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Measuring Instruments Directive (2014/34/EU) - Certification Guide

Measuring Instruments Directive (MID)

The Measuring Instruments Directive (MID) applies to a wide range of measuring instruments. The purpose of this directive is to create a single market for measuring instruments within the EU. The essential requirements of MID are:

  • Allowable errors (including specifications of the expected climatic, mechanical and electromagnetic environment for which the instrument has been designed)
  • Reproducibility
  • Repeatability
  • Discrimination and Sensitivity
  • Durability
  • Reliability
  • Suitability
  • Protection against corruption
  • Information to be borne by and accompany the instrument
  • Indication of result
  • Further processing of data to conclude the trading transaction
  • Conformity evaluation

The directive also requires instrument software to be identifiable, secure, safe from accidental or intentional corruption, and to not be influenced by other softwares.

 

1. Directive Name

Measuring Instruments Directive

 

2. Directive Number & Download Link to Legal Directive

Directive 2014/32/EU can be downloaded from the following link:

Measuring Instruments Directive 2014/32/EU

 

3. Notified Body (aka, Independent Assessment) Required?

Before a manufacturer can begin the required procedure to assess their product, it is important that they determine whether said product requires self-assessment or involvement of a Notified Body.

Most of the measuring instruments can be self-declared by manufacturers regarding their compliance with the MID. They may carry out assessments and ensure that the product satisfies all the requirements of the MID.

For higher risk measuring instruments, however, involvement of notified bodies is necessary.

 

4. Products Covered

The Measuring Instruments Directive covers a wide range of devices or systems with a measurement function. Also, the sub-assemblies, which function independently and make up a measuring instrument by being incorporated with other such compatible devices or into a compatible measuring instrument, fall under the scope of this directive.

 

5. Examples of Products Covered

Products which fall under the scope of this directive are as follows:

  • water meters
  • gas meters and volume
  • conversion devices
  • active electrical energy meters
  • heat meters
  • measuring systems for continuous and dynamic measurement of quantities of liquids
  • other than water
  • automatic weighing instruments
  • taximeters
  • material measures
  • dimensional measuring instruments
  • exhaust gas
  • analysers

 

6. Examples of Products NOT Covered

The following are not covered by Measuring Instruments Directive:

  • Material measures of capacity for liquids
  • Material measures of capacity for grain
  • Measuring containers
  • Bulk milk cooler tanks
  • Moisture content meters for cereal grain and oleaginous grain
  • Level indicators
  • Alcoholometers and hydrometers for alcohol and alcoholometric tables
  • Automatic saccharimeters for sugar beet delivered to refineries and distilleries
  • Refractometers for measuring sugar content of grape must
  • Breathalysers
  • Radar speed detectors
  • Instruments for measuring opacity of emissions from diesel engine vehicles
  • Manometers used for inflation of vehicle tyres
  • Sound level meters
  • Thermometers used by state officials to check the temperature of perishable foodstuffs

7. Enforcement & Penalties

Each EU member state is required to lay down rules on penalties for not complying with the Measuring Instruments Directive. Below you can find the penalties for member states Germany and the UK as an example. For penalties relevant to other specific EU member states, please consult that state's local legislation on product safety.

  • Germany - violation of the "Produktsicherheitsgesetz" (wikipedia link) can result in fines of €3,000 - €30,000 (§ 19) and imprisonment of up to 1 year (§ 20.
  • In the UK, directive violations are are covered under Section 33 HSWA offenses and can result in an unlimited fine and up to two years imprisonment.

 

8. How to Comply: Requirements & Process

Check Conformity

Measuring instruments need to provide high level of metrological protection and be designed and manufactured to a high level of quality. Manufacturers need to carry out appropriate conformity assessment procedures to ensure the safety and quality of their products and self-declare their compliance with the MID.

Perform Laboratory Tests

Most of the measuring instruments can be assessed by manufacturers and are, solely, responsibility of the manufacturer. But, in case of measuring instruments of higher risks, notified bodies are involved. Notified bodies perform necessary conformity assessment procedures and certify the product’s quality and compliance with the directive.

Declaration of Conformity (contents)

The basic layout and content of a declaration of conformity are common for all directives, but may differ slightly for each directive.

The following are required by most directives:

  • Manufacturer’s name and address
  • The equipment’s description and/or serial number
  • Reference to relevant harmonized standards
  • Reference to the specifications, where necessary, by which conformity is declared
  • Details of the signatory
  • The two ending digits of the year of CE mark affixation

 

Technical Documentation

Directive 2014/32/EU requires technical documentation to be established by the manufacturer. The technical document is instrumental in the assessment of the conformity of said appliance with the Directive’s requirements.

The technical document must contain the following elements:

  • Description of the electronic devices
  • Description of the instrument with diagrams, drawings, flow diagrams of logic and general software information, explaining characteristics and operation
  • Details of the manufacturing procedures
  • Product design and description showing the relationship of conformity documentation with parts, their materials and subassemblies
  • Risk assessment of the parts, materials and subassemblies
  • Conformity information
  • Harmonised standards and conformity procedures that have been applied
  • Design calculations
  • Manufacturing documentation

 

Affix CE Mark

When all the necessary steps have been taken, it is time to get the product affixed with the CE mark. The mark should be placed either on the equipment, the packaging or the instructions. The letters must be vertically equal in dimensions and must not be smaller 5 millimeters. If there are other Directives which cover the product as well, the CE marking must be affixed only when all the Directives have been met.

 

9. Free Template Download

For a free Declaration of Conformity template for the Measuring Instruments Directive, please refer to the downloads section of the page below:

Declaration of Conformity Templates

 

10. Related Directives

The directive is related to Electromagnetic Compatibility Directive (2014/30/EU). Since measuring instruments may be susceptible to electromagnetic disturbances, manufacturers must refer to the EMC directive to check the emission requirements.

 

11. Useful Links (testing Labs, further information)

Links you might find useful in gaining more information regarding the Measuring Instruments Directive.

Download Full Text Directive

Guidance Documents

Details of Draft Standards