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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Read the untranslated law here: http://www.ris.bka.gv.at/Dokumente/BgblAuth/BGBLA_2016_II_30/BGBLA_2016_II_30.html

30 Decree of the Federal Minister for science, research and industry establishing conformity assessment procedures relating to non-automatic weighing scales

On the basis of section 18 Z 4 the measurement and calibration Act (MEG), Federal Law Gazette No. 152/1950, as last amended by Federal Law Gazette I no. 148/2015, is prescribed:

Scope

1. (1) this Regulation applies to all non-automatic scales, called the "instruments", and lays down the requirements which must be complied with for the first-time placing on the market or for the initial entry into service.

(2) if the conformity of a non-automatic scales in the framework of this regulation is found, then applies this gauge as the first calibrated and may in the scope of the provisions of the measure and calibration Act (MEG), Federal Law Gazette No. 152/1950, as last amended by Federal Law Gazette I no. 148/2015, used and/or held be.

Definitions

§ 2. The purposes of this regulation, the term may refer to:



1 "Balance": a measuring instrument for determining the mass of a body on the basis of gravity acting on the body. A scale can be also used with the mass of related sizes, quantities, parameters or characteristics to determine other;

2. "non-automatic weighing scale": a weighing instrument requiring the intervention of an operator during weighing;

3. "Making available on the market": any payment or free of charge of a meter for distribution or use on the Union market in the course of a business;

4. 'placing on the market': the first making available of a meter on the Union market;

5. 'Manufacturer': any natural or legal person that produces a meter or develop or manufactured and marketed this device under their own name or their own trade mark.

6 "authorised representative": each resident within the European Union, natural or legal person, in writing, appointed by a manufacturer to perceive certain tasks on his behalf;

7 "importer": each natural or legal person established in the European Union, presents a meter from a third country on the Union market;

8 'Dealer': any natural or legal person in the supply chain, providing a gauge on the market, with the exception of the manufacturer or the importer;

9 "Economic operators": the manufacturer, the agents, the importer and the Distributor;

10 'technical specification': a document in which the technical requirements are prescribed, an instrument must, meet

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

12 "Accreditation": an accreditation within the meaning of article 2 Z 10 of Regulation (EC) No. 765/2008 on the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 of the Council, OJ No. L 218 of August 13, 2008 p. 30;

13 "national accreditation body": a national accreditation body within the meaning of article 2 Z 11 of Regulation (EC) No. 765/2008;

14 "Conformity assessment": the procedures for the assessment, if the essential requirements of this regulation to an instrument have; been fulfilled

15 "Conformity assessment body": a body that performs conformity assessment activities including calibration, testing, certifications and inspections;

16 "Callback": any measure which one targets the end user of already provided meter on the achieving of the return;

17 'Withdrawal': any measure, that is, to prevent a supply chain as an instrument on the market, provide

18 ' harmonisation legislation of the Union ': legislation of the European Union on the harmonisation of the conditions for the marketing of products;

19 'CE marking': marking by which the manufacturer declares that the meter meets the requirements laid down in Community harmonisation of the European Union about its affixing.         

Essential requirements

3. (1) the essential requirements on non-automatic scales, as well as the inscriptions are determined by the calibration regulations of the Bundesamt für Eich - und Vermessungswesen relating to non-automatic weighing scales.

(2) there are facilities on a non-automatic weighing machine or the non-automatic weighing equipment is connected, that do not fall under the scope of the measurement and calibration law, so the essential requirements do not apply for these facilities.

Obligations of the manufacturers

4. (1) the manufacturer guarantee instruments, should they bring in traffic and that are used within the framework of the provisions of the measurement and calibration Act, were designed in accordance with the essential requirements of the relevant calibration regulations and manufactured.

(2) the producers create the technical documentation referred to in annex 1 Z 1.3 lit. c and perform the relevant conformity assessment procedures pursuant to section 11 or let it carry out. Has been demonstrated with this conformity assessment procedures that a measuring instrument complies with the applicable requirements of this regulation and the calibration regulations, the manufacturer issuing an EU Declaration of conformity and affix the CE marking and supplementary metrology marking in accordance with article 13.

(3) the producers keep the technical documentation and the EC declaration of conformity from the placing on the market of the instrument over a period of ten years.

(4) the manufacturer through appropriate procedures ensure that compliance with this regulation is always ensured in repetitive manufacturing. Changes to the design of the measuring instrument or its characteristics as well as changes in the harmonized standards or other technical specifications referred to in the Declaration of conformity of a measuring instrument are adequately taken into account.

(5) the manufacturer, if this is considered appropriate in view of the risk posed by a meter, take samples of measuring instruments on the market, carry out audits and lead a register of complaints, of non-conforming meters the callbacks of measuring instruments, if necessary, and keep distributors informed of such monitoring.

(6) the producers make sure that instruments which they have placed on the market, a type, batch or serial number or a different flag wearing their identification in accordance with the respective provisions of the calibration and attach the labels provided for this purpose.

(7) manufacturers have instruments to attach the labels pursuant to § 7 para 4 MEG, not in the framework of the verification obligation used or intended to be used.

(8) there are facilities to a measuring instrument or the measuring equipment is connected, not within the framework of the provisions of the measure and calibration law, used or to be used, so manufacturers attach the icon for the use restriction pursuant to § 15 any of this institution.

(9) the manufacturer indicate their name, registered trade name or registered trade mark and the address at which they can be reached, on the gauge. The address refers to a central point, at which the manufacturer can be achieved. The contact information is to specify in the German language.

(10) the manufacturer ensure that the operating instructions and information are attached the meter, which are written in the German language. These operating instructions and information, as well as all selections must be clear, understandable and clear.

(11) manufacturers who consider or have reason to believe that a meter installed by them in traffic corresponds to the requirements of this regulation or the calibration regulations, immediately take the corrective measures that are needed to establish the conformity of this instrument or to take it back, if necessary, or to call back. Also, inform the manufacturer the competent national authorities of the Member States of the European Union, in which they have provided the meter on the market, in, when are risks associated with the instrument, and do detailed information, in particular on the non-compliance and the corrective measures taken. As the competent authorities in Austria, the Federal Ministry for science to inform research and economy and the be are.


(12) the manufacturers provide all information and documents that are required to demonstrate the conformity of the measuring instrument with this regulation, in paper form or by electronic means in German language available to the Federal Ministry of science, research and economy and the be substantiated request. They cooperate with these authorities at their request with all measures to prevent risks associated with instruments, which they have placed on the market.

Agents

5. (1) a manufacturer may appoint a representative in writing. The obligations referred to in article 4, paragraph 1, and the obligation to prepare the technical documentation referred to in section 4, paragraph 2 are not part of the job of an agent.

(2) a representative has to carry out the tasks that are set on behalf of the manufacturer. The contract must allow the agent to carry out at least the following tasks:



a) keep of the EC declaration of conformity and the technical documentation for the national market surveillance authorities for a period of ten years from the placing on the market of the instrument;

(b) upon a reasoned request from a competent national authority to provide all information and documentation that are required to demonstrate of the conformity of a measuring instrument, this authority;

(c) at the request of the competent national authorities cooperation in all measures taken to avert the risks associated with instruments, that their responsibilities include.

Obligations of importers

Section 6 (1) the importers have to bring only compliant measuring instruments on the market.

(2) before you install a gauge on the market or operate the importers to ensure the question, referred to in article 11 conformity assessment procedure has been carried out by the manufacturer. Make sure that the manufacturer has created the technical documentation, that the meter with the CE marking and the supplementary metrology marking is provided, that the EU Declaration of conformity and the required documents are attached to him and that the manufacturer has satisfied the requirements of § 4 para 6 to 9.

(3) is an importer of considers or has reason to believe that a meter doesn't meet the essential requirements of the calibration regulations, he may only place this monitor on the market if the conformity of the measuring instrument has been manufactured. If a risk is connected with the measuring device, the importers informed the manufacturer and the Federal Ministry for science, research and economy, as well as the be this.

(4) the importer must ensure that the manufacturer has satisfied the requirements according to § 4 section 7 for instruments in the framework of the verification obligation used or to be used.

(5) the importer indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the gauge on the instrument. To do this, open the packaging would be necessary, this information on the packaging and in the can be made documents the gauge. The contact details are in German language.

(6) the importers make sure that the operating instructions and information in German are attached to the measuring device.

(7) while a gauge is your responsibility, importers make sure that the conditions of its storage or its transportation do not affect conformity with the essential requirements of the calibration regulations.

(8) the importer, if it is considered appropriate in view of the dangers of a gauge, take samples of measuring instruments on the market, perform tests and lead a register of complaints, of non-conforming meters the callbacks of measuring instruments, if necessary, and keep distributors informed of such monitoring.

(9) importers who consider or have reason to believe that a meter installed by them in traffic corresponds to the requirements of this regulation, immediately take the necessary corrective measures to establish the conformity of this instrument or to take it back, if necessary, or to call back. Also inform the importer the competent national authorities of the Member States of the European Union, where they have deployed the Messggerät on the market, about, when risks are connected with the gauge, and do detailed information, in particular on the non-compliance and the corrective measures taken. As the competent authorities in Austria, the Federal Ministry for science to inform research and economy and the be are.

(10) the importers have ready after the placing on the market of the measuring instrument for ten years a copy of the EC declaration of conformity for the market surveillance authorities and ensure that they can present them to the technical documentation on request.

(11) the importers provide the Federal Ministry for science, research and economy and the be substantiated request all information and documents which are necessary to demonstrate the conformity of the measuring instrument with this regulation, in paper form or by electronic means in German language available. They cooperate with these authorities at their request with all measures to prevent risks associated with instruments, which they placed on the market.

Obligations of distributors

Traders consider section 7 (1) the requirements of this regulation and the calibration regulations with due care when they provide a gauge on the market.

(2) before they provide a gauge on the market, the dealer check whether the measuring instrument with the CE marking and the supplementary metrology marking is provided, whether the necessary documents as well as the operating instructions and information in German language are accompanied him, and whether the manufacturer and the importer have fulfilled the requirements of § 4 para 6 to 9 and article 6 par. 5.

(3) a distributor of considers or has reason to believe that a meter does not match the requirements of the calibration standards, he provides only this monitor on the market when its conformity has been established. If a risk is connected with the measuring device, the dealer also informed the manufacturer or the importer, as well as the Federal Ministry for science, research and economy and the be about.

(4) the traders have to make sure that who has satisfied the requirements manufacturers and importers according to § 4 section 7 and section 6 para 5 for instruments, used in the context of the calibration required or should be used.

(5) while a meter is under their responsibility, the dealer ensure that the conditions of its storage or its transportation do not affect conformity with the essential requirements of the calibration regulations.

(6) distributors who consider or have reason to believe that a meter provided by them on the market is not this regulation or the calibration regulations, make sure that the necessary corrective measures are taken to establish the conformity of this instrument, if necessary to take back or get back. Also, inform the dealer risks associated with the device, without delay, the competent national authorities of the Member States of the European Union, in which they dasMessgerät have deployed on the market, in and make this detailed information, in particular on the non-compliance and the corrective measures taken. As the competent authorities in Austria, the Federal Ministry for science to inform research and economy and the be are.

(7) the dealer make the Federal Ministry for science, research and economy and the be substantiated request all information and documents which are required to demonstrate of the conformity of a measuring instrument, in paper form or electronically available. They cooperate with these authorities at their request with all measures to prevent risks associated with products that have deployed to the market.

Circumstances under which the obligations of the manufacturer also apply to importers and distributors

§ 8. An importer or Distributor is the manufacturer for the purposes of this regulation and subject to the obligations of a manufacturer according to § 4, when he under his own name or his own trade mark in trade presents a meter or a meter progress already on the market changed so that compliance with this regulation or the calibration regulations may be affected.

Identification of economic operators

§ 9 (1) the economic operators call the Federal Ministry for science, research and industry, as well as the be requested by economic operators.



a) of which they have; related a measuring instrument

b) to which they have given a measuring instrument.

(2) the economic operators can provide ten years from the cover of the meter, as well as ten years after the submission of the measuring device the information referred to in paragraph 1.

Presumption of conformity of measuring instruments


§ 10. A conformity with the essential safety requirements in accordance with the respective provisions of the calibration is suspected of instruments that comply with harmonised standards or parts thereof, the reference numbers of which have been published in the official journal of the European Union, which are 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 is for one to be selected by the manufacturer conformity assessment procedures, as follows:



1. module B referred to in annex 1 as well as the following either module D according to annex 1 or module F in annex 1;

2. module G referred to in annex 1.

(2) gauges, where no electronic device is used and which Auswägeeinrichtung used no spring to balance of the applied load, are however not mandatory to undergo the procedure according to module B pursuant to annex 1. For those instruments where module B is not true according to annex 1, module D1 is to apply 1 or module F1 pursuant to annex 1 annex.

(3) a body notified under section 16 is active, then records and correspondence related to the carried out conformity assessment procedures either in German or in another by this point must recognized language to it.

EU Declaration of conformity

Section 12 (1) the EU Declaration of conformity States that compliance with the essential requirements listed in the corresponding calibration regulations has been demonstrated.

(2) the EU Declaration of conformity in their construction corresponds to the model in annex 2, containing the items specified in the relevant modules of in annex 1 and is kept up to date. The manufacturer can assign a number on a voluntary basis of the Declaration of conformity. It is to write, if the meter in Austria in traffic is placed or made available in German language.

(3) a measuring instrument is subject to several legislative acts of the European Union, where each a EU Declaration of conformity is required, only a single EU conformity declaration for all legal acts of the European Union will be issued. The concerned legislative acts of the European Union shall be indicated in this statement together with their site in the official journal of the European Union.

(4) with the exhibition of the EU Declaration of conformity, the manufacturer assumes the responsibility that the meter meets the requirements of this regulation.

Conformity marking

13. (1) the conformity of a measuring instrument with the provisions of this regulation is specified by the "CE" marking referred to in paragraph 2 and the supplementary metrology marking referred to in paragraph 3 on the gauge.

(2) for the CE-marking the General principles referred to in article 30 in conjunction with annex II of to Regulation (EC) no 765/2008 shall apply.

(3) the supplementary metrology marking consists 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 General principles referred to in article 30 of Regulation (EC) apply for the supplementary metrology marking No. 765/2008 accordingly.

Affixing of the CE marking and the supplementary metrology marking

The CE marking and the supplementary metrology marking shall be 14 (1) visibly, legibly and permanently on the meter or its label to.

(2) the CE marking and the supplementary metrology marking is affixed prior to the placing on the market of the instrument.

(3) the supplementary metrology marking directly behind the CE marking.

(4) the CE marking and the supplementary metrology marking is / are the KENNNUMMER(n) of the notified body or bodies, in phase of production control in accordance with Annex 1 worked was.

(5) the identification number of the notified body shall be affixed by the body itself or according to its instructions, by the manufacturer or his authorised representative.

(6) another character can stand behind the CE marking, the supplementary metrology marking and, where appropriate, the identification number of the notified body, indicating a special risk or use.

Symbol for the restriction of the use

§ 15. The symbol referred to in article 4, paragraph 8 for the restriction of the use consists of a square with a side length of at least 25 mm, carrying the large letter M on a red background as black printing and is diagonally crossed through. This shall be affixed permanently and in a clearly visible.

Notification

Section 16 (1) the notification of bodies is performed by the procedures referred to in the sections 18a to 18 d MEG.

(2) the identification number assigned by the European Commission on the notified body is by the notified body for activities carried out in the framework of this regulation to use.

Requirements for notified bodies

17. (1) a conformity assessment body has the requirements for the purposes of notification to meet paragraph 2 to 15.

(2) any legal person or registered partnership can be notified in fulfilment of the requirements referred to in this Regulation as a conformity assessment body.

(3) in the case of a conformity assessment body it must be an independent third party, with the establishment or the meter, he assessed that, no connection is available. A body that belongs to a trade association or a trade association and rated the instruments, whose design, manufacturing, provision, Assembly, use or maintenance involving companies, represented by this Association, can be considered on condition that its independence and the absence of any conflicts of interest have been demonstrated, such an independent third body.

(4) a conformity assessment body, its top level of management and the personnel responsible for the conformity assessment tasks shall



1 not designer, manufacturer, supplier, Installer, purchaser, owner, user or maintenance operation of the instruments to be evaluated by them or representatives of one of these parties? This excludes using already assessed a conformity assessment instruments that are necessary for the activity of the conformity assessment body or the use of such instruments for personal use.

2. directly to design, manufacture or construction, marketing, installation, use or maintenance of these instruments be involved, nor represent the parties involved in these activities. They may not deal with activities, which might impair their independence in assessing or their integrity relating to the conformity assessment activities for which they are notified. This applies particularly for consulting services.

(5) the conformity assessment bodies to ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.

(6) the conformity assessment bodies and their employees have conformity assessment activities carried out with the utmost professionalism and the necessary expertise in the relevant field; they should not be exposed any inducements, particularly financial, which could affect their judgement or the results of their conformity assessment activities, and specifically emanates from persons or groups of persons who have an interest in the outcome of these activities.

(7) a conformity assessment body must be able, all conformity assessment tasks to deal with, that fall to you pursuant to annex 1 and for which they shall notify regardless of whether these tasks are carried out by the body itself, on its behalf or under its responsibility.

(8) a conformity assessment body has at any time to have for each conformity assessment procedure and for each type and category of measuring devices for which it has been notified, via the following:



1. the necessary staff with technical knowledge and sufficient relevant experience to perform the conformity assessment tasks;

2. descriptions of the procedures according to which conformity assessment is performed to ensure the transparency and the repeatability of these procedures. She has adequate tools and procedures is distinguished between the tasks which they perceived as notified body, and other activities

3. procedures for the implementation of activities, taking due account of the size of a company, the industry in which it operates, its structure, the degree of complexity of the product technology and the fact that the production process is a mass production or mass production.

(9) a conformity assessment body must have the necessary resources to the appropriate execution of the technical and administrative tasks associated with conformity assessment, and have access to all necessary equipment or facilities.

(10) the employees who are responsible for carrying out the conformity assessment tasks, must have the following:



1.

a sound technical and vocational training, which includes all activities for conformity assessment in the field, for which the conformity assessment body has been notified;

2. a satisfactory knowledge of the requirements associated with the reviews to be conducted, and the appropriate powers conduct such reviews;

3. appropriate knowledge and understanding of the essential requirements of annex 1 and the relevant calibration requirements, of the applicable harmonised standards and of the relevant provisions of Community harmonisation of the European Union and national legislation;

4. the ability to create certificates, protocols and reports as evidence of carried out reviews.

(11) the impartiality of the conformity assessment bodies, their top management levels and the personnel responsible for the conformity assessment tasks is to secure.

(12) the remuneration of top-level management and the personnel responsible for the conformity assessment tasks must not depend on the number of assessments carried or their results.

(13) the conformity assessment body has concluded a liability insurance unless liability is not covered by the Republic of Austria.

(14) information, which receive the personnel of a conformity assessment body in carrying out its tasks in accordance with Annex 1 as part of this regulation, be subject to the professional secrecy except to the competent authorities of the Member State in which they exercise their activities. Property rights are protected.

(15) the conformity assessment bodies have notified the relevant standardisation activities and the activities of the coordination group to participate, which was created within the framework of the relevant Community harmonisation of the European Union or have to ensure that the personnel responsible for the conformity assessment tasks also are informed, and apply the administrative decisions drawn up by this group and documents as general guidelines.

Presumption of conformity for notified bodies

§ 18 a conformity assessment body demonstrates that it harmonised the criteria of the relevant standards or parts thereof complies, the reference numbers of which have been published in the official journal of the European Union, may be suspected that it meets the requirements according to § 17, insofar as the applicable harmonised standards cover those requirements.

Affiliates of notified bodies and subcontracting

Section 19 (1) awards the notified specific tasks connected with conformity assessment to subcontractors or transfers it this a branch company, so she has to ensure that the subcontractor or the subsidiary meets the requirements of section 17 and shall inform the notifier of authority according to.

(2) the notified bodies independently suffer the full responsibility for the work carried out by subcontractors or subsidiaries, wherever these are established.

(3) work may be only given to a subcontractor or transfer a branch company, if the customer agrees.

(4) the notified bodies have to provide the relevant documentation concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by him in accordance with Annex 1 for the notifying authority.

Obligations of notified bodies in relation to their work

Notified bodies carry out conformity assessment in accordance with the conformity assessment procedure in accordance with Annex 1 section 20 (1).

(2) conformity assessment are perform respecting of proportionality, avoiding unnecessary burdens for economic operators. The conformity assessment bodies perform their activities taking due account of the size of a company, the industry in which it operates, its structure, and the degree of complexity of the affected product technology and the Massenfertigungs - or serial nature of the production process. This, however, is a such level of protection to meet, as it is required for the conformity of the measuring instrument with this regulation.

(3) a notified body finds that a manufacturer not met the essential requirements that are set in the appropriate harmonized standards or other technical specifications or in the calibration instructions, prompts them to the manufacturer to take appropriate corrective measures, and exhibits no certificate of conformity.

(4) a notified body already a certificate issued and it finds in the context of the monitoring of conformity, that the instrument no longer meets the requirements, it urges the manufacturer to take appropriate corrective measures, and suspends the certificate or she pulls back, unless this is necessary.

(5) If no corrective action is taken, or they show not having the required effect, the notified body shall limited all certificates if necessary, she stops or pulls them back.

Procedure for the treatment of instruments, to which a risk is connected at the national level

Section 21 (1) have reaching out the be the assumption that the aspects of protection of public interests, which fall under this regulation, endangered, judge a device covered by this regulation, whether the relevant instrument meets all the relevant requirements laid down in this regulation. The concerned economic operators have to cooperate with the be for this purpose to the extent necessary.

(2) enter the be in the course of the assessment pursuant to par. 1 to the result that the meter meets the requirements of this regulation, they urge without delay the relevant economic operator to take all appropriate corrective actions to establish the conformity of the measuring instrument with those requirements, to remove it from the market or recall within a period prescribed by the authority, appropriate to the nature of the risk.

(3) be informed the relevant notified body.

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

(5) are the be of the opinion that the non-compliance not limited to Austria, they shall inform the Federal Ministry for science, research and industry in. This informs the Commission and the other Member States of the European Union about the results of the assessment and the measures on which they have required the economic operator.

(6) the economic operator shall ensure that all appropriate corrective action he takes, extend all affected instruments, that he has provided in the European Union on the market.

(7) the relevant economic operator take any appropriate corrective action, within the time limit referred to in paragraph 2 the be take all appropriate provisional measures to prohibit the deployment of the measuring instrument on the domestic market or to restrict, to take the gauge of the market, or to recall.

(8) the Federal Ministry for science, research and industry immediately informs the Commission and the other Member States of the European Union on the measures.

(9) the information referred to in paragraph 8 have all available information to emerge, in particular, the data for the identification of the non-conforming meter, the origin of the measuring device, the way of the non-compliance alleged and the risk as well as the nature and duration of national measures taken and the arguments of the relevant economic operator. In particular, it is to determine whether the non-compliance on one of the following causes is due to:



1. the measuring instrument does not meet the requirements laid down in this regulation with regard to the aspects of the protection of public interests, or 2 that a presumption of conformity applies harmonised standards compliance according to § 10, are flawed.

(10) results in the review by the Commission, that the measure is not justified, is this measure to withdraw immediately.

Risk from compliant monitors

Section 22 (1) is the Federal Ministry for science, research and industry or the relevant economic operator to the be is proof that a device poses a risk for aspects of the protection of public interests, although it complies with this regulation, to ask, to take all appropriate measures to ensure that the relevant instrument at its placing on the market no longer has this risk or that it is reasonable within one type of risk , taken reasonable period of time from the market or recalled.

(2) the economic operator to ensure that all corrective actions are taken, extend to all relevant measuring instruments he has deployed in the European Union on the market.


(3) the Federal Ministry for science, research and economy shall inform the European Commission and the other Member States of the European Union forthwith. All available details emerge from this information, particularly the data for the identification of the monitor, the origin and the supply chain of the measuring instrument, the nature of the risk and the nature and duration of national measures taken.

Formal non-compliance

Section 23 (1) without prejudice to section of the 21st century is the relevant economic operator by the be to urge, to correct the non-compliance concerned if they notice one of the following cases:



1. the CE marking or the supplementary metrology marking has been in non-compliance with article 30 of Regulation (EC) No. 765/2008 or attached by section 14 of this regulation;

2. the CE marking or the supplementary metrology marking has not been affixed;

3. the inscriptions according to § 4 paragraph 6 to 8 were not installed or affixed under non-compliance with § 4 para 6 to 8;

4. the identification number of the notified body - if this place in the production control phase worked - was placed under non-compliance with section 14 or has not been affixed;

5. the EU Declaration of conformity was not issued;

6. the EC declaration of conformity has been improperly issued;

7. the technical documentation is either not available or not complete;

8. the information referred to in section 4, paragraph 9 or section 6 para 5 is missing, incorrect or incomplete;

9 other management requirement is not met according to § 4 or § 6.

(2) the non-compliance referred to in paragraph 1 persists, the be have all appropriate measures must be taken to limit the deployment of the measuring device on the market or to prohibit or to ensure that it is recalled or withdrawn from the market.

Linguistic equal treatment

§ 24. As far as this regulation to natural persons are related names only in the male form, they relate to women and men in the same way. In applying the term to certain natural persons, the respective gender-specific form is to use.

Implementation of legal acts of the European Union

§ 25. By this regulation, the directive is 2014/31/EC on the approximation of the laws of the Member States concerning the provision of non-automatic scales on the market, OJ No. L 96 of the 29.03.2014 p. 107, implemented.

Transitional provisions

§ 26 (1) from the 20th April 2016 only more instruments can in traffic for the first time be placed or started for the first time, which comply with this regulation.

(2) by way of derogation from paragraph 1 instruments can in traffic continues for the first time be placed or commissioned for the first time, if they have the provisions of the regulation of the Federal Minister for Economic Affairs on establishing conformity assessment procedures relating to non-automatic weighing scales, BGBl. No. 751/1994, in the amended Federal Law Gazette II No. 222/2010, match and a still-valid certificate for this.

Entry into force

27. (1) this regulation 20 April 2016 into force. At the same time the regulation of the Federal Minister for Economic Affairs on establishing conformity assessment procedures relating to non-automatic weighing scales, BGBl. No. 751/1994, as amended by Federal Law Gazette II No. 222/2010, override.

(2) from the date of publication of this Regulation pursuant to clause 17 can be designated.

(3) notified bodies may issue no certificates for CE marking under this regulation before the 20 April 2016.

(4) a placing on the market or a commissioning of instruments, which are marked in accordance with this regulation, before the 20 April 2016 is not permitted.

Mitterlehner

 

ANNEX 1

THE CONFORMITY ASSESSMENT PROCEDURES

1. module B: EC type examination



1.1. the EC type examination is it to the part of a conformity assessment procedure whereby the a notified body examines the technical design of a measuring instrument itself and checks and certifies that it meets the requirements applicable to the instrument of this regulation.

1.2. an EC type examination can be performed on each of the following types: (1) testing a representative for the production envisaged pattern of the complete measuring device (type);

2. assessment of the suitability of the technical design of the measuring instrument on the basis of an examination of the technical documentation referred to in Z 1.3 and supporting evidence, as well as examination of specimens, representative of the production envisaged one or more important parts of the measuring instrument (combination of construction and design patterns);

3. review the adequacy of the technical design of the measuring instrument on the basis of an examination of the technical documentation referred to in Z 1.3 and supporting evidence, without testing a pattern (design pattern).

1.3. who's proposal on EU type examination submitted by the manufacturer with 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 agent, and also its name and address;

(b) an affidavit is filed the same request with any other notified body;

(c) the technical documentation. On the basis of these documents, it must be possible to evaluate the conformity of the measuring instrument with the applicable requirements of this regulation; they must contain a proper risk analysis and risk assessment. In the technical documentation, the applicable requirements of design, manufacture and operation of the measuring instrument are to capture, as far as they are for the assessment of relevance. The technical documents contain, where appropriate, at least the following elements: i) a general description of the instrument;

(ii) designs and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;

III) descriptions and explanations that are necessary to the understanding of the drawings and diagrams and the operation of the measuring device;

IV) in a list, which harmonised standards, the reference numbers in the official journal of the European Union have been published, fully or in part has been applied are, and, if these harmonised standards were not applied a description of the solutions that have been, complied with the essential safety requirements of this regulation including a statement about which other relevant technical specifications have; been applied the parts which have been applied, in the event of partly applied harmonised standards are given in the technical documentation;

v) the results of the design calculations, examinations carried out, etc. as well as vi) the audit reports;

d) pattern representative for the production envisaged; the notified body may request additional patterns, if this is necessary for the implementation of the auditor;

(e) the supporting evidence for a reasonable solution through the technical design. In this additional evidence, all documents must be noted according to which especially is been taken, if the relevant harmonised standards not in full have been applied. The additional evidence, if necessary, include the results of tests conducted in accordance with other relevant technical specifications by an appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.

1.4. the notified body shall have the following duties: based on the meter: 1.4.1. examination of the technical documentation and supporting evidence to assess whether the technical design of the measuring instrument is appropriate;

Based on the pattern: 1.4.2. test whether that and the pattern in accordance with the technical documentation was established / n, and finding, which parts have been designed according to the regulations of the relevant harmonised standards and which parts in accordance with other relevant technical specifications designed;

1.4.3. conducting or arranging the appropriate examinations and tests, to determine whether the solutions in the relevant harmonised standards, been applied properly unless the manufacturer has opted for their application;

1.4.4. conducting or arranging the appropriate examinations and tests, to determine whether the solutions selected by the manufacturer - if it has not applied the solutions in the relevant harmonised standards and/or normative documents - have been achieved on the basis of other relevant technical specifications and meet the corresponding essential requirements of this regulation;

1.4.5. agreement with the manufacturer, where the examinations and tests to be performed.

1.5. the notified body created an audit report on the measures carried out in accordance with Z 1.4 and the results obtained. Without prejudice to their obligations towards the notifying authorities, the notified body shall published the content of this report, or parts of them only with the consent of the manufacturer.

1.6.

The sample corresponds to the requirements applicable to the question gauge this regulation, so the notified body issues an EU type examination certificate the manufacturer. The certificate must contain the name and address of the manufacturer, the results of the audit, any conditions for its validity and the particulars necessary for identification of the approved of type. One or more attachments can be added to the EU type examination certificate.

The EU type examination certificate and its annexes contain all relevant information, enabling an assessment of the conformity of the manufactured instrument with the tested design and control after its commissioning.

The EU type examination certificate is valid for ten years from their date of issue and may be renewed thereafter for another ten years. Fundamental changes in the design of the measuring device, E.g. due to the use of new techniques, the validity of the EU test certificate to two years can be limited and extended for three years.

The construction pattern is not the applicable requirements of this regulation, the notified body refuses to issue an EU type examination certificate and shall inform the applicant about where she extensively justified its refusal.

1.7. who informed himself continuously of any changes in the generally acknowledged State of the art, which suggest notified that the approved type no longer complies with the applicable requirements of this regulation, and shall decide whether such changes require further investigations. This is the case, the notified body shall inform the manufacturer accordingly. The manufacturer shall inform the notified body, the dossiers to the EU type examination certificate are available, you can over all modifications to the approved design which affect its conformity with the essential requirements of this regulation or the conditions for validity of the certificate. Such modifications require additional approval in the form of an addition to the original EU-type test certificate.

1.8. each notified body informed their notifying authority of the EU type examination certificates and/or any additions to that has issued it or withdrawn, and submit their notifying authority at regular intervals or at the request a list of all such certificates and/or additions to, who has denied, suspended or otherwise restricted.

Each notified body shall inform the other notified bodies of the EU type examination certificates and/or any additions, which has denied, withdrawn, suspended or otherwise restricted, and shares all certificates issued by them to request and/or additions to dazumit.

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 additions. The European Commission and the Member States of the European Union will receive a copy of the technical documentation and the results of the checks made by the notified body on request. The notified body shall so long kept a copy of the EU test certificate together with the annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the period of validity of this certificate.

1.9. the manufacturer keeps a copy of the EU type examination certificate, its annexes and additions together with the technical documentation for 10 years after the placing on the market of the instrument for the national authorities ready.

1.10. the authorised representative of the manufacturer can submit the application referred to in Z 1.3 and meet the obligations referred to in the Z 1.7 and 1.9, if they are set in the order.

2. module D: conformity with the design on the basis of a quality assurance of the production process



2.1. the conformity to type on the basis of a quality assurance on the production process, the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in the Z 2.2 and 2.5 is involved, as well as guarantees and explains on its own responsibility, that correspond to the relevant instruments of the type described in the EU type examination certificate and comply with the applicable requirements of this regulation.

2.2. manufacture the manufacturer operates an approved quality assurance system for production, final inspection and testing of the measuring instruments concerned in accordance with Z 2.3 and 2.4 Z undergoes surveillance in accordance with.

2.3. quality assurance system 2.3.1.
With the notified body, the manufacturer must apply the assessment of his 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 agent, and also its name and address;

(b) an affidavit is filed the same request with any other notified body;

(c) all relevant information for the instrument category envisaged;

d) the documentation concerning the quality assurance system and e) the technical documentation of the approved type and a copy the EU type examination certificate.

2.3.2. the quality assurance system ensures conformity of the instruments with the type as described in the EU type examination certificate and with the requirements of this regulation.

All elements considered by the manufacturer, requirements and regulations are written in the form of policies to create procedures and operating instructions properly and systematically. This quality assurance system documentation must permit a uniform interpretation of the quality programmes, plans, manual and reports.

Contain in particular an adequate description the following points: a) quality objectives and organizational structure, responsibilities and powers of the Executive Board in regard to product quality;

b) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions;

c) before, during and investigations carried out after manufacturing and testing frequency;

(d) quality-related records, such as inspection reports, test and calibration data, qualification reports of the personnel concerned, etc;

(e) means to monitor the achievement of the required product quality and the effective operation of the quality assurance system.

2.3.3. the notified body must assess the quality assurance system, to determine whether it meets the requirements referred to in Z 2.3.2.

In each part of the quality assurance system, which complies with the corresponding specifications of the relevant harmonised standard, it comes from the conformity with these requirements.

In addition to the experience with quality assurance systems, at least one member of the audit has experience with the evaluation in the relevant instrument and of the instrument technology concerned, and knowledge of the applicable requirements of this regulation. The audit includes also an inspection visit at the premises of the manufacturer. The audit team reviewed the in Z 2.3.1 lit. referred e technical documentation, to ensure that the manufacturer able is to identify the relevant requirements of this regulation and perform the necessary checks to ensure the conformity of the measuring instrument with these requirements.

The decision is notified to the manufacturer. The notification must include the results of the audit and the reasoned of assessment decision.

2.3.4. the manufacturer undertakes to fulfil the obligations associated with the approved quality assurance system and ensuring that it is held always correctly and efficiently.

2.3.5. the manufacturer shall inform the notified body that has approved the quality system of any planned changes of the quality assurance system.

The notified body shall evaluate the proposed changes and decide whether the modified quality assurance system complies with still referred to in Z 2.3.2 or whether a re-assessment is required.

It announces its decision to the manufacturer. The notification must include the results of the examination and the reasoned of assessment decision.

2.4. monitoring under the responsibility of the notified body 2.4.1.
The monitoring is to make sure that the manufacturer duly fulfils the obligations arising from the approved quality assurance system.

2.4.2. the manufacturer grants access to the manufacturing, inspection, testing and storage of the notified body for assessment and provides all necessary documents you to, in particular: a) the documentation concerning the quality assurance system;

(b) the quality records, such as inspection reports, test and calibration data, qualification reports of the personnel concerned, etc.


2.4.3. the notified body shall regularly conducts audits to ensure that the manufacturer is maintaining the quality assurance system and applies and passes him a corresponding report.

2.4.4. in addition the notified body the manufacturer may carry out unannounced visits. During these visits the notified body may, if necessary, perform meter tests or undergo to ensure the proper functioning of the quality assurance system. The notified body shall supply the manufacturer with a report on the visit and in the case of an examination report.

2.5. conformity marking and EC declaration of conformity 2.5.1.
The manufacturer shall affix its identification number to each individual gauge that corresponds with the type as described in the EU type examination certificate and satisfies the applicable requirements of this regulation, the CE marking, the supplementary metrology marking prescribed under this regulation and, under the responsibility of the notified body referred to in 2.3.1 Z -.

2.5.2. the manufacturer issues a written EC declaration of conformity for each meter model and holds it for a decade after the placing on the market of the instrument for the national authorities. Must be drawn from the EU Declaration of conformity, which gauge model she was issued.

A copy of the EC declaration of conformity is provided the competent authorities upon request.

2.6. the manufacturer has for ten years following documents after the placing on the market of the instrument for the national authorities: a) the documentation referred to in Z 2.3.1;

(b) the information on the amendment in accordance with Z 2.3.5 in their approved version;

(c) the decisions and reports of the notified body according to the Z 2.3.5, 2.4.3 and 2.4.4.

2.7. each notified body shall inform their notifying authority the approval of quality assurance systems that has issued it or withdrawn, and submitted a list of all approvals of quality assurance systems, which has denied, suspended or otherwise restricted their notifying authority at regular intervals or at the request.

2.8. Plenipotentiary in the Z 2.3.1, 2.3.5, can be fulfilled by his authorised representative, on his behalf and under his responsibility 2.5 and 2.6 mentioned obligations of the manufacturer, if they are set in the order.

3. module D1: quality assurance related to the production process



3.1. quality assurance related to the production process is the conformity assessment procedure, whereby the manufacturer which in the Z meets 3.2, 3.4, and 3.7 laid down obligations and guarantees and on their own responsibility declares that the measuring instruments concerned satisfy the requirements of this regulation.

3.2. technical documentation of the manufacturer creates the technical documentation. On the basis of the documents, it must be possible to evaluate the conformity of the measuring instrument with the relevant requirements; they must contain a proper risk analysis and risk assessment. In the technical documentation, the applicable requirements of design, manufacture and operation of the measuring instrument are to capture, as far as they are for the assessment of relevance. The technical documents contain, where appropriate, at least the following elements: a) a general description of the instrument;

(b) design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;

c) descriptions and explanations that are necessary to the understanding of the drawings and diagrams and the operation of the measuring device;

(d) a statement indicating which harmonised standards, the reference numbers in the official journal of the European Union have been published, fully or in part has been applied are, and, if these harmonised standards have not been applied, a description of the solutions, which, they have complied with the essential safety requirements of this regulation including a statement about which other relevant technical specifications have; been applied the parts which have been applied, in the event of partly applied harmonised standards are given in the technical documentation;

(e) the results of the design calculations, examinations, etc;

(f) the inspection reports.

3.3. the manufacturer holds the technical documentation for 10 years after placing on the market of the measuring device for the competent national authorities.

3.4. production the manufacturer operates a certified quality assurance system for production, final inspection and testing of the measuring instruments concerned in accordance with Z 3.5 and Z 3.6 undergoes surveillance in accordance with.

3.5. quality assurance system 3.5.1.
With the notified body, the manufacturer must apply the assessment of his 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 agent, and also its name and address;

(b) an affidavit is filed the same request with any other notified body;

(c) all relevant information for the instrument category envisaged;

(d) the documentation concerning the quality assurance system;

(e) the technical documentation according to Z 3.2.

3.5.2. the quality assurance system ensures conformity of the instruments with the requirements of this regulation.

All elements considered by the manufacturer, requirements, and provisions are systematically and properly in the form of written policies, to assemble procedures and instructions. This quality assurance system documentation must permit a uniform interpretation of the quality programmes, plans, manual and reports.

Contain in particular an adequate description the following points: a) quality objectives and organizational structure, responsibilities and powers of the Executive Board in regard to product quality;

b) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions;

c) before, during and investigations carried out after manufacturing and testing frequency;

(d) quality-related records, such as inspection reports, test and calibration data, qualification reports of the personnel concerned, etc;

(e) means to monitor the achievement of the required product quality and the effective operation of the quality assurance system.

3.5.3. the notified body must assess the quality assurance system, to determine whether it meets the requirements referred to in Z 3.5.2.

In each part of the quality assurance system, which complies with the corresponding specifications of the relevant harmonised standard, it comes from the conformity with these requirements.

In addition to the experience with quality assurance systems, at least one member of the audit has experience with the evaluation in the relevant instrument and of the instrument technology concerned, and knowledge of the applicable requirements of this regulation. The audit includes also an inspection visit at the premises of the manufacturer. The audit team reviewed the technical documentation referred to in Z 3.2, to make sure the manufacturer able to identify the relevant requirements of the Ordinance and carry out the necessary checks, ensure the consistency of the measuring device with these requirements.

The decision is notified to the manufacturer. The notification must include the results of the audit and the reasoned of assessment decision.

3.5.4. the manufacturer undertakes to fulfil the obligations associated with the approved quality assurance system and ensuring that it is held always correctly and efficiently.

3.5.5 the manufacturer shall keep the notified body that has approved the quality system of any planned changes of the quality assurance system.

The notified body shall evaluate the proposed changes and decide whether the modified quality assurance system complies with still referred to in Z 3.5.2 or whether a re-assessment is required.

It announces its decision to the manufacturer. The notification must include the results of the examination and the reasoned of assessment decision.

3.6. monitoring under the responsibility of the notified body 3.6.1.
The monitoring is to ensure that the manufacturer duly fulfils the obligations arising from the approved quality system.

3.6.2. the manufacturer grants access to the manufacturing, inspection, testing and storage of the notified body for assessment and provides all necessary documents you to, in particular: a) the documentation concerning the quality assurance system;

(b) the technical documentation referred to in 3.2; Z

(c) the quality records, such as inspection reports, test and calibration data, qualification reports of the personnel concerned, etc.

3.6.3.

The notified body shall regularly conducts audits to ensure that the manufacturer is maintaining the quality assurance system and applies and passes an appropriate audit report.

3.6.4. in addition the notified body the manufacturer may carry out unannounced visits. During these visits, the notified body may, if necessary, carry out product tests or undergo, in order to ensure the proper functioning of the quality assurance system. The notified body shall supply the manufacturer with a report on the visit and in the case of an examination report.

3.7. conformity marking and EC declaration of conformity 3.7.1.
The manufacturer must affix the CE marking and supplementary metrology marking in accordance with this regulation and under the responsibility of the notified body referred to in 3.5.1 Z whose identification number to each individual instrument that meets the applicable requirements of this regulation.

3.7.2. the manufacturer issues a written EC declaration of conformity for each meter model and holds it for a decade after the placing on the market of the instrument for the national authorities. Must be drawn from the EU Declaration of conformity, which gauge model she was issued.

A copy of the EC declaration of conformity is provided the competent authorities upon request.

3.8. the manufacturer has for ten years following documents after the placing on the market of the instrument for the national authorities: a) the documentation referred to in Z 3.5.1;

(b) the information on the amendment in accordance with Z 3.5.5 in their approved version;

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

3.9. each notified body shall inform their notifying authority the approval of quality assurance systems that has issued it or withdrawn, and submitted a list of all approvals of quality assurance systems, which has denied, suspended or otherwise restricted their notifying authority at regular intervals or at the request.

3.10. Plenipotentiary in the Z 3.3, 3.5.1, 3.5.5, can be fulfilled by his authorised representative, on his behalf and under his responsibility 3.7 and 3.8 mentioned obligations of the manufacturer, if they are set in the order.

4. module F: conformity to type based on a product audit



4.1. in conformity with the type based on product verification is the it is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in the Z 4.2 and 4.5 and to ensure and on their own responsibility explains that the 4.3 subdued instrumentation of the type described in the EU type examination certificate comply with the provisions of Z and comply with the applicable requirements of this regulation.

4.2. production of the producers take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured instruments with the approved type as described in the EU type examination certificate and with the requirements of this regulation.

4.3. check performs a notified body chosen by the manufacturer with the appropriate examinations and tests to check the conformity of the instruments with the approved type as described in the EU Baumusterprüfbescheinigung and the corresponding requirements of this regulation.

The examinations and tests to check of the conformity of the instruments with the appropriate requirements are carried out by means of examination and testing of every single measuring instrument according to Z 4.4.

4.4. verification of conformity by examination and testing of each individual instrument 4.4.1.
All instruments are examined individually and there are appropriate checks in accordance with the harmonised standard / /-en or equivalent tests that are listed in other relevant technical specifications, carried out to verify their conformity with the approved type described in the EU type examination certificate and the requirements of this regulation.

In the absence of such a harmonised standard, the notified body shall decide what checks are performed.

4.4.2. the notified body shall issue a certificate of conformity on the basis of examinations and tests and affix its identification number to each approved instrument or can bring them under their responsibility.

The manufacturer holds the certificates of conformity for ten years after the placing on the market of the measuring instrument to the national authorities for inspection.

4.5. conformity marking and EC declaration of conformity 4.5.1.
The manufacturer must affix the CE marking and supplementary metrology marking in accordance with this regulation and, under the responsibility of the notified body referred to in 4.3 Z - whose identification number to each individual instrument that complies with the approved type as described in the EU type examination certificate and satisfies the applicable requirements of this regulation.

4.5.2. the manufacturer issues a written EC declaration of conformity for each meter model and holds it for a decade after the placing on the market of the instrument for the national authorities. Must be drawn from the EU Declaration of conformity, which gauge model she was issued.

A copy of the EC declaration of conformity is provided the competent authorities upon request.

Agrees with the notified body referred to in 4.3 Z the manufacturer under their responsibility can now attach the identification number of the notified body on the meters.

4.6. the notified body agrees, can attach the manufacturers under their responsibility during the manufacturing process on the instruments the identification number of the notified body.

The obligations of the manufacturer can meet 4.7. representative by his authorised representative, on his behalf and under his responsibility, provided that they are set in the order. An authorised representative must meet not the manufacturer's obligations set out in Z 4.2.

5. module F1: Compliance on the basis of an examination of the products



5.1. the conformity based on product verification is the himself explains it to the conformity assessment procedure, whereby the manufacturer which in the Z meets 5.2, 5.3 and 5.6 laid down obligations and guarantees and on their own responsibility, that the the provisions of Z 5.4 subjected instruments meet the requirements of this regulation.

5.2. technical documentation 5.2.1.
The manufacturer creates the technical documentation. On the basis of these documents, it must be possible to evaluate the conformity of the measuring instrument with the relevant requirements; they must contain a proper risk analysis and evaluation. In the technical documentation, the applicable requirements of design, manufacture and operation of the measuring instrument are to capture, as far as they are for the assessment of relevance. The technical documents contain, where appropriate, at least the following elements: a) a general description of the instrument;

(b) design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;

c) descriptions and explanations that are necessary to the understanding of the drawings and diagrams and the operation of the measuring device;

(d) a statement indicating which harmonised standards, the reference numbers in the official journal of the European Union have been published, fully or in part has been applied are, and, if these harmonised standards have not been applied, a description of the solutions, which, they have complied with the essential safety requirements of this regulation including a statement about which other relevant technical specifications have; been applied the parts which have been applied, in the event of partly applied harmonised standards are given in the technical documentation;

e) the results of the design calculations, examinations carried out, etc., as well as f) test reports.

5.2.2. the manufacturer shall provide for ten years the technical documentation after placing on the market of the measuring device for the competent national authorities.

5.3. manufacture the manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured instruments with the applicable requirements of this regulation.

5.4. verification performs a notified body chosen by the manufacturer with the appropriate examinations and tests to check the conformity of the instruments with the applicable requirements of this regulation.

The examinations and tests to check of the conformity with these requirements are carried out by means of examination and testing of every single measuring instrument according to Z 5.5.

5.5. verification of conformity by examination and testing of each individual instrument 5.5.1.

All instruments are individually to investigate, and there are corresponding tests in accordance with the harmonised standard / /-en, or equivalent tests, that are listed in other relevant technical specifications, carry out to ensure their conformity with the requirements applicable to them. In the absence of such a harmonised standard, the notified body shall decide what checks are performed.

5.5.2. the notified body shall issue a certificate of conformity on the basis of examinations and tests and affix its identification number to each approved instrument or can bring them under their responsibility.

The manufacturer shall provide the certificates of conformity of ten years after the placing on the market of the instrument for the national authorities.

5.6. conformity marking and EC declaration of conformity 5.6.1.
The manufacturer must affix the CE marking and supplementary metrology marking in accordance with this regulation and under the responsibility of the notified body referred to in 5.4 Z whose identification number to each individual instrument that meets the applicable requirements of this regulation.

5.6.2. the manufacturer issues a written EC declaration of conformity for each meter model and holds it for a decade after the placing on the market of the instrument for the national authorities. Must be drawn from the EU Declaration of conformity, which gauge model she was issued.

A copy of the EC declaration of conformity is provided the competent authorities upon request.

Agrees with the notified body referred to in Z 5.5 the manufacturer under their responsibility can now attach the identification number of the notified body on the meters.

5.7. the notified body agrees, can attach the manufacturers under their responsibility during the manufacturing process on the instruments the identification number of the notified body.

The obligations of the manufacturer can meet 5.8. representative by his authorised representative, on his behalf and under his responsibility, provided that they are set in the order. An authorised representative must meet not the manufacturer's obligations set out in the Z 5.2.1 and 5.3.

6 module g conformity based on a single audit



6.1. the conformity is on the basis of a single audit agrees's to the conformity assessment procedure, the manufacturer which in the Z meets 6.2, 6.3 and 6.5 commitments referred to above and to ensure and on their own responsibility, that the the provisions according to Z 6.4 subjected meter meets the requirements applicable to it by this regulation.

6.2. technical documents 6.2.1.
The manufacturer created the technical documentation and of the notified body referred to in Z 6.4 makes it available. On the basis of these documents, it must be possible to evaluate the conformity of the measuring instrument with the relevant requirements; they must contain a proper risk analysis and evaluation. In the technical documentation, the applicable requirements of design, manufacture and operation of the measuring instrument are to capture, as far as they are for the assessment of relevance.

The technical documents contain, where appropriate, at least the following elements: a) a general description of the instrument;

(b) design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;

c) descriptions and explanations that are necessary to the understanding of the drawings and diagrams and the operation of the measuring device;

(d) a statement indicating which harmonised standards, the reference numbers in the official journal of the European Union have been published, fully or in part has been applied are, and, if these harmonised standards have not been applied, a description of the solutions, which, they have complied with the essential safety requirements of this regulation including a statement about which other relevant technical specifications have; been applied the parts which have been applied, in the event of partly applied harmonised standards are given in the technical documentation;

(e) the results of the design calculations, examinations, etc;

(f) the inspection reports.

6.2.2. the manufacturer shall provide for ten years the technical documentation after placing on the market of the measuring device for the competent national authorities.

6.3. manufacturing the manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured instruments with the applicable requirements of this regulation.

6.4. verification a notified body chosen by the manufacturer leads the appropriate examinations and tests according to the relevant harmonised standards or equivalent tests that are listed in other relevant technical specifications, through or may be performed to check 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 what checks are performed.

The notified body shall issue a certificate of conformity on the basis of these examinations and tests and affix its identification number to each approved instrument or can bring them under their responsibility.

The manufacturer shall provide the certificates of conformity of ten years after the placing on the market of the instrument for the national authorities.

6.5. conformity marking and EC declaration of conformity 6.5.1.
The manufacturer must affix the CE marking and supplementary metrology marking in accordance with this regulation and under the responsibility of the notified body referred to in 6.4 Z whose identification number to each measuring instrument that satisfies the applicable requirements of this regulation.

6.5.2. the manufacturer issues a written EC declaration of conformity and holds it for a decade after the placing on the market of the instrument for the national authorities. Must be drawn from the EU Declaration of conformity for which instrument was issued.

A copy of the EC declaration of conformity is provided the competent authorities upon request.

The obligations of the manufacturer referred to in the Z 6.2.2 and 6.5, 6.6. representative can be fulfilled by his authorised representative, on his behalf and under his responsibility if they are set in the order.

7. common provisions 7.1.
Conformity assessment according to the modules can perform D, D1, F, F1 or G in the manufacturer's operation or at any other place, if not their decomposition and commissioning at the place of use no reassembly or other technical work require carriage of the measuring device to the place of use, which can affect the accuracy of the measuring instrument, and the gravitational acceleration at the location of the operation is taken into account, or the accuracy of the measuring device is not affected by changes of the gravitational acceleration. In all other cases, it has to happen at the place of use of the meter.

7.2. the accuracy of the measuring instrument is affected by changes of the gravitational acceleration, the procedure is allowed after Z 7.1 in two stages, where the second stage of all other examinations and tests includes all examinations and tests, where, the result depends on the gravitational acceleration, and the first stage. The second stage is carried out at the place of use of the meter. On its territory, a Member State of the European Union has set gravity zones, the expression "at the place of use of the measuring instrument" may also be understood as "in the gravitational use zone of the measuring instrument".

7.2.1. a manufacturer chooses the proceedings mentioned in Z 7.1 in two stages and carried these two stages by different agencies, an instrument which has undergone the first stage of the procedure concerned, must bear the identification number of the notified body who was involved in the first stage.

7.2.2. the party which has carried out the first stage of the procedure, granted a certificate with the information necessary for the identification of the instrument and a specification of the investigations and tests for each individual instrument.

The party which carries out the second stage of the process, taking the examinations and tests that have not been conducted yet.

The manufacturer or his authorised representative can present at the request the certificates of conformity of the notified body.

7.2.3. the manufacturer has elected module D or D1 in the first stage, may either use the same procedure for the second stage or second level choose module F or F1 depending on the needs.

7.2.4. the CE marking and the supplementary metrology marking are after the second stage together with the identification number of the notified body which took part in the second stage, to attach the measuring device.

 

Annex 2

EU Declaration of conformity (No. XXXX)



1. meter model/meter (product, type, batch or serial number): 2. name and address of the manufacturer and, where appropriate, his authorised representative: 3. bears sole responsibility for issuing this Declaration of conformity the manufacturer.

4.

Object of the Declaration (designation of the instrument for the purpose of traceability; it can contain an image, unless this is necessary for the identification of the measuring instrument): 5. the above subject to the Declaration complies with the relevant Community harmonisation of the Union: 6 specifying of the relevant harmonised standards or normative documents that have been applied or indication of other normative documents or other technical specifications, for which conformity is declared : 7 which has notified body (identification number name)...... (Description of activities)... and following certificate issued: 8 additional information: signed for and on behalf of:

(Place and date of issue):

(Name, function) (Signature):