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

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

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$40 per month.

Regulation of the Federal Minister for Science, Research and the Economy on the establishment of conformity assessment procedures concerning 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 No 148/2015, shall be arranged:

Scope

§ 1. (1) This Regulation shall apply to all non-automatic weighing instruments, hereinafter also referred to as "measuring instruments", and shall lay down the requirements to be met for the initial placing on the market and/or for the initial entry into service of the system.

(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 following definitions shall apply:

1.

"Libra" means a measuring instrument for determining the mass of a body on the basis of the gravity acting on this body. A balance may also be used to determine other quantities, quantities, parameters or characteristics associated with the mass;

2.

"non-automatic balance" means a balance which, in weighing, requires the intervention of an operator;

3.

"making available on the market" means any supply of a measuring instrument for distribution or use on the Union market in the course of a business activity, whether in return for payment or free of charge;

4.

"placing on the market" means the first-time provision of a measuring instrument on the Union market;

5.

"manufacturer" means any natural or legal person who manufactures or manufactures a measuring instrument and which markets this measuring instrument under its own name or trademark;

6.

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

7.

"importer" means any natural or legal person established in the European Union who places a measuring instrument from a third country on the Union market;

8.

"trader" means any natural or legal person in the supply chain who provides a measuring instrument on the market, with the exception of the manufacturer or the importer;

9.

"economic operators" means the manufacturer, the authorised representative, the importer and the trader;

10.

"technical specification" means a document in which the technical requirements to be met by a measuring instrument are required;

11.

"harmonized standard" means 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" means an accreditation within the meaning of Article 2 Z 10 of Regulation (EC) No 765/2008 laying down the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 765/2008. 339/93, OJ L 339, 31.12.1993, No. OJ L 218, 13.08.2008 p. 30;

13.

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

14.

"conformity assessment" means the procedure for assessing whether the essential requirements of this Regulation have been met by a measuring instrument;

15.

"conformity assessment body" means a body carrying out conformity assessment activities, including calibrations, tests, certifications and inspections;

16.

"recall" means any measure aimed at the performance of the return of a measuring device already provided to the end user;

17.

"withdrawal" means any measure designed to prevent a measuring instrument in the supply chain from being made available on the market;

18.

"Union harmonisation legislation" means the legislation of the European Union on the harmonisation of the conditions for the marketing of products;

19.

"CE marking" means the marking by which the manufacturer declares that the measuring instrument complies with the applicable requirements laid down in the European Union's harmonisation legislation on its affixing.

Essential requirements

§ 3. (1) The essential requirements for non-automatic weighing instruments as well as the inscriptions are determined by the calibration regulations of the Federal Office of Eich-und Vermessungswesen concerning non-automatic weighing instruments.

(2) If equipment is available on a non-automatic scale or if the non-automatic scale is connected to devices which do not fall within the scope of the measure and calibration law, the essential requirements shall not apply. for these facilities.

Obligations of producers

§ 4. (1) Manufacturers shall ensure that measuring instruments which they place on the market and which are to be used within the framework of the provisions of the measure and calibration law are designed in accordance with the essential requirements of the relevant calibration rules; and have been produced.

(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 over 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 consideration.

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

(6) Manufacturers shall ensure that measuring instruments which they have placed on the market shall bear a type, batch or serial number or a different identification mark for their identification in accordance with the corresponding calibration requirements and shall take the necessary measures to ensure that they are identified in accordance with the relevant standard rules. shall be provided for.

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

(8) If equipment is present on a measuring instrument or if the measuring instrument is connected to devices which are not to be used or intended to be used within the scope of the provisions of the measure and calibration law, the manufacturers shall bring them to each other this device is the symbol of the usage limit 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 the German language. These operating instructions and information, as well as all markings, must be clear, comprehensible and clear.

(11) Manufacturers who are of the opinion or have reason to believe that a measuring instrument placed on the market are not in conformity with the requirements of this Regulation or the calibration requirements shall immediately take the corrective measures which: in order to establish 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. The competent authorities in Austria are to inform the Federal Ministry of Science, Research and the Economy and the calibration authorities.

(12) Manufacturers shall submit to the Federal Minister for Science, Research and Industry and the calibration authorities, at their reasonable request, all the information and documents necessary for the verification of conformity of the measuring instrument with this Regulation shall be available 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 they have placed on the market.

Plenipotentiaries

§ 5. (1) A manufacturer may designate 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 authorised 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)

keeping the EU declaration of conformity and the technical documentation available to the national market surveillance authorities for a period of ten years from the date on which the measuring instrument is placed on the market;

b)

on the basis of a reasoned request from a competent national authority, to have all the information and documents necessary to demonstrate the conformity of a measuring instrument to that authority;

c)

, at the request of the competent national authorities, cooperation in all measures to avoid the risks associated with measuring instruments belonging to their remit.

Obligations of the importer

§ 6. (1) The importer shall only place conformable measuring instruments on the market.

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) Where a importer considers or has reason to believe that a measuring instrument does not meet the essential requirements of the calibration requirements, he shall not place the measuring instrument on the market until the conformity of the measuring instrument is established. is. 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 laid down in § 4 (7) for measuring instruments which are not to be used or to be used within the scope of the calibration duty.

(5) The importer shall indicate on the measuring instrument its name, its registered trade name or registered trade mark and the postal address at which it can be contacted on the measuring instrument. 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 do not adversely affect the conformity with the essential requirements of the calibration rules.

(8) The importer shall, in the light of the hazards posed by a measuring instrument, take samples of measuring equipment on the market, carry out tests and, if necessary, carry out a list of: Complaints, non-conformable measuring instruments and recalls of measuring instruments and keep distributors informed of this 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 corrective measures to: the conformity of this measuring instrument or, if necessary, withdraw it or recall it. 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. The competent authorities in Austria are to inform the Federal Ministry of Science, Research and the Economy and the calibration authorities.

(10) The importer shall, after placing the measuring instrument on the market, keep a copy of the EU declaration of conformity to the market surveillance authorities for a period of 10 years and ensure that they submit the technical documentation to them on request .

(11) The importer shall provide the Federal Ministry of Science, Research and Industry and the calibration authorities with all the information and documents required for the verification of conformity of the measuring instrument with this Regulation on the basis of their substantiated request. shall be available in paper form or by electronic means in German. They shall cooperate with those authorities, at their request, in all measures to avert the risks associated with measuring instruments which they place on the market.

Obligations of traders

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

(2) Before they provide a measuring instrument on the market, dealers shall check whether the measuring instrument is marked with the CE marking and the additional metrology marking, whether it has the necessary documentation and the operating instructions and the Information in German is attached, 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 not provide this measuring instrument on the market until its conformity has been established. If a risk is associated with the measuring instrument, the dealer also informs the manufacturer or the importer as well as the Federal Ministry of Science, Research and Economy 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 § 4 (7) and § 6 (5) for measuring instruments which are not to be used or to be used within the framework 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 do not affect the conformity with the essential requirements of the calibration rules.

(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 rules shall ensure that the necessary corrective measures are taken , in order to establish the conformity of this measuring instrument, to withdraw it if necessary or to recall it. In addition, if risks are associated with the measuring device, dealers shall immediately inform the competent national authorities of the Member States of the European Union in which they have provided the measuring instrument on the market, and detailed information, in particular on the non-compliance and the corrective measures taken. The competent authorities in Austria are to inform the Federal Ministry of Science, Research and the Economy and the calibration authorities.

(7) The dealers shall provide the Federal Ministry of Science, Research and the Economy and the calibration authorities with all information and documents necessary for the verification of the conformity of a measuring instrument, at the request of the competent authorities, in accordance with the requirements of the Paper form or by electronic means. They shall cooperate with those authorities, at the request of those authorities, in all measures to avert the risks associated with products which they have made available on the market.

Circumstances under which the manufacturer ' s obligations shall also apply to importer and trader

§ 8. A importer or distributor shall be deemed to be a manufacturer for the purposes of this Regulation and shall be subject to the obligations of a manufacturer in accordance with § 4 if he places a measuring instrument on the market under his or her own name or trade mark or is already the measuring instrument on the market so as to alter the conformity of the measuring instrument with this Regulation or the calibration rules.

Identification of economic operators

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

a)

of which they referred to a measuring instrument;

b)

to which they have delivered a measuring instrument.

(2) The economic operators must be able to provide the information referred to in paragraph 1 for ten years from the point of reference of the measuring instrument and ten years after the supply of the measuring instrument.

Presumption of conformity of measuring instruments

§ 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 with the essential safety requirements shall be laid down in accordance with the , which are covered by the relevant standards 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 rules shall be carried out in accordance with a conformity assessment procedure to be selected by the manufacturer, 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 Annex 1;

2.

Module G in accordance with Annex 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, shall, however, not be subject to the procedure according to Module B in Annex 1. For those measuring instruments in which module B is not applicable in accordance with Annex 1, Module D1 as defined in Annex 1 or Module F1 to Annex 1 shall apply.

(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 another language recognised by this body to be taken.

EU Declaration of Conformity

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

(2) The EU declaration of conformity in its structure corresponds 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 if the measuring instrument is placed on the market or provided in Austria.

(3) A measuring instrument is subject to a number of European Union legislative acts, each of which requires an EU declaration of conformity, only one EU declaration of conformity is issued for all acts of the 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 indicated by the "CE" marking in accordance with para. 2 and the additional metrology marking in accordance with paragraph 3 on the measuring instrument.

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

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

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

Affixing of the CE marking and the additional metrology marking

§ 14. (1) The CE marking and the supplementary metrology marking shall be affixed legibly, legibly and permanently on the measuring instrument or its label.

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

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

(4) Behind the CE marking and the additional metrology marking, the identification number (s) of the notified body (s) involved in the production control phase referred to in Annex 1 (s) shall be identified.

(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 indicating a particular risk or use.

Usage limit icon

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

Notification

§ 16. (1) The notification of posts shall be carried out by the procedure in accordance with § § 18a to 18d MEG.

(2) The identification number awarded 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 set out in paragraphs 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 the event of compliance with the conditions laid down in this Regulation.

(3) A conformity assessment body must be an independent third party who does not have any connection with the equipment 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 demonstrated, as such an independent third party.

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

1.

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

2.

shall not be directly involved in the design, manufacture or construction, marketing, installation, use or maintenance of these measuring instruments, nor represent the parties involved in such 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 adversely affect the confidentiality, objectivity or impartiality of their conformity assessment activities.

(6) The conformity assessment bodies and their staff must carry out the conformity assessment activities with the greatest possible degree of professionalism and professional competence in the field in question; they shall not be allowed to: influence, in particular financial, which may affect its assessment or the results of its conformity assessment work, and which, in particular, emanates from persons or groups of persons who are interested in the outcome of the outcome of the of these activities.

(7) A conformity assessment body must be able to cope with all conformity assessment tasks assigned to it in accordance with the provisions of Annex 1 and for which it has been notified, whether those tasks are carried out by the body itself, in its Orders or under their responsibility will be executed.

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

1.

the necessary staff, with expertise and sufficient experience, to carry out the tasks of conformity assessment;

2.

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

3.

Procedures for carrying out activities with due regard to the size of a company, the industry in which it operates, its structure, the degree of complexity of the product technology concerned and the fact that it is Production process is a mass production or series production.

(9) A conformity assessment body must provide the necessary means for the appropriate execution of the technical and administrative tasks associated with the conformity assessment and access to all necessary equipment, or Facilities.

(10) The staff responsible for carrying out the tasks arising from conformity assessment shall have the following:

1.

sound professional and vocational training covering all the conformity assessment activities 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 carried out and the appropriate authority to carry out such assessments;

3.

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

4.

The ability to produce certificates, protocols and reports as proof of assessments carried out.

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

(12) The remuneration of the senior management level 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 vis-à-vis 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 which are within the framework of the relevant harmonisation legislation of the European Union , or shall ensure that the staff responsible for the performance of conformity assessment tasks are informed, and shall apply the administrative decisions and documents drawn up by that group as general guidelines.

Presumption of conformity in notified bodies

§ 18. Where a conformity assessment body proves that it meets the criteria of the relevant harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, it may be presumed that: complies with the requirements laid down in § 17, in so far as the applicable harmonised standards cover these requirements.

Branch companies of notified bodies and subcontracting

§ 19. (1) The notified body shall assign or transfer to a sub-contractor certain tasks associated with the conformity assessment, and shall ensure that the subcontractor or the branch undertaking has the following responsibilities: The requirements of § 17 shall be met 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.

The notified bodies shall keep the relevant documentation available for the notifying authority on the assessment of the qualifications of the subcontractor or of the branch undertaking and the work carried out by the notified body in accordance with Annex 1.

Obligations of notified bodies in relation to their work

§ 20. 1. The notified bodies shall carry out conformity assessment in accordance with the conformity assessment procedures referred to in Annex 1.

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

(3) Where a notified body finds 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, it shall: the manufacturer shall take appropriate corrective measures and shall not issue a certificate of conformity.

(4) Where 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 take appropriate corrective measures , and shall suspend or withdraw the certificate, if necessary.

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

Procedures for the treatment of measuring instruments at risk of exposure at national level

§ 21. (1) If the calibration authorities have reasonable grounds to believe that a measuring instrument covered by this Regulation endangers the aspects of the protection of the public interest covered by this Regulation, they shall assess whether the relevant instrument is Measuring instrument satisfies 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.

Where, in the course of the assessment referred to in paragraph 1, the calibration authorities have concluded that the measuring instrument does not comply with the requirements of this Regulation, they shall, without delay, request the economic operator concerned to do so within one of the authority to take all appropriate corrective measures to ensure the conformity of the measuring instrument with those requirements, to withdraw it from the market or to recall it, in order to meet the nature of the risk.

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

(4) Art. 21 of Regulation (EC) No 765/2008 applies 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. It 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 any appropriate corrective action he takes shall extend to all the measuring instruments concerned which he has provided in the European Union on the market.

(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 measuring instrument on the domestic market. to prohibit or restrict the measuring device from the market or to recall it.

(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 alleged non-conformity and the risk and the nature and duration of the national measures taken and the arguments of the economic operator concerned. In particular, it should be stated whether the non-compliance is due to one of the following reasons:

1.

The measuring instrument shall not comply with the requirements laid down in this Regulation with regard to aspects relating to the protection of public interests, or

2.

the harmonized standards, where compliance with Article 10 is subject to a presumption of conformity, are deficient.

(10) The Commission's review that the measure is not justified is to withdraw this measure without delay.

Risk from compliant measuring instruments

§ 22. (1) The Federal Ministry for Science, Research and the Economy or the calibration authorities shall establish that a measuring instrument poses a risk to aspects of the protection of public interests, although it is in accordance with this Regulation, the to invite the economic operator concerned to take all appropriate measures to ensure that the measuring instrument in question no longer has that risk on the market or that it is within one of the nature of the risk appropriate, reasonable period shall be 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 required by the calibration authorities to correct the non-compliance in question, if they determine any of the following cases:

1.

The CE marking or the additional metrology marking has been affixed in the event of non-compliance with Article 30 of Regulation (EC) No 765/2008 or in Article 14 of this Regulation;

2.

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

3.

the inscriptions in accordance with § 4 (6) to (8) have not been applied or are appropriate for failure to comply with § 4 (6) to (8);

4.

the identification number of the notified body, if this body was involved in the production control phase, was affixed or was not applied in the event of non-compliance with § 14;

5.

the EU declaration of conformity has not been issued;

6.

the EU declaration of conformity has not been properly issued;

7.

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

8.

the information referred to in § 4 (9) or § 6 (5) is missing, is incorrect or incomplete;

9.

A different administrative requirement pursuant to § 4 or § 6 is not fulfilled.

(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 it is recalled or from the market.

Linguistic equality

§ 24. As far as natural persons are referred to in this Regulation only in male form, they shall refer to women and men in the same way. In applying the name to certain natural persons, the gender-specific form shall be used.

Implementation of European Union legal 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-self-employed weighing instruments on the market, OJ L 327, 31.12.2014, p. No. OJ L 96 of 29.03.2014 p. 107.

Transitional provisions

§ 26. (1) From 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 in accordance 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 of Economic Affairs for the determination of Conformity assessment procedures relating to 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 presentation of this Regulation, bodies may be appointed in accordance with § 17.

(3) notified bodies shall not issue certificates for the CE marking under this Regulation before 20 April 2016.

(4) A placing on the market or putting into service of measuring instruments which are labelled in accordance with this Regulation shall not be allowed before 20 April 2016.

Mitterlehner

ANNEX 1

PROCEDURES FOR CONFORMITY ASSESSMENT

1. Module B: EU type-examination

1.1.

The EU type-examination is the part of a conformity assessment procedure, in which a notified body examines and certifies the technical design of a measuring instrument and certifies that it is the one in force for the measuring instrument. Requirements of this Regulation.

1.2.

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

1.

Examination of a model of the complete measuring instrument representative of the planned production (construction model);

2.

Assessment of the suitability of the technical design of the measuring instrument on the basis of an examination of the technical documentation and additional evidence referred to in Z 1.3, as well as the examination of the samples of one or more of the samples representative of the planned production important parts of the measuring instrument (combination of construction and design);

3.

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

1.3.

The application for EU type-examination must be submitted by the manufacturer to a single notified body of his choice.

The application shall contain the following:

a)

the name and address of the manufacturer and, if the application is submitted by the authorised representative, the name and address of the person concerned;

b)

a written declaration that the same application has not been lodged with any other notified body;

c)

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. Where appropriate, the technical documentation shall contain at least the following elements:

i)

a general description of the measuring instrument;

ii)

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

iii)

descriptions and explanations necessary for the understanding of these drawings and plans, as well as the operation of the measuring instrument;

iv)

a list of which harmonized standards, the references of which have been published in the Official Journal of the European Union, have been applied in full or in part, and, where these harmonized standards have not been applied, a a description of the solutions to meet the essential safety requirements of this Regulation, including a list of which other relevant technical specifications have been applied; in the case of partially applied harmonized standards shall be used for the parts which are applied have been indicated in the technical documentation;

v)

the results of design calculations, tests, etc. and

vi)

the audit reports;

d)

for the production in question, representative samples; the notified body may request additional samples where this is necessary for the implementation of the test programme;

e)

the additional evidence of a suitable 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 his responsibility.

1.4.

The notified body shall carry out the following tasks:

In relation to the measuring instrument:

1.4.1.

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

Based on the pattern (s):

1.4.2.

checking whether the design has been produced in accordance with the technical documentation, and determining which parts have been designed in accordance with the applicable harmonised standards and which parts, in accordance with the provisions of the relevant harmonised standards, relevant technical specifications;

1.4.3.

to carry out or initiate the appropriate examinations and tests to determine whether the solutions have been correctly applied in the relevant harmonised standards, provided that the manufacturer has opted for the application;

1.4.4.

To carry out or initiate the 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 meet the relevant essential requirements of this Regulation;

1.4.5.

Agreement with the manufacturer, where the examinations and tests are carried out.

1.5.

The notified body shall draw up an audit report on the measures carried out in accordance with Z 1.4 and the results obtained. 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.

Where the design corresponds to the requirements of this Regulation applicable to the measuring instrument in question, 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 shall contain all relevant information enabling an assessment of the conformity of the manufactured measuring instrument with the design tested and a check after it has been put into service.

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 may be limited to two years and extended by three years due to the use of new techniques.

Where the design does not comply with the applicable requirements of this Regulation, the notified body shall refuse to issue an EU type-examination certificate and shall inform the applicant thereof, in which case the applicant shall give a detailed view of its refusal to grant the certificate. is based.

1.7.

The notified body shall keep informed of any changes in the generally accepted state of the art which indicate that the approved type of design no longer complies with the applicable requirements of this Regulation, and shall decide: 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 authorisation in the form of an addition 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 it has issued or withdrawn, and shall transmit to its notifying authority in regular Any such certificates and/or supplements to which they are refused, suspended or otherwise restricted shall be established at intervals or at the request of the Commission.

Each notified body shall inform the other notified bodies of the EU type-examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and shall inform them of: the corresponding request shall be made by all the certificates and/or additions it has issued.

If they so request, the European Commission, the Member States of the European Union and the other notified bodies will receive a copy of the EU type-examination certificates and/or their additions. The European Commission and the Member States of the European Union shall, on request, receive a copy of the technical documentation and 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 shall keep a copy of the EU type-examination certificate, its annexes and additions, together with the technical documentation, ready for the national authorities for 10 years after the measuring instrument has been placed on the market.

1.10.

The authorised representative of the manufacturer may submit the application referred to in point Z. 1.3 and fulfil the obligations set out in Z 1.7 and 1.9 if they are laid down in the contract.

Module D: Conformity with the design on the basis of a quality assurance of the production process

2.1.

Conformity with the design on the basis of a quality assurance related to 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 shall ensure, on its own responsibility, that the measuring instruments in question are in conformity with the type as described in the EU type-examination certificate and satisfy the requirements of this Regulation which apply to them.

2.2.

Manufacture

The manufacturer shall operate an approved quality assurance system for the manufacture, final inspection and testing of the measuring instruments in question in accordance with Z 2.3 and shall be subject to the monitoring in accordance with Z 2.4.

2.3.

Quality assurance system

2.3.1.

The manufacturer shall apply to the notified body of his choice for the assessment of his quality system for the measuring instruments concerned.

The application shall contain the following:

a)

the name and address of the manufacturer and, if the application is submitted by the authorised representative, the name and address of the person concerned;

b)

a written declaration that the same application has not been lodged with any other notified body;

c)

all relevant information relating to the measuring equipment category provided;

d)

the documents relating to the quality system and

e)

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

2.3.2.

The quality assurance system shall ensure the conformity of the measuring instruments with the type as described in the EU type-examination certificate and with the requirements of this Regulation applicable to them.

All the elements, requirements and requirements taken into account by the manufacturer must be systematically and properly put together in the form of written principles, procedures and operating instructions. These documents relating to the quality assurance system must enable a uniform interpretation of the quality programmes, plans, manuals and reports.

In particular, they shall provide an adequate description of the following points:

a)

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

b)

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

c)

the examinations and tests carried out before, during and after manufacture, indicating their frequency;

d)

quality records, such as test reports, test and calibration data, as well as reports on the qualifications of the personnel concerned, etc.;

e)

Means to monitor the achievement of the required product quality and the effective functioning of the quality system.

2.3.3.

The notified body shall assess the quality system in order to determine whether it meets the requirements set out in point Z 2.3.2.

In the case of each component of the quality assurance system which meets the relevant specifications of the relevant harmonised standard, it shall comply with these requirements.

In addition to experience with quality assurance systems, at least one member of the audit team shall have experience of the assessment in the relevant measuring equipment sector and of the measuring instrument technology concerned, as well as 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 shall be notified to the manufacturer. The communication must contain the outcome of the audit and the justification for the evaluation decision.

2.3.4.

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

2.3.5.

The manufacturer shall inform the notified body which has approved the quality system of any planned changes to the quality system.

The notified body shall assess the proposed changes and decide whether the modified quality system still meets the requirements set out in point Z 2.3.2 or whether a re-evaluation is necessary.

It shall announce its decision to the manufacturer. The notification shall include the outcome of the examination and the justification for the evaluation decision.

2.4.

Surveillance under the responsibility of the notified body

2.4.1.

The purpose of monitoring is to ensure that the manufacturer complies with the obligations arising from the approved quality system.

2.4.2.

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

a)

the documents relating to the quality system;

b)

the quality-related records, such as test reports, test and calibration data, and reports on the qualifications of the personnel concerned, etc.

2.4.3.

The notified body shall carry out audits on a regular basis to ensure that the manufacturer maintains and applies the quality assurance system and shall submit a test report to it.

2.4.4.

In addition, the notified body may carry out 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 event of an audit, a report.

2.5.

Conformity marking and EU declaration of conformity

2.5.1.

The manufacturer shall affix the CE marking to each individual measuring instrument which is in conformity with the type as described in the EU type-examination certificate and satisfies the applicable requirements of this Regulation, which shall comply with the provisions of this Regulation additional metrology marking as well as-under the responsibility of the notified body referred to in Z 2.3.1-the identification number thereof.

2.5.2.

The manufacturer shall draw up a written EU declaration of conformity for each measuring instrument model and shall keep it ready for the national authorities for ten years after the measuring instrument has been placed on the market. The EU declaration of conformity must show which measuring instrument model it has been issued for.

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

2.6.

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

a)

the documents referred to in Z 2.3.1;

b)

the information relating to the change in accordance with Z 2.3.5 in its approved version;

c)

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 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 they have refused, suspended or otherwise restricted.

2.8.

Authorised representative

The manufacturer ' s obligations referred to in points 2.3.1, 2.3.5, 2.5 and 2.6 may be fulfilled by his authorised representative on his behalf and under his responsibility, if they are laid down in the contract.

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

3.1.

Quality assurance in relation to the production process is the conformity assessment procedure, in which the manufacturer fulfils the obligations laid down in the Z 3.2, 3.4 and 3.7 and ensures and on its own Responsibility shall declare that the measuring instruments in question comply with the requirements of this Regulation which apply to them.

3.2.

Technical documentation

The manufacturer shall draw up 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. Where appropriate, the technical documentation shall contain at least the following elements:

a)

a general description of the measuring instrument;

b)

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

c)

descriptions and explanations necessary for the understanding of these drawings and plans, as well as the operation of the measuring instrument;

d)

a list of which harmonized standards, the references of which have been published in the Official Journal of the European Union, have been applied in full or in part, and, where these harmonized standards have not been applied, a a description of the solutions to meet the essential safety requirements of this Regulation, including a list of which other relevant technical specifications have been applied; in the case of partially applied harmonized standards shall be used for the parts which are applied have been indicated in the technical documentation;

e)

the results of the design calculations, tests, etc.;

f)

the audit reports.

3.3.

The manufacturer shall keep the technical documentation available for 10 years after placing the measuring instrument on the market for the competent national authorities.

3.4.

Manufacture

The manufacturer shall operate an approved quality assurance system for the manufacture, final inspection and testing of the measuring instruments in question in accordance with Z 3.5 and shall be subject to monitoring in accordance with Z 3.6.

3.5.

Quality assurance system

3.5.1.

The manufacturer shall apply to the notified body of his choice for the assessment of his quality system for the measuring instruments concerned.

The application shall contain the following:

a)

the name and address of the manufacturer and, if the application is submitted by the authorised representative, the name and address of the person concerned;

b)

a written declaration that the same application has not been lodged with any other notified body;

c)

all relevant information relating to the measuring equipment category provided;

d)

the documents relating to the quality system;

e)

the technical documentation according to Z 3.2.

3.5.2.

The quality system shall ensure the conformity of the measuring instruments with the requirements of this Regulation which apply to them.

All the elements, requirements and requirements taken into account by the manufacturer must be systematically and properly put together in the form of written principles, procedures and instructions. These documents relating to the quality assurance system must enable a uniform interpretation of the quality programmes, plans, manuals and reports.

In particular, they shall provide an adequate description of the following points:

a)

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

b)

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

c)

the examinations and tests carried out before, during and after manufacture, indicating their frequency;

d)

quality records, such as test reports, test and calibration data, as well as reports on the qualifications of the personnel concerned, etc.;

e)

Means to monitor the achievement of the required product quality and the effective functioning of the quality system.

3.5.3.

The notified body shall evaluate the quality system in order to determine whether it meets the requirements set out in point Z 3.5.2.

In the case of each component of the quality assurance system which meets the relevant specifications of the relevant harmonised standard, it shall comply with these requirements.

In addition to experience with quality assurance systems, at least one member of the audit team shall have experience of the assessment in the relevant measuring equipment sector and of the measuring instrument technology concerned, as well as 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 Conformity of the measuring instrument with these requirements is ensured.

The decision shall be notified to the manufacturer. The communication must contain the outcome of the audit and the justification for the evaluation decision.

3.5.4.

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

3.5.5.

The manufacturer shall inform the notified body which has approved the quality system of any planned changes to the quality system.

The notified body shall assess the proposed changes and decide whether the modified quality system still meets the requirements set out in point Z 3.5.2 or whether a re-evaluation is necessary.

It shall announce its decision to the manufacturer. The notification shall include the outcome of the examination and the justification for the evaluation decision.

3.6.

Surveillance under the responsibility of the notified body

3.6.1.

The purpose of monitoring is to ensure that the manufacturer complies with the obligations arising out of the approved quality system.

3.6.2.

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

a)

the documents relating to the quality system;

b)

the technical documentation referred to in Z 3.2;

c)

the quality-related records, such as test reports, test and calibration data, and reports on the qualifications of the personnel concerned, etc.

3.6.3.

The notified body shall carry out audits on a regular basis to ensure that the manufacturer maintains and applies the quality assurance system and shall submit a test report to it.

3.6.4.

In addition, the notified body may carry out 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 provide the manufacturer with a survey report and, in the case of a test, a test report.

3.7.

Conformity marking and EU declaration of conformity

3.7.1.

The manufacturer shall affix the CE marking and the additional metrology marking in accordance with this Regulation to each individual measuring instrument which satisfies the applicable requirements of this Regulation, and under the responsibility of the Notified body of its identification number.

3.7.2.

The manufacturer shall draw up a written EU declaration of conformity for each measuring instrument model and shall keep it ready for the national authorities for ten years after the measuring instrument has been placed on the market. The EU declaration of conformity must show which measuring instrument model it has been issued for.

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

3.8.

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

a)

the documents referred to in Z 3.5.1;

b)

the information relating to the amendment to Z 3.5.5 in its approved version;

c)

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 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 they have refused, suspended or otherwise restricted.

3.10.

Authorised representative

The manufacturer ' s obligations referred to in Z 3.3, 3.5.1, 3.5.5, 3.7 and 3.8 may be fulfilled by his authorised representative on his behalf and under his responsibility, if they are laid down on the contract.

4. Module F: Conformity with the design on the basis of a product test

4.1.

Conformity with the design on the basis of a test of the products is the part of a conformity assessment procedure in which the manufacturer fulfils the obligations laid down in points (4.2) and (4.5) of this Directive, and ensures that the product is in conformity with the requirements of the manufacturer. and on its own responsibility, declares that the measuring instruments subject to the provisions of Z 4.3 are in accordance with the type as described in the EU type-examination certificate and satisfy the requirements of this Regulation which apply to them.

4.2.

Manufacture

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

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 conform to the approved type as described in the EU type-examination certificate and to the relevant tests and tests. to examine the requirements of this Regulation.

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

4.4.

Verification of conformity by examination and testing of each individual measuring instrument

4.4.1.

All measuring instruments shall be individually examined and appropriate tests shall be carried out in accordance with the relevant harmonised standard (s) or equivalent tests, as set out in other relevant technical specifications, in order to: To verify conformity with the approved type as described in the EU type-examination certificate and 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.

4.4.2.

The notified body shall draw up a certificate of conformity on the basis of the examinations and tests carried out and shall affix its identification number to any approved measuring instrument or allow it to bear the responsibility of the competent instrument.

The manufacturer shall keep the certificates of conformity ready for inspection for the national authorities for 10 years after the measuring instrument has been placed on the market.

4.5.

Conformity marking and EU declaration of conformity

4.5.1.

The manufacturer shall affix the CE marking and the additional CE marking to each individual measuring instrument which is in conformity with the approved type as described in the EU type-examination certificate and satisfies the applicable requirements of this Regulation. Metrology marking in accordance with this Regulation and, under the responsibility of the notified body referred to in Z 4.3, the identification number thereof.

4.5.2.

The manufacturer shall draw up a written EU declaration of conformity for each measuring instrument model and shall keep it ready for the national authorities for ten years after the measuring instrument has been placed on the market. The EU declaration of conformity must show which measuring instrument model it has been issued for.

A copy of the EU declaration of conformity shall 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 attach the identification number of the notified body to the measuring instruments.

4.6.

Where the notified body agrees, the manufacturer may, under the responsibility of the manufacturer, apply the identification number of the notified body to the measuring instruments during the manufacturing process.

4.7.

Authorised representative

The obligations of the manufacturer may be fulfilled by his authorised representative on his behalf and under his responsibility, provided that they are laid down on behalf of the manufacturer. An authorized representative may not fulfil the obligations of the manufacturer set out in Z 4.2.

5. Module F1: conformity based on a test of the products

5.1.

Conformity on the basis of a test of the products is the conformity assessment procedure in which the manufacturer fulfils the obligations laid down in points (5.2), (5.3) and (5.6), and ensures and on its own Responsibility shall declare that the measuring instruments subject to the provisions of Z 5.4 shall comply with the requirements of this Regulation which apply to them.

5.2.

Technical documentation

5.2.1.

The manufacturer shall draw up 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. Where appropriate, the technical documentation shall contain at least the following elements:

a)

a general description of the measuring instrument;

b)

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

c)

descriptions and explanations necessary for the understanding of these drawings and plans, as well as the operation of the measuring instrument;

d)

a list of which harmonized standards, the references of which have been published in the Official Journal of the European Union, have been applied in full or in part, and, where these harmonized standards have not been applied, a a description of the solutions to meet the essential safety requirements of this Regulation, including a list of which other relevant technical specifications have been applied; in the case of partially applied harmonized standards shall be used for the parts which are applied have been indicated in the technical documentation;

e)

the results of design calculations, tests, etc. and

f)

the audit reports.

5.2.2.

The manufacturer shall keep the technical documentation available for 10 years after placing the measuring instrument on the market for the competent national authorities.

5.3.

Manufacture

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

5.4.

Review

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

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

5.5.

Verification of conformity by examination and testing of each individual measuring instrument

5.5.1.

All measuring instruments shall be examined individually and appropriate tests shall be carried out in accordance with the relevant harmonised standard (s) or equivalent tests, which shall be included 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 shall draw up a certificate of conformity on the basis of the examinations and tests carried out and shall affix its identification number to any approved measuring instrument or allow it to bear the responsibility of the competent instrument.

The manufacturer shall keep the certificates of conformity ready for the national authorities ten years after the measuring instrument has been placed on the market.

5.6.

Conformity marking and EU declaration of conformity

5.6.1.

The manufacturer shall affix the CE marking and the additional metrology marking in accordance with this Regulation to each individual measuring instrument which satisfies the applicable requirements of this Regulation, and under the responsibility of the Notified body of its identification number.

5.6.2.

The manufacturer shall draw up a written EU declaration of conformity for each measuring instrument model and shall keep it ready for the national authorities for ten years after the measuring instrument has been placed on the market. The EU declaration of conformity must show which measuring instrument model it has been issued for.

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

If the notified body referred to in Z 5.5 is correct, the manufacturer may, under the responsibility of the manufacturer, also apply the identification number of the notified body to the measuring instruments.

5.7.

Where the notified body agrees, the manufacturer may, under the responsibility of the manufacturer, apply the identification number of the notified body to the measuring instruments during the manufacturing process.

5.8.

Authorised representative

The obligations of the manufacturer may be fulfilled by his authorised representative on his behalf and under his responsibility, provided that they are laid down on behalf of the manufacturer. 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: Conformity based on a single test

6.1.

Compliance on the basis of an individual test is the conformity assessment procedure with which the manufacturer fulfils the obligations set out in points Z 6.2, 6.3 and 6.5 and guarantees and on its own responsibility Declares that the measuring instrument subject to the provisions of Z 6.4 shall comply with the requirements of this Regulation which apply to it.

6.2.

Technical documentation

6.2.1.

The manufacturer shall draw up the technical documentation and make it available to the notified body referred to in Z 6.4. 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.

Where appropriate, the technical documentation shall contain at least the following elements:

a)

a general description of the measuring instrument;

b)

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

c)

descriptions and explanations necessary for the understanding of these drawings and plans, as well as the operation of the measuring instrument;

d)

a list of which harmonized standards, the references of which have been published in the Official Journal of the European Union, have been applied in full or in part, and, where these harmonized standards have not been applied, a a description of the solutions to meet the essential safety requirements of this Regulation, including a list of which other relevant technical specifications have been applied; in the case of partially applied harmonized standards shall be used for the parts which are applied have been indicated in the technical documentation;

e)

the results of the design calculations, tests, etc.;

f)

the audit reports.

6.2.2.

The manufacturer shall keep the technical documentation available for 10 years after placing the measuring instrument on the market for the competent national authorities.

6.3.

Manufacture

The manufacturer shall take all measures necessary to ensure that the manufacturing process and its monitoring ensure the conformity of the measuring instruments produced with 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 equivalent tests, which are set out in other relevant technical specifications, through or have them carried out 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 shall draw up a certificate of conformity on the basis of these tests and tests and shall affix its identification number to each approved measuring instrument or shall bring it under its responsibility.

The manufacturer shall keep the certificates of conformity ready for the national authorities ten years after the measuring instrument has been placed on the market.

6.5.

Conformity marking and EU declaration of conformity

6.5.1.

The manufacturer shall affix the CE marking and the additional metrology marking in accordance with this Regulation to each measuring instrument which satisfies the applicable requirements of this Regulation and under the responsibility of the provisions of the provisions of the provisions of this Regulation referred to in point (C) Notified body of its identification number.

6.5.2.

The manufacturer shall draw up a written EU declaration of conformity 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 produce the measuring instrument for which it was issued.

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

6.6.

Authorised representative

The manufacturer ' s obligations under Z 6.2.2 and 6.5 may be fulfilled by his authorised representative on his behalf and under his responsibility if they are laid down in the contract.

7.

Common provisions

7.1.

The conformity assessment according to the modules D, D1, F, F1 or G may be carried out in the manufacturer ' s premises or at any other place where the transport of the measuring instrument to the place of use does not include its dismantling and putting into service on the do not require re-assembly or other technical work which may affect the display accuracy of the measuring instrument, and where the case acceleration at the point of entry into service is taken into account or if: the display accuracy of the measuring instrument is not caused by changes in the Case acceleration is influenced. In all other cases, it has to be done at the point of use of the measuring instrument.

7.2.

If the measuring accuracy of the measuring instrument is influenced by changes in the acceleration of the case, the method according to Z 7.1 may be carried out in two stages, the second stage taking all the tests and tests in which the result of the Case acceleration depends, 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. Where 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 area of use of the measuring instrument'.

7.2.1.

Where a manufacturer chooses to carry out a procedure referred to in Z 7.1 in two stages and these two stages are carried out by different points, a measuring instrument which has passed through the first stage of the procedure in question shall be responsible for: The identification number of the notified body which was involved in the first stage.

7.2.2.

The party which has carried out the first stage of the procedure shall, for each individual measuring instrument, issue a certificate containing the information necessary for the identification of the measuring instrument and a specification of the tests carried out and Checks.

The party which carries out the second stage of the procedure shall carry out the studies and examinations which have not yet been carried out.

The manufacturer or his authorised representative must be able to submit the certificates of conformity to the notified body at the request of the manufacturer or his authorised representative.

7.2.3.

The manufacturer, who has chosen Module D or D1 in the first stage, may use either the same method for the second stage or, as required, select Module F or F1 for the second stage.

7.2.4.

The CE marking and the supplementary metrology marking shall be affixed to the measuring instrument after the end of the second stage together with the identification number of the notified body which was involved in the second stage.

Annex 2

EU-DECLARATION OF CONFORMITY (No XXXX)

1.

Measuring instrument model/measuring instrument (product, type, batch or serial number):

2.

Name and address of the manufacturer and, where appropriate, of his authorised representative:

3.

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

4.

Purpose of the declaration (designation of the measuring instrument for the purpose of traceability; it may contain an image, provided that this is necessary for the identification of the measuring instrument):

5.

The above-mentioned subject-matter of the Declaration shall comply with the relevant Union harmonisation legislation:

6.

Indication of the relevant harmonised standards or normative documents which have been used, 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:

(Place and date of the exhibition):

(Name, function) (Signature):