Directive 2014/31/EU of the European Parliament and of the CouncilShow full title
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) (Text with EEA relevance)
Introductory Text
CHAPTER 1 GENERAL PROVISIONS
Article 1.Scope
Article 2.Definitions
Article 3.Making available on the market and putting into service
Article 4.Essential requirements
Article 5.Free movement of instruments
CHAPTER 2 OBLIGATIONS OF ECONOMIC OPERATORS
Article 6.Obligations of manufacturers
Article 7.Authorised representatives
Article 8.Obligations of importers
Article 9.Obligations of distributors
Article 10.Cases in which obligations of manufacturers apply to importers and distributors
Article 11.Identification of economic operators
CHAPTER 3 CONFORMITY OF INSTRUMENTS
Article 12.Presumption of conformity of instruments
Article 13.Conformity assessment procedures
Article 14.EU declaration of conformity
Article 15.Conformity marking
Article 16.General principles of the CE marking and of the supplementary metrology marking
Article 17.Rules and conditions for affixing the CE marking, the supplementary metrology marking and other markings
Article 18.Restrictive use symbol
CHAPTER 4 NOTIFICATION OF CONFORMITY ASSESSMENT BODIES
Article 19.Notification
Article 20.Notifying authorities
Article 21.Requirements relating to notifying authorities
Article 22.Information obligation on notifying authorities
Article 23.Requirements relating to notified bodies
Article 24.Presumption of conformity of notified bodies
Article 25.Subsidiaries of and subcontracting by notified bodies
Article 26.Application for notification
Article 27.Notification procedure
Article 28.Identification numbers and lists of notified bodies
Article 29.Changes to notifications
Article 30.Challenge of the competence of notified bodies
Article 31.Operational obligations of notified bodies
Article 32.Appeal against decisions of notified bodies
Article 33.Information obligation on notified bodies
Article 34.Exchange of experience
Article 35.Coordination of notified bodies
CHAPTER 5 UNION MARKET SURVEILLANCE, CONTROL OF INSTRUMENTS ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE
Article 36.Union market surveillance and control of instruments entering the Union market
Article 37.Procedure for dealing with instruments presenting a risk at national level
Article 38.Union safeguard procedure
Article 39.Compliant instruments which present a risk
Article 40.Formal non-compliance
CHAPTER 6 COMMITTEE, TRANSITIONAL AND FINAL PROVISIONS
Article 41.Committee procedure
Article 42.Penalties
Article 43.Transitional provisions
Article 44.Transposition
Article 45.Repeal
Article 46.Entry into force and application
Article 47.Addressees
Signature
ANNEX I
ESSENTIAL REQUIREMENTS
The terminology used is that of the International Organisation of...
Preliminary observation
Metrological requirements
1. Units of mass
2. Accuracy classes
2.1. The following accuracy classes have been defined:
2.2. Scale intervals
2.2.1. The actual scale interval (d) and the verification scale interval...
2.2.2. For all instruments other than those with auxiliary indicating devices:...
2.2.3. For instruments with auxiliary indicating devices the following conditions apply:...
3. Classification
3.1. Instruments with one weighing range
3.2. Instruments with multiple weighing ranges
3.3. Multi-interval instruments
3.3.1. Instruments with one weighing range may have several partial weighing...
3.3.2. Each partial weighing range i of multi-interval instruments is defined...
3.3.3. The partial weighing ranges are classified according to Table 2....
4. Accuracy
4.1. On implementation of the procedures laid down in Article 13,...
4.2. The maximum permissible errors in service are twice the maximum...
5. Weighing results of an instrument shall be repeatable, and shall...
6. The instrument shall react to small variations in the load....
7. Influence quantities and time
7.1. Instruments of classes II, III and IIII, liable to be...
7.2. The instruments shall meet the metrological requirements within the temperature...
7.3. Instruments operated from a mains power supply shall meet the...
7.4. Electronic instruments, except those in class I and in class...
7.5. Loading an instrument in class II, III or IIII for...
7.6. Under other conditions the instruments shall either continue to function...
Design and construction
8. General requirements
8.1. Design and construction of the instruments shall be such that...
8.2. When exposed to disturbances, electronic instruments shall not display the...
8.3. The requirements of points 8.1 and 8.2 shall be met...
8.4. When external equipment is connected to an electronic instrument through...
8.5. The instruments shall have no characteristics likely to facilitate fraudulent...
8.6. Instruments shall be designed to permit ready execution of the...
9. Indication of weighing results and other weight values
10. Printing of weighing results and other weight values
11. Levelling
12. Zeroing
13. Tare devices and preset tare devices
14. Instruments for direct sales to the public, with a maximum...
15. Price labelling instruments
ANNEX II
CONFORMITY ASSESSMENT PROCEDURES
1. Module B: EU-type examination
1.1. EU-type examination is the part of a conformity assessment procedure...
1.2. EU-type examination may be carried out in any of the...
1.3. The manufacturer shall lodge an application for EU-type examination with...
1.4. The notified body shall:
1.5. The notified body shall draw up an evaluation report that...
1.6. Where the type meets the requirements of this Directive, that...
1.7. The notified body shall keep itself apprised of any changes...
1.8. Each notified body shall inform its notifying authority concerning the...
1.9. The manufacturer shall keep a copy of the EU-type examination...
1.10. The manufacturer’s authorised representative may lodge the application referred to...
2. Module D: Conformity to type based on quality assurance of...
2.1. Conformity to type based on quality assurance of the production...
2.2. Manufacturing
2.3. Quality system
2.3.1. The manufacturer shall lodge an application for assessment of his...
2.3.2. The quality system shall ensure that the instruments are in...
2.3.3. The notified body shall assess the quality system to determine...
2.3.4. The manufacturer shall undertake to fulfil the obligations arising out...
2.3.5. The manufacturer shall keep the notified body that has approved...
2.4. Surveillance under the responsibility of the notified body
2.4.1. The purpose of surveillance is to make sure that the...
2.4.2. The manufacturer shall, for assessment purposes, allow the notified body...
2.4.3. The notified body shall carry out periodic audits to make...
2.4.4. In addition, the notified body may pay unexpected visits to...
2.5. Conformity marking and EU declaration of conformity
2.5.1. The manufacturer shall affix the CE marking and the supplementary...
2.5.2. The manufacturer shall draw up a written EU declaration of...
2.6. The manufacturer shall, for a period ending 10 years after...
2.7. Each notified body shall inform its notifying authority of quality...
2.8. Authorised representative
3. Module D1: Quality assurance of the production process
3.1. Quality assurance of the production process is the conformity assessment...
3.2. Technical documentation
3.3. The manufacturer shall keep the technical documentation at the disposal...
3.4. Manufacturing
3.5. Quality system
3.5.1. The manufacturer shall lodge an application for assessment of his...
3.5.2. The quality system shall ensure compliance of the instruments with...
3.5.3. The notified body shall assess the quality system to determine...
3.5.4. The manufacturer shall undertake to fulfil the obligations arising out...
3.5.5. The manufacturer shall keep the notified body that has approved...
3.6. Surveillance under the responsibility of the notified body
3.6.1. The purpose of surveillance is to make sure that the...
3.6.2. The manufacturer shall, for assessment purposes, allow the notified body...
3.6.3. The notified body shall carry out periodic audits to make...
3.6.4. In addition, the notified body may pay unexpected visits to...
3.7. Conformity marking and EU declaration of conformity
3.7.1. The manufacturer shall affix the CE marking and the supplementary...
3.7.2. The manufacturer shall draw up a written EU declaration of...
3.8. The manufacturer shall, for a period ending 10 years after...
3.9. Each notified body shall inform its notifying authority of quality...
3.10. Authorised representative
4. Module F: Conformity to type based on product verification
4.1. Conformity to type based on product verification is the part...
4.2. Manufacturing
4.3. Verification
4.4. Verification of conformity by examination and testing of every instrument...
4.4.1. All instruments shall be individually examined and appropriate tests set...
4.4.2. The notified body shall issue a certificate of conformity in...
4.5. Conformity marking and EU declaration of conformity
4.5.1. The manufacturer shall affix the CE marking and the supplementary...
4.5.2. The manufacturer shall draw up a written EU declaration of...
4.6. If the notified body agrees and under its responsibility, the...
4.7. Authorised representative
5. Module F1: Conformity based on product verification
5.1. Conformity based on product verification is the conformity assessment procedure...
5.2. Technical documentation
5.2.1. The manufacturer shall establish the technical documentation. The documentation shall...
5.2.2. The manufacturer shall keep the technical documentation at the disposal...
5.3. Manufacturing
5.4. Verification
5.5. Verification of conformity by examination and testing of every instrument...
5.5.1. All instruments shall be individually examined and appropriate tests, set...
5.5.2. The notified body shall issue a certificate of conformity in...
5.6. Conformity marking and EU declaration of conformity
5.6.1. The manufacturer shall affix the CE marking and the supplementary...
5.6.2. The manufacturer shall draw up a written EU declaration of...
5.7. If the notified body agrees and under its responsibility, the...
5.8. Authorised representative
6. Module G: Conformity based on unit verification
6.1. Conformity based on unit verification is the conformity assessment procedure...
6.2. Technical documentation
6.2.1. The manufacturer shall establish the technical documentation and make it...
6.2.2. The manufacturer shall keep the technical documentation at the disposal...
6.3. Manufacturing
6.4. Verification
6.5. Conformity marking and EU declaration of conformity
6.5.1. The manufacturer shall affix the CE marking and the supplementary...
6.5.2. The manufacturer shall draw up a written EU declaration of...
6.6. Authorised representative
7. Common provisions
7.1. The conformity assessment according to Module D, D1, F, F1...
7.2. If the instrument’s performance is sensitive to gravity variations the...
7.2.1. Where a manufacturer has opted for execution in two stages...
7.2.2. The party which has carried out the first stage of...
7.2.3. A manufacturer who has opted for Module D or D1...
7.2.4. The CE marking and the supplementary metrology marking shall be...
ANNEX III
INSCRIPTIONS
1. Instruments intended to be used for the applications listed in...
1.1. Those instruments shall bear visibly, legibly and indelibly the following...
1.2. Those instruments shall have adequate facilities for the affixing of...
1.3. Where a data plate is used it shall be possible...
1.4. The inscriptions Max, Min, e, and d, shall also be...
1.5. Each load measuring device which is connected or can be...
2. Instruments not intended to be used for the applications listed...
3. Restrictive use symbol referred to in Article 18
ANNEX IV
EU DECLARATION OF CONFORMITY (No XXXX)
1. Instrument model/Instrument (product, type, batch or serial number):
2. Name and address of the manufacturer and, where applicable, his...
3. This declaration of conformity is issued under the sole responsibility...
4. Object of the declaration (identification of instrument allowing traceability; it...
5. The object of the declaration described above is in conformity...
6. References to the relevant harmonised standards used or references to...
7. The notified body … (name, number) performed … (description of...
8. Additional information:
ANNEX V
PART A
PART B
ANNEX VI
ATTACHMENTS
STATEMENT OF THE EUROPEAN PARLIAMENT