of June 16, 2015 No. 408
About approval of the Technical regulation about ensuring presence in the market of measuring instruments
According to part provisions (1) Article 18 and line item of the 28th appendix 3 to the Law No. 235 of December 1, 2011 on activities for accreditation and assessment of conformity (The official monitor of the Republic of Moldova, 2012, Art. No. 46-47, 136) DECIDES: the Government
1. Approve the Technical regulation about ensuring presence in the market of measuring instruments it (is applied).
2. This resolution becomes effective after 24 months from the date of publication in the Official monitor of the Republic of Moldova.
3. To the Ministry of Economic Development and digitalization within 6 months from the date of entry into force of this resolution to develop and approve the action plan on implementation of the Technical regulation about ensuring presence in the market of measuring instruments, except for Items 65, of 94, of 96, 128-132, 136-139, 154-158, which will become effective from the date of entry into force of the law on ratification of the Agreement on assessment of conformity and the acceptability of manufactured goods between the Republic of Moldova and the European Union.
4. Ensuring presence in the market of measuring instruments which meet the requirements of regulations, applicable to them, for legislative metrology, to the introduction in operation of this resolution, expiration of approval of standard sample is allowed.
5. Before the date of entry into force of the law on ratification of the Agreement on assessment of conformity and the acceptability of manufactured goods between the Republic of Moldova and the European Union:
1) ensuring presence in the market and commissioning of the measuring instruments marked by marking of compliance of SM (further – marking of SM), put according to the requirements established in the Law No. 235 of December 1, 2011 on activities for accreditation and assessment of conformity is allowed;
2) the producer or his authorized representative, the legal entity with location in the Republic of Moldova, puts marking of SM in case assessment of conformity of the measuring instruments intended for the national market is performed by acknowledged conformity assessment bodies by use of the procedures provided by Chapter XII of the Technical regulation about ensuring presence in the market of measuring instruments. It is forbidden in the conditions provided by this resolution, simultaneous drawing on the same gage of marking of compliance of SM and marking of SE;
3) provisions of this resolution are applied to marking of SE in addition to marking of SM;
4) the Ministry of Economic Development and digitalizations recognizes the bodies performing assessment of conformity of the measuring instruments intended for the national market according to the procedures provided in Chapter XII of the Technical regulation about ensuring presence in the market of measuring instruments. The procedure of notification is performed after the procedure of recognition established in Chapter IV-1 of the Law No. 235 of December 1, 2011 on activities for accreditation and assessment of conformity;
5) requirements to notified conformity assessment bodies are applied also to the acknowledged conformity assessment bodies having similar legal status according to Law No. 235 provisions of December 1, 2011 on activities for accreditation and assessment of conformity. When holding procedures for assessment of conformity the acknowledged bodies performing assessment of conformity of measuring instruments constitute the test certificate of standard sample;
6) the list including acknowledged conformity assessment bodies and their identification numbers is kept by the National center of accreditation MOLDAC and published on its official site.
6. Obligations and liability of the producer, his authorized representative, the importer or the distributor, legal entities, with the location in the Republic of Moldova, concerning the measuring instruments which are present at the market and put into operation under marking of SM correspond to those that are provided by this resolution for measuring instruments under marking of SE.
7. To national institute of metrology to develop within 18 months from the date of publication of this resolution of regulation on legislative metrology for carrying out metrological checkings of the measuring instruments which are in operation which are subject of this resolution and to provide them for approval to the Ministry of Economic Development and digitalization.
8. To impose control over the implementation of this resolution on the Ministry of Economic Development and digitalizations.
|
Prime Minister |
Kirill Gaburich |
|
Countersigns: Deputy Prime Minister, Minister of Economic Affairs |
Stefan Christoph Brid |
Approved by the Order of the Government of the Republic of Moldova of June 16, 2015, No. 408
This Technical regulation shifts the Directive 2014/32/EC of the European parliament and Council of February 26, 2014 about harmonization of the legislation of state members on presence in the market of measuring instruments (the reviewed version) published in the Official magazine of the European Union by L 96 of March 29, 2014.
1. The technical regulation about ensuring presence in the market of measuring instruments (further – the Technical regulation) establishes requirements to which measuring instruments, for ensuring their presence in the market and/or commissioning for the purpose of the measurements taken in areas of public interest, including health and safety of the population, public order, environmental protection, consumer protection, collection of payments and taxes, and also commercial transactions and transactions shall answer.
2. This Technical regulation is applied to the new gages for their introduction on the market made by the producer registered in the territory of the Republic of Moldova, and also to new measuring instruments or being in use, imported from other countries.
3. Legislative metrological control involves compliance to the essential requirements specified in appendix No. 1 to this Technical regulation.
4. In the areas of public interest which are subject to legislative metrological control only those gages which observe essential requirements are applied.
5. Compatibility of measuring instruments with electromagnetic waves is integral part of this Technical regulation, and for this reason of gage do not fall under action of the requirements to compatibility provided in the Technical regulation "Electromagnetic Compatibility of the Equipment" approved by the Order of the Government No. 807 of October 29, 2015.
6. The main state inspectorate for supervision of non-food products and consumer protection is responsible supervision body behind the market on ensuring compliance to the established and/or declared requirements to the products entered or which are present at the market. For prevention of presence in the market and/or commissioning of inappropriate gages the Main state inspectorate for supervision of non-food products and consumer protection cooperates with customs authorities of the Republic of Moldova.
7. Economic agents (producers, importers, distributors) bear responsibility for compliance of measuring instruments to requirements of this Technical regulation.
8. The importer or the distributor are considered as producer for the purposes of this Technical regulation and are subject to obligations which are assigned to the producer, according to Chapter VI of this Technical regulation when the gage is entered on the market under the name or under the sign or change the gage which is already entered on the market in such a way that it can affect compliance to requirements of this Technical regulation.
9. The economic agents participating in chain of supply and distribution take measures for ensuring presence in the market of measuring instruments which correspond to this Technical regulation.
10. Assessment of conformity of gages is exclusive obligation of the producer.
11. Each economic agent who enters on the market gage under the name or sign or changes gage in such a way that it can influence observance of requirements of this Technical regulation, it is considered the producer and, therefore, shall undertake obligations of the producer.
12. The distributors and importers participating in task of supervision of the market, the performed Main state inspectorate for supervision of non-food products and consumer protection, realization provide it all necessary information which belongs to gage, according to provisions of the existing legal acts which regulate activities of the state control and supervision of the market.
13. To gages which are entered on the market of the Republic of Moldova belonging to this Technical regulation, the regulations about supervision of the market provided by the Law No. 7 of February 26, 2016 on supervision of the market concerning realization of nonfood products are applied.
14. Ceased to be valid according to the Order of the Government of the Republic of Moldova of 14.06.2023 No. 386
15. The assessment procedures of compliance specified in this Technical regulation are performed by conformity assessment bodies, accredited and notified according to the Law No. 235 of December 1, 2011 on activities for accreditation and assessment of conformity (The official monitor of the Republic of Moldova, 2012, Art. No. 46-47, 136).
16. The conformity assessment bodies participating in assessment procedures of compliance, specified in this Technical regulation shall conform to mandatory requirements to the conformity assessment bodies established in Chapters XIX, XX and XXII of this Technical regulation.
17. If the conformity assessment body is accredited according to the requirements provided in the reference standards approved by the order of the Minister of Economic Affairs, in this case they meet the requirements specified in this Technical regulation.
18. Conformity assessment bodies apply assessment procedures of compliance, without creating excessive burden for economic agents. Ensuring equality to economic agents in consecutive application of technical procedures for assessment of conformity is reached by means of proper coordination and cooperation between notified bodies.
19. This Technical regulation is applied to the gages specified in special applications No. 3-12 to this Technical regulation (further – special applications of measuring instruments), on counters of water (MI-00l), counters of gas and devices of transformation of amount (MI-002), counters of the active electric power (MI-003), heat meters (MI-004), measuring systems to continuous and dynamic measurement of amount of any liquids, except water (MI-005), automatic weight measuring devices (MI-006), taximeters (MI-007), material measures (MI-008), gages of the linear sizes (MI-009) and analyzers of exhaust gases (MI-0l 0).
20. For the purposes of this Technical regulation the terminology stated in the Law No. 235 of December 1, 2011 on activities for accreditation and assessment of conformity and also terms and determinations of the following value are used:
gage – any device used for accomplishment of measurements separately or in combination with one or several auxiliary devices;
component (node) – the device mentioned in quality of that in special applications on measuring devices, operating independently and forming the measuring device together with other nodes to which it is compatible, or by means of one device to which it is compatible;
metrological checking – the method of metrological control executed by means of assessment procedure of compliance therefore the sign of metrological checking is put and/or is issued the bulletin of metrological checking;
commissioning – the first use of measuring instrument by the final consumer for the ordered purposes;
the economic agent – the producer, the authorized representative, the importer, the distributor;
return – any measure directed to return of measuring instrument which was already delivered to the end user;
cancellation – any measure directed to prevention of presence in the market of gage in supply chains;
the regulating document – the document containing the technical requirements accepted by the International organization of legislative metrology (further – MOZM), references to which are published in the Official monitor of the Republic of Moldova together with the list of those parts of the document which observance provides presumption of compliance to the conforming essential requirements of this Technical regulation.
21. If there are special applications establishing essential requirements to components, then provisions of this Technical regulation shall be applied to such components.
22. Assessment of conformity of components is performed according to this Technical regulation. If components are present at the market separately and irrespective of gage, assessment of conformity is performed irrespective of this gage.
23. The measuring instrument shall meet the essential requirements established in appendix No. 1 and in the special application relating to this type of measuring instrument to this Technical regulation.
24. For the correct use of measuring instrument information specified in appendix No. 1 or in the corresponding special application on gage type to this Technical regulation needs to be provided in state language.
25. Measuring instruments are present at the market and/or are put into operation, only if meet the essential requirements of this Technical regulation.
26. The gage shall meet the requirements regulating its commissioning which are proved by local climatic conditions. In that case according to the offer of National institute of metrology the order of the Minister of Economic Affairs sets the upper and lower limits of temperature, the corresponding table 1 of appendix No. 1 to this Technical regulation, humidity conditions (with or without condensation) and also if the gage is held for use in the closed or open space.
27. If for gage various classes of accuracy are determined:
1) the special applications relating to measuring instrument establish accuracy classes which will be used for specific applications in the heading "Commissioning";
2) in all other cases according to the offer of National institute of metrology the order of the Minister of Economic Affairs establishes accuracy classes which will be used for specific applications within certain classes provided that it is possible to use all classes of accuracy.
28. For the purposes of Item 27 of this Technical regulation at the request of the owner gages of the highest class of accuracy can be used.
29. At fairs, exhibitions, demonstrations or similar actions representation of the measuring instruments which are not corresponding to this Technical regulation is allowed provided that information is seen and accurately specifies that gages do not correspond and cannot be present at the market and/or to be put into operation until they are brought into accord.
30. When ensuring presence of measuring instruments in the market and/or commissioning producers shall guarantee that they were designed and made according to the essential requirements provided by the appendix No. 1 and special applications relating to gages, this Technical regulation.
31. Producers shall constitute the technical documentation specified in Chapter XIII of this Technical regulation and carry out the relevant assessment procedure of compliance specified in Chapter XII of this Technical regulation or dispose about its carrying out.
32. If gage compliance to the applied requirements of this Technical regulation by means of assessment procedure of compliance was confirmed, producers shall constitute the declaration of conformity and put marking of SE and additional metrological marking.
33. Producers shall store technical documentation and the declaration of conformity within 10 years after introduction on the market of measuring instrument.
34. Producers shall guarantee availability of procedures which provide continuous compliance for batch production to requirements of this Technical regulation. It is necessary to take into account changes in the project which belong to characteristics of measuring instrument, and changes in the harmonized standards or regulating documents or specifications concerning which it is declared measuring instrument compliance.
35. Producers, considering functionality of measuring instrument, shall carry out testing of the samples which are present at the market of measuring instruments, research of the claims relating to inappropriate measuring instruments and their return and in need of message the register of claims and also to inform distributors on any such activities for monitoring.
36. Producers shall provide availability on measuring instruments which are present at the market, designations of the type, batch number or serial number or other element allowing to identify their measuring instruments and if the size or nature of gage of it do not allow to make then they provide that the information required provided by the document was placed on packaging or in the accompanying documentation according to Item 9.2 of appendix No. 1 to this Technical regulation.
37. On gages producers shall specify the name, registered trade mark or registered trademark and the address to which it is possible to contact them, or if it is impossible, to specify on the accompanying document of gage and on packaging according to Item 9.2 of appendix No. 1 to this Technical regulation. Contact information should be specified in language which end users and bodies for supervision of the market can easily understand.
38. Producers shall guarantee that the gage which presence they provided in the market is followed by the copy of the declaration of conformity, and also the instruction and information according to Item 9.3 of appendix No. 1 to this Technical regulation in state language. Instructions and information, and also any printing text labels shall be accurate and clear.
39. Producers which consider or they have reason to assume that the gage which is present at the market does not conform to requirements of this Technical regulation, shall undertake without delay the necessary adjusting measures, for its reduction in compliance with requirements, cancellation or response. Besides, if the gage represents risk, then his producers shall inform without delay on it the Ministry of Economic Development and digitalizations or the Main state inspectorate for supervision of non-food products and consumer protection with indication of detailed data, in particular on discrepancy or on taken corrective actions.
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