Measuring Instruments (CE) Certification

The Measuring Instruments Directive (MID — 2014/32/EU) governs measuring instruments used in commercial transactions and measurements in the public interest. Its aim is for measurement to be reliable and accurate between parties. The directive covers ten instrument categories, with a separate annex (MI-001 to MI-010) defining specific requirements for each. In addition to the CE mark, the supplementary metrology mark (M and the last two digits of the year) is affixed.

• Manufacturers of water, gas, electricity and heat meters
• Manufacturers of fuel dispensers and liquid-measuring systems
• Manufacturers of automatic weighing instruments
• Manufacturers of taximeters
• Manufacturers of exhaust-gas analysers and dimensional-measuring instruments

Mandatory for instruments within scope, with notified-body involvement without exception. The manufacturer selects the module combination suited to its product (e.g. B+D, B+F, or H1). The supplementary metrology mark and the notified body's identification number are affixed alongside the CE mark. Periodic in-service inspection of instruments is subject to national metrology legislation and is outside MID's scope.

• Scope: ten instrument categories (MI-001 water meters ... MI-010 exhaust-gas analysers)
• Essential requirements (Annex I): permitted error limits, repeatability, discrimination threshold
• Rated operating conditions and influence quantities (temperature, humidity, voltage, electromagnetic disturbance)
• Durability and stability against change over time
• Conformance classes and accuracy classes
• Protection against fraud and unauthorised intervention; sealing
• Displaying and recording the measurement result
• Software protection and software identification
• Marking: CE, the supplementary metrology mark (M), the notified body's number
• Conformity-assessment modules (Annex II) and their selection by the product annex

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 and measuring range
• Design and manufacturing drawings
• Metrological performance test reports
• Influence-quantity and durability test reports
• The software identification, version information 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.

• CENon-Automatic Weighing Instruments
• CEToy Safety
• CEMachinery Safety
• CELVD
• CEEMC
• CERED
• CEMDR
• CEIVDR