Regulation Laying Down Conformity Assessment Procedures Relating To Non-Automatic Weighing Scales

Original Language Title: Verordnung zur Festlegung von Konformitätsfeststellungsverfahren betreffend Nichtselbsttätige Waagen

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30. Ordinance of the Federal Minister for Science, Research and the Economy on the establishment of conformity assessment procedures concerning non-automatic weighing instruments

"non-automatic weighing instruments")

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 n ° 148/2015, shall be assigned:

Scope

§ 1. (1) This Regulation shall apply to all non-automatic weighing scales, hereinafter also referred to as "measuring instruments", and shall lay down the requirements for the initial placing on the market and/or for the initial commissioning must be complied with.

(2) If the conformity of a non-automatic balance within the scope of this Regulation is established, this measuring instrument shall be deemed to be the first and shall be within the scope of the provisions of the Measure and Verification Act (MEG), BGBl. No 152/1950, as last amended by the Federal Law BGBl.  I No 148/2015, are used and/or are kept ready.

Definitions

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

1.

"Libra": a meter to determine the mass of a body based on the mass of a body Body acting gravity. A balance can also be used to determine other quantities, quantities, parameters, or characteristics associated with the mass;

2.

"Non-automatic balance": a scale that is used by an operator to intervene in weighing

3.

"Providing on the market": any delivery of a measuring device, whether in return for payment or free of charge for distribution or use on the Union market in the context of a business activity;

4.

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

5.

"Manufacturer": any natural or legal person who makes a measuring instrument or develop or manufacture the measuring instrument under its own name or trademark;

6.

"Plenipotentiary" means any natural or legal person established in the European Union, which has been commissioned by a manufacturer to carry out certain tasks in its name;

7.

"importer" means any natural or legal person resident in the European Union who is a member of the European Union the placing on the market of a measuring instrument from a third country on the Union market;

8.

"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;

9.

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

10.

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

11.

"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;

12.

"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;

13.

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

14.

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

15.

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

16.

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

17.

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

18.

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

19.

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

Essential Requirements

§ 3. (1) The essential requirements for non-automatic weighing instruments as well as the inscriptions are due to the verification regulations of the Federal Office for Eich-und Vermessungswesen (Federal Office of Eich-und Vermessungswesen) non-automatic weighing instruments.

(2) Where there are devices on a non-automatic scale, or if the non-automatic scale is connected to equipment which does not fall within the scope of the measure and calibration law, the balance shall be: essential requirements not for these facilities.

Obligations of manufacturers

§ 4. (1) Manufacturers shall ensure that measuring instruments which they place on the market and which are to be used in accordance with the provisions of the measure and calibration law, in accordance with the essential The requirements of the corresponding calibration regulations have been designed and manufactured.

(2) Manufacturers shall draw up the technical documentation referred to in Annex 1 Z 1.3 lit.  c and carry out the relevant conformity assessment procedure in accordance with § 11 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 § 13.

(3) Manufacturers shall keep the technical documentation and the EU declaration of conformity from the placing on the market of the measuring instrument 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. Any changes to the design of the measuring instrument or its characteristics, as well as any changes to the harmonised standards or other technical specifications referred to in the declaration of conformity of a measuring instrument, shall be proportionate to the requirements of the

(5) If this is considered appropriate in the light of the risk posed by a measuring instrument, manufacturers shall take samples of measuring instruments available on the market, carry out tests and carry out tests if necessary, a list of complaints, non-compliant measuring instruments and recalls of measuring instruments, and keep distributors informed of such monitoring.

(6) Manufacturers shall ensure that measuring instruments which they have placed on the market shall have a type, batch or serial number or a different identifier for their identification in accordance with the relevant calibration rules and bring the inscriptions provided for this purpose.

(7) Manufacturers shall attach the inscriptions in accordance with § 7 (4) MEG to measuring instruments which are not to be used or intended to be used within the scope of the calibration duty.

(8) There are devices on a measuring instrument or the measuring instrument is connected to devices which are not to be used or to be used within the scope of the provisions of the measure and calibration law, such The manufacturers attach the usage limit symbol to each of these devices in accordance with § 15.

(9) 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. The address refers to a one-stop shop where the manufacturer can be reached. The contact details are to be stated in German.

(10) Manufacturers shall ensure that the measuring instrument is accompanied by an operating instructions and information written in German. These operating instructions and information, as well as all markings, must be clear, understandable and clear.

(11) 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 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.

(12) 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

§ 5. (1) A manufacturer may nominate an authorised representative in writing. The obligations pursuant to § 4 (1) and the obligation to draw up the technical documentation pursuant to § 4 (2) are not part of the mandate of an authorized representative.

(2) An authorised 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 over 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

§ 6. (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 Article 11 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 must comply with the requirements of Section 4 (6) to (9).

(3) If a importer considers or has reason to believe that a measuring instrument does not meet the essential requirements of the calibration requirements, it shall not place the measuring instrument on the market until such time as the measuring instrument has been placed on the market. Conformity of the measuring instrument is manufactured. 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 ensure that the manufacturer has complied with the requirements of § 4 (7) for measuring instruments which are not to be used or intended to be used within the scope of the calibration duty.

(5) The importer shall indicate on the measuring instrument its name, registered trade name or registered trade mark and the postal address at which it can be contacted. If it is necessary to open the packaging, this information can be provided on the packaging and in the documents attached to the measuring instrument. The contact details are to be installed in German.

(6) The importer shall ensure that the measuring instrument is accompanied by the operating instructions and information in the German language.

(7) 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 the Do not interfere with the calibration rules.

(8) If, in view of the hazards posed by a measuring instrument, the importer is considered to be appropriate, the importer shall take samples of measuring instruments available on the market, carry out tests and carry out tests. if necessary, a list of complaints, non-compliant measuring instruments and recalls of measuring instruments, and keep distributors informed of such monitoring.

(9) The 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: Corrective measures to ensure 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.

(10) 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 10 years and shall ensure that they have the technical Submit documents on request.

(11) The importer shall provide the Federal Ministry of Science, Research and the Economy and the calibration 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 are placed on the market.

Obligations of traders

§ 7. (1) The dealers shall take due care to comply with the requirements of this Regulation and the calibration rules with due care when they provide a measuring instrument on the market.

(2) Before they provide a measuring instrument on the market, dealers shall verify that the meter is marked with the CE marking and the additional metrology marking, whether it is accompanied by the required documents, and the operating instructions and the information are attached in German, and whether the manufacturer and the importer have complied with the requirements of § 4 (6) to (9) and Section 6 (5).

(3) If a trader is of the opinion or has reason to believe that a measuring instrument does not comply with the requirements of the calibration requirements, he shall only provide this measuring instrument on the market if its Compliance is established. If a risk is associated with the measuring instrument, the dealer also informs the manufacturer or importer as well as the Federal Ministry for Science, Research and Economics and the calibration authorities about it.

(4) The distributors shall ensure that the manufacturer and the importer have complied with the requirements laid down in Article 4 (7) and Section 6 (5) for measuring instruments which are not used or used in the context of the calibration plight .

(5) 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 the calibration rules do not affect.

(6) Traders who are of the opinion or have reason to believe that a measuring instrument supplied by them on the market is not in conformity with this Regulation or the calibration requirements shall ensure that the the necessary corrective measures are taken to ensure the conformity of this measuring instrument, to take it back or to recall it if necessary. 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.

(7) The dealers shall provide the Federal Ministry of Science, Research and the Economy and the calibration authorities with all the information and documents required for the proof of conformity of a Measuring instruments are 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

§ 8. A importer or trader 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 § 4 if he/she is a measuring instrument under his own name or of 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

§ 9. (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 referred to in paragraph 1 10 years from the point of reference of the measuring instrument and ten years after the measurement device has been handed over.

Compliance of measuring devices

§ 10. In the case of measuring instruments which are in conformity with harmonised standards or parts of which the references have been published in the Official Journal of the European Union, conformity shall be subject to: , the essential safety requirements are presumed to be in accordance with the relevant calibration requirements covered by the relevant standards or parts thereof.

Conformity Assessment Procedures

§ 11. (1) The assessment of the conformity of a measuring instrument with the requirements of the corresponding calibration regulations shall be carried out in accordance with a procedure to be selected by the manufacturer. Conformity assessment procedures, as follows:

1.

Module B as defined in Annex 1 and subsequently either Module D as defined in Annex 1 or Module F in accordance with the Annex 1;

2.

Module G according to Appendix 1.

(2) Measuring instruments in which no electronic device is used and whose weighing device does not use a spring to compensate for the load applied, does not, however, have to make the procedure according to module B mandatory after Annex 1 shall be submitted. For those measuring instruments where module B does not apply in accordance with Annex 1, module D1 as defined in Annex 1 or module F1 shall be applied in accordance with Annex 1.

(3) If a body notified in accordance with Section 16 is active, records and correspondence relating to the conformity assessment procedures carried out shall be either in German or in any other place from that point of view. to write a recognized language.

EU Declaration of Conformity

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

(2) The EU declaration of conformity corresponds in its structure to the specimen in Annex 2, contains the elements specified in the relevant modules in Annex 1 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

§ 13. (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 apply the general principles in accordance with Article 30 of Regulation (EC) No 765/2008 mutagenly.

Affixing the CE marking and the additional metrology marking

§ 14. (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 label.

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

(3) The additional metrology marking is immediately behind the CE mark.

(4) Behind the CE marking and the additional metrology marking, the identification number (s) of the notified body (s) operating in the production control phase in accordance with Annex 1 shall be (s).

(5) 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.

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

Usage Limit icon

§ 15. The use restriction symbol referred to in Article 4 (8) consists of a square with an edge length of at least 25 mm, which is the black imprint on the upper case M the red background is crossed and diagonally crossed. This is easily visible and durable.

Notification

§ 16. (1) The notification of digits 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

§ 17. (1) A conformity assessment body shall 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 work 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.

(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, and for which it has been notified, in accordance with Annex 1, whether or not these 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 appropriate instruments and procedures to distinguish between the tasks it performs 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 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 1 under this Regulation shall be subject to professional secrecy except in relation to: the competent authorities of the Member State 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

§ 18. 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 § 17, in so far as the applicable harmonised standards cover these requirements.

Branch companies of notified bodies and subcontracting

§ 19. (1) The notified body assigns or transfers to a subcontractor certain tasks associated with the conformity assessment, and it shall have ensure that the subcontractor or the branch undertaking meets the requirements laid down in § 17 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 1 for the to keep the notifying authority.

Obligations of notified bodies in relation to their work

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

(2) Compliance assessments shall be carried out with due regard for 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) It shall establish a notified body that a manufacturer has failed to meet the essential requirements laid down in the calibration rule or in the relevant harmonised standards or other technical specifications. 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

§ 21. (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 where compliance is subject to a presumption of conformity in accordance with § 10 deficient.

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

Risk through compliant measuring devices

§ 22. (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 measuring instruments 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

§ 23. (1) Without prejudice to § 21, the economic operator concerned shall be called upon 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 14 of this Regulation;

2.

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

3.

The inscriptions according to § 4 (6) to (8) were not applied or were not subject to § 4. Par. 6 to 8;

4.

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 § 14;

5.

The EU declaration of conformity has not been issued;

6.

The EU Declaration of Conformity has not been issued correctly;

7.

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

8.

missing the information specified in Section 4 (9) or § 6 (5) is incorrect or incomplete;

9.

A different administrative request according to § 4 or § 6 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

§ 24. 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

§ 25. This Regulation provides for Directive 2014 /31/EU on the approximation of the laws of the Member States relating to the provision of non-automatic weighing instruments on the market, OJ L 327, 28.1.2014, p. No.  OJ L 96, 29.03.2014 p.

.

Transitional provisions

§ 26. (1) As of 20 April 2016, only more measuring instruments may be placed on the market for the first time or put into service 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 Regulation of the Federal Minister for Economic Affairs on the establishment of conformity assessment procedures concerning non-automatic weighing instruments, BGBl. No 751/1994, in the BGBl version.  II No 222/2010, and have a valid certificate for that purpose.

Entry into force

§ 27. (1) This Regulation shall enter into force on 20 April 2016. At the same time, the regulation of the Federal Minister of Economic Affairs for the establishment of conformity assessment procedures concerning non-automatic weighing instruments, BGBl. No 751/1994, in the BGBl version.  II No 222/2010, except for force.

(2) From the date of the proclamation of this Regulation, entities may be appointed in accordance with § 17.

(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.

Mitterlehner

ANNEX 1

CONFORMITY ASSESSMENT PROCEDURE

1. Module B: EU type-examination

1.1.

The EU type-examination is the part of a conformity assessment procedure, in the case of a notified body, the technical design of a measuring instrument shall be examined and tested and certified that it complies with the requirements of this Regulation applicable to the measuring instrument.

1.2.

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

1.

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

2.

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 1.3 (a) technical documentation and additional evidence, as well as the examination of samples of one or more important parts of the measuring instrument which are representative of the planned production (combination of design and design);

3.

Evaluation of the appropriateness of the technical design of the meter on the basis of an examination of the Z 1.3 technical documentation and additional evidence, without examination of a pattern (design pattern).

1.3.

The application for EU type-examination is from the manufacturer to a single to the notified body of its 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. On the basis of these documents, it must be possible to assess the conformity of the measuring instrument with the applicable requirements of this Regulation; it must contain a suitable risk analysis and risk assessment. The technical documentation shall cover the applicable requirements and the design, manufacture and operation of the measuring instrument, insofar as they are relevant to the assessment. The technical documentation shall contain, where appropriate, at least the following elements:

i)

a general description of the measuring device;

ii)

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

iii)

Descriptions and explanations that are used to understand these drawings and plans, and the functioning of the measuring device is required;

)

a list of the harmonised standards, the references of which are published in the Official Journal of the The European Union has been published, fully or in part, and, if these harmonized standards have not been applied, a description of the solutions which meet the essential safety requirements of this Regulation has been complied with, including a list of which other relevant technical specifications have been applied; in the case of harmonised standards partially applied, the parts which have been applied shall be indicated in the technical documentation;

)

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

vi)

the audit reports;

)

representative samples for the production in question; the notified body may have additional Request a pattern when required to perform 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 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.

1.4.

The notified body has the following tasks:

Based on the measuring device:

1.4.1.

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

Based on the pattern/pattern:

1.4.2.

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 which parts have been designed in accordance with other relevant technical specifications;

1.4.3.

conducting or initiating appropriate examinations and tests to determine whether the solutions from the relevant harmonised standards have been correctly applied, provided that the manufacturer has opted for their application;

1.4.4.

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 Relevant essential requirements of this Regulation ;

1.4.5.

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

1.5.

The notified body creates an audit report on the z 1.4 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.

1.6.

The design pattern corresponds to the requirements of the meter in question for the meter 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 makes an assessment of the conformity of the manufactured Measuring instruments with the tested design and a control after it is put into operation.

The EU type-examination certificate is valid for ten years from its date of issue and can then be extended for another ten years thereafter. In the case of fundamental changes in the construction of the measuring instrument, e.g.  The validity of the EU type-examination certificate can be limited to two years and extended by three years due to the use of new techniques.

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.

1.7.

The notified body is continuously informed of any changes in the generally accepted State of the art which indicates that the approved design no longer complies with the applicable requirements of this Regulation, and decides whether 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 which has received the technical documentation relating to the EU type-examination certificate of all modifications to the approved type, which shall be in conformity with the essential requirements of the approved model. Regulation or the conditions of validity of the certificate. Such changes require an additional permit in the form of a supplement to the original EU type-examination certificate.

1.8.

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  .

Each notified body shall inform the other notified bodies of the EU type-examination certificates and/or any additions they may have made to them. , refused, withdrawn, suspended or otherwise restricted, and, if so requested, shall inform them of all certificates and/or additions issued by the Commission.

If you require 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 supplements. The European Commission and the Member States of the European Union shall, on request, receive a copy of the technical documentation and the results of the tests carried out by the notified body. The notified body shall keep a copy of the EU type-examination certificate, including its annexes and additions, and the technical dossier, including the documents submitted by the manufacturer, until such time as the validity of the certificate is valid. Certificate ends.

1.9.

The manufacturer holds a copy of the EU type-examination certificate, its attachments, and Supplements, together with the technical documentation, shall be ready for the national authorities for 10 years after the measuring instrument has been placed on the market.

1.10.

The authorized agent of the manufacturer may submit the application mentioned in Z 1.3 and the Obligations under Z 1.7 and 1.9 shall be fulfilled if they are fixed on behalf of the contract.

2. Module D: Conformity with the construction pattern based on a quality assurance of the production process

2.1.

Conformance with design based on a 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 points 2.2 and 2.5 and ensures and declares on its own responsibility that the measuring instruments in question are in conformity with the requirements of the of the type of type described in the EU type-examination certificate, and comply with the applicable requirements of this Regulation.

2.2.

Manufacturing

The manufacturer operates an approved quality assurance system for the manufacture, final inspection and testing of the relevant measuring devices according to Z 2.3 and is subject to surveillance in accordance with Z 2.4.

2.3.

Quality assurance system

2.3.1.

The manufacturer applies to the notified body of his choice the rating of its 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 measurement device category provided;

d)

the quality assurance system and

e)

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

2.3.2.

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 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 operational 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 staff working in this area, etc.;

e)

means the realization of the required product quality and the effective How the quality assurance system works.

2.3.3.

The notified body evaluates the quality assurance system to determine if: it meets the requirements set out in Z 2.3.2.

For each component of the quality assurance system that meets the relevant specifications of the relevant harmonised standard, it shall be taken from the 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 Measuring equipment and measuring instrument technology, 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 data in Z 2.3.1 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 measuring instrument with of these requirements.

The decision is notified to the manufacturer. The communication must contain the outcome of the audit and the justification of the assessment decision.

2.3.4.

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

2.3.5.

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 changed quality assurance system is still the same as those specified in Z 2.3.2. Requirements are met, or a reassessment is required.

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

2.4.

Monitoring under the responsibility of the notified body

2.4.1.

The monitor is designed to ensure that the manufacturer has the obligations under approved quality assurance system.

2.4.2.

The manufacturer provides the notified body for the assessment access to the Manufacture, 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 staff working in this area, etc.

2.4.3.

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.

2.4.4.

In addition, the notified body can see unannounced visits to the manufacturer. . During such visits, the notified body may, where necessary, carry out measurement equipment tests or have it carried out in order to ensure 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.

2.5.

Conformance marking and EU Declaration of Conformity

2.5.1.

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 required under this Regulation and-under the Responsibility of the notified body referred to in Z 2.3.1-the identification number thereof.

2.5.2.

The manufacturer provides a written EU declaration of conformity for each measuring device model. and shall keep it available to the national authorities for 10 years after the measuring instrument has been placed on the market. The EU declaration of conformity must show which measuring 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.

2.6.

The manufacturer holds the meter for 10 years after the meter has been placed on the market. The following documents are available to national authorities:

a)

The documents in accordance with Z 2.3.1;

)

the information related to the change according to Z 2.3.5 in its approved version;

)

the decisions and reports of the notified body according to z 2.3.5, 2.4.3, and 2.4.4.

2.7.

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.

2.8.

Plenipotentiary

The manufacturer ' s obligations referred to in points 2.3.1, 2.3.5, 2.5, and 2.6 may be fulfilled by his authorized representative on his behalf and under his/her mandate. Responsibility will be met if they are set on the work order.

3. Module D1: Quality assurance in relation to the production process

3.1.

The quality assurance related to the production process is the Conformity assessment procedure, in which the manufacturer fulfils the obligations laid down in Z 3.2, 3.4 and 3.7 and ensures and declares on its own responsibility that the measuring instruments in question comply with the requirements applicable to them of this Regulation.

3.2.

Technical documents

The manufacturer creates the technical documentation. It must be possible, on the basis of the documentation, to assess the conformity of the measuring instrument with the relevant requirements; it must contain a suitable risk analysis and risk assessment. The technical documentation shall cover the applicable requirements and the design, manufacture and operation of the measuring instrument, insofar as they are relevant to the assessment. The technical documentation shall contain, where appropriate, at least the following elements:

a)

a general description of the measuring device;

)

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

)

descriptions and explanations that are used to understand these drawings and plans, and the Operation of the measuring device is required;

)

a list of the harmonised standards, the references of which are published in the Official Journal of the The European Union has been published, fully or in part, and, if these harmonized standards have not been applied, a description of the solutions which meet the essential safety requirements of this Regulation has been complied with, including a list of which other relevant technical specifications; in the case of harmonised standards partially applied, the parts which have been applied shall be indicated in the technical documentation;

e)

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

f)

the audit reports.

3.3.

The manufacturer shall keep the technical documentation for 10 years after placing the product on the market. Measuring instruments available to the competent national authorities.

3.4.

Manufacturing

The manufacturer operates an approved quality assurance system for the manufacture, final inspection and testing of the relevant measuring instruments according to Z 3.5 and is subject to monitoring according to Z 3.6.

3.5.

Quality assurance system

3.5.1.

The manufacturer applies to the notified body of his choice the rating of its 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 measurement device category provided;

d)

The documentation of the quality assurance system;

e)

the technical documentation according to Z 3.2.

3.5.2.

The quality assurance system ensures the conformity of the measuring instruments with 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;

)

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 staff working in this area, etc.;

e)

means to achieve the required product quality and to ensure the effective operation of the Quality assurance systems can be monitored.

3.5.3.

The notified body evaluates the quality assurance system to determine if it is requirements mentioned in Z 3.5.2.

For each component of the quality assurance system that meets the relevant specifications of the relevant harmonised standard, it shall be taken from the 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 Measuring equipment and measuring instrument technology, and knowledge of the applicable requirements of this Regulation. The audit also includes a visit to the premises of the manufacturer. The audit team shall verify the technical documentation referred to in Z 3.2 in order to ensure that the manufacturer is able to identify the relevant requirements of the Regulation and to carry out the necessary tests to ensure that the Compliance of the measuring instrument with these requirements is ensured.

The decision is notified to the manufacturer. The communication must contain the outcome of the audit and the justification of the assessment decision.

3.5.4.

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

3.5.5.

The manufacturer shall inform the notified body that the quality assurance system has been notified. , 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 specified in Z 3.5.2. Requirements are met, or a reassessment is required.

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

3.6.

Monitoring under the responsibility of the notified body

3.6.1.

The monitor is designed to ensure that the manufacturer has the obligations under the approved quality assurance system.

3.6.2.

The manufacturer shall grant the notified body for the assessment access to the Manufacture, 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 3.2;

)

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

3.6.3.

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.

3.6.4.

In addition, the notified body can see unannounced visits to the manufacturer. . During such visits, the notified body may, if necessary, carry out product testing 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 a test report in the event of a test.

3.7.

Compliance Labeling and EU Declaration of Conformity

3.7.1.

The manufacturer will bring to each individual meter that meets the applicable requirements of this the CE marking and the supplementary metrology marking in accordance with this Regulation and under the responsibility of the notified body referred to in point Z 3.5.1 shall indicate the identification number thereof.

3.7.2.

The manufacturer presents a written EU declaration of conformity for each measuring device model. and shall keep it available to the national authorities for 10 years after the measuring instrument has been placed on the market. The EU declaration of conformity must show which measuring 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.

3.8.

The manufacturer shall last 10 years after placing the measuring instrument on the market for the The following documents are available to national authorities:

a)

The documents in accordance with Z 3.5.1;

)

the information related to the change according to Z 3.5.5 in its approved version;

)

the decisions and reports of the notified body according to Z 3.5.5, 3.6.3, and 3.6.4.

3.9.

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.

3.10.

Plenipotentiary

The manufacturer ' s obligations in Z 3.3, 3.5.1, 3.5.5, 3.7 and 3.8 may be fulfilled by his authorized representative on his behalf and under his/her mandate. Responsibility will be met if they are set on the work order.

4. Module F: Conformance with design based on a product check

4.1.

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 points (4.2) and (4.5), and declares on his own responsibility that the measuring instruments subject to the provisions of Z 4.3 comply with the type as described in the EU type-examination certificate, and shall comply with the requirements of this Regulation applicable to them.

4.2.

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.

4.3.

Review

A notified body chosen by the manufacturer shall carry out the appropriate examinations and tests in order to ensure that the measuring instruments are in accordance with the requirements of the the type of approved type as described in the EU type-examination certificate and the relevant requirements of this Regulation.

The examinations and tests to check the conformity of the measuring instruments with the relevant requirements are carried out by examination and testing. Each individual measuring instrument according to Z 4.4.

4.4.

Review of compliance by examining and checking each meter

4.4.1.

All measuring devices will be individually examined and appropriate tests will be carried out according to the relevant harmonised standards or equivalent tests, as listed in other relevant technical specifications, in order to ensure conformity with the approved EU type-examination certificate Type and the applicable requirements of this Regulation

In the absence of such a harmonised standard, the notified body decides which checks are to be performed.

4.4.2.

The notified body provides a basis for the investigations and tests certificate of conformity and shall affix its identification number to any approved measuring instrument or allow the identification number to be brought under its responsibility.

The manufacturer complies with the certificates of conformity for 10 years after placing the measuring instrument on the market for the national authorities to view the certificate ready.

4.5.

Compliance Labeling and EU Declaration of Conformity

4.5.1.

The manufacturer will bring to each individual measuring device that is used in the EU-type-examination certificate as described in this Regulation and the applicable requirements of this Regulation, the CE marking and the additional metrology marking in accordance with this Regulation, as well as-under the Responsibility of the notified body referred to in Z 4.3-the identification number thereof.

4.5.2.

The manufacturer provides a written EU declaration of conformity for each measuring device model. and shall keep it available to the national authorities for 10 years after the measuring instrument has been placed on the market. The EU declaration of conformity must show which measuring 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.

If the notified body referred to in Z 4.3 agrees, the manufacturer may, under their responsibility, also the identification number of the notified body to the notified body. Attach measuring devices.

4.6.

If the notified body is correct, the manufacturer can use the identification number under their responsibility. of the notified body during the manufacturing process on the measuring instruments.

4.7.

Plenipotentiary

The obligations of the manufacturer may be fulfilled by his authorized representative on his behalf and under his responsibility, provided that they are commissioned by the shall be established. An authorized representative shall not comply with the obligations of the manufacturer set out in Z 4.2.

5. Module F1: Compliance based on product verification

5.1.

Compliance based on a test of the products is the Conformity assessment procedure, in which the manufacturer fulfils the obligations laid down in the provisions of Z 5.2, 5.3 and 5.6 and ensures and declares on its own responsibility that the measuring instruments subject to the provisions of Z 5.4 shall meet the requirements of shall comply with the requirements of this Regulation.

5.2.

Technical documents

5.2.1.

The manufacturer creates the technical documentation. On the basis of these documents, it must be possible to assess the conformity of the measuring instrument with the relevant requirements; they must contain a suitable risk analysis and assessment. The technical documentation shall cover the applicable requirements and the design, manufacture and operation of the measuring instrument, insofar as they are relevant to the assessment. The technical documentation shall contain, where appropriate, at least the following elements:

a)

a general description of the measuring device;

)

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

)

descriptions and explanations that are used to understand these drawings and plans, and the Operation of the measuring device is required;

)

a list of the harmonised standards, the references of which are published in the Official Journal of the The European Union has been published, fully or in part, and, if these harmonized standards have not been applied, a description of the solutions which meet the essential safety requirements of this Regulation has been complied with, including a list of which other relevant technical specifications; in the case of harmonised standards partially applied, the parts which have been applied shall be indicated in the technical documentation;

e)

the results of design calculations, checks, etc., and

f)

the audit reports.

5.2.2.

The manufacturer holds the technical documentation for 10 years after placing the product on the market. Measuring instruments available to the competent national authorities.

5.3.

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.

5.4.

Review

A notified body chosen by the manufacturer shall carry out the appropriate examinations and tests to ensure the conformity of the measuring instruments with the the applicable requirements of this Regulation.

The examinations and tests to check compliance with these requirements will be carried out by examining and testing each individual measuring instrument. carried out according to Z 5.5.

5.5.

Review of compliance by examining and checking each meter

5.5.1.

All measuring devices are to be examined individually, and appropriate checks are performed in accordance with the relevant harmonised standard (s) or equivalent tests as set out in other relevant technical specifications in order to ensure their conformity with the requirements applicable to them. In the absence of such a harmonised standard, the notified body shall decide which tests are to be carried out.

5.5.2.

The notified body provides a basis for the investigations and tests certificate of conformity and shall affix its identification number to any approved measuring instrument or allow the identification number to be brought under its responsibility.

The manufacturer holds the conformity certificates for the national authorities ten years after the measuring device is placed on the market.

5.6.

Compliance Labeling and EU Declaration of Conformity

5.6.1.

The manufacturer will bring to each individual meter that will meet the applicable requirements of this the CE marking and the additional metrology marking in accordance with this Regulation and under the responsibility of the notified body referred to in Z 5.4.

5.6.2.

The manufacturer provides a written EU declaration of conformity for each measuring device model. and shall keep it available to the national authorities for 10 years after the measuring instrument has been placed on the market. The EU declaration of conformity must show which measuring 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.

If the notified body referred to in Z 5.5 agrees, the manufacturer may, under their responsibility, also the identification number of the notified body to the Attach measuring devices.

5.7.

If the notified body is correct, the manufacturer can use the identification number under their responsibility. of the notified body during the manufacturing process on the measuring instruments.

5.8.

Plenipotentiary

The obligations of the manufacturer may be fulfilled by his authorized representative on his behalf and under his responsibility, provided that they are commissioned by the shall be established. An authorized representative shall not comply with the obligations of the manufacturer set out in points 5.2.1 and 5.3.

6. Module G: Compliance based on an individual check

6.1.

The compliance on the basis of an individual audit is the Conformity assessment procedure with which the manufacturer fulfils the obligations set out in Z 6.2, 6.3 and 6.5 and ensures and declares on its own responsibility that the measuring instrument, which is subject to the provisions of Z 6.4, complies with the requirements of applicable requirements of this Regulation.

6.2.

Technical documents

6.2.1.

The manufacturer creates the technical documentation and places it in the Z 6.4 Notified body shall be made available. On the basis of these documents, it must be possible to assess the conformity of the measuring instrument with the relevant requirements; they must contain a suitable risk analysis and assessment. The technical documentation shall cover the applicable requirements and the design, manufacture and operation of the measuring instrument, insofar as they are relevant to the assessment.

The technical documentation may contain at least the following elements:

a)

a general description of the measuring device;

)

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

)

descriptions and explanations that are used to understand these drawings and plans, and the Operation of the measuring device is required;

)

a list of the harmonised standards, the references of which are published in the Official Journal of the The European Union has been published, fully or in part, and, if these harmonized standards have not been applied, a description of the solutions which meet the essential safety requirements of this Regulation has been complied with, including a list of which other relevant technical specifications; in the case of harmonised standards partially applied, the parts which have been applied shall be indicated in the technical documentation;

e)

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

f)

the audit reports.

6.2.2.

The manufacturer shall keep the technical documentation for 10 years after placing the product on the market. Measuring instruments available to the competent national authorities.

6.3.

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.

6.4.

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 equivalent tests as set out in other relevant technical specifications, in order to verify the conformity of the measuring instrument with the applicable requirements of this Regulation. In the absence of such a harmonised standard, the notified body shall decide which tests are to be carried out.

The notified body provides a certificate of conformity on the basis of these examinations and tests, and delivers it to each approved Measuring instrument indicates or allows the identification number to be attached to the meter under its responsibility.

The manufacturer holds the conformity certificates for the national authorities ten years after the measuring device is placed on the market.

6.5.

Conformance marking and EU Declaration of Conformity

6.5.1.

The manufacturer will bring to each meter that meets the applicable requirements of this Regulation. , the CE marking and the supplementary metrology marking in accordance with this Regulation, and under the responsibility of the notified body referred to in Z 6.4, their identification number.

6.5.2.

The manufacturer issues a written EU declaration of conformity and holds it for ten years long after the measuring instrument has been placed on the market 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.

6.6.

Plenipotentiary

The manufacturer ' s obligations under Z 6.2.2 and 6.5 may be fulfilled by his authorized representative on his behalf and under his responsibility. if they are set on the work order.

7.

Common provisions

7.1.

The conformity assessment according to the modules D, D1, F, F1, or G can be used by the manufacturer or in any other place where the transport of the measuring instrument to the place of use does not require any reassembly or other technical work to be dismantled and put into service at the place of use, by which can be affected by the display accuracy of the measuring instrument, and if the case acceleration at the site of the commissioning is taken into account or if the display accuracy of the measuring instrument is not influenced by changes in the acceleration of the fall. In all other cases, it has to be done at the point of use of the measuring instrument.

7.2.

If the measurement accuracy of the measuring device is affected by changes in the acceleration of the case, the procedure after Z 7.1 may be carried out in two stages, the second stage comprising all examinations and tests in which the result depends on the acceleration of the case, and the first stage shall include all other examinations and tests. The second stage shall be carried out at the point of use of the measuring instrument. If a Member State of the European Union has established gravitational zones on its territory, the term "at the place of use of the measuring instrument" shall also be understood as "in the gravitational use zone of the measuring instrument".

7.2.1.

A manufacturer selects the execution of a method mentioned in Z 7.1 in two stages, and if these two stages are carried out by different bodies, a measuring instrument which has passed through the first stage of the procedure in question shall bear the identification number of the notified body which was involved in the first stage.

7.2.2.

The party that carried out the first stage of the procedure is granted for each individual measuring instrument, a certificate with the information necessary for the identification of the measuring instrument and a specification of the examinations and tests carried out.

The party that performs the second stage of the procedure will perform the investigations and checks that have not yet been performed.

The manufacturer or his authorized representative must be able to present the certificate of conformity of the notified body on request.

7.2.3.

The manufacturer who has chosen Module D or D1 in the first stage is allowed to use the second module Either use the same procedure, or select Module F or F1 for the second level, as required.

7.2.4.

The CE marking and the additional metrology labeling are after the completion of the the second stage, together with the identification number of the notified body which was involved in the second stage, must be fitted to the measuring instrument.

Appendix 2

EU-DECLARATION OF CONFORMITY (No.  XXXX)

1.

Measuring device model/gauge (product, type, batch, 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 measuring device for traceability; it can be a Figure, if necessary for identification of the meter):

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.

The notified body (name, identification number) ... has ... (description of its activity) ... and the following Certificate issued:

8.

Additional information:

Signed for and on behalf of:

(location and date of the exhibition):

(name, function) (signature):