Directives

If your product(s) fall(s) within the measuring instruments sector Directive 2014/32/EU applies.

• Directive 2014/32/EU on measuring instruments
• For further information on Directive 2014/32/EU on measuring instruments, please also 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 documents for measuring instruments, please visit: http://ec.europa.eu/growth/single-market/goods/building-blocks/legal-metrology/measuring-instruments/guidance-standards_en

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.

Directive 2014/32/EU on measuring instruments specifies in detail the essential requirements the product needs to meet in order for the manufacturer to affix the CE marking.

The Directive covers the following measuring devices and systems: water meters, gas meters and volume conversion devices, active electrical energy meters, thermal energy meters, measuring systems for continuous and dynamic measurement of quantities of liquids other than water, automatic weighing instruments, taximeters, material measures, dimensional measuring instruments and exhaust gas analysers.

The essential requirements are listed in Annex I to the Directive, while specific requirements for each type of measuring instrument are presented in the 10 sector-specific annexes (MI-001 to MI-010).

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.

When dealing with measuring instruments, the manufacturer is allowed to choose between assessment procedures stipulated in Annex II to the Directive.

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 be listed after the CE marking.

When the Notified Body is convinced of product’s compliance, it will issue a certificate of conformity to confirm this. The manufacturer will then draw up a Declaration of Conformity (DoC) to declare that he is solely responsible for the product’s conformity to the relevant Directive. The establishment of the DoC is a legal obligation.

The 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 use 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

Annex II to the Directive specifies conformity assessment procedures for measuring instruments and 10 sector-specific annexes (Annex III-XII) provide for choice of conformity assessment for each of the 10 sectors.

For example, manufacturers of water meters can choose from the procedures: B+F or B+D or H1 as set in Annex II.

Whether a Notified Body has been involved or not, the manufacturer must draw up and sign the EU Declaration of Conformity.

Technical documentation

According to Directive 2014/32/EU, the technical documentation shall render the design, manufacture and operation of the measuring instrument intelligible and shall permit an assessment of its conformity with the applicable requirements of the Directive. In detail, Article 18, Par. 2 lists the documentation of:

• the definition of the metrological characteristics,
• the reproducibility of the metrological performances of produced instruments when properly adjusted using appropriate intended means, and
• the integrity of the instrument.

More details are listed in Article 18 depending on the type of instrument. Please consult your Directive for an extensive list.

The manufacturer, or his authorised representative, is requested to keep copies of the technical documentation for a period of 10 years after the last product is placed on the market.

Affix CE marking

Once the necessary steps have been successfully completed, the CE marking 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 only. 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.

The CE marking on measuring instruments must be accompanied by supplementary metrology marking consisting of the capital letter ‘M’ and the last two digits of the year of its affixing, surrounded by a rectangle. Both markings must be at least 5 mm in height.

If the measuring instrument consists of multiple devices operating together, the markings are required to be affixed on the main device. If a measuring instrument is too small or too sensitive to carry these markings, they may be displayed on the packaging and accompanying documents.

If a Notified Body is involved in the production control phase, its identification number must be also displayed.

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