Industry

This is the first QI Project with a defined industrial component. The Project seeks to improve the ability of QI institutions to give support to industry - especially export-oriented companies - in two sectors: construction products and electrical and electronic equipment (EEE).

Our experts work together with representatives of national ministries and QI institutions to support producers of construction products and EEE so they can better understand the rules of the EU/EFTA market and participate on equal terms with other producers.

One-stop shop is a Q&A service provided by the Project, aimed at industry representatives - producers, exporters, importers, chambers of commerce, conformity assessment bodies - and other interested parties. Below are questions submitted to the project and answered by our experts*. If you wish to submit a question, please click HERE. You will receive an answer as soon as possible and then both your question and our answer may be added to the list.

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  • 1. We would like to ask for more information on the technical assessment procedure for construction products which are not covered by harmonised European standards (hENs). We are interested in how the procedure is conducted i.e. whether there are any EU rules on how to conduct the process of technical evaluation of the product.
     

    European Technical Assessments (ETA) for construction products are issued in line with EU provisions on constructions products (Regulation EU 305/2011), articles 19-26, and the procedure for adoption of European Assessment Document (EAD), based on which the ETA is issued, is regulated by Annex II of the Regulation.
    According to the provisions of the Regulation, a manufacturer refers to a body responsible for the technical assessment of construction products (TAB – Technical Assessment Body) in a situation when a product is not covered by a hEN or when the products is only partially covered by a hEN, which happens in the following cases:
    1) The product is not under the scope of any existing hEN;
    2) The assessment method, mentioned in the hEN, is not adequate for at least one characteristic of the specific construction product;
    3) The hEN does not include an assessment method for at least one characteristic of the specific construction product.
    In these cases, the manufacturer submits a request to the TAB and, after concluding a commercial confidentiality agreement, unless the manufacturer decides otherwise, the manufacturer shall submit to the responsible TAB a technical file describing the product, its use as foreseen by the manufacturer and details of the factory production control the manufacturer intends to apply. Within 1 month of receiving the technical file, a contract shall be concluded between the manufacturer and the responsible TAB for the production of an ETA, defining the work programme for drawing up the EAD. The work programme is sent to the European Commission (EC) which can participate in the development of the EAD as an observer. The European Organisation for Technical Assessment (EOTA) prepares a draft EAD within 6 months of the date the EC was informed of the work programme. After drafting the EAD, the TAB shall inform the manufacturer who has 15 days to make comments. EOTA informs the manufacturer about its response to the manufacturer’s comments, adopts the EAD and sends a copy to the EC to make their comments within 15 days. After that, EOTA makes amendments based on EC instructions and submits the final document to the EC and the manufacturer.
    After the EAD has been adopted, the TAB issues a technical assessment based on the EAD. In other words, the EAD replaces a hEN and, based on that document, the TAB issues an ETA.
    It is recommended that candidate countries learn from the EU experience i.e. to base their technical assessments on ETA and EAD for a product not covered by any hEN. This way, assessment bodies in candidate countries gain experience which will facilitate their notification as bodies for technical assessment (TABs) once the country becomes an EU member state.

  • 2. I am a producer of electrical equipment and I found competition’s products on the market which are not tested nor the required quality, with lower price. Who can I address to protect my rights?
     

    Unfair competition is the problem that authorities responsible for trade, unfair competition and consumer protection should deal with. For more information about your local authorities please visit the partners page on our website.

  • 3. I am importer of electrical equipment, and I exhibited my products on trade fair. My competition exhibited same type of products, but they did not have any conformity mark on it. Can I make a complaint and to whom?
     

    Trade fairs, exhibitions and demonstrations are exceptions to the principle that market surveillance can only take place after the manufacturer has taken formal responsibility for the products. Most Union harmonization legislation allows showing and display of non-CE marked products at trade fairs, exhibitions and demonstrations, provided that a visible sign clearly indicates that the products may not be marked or put into service until they have been made to comply, and that adequate measures are taken during demonstrations, where appropriate, to ensure the protection of public interest. Market surveillance authorities must monitor that this obligation is respected. If the above-mentioned requirements haven’t been met, please find more information about your local market surveillance authorities on the partners page on our website.

  • 4. Where can I find assessment systems of construction products (1, 1+, 2+, 3 and 4)? I know that every construction product in the harmonised standard for that product has an assessment system of constancy of performance. However, I am interested whether CEN/CENELEC created some kind of list which shows the name of the construction product and assessment system for that product. I need this so that I could bring this matter closer to the inspectors who are supervising the market of construction products. I have already presented to them that, in technical specification - standards, assessment system is mentioned/shown, but they objected to this by saying that it is impossible for them to know all standards.
     

    There are two parts of the question:
    - AVCP systems are explained/defined as tasks and roles assigned to manufacturers and notified bodies in the Annex V of the CPR.
    - The applicable systems are indicated in the tables of the hEN’s, usually in the Annex ZA.
    This worked rather well and transparent over the years and was generally well understood by the users of the standards.
    However, the EC has recently introduced a slightly different approach in this respect. It turned out that the AVCP system to be applied according the hEN did not always follow the mandate (CEN response to the mandate was not always as requested), therefore recent Annexes ZA may be limited to reference to the mandate in which the applicable AVCP systems had been defined. In the current approach undesired AVCP changes made by CEN are eliminated and compliance to the EC mandate is assured. From a legal point of view this might be desirable but for economic operators it requires some more investigation by looking at the current version of the mandates. These should be publicly available but still could lead to errors in understanding the use of the hEN, in case of new mandates but especially when mandates are amended.

  • 5. I am producer of construction products and I need to place my product on EU market. When does a construction product fall within the scope of the EU CPR?
     

    The EU CPR applies to a construction product if it has been placed or made available on the EU/EFTA market and: a) if the construction product is covered by a harmonised standard established in accordance with EU CPR, published by European Commission in the Official Journal of EU and transposed into your national system or b) if a European Technical Assessment has been issued for the product on request of the manufacturer.

    For the standards transposed, please, visit the partners page of our website to find details and contact your Standards body.

  • 6. I am producer of construction products and I need to place my product on EU market. How should I ensure that my product is compatible to basic requirements of construction works set out in the Regulation?
     

    CPR is unique amongst the New Approach Directives, in that the basic requirements do not directly apply to the products. Whereas, other New Approach Directives (related to the safety of toys, machines…) allow manufacturers to declare that their products directly comply with safety requirements (toy is safe…), construction products, on their own, have no implications on general safety. It is only when they are incorporated in works that their performance becomes important. This is why the manufacturer`s Declaration of performance has to relate to the performance characteristics of the product, as set out in the harmonized technical specifications (Harmonized standards and European Assessment Documents) and not directly to the basic requirements of the works set out in the Regulation.

    If the Regulation is transposed into your legal system, please visit the partners page of our website to find details and contact your competent Ministry; If not transposed please visit webpage: http://www.ec.europa.eu/growth/sectors/construction/product-regulation/

  • 7. I am producer of construction products and I need to place my product on EU market. Which information is provided in a harmonized standards apart from performance characteristics of construction product?
     

    Harmonized standards provide the methods and criteria for assessing the performance of the construction products in relation to their essential characteristics.

    If the Regulation is transposed into your legal system, please visit the partners page of our website to find details and contact your competent Ministry; If not transposed, please visit webpage: http://www.ec.europa.eu/growth/sectors/construction/product-regulation/

  • 8. Can I sell my product anywhere in Europe, if my product meets European standard?
     

    Unfortunately, this was not necessarily be the case, for two reasons. Firstly the Member States will require you to demonstrate compliance with European specifications by affixing the CE marking to your product, so your product firstly has to be tested in an appropriate way and subject to a certain rules about affixing the marking. Secondly, due to different geographic and climatic conditions across the Europe, Member States are allowed to establish “levels and classes” of performance of products to reflect these different conditions. So, for.eg if you want to export your product to Denmark, the properties of your product must meet Danish legal requirements.

    If the Regulation is transposed into your legal system, please visit the partners page of our website to find details and contact your competent Ministry; If not transposed, please visit webpage: http://www.ec.europa.eu/growth/sectors/construction/product-regulation/

  • 9. As a construction product manufacturer I would like to know how to get CE mark for EU/EFTA market?
     

    You have to test you products to the appropriate level and to demonstrate that the product meets performance requirements. You have also to ensure that your product meets the specific national regulatory requirements of the country concerned.

    For more information please visit the partners page of our website to find details and contact your competent Ministry or visit webpage: http://www.ec.europa.eu/growth/sectors/construction/product-regulation

  • 10. As a producer of EE equipment, I would like to know what exactly CE marking is and where do I get it?
     

    The CE marking is a conformity marking of products sold in EU. This one mark supersedes all individual national marks of countries in the EU and presents a “symbol of safety” for EU market presuming that a product has met all applicable requirements of “New Approach Directives” such as Electromagnetic Compatibility Directive, Law Voltage Directive. Candidate countries are not allowed to affix CE marking to national products placed on their national markets. Many of candidate countries created their national markings mirroring CE marking which will be replaced with CE marking upon the date of entry into EU or signature an ACAA. The manufacturer is legally responsible for affixing the CE marking/national marking to his/her product after meeting the requirements of the applicable Directives/transposed Laws.

    For more information on legislation, please visit the partners page of our website to find details and contact your competent Ministry; if the Directives have not been transposed please visit webpage: http://eur-lex.europa.eu/homepage.html

  • 11. As a construction product manufacturer how could I get know specific national, regulatory requirements?
     

    Each Member State is to establish Product Contact Points for Construction with a goal to provide importers with information on specific provisions within its territory aimed at fulfilling basic requirements for construction works .

    For more information please visit the partners page of our website to find details and contact your competent Ministry or visit webpage: http://www.ec.europa.eu/growth/sectors/construction/product-regulation

  • 12. Who and how monitors whether the product is compliant with all essential requirements of LVD/EMC?
     

    Market Surveillance Authorities in close cooperation with economic operators ensure that the electrical equipment concerned covers all relevant requirements laid down in Directives. Special “Safeguard procedures “have been laid down in all Directives from “Alignment Package” including LVD and EMC.

    For more information on legislation, please visit the partners page of our website to find details and contact your competent Ministry or visit webpage: http://eur-lex.europa.eu/homepage.html

  • 13. As a construction product manufacturer I would like to know In which cases and by whom is European Assessment Document drawn up?
     

    A European Assessment Document (EAD) may be drawn up for a construction product not covered or not fully covered by a harmonized standard. The EAD is drawn up following a request for a European Technical Assessment (ETA) by a manufacturer for which it provides basis. The European Assessment Documents are drawn up by the European Organization of Technical Assessment Bodies which comprises of national technical assessment bodies (TABS) designated by Member States.

    For more information please visit the partners page of our website to find details and contact your competent Ministry or visit webpage: http://www.ec.europa.eu/growth/sectors/construction/product-regulation

  • 14. I am a manufacturer of electrical equipment (electric and electronic appliances) under the scope of EMC and the EU declaration of conformity for my equipment, I have to draw up according to the model in Annex IV of EMC, in point 7 requires the declaration of intervention performed by the notified body. What kind of intervention is necessary to be performed?
     

    The conformity assessment procedures the manufacturer can choose to demonstrate the compliance of its equipment with the essential requirements are described in Annex II (Module A) and Annex III (Module B followed by Module C). Module A requires conformity assessment activities from the manufacturer but doesn’t require intervention of any notified bodies. However, Module B, besides the conformity assessment activities required from the manufacturer, requires intervention from notified bodies (e.g. examine the technical documentation, draw up an evaluation report, issue an EU-type examination certificate, see points 4-8 of Annex III).

  • 15. What does a European Assessment (ETA) include, and how could I, as a producer from non EU member country get an ETA for my construction product with a view to place it on EU/EFTA market?
     

    A European Technical Assessment includes the documented assessment of the performance of a construction product in relation to its essential characteristics in accordance with the respective EAD and the technical details necessary for the implementation of the system of assessment and verification of constancy of performance. ETA is issued by a national Technical Assessment Body from a Member State. Manufacturer from any country may submit application for an ETA which will be issued by a TAB from any Member State. You, as a construction product producer, might have contact with TAB through your national designated body in construction sector which is connected to any EU/EFTA TAB, if any.

    For more information please visit the partners page of our website to find details and contact your competent Ministry or visit webpage: http://www.ec.europa.eu/growth/sectors/construction/product-regulation

  • 16. I am a manufacturer of construction products under the scope of Regulation (EU) 305/2011 (CPR) and the declaration of performance of my products, I have to draw up by using the model set out in Annex III, in point 6 requires the declaration system or systems of assessment and verification of constancy of performance of the construction products as set out in Annex V. How should I know which system or systems of Annex V is/are to be applied for my products?
     

    The system(s) for assessment and verification of constancy of a construction product performance (so-called AVCP) is set out in the relevant technical specification. For harmonized European standards this usually appears in Annex ZA.2, whereas for European Technical Assessments this is in a section of the relevant European Assessment Document.

  • 17. As a producer of construction product, I would like to know if there are any legal requirements concerning the format and the content of the “certificate of constancy of performance” and “the certificate of conformity of factory production control”?
     

    No, there are no legally binding models nor any EU CPR provisions referring to the “certificate of constancy of performance” and “the certificate of conformity of factory production control”.

    For more information please visit the partners page of our website to find details and contact your competent Ministry or visit webpage: http://www.ec.europa.eu/growth/sectors/construction/product-regulation

  • 18. I am a manufacturer of construction products and I would like to know what kind of activities I need to carry out in the process of assessment and verification of constancy of performance of my products?
     

    For each of the five systems of AVCP Annex V clearly lists the activities the manufacturer shall carry out. These activities slightly differ from system to system, but for all systems the manufacturer shall carry out factory production control.

  • 19. Who and how monitors whether the product achieves declared performance?
     

    Market Surveillance Authorities in close cooperation with economic operators ensure that the construction products are in accordance with declaration of performance and applicable requirements of the Regulation. Special “Safeguard procedures“ have been laid down in CPR provisions.

    For more information please visit the partners page of our website to find details and contact your competent Ministry or visit webpage: http://www.ec.europa.eu/growth/sectors/construction/product-regulation

  • 20. I am a manufacturer of construction products and the declaration of performance of my products, I have to draw up by using the model set out in Annex III, in points 7 and 8 require information on certificates and test/calculation reports. Which organisations can provide me with them?
     

    These certificates and test/calculation reports are relevant to the third-party tasks, i.e. the AVCP, as set out in Annex V of CPR. Three (systems 1, 1+ and 2+) out of the five systems listed in Annex V require third-party tasks to be performed by notified product certification bodies, and one system (system 3) requires third party tasks to be performed by notified testing laboratories.

  • 21. I am producer of electrical equipment and I need to place my product on EU market. When does electrical equipment fall within the scope of the EU LVD and EU EMC?
     

    The EU LVD applies to electrical equipment if it has been placed or made available on the EU/EFTA market and if it is covered by harmonized standards or parts thereof, (the references of which have been published in the Official Journal of the EU and which have been transposed into your national system,) through which presumption of conformity with safety objectives referred to in LVD/transposed Law should be provided; LVD applies to electrical equipment designed for use with a voltage rating of between 50 and 1000 V for alternating current and between 75 and 1500 V for the direct current other than equipment and phenomena listed in ANNEX II of the Directive/transposed Law.

    The EU EMC applies to electrical equipment if it has been placed or made available on the EU/EFTA market and if it is covered by harmonized standards or parts thereof (the references of which have been published in the Official Journal of the EU and which have been transposed into your national system) through which presumption of conformity with essential requirements set out in Annex I referred to in EMC/transposed Law should be provided; EMC applies to EE with a goal to ensure that EE has been designed and manufactured to be “electromagnetically compatible”: EE will not cause electromagnetic disturbance to radio, telecom and other equipment and EE must have necessary level of immunity of electromagnetic disturbance.

    For the standards transposed, please, visit the partners page of our website to find details and contact your Standards body. For more information on legislation, please visit the partners page of our website to find details and contact your competent Ministry or please visit webpage: http://eur-lex.europa.eu/homepage.html

  • 22. I am a manufacturer of construction products and the systems of assessment and verification of constancy of performance of my products require the use of notified bodies. Where can I find a notified body appropriate for the third-party tasks I need?
     

    The Member States shall notify the European Commission and the other member states of bodies authorised to carry out third-party tasks in the process of AVCP. These are the so-called “notified bodies”. The Commission assigns an identification number to each notified body and make publicly available the list of bodies notified under the CPR, including the identification number and the activities for which the body has been notified notably using the electronic notification tool developed and managed by the Commission, (NANDO database) (http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=33). The Commission ensures that this list is kept up-to-date.

  • 23. I am a manufacturer of construction products and I would like to know which notified body, listed in the NANDO database, is appropriate for the process of assessment and verification of constancy of performance of my products?
     

    The NANDO database contains all bodies notified either by any of the Member States or by countries which have signed mutual recognition agreement (MRA) with the EU. The data can be sorted by countries as well and a search facility allows looking for bodies notified to a specific product family (e.g. cement, building limes and other hydraulic binders). For each notified body the database include the table of tasks performed by the body providing information on the product family and product/intended use, the related decision, the related AVCP system and the related technical specifications. These notified bodies comply with the same requirements of CPR and are regularly monitored by the notifying authority of the Member State or, in case of a complaint, by the Commission.  When a notified body does not meet or no longer meets the requirements of its notification, the notifying Member State takes the necessary corrective measures, including withdrawal of notification, if necessary. So, the manufacturer can choose any of the notified bodies listed in the NANDO database with the relevant competence in terms of product family and AVCP.

  • 24. I, as a producer of EEE, would like to know how the standards relate to Safety Objectives (LVD) and how do I demonstrate compliance with the LVD?
     

    The Safety Objectives in the LVD give broad requirements to ensure safety of persons, domestic animals and property. They are not technical specifications, so they do not define any specific design or build requirements, safety objectives are focused on desired results only. The LVD/ Transposed Law has supporting published harmonized standards (the hENs/ national hENs) which confer conformity with the Directive/transposed Law, and these can be used to demonstrate compliance with Safety Objectives; As a producer of EE you have to ensure and declare, on your sole responsibility, that the EE satisfy the requirements of the Directive/transposed Law; in addition, you should establish technical documentation which will make it possible to assess the EE`s conformity to the relevant requirements and shall include an adequate analyses and assessment of risks (Module A: internal production control)

    For the standards transposed, please, visit the partners page of our website to find details and contact your Standards body. For more information on legislation, please visit the partners page of our website to find details and contact your competent Ministry; if the Directive has not been transposed please visit webpage: http://eur-lex.europa.eu/homepage.html

  • 25. When should I, as a producer of EEE, use “EMC Assessment” of the product and compiling documentary evidence in a Technical File as a way of demonstrating the conformity of the product?
     

    Generally, Technical File can be used to demonstrate conformity in many different cases; (e.g. a product is too large or complex to be fully tested strictly in accordance with requirements of applicable harmonised standards, no harmonised standards exist which are applicable to the product etc.)

    For more information on legislation, please visit the partners page of our website to find details and contact your competent Ministry; if the Directive has not been transposed please visit webpage: http://eur-lex.europa.eu/homepage.html

  • 26. I am a manufacturer of electrical equipment under the scope of Directive 2014/35/EU: LVD) and technical documentation of my equipment, I need to draw up according to Annex III of LVD, shall contain information about the examinations carried out and test reports. Do I need to have my own testing facility for that or can I use the services of external laboratories?
     

    The conformity assessment procedure referred to in Annex III (Module A: Internal production control) doesn’t require the manufacturer to have its own test facilities for performing the examinations and tests necessary to assess the electrical equipment’s conformity to the relevant requirements. However, the examinations and tests should be carried out by competent testing laboratories. It is therefore preferable to use the services of an accredited testing laboratory, either in-house or external.  Accreditation of a testing laboratory means validity and appropriateness of test methods, suitability and maintenance of test equipment, proper sampling, handling and transportation of test items, and quality control and assurance of test data. The tests performed by an accredited testing laboratory guarantee reliable and accurate results. Accreditation of testing laboratories is against the standard ISO/IEC 17025 and also means that the laboratory meets the management system principles of ISO 9001. If you need further information on accreditation or accredited test laboratories, or you look for accreditation of your in-house test facility, please visit the partners page of our website to find details and contact your national accreditation body.

  • 27. I am a manufacturer of construction products and the systems of assessment and verification of constancy of performance of my products require me to carry out factory production control, further testing of samples taken at the factory or type testing, type evaluation. Should I need to be accredited for testing and/or for product certification?
     

    No, the CPR does not require the manufacturer to have accredited facilities for these activities. However, it is very preferable as accreditation of a testing laboratory means validity and appropriateness of test methods, suitability and maintenance of test equipment, proper sampling, handling and transportation of test items, and quality control and assurance of test data. The tests performed by an accredited testing laboratory guarantee reliable and accurate results. Accreditation of testing laboratories is against the standard ISO/IEC 17025 and also means that the laboratory meets the management system principles of ISO 9001. If you need further information on accreditation or look for accreditation, please visit the partners page of our website to find details and contact your national accreditation body.

  • 28. As a producer of EE equipment, how do I demonstrate compliance with the EMC Directive?
     

    The requirements of EMC Directive/ transposed Law state that the product must not generate a level of disturbance which prevents radio and telecommunications and other equipment from operating as intended and must have a level of immunity to enable it to operate as intended.

    There are two ways for you demonstrate compliance with the EMC Directive/transposed Law: either by testing in full to the EMC hENs as published in OJEU /transposed into your legal system or by completing an “EMC Assessment” of the product and compiling documentary evidence in a Technical File: Module A: Internal Production Control/ Module B: EU- type examination +Module C: conformity to type based on internal production control

    For more information on legislation, please visit the partners page of our website to find details and contact your competent Ministry; if the Directive has not been transposed please visit webpage: http://eur-lex.europa.eu/homepage.html

  • 29. Can I, as a producer of EEE, do the testing myself? When should notified/designated body be used?
     

    You can test anywhere you wish as long as the equipment, capability and expertise are liable to produce test results according to the requirements of harmonized standards. In Member States, in-house testing is much more often, and it is up to manufacturer to voluntarily choose to engage a notified body to review technical documentation in order to give additional confidence to a claim of conformity to the EMC Directive (Module B: EU- type examination followed by conformity to the type).  In candidate countries, role of designated body is much more important in terms of testing, since in most of the cases, manufacturer` testing capacity is not enough strong and designated bodies are those who primarily do the testing.

    For more information on legislation, please visit the partners page of our website to find details and contact your competent Ministry; if the Directive has not been transposed please visit webpage: http://eur-lex.europa.eu/homepage.html

  • 30. I am a manufacturer of electrical equipment (electric and electronic appliances) under the scope EMC and I would like to know what kind of activities I need to carry out to demonstrate the compliance of my equipment with the essential requirements set out in Annex II of EMC.
     

    Article 14 of EMC requires the manufacturer to demonstrate the compliance of its equipment with the essential requirements set out in Annex I by means of one of two conformity assessment procedures: (a) Module A: Internal production control set out in Annex II or (b) Module B: EU type examination followed by Module C: Conformity to type based on internal production control set out in Annex III.

  • 31. I am a manufacturer of electrical equipment (electric and electronic appliances) under the scope EMC and the EU declaration of conformity for my equipment, I have to draw up according to the model in Annex IV of EMC, in point 7 requires the declaration of the notified body. Where can I find notified bodies appropriate for the third-party tasks described in Annex III?
     

    The Member States shall notify the European Commission and the other member states of bodies authorised to carry out third-party tasks in the process of Module B. These are the so-called “notified bodies”. The Commission assigns an identification number to each notified body and make publicly available the list of bodies notified under the EMC, including the identification number and the activities for which the body has been notified notably using the electronic notification tool developed and managed by the Commission, (NANDO database) (http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=153681). The Commission ensures that this list is kept up-to-date. The NANDO database also contains all bodies notified by countries which have signed mutual recognition agreement (MRA) with the EU. These notified bodies comply with the same requirements of EMC and are regularly monitored by the notifying authority of the Member State or, in case of a complaint, by the Commission.  When a notified body does not meet or no longer meets the requirements of its notification, the notifying Member State takes the necessary corrective measures, including withdrawal of notification, if necessary. So, the manufacturer can choose any of the notified bodies listed in the NANDO database.

  • 32. Can I add other marks to the product if I have the CE marking?
     

    Other marks may be applied to the product to indicate that safety standards have been complied as long as these marks do not obscure or become confused with the CE marking. Often it is a customer or contractual requirement that such marks are on the product and in these cases, where it is felt that a commercial disadvantage may occur from dropping the marks, they will be retained. BUT: The CE marking is the only marking which attests the conformity of the product with the applicable requirements of the relevant legislation. No markings shall be used to deceive third parties, the CE marking must be visible and legible and not covered by any other markings.

     For more information on legislation, please visit the partners page of our website to find details and contact your competent Ministry or visit webpage: http://eur-lex.europa.eu/homepage.html

  • 33. I am a manufacturer of electrical equipment (electric and electronic appliances) under the scope EMC. Do I need to have my own test facility for supporting the demonstration of compliance of my equipment with the essential requirements by either Module A or Module B/C with examinations carried out and/or test reports, or can I use the services of external testing laboratories?
     

    Article 7(2) of EMC requires the manufacturer to carry out the relevant conformity assessment procedure referred to in Article 14 or have it carried out. So, the EMC doesn’t require the manufacturer to have its own test facilities for performing the examinations and tests necessary to assess the electrical equipment’s conformity to the relevant requirements.

  • 34. I am a manufacturer of electrical equipment (electric and electronic appliances) under the scope EMC. Is it necessary that the laboratory, in-house or external, carrying out examinations and issuing test reports as required by Module A or Module B be accredited?
     

    No, the EMC does not require the manufacturer to have accredited facilities or use the services of accredited testing laboratories for these activities. However, it is very preferable as accreditation of a testing laboratory means validity and appropriateness of test methods, suitability and maintenance of test equipment, proper sampling, handling and transportation of test items, and quality control and assurance of test data. The tests performed by an accredited testing laboratory guarantee reliable and accurate results. Accreditation of testing laboratories is against the standard ISO/IEC 17025 and also means that the laboratory meets the management system principles of ISO 9001. If you need further information on accreditation or look for accreditation, please visit the partners page of our website to find details and contact your national accreditation body.

  • 35. I am a producer of construction products and I was asked by the certification body to provide calibration certificates for several measuring devices with clear measurement traceability evidence to the SI units, is there anybody to explain me how I can do this?
     

    A straightforward way to provide evidence for measurement traceability to SI units is to use calibration certificates issued by accredited laboratories and carrying the accreditation logo (normally on the top of the each page). So, please visit the partners page of our website to find details of your national accreditation body.  Their websites include lists of all accredited calibration laboratories.

  • 36. I am a manufacturer of construction products and I need to know how I can have my staff trained in issues related to the selection, use, handling and calibration of measurement instruments. What can I do?
     

    Please visit the partners page of our website to find details of your National Metrology Institute for more information.

  • 37. I am a producer of construction products and I need to buy and use a non-automatic weighing instrument for the trade transactions of the products. Are there any legal issues for metrological control of this instrument?
     

    Please visit the partners page of our website to find details and contact your National Metrology Institute for more information on the Directive 2014/31 of EU regarding Non-automatic Weighing Instruments (NAWI).

  • 38. I am a producer of Electrical Products and I need the services of a calibration laboratory. Should I select just a certified laboratory according to ISO 9001?
     

    It would be preferable to select an accredited laboratory, according to ISO 17025. In this respect, please visit the partners page of our website to find details of your national accreditation body. Their websites include lists of all accredited calibration laboratories.

  • 39. I am a producer of Electrical Products and following the recommendation of a certification body I had some of the measuring instruments used for quality control calibrated by a calibration laboratory, which also issued the respective calibration certificates. Does this mean that these instruments are suitable for use?
     

    A calibration certificate does not imply that the respective instrument is suitable for use. In any case, please visit the partners page of our website to find details of your National Metrology Institute for more information.

  • 40. I am a producer of construction products and I was informed that in the context of ISO 9001 implementation I should have weight balances and thermometers calibrated. Where and how can I find appropriate calibration laboratories for these calibrations?
     

    Please visit the partners page of our website to find details and contact your Accreditation Body. Their websites include lists of all accredited calibration laboratories.

  • 41. I am a producer of construction products and I need to buy weight standards in order to check weight balances used for quality control. Who can help me and give me some information as to what types of weight standards do I need and how many?
     

    Please visit the partners page of our website to find details and contact your Metrology Institute. This should be able to provide you with the necessary information.

  • 42. I am a producer of electrical products and I just bought an electricity multi-meter to perform some simple measurements. This multi-meter is accompanied by a calibration report issued by its manufacturer, is this appropriate?
     

    Have in mind that a calibration certificate is issued for a unique, individual measuring instrument. It is true that some manufacturers issue the so called “Calibration Reports”, which correspond to a batch of measuring instruments. Please check if the Calibration Report has a serial number of the measuring instrument. In any case, please visit the partners page of our website to find details and contact your Metrology Institute.

  • 43. I am a producer of construction products and in the context of ISO 9001 I need to have several measurement instruments, such as weight balances, thermometers, calipers, chambers, calibrated, according to a calibration plan. Can you please inform me what should be the re-calibration intervals for each of these instruments?
     

    Have in mind that the re-calibration interval is normally determined by the user/owner taking into account issues of cost and risk. In many cases due to lack of specific information, a re-calibration interval of 12 months is selected, at least at the beginning. In any case however, please visit the partners page of our website to find details and contact your Metrology Institute to speak with some of the metrology experts there.

  • 44. I am a testing laboratory within a producer of construction materials. In applying a specific method for testing, it is required to use a thermometer with an accuracy ±0.05 oC. What type of a thermometer should I select in terms of its resolution?
     

    This requirement for accuracy can be interpreted as a requirement for calibration uncertainty. In other words, you are looking for a thermometer to be calibrated with an uncertainty lower than the above accuracy. In any case, please visit the partners page of our website to find details of your National Metrology Institute for more information.

  • 45. I am a manufacturer of construction materials and I use several weight balances as well as other instruments, such as calipers, tapes, pressure gages, which have to be calibrated by a calibration laboratory. Which method should be specified in my request?
     

    The easiest thing to do is to contact accredited calibration laboratories and just make a request for calibration services according to the scope of accreditation. In any case, please visit the partners page of our website to find details of your National Metrology Institute for more information.

  • 46. I am a manufacturer of electrical products and I use several measuring instruments which are calibrated. In some cases, looking at the calibration certificates, I see that in some cases there are deviations from the reference values. Is it necessary to make corrections when making measurements?
     

    Before making corrections you should contact the calibration laboratory and see if adjustments can be made. If not, then you should consider making corrections. In any case, please visit the partners page of our website to find details of your National Metrology Institute for more information.

  • 47. I am a manufacturer of electrical products and I need to have several measuring instruments calibrated by an accredited laboratory. How can I choose one that covers all my calibration needs?
     

    Please visit the partners page of our website to find details of your national accreditation body. Their websites include lists of all accredited calibration laboratories with their respective scope of accreditation.

  • Construction Products
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  • 1. We would like to ask for more information on the technical assessment procedure for construction products which are not covered by harmonised European standards (hENs). We are interested in how the procedure is conducted i.e. whether there are any EU rules on how to conduct the process of technical evaluation of the product.
     

    European Technical Assessments (ETA) for construction products are issued in line with EU provisions on constructions products (Regulation EU 305/2011), articles 19-26, and the procedure for adoption of European Assessment Document (EAD), based on which the ETA is issued, is regulated by Annex II of the Regulation.
    According to the provisions of the Regulation, a manufacturer refers to a body responsible for the technical assessment of construction products (TAB – Technical Assessment Body) in a situation when a product is not covered by a hEN or when the products is only partially covered by a hEN, which happens in the following cases:
    1) The product is not under the scope of any existing hEN;
    2) The assessment method, mentioned in the hEN, is not adequate for at least one characteristic of the specific construction product;
    3) The hEN does not include an assessment method for at least one characteristic of the specific construction product.
    In these cases, the manufacturer submits a request to the TAB and, after concluding a commercial confidentiality agreement, unless the manufacturer decides otherwise, the manufacturer shall submit to the responsible TAB a technical file describing the product, its use as foreseen by the manufacturer and details of the factory production control the manufacturer intends to apply. Within 1 month of receiving the technical file, a contract shall be concluded between the manufacturer and the responsible TAB for the production of an ETA, defining the work programme for drawing up the EAD. The work programme is sent to the European Commission (EC) which can participate in the development of the EAD as an observer. The European Organisation for Technical Assessment (EOTA) prepares a draft EAD within 6 months of the date the EC was informed of the work programme. After drafting the EAD, the TAB shall inform the manufacturer who has 15 days to make comments. EOTA informs the manufacturer about its response to the manufacturer’s comments, adopts the EAD and sends a copy to the EC to make their comments within 15 days. After that, EOTA makes amendments based on EC instructions and submits the final document to the EC and the manufacturer.
    After the EAD has been adopted, the TAB issues a technical assessment based on the EAD. In other words, the EAD replaces a hEN and, based on that document, the TAB issues an ETA.
    It is recommended that candidate countries learn from the EU experience i.e. to base their technical assessments on ETA and EAD for a product not covered by any hEN. This way, assessment bodies in candidate countries gain experience which will facilitate their notification as bodies for technical assessment (TABs) once the country becomes an EU member state.

  • 2. Where can I find assessment systems of construction products (1, 1+, 2+, 3 and 4)? I know that every construction product in the harmonised standard for that product has an assessment system of constancy of performance. However, I am interested whether CEN/CENELEC created some kind of list which shows the name of the construction product and assessment system for that product. I need this so that I could bring this matter closer to the inspectors who are supervising the market of construction products. I have already presented to them that, in technical specification - standards, assessment system is mentioned/shown, but they objected to this by saying that it is impossible for them to know all standards.
     

    There are two parts of the question:
    - AVCP systems are explained/defined as tasks and roles assigned to manufacturers and notified bodies in the Annex V of the CPR.
    - The applicable systems are indicated in the tables of the hEN’s, usually in the Annex ZA.
    This worked rather well and transparent over the years and was generally well understood by the users of the standards.
    However, the EC has recently introduced a slightly different approach in this respect. It turned out that the AVCP system to be applied according the hEN did not always follow the mandate (CEN response to the mandate was not always as requested), therefore recent Annexes ZA may be limited to reference to the mandate in which the applicable AVCP systems had been defined. In the current approach undesired AVCP changes made by CEN are eliminated and compliance to the EC mandate is assured. From a legal point of view this might be desirable but for economic operators it requires some more investigation by looking at the current version of the mandates. These should be publicly available but still could lead to errors in understanding the use of the hEN, in case of new mandates but especially when mandates are amended.

  • 3. I am producer of construction products and I need to place my product on EU market. When does a construction product fall within the scope of the EU CPR?
     

    The EU CPR applies to a construction product if it has been placed or made available on the EU/EFTA market and: a) if the construction product is covered by a harmonised standard established in accordance with EU CPR, published by European Commission in the Official Journal of EU and transposed into your national system or b) if a European Technical Assessment has been issued for the product on request of the manufacturer.

    For the standards transposed, please, visit the partners page of our website to find details and contact your Standards body.

  • 4. I am producer of construction products and I need to place my product on EU market. How should I ensure that my product is compatible to basic requirements of construction works set out in the Regulation?
     

    CPR is unique amongst the New Approach Directives, in that the basic requirements do not directly apply to the products. Whereas, other New Approach Directives (related to the safety of toys, machines…) allow manufacturers to declare that their products directly comply with safety requirements (toy is safe…), construction products, on their own, have no implications on general safety. It is only when they are incorporated in works that their performance becomes important. This is why the manufacturer`s Declaration of performance has to relate to the performance characteristics of the product, as set out in the harmonized technical specifications (Harmonized standards and European Assessment Documents) and not directly to the basic requirements of the works set out in the Regulation.

    If the Regulation is transposed into your legal system, please visit the partners page of our website to find details and contact your competent Ministry; If not transposed please visit webpage: http://www.ec.europa.eu/growth/sectors/construction/product-regulation/

  • 5. I am producer of construction products and I need to place my product on EU market. Which information is provided in a harmonized standards apart from performance characteristics of construction product?
     

    Harmonized standards provide the methods and criteria for assessing the performance of the construction products in relation to their essential characteristics.

    If the Regulation is transposed into your legal system, please visit the partners page of our website to find details and contact your competent Ministry; If not transposed, please visit webpage: http://www.ec.europa.eu/growth/sectors/construction/product-regulation/

  • 6. Can I sell my product anywhere in Europe, if my product meets European standard?
     

    Unfortunately, this was not necessarily be the case, for two reasons. Firstly the Member States will require you to demonstrate compliance with European specifications by affixing the CE marking to your product, so your product firstly has to be tested in an appropriate way and subject to a certain rules about affixing the marking. Secondly, due to different geographic and climatic conditions across the Europe, Member States are allowed to establish “levels and classes” of performance of products to reflect these different conditions. So, for.eg if you want to export your product to Denmark, the properties of your product must meet Danish legal requirements.

    If the Regulation is transposed into your legal system, please visit the partners page of our website to find details and contact your competent Ministry; If not transposed, please visit webpage: http://www.ec.europa.eu/growth/sectors/construction/product-regulation/

  • 7. As a construction product manufacturer I would like to know how to get CE mark for EU/EFTA market?
     

    You have to test you products to the appropriate level and to demonstrate that the product meets performance requirements. You have also to ensure that your product meets the specific national regulatory requirements of the country concerned.

    For more information please visit the partners page of our website to find details and contact your competent Ministry or visit webpage: http://www.ec.europa.eu/growth/sectors/construction/product-regulation

  • 8. As a construction product manufacturer how could I get know specific national, regulatory requirements?
     

    Each Member State is to establish Product Contact Points for Construction with a goal to provide importers with information on specific provisions within its territory aimed at fulfilling basic requirements for construction works .

    For more information please visit the partners page of our website to find details and contact your competent Ministry or visit webpage: http://www.ec.europa.eu/growth/sectors/construction/product-regulation

  • 9. As a construction product manufacturer I would like to know In which cases and by whom is European Assessment Document drawn up?
     

    A European Assessment Document (EAD) may be drawn up for a construction product not covered or not fully covered by a harmonized standard. The EAD is drawn up following a request for a European Technical Assessment (ETA) by a manufacturer for which it provides basis. The European Assessment Documents are drawn up by the European Organization of Technical Assessment Bodies which comprises of national technical assessment bodies (TABS) designated by Member States.

    For more information please visit the partners page of our website to find details and contact your competent Ministry or visit webpage: http://www.ec.europa.eu/growth/sectors/construction/product-regulation

  • 10. What does a European Assessment (ETA) include, and how could I, as a producer from non EU member country get an ETA for my construction product with a view to place it on EU/EFTA market?
     

    A European Technical Assessment includes the documented assessment of the performance of a construction product in relation to its essential characteristics in accordance with the respective EAD and the technical details necessary for the implementation of the system of assessment and verification of constancy of performance. ETA is issued by a national Technical Assessment Body from a Member State. Manufacturer from any country may submit application for an ETA which will be issued by a TAB from any Member State. You, as a construction product producer, might have contact with TAB through your national designated body in construction sector which is connected to any EU/EFTA TAB, if any.

    For more information please visit the partners page of our website to find details and contact your competent Ministry or visit webpage: http://www.ec.europa.eu/growth/sectors/construction/product-regulation

  • 11. I am a manufacturer of construction products under the scope of Regulation (EU) 305/2011 (CPR) and the declaration of performance of my products, I have to draw up by using the model set out in Annex III, in point 6 requires the declaration system or systems of assessment and verification of constancy of performance of the construction products as set out in Annex V. How should I know which system or systems of Annex V is/are to be applied for my products?
     

    The system(s) for assessment and verification of constancy of a construction product performance (so-called AVCP) is set out in the relevant technical specification. For harmonized European standards this usually appears in Annex ZA.2, whereas for European Technical Assessments this is in a section of the relevant European Assessment Document.

  • 12. As a producer of construction product, I would like to know if there are any legal requirements concerning the format and the content of the “certificate of constancy of performance” and “the certificate of conformity of factory production control”?
     

    No, there are no legally binding models nor any EU CPR provisions referring to the “certificate of constancy of performance” and “the certificate of conformity of factory production control”.

    For more information please visit the partners page of our website to find details and contact your competent Ministry or visit webpage: http://www.ec.europa.eu/growth/sectors/construction/product-regulation

  • 13. I am a manufacturer of construction products and I would like to know what kind of activities I need to carry out in the process of assessment and verification of constancy of performance of my products?
     

    For each of the five systems of AVCP Annex V clearly lists the activities the manufacturer shall carry out. These activities slightly differ from system to system, but for all systems the manufacturer shall carry out factory production control.

  • 14. Who and how monitors whether the product achieves declared performance?
     

    Market Surveillance Authorities in close cooperation with economic operators ensure that the construction products are in accordance with declaration of performance and applicable requirements of the Regulation. Special “Safeguard procedures“ have been laid down in CPR provisions.

    For more information please visit the partners page of our website to find details and contact your competent Ministry or visit webpage: http://www.ec.europa.eu/growth/sectors/construction/product-regulation

  • 15. I am a manufacturer of construction products and the declaration of performance of my products, I have to draw up by using the model set out in Annex III, in points 7 and 8 require information on certificates and test/calculation reports. Which organisations can provide me with them?
     

    These certificates and test/calculation reports are relevant to the third-party tasks, i.e. the AVCP, as set out in Annex V of CPR. Three (systems 1, 1+ and 2+) out of the five systems listed in Annex V require third-party tasks to be performed by notified product certification bodies, and one system (system 3) requires third party tasks to be performed by notified testing laboratories.

  • 16. I am a manufacturer of construction products and the systems of assessment and verification of constancy of performance of my products require the use of notified bodies. Where can I find a notified body appropriate for the third-party tasks I need?
     

    The Member States shall notify the European Commission and the other member states of bodies authorised to carry out third-party tasks in the process of AVCP. These are the so-called “notified bodies”. The Commission assigns an identification number to each notified body and make publicly available the list of bodies notified under the CPR, including the identification number and the activities for which the body has been notified notably using the electronic notification tool developed and managed by the Commission, (NANDO database) (http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=33). The Commission ensures that this list is kept up-to-date.

  • 17. I am a manufacturer of construction products and I would like to know which notified body, listed in the NANDO database, is appropriate for the process of assessment and verification of constancy of performance of my products?
     

    The NANDO database contains all bodies notified either by any of the Member States or by countries which have signed mutual recognition agreement (MRA) with the EU. The data can be sorted by countries as well and a search facility allows looking for bodies notified to a specific product family (e.g. cement, building limes and other hydraulic binders). For each notified body the database include the table of tasks performed by the body providing information on the product family and product/intended use, the related decision, the related AVCP system and the related technical specifications. These notified bodies comply with the same requirements of CPR and are regularly monitored by the notifying authority of the Member State or, in case of a complaint, by the Commission.  When a notified body does not meet or no longer meets the requirements of its notification, the notifying Member State takes the necessary corrective measures, including withdrawal of notification, if necessary. So, the manufacturer can choose any of the notified bodies listed in the NANDO database with the relevant competence in terms of product family and AVCP.

  • 18. I am a manufacturer of construction products and the systems of assessment and verification of constancy of performance of my products require me to carry out factory production control, further testing of samples taken at the factory or type testing, type evaluation. Should I need to be accredited for testing and/or for product certification?
     

    No, the CPR does not require the manufacturer to have accredited facilities for these activities. However, it is very preferable as accreditation of a testing laboratory means validity and appropriateness of test methods, suitability and maintenance of test equipment, proper sampling, handling and transportation of test items, and quality control and assurance of test data. The tests performed by an accredited testing laboratory guarantee reliable and accurate results. Accreditation of testing laboratories is against the standard ISO/IEC 17025 and also means that the laboratory meets the management system principles of ISO 9001. If you need further information on accreditation or look for accreditation, please visit the partners page of our website to find details and contact your national accreditation body.

  • 19. I am a producer of construction products and I was asked by the certification body to provide calibration certificates for several measuring devices with clear measurement traceability evidence to the SI units, is there anybody to explain me how I can do this?
     

    A straightforward way to provide evidence for measurement traceability to SI units is to use calibration certificates issued by accredited laboratories and carrying the accreditation logo (normally on the top of the each page). So, please visit the partners page of our website to find details of your national accreditation body.  Their websites include lists of all accredited calibration laboratories.

  • 20. I am a manufacturer of construction products and I need to know how I can have my staff trained in issues related to the selection, use, handling and calibration of measurement instruments. What can I do?
     

    Please visit the partners page of our website to find details of your National Metrology Institute for more information.

  • 21. I am a producer of construction products and I need to buy and use a non-automatic weighing instrument for the trade transactions of the products. Are there any legal issues for metrological control of this instrument?
     

    Please visit the partners page of our website to find details and contact your National Metrology Institute for more information on the Directive 2014/31 of EU regarding Non-automatic Weighing Instruments (NAWI).

  • 22. I am a producer of construction products and I was informed that in the context of ISO 9001 implementation I should have weight balances and thermometers calibrated. Where and how can I find appropriate calibration laboratories for these calibrations?
     

    Please visit the partners page of our website to find details and contact your Accreditation Body. Their websites include lists of all accredited calibration laboratories.

  • 23. I am a producer of construction products and I need to buy weight standards in order to check weight balances used for quality control. Who can help me and give me some information as to what types of weight standards do I need and how many?
     

    Please visit the partners page of our website to find details and contact your Metrology Institute. This should be able to provide you with the necessary information.

  • 24. I am a producer of construction products and in the context of ISO 9001 I need to have several measurement instruments, such as weight balances, thermometers, calipers, chambers, calibrated, according to a calibration plan. Can you please inform me what should be the re-calibration intervals for each of these instruments?
     

    Have in mind that the re-calibration interval is normally determined by the user/owner taking into account issues of cost and risk. In many cases due to lack of specific information, a re-calibration interval of 12 months is selected, at least at the beginning. In any case however, please visit the partners page of our website to find details and contact your Metrology Institute to speak with some of the metrology experts there.

  • 25. I am a testing laboratory within a producer of construction materials. In applying a specific method for testing, it is required to use a thermometer with an accuracy ±0.05 oC. What type of a thermometer should I select in terms of its resolution?
     

    This requirement for accuracy can be interpreted as a requirement for calibration uncertainty. In other words, you are looking for a thermometer to be calibrated with an uncertainty lower than the above accuracy. In any case, please visit the partners page of our website to find details of your National Metrology Institute for more information.

  • 26. I am a manufacturer of construction materials and I use several weight balances as well as other instruments, such as calipers, tapes, pressure gages, which have to be calibrated by a calibration laboratory. Which method should be specified in my request?
     

    The easiest thing to do is to contact accredited calibration laboratories and just make a request for calibration services according to the scope of accreditation. In any case, please visit the partners page of our website to find details of your National Metrology Institute for more information.

  • Electrical and Electronic Equipment
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  • 1. I am a producer of electrical equipment and I found competition’s products on the market which are not tested nor the required quality, with lower price. Who can I address to protect my rights?
     

    Unfair competition is the problem that authorities responsible for trade, unfair competition and consumer protection should deal with. For more information about your local authorities please visit the partners page on our website.

  • 2. I am importer of electrical equipment, and I exhibited my products on trade fair. My competition exhibited same type of products, but they did not have any conformity mark on it. Can I make a complaint and to whom?
     

    Trade fairs, exhibitions and demonstrations are exceptions to the principle that market surveillance can only take place after the manufacturer has taken formal responsibility for the products. Most Union harmonization legislation allows showing and display of non-CE marked products at trade fairs, exhibitions and demonstrations, provided that a visible sign clearly indicates that the products may not be marked or put into service until they have been made to comply, and that adequate measures are taken during demonstrations, where appropriate, to ensure the protection of public interest. Market surveillance authorities must monitor that this obligation is respected. If the above-mentioned requirements haven’t been met, please find more information about your local market surveillance authorities on the partners page on our website.

  • 3. As a producer of EE equipment, I would like to know what exactly CE marking is and where do I get it?
     

    The CE marking is a conformity marking of products sold in EU. This one mark supersedes all individual national marks of countries in the EU and presents a “symbol of safety” for EU market presuming that a product has met all applicable requirements of “New Approach Directives” such as Electromagnetic Compatibility Directive, Law Voltage Directive. Candidate countries are not allowed to affix CE marking to national products placed on their national markets. Many of candidate countries created their national markings mirroring CE marking which will be replaced with CE marking upon the date of entry into EU or signature an ACAA. The manufacturer is legally responsible for affixing the CE marking/national marking to his/her product after meeting the requirements of the applicable Directives/transposed Laws.

    For more information on legislation, please visit the partners page of our website to find details and contact your competent Ministry; if the Directives have not been transposed please visit webpage: http://eur-lex.europa.eu/homepage.html

  • 4. Who and how monitors whether the product is compliant with all essential requirements of LVD/EMC?
     

    Market Surveillance Authorities in close cooperation with economic operators ensure that the electrical equipment concerned covers all relevant requirements laid down in Directives. Special “Safeguard procedures “have been laid down in all Directives from “Alignment Package” including LVD and EMC.

    For more information on legislation, please visit the partners page of our website to find details and contact your competent Ministry or visit webpage: http://eur-lex.europa.eu/homepage.html

  • 5. I am a manufacturer of electrical equipment (electric and electronic appliances) under the scope of EMC and the EU declaration of conformity for my equipment, I have to draw up according to the model in Annex IV of EMC, in point 7 requires the declaration of intervention performed by the notified body. What kind of intervention is necessary to be performed?
     

    The conformity assessment procedures the manufacturer can choose to demonstrate the compliance of its equipment with the essential requirements are described in Annex II (Module A) and Annex III (Module B followed by Module C). Module A requires conformity assessment activities from the manufacturer but doesn’t require intervention of any notified bodies. However, Module B, besides the conformity assessment activities required from the manufacturer, requires intervention from notified bodies (e.g. examine the technical documentation, draw up an evaluation report, issue an EU-type examination certificate, see points 4-8 of Annex III).

  • 6. I am producer of electrical equipment and I need to place my product on EU market. When does electrical equipment fall within the scope of the EU LVD and EU EMC?
     

    The EU LVD applies to electrical equipment if it has been placed or made available on the EU/EFTA market and if it is covered by harmonized standards or parts thereof, (the references of which have been published in the Official Journal of the EU and which have been transposed into your national system,) through which presumption of conformity with safety objectives referred to in LVD/transposed Law should be provided; LVD applies to electrical equipment designed for use with a voltage rating of between 50 and 1000 V for alternating current and between 75 and 1500 V for the direct current other than equipment and phenomena listed in ANNEX II of the Directive/transposed Law.

    The EU EMC applies to electrical equipment if it has been placed or made available on the EU/EFTA market and if it is covered by harmonized standards or parts thereof (the references of which have been published in the Official Journal of the EU and which have been transposed into your national system) through which presumption of conformity with essential requirements set out in Annex I referred to in EMC/transposed Law should be provided; EMC applies to EE with a goal to ensure that EE has been designed and manufactured to be “electromagnetically compatible”: EE will not cause electromagnetic disturbance to radio, telecom and other equipment and EE must have necessary level of immunity of electromagnetic disturbance.

    For the standards transposed, please, visit the partners page of our website to find details and contact your Standards body. For more information on legislation, please visit the partners page of our website to find details and contact your competent Ministry or please visit webpage: http://eur-lex.europa.eu/homepage.html

  • 7. I, as a producer of EEE, would like to know how the standards relate to Safety Objectives (LVD) and how do I demonstrate compliance with the LVD?
     

    The Safety Objectives in the LVD give broad requirements to ensure safety of persons, domestic animals and property. They are not technical specifications, so they do not define any specific design or build requirements, safety objectives are focused on desired results only. The LVD/ Transposed Law has supporting published harmonized standards (the hENs/ national hENs) which confer conformity with the Directive/transposed Law, and these can be used to demonstrate compliance with Safety Objectives; As a producer of EE you have to ensure and declare, on your sole responsibility, that the EE satisfy the requirements of the Directive/transposed Law; in addition, you should establish technical documentation which will make it possible to assess the EE`s conformity to the relevant requirements and shall include an adequate analyses and assessment of risks (Module A: internal production control)

    For the standards transposed, please, visit the partners page of our website to find details and contact your Standards body. For more information on legislation, please visit the partners page of our website to find details and contact your competent Ministry; if the Directive has not been transposed please visit webpage: http://eur-lex.europa.eu/homepage.html

  • 8. When should I, as a producer of EEE, use “EMC Assessment” of the product and compiling documentary evidence in a Technical File as a way of demonstrating the conformity of the product?
     

    Generally, Technical File can be used to demonstrate conformity in many different cases; (e.g. a product is too large or complex to be fully tested strictly in accordance with requirements of applicable harmonised standards, no harmonised standards exist which are applicable to the product etc.)

    For more information on legislation, please visit the partners page of our website to find details and contact your competent Ministry; if the Directive has not been transposed please visit webpage: http://eur-lex.europa.eu/homepage.html

  • 9. I am a manufacturer of electrical equipment under the scope of Directive 2014/35/EU: LVD) and technical documentation of my equipment, I need to draw up according to Annex III of LVD, shall contain information about the examinations carried out and test reports. Do I need to have my own testing facility for that or can I use the services of external laboratories?
     

    The conformity assessment procedure referred to in Annex III (Module A: Internal production control) doesn’t require the manufacturer to have its own test facilities for performing the examinations and tests necessary to assess the electrical equipment’s conformity to the relevant requirements. However, the examinations and tests should be carried out by competent testing laboratories. It is therefore preferable to use the services of an accredited testing laboratory, either in-house or external.  Accreditation of a testing laboratory means validity and appropriateness of test methods, suitability and maintenance of test equipment, proper sampling, handling and transportation of test items, and quality control and assurance of test data. The tests performed by an accredited testing laboratory guarantee reliable and accurate results. Accreditation of testing laboratories is against the standard ISO/IEC 17025 and also means that the laboratory meets the management system principles of ISO 9001. If you need further information on accreditation or accredited test laboratories, or you look for accreditation of your in-house test facility, please visit the partners page of our website to find details and contact your national accreditation body.

  • 10. As a producer of EE equipment, how do I demonstrate compliance with the EMC Directive?
     

    The requirements of EMC Directive/ transposed Law state that the product must not generate a level of disturbance which prevents radio and telecommunications and other equipment from operating as intended and must have a level of immunity to enable it to operate as intended.

    There are two ways for you demonstrate compliance with the EMC Directive/transposed Law: either by testing in full to the EMC hENs as published in OJEU /transposed into your legal system or by completing an “EMC Assessment” of the product and compiling documentary evidence in a Technical File: Module A: Internal Production Control/ Module B: EU- type examination +Module C: conformity to type based on internal production control

    For more information on legislation, please visit the partners page of our website to find details and contact your competent Ministry; if the Directive has not been transposed please visit webpage: http://eur-lex.europa.eu/homepage.html

  • 11. Can I, as a producer of EEE, do the testing myself? When should notified/designated body be used?
     

    You can test anywhere you wish as long as the equipment, capability and expertise are liable to produce test results according to the requirements of harmonized standards. In Member States, in-house testing is much more often, and it is up to manufacturer to voluntarily choose to engage a notified body to review technical documentation in order to give additional confidence to a claim of conformity to the EMC Directive (Module B: EU- type examination followed by conformity to the type).  In candidate countries, role of designated body is much more important in terms of testing, since in most of the cases, manufacturer` testing capacity is not enough strong and designated bodies are those who primarily do the testing.

    For more information on legislation, please visit the partners page of our website to find details and contact your competent Ministry; if the Directive has not been transposed please visit webpage: http://eur-lex.europa.eu/homepage.html

  • 12. I am a manufacturer of electrical equipment (electric and electronic appliances) under the scope EMC and I would like to know what kind of activities I need to carry out to demonstrate the compliance of my equipment with the essential requirements set out in Annex II of EMC.
     

    Article 14 of EMC requires the manufacturer to demonstrate the compliance of its equipment with the essential requirements set out in Annex I by means of one of two conformity assessment procedures: (a) Module A: Internal production control set out in Annex II or (b) Module B: EU type examination followed by Module C: Conformity to type based on internal production control set out in Annex III.

  • 13. I am a manufacturer of electrical equipment (electric and electronic appliances) under the scope EMC and the EU declaration of conformity for my equipment, I have to draw up according to the model in Annex IV of EMC, in point 7 requires the declaration of the notified body. Where can I find notified bodies appropriate for the third-party tasks described in Annex III?
     

    The Member States shall notify the European Commission and the other member states of bodies authorised to carry out third-party tasks in the process of Module B. These are the so-called “notified bodies”. The Commission assigns an identification number to each notified body and make publicly available the list of bodies notified under the EMC, including the identification number and the activities for which the body has been notified notably using the electronic notification tool developed and managed by the Commission, (NANDO database) (http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=153681). The Commission ensures that this list is kept up-to-date. The NANDO database also contains all bodies notified by countries which have signed mutual recognition agreement (MRA) with the EU. These notified bodies comply with the same requirements of EMC and are regularly monitored by the notifying authority of the Member State or, in case of a complaint, by the Commission.  When a notified body does not meet or no longer meets the requirements of its notification, the notifying Member State takes the necessary corrective measures, including withdrawal of notification, if necessary. So, the manufacturer can choose any of the notified bodies listed in the NANDO database.

  • 14. Can I add other marks to the product if I have the CE marking?
     

    Other marks may be applied to the product to indicate that safety standards have been complied as long as these marks do not obscure or become confused with the CE marking. Often it is a customer or contractual requirement that such marks are on the product and in these cases, where it is felt that a commercial disadvantage may occur from dropping the marks, they will be retained. BUT: The CE marking is the only marking which attests the conformity of the product with the applicable requirements of the relevant legislation. No markings shall be used to deceive third parties, the CE marking must be visible and legible and not covered by any other markings.

     For more information on legislation, please visit the partners page of our website to find details and contact your competent Ministry or visit webpage: http://eur-lex.europa.eu/homepage.html

  • 15. I am a manufacturer of electrical equipment (electric and electronic appliances) under the scope EMC. Do I need to have my own test facility for supporting the demonstration of compliance of my equipment with the essential requirements by either Module A or Module B/C with examinations carried out and/or test reports, or can I use the services of external testing laboratories?
     

    Article 7(2) of EMC requires the manufacturer to carry out the relevant conformity assessment procedure referred to in Article 14 or have it carried out. So, the EMC doesn’t require the manufacturer to have its own test facilities for performing the examinations and tests necessary to assess the electrical equipment’s conformity to the relevant requirements.

  • 16. I am a manufacturer of electrical equipment (electric and electronic appliances) under the scope EMC. Is it necessary that the laboratory, in-house or external, carrying out examinations and issuing test reports as required by Module A or Module B be accredited?
     

    No, the EMC does not require the manufacturer to have accredited facilities or use the services of accredited testing laboratories for these activities. However, it is very preferable as accreditation of a testing laboratory means validity and appropriateness of test methods, suitability and maintenance of test equipment, proper sampling, handling and transportation of test items, and quality control and assurance of test data. The tests performed by an accredited testing laboratory guarantee reliable and accurate results. Accreditation of testing laboratories is against the standard ISO/IEC 17025 and also means that the laboratory meets the management system principles of ISO 9001. If you need further information on accreditation or look for accreditation, please visit the partners page of our website to find details and contact your national accreditation body.

  • 17. I am a producer of Electrical Products and I need the services of a calibration laboratory. Should I select just a certified laboratory according to ISO 9001?
     

    It would be preferable to select an accredited laboratory, according to ISO 17025. In this respect, please visit the partners page of our website to find details of your national accreditation body. Their websites include lists of all accredited calibration laboratories.

  • 18. I am a producer of Electrical Products and following the recommendation of a certification body I had some of the measuring instruments used for quality control calibrated by a calibration laboratory, which also issued the respective calibration certificates. Does this mean that these instruments are suitable for use?
     

    A calibration certificate does not imply that the respective instrument is suitable for use. In any case, please visit the partners page of our website to find details of your National Metrology Institute for more information.

  • 19. I am a producer of electrical products and I just bought an electricity multi-meter to perform some simple measurements. This multi-meter is accompanied by a calibration report issued by its manufacturer, is this appropriate?
     

    Have in mind that a calibration certificate is issued for a unique, individual measuring instrument. It is true that some manufacturers issue the so called “Calibration Reports”, which correspond to a batch of measuring instruments. Please check if the Calibration Report has a serial number of the measuring instrument. In any case, please visit the partners page of our website to find details and contact your Metrology Institute.

  • 20. I am a manufacturer of electrical products and I use several measuring instruments which are calibrated. In some cases, looking at the calibration certificates, I see that in some cases there are deviations from the reference values. Is it necessary to make corrections when making measurements?
     

    Before making corrections you should contact the calibration laboratory and see if adjustments can be made. If not, then you should consider making corrections. In any case, please visit the partners page of our website to find details of your National Metrology Institute for more information.

  • 21. I am a manufacturer of electrical products and I need to have several measuring instruments calibrated by an accredited laboratory. How can I choose one that covers all my calibration needs?
     

    Please visit the partners page of our website to find details of your national accreditation body. Their websites include lists of all accredited calibration laboratories with their respective scope of accreditation.

*Whilst every effort has been made to ensure the accuracy of these answers, they are nonetheless the opinions of the Project's experts and do not necessarily reflect the views of Sida, EFTA, CEN nor the governments of partner countries and the Project cannot be held responsible for decisions taken based on these answers.