Directives

If your product(s) fall(s) within the sector of Non-automatic weighing instruments Directive 2014/31/EU applies.

• Directive 2014/31/EU on Non-automatic weighing instruments
• For further information on the Directive 2014/31/EU on Non-automatic weighing instruments, please visit the Directorate-General (DG) for Internal Market, Industry, Entrepreneurship and SMEs webpage dedicated to this sector by following this link: http://ec.europa.eu/growth/single-market/goods/building-blocks/legal-metrology/measuring-instruments_en
• For a further look at the guidance for measuring instruments, please visit: http://ec.europa.eu/growth/single-market/goods/building-blocks/legal-metrology/measuring-instruments/guidance-standards_en

Certificates issued under the repealed Directive 2009/23/EC remain valid under Directive 2014/31/EU and references to the repealed Directives 2009/23/EC and 90/384/EEC shall be construed as references to Directive 2014/31/EU in accordance with the correlation tables in Annex VI of Directive 2014/31/EU and Annex VIII of Directive 2009/23/EC.

Verify requirements

The New Approach Directives for the CE marking have been designed by the European Union in such a manner that they cover all requirements for products from each of the aforementioned sectors.

The Directive defines a non-automatic weighing instrument as ‘a measuring instrument serving to determine the mass of a body by using the action of gravity on that body’ and ‘requiring the intervention of an operator during weighing’.

As far as CE marking is concerned, the Directive applies to instruments intended to be used for determining mass in the following situations: commercial transactions; for calculating tolls, tariffs, taxes, bonuses, penalties, remunerations or indemnities; for the application of laws or regulations or for an expert opinion given in court proceedings; in the practice of medicine for weighing patients for purposes of monitoring, diagnosing and medical treatment; for making up medicines on prescription in a pharmacy and determination of mass in analyses carried out in medical and pharmaceutical laboratories ; or for determining a price on the basis of mass for the purposes of direct sales to the public and the making-up of prepackages.

Directive 2014/31/EU on Non-Automatic Weighing Equipment specifies the essential requirements the product must meet in order for the manufacturer to affix the CE marking in Annex I to the Directive.

Need for notified body?

Before proceeding with the assessment procedure, it is important to determine whether you, the manufacturer, can assess your product by yourself or whether you have to involve a Notified Body.

In the case of non-automatic weighing equipment the manufacturer can choose from different assessment procedures and for instruments intended for any of the uses -mentioned in the section "Verify requirements" must involve a Notified Body.

A Notified Body verifies the compliance of a product by conducting a conformity assessment. It also ensures that the technical documentation sufficiently supports product compliance. If the Notified Body is involved in the production control phase, its identification number will follow the CE marking.

When the Notified Body is convinced of a product’s compliance, it will issue a certificate of conformity to confirm this. The manufacturer will then draw up the EU Declaration of Conformity (DoC) to declare on his sole responsibility conformity to the relevant Directive. The establishment of the EU DoC is a legal obligation.

The EU Declaration of Conformity must include the manufacturer’s details such as name and address, essential characteristics the product complies with, any European standards and performance data and the identification number of the Notified Body as well as a legally binding signature on behalf of the organisation. For further details please consult your specific Directive.

To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please consult NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive or by country via the NANDO homepage.

Check conformity

Manufacturers can choose between two sets of procedures for assessing the conformity of their non-automatic weighing instruments with the essential requirements set out in the Directive.

The first option is the EU-type examination (Module B in Annex II), carried out by a Notified Body, and followed by either the EU declaration of type conformity (guarantee of production quality) (Module D or D1 in Annex II), or by the EU verification (Module F or F1 in Annex II).

The second option is the EU unit verification procedure, (Module G in Annex II).

After the involvement of the Notified Body, the manufacturer draws up and signs the EU Declaration of Conformity. He may also opt for an execution of the production (Modules D, D1, F, F1 or G) in two stages, subject to the conditions in Annex II, point 7 concerning common provisions.

Technical documentation

Article 6 and Annex II to the Directive non-automatic weighing instruments requires the manufacturer to establish a technical documentation. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Directive. The documentation shall, wherever applicable, contain at least the following elements:

• a general description of the instrument,
• conceptual designs and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.,
• descriptions and explanations necessary for the understanding of those drawings and the operation of the instrument,
• a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union, and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of this Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied;,
• results of design calculations made. examinations carried out, etc.,
• test reports.

The manufacturer, or their authorised representative established in the European Union, is requested to keep copies of the technical documentation for a period of 10 years after the last product has been placed on the market.

Affix CE marking

Once the necessary steps have been successfully completed, the logo must be affixed to the product.

The marking must be placed visibly and legibly on the product or, if not possible due to the nature of the product, be affixed to the packaging and the accompanying document. The CE marking shall consist of the initials 'CE' taking the following form:

The various components of the CE marking must have the same vertical dimension and may not be smaller than 5 mm. If the CE marking is reduced or enlarged, the proportions given in the graduated drawing above must be respected.

When the product is subject to other Directives covering other aspects and which also provide for the ‘CE’ marking, the accompanying documents must indicate that the product also conforms to those other Directives.

However, when one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the ‘CE’ marking must indicate conformity with the Directives applied by the manufacturer. In this case, the particularities of the Directives applied, as published in the Official Journal of the European Union, must be given in the documents, notices or instructions required by the Directives and accompanying such products.

As one or more Notified Bodies can be involved in the production control phase, their identification numbers must be also displayed.

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