the branch undertaking satisfies the requirements of section 19 and shall inform the notifying authority accordingly.

(2) The notified bodies shall be fully responsible for the work carried out by subcontractors or branch undertakings, irrespective of where they are established.

(3) Work may only be awarded to a subcontractor or transferred to a subsidiary company if the customer agrees to it.

(4) The notified bodies shall have the relevant documentation relating to the assessment of the qualifications of the subcontractor or of the branch undertaking and the work carried out by it in accordance with Annex 3 for the to keep the notifying authority.

Internal Accredited Bodies

§ 22. (1) An accredited internal body may, in the case of conformity assessment activities for the company to which it belongs, for the purpose of carrying out the tasks listed in Annex 3 Module A2 and Module C2 shall be carried out. This body shall represent a separate and separate part of the enterprise and shall not participate in the design, production, supply, installation, use or maintenance of the measuring instruments it has assessed.

(2) Accredited Internal Bodies shall meet the following criteria:

1.

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

2.

The entities and their employees are organized by the company to which they belong distinguishable and have reporting procedures that ensure their impartiality to the national accreditation body;

3.

neither the jobs nor their employees are designed for design, manufacture, delivery, The installation, operation or maintenance of the measuring instruments to be evaluated shall be responsible or shall be carried out in accordance with an activity likely to damage the independence of their judgment or their integrity in relation to the evaluation tasks;

4.

The bodies perform their services exclusively for the company to which they belong.

(3) Accredited internal bodies shall not be notified to the other Member States of the European Union or to the European Commission, but the notifying authority shall, on request, provide information on its Accreditation of the company to which they belong, or from the national accreditation body.

Deployment on the market and commissioning

§ 23. The requirements with regard to commissioning (climatic conditions) are defined in the calibration regulations as described below. The appropriate upper and lower temperature limits must be selected from Table 1 of Annex 1, and moisture conditions (condensation or no condensation), as well as the nature of the intended use, may be made. (open or closed).

§ 24. If different accuracy classes for specific applications are specified in the calibration regulations for measuring instruments, the owner of the measuring instrument can at any time a higher Use the accuracy class for this application.

§ 25. Measuring instruments, which are shown at trade fairs, exhibitions, presentations and the like, do not have to comply with the provisions of this Regulation, if clearly visible to them , it shall be pointed out that they do not meet the requirements and must not be placed on the market and/or put into service before conformity with the provisions of this Regulation has been established.

Obligations of notified bodies in relation to their work

§ 26. (1) The notified bodies carry out the conformity assessment in accordance with the conformity assessment procedures in accordance with Annex 2.

(2) Compliance assessments shall be carried out in accordance with proportionality, avoiding unnecessary burdens on economic operators. The conformity assessment bodies shall carry out their activities with due regard to the size of a company, the industry in which it operates, its structure and the degree of complexity of the product technology concerned and of the product technology concerned. Mass-production or serial character of the manufacturing process. However, such a level of protection is to be observed, as is necessary for the conformity of the measuring instrument with this Regulation.

(3) A notified body shall establish that a manufacturer has failed to meet the essential requirements set out in Annex 1 and in the relevant calibration rules or in the relevant harmonised standards, normative documents or other technical specifications, it shall require the manufacturer to take appropriate corrective measures and shall not issue a certificate of conformity.

(4) If a notified body has already issued a certificate and, in the context of the monitoring of conformity, it shall establish that the measuring instrument no longer meets the requirements, it shall require the manufacturer to: appropriate corrective action, and shall suspend or withdraw the certificate, if necessary.

(5) If corrective measures are not taken or do not show the necessary effect, the notified body shall, if appropriate, restrict or withdraw all certificates.

Methods for the treatment of measurement devices at risk of being associated with a risk at national level

§ 27. (1) The calibration authorities have reasonable grounds to believe that a measuring instrument covered by this Regulation concerns the aspects of the protection of the public interests covered by this Regulation. of the Regulation, they shall assess whether the measuring instrument in question meets all the relevant requirements laid down in this Regulation. To this end, the economic operators concerned shall cooperate with the calibration authorities to the extent necessary.

(2) In the course of the assessment referred to in paragraph 1, the calibration authorities shall, on the basis that the measuring instrument does not comply with the requirements of this Regulation, call upon the economic operator concerned to: to take all appropriate corrective measures within a time-limit prescribed by the Authority, appropriate to the nature of the risk, in order to establish the conformity of the measuring instrument with those requirements, to withdraw it from the market, or to recall.

(3) The calibration authorities shall inform the relevant notified body.

(4) Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in paragraph 2.

(5) If the calibration authorities consider that the non-compliance is not limited to Austria, they shall inform the Federal Ministry for Science, Research and Economics of this. This information shall inform the European Commission and the other Member States of the European Union of the results of the evaluation and of the measures to which they have requested the economic operator.

(6) The economic operator shall ensure that all appropriate corrective measures it takes extend to all the measuring instruments concerned which it has provided on the market in the European Union.

(7) Within the period referred to in paragraph 2, the economic operator concerned does not take appropriate corrective measures, the calibration authorities shall take all appropriate provisional measures to ensure the provision of the To prohibit or restrict measuring equipment on the domestic market, to withdraw or to recall the measuring instrument from the market.

(8) The Federal Ministry of Science, Research and the Economy shall immediately inform the European Commission and the other Member States of the European Union of the measures taken.

(9) From the information referred to in paragraph 8, all available information shall be produced, in particular the data for the identification of the non-conforming measuring instrument, the origin of the measuring instrument, the nature of the claimed Non-compliance and the risk, as well as the nature and duration of the national measures taken and the arguments of the economic operator concerned. In particular, specify whether the non-compliance is due to one of the following reasons:

1.

The meter meets the requirements set out in this Regulation with regard to the Aspects of the protection of public interests do not, or

2.

the harmonized standards or normative documents that comply with § 12 of the harmonised standards or normative documents A presumption of conformity is not valid.

(10) The review by the European Commission that the measure is not justified is to be withdrawn without delay.

Risk through compliant devices

§ 28. (1) The Federal Ministry of Science, Research and the Economy, or the calibration authorities, determines that a measuring instrument poses a risk to aspects of the protection of public interests , although it is in accordance with this Regulation, the economic operator concerned shall be required to take all appropriate measures to ensure that the measuring instrument concerned does not take such a risk when it is placed on the market. is more or less appropriate within one of the nature of the risk, a reasonable period of time is withdrawn or recalled from the market.

(2) The economic operator shall ensure that all corrective measures taken extend to all the equipment concerned, which it has made available on the market in the European Union.

(3) The Federal Ministry of Science, Research and the Economy shall immediately inform the European Commission and the other Member States of the European Union thereof. This information shall indicate all available information, in particular the data for the identification of the measuring instrument concerned, the origin and supply chain of the measuring instrument, the nature of the risk, and the nature and duration of the measures taken. national measures.

Formal Non-Compliance

§ 29. (1) Without prejudice to § 27, the economic operator concerned shall be required by the calibration authorities to correct the non-compliance in question if it has one of the following cases: Note:

1.

the CE mark or the additional metrology label has been identified in violation by Article 30 of Regulation (EC) No 765/2008 or by Article 17 of this Regulation;

2.

The CE mark or the additional metrology label was not attached;

3.

the identification number of the notified body, if this is in the production control stage. -has been or has not been applied for non-compliance with § 17;

4.

The EU declaration of conformity was not attached to the meter;

5.

The EU Declaration of Conformity has not been issued correctly;

6.

The technical documentation is either not available or is not complete;

7.

missing the information specified in Section 6 (7) or § 8 (4) is incorrect or incomplete;

8.

A different administrative request according to § 6 or § 8 is not satisfied.

(2) If the non-compliance referred to in paragraph 1 continues, the calibration authorities shall take all appropriate measures to restrict or prohibit the provision of the measuring instrument on the market or to ensure that the measurement is made available to the public. that it is recalled or withdrawn from the market.

Linguistic equality

§ 30. As far as natural persons are referred to in this Regulation only in male form, they relate to women and men in the same way. The use of the designation for certain natural persons shall be based on the gender-specific form.

Implementation of European Union legislative acts

§ 31. This Regulation repeals 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 L 376, 27.4.2014, p. No.  OJ L 96, 29.03.2014 p.

.

Transitional provisions

§ 32. (1) As of 20 April 2016, only more measuring instruments may be placed on the market or put into service for the first time for the first time, which comply with this Regulation.

(2) By way of derogation from paragraph 1, measuring instruments may continue to be placed on the market for the first time or be put into service for the first time when they are subject to the provisions of the Measuring Instruments Ordinance, BGBl.  II No 274/2006, and have a valid certificate for this purpose.

(3) By way of derogation from paragraph 1, measuring instruments which are subject to the provisions of § 23 (1) of the Measuring Instruments Ordinance, BGBl.  II No 274/2006, only up to 30.  They will be put on the market for the first time or put into service for the first time in October

.

Entry into force

§ 33. (1) This Regulation shall enter into force on 20 April 2016. At the same time, the measuring instrument regulation, BGBl.  II No 274/2006.

(2) From the date of the presentation of this Regulation, posts may be designated in accordance with § 18.

(3) Named bodies shall not issue certificates of CE marking under this Regulation before 20 April 2016.

(4) A placing on the market or putting into service of measuring instruments which are identified in accordance with this Regulation shall be inadmissible before 20 April 2016.

ANNEX 1

Essential Requirements

A measuring instrument must ensure a high level of measurement reliability, so that the data subjects can trust the measurement results; design and production must be made in terms of measurement technology and the safety of measurement data have a high quality level.

The following are the requirements to be met by the measuring devices. These are supplemented by device-specific requirements, which are contained in the calibration regulations of the Federal Office of Eich-und Vermessungswesen (Federal Office for Eich and Vermetungswesen).

The solutions chosen on the basis of the requirements shall take into account the intended use of the measuring instrument and any foreseeable improper use.

Definitions

Metric

The metric is the size that is the object of a measurement.

Influence size

An influence size is a size that is not the metric, but affects the measurement result.

nominal operating conditions

The nominal operating conditions are the values for the measured quantity and the influencing variables for the normal operating state of a measuring device.

Disturbance size

A disturbance variable is an influencing variable whose value lies within the limits specified by the respective request, but outside the predetermined nominal operating conditions of the measuring instrument. An influence size is a disturbance variable if the nominal operating conditions are not specified for this influence size.

Limit

The limit value is the value at which the change in the measurement result is considered undesirable.

Measure embodied

A measure is a device that is used to permanently reproduce or provide one or more known values of a given size during their use.

Direct Sales

A business process is referred to as a direct sale if

-

The measurement result serves as the basis for the price to be paid, and

-

at least one of the parties involved in the measurement related to a measurement is a consumer or other party that requires comparable protection, and

-

All parties affected by the operation acknowledge the measurement result in place.

Climate environment conditions

The climatic environmental conditions are the conditions under which measuring instruments may be used. In order to take account of climatic differences between the Member States of the European Union, different temperature limits have been established.

Utilities

Companies are considered to be companies that ensure the supply of electricity, gas, district heating, or water.

Essential Requirements

1.

Error limits

1.1

Under nominal operating conditions and without the occurrence of a disturbance variable, the measurement deviation may be the shall not exceed the outermost deviations (error limits) permitted by the corresponding calibration rules. Unless otherwise specified in the calibration rules, an error limit is expressed as a two-sided value of the deviation from the true measured value.

1.2

Under nominal operating conditions, and if a disturbance occurs, the Power requirement for the device of the specification in the corresponding calibration regulations. If the device is to be used in a given continuous electromagnetic field, the permitted measurement properties must be carried out during the test in an amplitude modulated electromagnetic RF field within the error limits.

1.3

The manufacturer has the climatic, mechanical and electromagnetic environmental conditions, where the equipment is to be used, as well as the power supply and other influencing factors which may affect its accuracy, and in so doing to meet the requirements laid down in the relevant calibration rules,

1.3.1

climatic environment conditions

The manufacturer, using the values shown in Table 1, shall establish the upper and lower temperature limits, unless otherwise specified in the calibration rules, and shall indicate for which: Humidity conditions (condensation or no condensation) and the place of use (open or closed) the device is designed.

Temperature limits

temperature limit

30 ° C

40 ° C

55 ° C

70 ° C

temperature limit

5 ° C

-10 ° C

-25 ° C

-40 ° C

Table 1

1.3.2

a) the mechanical environmental conditions will be in the classes M1 to M3 as follows: Split:

M1

This class applies to measuring devices used in operations at which insignificant vibrations and shocks may occur, e.g.  For example, measuring instruments attached to light supporting structures, the minor ones, the local sprinkles or ramming works, the doors to be sleeved, etc. are exposed to vibrations and shocks.

M2

This class applies to measuring devices used in operations , where significant to severe vibrations and shocks may occur,  B. of nearby machines and passing vehicles, or starting from adjacent heavy machinery, conveyor belts, etc.

This class applies to measuring devices used in operations , where strong to very strong vibrations and shocks can occur, e.g.  For example, for measuring instruments directly on machines, conveyor belts, etc. .

)

In terms of the mechanical environmental conditions, the following influencing variables are

-

vibrations;

-

shocks.

1.3.3

a) The electromagnetic environmental conditions are placed in classes E1, E2, and E3, as follows: Unless otherwise specified in the calibration rules.

E1

This class applies to measuring devices that are used in operations where electromagnetic interference such as in residential and commercial buildings as well as light industry buildings can occur.

E2

This class applies to measuring devices used in operations , where electromagnetic interference can occur as in other industrial buildings.

E3

This class applies to power meters with power the vehicle battery. These measuring instruments must meet the requirements of class E2 and the following additional requirements:

Voltage waste caused by turning on the starter motor circuits of internal combustion engines;

Transient at load drop, which occurs when a discharged battery is clamped when the engine is running.

)

In terms of the electromagnetic environmental conditions, the following influencing variables are

-

Voltage interrupts;

Short-term voltage drops;

Power-supply and/or signal-line voltage transevers;

-

Static electricity discharge;

RF electromagnetic field;

Line-guided electromagnetic RF fields in supply and/or signal lines;

-

surge voltages in supply and/or signal lines.

1.3.4.

Other influencing variables that might be taken into account are:

Voltage fluctuations;

-

fluctuation of network frequency;

-

Network-frequented magnetic fields;

Other sizes that can have a significant impact on the accuracy of the meter.

1.4.

The following rules apply to the performance of the checks provided for in this Regulation:

1.4.1.

Basic rules for validation and determination of errors

The basic requirements of Z 1.1 and 1.2 are to be checked for any relevant influence size. Unless otherwise specified in the corresponding calibration provision, these essential requirements shall apply where the application of the influence quantity and the determination of its effect shall be made separately for each individual influencing variable, with all the others Influencing variables are kept relatively constant on their reference value.

The metrological test shall be carried out during or after the application of the influence quantity, taking into account the condition which corresponds to the normal operating state of the measuring instrument, in which the Probability of occurrence of this influence size.

1.4.2.

ambient humidity

)

Depending on the climatic environment in which the measuring device is to be used, it can be either a wet heat and constant temperature test (no defrost) or a wet heat test and a cyclic temperature change (defrowing) are performed.

)

The wet heat test and the cyclic temperature change are appropriate when the The penetration of steam by the respiratory effect is accelerated. Under conditions where a moisture-free humidity is important, the test can be chosen in the case of a humid heat and a constant temperature.

2.

Reproducibility

The determination of the identical measurement size in different locations and by different users must-under otherwise unchanged conditions-a close match between the following measurement results . Compared to the error limits, the individual measurement results are only slightly different from each other.

3.

repeatability

The measurement of an identical measured variable under identical measurement conditions must result in a close match between the following measurement results. Compared to the error limits, the individual measurement results are only slightly different from each other.

4.

Response threshold and sensitivity

A measuring device must be sufficiently sensitive to the intended measurements and must have a sufficiently low response threshold.

5.

Resistance

A measuring instrument shall be designed in such a way that its metrological characteristics remain sufficiently stable over a period of time estimated by the manufacturer, provided that it is properly positioned and maintained and, accordingly, the operating instructions are used under the intended environmental conditions.

6.

Reliability

A measuring instrument shall be designed to reduce as far as possible the influence of a defect that would lead to an inaccurate measurement result, provided such a defect is not obvious.

7.

suitability

7.1.

A gauge must not have any properties that are fraudulent , and the possibility of unintended incorrect operation is to be kept as low as possible.

7.2.

A measuring device must be used for the practical conditions of use for the intended use and may not be subject to unreasonably high standards to the user in order to obtain a correct measurement result.

7.3.

In case of flow or flow outside of the allowed range, the error of a Power meter does not have excessive one-sided deviation.

7.4.

Is a measuring device designed to measure metrics that are constant over time, The measuring instrument must be insensitive to small fluctuations in the measurement variable or react appropriately.

7.5.

A gauge must be robust, and the materials it is made of must be robust for the intended use conditions.

7.6.

A meter is to be designed to control the measurement operations after the Measuring device has been placed on the market and put into operation. Where necessary, the measuring instrument shall have a special equipment or software for this control. The test method must be described in the operating instructions.

If a measuring device has associated additional software that performs additional functions in addition to the measuring function, the software that is critical to the metrological characteristics must be identifiable; it may be identified by the associated additional software will not be unduly influenced.

8.

Protection against counterfeit

8.1.

The metrological characteristics of a meter may be due to the connection of another The device is not unduly influenced by the characteristics of the attached device or the characteristics of a severed device that is in communication with the meter.

8.2.

A structural unit that is critical to the metrological features must be designed so that it can be secured. The security measures provided for must enable the detection of possible interventions.

8.3.

Software that is critical to the metrological characteristics is appropriate for and to secure it. The identification of the software must be made available in a simple way by the measuring instrument. Possible interventions must be verifiable over a reasonable period of time.

.

Measurement data, software that is critical to the metrological characteristics, and metrological important parameters that are stored or transmitted are to be adequately protected against accidental or deliberate falsification.

8.5.

In the case of visual display of measurement devices for the measurement of power supplies, The display of the total supply quantity or the views from which the total amount of delivery can be derived and which serve as a basis for the settlement, in whole or in part, cannot be reset during operation.

9.

Information to be attached to the meter

to the meter

9.1.

The following information is available on a measuring device:

a)

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

)

Measuring precision information

as well as

)

Terms and conditions of use

d)

Measuring capacity

e)

Measuring range

f)

Identity label

g)

The EU type-examination certificate number or the EU design-examination certificate

h)

whether additional devices that deliver measurement results are subject to the terms of the Ordinance on legal metrological control is sufficient or not.

9.2.

If a meter is too small or too sensitive to provide the required information, you must: the packaging (where available) and the accompanying documents to be drawn up in accordance with this Regulation shall be marked accordingly.

9.3.

The meter must be provided with information about its mode of operation, if this is due to the simplicity of the measuring instrument does not make any unnecessary. This information must be easy to understand and, if necessary, include the following information:

a)

nominal operating conditions

)

Class of mechanical and electromagnetic environmental conditions

)

upper and lower temperature limits, condensation possible, or not possible, open or closed location

)

Instructions for installation, maintenance, repair, and allowed settings

e)

Instructions to ensure fault-free operation, as well as information about special Usage conditions

)

Terms and conditions for compatibility with interfaces, devices, or measuring devices.

9.4.

For groups of identical measuring devices that are used in one and the same location, or for measuring instruments for the measurement of power supplies, individual operating instructions are not absolutely necessary.

9.5.

Unless otherwise specified in the calibration rules, the partial line spacing is for a metric 1 x 10n, 2 x 10n , or 5 x 10n, where n is an integer or zero. The unit of measure or its symbol is displayed in the immediate vicinity of the numerical value.

9.6.

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

9.7.

The units of measure used and their symbols must be subject to Community legislation about the units in the metrology and their symbols.

9.8.

All marks and inscriptions required after a request must be clear, be indelible, unambiguous, and non-transferable.

10.

Display of result

10.1.

The display of the result is in the form of a visual display or a paper expression.

10.2.

The display of the result must be clear and unique, as well as with the necessary markers and Inscriptions shall be provided to illustrate the meaning of the result to the user. Under normal conditions of use, a problem-free reading of the result shown must be ensured. Additional displays are permitted, provided that confusion is excluded with the ads subject to metrological control.

10.3.

If the results are printed out or recorded, the expression and the Recording is easy to read and indelible.

10.4.

A measuring device that is used to handle a direct sale must be designed to Measurement result when the measuring instrument is set up as intended, both parties are displayed. To the extent that this is essential in the case of direct sales, any document issued by peripheral equipment which does not meet the relevant requirements of this Regulation shall be issued to the customer, a corresponding Limiting hint.

.

Measuring devices for the measurement of utility services are independent of whether they are remote-read , it shall be possible to provide, in any event, a visual display which is subject to metrological control and which is accessible to the consumer without aid. The display value of this view display is the measurement result that represents the basis for the price to be paid.

11.

Processing data processing to complete the business process

11.1.

A measuring device that does not measure the power supply must have the measurement result and record the information required for the determination of a particular transaction if the measurement is not repeatable and the measuring instrument is normally intended to be used in the absence of one of the parties.

11.2.

In addition, at the conclusion of the measurement on request, a permanent proof of the Measurement results and the information required to determine a particular business process.

12.

Conformity Assessment

A measuring instrument shall be designed in such a way as to enable a problem-free assessment of its conformity with the relevant requirements of this Regulation.

ANNEX 2

Allowable Compliance Assessment Procedures

1.

Water meters intended for volume measurement of clean cold water or hot water:

B + F or B + D or H1;

2.

Gas meter and quantity conversion:

B + F or B + D or H1;

.

Power meter for power consumption, used in household, commercial and in the The light industry is determined:

B + F or B + D or H1;

4.

Heat meter:

B + F or B + D or H1;

5.

Measuring systems for the continuous and dynamic measurement of quantities of liquids other than Water:

B + F or B + D or H1 or G;

6.

Self-acting scales:

a)

For mechanical measuring devices:

B + D or B + E or B + F or D1 or F1 or G or H1;

)

For electromechanical measuring devices:

B + D of B + E or B + F or G or H1;

)

Measuring instruments that contain electronic measuring devices or software:

B + D or B + F or G or H1;

7.

Taxameter:

B + F or B + D or H1;

8.

Dimension epitomes:

a)

embodied length dimensions:

F1 or D1 or B + D or H or G;

b)

Procurement dimensions:

A2 or F1 or D1 or E1 or B + E or B + D or H;

9.

Measuring devices to measure lengths and their combinations:

a)

For mechanical or electromechanical measuring devices:

F1 or E1 or D1 or B + F or B + E or B + D or H or H1 or G;

)

For electronic measuring devices or measuring devices that contain software:

B + F or B + D or H1 or G.

ANNEX 3

Module A: Internal Manufacturing Control

1.

The internal manufacturing control is the conformity assessment procedure, with the manufacturer fulfils the obligations set out in Z 2, 3 and 4 and ensures and declares his sole responsibility that the measuring instruments in question satisfy the requirements of this Regulation which apply to them.

2.

Technical documents

The manufacturer creates the technical documentation described in § 14. On the basis of these documents, it must be possible to assess the conformity of the measuring instrument with the relevant requirements; it must contain a suitable risk analysis and assessment. The technical documentation shall be accompanied by the requirements in force and shall cover the design, manufacture and operation of the product, insofar as they are relevant to the assessment.

3.

Manufacturing

The manufacturer must take all the necessary measures to ensure that the manufacturing process and its monitoring meet the conformity of the measuring instruments with those referred to in Z 2. the technical documentation and the requirements of this Regulation which apply to them.

4.

Conformance marking and EU Declaration of Conformity

4.1.

The manufacturer will bring to each individual meter that meets the applicable requirements of this This Regulation shall apply to the CE marking and to the additional metrology marking.

4.2.

The manufacturer presents a written EU declaration of conformity for a measuring device model. and, together with the technical documentation, shall, after placing the measuring instrument on the market, provide it for 10 years for the national authorities. The EU declaration of conformity must show which measuring instrument it has been issued for.

A copy of the EU declaration of conformity will be made available to the competent authorities on request.

A copy of the EU declaration of conformity is attached to each meter that is placed on the market. In cases where a large number of measuring devices are delivered to one and the same user, this requirement may be interpreted in such a way that it does not apply to individual devices, but to a lot or a shipment.

5.

Plenipotentiary

The obligations of the manufacturer referred to in Z 4 may be fulfilled by his authorized representative on his behalf and under his responsibility, if in the Work order is set.

Module A2: Internal manufacturing control with monitored device checks at irregular intervals

1.

During internal production control, monitored at irregular intervals. Equipment testing is the conformity assessment procedure with which the manufacturer fulfils the obligations set out in points Z 2, 3, 4 and 5 and ensures and declares on its own responsibility that the measuring instruments in question shall meet the requirements of the shall comply with the requirements of this Regulation.

2.

Technical documents

The manufacturer creates the technical documentation described in § 14. On the basis of these documents, it must be possible to assess the conformity of the device with the relevant requirements; it must contain a suitable risk analysis and assessment. The technical documentation shall be accompanied by the requirements in force and shall cover the design, manufacture and operation of the product, insofar as they are relevant to the assessment.

3.

Manufacturing

The manufacturer must take all the necessary measures to ensure that the manufacturing process and its monitoring ensure that the equipment manufactured is in conformity with the requirements of the Z 2 technical documentation and with the requirements of this Regulation applicable to them.

4.

Device Checks

Depending on the manufacturer's decision, an accredited internal body or a notified body he or she has chosen shall perform in accordance with the requirements of the manufacturer. carry out or have carried out equipment tests at irregular intervals in order to check the quality of the internal equipment tests, taking into account, inter alia, the technical complexity of the equipment and the quantity of production. Before being placed on the market, the site shall carry out an appropriate sample of the final measuring equipment on the spot and shall examine it and carry out appropriate tests in accordance with the relevant sections of the harmonised standard and/or the normative Document and/or equivalent tests in accordance with other relevant technical specifications, in order to verify the conformity of the instrument with the relevant requirements of this Regulation. In the absence of a relevant harmonised standard or a relevant normative document, the accredited internal body or the notified body shall decide which tests are to be carried out.

A significant number of devices taken as a sample does not meet an acceptable level of quality, so the accredited internal body or the Notified body shall take the necessary measures.

If a notified body carries out the tests, the manufacturer will take the responsibility of the notified body during the manufacturing process. whose identification number is attached.

5.

Compliance Labeling and EU Declaration of Conformity

5.1.

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

5.2.

The manufacturer makes a written EU declaration of conformity for a device model, and , together with the technical documentation following the placing on the market of the equipment, it shall be ready for 10 years for the national authorities. The EU declaration of conformity must show the device for which it was issued.

A copy of the EU declaration of conformity will be made available to the competent authorities on request.

A copy of the EU declaration of conformity is attached to each meter that is placed on the market. In cases where a large number of devices are delivered to one and the same user, this requirement can be interpreted in such a way that it does not apply to individual devices, but to a lot or a shipment.

6.

Plenipotentiary

The obligations of the manufacturer referred to in Z 5 may be fulfilled by his authorized representative on his behalf and under his responsibility, if in the Work order is set.

Module B: EU Type Check

1.

The "EU type examination" is the part of a conformity assessment procedure, where a notified body is to examine and verify the technical design of a measuring instrument and certify that it satisfies the requirements of this Regulation which apply to the equipment.

2.

An EU type-examination can be performed in any of the following ways:

)

Testing a sample of the complete measuring device representative of the planned production (Construction pattern);

)

Evaluation of the suitability of the technical design of the measuring instrument on the basis of an examination of the technical design of the measuring instrument in Z 3 (a) technical documentation and additional evidence, as well as the examination of samples of one or more important parts of the equipment, representative of the intended production, (combination of design and design);

)

Evaluation of the appropriateness of the technical design of the device, based on an examination of the technical design of the device in Z 3 and additional evidence, without examination of a pattern (design model).

The notified body decides on the appropriate shape and pattern.

3.

The application for EU type-examination is from the manufacturer to a single notified body. of his choice.

The application contains the following:

a)

The name and address of the manufacturer and, if the application is submitted by the plenipotentiary, also its name and address;

b)

a written declaration that the same application does not apply to any other notified body. ;

)

the technical documentation described in § 14. On the basis of the technical documentation, it must be possible to assess the conformity of the device with the applicable requirements of this Regulation; it must contain a suitable risk analysis and assessment. The technical documentation shall be accompanied by the requirements in force and shall cover the design, manufacture and operation of the product, insofar as they are relevant to the assessment.

The application may contain at least the following elements:

)

representative samples for the production in question. The notified body may request additional samples if necessary to complete the validator;

e)

the additional evidence for an appropriate solution through the technical design. Such additional evidence shall indicate all the documents which have been followed, in particular, where the relevant harmonised standards and/or normative documents have not been fully applied. The additional evidence shall, where necessary, include the results of tests carried out in accordance with other relevant technical specifications by an appropriate laboratory of the manufacturer or by another test laboratory on its behalf and under of its responsibility.

4.

The notified body has the following tasks:

Based on the device:

4.1.

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

Based on the pattern/pattern:

4.2.

Check to see if the pattern is manufactured in accordance with the technical documentation , and identify 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;

4.3.

conducting or initiating appropriate examinations 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;

4.4.

conducting or initiating appropriate examinations and tests to determine whether the solutions adopted 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 comply with the relevant essential requirements of this Regulation;

4.5.

Agreement with the manufacturer, where the investigations and checks are performed.

Based on the other parts of the measuring device:

4.6.

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

5.

The notified body creates an audit report on the z 4 Measures and the results achieved. Without prejudice to its obligations to the notifying authorities, the notified body shall publish the contents of this report or parts thereof only with the consent of the manufacturer.

6.

The design pattern corresponds to the requirements of the meter in question Regulation, the notified body shall issue an EU type-examination certificate to the manufacturer. This certificate shall contain the name and address of the manufacturer, the results of the examination, any conditions for its validity and the information required for the identification of the approved type. The EU type-examination certificate may be attached to one or more annexes.

The EU type-examination certificate and its annexes contain all the relevant information that is used to match the manufactured measuring instruments. assess the type of design examined and, if necessary, carry out any checks after they have been put into service. In order to be able to assess the conformity of the manufactured equipment, if it is properly adjusted, with appropriate means, with regard to the repeatability of its measurement powers, to be able to assess the conformity of the equipment with the tested design, it is particularly appropriate to: Specify the following:

The metrological characteristics of the device's construction pattern;

-

to ensure the integrity of the device (plotting, identifying the software and so on);

-

Other information that is used to identify the device and to monitor its visibility in relation to its External conformity with the design is required;

-

any other specific information that is used to verify the characteristics of the manufactured Devices are required;

-

in the case of a subdevice, all the information needed to ensure compatibility with other sub-devices or measuring devices.

The EU type-examination certificate is valid for ten years from its date of issue, and can then be extended for another ten years.

The construction pattern does not meet the applicable requirements of this Regulation, and the notified body refuses to issue a EU type-examination certificate and shall inform the applicant of this, giving a detailed explanation of its refusal.

7.

The notified body is continuously informed of any changes in the generally accepted State of the art; if they indicate that the approved model no longer complies with the applicable requirements of this Regulation, it shall decide whether any such changes will require further investigation. If this is the case, the notified body shall inform the manufacturer thereof.

8.

The manufacturer must inform the notified body that is responsible for the technical documentation. The EU type-examination certificate shall be accompanied by any modifications to the approved type which affect its conformity with the essential requirements of this Regulation or the conditions for the validity of this certificate . Such changes require an additional permit in the form of a supplement to the original EU type-examination certificate.

9.

Each notified body shall inform its notifying authority of the EU type-examination certificates and/or any additions to which they have been issued or withdrawn, and shall transmit to their notifying authority, at regular intervals or on request, a list of all such certificates. and/or additions to which they are refused, suspended or otherwise restricted .

If you ask for this, the European Commission, the Member States of the European Union and the other notified bodies will receive a copy. of the EU type-examination certificates and/or their additions. The European Commission and the Member States of the European Union shall, on request, receive a copy of the technical documentation and of the results of the tests carried out by the notified body.

The notified body preserves a copy of the EU type-examination certificate, including its annexes and supplements, as well as the technical dossier, including the shall be submitted by the manufacturer until the period of validity of this certificate expires.

10.

The manufacturer holds a copy of the EU type-examination certificate together with attachments and additions. together with the technical documentation after the device has been placed on the market, ready for the national authorities for ten years.

11.

The authorized representative of the manufacturer may submit the application referred to in Z 3 and the application in the Z 8 and 10, if they are specified on the order.

Module C: Conformance with design based on internal manufacturing control

1.

The design is based on an internal production control. it is the part of a conformity assessment procedure in which the manufacturer fulfils the obligations set out in points Z 2 and 3 and ensures and declares that the measuring instruments concerned are the same as those described in the EU type-examination certificate are in conformity with the requirements of this Regulation applicable to them;

2.

Manufacturing

The manufacturer must take all the necessary measures to ensure that the manufacturing process and its monitoring ensure that the measuring instruments manufactured are consistent with the the approved type as described in the EU type-examination certificate and with the requirements of this Regulation applicable to them.

3.

Conformance marking and EU Declaration of Conformity

3.1.

The manufacturer is bringing in each individual device that is used in the The EU type-examination certificate shall be in conformity with the relevant requirements of this Regulation, the CE marking and the additional metrology marking prescribed in accordance with this Regulation.

3.2.

The manufacturer makes a written EU declaration of conformity for each device model, and After placing the equipment on the market, it shall be ready for 10 years for the national authorities. The EU declaration of conformity must show which device model it has been issued for.

A copy of the EU declaration of conformity will be made available to the competent authorities on request.

A copy of the EU declaration of conformity is attached to each meter that is placed on the market. In cases where a large number of devices are delivered to one and the same user, this requirement can be interpreted in such a way that it does not apply to individual devices, but to a lot or a shipment.

4.

Plenipotentiary

The obligations of the manufacturer referred to in Z 3 may be fulfilled by his authorized representative on his behalf and under his responsibility, if in the Work order is set.

Module C2: Conformance with design on the basis of internal production control with monitored device checks at regular intervals

1.

In compliance with design, based on an internal manufacturing control monitored product tests at irregular intervals shall be the part of a conformity assessment procedure in which the manufacturer fulfils the obligations set out in Z 2, 3 and 4 and guarantees and on its own responsibility Declares that the measuring instruments in question are those of the EU type-examination certificate shall be in conformity with the requirements of this Regulation applicable to them.

2.

Manufacturing

The manufacturer must take all the necessary measures to ensure that the manufacturing process and its monitoring ensure that the measuring instruments manufactured are consistent with the the type as described in the EU type-examination certificate and with the requirements of this Regulation applicable to them.

3.

Device Checks

Depending on the manufacturer's decision, an accredited internal body or a notified body he or she has chosen shall perform in accordance with the requirements of the manufacturer. carry out or have carried out equipment tests at irregular intervals in order to check the quality of the internal equipment tests, taking into account, inter alia, the technical complexity of the measuring instruments and the quantity of production. Before being placed on the market, the accredited internal body or the notified body on the spot shall carry out an appropriate sample of the measuring instruments intended for the end user and shall examine them, and shall carry out appropriate tests in accordance with the relevant sections of the harmonised standards and/or the normative documents and/or equivalent tests in accordance with other relevant technical specifications, in order to ensure conformity of the equipment with the relevant technical specifications in the EU type-examination certificate and with the corresponding requirements of this type  Regulation.

The sample does not meet an acceptable level of quality, so the accredited internal Place or the notified body must take the necessary measures.

This sampling method is used to determine whether the device's manufacturing process moves within acceptable limits to ensure compliance of the device with the device. Device to be guaranteed.

If a notified body carries out the tests, the manufacturer will take the responsibility of the notified body during the manufacturing process. whose identification number is attached.

4.

Conformance marking and EU Declaration of Conformity

.

The manufacturer will bring to each individual meter that is used in the EU type-examination certificate shall be in conformity with the applicable requirements of this Regulation, the CE marking and the additional metrology marking shall be applied.

4.2.

The manufacturer issues a written EU declaration of conformity for each device model, and After placing the equipment on the market, it shall be ready for 10 years for the national authorities. The EU declaration of conformity must show which device model it has been issued for.

A copy of the EU declaration of conformity will be made available to the competent authorities on request.

A copy of the EU declaration of conformity is attached to each meter that is placed on the market. In cases where a large number of devices are delivered to one and the same user, this requirement can be interpreted in such a way that it does not apply to individual devices, but to a lot or a shipment.

5.

Plenipotentiary

The obligations of the manufacturer referred to in Z 4 may be fulfilled by his authorized representative on his behalf and under his responsibility, if in the Work order is set.

Module D: Conformance with design based on quality assurance based on the production process

1.

Conformance with design based on quality assurance based on the The production process is the part of a conformity assessment procedure, in which the manufacturer fulfils the obligations laid down in the Z 2 and 5 and ensures and declares on its own responsibility that the measuring instruments in question are those in the EU type-examination certificate as described in the following: Meet the requirements of this Regulation.

2.

Manufacturing

The manufacturer operates a quality assurance system for the manufacture, final inspection and testing of the relevant measuring instruments according to Z 3 and is subject to the Monitoring according to Z 4.

3.

Quality assurance system

3.1.

The manufacturer requests a notified body of his choice to evaluate his or her choice. Quality assurance system for the measuring instruments concerned.

The application contains the following:

a)

The name and address of the manufacturer and, if the application is submitted by the plenipotentiary, also its name and address;

b)

a written declaration that the same application does not apply to any other notified body. ;

)

all relevant information about the provided device category;

d)

The documentation of the quality assurance system;

e)

the technical documentation of the approved type and a copy of the EU type-examination certificate.

3.2.

The quality assurance system ensures that the measuring instruments match the one in the EU type-examination certificate and with the requirements of this Regulation applicable to it.

All elements, requirements, and regulations taken into account by the manufacturer are systematically and correctly written in the form of written principles, procedures and instructions. These quality assurance documents must enable a uniform interpretation of the quality assurance programmes, plans, manuals and reports.

In particular, you have an appropriate description of the following points:

a)

Quality objectives and organizational structure, responsibilities, and powers of the Executive management in terms of product quality;

)

appropriate manufacturing, quality control and quality assurance techniques, applied Procedures and systematic measures provided for;

)

Before, during, and after manufacture, tests and tests their frequency;

d)

quality-related records, such as audit reports, test and calibration data, and reports on the qualifications of the staff employed in this area;

e)

means to achieve the required product quality and to work effectively of the quality assurance system.

3.3.

The notified body evaluates the quality assurance system to determine whether it is in Z 3.2 requirements are met.

For each component of the quality assurance system that meets the relevant specifications of the relevant harmonised standard, it goes from a Compliance with these requirements.

In addition to experience with quality management systems, at least one member of the audit team has experience with the assessment in the relevant the equipment and equipment concerned and knowledge of the applicable requirements of this Regulation. The audit also includes a visit to the premises of the manufacturer.

The audit team checks the in Z 3.1 lit.  (e) technical documentation, in order to ensure that the manufacturer is able to identify the relevant requirements of this Regulation and to carry out the necessary tests in order to ensure that the conformity of the appliance with of these requirements.

The decision is notified to the manufacturer. The communication must contain the conclusions of the audit and the justification of the evaluation decision.

.

The manufacturer undertakes to use the approved quality assurance system and to ensure that it is always properly and effectively kept.

3.5.

The manufacturer shall inform the notified body that the quality assurance system , all scheduled changes to the quality assurance system.

The notified body assesses any planned changes and decides whether the modified quality assurance system is still the same as those referred to in Z 3.2. Requirements are met, or a reassessment is required.

You are announcting your decision to the manufacturer. The notification must include the conclusion of the assessment and the justification for the assessment decision.

4.

Monitoring under the responsibility of the notified body

4.1.

Monitoring is designed to ensure that the manufacturer has the obligations under the approved Quality assurance system in compliance with the rules.

4.2.

The manufacturer shall grant the notified body for the assessment access to the manufacturing, Inspection, testing and storage facilities and provide it with all necessary documents, in particular:

a)

The documentation of the quality assurance system;

)

quality-related records, such as audit reports, test and calibration data, and reports on the qualifications of the personnel concerned in this area.

4.3.

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

4.4.

In addition, the notified body can see unannounced visits to the manufacturer. . During such visits, the notified body may, if necessary, carry out equipment tests or have it carried out in order to satisfy itself of the proper functioning of the quality assurance system. The notified body shall submit a survey report to the manufacturer and, in the case of a test, a test report.

5.

Compliance Labeling and EU Declaration of Conformity

5.1.

The manufacturer will bring to each individual measuring device that is used in the EU-type-examination certificate as described in this Regulation meets the applicable requirements of this Regulation, the CE marking, the additional metrology marking in accordance with this Regulation and under the responsibility of those in Z 3.1 , the notified body of the notified body shall be notified of the identification number.

5.2.

The manufacturer issues a written EU declaration of conformity for each device model, and After placing the equipment on the market, it shall be ready for 10 years for the national authorities. The EU declaration of conformity must show which device model it has been issued for.

A copy of the EU declaration of conformity will be made available to the competent authorities on request.

A copy of the EU declaration of conformity is attached to each meter that is placed on the market. In cases where a large number of devices are delivered to one and the same user, this requirement can be interpreted in such a way that it does not apply to individual devices, but to a lot or a shipment.

6.

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

a)

The documents according to Z 3.1;

)

the information in relation to the change according to Z 3.5 in its approved form;

)

the decisions and reports of the notified body according to Z 3.5, 4.3, and 4.4.

7.

Each notified body shall inform its notifying authority of the authorisations of the quality assurance systems which it has issued or withdrawn, and shall transmit to its notifying authority, at regular intervals or on request, a list of all the authorisations of quality assurance systems which it refuses, suspended or restricted in some other way.

8.

Plenipotentiary

The manufacturer's obligations in Z 3.1, 3.5, 5, and 6 can be fulfilled by his authorized representative on his behalf and under his responsibility. if they are set on the work order.

Module D1: Quality Assurance related to the production process

1.

The quality assurance related to the production process is the Conformity assessment procedure, in which the manufacturer fulfils the obligations laid down in Z 2, 4 and 7 and ensures and declares on its own responsibility that the measuring instruments concerned comply with the requirements of this Regulation

2.

Technical documents

The manufacturer creates the technical documentation described in § 14. On the basis of these documents, it must be possible to assess the conformity of the device with the requirements in question; it must contain a suitable risk analysis and assessment. The technical documentation shall specify the requirements in force and shall cover the design, manufacture and operation of the equipment, insofar as they are relevant to the assessment.

3.

The manufacturer holds the technical documentation ten years after the device has been placed on the market. long for the national authorities.

4.

Manufacturing

The manufacturer operates an approved quality assurance system for the manufacture, final inspection and testing of the relevant measuring devices according to Z 5 and is subject to surveillance in accordance with Z 6.

5.

Quality assurance system

5.1.

The manufacturer requests a notified body of his choice to evaluate his or her choice. Quality assurance system for the measuring instruments concerned.

The application contains the following:

a)

The name and address of the manufacturer and, if the application is submitted by the plenipotentiary, also its name and address;

b)

a written declaration that the same application does not apply to any other notified body. ;

)

all relevant information about the provided device category;

d)

The documentation of the quality assurance system;

e)

the technical documentation according to Z 2.

5.2.

The quality assurance system ensures that the measuring instruments match those for them applicable requirements of this Regulation.

All elements, requirements, and regulations taken into account by the manufacturer are systematically and correctly written in the form of written principles, procedures and instructions. These quality assurance documents must enable a uniform interpretation of the quality assurance programmes, plans, manuals and reports.

In particular, you have an appropriate description of the following points:

a)

Quality objectives and organizational structure, responsibilities, and powers of the Executive management in terms of product quality;

)

appropriate manufacturing, quality control and quality assurance techniques, applied Procedures and systematic measures provided for;

)

Before, during, and after manufacture, tests and tests their frequency;

)

Quality-related records such as audit reports, test and calibration data, and reports on the qualifications of the personnel concerned in this field;

e)

means to achieve the intended product quality and the effective operation of the quality assurance system.

5.3.

The notified body evaluates the quality assurance system to determine whether it is in Z 5.2 requirements are met.

For each component of the quality assurance system that meets the relevant specifications of the relevant harmonised standard, it goes from a Compliance with these requirements.

In addition to experience with quality assurance systems, at least one member of the audit team has experience with the assessment in the relevant equipment and equipment, and knowledge of the applicable requirements of this Regulation. The audit also includes a visit to the premises of the manufacturer.

The audit team reviews the technical documentation referred to in Z 2 to verify that the manufacturer is able to do so To identify the requirements of the Regulation and to perform the necessary checks to ensure that the device complies with these requirements.

The decision is notified to the manufacturer. The communication must contain the conclusions of the audit and the justification of the evaluation decision.

5.4.

The manufacturer undertakes to use the approved quality assurance system and to ensure that it is always properly and effectively kept.

5.5.

The manufacturer shall inform the notified body that the quality assurance system is , all scheduled changes to the quality assurance system.

The notified body assesses the planned changes and decides whether the modified quality assurance system is still the same as those referred to in Z 5.2. Requirements are met, or a reassessment is required.

You are announcting your decision to the manufacturer. The notification must include the conclusion of the assessment and the justification for the assessment decision.

6.

Monitoring under the responsibility of the notified body

6.1.

Monitoring is designed to ensure that the manufacturer has the obligations under the approved Quality assurance system in compliance with the rules.

6.2.

The manufacturer shall grant the notified body for the assessment access to the manufacturing, Inspection, testing and storage facilities and provide it with all necessary documents, in particular:

a)

The documentation of the quality assurance system;

)

the technical documentation according to Z 2;

)

quality-related records, such as audit reports, test and calibration data, and reports on the qualifications of the personnel concerned in this area.

6.3.

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

6.4.

In addition, the notified body can see unannounced visits to the manufacturer. . During such visits, the notified body may, if necessary, carry out equipment tests or have it carried out in order to satisfy itself of the proper functioning of the quality assurance system. The notified body shall submit a survey report to the manufacturer and, in the case of a test, a test report.

7.

Conformance marking and EU Declaration of Conformity

7.1.

The manufacturer will bring to each individual meter that meets the applicable requirements of this The CE marking, the additional metrology marking in accordance with this Regulation and the responsibility of the notified body referred to in Z 5.1 shall be subject to the identification number thereof.

7.2.

The manufacturer issues a written EU declaration of conformity for each device model, and After placing the equipment on the market, it shall be ready for 10 years for the national authorities. The EU declaration of conformity must show which device model it has been issued for.

A copy of the EU declaration of conformity will be made available to the competent authorities on request.

A copy of the EU declaration of conformity is attached to each meter that is placed on the market. In cases where a large number of devices are delivered to one and the same user, this requirement can be interpreted in such a way that it does not apply to individual devices, but to a lot or a shipment.

8.

The manufacturer holds for a period of 10 years from the placing on the market of the device for the the national authorities shall provide the following documents:

a)

The documents according to Z 5.1;

)

the information in relation to the change according to Z 5.5 in its approved form;

)

the decisions and reports of the notified body according to Z 5.5, 6.3, and 6.4.

9.

Each notified body shall inform its notifying authority of the authorisations of the quality assurance systems which it has issued or withdrawn, and shall transmit to its notifying authority, at regular intervals or on request, a list of all the authorisations of quality assurance systems which it refuses, suspended or restricted in some other way.

10.

Plenipotentiary

The manufacturer's obligations in Z 3, 5.1, 5.5, 7 and 8 may be fulfilled by his authorized representative on his behalf and under his responsibility. if they are set on the work order.

Module E: Conformance with design based on the quality assurance based on the device

1.

Conformance with design based on quality assurance based on the device is the part of a conformity assessment procedure in which the manufacturer fulfils the obligations laid down in points 2 and 5 and ensures and declares on its own responsibility that the measuring instruments in question shall be the one in the EU type-examination certificate and the requirements applicable to them of this Regulation.

2.

Manufacturing

The manufacturer operates an approved quality assurance system for the final inspection and testing of the relevant measuring instruments according to Z 3 and is subject to the Monitoring according to Z 4.

3.

Quality assurance system

3.1.

The manufacturer requests a notified body of his choice to evaluate his or her choice. Quality assurance system for the measuring instruments concerned.

The application contains the following:

a)

The name and address of the manufacturer and, if the application is submitted by the plenipotentiary, also its name and address;

b)

a written declaration that the same application does not apply to any other notified body. ;

)

all relevant information about the provided device category;

d)

The documentation of the quality assurance system;

e)

the technical documentation of the approved type and a copy of the EU type-examination certificate.

3.2.

The quality assurance system ensures that the measuring instruments match the one in the EU type-examination certificate and the requirements of this Regulation applicable to them.

All elements, requirements, and regulations taken into account by the manufacturer are systematically and correctly written in the form of written principles, procedures and instructions. These quality assurance documents must enable a uniform interpretation of the quality assurance programmes, plans, manuals and reports.

In particular, you have an appropriate description of the following points:

a)

Quality objectives and organizational structure, responsibilities, and powers of the Executive management in terms of product quality;

)

Investigations and checks performed after manufacture;

)

Quality-related records such as audit reports, test and calibration data, and reports on the qualifications of the personnel concerned in this field;

)

Medium that monitors the effective operation of the quality assurance system.

3.3.

The notified body evaluates the quality assurance system to determine whether it is in Z 3.2 requirements are met.

For each component of the quality assurance system that meets the relevant specifications of the relevant harmonised standard, it goes from a Compliance with these requirements.

In addition to experience with quality management systems, at least one member of the audit team has experience with the assessment in the relevant the equipment and equipment concerned and knowledge of the applicable requirements of this Regulation. The audit also includes a visit to the premises of the manufacturer.

The audit team checks the in Z 3.1 lit.  (e) technical documentation, in order to ensure that the manufacturer is able to identify the relevant requirements of this Regulation and to carry out the necessary tests in order to ensure that the conformity of the appliance with of these requirements.

The decision is notified to the manufacturer. The communication contains the conclusions of the audit and the justification of the evaluation decision.

.

The manufacturer undertakes to use the approved quality assurance system and to ensure that it is always properly and effectively kept.

3.5.

The manufacturer shall inform the notified body that the quality assurance system , all scheduled changes to the quality assurance system.

The notified body assesses all planned changes and decides whether the modified quality assurance system is still the same as the one mentioned in Z 3.2. Requirements or whether a reassessment is required.

You are announcting your decision to the manufacturer. The notification must include the conclusion of the assessment and the justification for the assessment decision.

4.

Monitoring under the responsibility of the notified body

4.1.

Monitoring is designed to ensure that the manufacturer has the obligations under the approved Quality assurance system in compliance with the rules.

4.2.

The manufacturer shall grant the notified body for the assessment access to the manufacturing, Inspection, testing and storage facilities and provide it with all necessary documents, in particular:

a)

The documentation of the quality assurance system;

)

quality-related records, such as audit reports, test and calibration data, and reports on the qualifications of the personnel concerned in this area.

4.3.

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

4.4.

In addition, the notified body can see unannounced visits to the manufacturer. . During such visits, the notified body may, if necessary, carry out equipment tests or have it carried out in order to satisfy itself of the proper functioning of the quality assurance system. The notified body shall submit a survey report to the manufacturer and, in the case of a test, a test report.

5.

Compliance Labeling and EU Declaration of Conformity

5.1.

The manufacturer is bringing in each individual device that is used in the EU-type-examination certificate as described in this Regulation meets the applicable requirements of this Regulation, the CE marking, the additional metrology marking required by this Regulation and the Responsibility of the notified body referred to in Z 3.1 the identification number thereof.

5.2.

The manufacturer issues a written EU declaration of conformity for each device model, and After placing the equipment on the market, it shall be ready for 10 years for the national authorities. The EU declaration of conformity must show which device model it has been issued for.

A copy of the EU declaration of conformity will be made available to the competent authorities on request.

A copy of the EU declaration of conformity is attached to each meter that is placed on the market. In cases where a large number of devices are delivered to one and the same user, this requirement can be interpreted in such a way that it does not apply to individual devices, but to a lot or a shipment.

6.

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

a)

The documents according to Z 3.1;

)

the information in relation to the change according to Z 3.5 in its approved form;

)

the decisions and reports of the notified body according to Z 3.5, 4.3, and 4.4.

7.

Each notified body shall inform its notifying authority of the authorisations of the quality assurance systems which it has issued or withdrawn, and shall transmit to its notifying authority, at regular intervals or on request, a list of all the authorisations of quality assurance systems which it refuses, suspended or restricted in some other way.

8.

Plenipotentiary

The manufacturer's obligations in Z 3.1, 3.5, 5, and 6 can be fulfilled by his authorized representative on his behalf and under his responsibility. if they are set on the work order.

Module E1: Quality assurance of end acceptance and testing of devices

1.

The quality assurance of the end acceptance and testing of the devices is the Conformity assessment procedure, in which the manufacturer fulfils the obligations laid down in Z 2, 4 and 7 and ensures and declares on its own responsibility that the measuring instruments concerned comply with the requirements of this Regulation

2.

Technical documents

The manufacturer creates the technical documentation described in § 14. On the basis of these documents, it must be possible to assess the conformity of the device with the requirements in question; it must contain a suitable risk analysis and assessment. The technical documentation shall specify the requirements in force and shall cover the design, manufacture and operation of the equipment, insofar as they are relevant to the assessment.

3.

The manufacturer must have 10 years of technical documentation after placing the device on the market. long for the competent national authorities.

4.

Manufacturing

The manufacturer maintains an approved quality assurance system for the final inspection and testing of the relevant measuring instruments according to Z 5 and is subject to the Monitoring according to Z 6.

5.

Quality assurance system

5.1.

The manufacturer requests a notified body of his choice to evaluate his or her choice. Quality assurance system for the measuring instruments concerned.

The application contains the following:

a)

The name and address of the manufacturer and, if the application is submitted by the plenipotentiary, also its name and address;

b)

a written declaration that the same application does not apply to any other notified body. ;

)

all relevant information about the provided device category;

d)

The documentation of the quality assurance system;

e)

the technical documentation according to Z 2.

5.2.

The quality assurance system ensures that the measuring instruments match those for them applicable requirements of this Regulation.

All elements, requirements, and regulations taken into account by the manufacturer are systematically and correctly written in the form of written principles, procedures and instructions. These quality assurance documents must enable a uniform interpretation of the quality assurance programmes, plans, manuals and reports.

In particular, you have an appropriate description of the following points:

a)

Quality objectives and organizational structure, responsibilities, and powers of the Executive management in terms of product quality;

)

Investigations and checks performed after manufacture;

)

quality-related records, such as audit reports, test and calibration data, and reports on the qualifications of the staff employed in this area;

)

Medium that monitors the effective operation of the quality assurance system.

5.3.

The notified body evaluates the quality assurance system to determine whether it is in Z 5.2 requirements are met.

For each component of the quality assurance system that meets the relevant specifications of the relevant harmonised standard, it goes from a Compliance with these requirements.

In addition to experience with quality management systems, at least one member of the audit team has experience with the assessment in the relevant the equipment and equipment concerned and knowledge of the applicable requirements of this Regulation. The audit also includes a visit to the premises of the manufacturer.

The audit team reviews the technical documentation referred to in Z 2 to verify that the manufacturer is able to do so to identify the requirements of the Regulation and to carry out the necessary tests to ensure that the conformity of the equipment with these requirements is ensured. The decision shall be notified to the manufacturer. The communication must contain the conclusions of the audit and the justification of the evaluation decision.

5.4.

The manufacturer undertakes to use the approved quality assurance system and to ensure that it is always properly and effectively kept.

5.5.

The manufacturer shall inform the notified body that the quality assurance system is , all scheduled changes to the quality assurance system.

The notified body assesses all planned changes and decides whether the modified quality assurance system will still be the same as the one mentioned in Z 5.2. Requirements, or whether a reassessment is required. It shall announce its decision to the manufacturer. The notification must include the conclusion of the assessment and the justification for the assessment decision.

6.

Monitoring under the responsibility of the notified body

6.1.

Monitoring is designed to ensure that the manufacturer has the obligations under the approved Quality assurance system in compliance with the rules.

6.2.

The manufacturer shall grant the notified body for the assessment access to the manufacturing, Inspection, testing and storage facilities and provide it with all necessary documents, in particular:

a)

The documentation of the quality assurance system;

)

the technical documentation according to Z 2;

)

quality-related records, such as audit reports, test and calibration data, and reports on the qualifications of the personnel concerned in this area.

6.3.

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

6.4.

In addition, the notified body can see unannounced visits to the manufacturer. . During such visits, the notified body may, if necessary, carry out equipment tests or have it carried out in order to satisfy itself of the proper functioning of the quality assurance system. The notified body shall submit a survey report to the manufacturer and, in the case of a test, a test report.

7.

Conformance marking and EU Declaration of Conformity

7.1.

The manufacturer will bring to each individual meter that meets the requirements of this The CE marking, the additional metrology marking in accordance with this Regulation and the responsibility of the notified body referred to in Z 5.1 shall be subject to the identification number thereof.

7.2.

The manufacturer issues a written EU declaration of conformity for each device model, and After placing the equipment on the market, it shall be ready for 10 years for the national authorities. The EU declaration of conformity must show which device model it has been issued for.

A copy of the EU declaration of conformity will be made available to the competent authorities on request. A copy of the EU declaration of conformity shall be attached to any measuring instrument which is placed on the market. In cases where a large number of devices are delivered to one and the same user, this requirement can be interpreted in such a way that it does not apply to individual devices, but to a lot or a shipment.

8.

The manufacturer holds for a period of 10 years from the placing on the market of the device for the the national authorities shall provide the following documents:

a)

the documents according to Z 5.1,

)

the information in relation to the change according to Z 5.5 in its approved form;

)

the decisions and reports of the notified body according to Z 5.5, 6.3, and 6.4.

9.

Each notified body shall inform its notifying authority of the authorisations of the quality assurance systems which it has issued or withdrawn, and shall transmit to its notifying authority, at regular intervals or on request, a list of all the authorisations of quality assurance systems which it refuses, suspended or restricted in some other way.

10.

Plenipotentiary

The manufacturer's obligations in Z 3, 5.1, 5.5, 7 and 8 may be fulfilled by his authorized representative on his behalf and under his responsibility. if they are set on the work order.

Module F: Conformance with type based on a product check

1.

Conformance with the design on the basis of a test of the products is part of a conformity assessment procedure in which the manufacturer fulfils the obligations laid down in Z 2, 5.1 and 6 and ensures, on its own responsibility, that the affected persons subject to the provisions of Z 3 are concerned Measuring instruments of the type as described in the EU type-examination certificate and comply with the requirements of this Regulation applicable to them.

2.

Manufacturing

The manufacturer must take all the necessary measures to ensure that the manufacturing process and its monitoring ensure that the measuring instruments manufactured are consistent with the the approved type as described in the EU type-examination certificate and with the requirements of this Regulation applicable to them.

3.

Review

A notified body chosen by the manufacturer shall carry out the appropriate examinations and necessary tests or have them carried out in order to: To check the conformity of the equipment with the type as described in the EU type-examination certificate and the applicable requirements of this Regulation. The examinations and tests to check the conformity of the measuring instruments with the relevant requirements shall be carried out at the choice of the manufacturer either by means of testing and testing of each individual device according to Z 4 or by means of a statistical system. Testing and testing of the measuring instruments according to Z 5 performed.

4.

Review of compliance by testing and testing each device

4.1.

All measuring devices will be individually examined and appropriate tests will be carried out according to the relevant harmonised standard/s and/or the normative documents and/or equivalent tests in accordance with other relevant technical specifications in order to comply with the requirements of the EU type-examination certificate. Approved type and the applicable requirements of this Regulation , In the absence of a harmonised standard or a normative document, the notified body shall decide which tests are to be carried out.

4.2.

The notified body provides a basis for these examinations and tests. certificate of conformity and shall affix its identification number to any approved device or allow it to be brought under its responsibility. The manufacturer shall keep the certificates of conformity after placing the equipment on the market for ten years for the national authorities for inspection.

5.

Checking compliance with statistical means

5.1.

The manufacturer must take all the necessary measures to ensure that the manufacturing process and its Monitoring ensures uniformity of all produced lots and sets up its measuring instruments in uniform lots for inspection.

5.2.

Any sample will be taken from any batch according to Z 5.3. Each measuring instrument from a sample shall be examined individually and appropriate tests shall be carried out in accordance with the relevant harmonised standard (s), and/or the normative document (s) and/or equivalent tests in accordance with other to carry out relevant technical specifications in order to ensure conformity with the type as described in the EU type-examination certificate and with the applicable requirements of this Regulation, and in such a way as to determine whether the lot accepted or rejected. In the absence of such a harmonised standard or any such normative document, the notified body shall decide on which tests are to be carried out.

5.3.

The statistical method has the following points to consider:

The statistical control is based on functional characteristics. The sampling plan must ensure:

a)

a standard quality level corresponding to a 95% acceptance probability and a Disagreement ratio of less than 1%;

)

a quality limit level corresponding to an acceptance probability of 5% and one Disagreement ratio of less than 7%.

5.4.

If a lot is accepted, all measuring devices of the lot shall be considered to be approved, except for the Sample derived measuring instruments with negative test result.

The notified body shall issue a certificate of conformity on the basis of these examinations and tests, and shall bring it to each approved device their identification number, or have them brought under their responsibility. The manufacturer shall keep the certificates of conformity after placing the equipment on the market for ten years for the national authorities.

5.5.

If a lot is rejected, the notified body shall take appropriate measures to: prevent the lot from being placed on the market. The notified body may suspend statistical control and take appropriate measures in the event of a looted rejection of lots.

6.

Conformance marking and EU Declaration of Conformity

6.1.

The manufacturer will bring to each individual device the one with the in the EU-type-examination certificate, which complies with the applicable requirements of this Regulation, the CE marking and the additional metrology marking prescribed in accordance with this Regulation, and- under the responsibility of the notified body referred to in Z 3-the identification number thereof.

6.2.

The manufacturer will issue a written EU declaration of conformity for each device model, and After placing the equipment on the market, it shall be ready for 10 years for the national authorities. The EU declaration of conformity must show which device model it has been issued for.

A copy of the EU declaration of conformity will be made available to the competent authorities on request. A copy of the EU declaration of conformity shall be attached to any measuring instrument which is placed on the market. In cases where a large number of devices are delivered to the same user, this requirement may be interpreted in such a way that it does not apply to individual devices, but to a lot or a shipment. If the notified body referred to in Z 3 is correct, the manufacturer may, under the responsibility of this notified body, also attach the identification number of the notified body to the products.

7.

If the notified body is correct, the manufacturer can be under the responsibility of the The notified body shall attach the identification number of the notified body to the products during the manufacturing process.

8.

Plenipotentiary

The obligations of the manufacturer may be fulfilled by his authorized representative on his behalf and under his responsibility, if they are commissioned by the shall be established. An authorized representative may not fulfil the obligations of the manufacturer as defined in the Z 2 and 5.1.

MODULE F1: Compliance based on product verification

1.

Compliance based on a review of the products is the part a conformity assessment procedure in which the manufacturer fulfils the obligations laid down in z 2, 3, 6.1 and 7 and ensures and declares on its own responsibility that the relevant measuring instruments subject to the provisions of Z 4 are the subject of: for the requirements of this Regulation applicable to them.

2.

Technical documents

The manufacturer creates the technical documentation described in § 14. On the basis of these documents, it must be possible to assess the conformity of the device with the requirements in question; it must contain a suitable risk analysis and assessment. The technical documentation shall specify the requirements in force and shall cover the design, manufacture and operation of the equipment, insofar as they are relevant to the assessment.

The manufacturer must keep the technical documentation ready for the competent national authorities for 10 years after placing the device on the market.

3.

Manufacturing

The manufacturer shall take all the necessary measures to ensure that the manufacturing process and its monitoring ensure the conformity of the manufactured measuring instruments with the shall ensure the applicable requirements of this Regulation.

4.

Review

A notified body chosen by the manufacturer shall carry out the appropriate examinations and tests or have them carried out in order to ensure conformity of the to check measuring instruments with the applicable requirements of this Regulation. The examinations and tests to check conformity with the requirements shall be carried out at the choice of the manufacturer either by means of testing and testing of each individual device according to Z 5 or by means of a statistical testing and testing of the Measuring devices according to Z 6 performed.

5.

Review of compliance by testing and testing each device

5.1.

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

5.2.

The notified body provides a basis for these examinations and tests. certificate of conformity and shall affix its identification number to any approved device or allow it to be brought under its responsibility. The manufacturer shall keep the certificates of conformity after placing the equipment on the market for ten years for the national authorities.

6.

Checking compliance with statistical means

6.1.

The manufacturer must take all the necessary measures to ensure that the manufacturing process is Uniformity of all produced lots is guaranteed and presents its measuring instruments in uniform lots for inspection.

6.2.

Any sample will be taken out of any sample in accordance with Z 6.4.

6.3.

Each sample from a sample is to be examined individually and there are appropriate to carry out tests in accordance with the relevant harmonised standards and/or normative documents and/or equivalent tests in accordance with other relevant technical specifications, in order to ensure conformity with the applicable requirements of such standards and/or to ensure and determine whether the lot is adopted or is rejected. In the absence of such a harmonised standard or any such normative document, the notified body shall decide on which tests are to be carried out.

6.4.

For statistical purposes, consider the following points:

The statistical control is based on functional characteristics. The sampling plan must ensure:

a)

a standard quality level corresponding to a 95% acceptance probability and a Disagreement ratio of less than 1%;

)

a quality limit level corresponding to an acceptance probability of 5% and one Disagreement ratio of less than 7%.

6.5.

If a lot is accepted, all measuring devices of the lot shall be considered to be approved, except for the Sample derived measuring instruments with negative test result.

The notified body shall issue a certificate of conformity on the basis of these examinations and tests, and shall bring it to each approved device their identification number, or let them be brought under their responsibility.

The manufacturer holds the certificate of conformity after placing the device on the market for 10 years for the national authorities.

If a lot is rejected, the notified body shall take appropriate measures to prevent the batch from being placed on the market. The notified body may suspend statistical control and take appropriate measures in the event of a looted rejection of lots.

7.

Conformance marking and EU Declaration of Conformity

7.1.

The manufacturer will bring to each individual meter that meets the applicable requirements of this the CE marking and the additional metrology marking prescribed in accordance with this Regulation and the responsibility of the notified body referred to in Z 4 shall be the identification number thereof.

7.2.

The manufacturer issues a written EU declaration of conformity for each device model, and After placing the equipment on the market, it shall be ready for 10 years for the national authorities. The EU declaration of conformity must show which device model it has been issued for.

A copy of the EU declaration of conformity will be made available to the competent authorities on request.

A copy of the EU declaration of conformity is attached to each meter that is placed on the market. In cases where a large number of devices are delivered to one and the same user, this requirement may be interpreted in such a way that it does not apply to individual measuring devices, but to a lot or a shipment.

If the notified body referred to in Z 5 is correct, the manufacturer may, under the responsibility of this notified body, also be able to identify the identification number of the the notified body on the products.

8.

If the notified body is correct, the manufacturer can be under the responsibility of the The notified body shall attach the identification number of the notified body to the equipment during the manufacturing process.

9.

Plenipotentiary

The obligations of the manufacturer may be fulfilled by his authorized representative on his behalf and under his responsibility, if they are commissioned by the shall be established. An authorized representative may not fulfil the obligations of the manufacturer set out in Z 2, first paragraph, Z 3, and Z 6.1.

Module G: Compliance based on a single audit

1.

The compliance on the basis of a single audit is the Conformity assessment procedure with which the manufacturer fulfils the obligations laid down in the Z 2, 3 and 5 and ensures and declares on its own responsibility that the measuring instrument, which is subject to the provisions of Z 4, shall be those for the measuring instrument applicable requirements of this Regulation.

2.

Technical documents

The manufacturer creates the technical documentation described in § 14 and makes it available to the notified body named in Z 4. On the basis of these documents, it must be possible to assess the conformity of the device with the requirements in question; it must contain a suitable risk analysis and assessment. The technical documentation shall include the requirements in force and shall cover the design, manufacture and operation of the equipment, insofar as they are relevant to the assessment. The manufacturer shall keep the technical documentation available to the competent national authorities for 10 years after the equipment has been placed on the market.

3.

Manufacturing

The manufacturer shall take all the necessary measures to ensure that the manufacturing process and its monitoring ensure the conformity of the manufactured equipment with the shall ensure the applicable requirements of this Regulation.

4.

Review

A notified body chosen by the manufacturer shall carry out the appropriate examinations and tests in accordance with the relevant harmonised standards and/or Carry out or have carried out normative documents or equivalent tests in accordance with other relevant technical specifications, in order to verify the conformity of the equipment with the applicable requirements of this Regulation. In the absence of such a harmonised standard or any such normative document, the notified body shall decide on which tests are to be carried out.

The notified body shall issue a certificate of conformity on the basis of these examinations and tests, and shall bring it to each approved device their identification number, or let them be brought under their responsibility.

The manufacturer holds the certificate of conformity after placing the device on the market for 10 years for the national authorities.

5.

Compliance Labeling and EU Declaration of Conformity

5.1.

The manufacturer will bring to each device that meets the applicable requirements of this Regulation , the CE marking and the additional metrology marking prescribed by the Regulation, and under the responsibility of the notified body referred to in Z 4, the identification number thereof.

5.2.

The manufacturer issues a written EU declaration of conformity and keeps it after the Placing the device on the market for 10 years for the national authorities. The declaration of conformity must show the device for which it was issued.

A copy of the EU declaration of conformity will be made available to the competent authorities on request.

A copy of the EU declaration of conformity is attached to the meter.

6.

Plenipotentiary

The obligations of the manufacturer specified in Z 2 and 5 may be fulfilled by his authorized representative on his behalf and under his responsibility, if they are set on the work order.

Module H: Compliance based on a comprehensive quality assurance

1.

Conformance based on a comprehensive quality assurance is the Conformity assessment procedure with which the manufacturer fulfils the obligations laid down in the Z 2 and 5 and ensures, on its own responsibility, that the measuring instruments concerned comply with the requirements of this Regulation which apply to them

2.

Manufacturing

The manufacturer operates an approved quality assurance system for the development, manufacture, final inspection and testing of the relevant measuring devices after Z 3; it is subject to monitoring after Z 4.

3.

Quality assurance system

3.1.

The manufacturer requests a notified body of his choice to evaluate his or her choice. Quality assurance system for the measuring instruments concerned.

The application contains the following:

a)

The name and address of the manufacturer and, if the application is submitted by the plenipotentiary, also its name and address;

)

the technical documentation described in § 14, each for a model of each Measuring equipment category, these documents shall make it possible to assess the conformity of the equipment with the requirements in question, and shall include a suitable risk analysis and assessment. The technical documentation shall specify the requirements in force and shall cover the design, manufacture and operation of the equipment, insofar as they are relevant to the assessment.

)

the quality assurance system and

d)

a written declaration that the same application does not apply to any other notified body.

3.2.

The quality assurance system ensures the conformity of the measuring instruments with the applicable requirements of this Regulation.

All elements, requirements, and regulations taken into account by the manufacturer are systematically and correctly written in the form of written principles, procedures and instructions. These quality assurance documents must enable a uniform interpretation of the quality assurance programmes, plans, manuals and reports.

In particular, you have an appropriate description of the following points:

a)

Quality objectives and organizational structure, responsibilities, and powers of the Executive management in terms of design and device quality;

)

technical design specifications, including the standards to be applied, and-if the relevant harmonised standards and/or normative documents, the means to ensure that the essential requirements of this Regulation applicable to the measuring instruments are applied of other relevant technical specifications;

)

techniques for controlling development and validation of the development result, procedures, and systematic measures to be applied in the development of measuring instruments belonging to the category of equipment concerned;

)

appropriate manufacturing, quality control and quality assurance techniques, applied Procedures and systematic measures provided for;

e)

Before, during, and after manufacture, tests and tests their frequency;

)

Quality-related records such as audit reports, test and calibration data, and reports on the qualifications of the personnel concerned in this field;

)

means to achieve the required quality of the design and the device, as well as the the effective functioning of the quality assurance system.

3.3.

The notified body evaluates the quality assurance system to determine whether it is in Z 3.2 requirements are met.

For each component of the quality assurance system that meets the relevant specifications of the relevant harmonised standard, it goes from a Compliance with these requirements.

In addition to experience with quality management systems, at least one member of the audit team has experience with the assessment in the relevant the equipment and equipment concerned and knowledge of the applicable requirements of this Regulation. The audit also includes a visit to the premises of the manufacturer.

The audit team checks the in Z 3.1 lit.  (b) technical documentation, in order to ensure that the manufacturer is able to identify the relevant requirements of this Regulation and to carry out the necessary tests to ensure that the conformity of the appliance with of these requirements.

The manufacturer or its authorized representative is informed of the decision. The communication must contain the conclusions of the audit and the justification of the evaluation decision.

.

The manufacturer undertakes to use the approved quality assurance system and to ensure that it is always properly and effectively kept.

3.5.

The manufacturer shall inform the notified body that the quality assurance system , all scheduled changes to the quality assurance system.

The notified body assesses all planned changes and decides whether the modified quality assurance system is still the same as the one mentioned in Z 3.2. Requirements or whether a reassessment is required.

You are announcting your decision to the manufacturer. The notification must include the conclusion of the assessment and the justification for the assessment decision.

4.

Monitoring under the responsibility of the notified body

4.1.

Monitoring is designed to ensure that the manufacturer has the obligations under the approved Quality assurance system in compliance with the rules.

4.2.

The manufacturer shall grant the notified body for evaluation access to the development, Manufacture, inspection, testing and storage facilities and provide it with all necessary documents, in particular:

a)

The documentation of the quality assurance system;

)

the quality-related quality assurance system part of the quality assurance system Records such as results of analyses, calculations, tests;

)

the quality-related quality-related part of the quality assurance system Records such as test reports, test and calibration data, and reports on the qualifications of the personnel concerned in this area.

4.3.

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

4.4.

In addition, the notified body can see unannounced visits to the manufacturer. . During such visits, the notified body may, if necessary, carry out tests on equipment or have it carried out in order to satisfy itself of the proper functioning of the quality system. The notified body shall submit a survey report to the manufacturer and, in the case of a test, a test report.

5.

Compliance Labeling and EU Declaration of Conformity

5.1.

The manufacturer will bring to each individual device that meets the applicable requirements of this the CE marking, the additional metrology marking in accordance with this Regulation and the responsibility of the notified body referred to in Z 3.1, the identification number thereof.

5.2.

The manufacturer issues a written EU declaration of conformity for each device model, and After placing the equipment on the market, it shall be ready for 10 years for the national authorities. The EU declaration of conformity must show which device model it has been issued for.

A copy of the EU declaration of conformity will be made available to the competent authorities on request.

A copy of the EU declaration of conformity is attached to each meter that is placed on the market. In cases where a large number of devices are delivered to one and the same user, this requirement can be interpreted in such a way that it does not apply to individual devices, but to a lot or a shipment.

6.

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

a)

the technical documentation according to Z 3.1;

)

The documentation of the quality assurance system according to Z 3.1;

)

the information in relation to the change according to Z 3.5 in its approved form;

d)

the decisions and reports of the notified body according to Z 3.5, 4.3, and 4.4.

7.

Each notified body shall inform its notifying authority of the authorisations of the quality assurance systems which it has issued or withdrawn, and shall transmit to its notifying authority, at regular intervals or on request, a list of all the authorisations of quality assurance systems which it refuses, suspended or restricted in some other way.

8.

Plenipotentiary

The manufacturer's obligations in Z 3.1, 3.5, 5, and 6 can be fulfilled by his authorized representative on his behalf and under his responsibility. if they are set on the work order.

Module H1: Compliance based on a comprehensive quality assurance with design review

1.

Conformance based on a comprehensive quality assurance with design review it is the conformity assessment procedure in which the manufacturer fulfils the obligations set out in points (2) and (6) and ensures and declares on his own responsibility that the measuring instruments in question meet the requirements applicable to them of the Regulation.

2.

Manufacturing

The manufacturer operates an approved quality assurance system for development, manufacture, final inspection and testing of the measuring instrument in question after Z 3; it is subject to surveillance after Z 5. The suitability of the technical design of the measuring instruments must have been tested in accordance with Z 4.

3.

Quality assurance system

3.1.

The manufacturer requests a notified body of his choice to evaluate his or her choice. Quality assurance system for the measuring instruments concerned.

The application contains the following:

a)

The name and address of the manufacturer and, if the application is submitted by the plenipotentiary, also its name and address;

b)

all relevant information about the provided device category;

)

The documentation of the quality assurance system;

d)

a written declaration that the same application does not apply to any other notified body.

3.2.

The quality assurance system ensures the conformity of the measuring instruments with the applicable requirements of this Regulation.

All elements, requirements, and regulations taken into account by the manufacturer are systematically and correctly written in the form of written principles, procedures and instructions. These quality assurance documents must enable a uniform interpretation of the quality assurance programmes, plans, manuals and reports.

In particular, you have an appropriate description of the following points:

a)

Quality objectives and organizational structure, responsibilities, and powers of the Executive management in terms of design and device quality;

)

technical design specifications, including the standards to be applied, and-if the relevant harmonised standards and/or normative documents, the means to ensure that the essential requirements of this Regulation applicable to the measuring instruments are applied of other relevant technical specifications;

)

techniques for controlling development and validation of the development result, procedures, and systematic measures to be applied in the development of measuring instruments belonging to the category of equipment concerned;

)

appropriate manufacturing, quality control and quality assurance techniques, applied Procedures and systematic measures provided for;

e)

Before, during, and after manufacture, tests and tests their frequency;

)

Quality-related records such as audit reports, test and calibration data, and reports on the qualifications of the personnel concerned in this field;

)

means to achieve the required quality of the design and the device, as well as the the effective functioning of the quality assurance system.

3.3.

The notified body evaluates the quality assurance system to determine whether it is in Z 3.2 specified. In the case of each component of the quality assurance system which meets the relevant specifications of the relevant harmonised standard, it shall comply with these requirements.

In addition to experience with quality assurance systems, at least one member of the audit team has experience with the assessment in the relevant equipment and equipment, and knowledge of the applicable requirements of this Regulation. The audit also includes a visit to the premises of the manufacturer.

The manufacturer or its authorized representative is informed of the decision. The communication must contain the conclusions of the audit and the justification of the evaluation decision.

.

The manufacturer undertakes to use the approved quality assurance system and to ensure that it is always properly and effectively kept.

3.5.

The manufacturer shall inform the notified body that the quality assurance system , all scheduled changes to the quality assurance system.

The notified body assesses all planned changes and decides whether the modified quality assurance system is still the same as the one mentioned in Z 3.2. Requirements or whether a reassessment is required.

You are aware of your decision to the manufacturer or his authorized representative. The notification must include the conclusion of the assessment and the justification for the assessment decision.

3.6.

Each notified body shall inform its notifying authority of the authorisations of the quality assurance systems which it has issued or withdrawn, and shall transmit to its notifying authority, at regular intervals or on request, a list of all the authorisations of quality assurance systems which it refuses, suspended or restricted in some other way.

4.

Design Check

4.1.

The manufacturer requests the examination of the draft at the place notified in Z 3.1.

4.2.

The application provides information about the design, production, and operation of the device, and allows an assessment of compliance with the applicable requirements of the Regulation.

It contains

a)

Name and address of the manufacturer;

b)

a written declaration that the same application does not apply to any other notified body. ;

)

the technical documentation described in § 14. On the basis of these documents, it must be possible to assess the conformity of the device with the requirements in question; it must contain a suitable risk analysis and assessment. They collect the design and operation of the device to the extent that they are relevant to the assessment.

)

the additional evidence for an appropriate solution through the technical design. This additional evidence shall contain a reference to all the documents which have been used, in particular where the relevant harmonised standards and/or normative documents have not been fully applied, and shall include: where appropriate, the results of tests carried out in accordance with other relevant technical specifications in a suitable laboratory of the manufacturer or on his behalf and under his responsibility in another laboratory test laboratory .

4.3.

The notified body inspects the application and presents the manufacturer with a EU design-examination certificate if the design meets the requirements of this Regulation applicable to the equipment. This certificate shall contain the name and address of the manufacturer, the results of the tests, any conditions for their validity and the data required for the identification of the approved design. This certificate may be attached to one or more annexes.

This certificate and its annexes contain all relevant information on the basis of which the conformity of the manufactured measuring instruments with the shall assess the design and, if necessary, carry out a check after its entry into service. In order to be able to assess the conformity of the manufactured equipment, if it is properly adjusted, with appropriate means, with respect to the repeatability of its measurement performance with the design examined, it shall be particularly appropriate to: Specify the following:

)

the metrological characteristics of the device design;

)

to ensure the integrity of the devices (plotting, identifying the software and so on);

)

Other information that is used to identify the device and to monitor its visibility in relation to its external compliance with the design is required;

d)

any other specific information that is used to verify the characteristics of the produced Devices are required;

e)

in the case of a subdevice, all the information needed to ensure compatibility with other sub-devices or measuring devices.

The notified body will prepare an audit report in this respect and will keep it ready for the Member State that has notified it. Without prejudice to Section 19 (14), the notified body shall publish the contents of this report or parts thereof only with the consent of the manufacturer. The certificate is valid for ten years from the date of issue and can then be renewed for a further ten years. Where the draft does not comply with the applicable requirements of the Regulation, the notified body refuses to issue an EU design-examination certificate and shall inform the applicant thereof, in which case it shall give a detailed refusal to grant the certificate.

4.4.

The notified body is continuously informed of any changes in the generally accepted State of the art; if they indicate that the approved model no longer complies with the applicable requirements of this Regulation, it shall decide whether any such changes will require further investigation. If this is the case, the notified body shall inform the manufacturer thereof.

The manufacturer shall inform the notified body that issued the EU design examination certificate of any changes to the approved design, which may affect its conformity with the essential requirements of this Regulation or the conditions for the validity of the certificate. Such changes require additional approval by the notified body which issued the EU design examination certificate, in the form of an addition to the original EU design examination certificate.

4.5.

Each notified body shall inform its notifying authority of the EU design examination certificates and/or any additions to which they have been issued or withdrawn, and shall transmit to their notifying authority, at regular intervals or on request, a list of all certificates and/or Supplements to which it has been refused, suspended or otherwise restricted.

If you ask for this, the European Commission, the Member States of the European Union and the other notified bodies will receive a copy. of the EU type-examination certificates and/or their additions. The European Commission and the Member States of the European Union shall, on request, receive a copy of the technical documentation and of the results of the tests carried out by the notified body.

The notified body preserves a copy of the EU type-examination certificate, including its annexes and supplements, as well as the technical dossier, including the documents submitted by the manufacturer until the period of validity of the certificate expires.

4.6.

The manufacturer holds a copy of the EU design-examination certificate, its annexes, and Additions, together with the technical documentation after placing the device on the market, shall be ready for the national authorities for ten years.

5.

Monitoring under the responsibility of the notified body

5.1.

Monitoring is designed to ensure that the manufacturer has the obligations under the approved Quality assurance system in compliance with the rules.

5.2.

The manufacturer grants the notified body for evaluation access to the development, Manufacture, inspection, testing and storage facilities and provide it with all necessary documents, in particular:

a)

The documentation of the quality assurance system;

)

the quality-related quality assurance system for the development area Records such as results of analyses, calculations, tests, etc.;

)

the quality-related quality-related part of the quality assurance system Records such as test reports, test and calibration data, and reports on the qualifications of the personnel concerned in this area, etc.

5.3.

The notified body performs audits on a regular basis to ensure that the manufacturer maintains and applies the quality assurance system, and submits a corresponding audit report to it.

5.4.

In addition, the notified body can see unannounced visits to the manufacturer. . During such visits, the notified body may, if necessary, carry out tests on equipment or have it carried out in order to satisfy itself of the proper functioning of the quality system. The notified body shall submit a survey report to the manufacturer and, in the case of a test, a test report.

6.

Conformance marking and EU Declaration of Conformity

6.1.

The manufacturer will bring to each individual device that meets the requirements of this the CE marking, the additional metrology marking in accordance with this Regulation and the responsibility of the notified body referred to in Z 3.1, the identification number thereof.

6.2.

The manufacturer will issue a written EU declaration of conformity for each device model, and After placing the equipment on the market, it shall be ready for 10 years for the national authorities. The EU declaration of conformity shall indicate the device model for which it was issued and the number of the design-examination certificate.

A copy of the EU declaration of conformity will be made available to the competent authorities on request.

A copy of the EU declaration of conformity is attached to each meter that is placed on the market. In cases where a large number of devices are delivered to one and the same user, this requirement can be interpreted in such a way that it does not apply to individual devices, but to a lot or a shipment.

7.

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

a)

The documentation of the quality assurance system according to Z 3.1;

)

the information in relation to the change according to Z 3.5 in its approved form;

)

the decisions and reports of the notified body according to Z 3.5, 5.3, and 5.4.

8.

Plenipotentiary

The authorized representative of the manufacturer may submit the application referred to in Z 4.1 and 4.2 and the obligations referred to in Z 3.1, 3.5, 4.4, 4.6, 6 and 7 on his behalf and under his responsibility, if they are defined on behalf of the contract.

ANNEX 4

EU-DECLARATION OF CONFORMITY (No.  XXXX)

1.

Device Model/Device (Product, Type, Charging, or Serial Number):

2.

The name and address of the manufacturer and, where appropriate, its authorized representative:

3.

The sole responsibility for the issue of this declaration of conformity is borne by the Manufacturer.

4.

The object of the declaration (label of the device for traceability; it can be a Figure, if necessary to identify the device):

5.

The subject-matter of the statement described above meets the relevant Harmonisation legislation of the Union:

6.

specification of the relevant harmonized standards or normative documents that are based on , or indication of the other normative documents or other technical specifications for which conformity is declared:

7.

(If applicable:) The notified body (name, identification number) ... has ... (description of its Activity) ... and the following certificate:

8.

Additional information:

Undersigned for and on the name of:

(location and date of the exhibition):

(name, function) (signature):

Article 2

Amendment of the Regulation on mutual recognition in the field of measurement and calibration

On the basis of § 18 Z 4 and § 49 (2) of the Measure and Verification Act (MEG), BGBl. No 152/1950, as last amended by the Federal Law BGBl.  I No 148/2015 shall be prescribed:

The regulation of the Federal Minister for Economic Affairs on Mutual Recognition in the Field of Measure and Verification, BGBl. No 858/1993, as last amended by the BGBl Regulation.  II No 274/2006, shall be amended as follows:

1. § § 1 and 2 are:

"§ 1. The reciprocity and equivalence of provisions relating to bottles is considered to be a measure, provided that it is laid down in Directive 75 /107/EEC on the approximation of the laws of the Member States. Member States on bottles as a measure, OJ L 327, 30.4.2002, No.  14., which are based on the states indicated in the Annex.

§ 2. The reciprocity and equivalence of the quantities of pre-packed packagings carried out shall be subject to the provisions of Council Directive 76 /211/EEC of 20 June 1992 on the implementation of the Directive on the quality of the contents of pre-packed packages.  Jänner 1976 on the approximation of the laws of the Member States relating to the bottling of certain products by weight or volume in pre-packed packages (OJ 1976 L 327, p. No.  OJ No L 46, 21 February 1976, p. 1; Annex II, IX. Measuring instruments, Pct 15 of the EEA Agreement), as amended by Directive 78 /891/EEC (OJ L 136, 31.4.1978, p. No.  21), as amended by Directive 2007/45 laying down rules on nominal quantities for pre-packed products, repealing Council Directives 75 /106/EEC and 80 /232/EEC, and amending Council Directive 76 /211/EEC , OJ L 327, No.  OJ L 247, 21.09.2007 S 17, for the States indicated in the Annex. '

2. The entry rate in § 3 is:

" The reciprocity and equivalence of EC approval and initial calibration, provided that it is laid down in Directive 2009 /34/EC on common rules for measuring instruments and on measurement and testing procedures (recast), OJ C No.  OJ L 106 of 28.04.2009 S 7, for which the states indicated in the Annex are responsible for the following Directives: '

3. § 3 Z 7 is repealed.

4. Section 4 (1) reads:

"(1) The acceptance of the authorisations according to § 3 and related Z 1, 4, 9, 12 and 18 will be repealed with 30 November 2015."

5. § 4 (4) reads:

"(4) The acceptance of the authorisations according to § 3 and related Z 10 will be repealed with 30 November 2015."

6. In Section 4 (5), the sequence of letters "EEC" is replaced by the letter sequence "EG" .

7. The following paragraphs 7 and 8 shall be added to § 4:

" (7) The acceptance of the admission according to § 3 and the associated Z 6 shall be repealed.

(8) The EC authorisations issued as of 30 November 2015 shall continue to apply to measuring instruments referred to in paragraphs 1 and 4 until the expiry of their validity. "

8. The terms of the asset are:

"Member States of the European Union, States Parties to the EEA, Switzerland and Turkey"

Article 3

Change of the Schankvaseverordnung

On the basis of § 21 of the Measure and Verification Act (MEG), BGBl. No 152/1950, as last amended by the Federal Law BGBl.  I n ° 148/2015, shall be assigned:

The Schankvasßeverordnung, BGBl. No 572/1991, as last amended by the BGBl Regulation.  II No 274/2006, shall be amended as follows:

1. In § 8 (2), the term "I"is deleted after the word "Attachment" .

2. In the attachment set of the asset, the string " BGBl.  II No. 274/2006 " by the string " BGBl.  II No. 31/2016 " .

3. In Appendix Z 1.2, the phrase "flat surface" is replaced by the phrase "horizontal surface" .

4. In Table 1, in Table 1, in Table 1, the formula "+ 5 ml + 2.5%" is replaced by the formula "+ (5 ml + 2.5%)" .

Article 4

Amendment of the Oak Registration Ordinance of the Federal Minister for Economic Affairs concerning the approval of measuring instruments or measuring instrument parts for calibration as well as those for the approval and calibration Characters and stamps to use

On the basis of § § 18 Z 4, 36 Abs. 3 und 38 Abs. 8 des Measure-und Eichgesetz (MEG), BGBl. No 152/1950, as last amended by the Federal Law BGBl.  I n ° 148/2015, shall be assigned:

The Oak Admission Ordinance, BGBl. No 785/1992 as last amended by Regulation BGBl.  II No 172/2008, shall be amended as follows:

1. § 1 (3) reads:

"(3) The term" domestic "means the Member States of the European Union, the contracting states of the EEA, Switzerland and Turkey."

2. § 1a is:

"§ 1a. This Regulation applies to approvals for calibration, for which a conformity assessment is carried out in accordance with the Regulation laying down the conformity assessment procedures for Non-automatic weighing instruments, BGBl.  II No. 30/2016, or the Measuring Equipment Ordinance 2016, BGBl.  II No 31/2016. '

3. In Section 2 (3), the phrase "§ 18a (2) or § 40 Z 1 to Z 3" is replaced by the phrase "§ 40 Z 1 to 2" .

4. In § 2 para. 4, § 3 para. 3, § 4 para. 1 Z 10 and in the entire Section IX, the string "EEC" is replaced by the string "EG" .

5. The following paragraphs 6 and 7 shall be added to Article 26:

" (6) A grant of EC type approval is not permitted from 30 November 2015.

(7) If the validity of the EC type-approval is not renewed, this authorisation shall continue to apply to measuring instruments already in use. "

Article 5

Amendment of the Regulation of the Federal Minister for Economic Affairs and Labour concerning the recognition of verification of oak-technical tests

On the basis of § 18 Z 3 and § 49 (2) of the Measure and Verification Act (MEG), BGBl. No 152/1950, as last amended by the Federal Law BGBl.  I n ° 148/2015, shall be assigned:

The regulation of the Federal Minister of Economics and Labour concerning the recognition of calibration tests, BGBl.  II No 169/2000, as last amended by the BGBl Regulation.  II No 274/2006, shall be amended as follows:

1. 1 (1) (1) (1), including the rate of introduction of paragraph 1, reads as follows:

" (1) On measuring instruments manufactured in another Member State of the European Union, a Contracting State of the EEA Agreement, Switzerland or Turkey, the foreign oak-technical examination of the Domestic equivalent if

1.

measuring devices

a)

No EC confirmations pursuant to Directive 2009 /34/EC concerning common rules on Measuring instruments as well as measurement and test procedures, OJ L 327, 28.4. No.  OJ L 106, 28.04.2009, p. 7;

)

No CE marking on the basis of Directive 2014 /31/EU on the approximation of laws of the Member States concerning the provision of non-automatic weighing instruments on the market (recast), OJ L 327, 31.12.2002, p No.  107, may and may not fall within the scope of this Directive;

)

No CE marking on the basis of Directive 2014 /32/EU on the harmonisation of the Legislation of the Member States on the provision of measuring instruments on the market (recast), OJ C 327, 28.4.2002 No.  OJ L 96, 29.03.2014 p. 149, and do not fall within the scope of this Directive; '

2. In § 2 paragraph 1 Z 2 the phrase "(§ 58 MEG)" be deleted and the phrase " Accreditation Act, BGBl. No 486/1992, as last amended by the Federal Law BGBl. No. 430/1996 " by the phrase " Accreditation Act 2012, BGBl.  I n ° 28/2012, in the version BGBl.  I No 40/2014 " .

3. Section 2 (4) eliminates the word sequence "(§ 58 MEG)".

4. § 3 is:

"§ 3. The legal entities are subject to charges in the amount of the fees in accordance with § 14 of the Eichfee Ordinance 2013, BGBl.  II No 311/2013. '

5. In accordance with § 6, the following § 7 is added:

"§ 7. § 1 (1) Z 1 in the version of the BGBl Regulation.  II No. 31/2016 enters into force with 20 April 2016. "

Mitterlehner