What is the definition of "scale"?
A scale is a measuring device used to determine the mass of a body by using gravity on that body. It can also determine other mass-related quantities, parameters or features.
What is the purpose of Directive 2014/31 on non-automatic scales?
Directive 2014/31 applies to all non-automatic scales, and the following are some of the purposes of the Directive
- Determining the mass for calculating a toll, fare, bonus, penalty or similar payments.
- Determining the mass for the application of laws and regulations.
- Determination of the mass in pharmaceutical laboratories for the purpose of analysis.
- For direct sales to the public, the price is set on the basis of mass.
- Determination of the mass in trading transactions.
Who is the manufacturer within the meaning of Directive 2014/31?
A manufacturer is a natural or legal person who develops or manufactures a device and sells it under its brand or name.
What is necessary to place non-automatic scales from third countries on the Union market?
It is necessary that non-automatic scales comply with the relevant Directive and that the manufacturer has carried out appropriate conformity assessment procedures for non-automatic scales placed on the Union market.
What particular responsibility does the importer bear when placing a non-automatic scale on the market?
The importer is responsible for ensuring that on each non-automatic scale his name, registered trade name or trademark and the postal address where he can be contacted are indicated.
Why should the manufacturer issue an EU declaration of conformity?
The manufacturer shall issue an EU declaration of conformity to provide the necessary information in accordance with Directive 2014/31 on the conformity of non-automatic scales with the requirements of this Directive and other harmonised standards and legislation.
Who is the "authorised representative" within the meaning of Directive 2014/31?
An authorised representative has been mandated by a manufacturer to perform certain tasks on its behalf and may be a natural or legal person established in the Union.
What is the manufacturer’s obligation in the Non-automatic Scales Directive?
The following are some of the manufacturers' obligations
- The manufacturer must ensure that the device is designed and manufactured in accordance with the requirements of the Directive and the intended use of the device.
- The manufacturer shall carry out the relevant conformity assessment procedures and prepare the technical documentation for the intended use of the equipment.
- The manufacturer shall keep the EU declaration of conformity and the technical documentation for ten years after the device has been placed on the market.
- Changes in equipment design or harmonized standards shall be taken into account by the manufacturer.
- The manufacturer shall ensure the identification of the equipment placed on the market by means of information such as type, lot or serial number.
- The manufacturer shall provide information or instructions on the device in a language that is easy for the end user to understand.
What tasks should the authorised representatives perform?
An authorised representative shall perform at least the following tasks specified by the manufacturer
- Keep the EU declaration of conformity and the technical documentation for 10 years after placing the device on the market.
- At the request of the competent national authority, provide all the necessary information and documentation to help demonstrate the conformity of the device.
- Cooperation with the competent national authorities in all measures taken to eliminate the risk posed by the instrument.
What are the metrological requirements?
Here are some metrological requirements,
- Unit of mass
The mass units used must be the legal units within the meaning of Council Directive 80/181/EEC. Subject to compliance, the following units are permitted
- SI units: kilogram, microgram, milligram, gram, ton.
- Imperial Units: Troy ounce when weighing precious metals.
- Other non-SI units: metric carat when weighing gems.
- Accuracy
The error display must not exceed the maximum permissible display error. For digital display, the display error must be corrected by the rounding error.
What are the general requirements for planning and construction?
Below are the general requirements for design and construction,
- The equipment shall be designed and constructed to retain its metrological characteristics when properly used and installed and used in an environment for which it is intended. The value of the mass must be specified.
- Electronic devices exposed to interference shall not display or automatically detect and display the effects of significant faults.
- If external devices are connected to an electronic device via a suitable interface, the metrological properties of the device must not be impaired.
- The equipment shall not have features that facilitate fraudulent use and the possibility of unintentional misuse shall be minimal. Components that may not be disassembled or adjusted by the user must be secured against such actions.
- The printed results shall be correct, appropriately labelled and unambiguous. The print must be clear, legible, indelible and durable.
- Where appropriate, the equipment shall be equipped with a levelling device and a level indicator so sensitive that proper installation is possible.
What types of scales are non-automatic?
Here are some examples of non-automatic scales,
- Kitchen or bathroom scale.
- Scales for retail and industry.
- Weighing systems at supermarket checkouts.
- weighbridges.
- Laboratory and pharmaceutical scales.
Which elements must be included in the technical documentation?
The technical document should include
- General description of the instrument.
- Design and production drawings as well as plans of components.
- Descriptions and explanations are required for understanding these drawings and plans as well as for the operation of the device.
- List of fully or partially applied harmonised standards whose references have been published in the Official Journal of the European Union.
- Results of design calculations, tests carried out, etc.
- Test reports.
What should be considered when evaluating the quality system?
For the instrument concerned, the application for quality assessment shall include
- The name and address of the manufacturer and, if the application is submitted by the authorised representative, the name and address of the manufacturer.
- A written statement that the same application was not submitted to another notified body.
- All relevant information for the device category is provided.
- Documents on the quality system.
- The technical documentation of the approved type and a copy of the EU type examination certificate.
What is the CE marking?
"CE marking" is a marking used by the manufacturer to indicate that the device complies with the applicable requirements of the Union harmonisation legislation in which its affixing is provided.
How can a manufacturer obtain the CE mark?
When the entire development and manufacturing process is complete and you want to enter the market, you need to present a conformity assessment of the scale and the corresponding technical documentation, containing all information on the scale and its components and its intended use and ensuring that it complies with the Scale Directive and harmonised standards. We at easyCE are happy to help you with these steps.
What are the rules and conditions for affixing the CE marking?
The following are some rules and conditions for affixing the CE marking,
- The CE marking and the additional metrology marking shall be clearly visible, legible and permanently affixed to the device or its data plate.
- The CE marking and the additional metrology marking shall be affixed before the device is placed on the market.
- The additional metrology marking must be carried out immediately after the CE marking.
- Behind the CE marking and the additional metrology marking is/are the identification number(s) of the notified body.
- The CE marking, the additional metrology marking and the identification number(s) of the notified body(s) may be followed by any other marking indicating a particular hazard or use.
What must the EU declaration of conformity contain?
The EU declaration of conformity shall include
- Device model/device (product, type, batch or serial number).
- Name and address of the manufacturer and, if applicable, his authorized representative.
- The declaration of conformity is issued under the sole responsibility of the manufacturer.
- References to the relevant harmonised standards applied or references to the other technical specifications whose conformity is declared.
- Additional information: Signed for and on behalf of (place and date of issue), (name, function) (signature).
What additional activities are required to obtain the CE marking for non-automatic scales?
Article 6 of Directive 2014/31 deals with all the necessary obligations of a manufacturer to obtain the CE marking for non-automatic scales. The following are some points from Article 6:
- When placing on the market their equipment intended for the applications referred to in Article 1 paragraph 2 letters a) to f) (all products falling within the scope of the Directive)ensure that they have been designed and manufactured in accordance with the essential requirements set out in Annex I.
- For equipment intended for the applications referred to in Article 1 paragraph 2 letters a to f (all products covered by the Directive)draw up the technical documentation referred to in Annex II and carry out or have carried out the relevant conformity assessment procedure referred to in Article 13. Where this conformity assessment procedure has demonstrated that a device intended for the applications referred to in Article 1 paragraph 2 letters a to f (all products falling within the scope of the Directive) complies with the applicable requirements Manufacturers shall issue an EU declaration of conformity and affix the CE marking and the additional metrology marking.
- For equipment intended for the applications referred to in Article 1, paragraph 2, letters a to f (all products falling within the scope of the Directive), manufacturers shallKeep the declaration of conformity for ten years after placing the device on the market.
- Manufacturers shall ensure that conformity with this Directive is maintained during series production. Changes to the design of the device or its features, as well as changes to the harmonised standards or other technical specifications referred to in the declaration of conformity of a device, shall be duly taken into account. If it is considered appropriate in view of the risks posed by a device intended for the applications referred to in Article 1, paragraph 2, letters a to f (all products covered by the Directive), Manufacturers shall carry out sampling of devices made available on the market, investigate complaints, non-compliant devices and device recalls and, where necessary, maintain a list of complaints and keep traders informed of such monitoring.
- Manufacturers shall ensure that the devices they place on the market bear a type, batch or serial number or other identification mark for their identification in accordance with Annex III.
Is a type examination required?
The EU type examination is the essential part of a conformity assessment procedure in accordance with Directive EU 2014/31. Article 13 and Annex 2 of the Directive specify detailed conformity assessment procedures for non-automatic scales (NAWI). In summary, the conformity assessment requirements for some appliances such as kitchen or bathroom scales are simple for personal use at home. In such cases, only the name of the manufacturer and the weighing range must be indicated on the scale. For other scales, however, NAWI must undergo an EC type-examination and receive an EC type-approval certificate. NAWI must be produced in accordance with the EC type approval certificate.
Is a laboratory test required?
According to this Directive, the essential part of a conformity assessment procedure is the EU type-examination in which a notified body verifies and confirms the technical documentation and additional evidence that the technical design of the equipment complies with the essential requirements set out in Annex 1 to the Directive. The prescribed conformity assessment procedure requires laboratory testing in the following cases:
- The technical documentation and additional evidence shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by a suitable laboratory of the manufacturer or by another test laboratory on his behalf and under his responsibility.
- The notified body shall carry out or have carried out the relevant investigations and tests to determine whether the solutions chosen by the manufacturer using the relevant technical specifications comply with the relevant essential requirements of this Directive.
- The notified body and the manufacturer must agree on a place where the tests and tests are to be carried out.
Is it necessary to involve a notified body?
Article 31 of the Directive requires a notified body to carry out "the conformity assessment in accordance with the conformity assessment procedures laid down in Annex II".
Annex 2 to the Directive lays down the procedure by which either a notified body shall
- Examines and tests the scale and applies the conformity assessment mark
- approve a quality assurance system set up by the manufacturer to meet the requirements of conformity assessment.
In all cases, the established conformity assessment procedure requires the active participation of the notifying bodies in the process.
