Non-Automatic Weighing Instruments (CE) Certification

The Non-Automatic Weighing Instruments Directive (NAWI — 2014/31/EU) governs weighing instruments that require operator intervention during the weighing operation. Its scope covers instruments used in commercial transactions, calculating tax and duties, preparing pharmaceuticals, and medical applications. Industrial scales used outside these 'legal metrology' uses (e.g. for internal production control only) are outside the directive's scope.

• Manufacturers of retail, butcher's and greengrocer's scales
• Manufacturers of industrial platform scales
• Manufacturers of laboratory and precision balances
• Manufacturers of medical scales (patient scales)
• Those importing weighing instruments and selling them under their own brand

Mandatory for instruments in legal metrology uses, with notified-body involvement required. The manufacturer can start with EU type examination (Module B) and choose a production-phase module (D or F); alternatively, unit verification (Module G) can be applied for individual instruments. In addition to the CE mark, the supplementary metrology mark (M) and the accuracy-class mark are affixed.

• Scope: legal metrology uses and excluded uses
• Essential requirements (Annex I): metrological requirements and design/manufacture requirements
• Accuracy classes (I, II, III, IIII) and the verification scale interval
• Maximum permissible errors and repeatability
• Stability against influence quantities: temperature, tilt, power supply, electromagnetic disturbance
• Zero-setting and tare devices
• Display legibility and additional requirements for price-computing scales
• Protection against fraud and sealing
• Marking: CE, the supplementary metrology mark, accuracy class, maximum capacity, scale interval
• Conformity-assessment modules: B+D, B+F, G

1. 1Determining the LegislationIt is determined which EU legislation applies to the product. A product can fall within scope of more than one piece of legislation at the same time; all of them must be met.
2. 2Selecting the Conformity Assessment ModuleThe legislation determines the module to follow according to the product's risk class. The manufacturer self-declares under some modules, while a notified body is involved under others.
3. 3Testing Against Harmonised StandardsConformity with harmonised standards published in the EU Official Journal is demonstrated through testing; this provides a presumption of conformity with the legislation.
4. 4Risk Analysis and the Technical FileThe risk assessment, design calculations, test reports, instructions for use and sample labels are compiled in the technical file.
5. 5The EU Declaration of ConformityThe manufacturer or its EU-based authorised representative signs the declaration of conformity. Responsibility rests with the signatory of the declaration.
6. 6Affixing the CE MarkThe mark is affixed to the product in the form and size the legislation prescribes; the notified body's identification number is added if one is involved.
7. 7Retaining the Technical FileThe technical file is retained for the period the legislation sets from the product's placing on the market (10 years under most legislation) and presented to the competent authority on request.

The CE mark is not a certificate but the manufacturer's declaration of conformity, and it has no expiry. However, the declaration remains valid as long as the product and the legislation do not change: the technical file must be updated if the legislation or the harmonised standard is updated. Notified-body certificates (e.g. an EU Type-Examination Certificate) are subject to a validity period.

• The product description, model list and technical drawings
• Risk assessment
• The list of harmonised standards applied
• Test reports
• Instructions for use and warning labels (in the target market's language)
• A draft EU Declaration of Conformity
• The instrument description, accuracy class, maximum capacity and scale-interval value
• Design drawings and load-cell information
• Metrological performance and influence-quantity test reports
• The software identification and protection measures
• The sealing plan
• Instructions for use and a sample label

There is no fixed list price; the cost is calculated based on the following variables and provided in writing in the quote.

• The number of pieces of legislation applicable to the product
• The conformity-assessment module — whether a notified body is involved
• The required test scope and number of samples
• The current state of the technical file
• Translation and documentation needs

A Notified Body under CE is registered in the European Commission's NANDO database for the relevant EU regulation and carries a four-digit identification number. Notified body authority is based on legislation and product scope; The authority granted for one regulation does not extend to another. Testing is within the scope of ISO/IEC 17025, product certification is within the scope of ISO/IEC 17065.

The scope under which this scheme can be offered varies according to your product and activity; it is confirmed in writing at the quote stage.

• CEMeasuring Instruments
• CEToy Safety
• CEMachinery Safety
• CELVD
• CEEMC
• CERED
• CEMDR
• CEIVDR