WHAT IS THE AIM OF THE DIRECTIVE?
- The directive sets out the general rules for European Union (EU) (previously European Community (EC)) pattern approval, initial verification and methods of metrological control for measuring instruments.
- Further directives cover these technical requirements in detail: Directives 2014/32/EU on measuring instruments (see summary) and 2014/31/EU on non-automatic weighing instruments (see summary).
KEY POINTS
Before measuring instruments are brought into use, EU Member States are responsible for ensuring that they conform with technical requirements. This is achieved through granting EC pattern approval and verification, recognised throughout the EU. This directive covers:
- measuring equipment, covering measuring instruments, components of measuring instruments, additional devices and measurement equipment;
- units of measurement;
- the harmonising of methods of measurement and metrological control;
- the means of applying harmonisation methods;
- methods of measurement, metrological control and marking of quantities of pre-packaged products.
EC pattern approval
- An EC pattern approval application can be made only by the manufacturer or a representative established in the EU, in one Member State only.
- Member States must ensure that they are kept informed of any modification to the approved pattern requiring additional approval and, where changes occur, must inform other Member States.
- A new EC pattern approval may be needed when a pattern is modified and where relevant directives introduce new requirements.
- Following approval, the Member State provides a certificate and the manufacturer applies the official approval sign to the equipment concerned.
- Certificates are valid for 10 years, extendable for further 10-year periods.
Applications include the following information:
- intended use;
- measurement characteristics;
- how they are built and operate;
- devices to regulate and adjust them;
- the intended locations for verification marks (where they will be affixed to the instrument);
- general and detailed drawings of important components;
- drawings or photographs illustrating the principles of operation.
The examination includes a document study and an examination of the measurement characteristics of the pattern covering the entire performance of the instrument under normal conditions of use.
The Member State that has granted EC pattern approval may withdraw it if it was granted improperly, or if a defect is subsequently found in the equipment. It must immediately inform the other Member States and the European Commission, and attempt to settle any disputes, in consultation with the Commission, where necessary.
Where new techniques are used that are not covered by a separate directive, limited EC pattern approval for up to 2 years (extendable by up to 3 years) may be granted with certain restrictions, including a limit on the number of instruments covered, and restrictions on use and the technique used.
Initial verification
EC initial verification is the examination of a new or reconditioned1 instrument to ensure it conforms to the approved EC pattern and/or to the related relevant directives, and is certified by the EC initial verification mark.
The examination includes an assessment of:
- the metrological characteristics,
- the maximum permissible errors,
- the reliability of construction.
When an instrument has passed EC initial verification in accordance with this directive and the related, more detailed directives, the EC verification mark can be applied by the manufacturer.
Checking of instruments in use
Directive 2011/17/EU repealed a number of separate, product-specific directives that covered control requirements for measuring instruments already in use because they were technically outdated, did not reflect the state of the art in measurement technology or concerned instruments that were not subject to technological development:
Adjustment to technical progress
Regulation (EU) 2019/1243 amends Directive 2009/34/EC, giving the Commission the power to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union to adapt the annexes to reflect technical progress.
Directive 2009/34/EC recasts and repeals Directive 71/316/EEC and its subsequent amendments.
FROM WHEN DO THE RULES APPLY?
The directive had to be transposed into national law by 18 May 2009. The rules have applied since 18 May 2009.
BACKGROUND
For further information, see:
KEY TERMS
- Reconditioned. A used instrument that has been restored to good condition.
MAIN DOCUMENT
Directive 2009/34/EC of the European Parliament and of the Council of 23 April 2009 relating to common provisions for both measuring instruments and methods of metrological control (Recast) (OJ L 106, 28.4.2009, pp. 7–24).
Successive amendments to Directive 2009/34/EC have been incorporated into the original text. This consolidated version is of documentary value only.
RELATED DOCUMENTS
Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments (recast) (OJ L 96, 29.3.2014, pp. 107–148).
Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments (recast) (OJ L 96, 29.3.2014, pp. 149–250).
See consolidated version.
Directive 2011/17/EU of the European Parliament and of the Council of 9 March 2011 repealing Council Directives 71/317/EEC, 71/347/EEC, 71/349/EEC, 74/148/EEC, 75/33/EEC, 76/765/EEC, 76/766/EEC and 86/217/EEC regarding metrology (OJ L 71, 18.3.2011, pp. 1–3).
