EN    EN  
 EUROPEAN COMMISSION 
Brussels, 21.11.2011 
COM(2011) 769 final 
2011/0353 (COD) 
  
NEW LEGISLATIVE FRAMEWORK (NLF) ALIGNMENT PACKAGE 
(Implementation of the Goods Package) 
Proposal for a 
DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on the harmonisation of the laws of the Memb er States relating to making available on 
the market of measuring instruments  
(Recast) 
 
(Text with EEA relevance) 
 EN 1   EN EXPLANATORY MEMORANDUM  
1. CONTEXT OF THE PROPOSAL  
General context, reasons for and objectives of this proposal  
This proposal is presented in the framework of the implementation of the “goods package”  
adopted in 2008. It is part of  a package of proposals aligni ng ten product directives to 
Decision No 768/2008/EC  establishing a common framework for the marketing of products. 
Union (EU) harmonisation legislation ensuring th e free movement of products has contributed 
considerably to the completion and operation of the Single Market. It is based on a high level of protection and provides econom ic operators with the means to demonstrate conformity, 
thus ensuring free movement through trust in the products.  
Directive 2004/22 EC is an exam ple of that Union harmonisation legislation, ensuring the free 
movement of measuring instruments. It sets  out essential requirements that measuring 
instruments must comply with in order to be made available on the EU market. Manufacturers 
must demonstrate that a measuring instrume nt has been designed and manufactured in 
compliance with the essential requirement s and affix the CE marking and the M 
supplementary metrology marking.  
Experience with the implementation of Uni on harmonisation legislation has shown – on a 
cross-sector scale - certain weaknesses and inconsistencies in the implementation and 
enforcement of this legislation, leading to 
(1) the presence of non-compliant or da ngerous products on the market and 
consequently a certain lack  of trust in CE marking 
(2) competitive disadvantages for economic operato rs complying with the legislation as 
opposed to those circumventing the rules 
(3) unequal treatment in the case of non-co mpliant products and distortion of 
competition amongst economic operators due to different enforcement practices 
(4) differing practices in the de signation of conformity a ssessment bodies by national 
authorities 
(5) problems with the quality of certain notified bodies 
Furthermore the regulatory environment has beco me more and more complex, as frequently 
several pieces of legisla tion apply simultaneously to one and the same product. 
Inconsistencies in these piece s of legislation make it increasingly difficult for economic 
operators and authorities to correctly interpret an d apply that legislation. 
To remedy these horizontal shortcomings in Union harmonisation legislation observed across 
several industrial sectors, th e “New Legislative Framework” was adopted in 2008 as part of 
the goods package. Its objective is to strengthen and comple te the existing rules and to 
improve practical aspects of their applica tion and enforcement. The New Legislative 
Framework (NLF) consists of two complement ary instruments, Regulation (EC) No 765/2008 EN 2   EN on accreditation and market surveillance an d Decision No 768/2008/EC establishing a 
common framework for the marketing of products. 
The NLF Regulation has introduced rules on accreditation (a tool for the evaluation of 
competence of conformity assessment bodies) and requirements for the organisation and 
performance of market surveillance and contro ls of products from th ird countries. Since 1 
January 2010 these rules apply di rectly in all Member States. 
The NLF Decision sets out a common framewor k for EU product harmonisation legislation. 
This framework consists of the provision s which are commonly used in EU product 
legislation (e.g. definitions, obligations of economic operators, notified bodies, safeguard 
mechanisms, etc). These common provisions ha ve been reinforced to ensure that the 
directives can be applied and enforced more ef fectively in practice. New elements, such as 
obligations on importers, have been introduced, which are crucial for improving the safety of 
products on the market.  
The provisions of the NLF Decision and those of the NLF Regulation are complementary and 
closely interlinked. The NLF Decision contains  the corresponding obligations for economic 
operators and notified bodies allowing market  surveillance authoriti es and authorities 
responsible for notified bodies to properly pe rform the tasks imposed on them by the NLF 
Regulation and to ensure an effective and cons istent enforcement of EU product legislation.  
However, unlike the NLF Regulation, the provis ions of the NLF Deci sion are not directly 
applicable. To ensure that all economic sect ors subject to Union ha rmonisation legislation 
benefit from the improvements of the NLF, th e provisions of the NLF Decision need to be 
integrated into the ex isting product legislation. 
A survey after the adoption of the goods packag e in 2008 showed that a majority of Union 
harmonisation legislation on products was due to be revised within the following 3 years, not 
only to address the problems observed throughout  all sectors but also for sector-specific 
reasons. Any such revision would automatically  include an alignment of the legislation 
concerned to the NLF Decision since Parlia ment, Council and Comm ission have committed 
themselves to use its provisions as much as po ssible in future legislation on products in order 
to further the utmost coheren ce of the regulatory framework.  
For a number of other Union harmonisation di rectives, including Di rective 2004/22/EC no 
revision for sector-specific probl ems had been envisaged within this timeframe. To ensure 
that the problems in relation to non-compliance and no tified bodies are neve rtheless addressed 
in these sectors, and for the sake of consistency of the overall regulatory environment on products, it was decided to alig n these directives w ithin a package to th e provisions of the 
NLF Decision. 
Consistency with other policies and objectives of the Union 
This initiative is in line with the Single Market Act
1, which has stressed the need to restore 
consumer confidence in the quality of products on the market and the importance of reinforcing market surveillance. 
                                                
 
1 Communication from the Commission to the European  Parliament, the Council, the Economic and 
Social Committee and the Committee of the Regions, COM(2011) 206 final. EN 3   EN Furthermore it supports the Commission’s polic y on Better Regulation and simplification of 
the regulatory environment. 
2. CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT  
Consultation of interested parties 
The alignment of Directive 2004/22/EC to the NL F Decision has been discussed with national 
experts responsible for the implementation of this Directive and w ith other interested 
stakeholders, as well as in bilateral meetings with industry associations.  
From June to October 2010 a public consultation was organised that comprised all the sectors 
involved in this initiative. It consisted of four targeted quest ionnaires for economic operators, 
authorities, notified bodies and users and the Commission servic es received 300 replies. The 
results are published at:  
http://ec.europa.eu/enterpri se/policies/single-market-goods /regulatory-policies-common-
rules-for-products/new-legislative-framework/index_en.htm  
In addition to the general cons ultation a specific SME consulta tion was carried out. 603 SMEs 
were consulted through the En terprise Europe Network in May/June 2010. The results are 
available at http://ec.europa.eu/ enterprise/policies/ single-market-goods/f iles/new-legislative-
framework/smes_statistics_en.pdf  
The consultation process revealed widespread su pport for the initiative. There is unanimity on 
the need to improve market surveillance and th e system for assessing and monitoring Notified 
Bodies. Authorities fully support the exercise b ecause it will strengthen the existing system 
and improve cooperation at EU level. Industry expects a more level playing field resulting 
from more effective actions agai nst products that do not comply with the legislation, as well 
as a simplification effect from the alignment of  legislation. Certain co ncerns were expressed 
on some obligations which are, however, indispen sable for increasing the efficiency of market 
surveillance. These measures wi ll not entail significant costs for industry, and the benefits 
resulting from improved market surveill ance should by far outweigh the costs.  
Collection and use of expertise 
The impact assessment for this implementati on package has largely built on the impact 
assessment carried out for the New Legislativ e Framework. In addition to the expertise 
collected and analysed in that context, furt her consultation of sector-specific experts and 
interest groups, as well as horizontal expert s active in the area of technical harmonisation, 
conformity assessment, accreditation and market surveillance, has taken place. 
External expertise was also used to obtain some basic data on the measuring instruments 
sector. In their evaluatio n report external experts2 have estimated that  Directive 2004/22/EC 
applies to around 345 million units of measuri ng instruments (MIs) sold annually in the 
European market with a total sales value of around €3.25 billion. The evaluation showed that 
the quality of market surveillance appears as an important  concern of industry and it is an area 
                                                 
2 Centre for Strategic & Evaluation Services (UK), Interim evaluation of the Measuring Instruments 
Directive , July 2010: http://ec.europa.eu/enterprise/sectors /legal-metrology-and-prepack/public-
consultation/public-consultation-files/evaluation_report_by_cses_en.pdf  EN 4   EN where most authorities recognise that their effo rt until recently has been limited. Furthermore, 
there appear to be inconsistencies among the notified bodies in terms of interpreting the 
Directive’s requirements and other guidance as well as differing levels of capacity. A 
subsequent public consultation3 showed that the evaluation of Directive 2004/22/EC can be 
deemed to be complete as regards the evaluatio n and is generally supported by stakeholders as 
regards its analysis. 
The weaknesses remarked in market surveill ance and quality of notified bodies will be 
addressed in part by the alignment of Directive 2004/22/EC to the NLF decision. 
Impact assessment  
Based on the information collected, the Commissi on carried out an impact assessment which 
examined and compared three options. 
Option 1 - No changes to  the current situation  
This option proposes no changes to the current  directive and relies exclusively on certain 
improvements that can be expected from the NLF Regulation. 
Option 2 – Alignment to the NLF Deci sion by non-legislative measures 
Option 2 considers the possibility  of encouraging a voluntary ali gnment to the provisions set 
out in the NLF Decision by, e.g., presenting them  as best practices in guidance documents. 
Option 3 – Alignment to NLF Deci sion by legislative measures 
This option consists in integrating the provis ions of the NLF Decisi on into the existing 
directives. 
Option 3 was found to be the preferred option because 
– it will improve the competitiveness of companies and notified bodies taking their 
obligations seriously, as opposed to those cheating on the system; 
– it will improve the functioning of the inte rnal market by ensuring equal treatment 
of all economic operators, notably importers  and distributors, as well as notified 
bodies; 
– it does not entail significant costs for ec onomic operators and notified bodies; for 
those who are already acting responsibly, no extra costs or only negligible costs 
are expected; 
– it is considered more effective than option 2: due to the lack of enforceability of 
option 2 it is questionable that the positive impacts would materialise under that option; 
                                                
 
3 Public consultation until 1 November 2010: http://ec.europa.eu/enterprise/sectors/legal-metrology-and-
prepack/public-consultation/index_en.htm  EN 5   EN – options 1 and 2 do not provide answers to the problem of inconsistencies in the 
regulatory framework and therefore have no positive impact on the simplification of the regulatory environment. 
3. 
MAIN ELEMENTS OF THE PROPOSAL  
3.1. Horizontal definitions 
The proposal modifies a number of definitio ns which are commonly used throughout Union 
harmonisation legislation in or der to harmonise their meani ng throughout that legislation. 
3.2. Obligations of economic operators  and traceability requirements 
The proposal clarifies the obligat ions of manufacturers and au thorised representatives and 
introduces obligations for impor ters and distributors. Importe rs must verify that the 
manufacturer has carried out the applicable conformity assessment procedure and has drawn 
up a technical documentation. They must also ma ke sure with the manufacturer that this 
technical documentation can be made availa ble to authorities upon request. Furthermore 
importers must verify that the measuring instruments are correctly marked and accompanied by the instructions and information. They must keep a copy of the Declaration of conformity 
and indicate their name and address on the pr oduct, or where this is not possible on the 
packaging or the accompanying documentation. Distributors must veri fy that a measuring 
instrument bears the CE marking, the name of  the manufacturer and of the importer, if 
relevant, and that it is accompanied by th e required documentation and instructions. 
Importers and distributors must cooperate w ith market surveillance authorities and take 
appropriate actions when they have supp lied non-compliant measuring instruments. 
Enhanced traceability obligations  are introduced for all ec onomic operators. Measuring 
instruments have to bear the manufacturer’s name and address and a number allowing to 
identify and link the measuring instrument to its technical documentation. When a measuring 
instrument is imported, the importer’s name and address must also be on the measuring 
instrument. Furthermore, every economic operator must be able to identify towards authorities 
the economic operator who has supplied him with a measuring instrument or to whom he has 
supplied a measuring instrument. 
3.3. Harmonised standards 
Compliance with harmonised standards provides for a presumption of conformity with the 
essential requirements. On 1 June 2011 the Commission adopted a pro posal for a Regulation 
on European Standardisation
4 that sets out a horizontal legal framework for European 
standardisation. The proposal for the Regu lation contains inter alia provisions on 
standardisation requests from the Commission to  the European Standardisation Organisation, 
on the procedure for objections to harmonised standards and on stakehol der participation in 
the standardisation process. Consequently the provisions of Directive 2004/22/EC which 
cover the same aspects have been  deleted in this proposal for reasons of legal certainty. The 
                                                 
4 Proposal for a Regulation of the European Parliament and of the Council on European Standardisation 
and amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 
95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/105/EC and 2009/23/EC of the 
European Parliament and of the Council. COM(2011) 315 final  EN 6   EN provision conferring presumption of  conformity to harmonised standards has been modified to 
clarify the extent of the presumption of confor mity when standards only partially cover the 
essential requirements.  
3.4. Conformity assessment and CE marking 
Directive 2004/22/EC has selected the appropria te conformity assessment procedures which 
manufacturers have to apply in order to demons trate that their measuring instruments comply 
with the essential requirements. The proposal  aligns these procedures to their updated 
versions set out in the NLF D ecision. It also keeps some sect or specific elements already 
provided for in Directive 2004/22/EC such as the mandatory metrology M marking in addition to the CE marking. 
General principles of the CE marking are set out in Article 30 of Regulation 765/2008, while 
the detailed provisions on the affixing of the CE marking and the M marking to measuring 
instruments have been in serted in this proposal. 
3.5. Notified Bodies 
The proposal reinforces the notification crite ria for notified bodies.  It clarifies that 
subsidiaries or subcontractors mu st also comply with the notif ication requirements. Specific 
requirements for notifying authorities are intro duced, and the procedure for notification of 
notified bodies is revised. The competence of a notified body must be demonstrated by an 
accreditation certificate. Where accr editation has not been used to evaluate the competence of 
a notified body, the notification must compri se the documentation demonstrating how the 
competence of that body has been evaluated. Member  States will have the possibility to object 
to a notification. 
3.6. Market surveillance and the safeguard clause procedure 
The proposal revises the existing safeguard cl ause procedure. It introduces a phase of 
information exchange between Member States, and specifies the steps to be taken by the authorities concerned, when a non-compliant meas uring instrument is found. A real safeguard 
clause procedure - leading to a Decision at  Commission level on whether a measure is 
justified or not - is only launched when anot her Member State objects to a measure taken 
against a measuring instrument. Where there is  no disagreement on the restrictive measure 
taken, all Member States must take th e appropriate action on their territory. 
3.7. Comitology and Delegated acts 
The provisions on the operation of the Measur ing Instruments Committee have been adapted 
to the new rules on delegated acts laid down in Artic le 290 of the Treat y on the Functioning 
of the EU and to the new pr ovisions on implementing acts laid  down in Regulation (EU) No 
182/2011 of the European Parliament and of th e Council of 16 February 2011 laying down the 
rules and general principles concerning mechanis ms for control by the Member States of the 
Commission's exercise of implementing powers
5. 
                                                 
5 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 
laying down the rules and the general principles concerning mechanisms for control by Member States 
of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p.13). EN 7   EN 4. LEGAL ELEMENTS OF THE PROPOSAL  
Legal basis  
The proposal is based on Article 114 of the Tr eaty on the Functioning of the European Union. 
Subsidiarity principle 
The internal market is a competence that is sh ared between the Union and the Member States. 
The subsidiarity principle aris es in particular with regard  to the newly added provisions 
aiming at the improvement of effective enfo rcement of Directive 2004/22/EC, namely, the 
importer and distributor obligations, the tr aceability provisions, the provisions on the 
assessment and notification of notified bodies, and the enhanced cooperation obligations in 
the context of the revised market su rveillance and safeguard procedures.  
Experience with the enforcement of the legislat ion has shown that measures taken at national 
level have led to divergent ap proaches and to a different tr eatment of economic operators 
inside the EU, which undermines the objective of th is directive. If actions are taken at national 
level to address the problems, this risks cr eating obstacles to the free movement of goods. 
Furthermore action at national level is limited to the territorial competence of a Member State. 
In view of the increasing internationalisation of  trade, the number of cross-border cases is 
constantly rising. Coordinated ac tion at EU level can much be tter achieve the objectives set, 
and will in particular render market surveillance  more effective. Hence it is more appropriate 
to take action at EU level. 
As regards the problem of inconsistencies thro ughout the directives, th is is a problem which 
can only be solved by the EU legislator. 
Proportionality  
In accordance with the principle of proportiona lity, the proposed modifications do not go 
beyond what is necessary to achieve the objectives set.  
The new or modified obligations do not impos e unnecessary burdens an d costs on industry - 
especially on small and medium sized enterpri ses - or administrations . Where modifications 
have been identified to have negative impacts, the analysis of the impacts of the option serves 
to provide the most proportionate respons e to the problems identified. A number of 
modifications concern the improvement of cl arity of the existing Directive without 
introducing new requirements that entail added cost. 
Legislative technique used 
The alignment to the NLF Decision requires a number of substantive amendments to the 
provisions of Directive 2004/22/EC . To ensure the r eadability of the amended text the 
technique of recasting has been chosen in line with the Interinstitutional Agreement of 28 
November 2001 on a more structured use of  the recasting technique for legal acts6.  
The changes made to the provisions of Direct ive 2004/22/EC concern: the definitions, the 
obligations of economic operators, the presum ption of conformity provided by harmonised 
                                                 
6 OJ C 77, 28.3.2002. EN 8   EN standards, the declaration of conformity, CE  marking, notified bodies, the safeguard clause 
procedure and the conformity assessment procedures. 
The proposal does not change the scope of Directive 2004/22/EC and the essential 
requirements.  
5. BUDGETARY IMPLICATIONS  
This proposal does not have any implications for the EU budget. 
6. ADDITIONAL INFORMATION  
Repeal of existing legislation 
The adoption of the proposal will lead  to repeal of Directive 2004/22/EC. 
European Economic Area 
The proposal concerns the EEA and should therefore be extended to the European Economic 
Area.EN 9   EN  
Ð 2004/22/EC (adapted) 
2011/0353 (COD) 
Proposal for a 
DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on the harmonisation of the laws of the Member States relating to making available on 
the market of measuring instruments  
(Recast) 
 
(Text with EEA relevance) 
THE EUROPEAN PARLIAMENT AND THE CO UNCIL OF THE EUROPEAN UNION, 
Having regard to the Treaty esta blishing the European Community  ⌦ on the Functioning of 
the European Union ⌫ , and in particular Article 95  ⌦ 114 ⌫ thereof, 
Having regard to the proposal from the European Commission, 
After transmission of the draft legislative act to the national Parliaments, Having regard to the opinion of the Eu ropean Economic and Social Committee
7, 
Acting in accordance with the or dinary legislative procedure, 
Whereas: 
 
Ð 2004/22/EC recital 1 (adapted) 
A number of measuring instruments are covered by specific Di rectives, adopted on 
the basis of Council Dir ective 71/316/EEC of 26  July 1971 on the approximation of 
the laws of the Member States relati ng to common provisions for both measuring 
instruments and methods of metrological control8. Specific Directives that are 
technically outdated should be repealed and replaced by an independent Directive 
                                                 
7 OJ C […], […], p. […]. 
8 OJ  L 202, 6.9.1971, p.  1. Directive as last amended by Regulation (EC) No  807/2003 (OJ L 122, 
16.5.2003, p.  36)  EN 10   EN reflecting the spirit of th e Council Resolution of 7  May 1985 on a new approach to 
technical harmonisation a nd standards9. 
 
Ø new 
(1) Directive 2004/22/EC of the European Parliament and of the Council of 31 March 
2004 on measuring instruments10 has been substantially amended several times. Since 
further amendments are to be made, it shoul d be recast in the in terests of clarity. 
(2) Regulation (EC) No 765/2008/EC of the Europe an Parliament and of  the Council of 9 
July 2008 setting out the requirements fo r accreditation and market surveillance 
relating to the marketing of products and repealing Regulation (EEC) No 339/9311 lays 
down rules on the accreditation of conf ormity assessment bodies, provides a 
framework for the market surveillance of products and for controls on products from 
third countries, and lays down the gene ral principles of the CE marking. 
(3) Decision No 768/2008/EC of the European Par liament and of the Council of 9 July 
2008 on a common framework for the marketi ng of products and repealing Council 
Decision 93/465/EEC12 lays down a common framework of general principles and 
reference provisions intende d to apply across the le gislation harmonising the 
conditions for the marketing of products in order to provide a coherent basis for 
revision or recasts of that legislation. Directive 2004/22/EC should therefore be 
adapted to that Decision. 
 
Ð 2004/22/EC recital 2 
(4) Correct and traceable measuring instruments can be used for a variety of measurement 
tasks. Those responding to reasons of public interest, public health, safety and order, 
protection of the environment and the cons umer, of levying taxes and duties and of 
fair trading, which directly and indirectly aff ect the daily life of citizens in many ways, 
may require the use of legally controlled measuring instruments. 
 
Ð 2004/22/EC recital 3 (adapted) 
(5) Legal metrological control should not lead to barriers to the free movement of 
measuring instruments. The provisions conc erned should be the same in all Member 
States and proof of conformity  accepted throughout the Community  ⌦ Union ⌫ . 
                                                 
9 OJ C 136, 4.6.1985, p.  1. 
10 OJ L 135, 30.4.2004, p. 1. 
11 OJ L 218, 13.8.2008, p. 30. 
12 OJ L 218, 13.8.2008, p. 82. EN 11   EN  
Ð 2004/22/EC recital 4 
(6) Legal metrological control requires conf ormity with specified performance 
requirements. The performance requirement s that the measuring instruments must 
meet should provide a high le vel of protection. The conf ormity assessment should 
provide a high level of confidence. 
 
Ð 2004/22/EC recital 5 
(7) Member States should as a general rule pr escribe legal metrological control. Where 
legal metrological control is prescribed, only measuring instruments complying with 
common performance requirements should be used. 
 
Ð 2004/22/EC recital 6 (adapted) 
(8) The principle of optionality introduced by this  Directive ⌦ 2004/22/EC allows ⌫ , 
whereby  Member States may  ⌦ to ⌫ exercise their right to decide whether or not to 
regulate any  ⌦ prescribe the use ⌫ of the instruments cove red by this Directive,  
should be applicable only to the extent th at this will not cause unfair competition . 
 
Ð 2004/22/EC recital 7 
The responsibilities of the ma nufacturer for compliance with  the requirements of this 
Directive should be specifically stated.  
 
Ð 2004/22/EC recital 8 (adapted) 
(9) The performance of measuring instruments is particularly sensitive to the 
environment, ⌦ in ⌫ particular the electromagnetic environment. Immunity of 
measuring instruments to electromagnetic interference ⌦ should ⌫ forms  an integral 
part of this Directive and the immunity requirements of Council  Directive 89/336/EEC  
2004/108/EC of the European Parliament and of the Council  of 3  May 1989  15 
December 2004  on the approximation of the laws of  the Member States relating to 
electromagnetic compatibility a nd repealing Directive 89/336/EEC13 should therefore 
not apply. 
                                                 
13 OJ L 390, 31.12.2004, p. 24.  EN 12   EN  
Ð 2004/22/EC recital 17 (adapted) 
Ö new 
(10) Ö In order to ensure the free circula tion of measuring instruments in the 
Union,  Member States should not impede the placing on the market  and/or putting 
into use of measuring instruments that carry the ‘CE’  ⌦ CE ⌫ marking and 
supplementary metrology marking in accordance w ith the provisions of this Directive. 
 
Ð 22/2004 recital 18 (adapted) 
(11) Member States should take appropriate act ion to prevent non-complying measuring 
instruments from being placed on the ma rket and/or put into use. Adequate 
cooperation between the competent authoritie s of the Member States is therefore 
necessary to ensure a Community -wide  ⌦ Union-wide ⌫ effect of this objective. 
 
Ø new 
(12) Economic operators should be responsib le for the compliance of measuring 
instruments, in relation to their respective ro les in the supply chain, so as to ensure a 
high level of protection of public interests, su ch as health and safety and the protection 
of users, and to guarantee fair  competition on the Union market. 
(13) All economic operators interv ening in the supply and dist ribution chain should take 
appropriate measures to ensure that they only make available on the market measuring 
instruments which are in conformity with this  Directive. It is necessary to provide for 
a clear and proportionate dist ribution of obligations whic h correspond to the role of 
each operator in the supply and distribution process. 
(14) The manufacturer, having detailed knowledge  of the design and pr oduction process, is 
best placed to carry out the complete conf ormity assessment procedure. Conformity 
assessment should therefore remain the ob ligation of the manu facturer alone. 
(15) It is necessary to ensure that measuring instruments from third countries entering the 
Union market comply with the requirements of this Directive, and in particular that the 
appropriate assessment procedures have been carried out by manuf acturers with regard 
to those measuring instruments. Provision should therefore be made for importers to 
make sure that the measuring instruments they place on the market comply with the 
requirements of this Directive and that they do not place on the market measuring 
instruments which do not comply with such requirements or pres ent a risk. Provision 
should also be made for importers to ma ke sure that the conformity assessment 
procedures have been carried out and th at product marking and documentation drawn 
up by manufacturers are available for inspec tion by the supervisory authorities. 
(16) The distributor makes a measuring instrument available on the market after it has been 
placed on the market by the manufacturer or the importer and should act with due care 
to ensure that its handling of the measuri ng instrument does not adversely affect the 
compliance of the measuring instrument.  EN 13   EN (17) When placing a measuring instrument on th e market, every impor ter should indicate 
on the measuring instrument his name and th e address at which he  can be contacted. 
Exceptions should be provided for in cases where the size or nature of the product 
does not allow it. This includes cases where the importer would have to open the 
packaging to put his name and address on the product. 
(18) Any economic operator that either places a measuring instrument on the market under 
its own name or trademark or modifies a measuring instrument in such a way that 
compliance with the requirements of this  Directive may be affected should be 
considered to be the manufacturer and should assume the obligations of the 
manufacturer. 
(19) Distributors and importers, being close to the market place, should be involved in 
market surveillance tasks car ried out by competent national authorities, and should be 
prepared to participate actively, providing those  authorities with all necessary 
information relating to the m easuring instrument concerned. 
(20) Ensuring traceability of a measuring inst rument throughout the whole supply chain 
helps to make market surveillance simpler a nd more efficient. An efficient traceability 
system facilitates market su rveillance authorities' task of tracing economic operators 
who made non compliant measuring in struments available on the market. 
 
Ð 2004/22/EC recital 9 (adapted) 
Ö new 
(21) Community legislation should specify  ⌦ This Directive should be limited to the 
expression of ⌫ essential requirements that do not impede technical progress, 
preferably performance requirements. Provisi ons to remove technical barriers to trade 
should follow the Council Resolution of 7  May 1985 on a new approach to technical 
harmonisation and standards.  Ö In order to facilitate conformity assessment with those 
requirements it is necessary to provide for presumption of confor mity for measuring 
instruments which are in conformity with harmonised standards that are adopted in 
accordance with Regulation (EU) No […/…] of  the European Parliament and of the 
Council of […] on European Standardis ation and amending Council Directives 
89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 
98/34/EC, 2004/22/EC, 2007/23/ EC, 2009/105/EC and 2009/23/EC of the European 
Parliament and of the Council14 for the purpose of expressing detailed technical 
specifications of those requirements.  
 
Ø new 
(22) Regulation (EU) No […/…] [on European St andardisation] provi des for a procedure 
for objections to harmonised standards wh ere those standards do not entirely satisfy 
requirements of this Directive. 
                                                 
14 OJ L […], […], p. […]. EN 14   EN  
Ð 2004/22/EC recital 12 (adapted) 
(23) The technical and performance specifications of internationally agreed normative 
documents may also comply, in part or in full, with the essential requirements laid 
down by this Directive. In those cases th e use of these internationally agreed 
normative documents can be  ⌦ should be allowed as ⌫ an alternative to the use of 
harmonised standards and, under specific conditions, give rise to a presumption of conformity. 
 
Ð 2004/22/EC recital 13 
(24) Conformity with the essential requirements  laid down by this Directive can also be 
provided by specifications that are not supplied by a European  technical standard or an 
internationally agreed normative document. The use of European technical standards 
or internationally agreed  normative documents should therefore be optional. 
 
Ø new 
(25) In order to enable economic operators to de monstrate and the competent authorities to 
ensure that measuring instruments made available on the market comply with the 
essential requirements it is necessary to pr ovide for conformity assessment procedures. 
Decision No 768/2008/EC establishes modules for conformity assessment procedures, 
which include procedures from the least to the most stringent, in proportion to the 
level of risk involved and the level of safety required. In order to ensure inter-sectoral 
coherence and to avoid ad-hoc variants, conf ormity assessment procedures should be 
chosen from among those modules. However, it  is necessary to ad apt those modules in 
order to reflect specific asp ects of metrological control.  
 
Ð 2004/22/EC recital 14 (adapted) 
(26) The conformity assessment of sub-assemblies should ⌦ be carried out in accordance 
with ⌫ respect the provisions of  this Directive. If sub-assemblies are traded 
separately and independently of an instrume nt, the exercise of conformity assessment 
should be undertaken independently  of the instrument concerned. 
 
Ð 2004/22/EC recital 15 
(27) The state of the art in measurement technol ogy is subject to cons tant evolution which 
may lead to changes in the needs for conformity assessments. Therefore, for each category of measurement and, where appropria te, sub-assemblies, there must be an 
appropriate procedure or a choice between  different procedures of equivalent 
stringency. The procedures adopted are as required by Counci l Decision 93/465/EEC 
of 22  July 1993 concerning the modules for the various phases of the conformity EN 15   EN assessment procedures and th e rules for the affixing and use of the ‘CE’ marking, 
which are intended to be used in the technical harmonisation Directives15. However, 
derogations may have to be made for these modules in order  to reflect specific aspects 
of metrological control. Provision should be made for the ‘CE’ marking to be affixed 
during the fabrication process.  
 
Ø new 
(28) Manufacturers should draw up an EU declara tion of conformity to provide detailed 
information on the conformity of a measuring instrument with the requirements of this 
Directive and of other relevant  Union harmonisation legislation. 
(29) The CE marking and the supplementary metr ology marking, indicating the conformity 
of a measuring instrument, are the visible consequence of a whol e process comprising 
conformity assessment in a broad sense. Ge neral principles governing the CE marking 
and its relationship to other markings ar e set out in Regula tion (EC) No 765/2008. 
Rules governing the affixing of the CE ma rking and the supplementary metrology 
marking should be laid down in this Directive . 
 
Ð 2004/22/EC recital 10 (adapted) 
Ö new 
(30) In order to take account of differences in c limatic conditions or of different levels of 
consumer protection that ma y apply at national level, ⌦ it is necessary to 
establish ⌫ essential requirements may give rise to the establishment of  
environmental or accuracy classes Ö as essential requirements  . 
 
Ð 2004/22/EC recital 11 
In order to ease the task of proving conform ity with the essential requirements and to 
enable conformity to be assessed, it is desi rable to have harmoni sed standards. Such 
harmonised standards are drawn up by p rivate -law bodies and shoul d retain their 
status as non -mandatory texts. To this end, the European Committee for 
Standardisation (CEN), the Europ ean Committee for Electrotechnical 
Standardisation (CENELEC) and the Eur opean Telecommunications Standards 
Institute (ETSI) are recognised as the co mpetent bodies for the adoption of 
harmonised standards in accordance with  the general guidelines on cooperation 
between the Commission and the Europ ean Standardisati on bodies signed on 
13 November 1984.  
                                                 
15 OJ L 220, 30.8.1993, p.  23. EN 16   EN  
Ø new 
(31) The conformity assessment procedures set out in this Directive require the intervention 
of conformity assessment bodies, which are notified by the Member States to the 
Commission. 
 
Ð 2004/22/EC recital 16 (adapted) 
Continued development  in measurement technology as well as concerns expressed 
by stakeholders about certifi cation, stress the need to en sure consistent conformity 
assessment procedures for industrial products, as requested by the Council 
Resolution adopted on 10  November 200316. 
 
Ø new 
(32) Experience has shown that the criteria set out in Directive 2004/22/ EC that conformity 
assessment bodies have to fulfil to be notif ied to the Commission are not sufficient to 
ensure a uniformly high level of performan ce of notified bodies th roughout the Union. 
It is, however, essential that all notified bodies perform their functions to the same 
level and under conditions of fair competition. That requires the setting of obligatory 
requirements for conformity assessment bodies wishing to be notified in order to 
provide conformity assessment services. T hose requirements should take into account 
continued development in measurement technology. 
(33) In order to ensure a consistent level of quality in the performance of conformity 
assessment of measuring instruments, it is  also necessary to set requirements for 
notifying authorities an d other bodies involved in th e assessment, notification and 
monitoring of notified bodies. 
(34) If a conformity assessment body demonstrates conformity with the criteria laid down 
in harmonised standards, it should be pres umed to comply w ith the corresponding 
requirements set out in this Directive. 
(35) The system set out in this Directive s hould be complemented by the accreditation 
system provided for in Regulation (EC)  No 765/2008. Since accreditation is an 
essential means of verifying the compet ence of conformity assessment bodies, it 
should also be used for th e purposes of notification. 
(36) Transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring 
the necessary level of confid ence in conformity certificates , should be considered by 
the national public authorit ies throughout the Union as the preferred means of 
demonstrating the technical competence of  conformity assessment bodies. However, 
national authorities may consider that they  possess the appropriate means of carrying 
out this evaluation themselves. In such cases , in order to ensure the appropriate level 
                                                 
16 OJ C 282, 25.11.2003, p.  3. EN 17   EN of credibility of evaluations carried out  by other national authorities, they should 
provide the Commission and the other Member  States with the necessary documentary 
evidence demonstrating the compliance of th e conformity assessment bodies evaluated 
with the relevant regu latory requirements. 
(37) Conformity assessment bodies frequently subc ontract parts of their activities linked to 
the assessment of conformity or have recour se to a subsidiary. In  order to safeguard 
the level of protection requi red for the measuring instruments to be placed on the 
Union market, it is essential that conf ormity assessment subcontractors and 
subsidiaries fulfil the same requirement s as notified bodies in relation to the 
performance of conformity assessment tasks. Therefore, it is important that the 
assessment of the competence and the performance of bodies  to be notified and the 
monitoring of bodies alr eady notified cover also activities carried out by 
subcontractors and subsidiaries. 
(38) It is necessary to increase the efficiency a nd transparency of the notification procedure 
and, in particular, to adapt it to new technol ogies so as to enable online notification. 
(39)  Since notified bodies may offer their servi ces throughout the Union, it is appropriate 
to give the other Member States and the Commission the opportunity to raise 
objections concerning a notified body. It is therefore important to provide for a period 
during which any doubts or concerns as to the competence of conformity assessment 
bodies can be clarified before they  start operating as notified bodies. 
 
Ð 22/2004 recital 17 (adapted) 
 Member States should no t impede the placing on the mark et and/or putting into use of 
measuring instruments that carry the ‘CE’ marking and supplementary metrology 
marking in accordance with the provisions of this Directive . 
 
Ð 22/2004 recital 18 
 Member States shou ld take appropriate action to prevent non -complying measuring 
instruments from being placed on the ma rket and/or put into use. Adequate 
cooperation between the competent authoritie s of the Member States is therefore 
necessary to ensure a Community -wide eff ect of this objective.  
 
Ø new 
(40) In the interests of competitiveness, it is  crucial that notified bodies apply the 
conformity assessment procedures without  creating unnecessary burdens for economic 
operators. For the same reason, and to ensu re equal treatment of  economic operators, 
consistency in the technical application of the conformity assessment procedures needs 
to be ensured. That can best be achie ved through appropriate  coordination and 
cooperation between notified bodies. EN 18   EN (41) In order to ensure legal certainty, it is necessary to clarify that rules on Union market 
surveillance and control of products ente ring the Union market provided for in 
Regulation (EC) No 765/2008 apply to measuring instruments. 
(42) Directive 2004/22/EC already provides for a safeguard procedure allowing the 
Commission to examine the justification for a measure taken by a Member State 
against measuring instruments it considers to be non-compliant. In order to increase 
transparency and to reduce processing time, it is necessary to improve the existing 
safeguard clause procedure, with the view to making it more efficient and drawing on 
expertise available in Member States. 
(43) The existing system should be supplemen ted by a procedure under which interested 
parties are informed of measures intended to be taken with re gard to measuring 
instruments presenting a risk to the aspect s of public interest protection covered by 
this Directive. It should also allow market  surveillance authorities, in cooperation with 
the relevant economic operators, to act at an earlier stage in respec t of such measuring 
instruments. 
(44) Where Member States and the Commission agree as to the justification for a safeguard 
measure taken by a Member State, no furt her involvement of the Commission should 
be required, except where non- compliance can be attributed to shortcomings of a 
harmonised standard. 
 
Ð 2004/22/EC recital 19 
Manufacturers should be informed of the grounds on which nega tive decisions in 
respect of their products were taken, and of the lega l remedies available to them.  
 
Ð 2004/22/EC recital 20 
Manufacturers should be offered the possibility  to exercise the rights obtained before 
the entry into force of this Directive, during a reasonable transitional period.  
 
Ð 2004/22/EC recital 21 
(45) National specifications con cerning the appropriate nationa l requirements in use should 
not interfere with the provisions of this Directive on ‘putting into use’. EN 19   EN  
Ð 2004/22/EC recital 22 (adapted)  
The measures necessary f or the implementation of this  Directive should be adopted 
in accordance with Council Decision 1999/468/EC of 28  June 1999 laying down the 
procedures for the exercise of impl ementing powers conferred on the Commission17. 
 
Ð 2004/22/EC recital 23 
The activity o f the Measuring Instruments Com mittee should include proper 
consultations with representa tives of interested parties.  
 
Ð 2004/22/EC recital 24 (adapted) 
Directives 71/318/EEC, 71/319/EEC, 71/ 348/EEC, 73/362/EEC, 75/33/EEC, as 
concerns the meters defined in Annex MI -001 of this Directive, 75/410/EEC, 
76/891/EEC, 77/95/EEC, 77/313/EEC, 78/1031/EEC and 79/830/EEC should 
therefore be repealed,  
 
Ø new 
(46) It is necessary to provide for transitional arrangements that allow making available on 
the market and putting into use measuring in struments that have already been placed 
on the market in accordan ce with Directive 2004/22/EC. 
(47) The Member States should lay down rules on penalties applicable to infringements of 
the national provisions adopted pursuant to this Directive and ensure that they are 
implemented. Those penalties should be effective, proportionate and dissuasive. 
(48) In order to ensure uniform conditions fo r the implementation of this Directive, 
implementing powers should be conferred to the Commission. Those powers should 
be exercised in accordance with Regulation (EU) No  182/2011 of the European 
Parliament and of the Council of 16 Februa ry 2011 laying down the rules and general 
principles concerning mechanisms for control by the Member States of the 
Commission's exercise of implementing powers18.  
(49) The examination procedure should be used  for the implementing decisions with 
respect to the objections to the internat ionally agreed normative documents whose 
references were already published in the Official Journal of the European Union  and 
which the Commission considers justified, given that such decisions could have 
consequences on the presumption of conf ormity with the applicable essential 
requirements.  
                                                 
17 OJ L 184, 17.7.1999, p.  23. 
18 OJ L 55, 28.2.2011, p. 13. EN 20   EN (50) In order to take into ac count the developments in the measurement technology, the 
power to adopt acts in accordance with Ar ticle 290 of the Treaty on the Functioning of 
the European Union should be delegated to the Commission in respect of amendments 
to the instrument-specific Annexes. It is of particular importan ce that the Commission 
carry out appropriate consulta tions during its preparatory work, including at expert 
level. 
(51) The Commission, when preparing and drawin g-up delegated acts, should ensure a 
simultaneous, timely and appropriate transmission of relevant documents to the 
European Parliament and Council. 
(52) Since the objective of this Directive, name ly to ensure that measuring instruments on 
the market fulfil the requirements providing  a high level of prot ection of the public 
interests covered by this Directive while guaranteeing the functioni ng of the internal 
market cannot be sufficiently achieved by th e Member States a nd can therefore, by 
reason of its scale and effects, be better achieved at Union level, the Union may adopt 
measures, in accordance with the principle of subsidiarity as set out in Article 5 of the 
Treaty on European Union. In accordance with the principle of proportionality, as set 
out in that Article, this Directive does not  go beyond what is necessary in order to 
achieve that objective. 
(53) The obligation to transpose this Directive in to national law should be  confined to those 
provisions which represent a substantive chan ge as compared with  earlier Directives. 
The obligation to transpose the provisions which are unchanged arises under earlier 
Directives. 
(54) This Directive should be without prejudice to the obligations of the Member States 
relating to the time-limits for transposition into national law and application of the 
Directives set out in Annex XIII, Part B, 
 
Ð 2004/22/EC (adapted) 
Ö new 
HAVE ADOPTED THIS DIRECTIVE: 
CHAPTER 1  
⌦ GENERAL PROVISIONS ⌫ 
Article 3 1 
Object  ⌦ Subject matter  ⌫ 
This Directive establishes the requirements that the devices and systems referred to in Article 
1 ⌦ measuring instruments ⌫ have to satisfy with a view to their being placed  Ö made EN 21   EN available  on the market and/or put into use for those  ⌦ the measuring ⌫ tasks mentioned  
⌦ referred to ⌫ in Article 2 3(1). 
Article 1 2 
Scope 
1. This Directive applies to the ⌦ measuring instruments ⌫ devices and systems with a 
measuring function  defined in the instrument-specific a Annexes III to XII  ⌦ , hereinafter 
instrument-specific Annexes, ⌫ concerning water meters (M I-001), gas meters and volume 
conversion devices (MI-002), activ e electrical energy meters (M I-003), heat meters (MI-004), 
measuring systems for continuous and dynamic m easurement of quantities of liquids other 
then water (MI-005), automatic weighing in struments (MI-006), taximeters (MI-007), 
material measures (MI-008), dimensional meas uring instruments (MI-009) and exhaust gas 
analysers (MI-010). 
 
Ð 2004/22/EC  
2. This Directive is a specific Directive in  respect of requirements for electromagnetic 
immunity in the sense of Article 2 1(24) of Directive 2004/108/EC  89/336/EEC . Directive 
2004/108/EC  89/336/EEC  continues to apply with rega rd to emission requirements. 
 
Ð 2004/22/EC (adapted) 
Article 2 3 
⌦ Optionality  ⌫ 
1. Member States may prescribe the us e of measuring instruments mentioned  in Article 1  
for measuring tasks for reasons of public interest, pub lic health, public sa fety, public order, 
protection of the environment, protection of consumers, levying of taxes and duties and fair 
trading, where they c onsider it justified. 
 
Ð 2004/22/EC 
2. Where Member States do not prescribe such  use, they shall communicate the reasons 
therefore  to the Commission and th e other Member States. EN 22   EN  
Ð 2004/22/EC (adapted) 
Article 4 
Definitions 
For the purposes of this Directive ⌦ the following definitions apply ⌫ : 
 
Ð 2004/22/EC 
(a1) ‘measuring instrument’ means any de vice or system with a measurement 
function that is covered by Articles  1 and 3 2(1); 
(b2) ‘sub-assembly’ means a hardware device , mentioned as such in the specific 
annexes, that functions independently  and makes up a measuring instrument 
together with other sub-assemblies with  which it is compatible, or with a 
measuring instrument with which it is compatible; 
(c3) ‘legal metrological control’ means the control of the measurement tasks 
intended for the field of a pplication of a measuring in strument, for reasons of 
public interest, public health, public safe ty, public order, protection of the 
environment, levying of taxes and duties,  protection of the consumers and fair 
trading; 
 
Ð 2004/22/EC (adapted) 
(i4) ‘normative document’ means a document containing technical specifications 
adopted by the ⌦ International ⌫ Organisation ⌦ of Legal Metrology, 
hereinafter “OIML” ⌫ Internationale de Métrologie Légale (OIML), subject 
to the procedure stipulated in Article 16(1) . 
(e5) ‘placing on the market’ means ⌦ the first ⌫ making available for the first 
time ⌦ of a measuring instrument on ⌫ in the Community  ⌦ Union 
market ⌫ an instrument intended for an e nd user, whether for reward or free 
of charge;  
 
Ø new 
(6) ‘making available on the market ‘ means any supply of a measuring instrument 
for distribution or use on the Union mark et in the course of a commercial 
activity, whether in return for payment or free of charge;  EN 23   EN  
Ð 2004/22/EC 
(f7) ‘putting into use’ means the first use of  an instrument intended for the end user 
for the purposes for which it was intended; 
 
Ð 2004/22/EC (adapted) 
Ö new 
(d8) ‘manufacturer’ means a  ⌦ any ⌫ natural or legal person responsible for the 
conformity of the  Ö who manufactures a measur ing instrument or has a  
measuring instrument Ö designed or manufactured, and  with this Directive 
with a view to either placing it on the  market  Ö markets that measuring 
instrument  under his own  name Ö or trademark  and/ or putting  
⌦ puts ⌫ it into use for his own purposes; 
 
Ð 2004/22/EC (adapted) 
(g9) ‘authorised representative’ means a  ⌦ any ⌫ natural or legal person who is  
established within the Community  ⌦ Union ⌫ and authorised by  ⌦ who 
has received a written mandate from ⌫ a manufacturer, in writing,  to act on 
his behalf for  ⌦ in relation to ⌫ specified tasks within the meaning of this 
Directive ; 
 
Ø new 
(10) ‘importer’ means any natural or legal person established within the Union who 
places a measuring instrument from a third country on the Union market; 
(11) ‘distributor’ means any natural or lega l person in the supply chain, other than 
the manufacturer or the importer, who ma kes a measuring instrument available 
on the market; 
(12) ‘economic operators’ means the manufacturer , the authorised representative, the 
importer and the distributor;  
(13) ‘technical specification’ means a doc ument that prescribes technical 
requirements to be fulfilled by a measuring instrument; 
 
Ð 2004/22/EC 
Ö new 
(h14) ‘harmonised standard’ means Ö harmonised standard as defined in Article 
2(1)(c) of Regulation (EU) No […/… ] [on European Standardisation]  a 
technical specification adopted by CEN,  CENELEC or ETSI or jointly by two EN 24   EN or all of these organisations, at the request of the Commission pursuant to 
Directive 98/34/EC of the European Parliament and of the Council of 22  June 
1998 laying down a procedure for the provision of information in the field of 
technical standards and regulations and of rules on Information Society 
services19 and prepared in accordance with the General Guidelines agreed 
between the Commission and the Eu ropean standards organisations  ; 
 
Ø new 
(15) ‘accreditation’ means accre ditation as defined in Ar ticle 2(10) of Regulation 
(EC) no 765/2008; 
(16) ‘national accreditati on body’ means national accredi tation body as defined in 
Article 2(11) of Regulation (EC) no 765/2008; 
(17) "conformity assessment" means th e process demonstrating whether the 
requirements of this Directive relating to a measuring instrument have been 
fulfilled; 
(18) "conformity assessment body" m eans a body that performs conformity 
assessment activities includi ng calibration, testing, certi fication and inspection; 
(19) "recall" means any measure aimed at  achieving the return of a measuring 
instrument that has already been made available to the end user; 
(20) "withdrawal" means any measure aime d at preventing a measuring instrument 
in the supply chain from being made available on the market; 
(21) "CE marking" means a marking by whic h the manufacturer indicates that the 
measuring instrument is in conformity with the applicable requirements set out 
in the Union harmonisation legisl ation providing for its affixing; 
(22) "Union harmonisation legislation" means any Union legislation harmonising 
the conditions for the marketing of products. 
 
Ð 2004/22/EC 
Article 5  
Applicability to sub-assemblies 
                                                 
19 OJ L 204, 21.7.1998, p.  37. Directive as amended by Directive 98/48/EC (OJ L 217, 5.8.1998, p.  18). EN 25   EN  
Ð 2004/22/EC (adapted) 
Where specific annexes exist, laying down the essential requirements for sub-assemblies, the 
provisions of  this Directive shall apply mutatis mutandis to such sub-assemblies. 
 
Ð 2004/22/EC 
Sub-assemblies and measuring instruments may be  assessed independently and separately for 
the purpose of establishing conformity. 
Article 6 
Essential requirements and assessment of conformity 
 
Ð 2004/22/EC (adapted) 
1. A measuring instrument shall meet the essential requirements laid down  ⌦ set out ⌫ in 
Annex I and in the relevant  instrument-specific Annex. 
 
Ð 2004/22/EC  
Ö new 
Member States may require, if it is needed fo r correct use of the instrument, the information 
referred to in point 9 of  Annex I or in the releva nt instrument-specific a Annexes to be 
provided in the official language (s) of the Member State in wh ich the instrument is placed  
Ö made available  on the market. 
2. The conformity of a measuring instrument with the essential require ments shall be assessed 
in accordance with Article 9.  
 
Ð 2004/22/EC (adapted) 
Article 8 7 
Placing  ⌦ Making available ⌫ on the market and putting into use 
 
Ð 2004/22/EC (adapted) 
Ö new 
1. Member States shall not im pede for reasons covered by this Directive the placing  
Ö making available  on the market and/or putting into us e of any measuring instrument that EN 26   EN carries the ‘CE’  ⌦ CE ⌫ marking and supplementary metrology marking in accordance 
with Article 7 23. 
2. Member States shall take all appropriate measures to ensure that measuring instruments be 
placed  Ö are made available  on the market and/or put into use only if they satisfy the 
requirements of this Directive. 
 
Ð 2004/22/EC (adapted) 
3. A Member State may require a measuring inst rument to satisfy provisions governing its 
putting into use that are justified by local c limatic conditions. In such a case, the Member 
State shall choose appropriate upper and lower temperature limits from Table 1 of Annex I 
and, in addition,  may specify humidity conditions (condensing or non-condensing) and 
whether the intended location of use is open or closed. 
 
Ð 2004/22/EC 
4. When different accuracy classes are defined for a measuring instrument: 
 (a) the instrument-specific a Annexes under the heading ‘Putting into use’ may 
indicate the accuracy classes to be  used for specific applications, ; 
 (b) in all other cases a Member State may determine the accuracy classes to be used 
for specific applications within the classes defined, subject to allowing the use of all 
accuracy classes on its territory. 
 
Ð 2004/22/EC (adapted) 
Ö new 
In either case falling under  ⌦ For the purposes of point ⌫ (a) or (b), measuring instruments 
of a better accuracy class may be  used if the owner so chooses. 
5. At trade fairs, exhibi tions, demonstrations, etc.  ⌦ or similar events ⌫ , Member States 
shall not prevent the showing of ⌦ measuring ⌫ instruments not in conformity with this 
Directive, provided that a vi sible sign clearly indicates th eir non-conformity and their non-
availability for placing  Ö making available  on the market and/or putting into use until 
⌦ they are ⌫ brought into conformity. EN 27   EN  
Ø new 
CHAPTER 2  
OBLIGATIONS OF ECONOMIC OPERATORS  
Article 8 [Article R2 of Decision No 768/2008/EC] 
Obligations of manufacturers 
1. When placing their measuring instruments on the market and/or putting them into 
use, manufacturers shall ensure that they have been designed and manufactured in 
accordance with the essential requirements set out in Annex I and in the relevant 
instrument specific Annexes. 
2. Manufacturers shall draw up the required technical documentation referred to in 
Article 19 and carry out the re levant conformity assessment procedure referred to in 
Article 18 or have it carried out.  
Where compliance of a measuring instrument  with the applicable requirements of 
this Directive has been demonstrated by th at procedure, manufacturers shall draw up 
an EU declaration of conformity and a ffix the CE marking and the supplementary 
metrology marking. 
3. Manufacturers shall keep the technical documentation and the EU declaration of 
conformity for 10 years after the measur ing instrument has been placed on the 
market. 
4. Manufacturers shall ensure that procedur es are in place for series production to 
remain in conformity. Changes in measurin g instrument design or characteristics and 
changes in the harmonised standards, normative documents or in technical 
specifications by reference to which conf ormity of a measuring instrument is 
declared shall be adequately taken into account. 
When deemed appropriate with regard to the performance of a measuring instrument, 
manufacturers shall carry out sample te sting of measuring instruments made 
available on the market, investigate and, if necessary, keep a register of complaints, 
of non-conforming measuring instruments and measuring instrument recalls, and 
shall keep distribu tors informed of any such monitoring. 
5. Manufacturers shall ensure that their meas uring instruments bear a type, batch or 
serial number or other element allowing th eir identification, or, where the size or 
nature of the measuring instrument does not allow it, that the required information is 
provided on the packaging or in a document accompanying the measuring 
instrument. EN 28   EN 6. Manufacturers shall indicate th eir name, registered trade  name or registered trade 
mark  and the address at which they can be c ontacted on the measuring instrument or, 
where that is not possible, on its packaging or in a document accompanying the 
measuring instrument. The address must indicate a single point at which the 
manufacturer can be contacted. 
7. Manufacturers shall ensure that the measuring instrument is accompanied by 
instructions and information in accordance with point 9.3 of Annex I, in a language 
which can be easily understood by end-users,  as determined by the Member State 
concerned. 
8. Manufacturers who consider or have reason  to believe that a measuring instrument 
which they have placed on the market is not  in conformity with this Directive shall 
immediately take the necessary correctiv e measures to bring that measuring 
instrument into conformity, to withdraw it  or recall it, if appr opriate. Furthermore, 
where the measuring instrument presents a risk, manufacturers shall immediately 
inform the competent national authorities of the Member States in which they made 
the measuring instrument available to that effect, giving details, in particular, of the 
non-compliance and of any corrective measures taken. 
9. Manufacturers shall, further to a reas oned request from a competent national 
authority, provide it with all the information and documentation necessary to 
demonstrate the conformity of the measuri ng instrument, in a language which can be 
easily understood by that authority. They shal l cooperate with that  authority, at its 
request, on any action taken to  eliminate the risks posed by measuring instruments 
which they have placed on the market. 
Article 9 [Article R3 of Decision No 768/2008/EC] 
Authorised representatives 
1. A manufacturer may, by a written mandate, appoint an authorised representative. 
The obligations laid down in Article 8(1) a nd the drawing up of technical documentation shall 
not form part of the author ised representative's mandate. 
2. An authorised representative shall perform the tasks specified in the mandate received 
from the manufacturer. The mandate shall allow th e authorised representative to do at least 
the following: 
(a) keep the EU declaration of conform ity and the technical documentation at the 
disposal of national surveillance author ities for 10 years after the measuring 
instrument has been placed on the market; 
(b) further to a reasoned request from a competent national authority, provide that 
authority with all the information and documentation necessary to demonstrate 
the conformity of a measuring instrument; EN 29   EN (c) cooperate with the competent national authorities, at their request, on any 
action taken to eliminate the risks pose d by measuring instruments covered by 
their mandate. 
Article 10 [Article R4 of Decision No 768/2008/EC] 
Obligations of importers 
1. Importers shall place only compliant measuring instruments on the Union market. 
2. Before placing a measuring instrument on the market and/or putting a measuring 
instrument into use importers shall ensure that the appropriate conformity assessment 
procedure has been carried out by the ma nufacturer. They shall ensure that the 
manufacturer has drawn up the technica l documentation, that the measuring 
instrument bears the CE marking and th e supplementary metrology marking and is 
accompanied by the required documents, and that the manufacturer has complied 
with the requirements set out in Article 8(5) and (6). 
Where an importer considers or has reason to believe  that a measuring instrument is 
not in conformity with the essential re quirements set out in Annex I and in the 
relevant instrument specifi c Annexes, he shall not  place the measuring instrument on 
the market until it has been brought into  conformity. Furthermore, where the 
measuring instrument presents a risk, the importer shall inform the manufacturer and 
the market surveillance aut horities to that effect. 
3. Importers shall indicate th eir name, registered trade  name or registered trade mark 
and the address at which they can be c ontacted on the measuring instrument or, 
where that is not possible, on its packaging or in a document accompanying the 
measuring instrument in accordance with point 9.2 of Annex I. 
4. Importers shall ensure that the measuring instrument is accompanied by instructions 
and information in accordance with point 9.3 of Annex I, in a language which can be 
easily understood by end-users, as determ ined by the Member State concerned. 
5. Importers shall ensure that, while a measuring instrument is under their 
responsibility, storage or transport conditions do not jeopardise its compliance with 
the requirements set out in Annex I and in the relevant instrument specific Annexes.  
6. When deemed appropriate with regard to the performance of a measuring instrument, 
importers shall carry out sample testi ng of marketed measuring instruments, 
investigate, and, if necessary, keep a re gister of complaints, of non-conforming 
measuring instruments and measuring instrume nt recalls, and shall keep distributors 
informed of such monitoring. 
7. Importers who consider or have reason to believe that a measuring instrument which 
they have placed on the market is not in  conformity with this Directive shall 
immediately take the corrective measures  necessary to bring that measuring 
instrument into conformity, to withdraw it  or recall it, if appr opriate. Furthermore, 
where the measuring instrument presents a risk, importers shall immediately inform 
the competent national authorities of the Member States in which they made the EN 30   EN measuring instrument available to that eff ect, giving details, in particular, of the non-
compliance and of any corrective measures taken. 
8. Importers shall, for 10 year s after the measuring instrument has been placed on the 
market keep a copy of the EU declaration of conformity at the disposal of the market 
surveillance authorities and ensure that the technical documentation can be made 
available to those authorities, upon request. 
9. Importers shall, further to a reasoned re quest from a competent national authority, 
provide it with all the in formation and documentation ne cessary to demonstrate the 
conformity of a measuring instrument in a language which can be easily understood 
by that authority. They shall cooperate with  that authority, at its request, on any 
action taken to eliminate the risks posed by measuring instruments which they have 
placed on the market. 
Article 11 [Article R5 of Decision No 768/2008/EC] 
Obligations of distributors 
1. When making a measuring inst rument available on the mark et and/or put into use, 
distributors shall act with due care in relation to the requir ements of this Directive. 
2. Before making a measuring instrument available on the market and/or putting a 
measuring instrument into use distributors sh all verify that the measuring instrument 
bears the CE marking and the supplemen tary metrology marking, that it is 
accompanied by the required documents and by instructions and information in 
accordance with point 9.3 of Annex I, in a language which can be easily understood 
by end-users in the Member State in which the measuring instrument is to be made 
available on the market and/or put into  use, and that the manufacturer and the 
importer have complied with the requirements set out in Article 8(5) and (6) and 
Article 10(3). 
Where a distributor considers or has reason to  believe that a measuring instrument is 
not in conformity with the essential re quirements set out in Annex I and in the 
relevant instrument specific Annexes, he shall not make the measuring instrument 
available on the market or put it into us e, until it has been br ought into conformity. 
Furthermore, where the measuring instrument  presents a risk, the distributor shall 
inform the manufacturer or the importer to that effect as well as the market 
surveillance authorities. 
3. Distributors shall ensure  that, while a measuring instrument is under their 
responsibility, storage or transport conditions do not jeopardise its compliance with 
the essential requirements set out in Annex I and in the relevant instrument specific 
Annexes. 
4. Distributors who consider or have reas on to believe that a measuring instrument 
which they have made available on the mark et or put into use is not in conformity 
with this Directive shall make sure that the corrective measures necessary to bring 
that measuring instrument into conformity, to withdraw it or recall it, if appropriate, 
are taken. Furthermore, where the meas uring instrument presents a risk,  distributors EN 31   EN shall immediately inform the competent national authorities of the Member States in 
which they made the measuring instrument av ailable to that effect , giving details, in 
particular, of the non-compliance and of any corrective measures taken. 
5. Distributors shall, further to a reasoned  request from a competent national authority, 
provide it with all the in formation and documentation ne cessary to demonstrate the 
conformity of a measuring instrument. They shall cooperate with th at authority, at its 
request, on any action taken to  eliminate the risks posed by measuring instruments 
which they have made available on the market. 
Article 12 [Article R6 of Decision No 768/2008/EC] 
Cases in which obligations of manufactu rers apply to importers and distributors 
An importer or distributor shall be considered  a manufacturer for th e purposes of this 
Directive and he shall be subject to th e obligations of the manufacturer under 
Article 8, where he places a measuring inst rument on the market under his name or 
trademark or modifies a measuring instrume nt placed on the market in such a way 
that compliance with the requirements of this Directive may be affected. 
Article 13 [Article R7 of Decision No 768/2008/EC] 
Identification of economic operators 
Economic operators shall, on re quest, identify the following to  the market surveillance 
authorities , for 10 years: 
(a) any economic operator who has supplie d them with a measuring instrument; 
(b) any economic operator to whom they have supplied a measuring instrument. 
Economic operators shall be able to present the information referred to in the first paragraph 
for a period of 10 years after they  have been supplied with the measuring instrument and for a 
period of 10 years after they have supplied the measuring instrument. EN 32   EN  
Ð 2004/22/EC (adapted) 
CHAPTER 3 
⌦ CONFORMITY OF MEASURING INSTRUMENTS ⌫ 
Article 1314 [Article R8  of Decision 768/2008/EC]  
Harmonised standards and normative documents  ⌦ Presumption of conformity  ⌫ 
 
Ð 2004/22/EC 
1. Member States shall presume conf ormity with the essential requi rements referred to in 
Annex I and in the relevant instrument -specific Annexes in respect of a measuring instrument 
that complies with the elements of the na tional standards implem enting the European 
harmonised standard for that measuring instrument that c orrespond to those elements of this 
European harmonised standard the references in  respect of which have been published in the 
Official Journal of the European Union , C series.  
Where a measuring instrument complies only in part with the elements of the nat ional 
standards referred to in the first subparagraph, Member States shall presume conformity with 
the essential requirements corresponding to the el ements of the national standards with which 
the instrument complies.  
Member States shall publish the refere nces to the national standards referred to in the first 
subparagraph.  
2. Member States shall presume conformity with the essential requirements referred to in 
Annex I and in the relevant instrument -specific Annexes in respect of a measuring instrument 
that complies with the corresponding parts of the normative documents and lists referred to in 
Article 16(1)(a), the references in resp ect of which have been published in the Official 
Journal of the European Union , C series.  
Where a measuring instrument compli es only in part with the normative document referred to 
in the first subparagraph, Member States sh all presume conformity with the essential 
requirements corresponding to th e normative elements with which the instrument complies.  
Member States shall publis h the references of the normative document referred to in the first 
subparagraph.  EN 33   EN  
Ø new 
1. Measuring instruments which are in confor mity with harmonised standards or parts 
thereof the references of which have been published in the Official Journal of the 
European Union  shall be presumed to be in conformity with the essential 
requirements covered by those standards or parts thereof, set out in Annex I and in 
the relevant instrument specific Annexes. 
2. Measuring instruments which are in conformity with the normative documents or 
parts there of, the references of which have been published in the Official Journal of 
the European Union , shall be presumed to be in conformity with the requirements 
covered by those normative documents or parts thereof, set out in Annex I and in the 
relevant instrument specific Annexes. 
 
Ð 2004/22/EC (adapted) 
3. A manufacturer may choose to use any tech nical solution that complies with the 
essential requirements referred to in Annex I and in the relevant instrument-specific 
Annexes (MI -001 to MI -010) III to XII . In addition, to benefit from the presumption 
of conformity, the manufacturer  must correctly apply solu tions mentioned either in 
the relevant European  harmonised standards,  or in the corresponding parts of the  
normative documents and lists as  referred to in paragraphs 1 and 2. 
 
Ð 2004/22/EC 
4. Member States shall presume compliance with the appropriate tests mentioned in 
point (i) of Article 10 19(3)  if the corresponding test pr ogramme has been performed 
in accordance with the relevant documents mentioned in paragraphs 1 to , 2 and  3 and 
if the test results ensure compliance with the essential requirements. 
 
Ø new 
[Article 15] 
[Where a harmonised standard sa tisfies the requirements which it  covers and which are set out 
in Annex I and in the relevant instrument specific Annexes or Article 28, the Commission 
shall publish the reference of that standard in the Official Journal of the European Union ]. EN 34   EN  
Ð 2004/22/EC (adapted) 
Ö new 
Article 16 
Functions of the Measuring Instruments Committee  ⌦ Publication of the references of 
normative documents ⌫ 
1. Ö Where a normative document satisfies the requirements which it covers and which 
are set out in Annex I and in  the relevant instrument sp ecific Annexes, the Commission 
may  , on request by a Member State or on its own initiative, the Commission, acting in 
accordance with the procedure referred to in Art icle 15(2), may take a ny appropriate measure 
to: 
(a) identify normative documents drawn up by OI ML and, in a list, indicate the parts 
thereof compliance with which gives rise to  a presumption of conformity with the 
corresponding essential requirements of t his Directive;  
(b) publish the reference of the  ⌦ that ⌫ normative documents  and the list referred to 
in point (a)  in the Official Journal of the European Union , C series . 
 
Ð 2004/22/EC (adapted)  
Article 17  
⌦ Withdrawal of the references  of normative documents  ⌫ 
3. Where  ⌦ When ⌫ a Member State or the Commi ssion considers that a normative 
document whose references  have  ⌦ has ⌫ been published in the Official Journal of the 
European Union , C series, in accordance with paragraph 1(b) , does not fully meet  ⌦ entirely 
satisfy ⌫ the essential requirements ⌦ which it covers and which are set out ⌫ referred to  
in Annex I and in the relevant instrument -specific Annexes, that Member State or the 
Commission shall ⌦ decide ⌫ bring the matter before the Measuring Instruments 
Committee , giving the reasons for doing s o.  
The Commission, acting in accordance with th e procedure referred to in Article 15(2), shall 
inform the Member States  whether or not it is necessary  to withdraw the references  to 
⌦ of ⌫ the ⌦ that ⌫ normative document concerned  from publication in  the Official 
Journal of the European Union . 
 
Ø new 
Those decisions shall be adopted in accordance with the examination proc edure referred to in 
Article 46(2).  EN 35   EN  
Ð 2004/22/EC (adapted) 
Article 9 18 
Conformity assessment ⌦ procedures ⌫ 
 
Ð 2004/22/EC 
Conformity assessment of a measuring instrume nt with the relevant essential requirements 
shall be carried out by the a pplication, at the choice of th e manufacturer, of one of the 
conformity assessment procedures listed in the instrument-specific a Annex. The manufacturer 
shall provide, where appropria te, technical documentation for specific instruments or groups 
of instruments as set out in Article  10. 
 
Ð 2004/22/EC (adapted) 
The conformity assessment modules making up the  procedures are described  ⌦ set out ⌫ in 
Annexes A to H1  Annex II . 
 
Ð 2004/22/EC 
Records and correspondence rela ting to conformity assessment shall be drawn up in the 
official language(s) of the Member State wh ere the notified body carrying out the Conformity 
assessment procedures is established, or in a language accepted by that body. 
Article 10 19 
Technical Documentation 
1. The technical documentation shall render the design, manufact ure and operation of the 
measuring instrument intelligible and shall perm it an assessment of its conformity with the 
appropriate requirements of this Directive. 
 
Ð 2004/22/EC (adapted) 
2. The technical documentation shall be sufficiently detailed to ensure ⌦ compliance with 
the following requirements ⌫ : 
 
Ð 2004/22/EC 
(a) the definition of the me trological characteristics, ; EN 36   EN  
Ð 2004/22/EC (adapted) 
(b) the reproducibility of the metrological performances of produced instruments 
when properly adjusted using a ppropriate intended means, and ; 
(c) the integrity of the instrument. 
3. The technical documentation shall include  insofar as relevant for assessment and 
identification of the t ype and/or instrument ⌦ include the following information ⌫: 
 
Ð 2004/22/EC 
 (a) a general descrip tion of the instrument; 
 (b) conceptual design and manufacturing drawings and plans of components, sub-
assemblies, circuits, etc; 
 (c) manufacturing procedures to  ensure consistent production; 
 (d) if applicable, a descri ption of the electronic devices with drawings, diagrams, 
flow diagrams of the logic and genera l software information explaining their 
characteristics and operation; 
 (e) descriptions and explanations necessa ry for the understanding of paragraphs (b), 
(c) and (d), including the operation of the instrument; 
 (f) a list of the standard s and/or normative documents referred to in Article 13 14, 
applied in full or in part; 
 (g) descriptions of the solutions adopted to meet the essential requirements where the 
standards and/or normative documen ts referred to in Article 13 14 have not been 
applied; 
 (h) results of design calcul ations, examinations, etc; 
 
Ð 2004/22/EC (adapted) 
 (i) the appropriate test results, where nece ssary, to demonstrate th at the type and/or 
instruments comply with ⌦ the following ⌫ : 
 
Ð 2004/22/EC 
– the requirements of this Directive unde r declared rated operating conditions and 
under specified environmental disturbances, EN 37   EN – the durability specifications for gas-, wate r-, heat-meters as well as for liquids 
other than water. 
 
Ð 2004/22/EC (adapted) 
 (j) the ⌦ EU-type ⌫ EC-type examination certificates or ⌦ EU ⌫ EC design 
examination certificates in respect of instru ments containing part s identical to those 
in the design. 
 
Ð 2004/22/EC 
4. The manufacturer shall sp ecify where seals and markings have been applied. 
5. The manufacturer shall indicate the conditi ons for compatibility with interfaces and sub-
assemblies, where relevant. 
 
Ð 2004/22/EC 
Article 11  
Notification  
1. Member States shall notify to the other Member States and the Commission the bodies 
under their jurisdiction, which they have designated to car ry out the tasks pertaining to the 
conformity assessment modules referred to in Article 9, togeth er with the identification 
numbers given to them by the Commission in acc ordance with paragraph 4 of this Article, the 
kind(s) of measuring instrument for which ea ch body has been designated and in addition, 
where relevant, the instrument accuracy classes,  the measuring range, the measurement 
technology, and any other instrument characteri stic limiting the scope of the notification.  
2. Member States shall apply th e criteria set out in Article 12 for the designation of such 
bodies. Bodies that meet the crite ria laid down in the national standards which transpose the 
relevant harmonised standards, the referenc es of which have been published in the Official 
Journal of the European Union , shall be presumed to meet the corresponding criteria. 
Member States shall publish the references to these national standards.  
3. A Member State that has notified a body shall:  
– ensure that the body continues to meet  the criteria set out in Article 12,  
– withdraw such notificati on if it finds that the bod y no longer meets those crit eria. 
It shall forthwith inform the other Member  States and the Comm ission of any such 
withdrawal.  EN 38   EN 4. Each of the bodies to be notified sha ll be given an identification number by the 
Commission. The Commission shall publish the list of notified bodies, tog ether with the 
information in respect of the scope of the no tification referred to in  paragraph 1, in the 
Official Journal of the European Union , C series, and shall ensure th at the list is kept up to 
date.  
Article 12  
Criteria to be satisfied by designated  bodies  
Member States shall apply th e following criteria fo r the designation of bodies in accordance 
with Article 11(1).  
 1. The body, its director and staff involved in  conformity assessment tasks shall not 
be the designer, manufacturer, supplier, install er or user of the measuring instruments 
that they inspect, nor the authorised repres entative of any of th em. In addition, they 
may not be directly involved in the desi gn, manufacture, marketing or maintenance 
of the instruments, nor represent the parties e ngaged in these activities. The 
preceding criterion does not, however, prec lude in any way the possibility of 
exchanges of technical information between  the manufacturer and the body for the 
purposes of conformity assessment.  
 2. The body, its director and  staff involved in conformity assessment tasks shall be 
free from all pressures and inducements, in particular financial inducements, that 
might influence their judgement or the re sults of their conf ormity assessment, 
especially from persons or groups of p ersons with an interest in the results of the 
assessments.  
 3. The conformity assessment shall be ca rried out with the highest degree of 
professional integrity and re quisite competence in the fi eld of metrology. Should the 
body subcontract specific tasks, it shall first ensure that the subcontractor meets the 
requirements of this Directive, and in part icular of this Article. The body shall keep 
the relevant documents assessing the subc ontractor's qualifications and the work 
carried out by him under this Dir ective at the disposal of  the notifying authority.  
 4. The body shall be capable of carrying out all the conformity assessment tasks for 
which it has been designated, whether thos e tasks are carried out by the body itself or 
on its behalf and under its res ponsibility. It shall have at  its disposal the necessary 
staff and shall have access to the necessa ry facilities for carrying out in a proper 
manner the technical and administrative ta sks entailed in conf ormity assessment.  
 5. The body's staff shall have:  
– sound technical and vocational training, covering all conformity assessment 
tasks for which the body was designated;  
– satisfactory knowledge of the rules govern ing the tasks which it carries out, 
and adequate experience of such tasks;  
– the requisite ability to draw up the certificat es, records and reports 
demonstrating that the tasks have been carried out.  EN 39   EN  6. The impartiality of the body, its direct or and staff shall be guaranteed. The 
remuneration of the body shall not depe nd on the results of the tasks it carries out. 
The remuneration of the body's director and staff shall not depend on the number of 
tasks carried out or on the results of such tasks.  
 7. The body shall take out civil liability insu rance if its civil liab ility is not covered 
by the Member St ate concerned under national law.  
 8. The body's director and staff shall be bound to observe professional secrecy with 
regard to all information obtained in the performance of their duties pursuant to this 
Directive, except vis -à-vis the authority of the Member State which has designated it.  
Article 14  
Standing Committee  
Where a Member State or the Commission consid ers that a European harmonised standard as 
referred to in Article 13(1) does not fully meet the essential requirements referred to in Annex 
I and in the relevant instrument -specific Annexes, the Member State or the Commission shall 
bring the matter before the Standing Committee set up under Article 5 of  Directive 98/34/EC, 
giving its reasons for doing so. The Committee shall deliver an opinion wi thout delay.  
In the light of the Committee's opinion, the Co mmission shall inform the Member States 
whether or not it is necessary to withdraw the references to the national standards from the 
publication referred to in the th ird subparagraph of Article 13 (1). 
 
Ø new 
Article 20 [Article R10 of Decision No 768/2008/EC] 
EU declaration of conformity  
1. The EU declaration of conformity shall state that the fulfilment of the essential 
requirements set out in Annex I and in the relevant instrument specific Annexes has 
been demonstrated. 
2. The EU declaration of confor mity shall have the model structure set out in Annex III 
of Decision No 768/2008/EC, shal l contain the elements sp ecified in the relevant 
modules set out in Annex II to this Directive  and shall be continuously updated. It 
shall be translated into the language or languages required by the Member State in 
which market the measuring instrument is placed or made available. 
3. Where a measuring instrument is subject to more than one Un ion acts requiring an 
EU declaration of conformity, a single EU declaration of conformity shall be drawn 
up on respect of all such Union acts. That declaration shall contain the identification 
of the acts concerned, includi ng the publication references. EN 40   EN 4. By drawing up the EU declaration of co nformity, the manufacturer shall assume 
responsibility for the compliance of the measuring instrument. 
 
Ð 2004/22/EC (adapted) 
Article 7 21 
Conformity marking 
1. The conformity of a measuring instrument with  all the provisions of th is Directive shall be 
indicated by the presence on it of the ‘CE’  ⌦ CE ⌫ marking and the supplementary 
metrology marking as specified in Article 17 22. 
2. The ‘CE’ marking and supplementary metrology marking s hall be affixed by, or under the 
responsibility of, the ma nufacturer. These markings may be affixed to the instrument during 
the fabrication process, if justified.  
 
Ð 2004/22/EC 
3. The affixing of markings on a measuring instrument that are likely to deceive third parties 
as to the meaning and/or form of the ‘CE’ marking and the supplementary metrology marking 
shall be prohibited. Any other marking may be  affixed on a measuring instrument, provided 
that the visibility an d legibility of the ‘C E’ marking and the supplementary metrology 
marking is not thereby reduced.  
4. Where the measuring instrument is subject to measures adopted under other Directives 
covering other aspects which require the affi xing of the ‘CE’ marking, the marking shall 
indicate that the instrument in question is also  presumed to conform to the requirements of 
those other Directives. In such a case, the publication reference of  the said Directives, in the 
Official Journal of the European Union , must be given in the documents,  notices or 
instructions required by those Directives and accompanying the measuring instrument.  
Article 17  
Markings  
1. The ‘CE’ marking referred to in Article 7 co nsists of the symbol ‘CE’ according to the 
design laid down in paragr aph I.B(d) of the Annex  to Decision 93 /465/EEC. The ‘CE’ 
marking shall be at least 5  mm high.  
 
Ð 2004/22/EC (adapted) 
2. The supplementary metrology marking consists of the capital letter ‘M’ and the last two 
digits of the year of its  affixing, surrounded by a rect angle. The height of the rectangle shall EN 41   EN be equal to the height of the ‘CE’ marking. The supplementary metrology marking shall 
immediately follow the ‘CE’ marking.  
 
Ð 2004/22/EC 
3. The identification nu mber of the notified body concerned refe rred to in Article 11, if 
prescribed by the conformity assessment pro cedure, shall follow the ‘CE’ marking and 
supplementary metrology marking.  
 
Ð 2004/22/EC (adapted) 
4. When a measuring instrument consists  of a set of devices, not being sub -assemblies, 
operating together, the markings shall be  affixed on the instrument's main devi ce. 
 
Ð 2004/22/EC  
When a measuring instrument is too small or  too sensitive to carry the ‘CE’ marking and 
supplementary metrology marking, the markin gs shall be carried by the packaging, if any, and 
by the accompanying documents required by this Directive.  
5. The ‘CE’ marking and supplementary metrology marking shall be indelible. The 
identification number of the notif ied body concerned shall be indeli ble or self destructive 
upon removal. All markings shall be cl early visible or easily accessible.  
 
Ø new 
Article 22 [Article R11 of Decision No 768/2008/EC] 
General principles of the CE marking a nd of the supplementa ry metrology marking 
The CE marking shall be subject to the general principles set out in Ar ticle 30 of Regulation 
(EC) No 765/2008. 
 
Ð 2004/22/EC (adapted)  
17.2. The supplementary metrology marking shall co nsist of the capital letter ‘M’ and the 
last two digits of the year of its affixing, surrounded by a rectangle.  The height of the 
rectangle shall be equal to the height of the ‘CE’  ⌦ CE ⌫ marking. The 
supplementary metrology marking shall im mediately follow the ‘CE’ marking.  EN 42   EN  
Ø new 
Article 23 [Article R12 of Decision No 768/2008/EC] 
Rules and conditions for affixing the CE marking and the supplementary metrology 
marking  
1. The CE marking and the supplementary metr ology marking shall be  affixed visibly, 
legibly and indelibly to the m easuring instrument or to its data plate. Where that is 
not possible or not warranted on account of the nature of the measuring instrument, 
they shall be affixed to the packaging and to the accompanying documents, where 
the legislation concerned provides for such documents. 
 
Ð 2004/22/EC 
4.2. When a measuring instrument consists of a set of devices, not being sub-assemblies, 
operating together, the markings shall be affixed on the instrument's main device. 
 
Ø new 
3. The CE marking and the supplementary me trology marking shall be affixed before 
the measuring instrument is placed on the market. 
 
Ð 2004/22/EC (adapted) 
2.4. The ‘CE’  ⌦ CE ⌫ marking and supplementary metrology marking s hall be affixed 
by, or under the responsibility of, the manufacturer. These markings  may be affixed 
to the instrument during the fabr ication process, if justified. 
5. The supplementary metrology marking shall immediately follow the ‘CE’  ⌦ CE ⌫ 
marking.  
 
Ø new 
The CE marking and the supplementary me trology marking shall be followed by the 
identification number of the notified body, where that body is involved in the 
production control phase. 
The identification number of the notified body shall be affixed by the body itself or, 
under its instructions, by the manufacture r or his authorised representative. EN 43   EN 6. The CE marking, the supplementary metr ology marking and, where applicable, the 
identification number referred to in para graph 5 may be followed by a pictogram or 
any other mark indicating a special risk or use. 
The identification number of the notified body concerned shall be indelible or self 
destructive upon removal. 
CHAPTER 4 
NOTIFICATION OF CONFORMI TY ASSESSMENT BODIES 
Article 24 [Article R13 of Decision No 768/2008/EC] 
Notification 
1. Member States shall notify the Commissi on and the other Member States of bodies 
authorised to carry out third-party conformity  assessment tasks under this Directive. That 
notification shall include information on the ki nd(s) of measuring instrument(s) for which 
each body has been designated and, where releva nt, the instrument accuracy classes, the 
measuring range, the measurement technology, and any other instrume nt characteristic 
limiting the scope of the notification. 
 
Ð 2004/22/EC (adapted) 
2. If a Member State has not  introduced national legislat ion for tasks mentioned under  
⌦ referred to in ⌫ Article 2 3, it shall retain the right to desi gnate and  notify a body for 
tasks relating to that  ⌦ the measuring ⌫ instrument ⌦ concerned ⌫ . 
 
Ø new 
Article 25 [Article R14 of Decision No 768/2008/EC] 
Notifying authorities 
1. Member States shall designa te a notifying authority that  shall be responsible for 
setting up and carrying out the necessary procedures for the assessment and 
notification of conformity assessment bodi es and the monitoring of notified bodies, 
including compliance with th e provisions of Article 30. 
2. Member States may decide that the assessment and monitoring referred to in 
paragraph 1 shall be carried out by a natio nal accreditation body within the meaning 
of and in accordance with Regulation (EC) No 765/2008. EN 44   EN 3. Where the notifying authority delegates or otherwise entrusts the assessment, 
notification or monitoring referred to in paragraph 1 to a body which is not a 
governmental entity, that body shall be a legal entity and sh all comply mutatis 
mutandis with the requirements laid down in Article 26(1) to (6). In addition it shall  
have arrangements to cover liabi lities arising out of its activities. 
4. The notifying authority shall take full re sponsibility for the tasks performed by the 
body referred to in paragraph 3. 
Article 26 [Article R15 of Decision No 768/2008/EC] 
Requirements relating to notifying authorities 
1. A notifying authority shall be  established in such a way that no conflict of interest 
with conformity assessment bodies occurs. 
2. A notifying authority shall be organise d and operated so as to safeguard the 
objectivity and impartiality of its activities. 
3. A notifying authority shall be organised in such a way that each decision relating to 
notification of a conformity  assessment body is taken by competent persons different 
from those who carried out the assessment. 
4. A notifying authority shall not offer or provide any ac tivities that conformity 
assessment bodies perform or consultancy services on a commercial or competitive 
basis. 
5. A notifying authority shall safeguard the c onfidentiality of the information it obtains. 
6. A notifying authority shall have a suffici ent number of competent personnel at its 
disposal for the proper performance of its tasks. 
Article 27 [Article R16 of Decision No 768/2008/EC] 
Information obligation on  notifying authorities 
Member States shall inform the Commission of their procedures for the assessment and 
notification of conformity a ssessment bodies and the monitori ng of notified bodies, and of 
any changes thereto. 
The Commission shall make that information publicly available. EN 45   EN Article 28 [Article R17 of Decision No 768/2008/EC] 
Requirements relating to notified bodies 
1. For the purposes of notification, a c onformity assessment body shall meet the 
requirements laid down in paragraphs 2 to 11. 
2. A conformity assessment body shall be esta blished under national law and have legal 
personality. 
3. A conformity assessment body shall be a third-party body independent of the 
organisation or the measuring instrument it assesses. 
A body belonging to a business association or professional federation representing 
undertakings involved in the design, manu facturing, provision, assembly, use or 
maintenance of measuring instruments whic h it assesses, may, on condition that its 
independence and the absence of any conf lict of interest are demonstrated, be 
considered such a body. 
4. A conformity assessment body, its top level management and the personnel 
responsible for carrying out the conform ity assessment tasks shall not be the 
designer, manufacturer, supplier, installer, pu rchaser, owner, user or maintainer of 
the measuring instruments which they asse ss, nor the authorised representative of 
any of those parties. This shall not preclude the use of assessed measuring 
instruments that are necessary for the ope rations of the conformity assessment body 
or the use of such measuring instruments for personal purposes.  
A conformity assessment body, its top level management and the personnel 
responsible for carrying out the conformity assessment ta sks shall not be directly 
involved in the design, manuf acture or construction, the ma rketing, insta llation, use 
or maintenance of those measuring instrume nts, or represent the parties engaged in 
those activities. They shall not engage in  any activity that may conflict with their 
independence of judgement or integrity in relation to conformity assessment 
activities for which they are notified. This shall in particular apply to consultancy 
services . 
The second subparagraph does not, however, pr eclude the possibility of exchanges of 
technical information between  the manufacturer and th e body for the purposes of 
conformity assessment.  
Conformity assessment bodies shall ensure that  the activities of th eir subsidiaries or 
subcontractors do not affect the confidentia lity, objectivity or impartiality of their 
conformity assessment activities. 
5. Conformity assessment bodies and their pe rsonnel shall carry out the conformity 
assessment activities with the highest de gree of professional integrity and the 
requisite technical competence in the spec ific field and shall be free from all 
pressures and inducements, particularly financial, which might influence their 
judgement or the results of their conform ity assessment activitie s, especially as 
regards persons or groups of persons with an interest in the results of those activities. EN 46   EN 6. A conformity assessment body shall be capab le of carrying out all the conformity 
assessment tasks assigned to it by Article 24 and in relation to which it has been 
notified, whether those tasks are carried out by the conformity assessment body itself 
or on its behalf and under its responsibility. 
At all times and for each conformity asse ssment procedure and each kind or category 
of measuring instruments in relation to which it has been no tified, a conformity 
assessment body shall have at its disposal the necessary: 
(a) personnel with technical knowledge and sufficient and appropriate experience 
to perform the conformity assessment tasks; 
(b) descriptions of procedures in accord ance with which conformity assessment is 
carried out, ensuring the transparency and the ability of reproduction of those 
procedures. It shall have appropriate policies and procedures in place that 
distinguish between tasks it carries out as a notifi ed body and other activities; 
(c) procedures for the performance of activ ities which take due account of the size 
of an undertaking, the sector  in which it operates, it s structure, the degree of 
complexity of the measuring instrument  technology in question and the mass or 
serial nature of the production process. 
It shall have the means nece ssary to perform the techni cal and administrative tasks 
connected with the conformity assessment activities in an appropriate manner and 
shall have access to all necessa ry equipment or facilities. 
7. The personnel responsible for carrying out  conformity assessm ent activities shall 
have the following: 
(a) sound technical and vocational training covering all the conformity assessment 
activities in relation to  which the conformity assessment body has been 
notified; 
(b) satisfactory knowledge of the requiremen ts of the assessments they carry out 
and adequate authority to carry out those assessments; 
(c) appropriate knowledge and understanding of the essential requirements set out 
in Annex I and in the relevant instrument specific Annexes, of the applicable 
harmonised standards and normative documen ts and of the relevant provisions 
of Union harmonisation legislati on and of national legislation; 
(d) the ability to draw up certificates, records and reports demonstrating that 
assessments have been carried out. 
8. The impartiality of the conformity assessment bodies, their top level management 
and of the assessment personnel shall be guaranteed. 
The remuneration of the top level management and assessment personnel of a 
conformity assessment body shall not depend  on the number of assessments carried 
out or on the results of those assessments. EN 47   EN 9. Conformity assessment bodies shall take ou t liability insurance unless liability is 
assumed by the State in accordance with nati onal law, or the Member State itself is 
directly responsible for th e conformity assessment. 
10. The personnel of a conformity assessment body shall observe professional secrecy 
with regard to all information obtained in  carrying out their tasks under Article 24 or 
any provision of national law giving effect to it, except in relation to the competent 
authorities of the Member State in which its activities are carried out. Proprietary 
rights shall be protected. 
11. Conformity assessment bodies shall particip ate in, or ensure th at their assessment 
personnel are informed of, the relevant sta ndardisation activities and the activities of 
the notified body coordination group esta blished under the relevant Union 
harmonisation legislation and apply as gene ral guidance the administrative decisions 
and documents produced as a resu lt of the work of that group. 
Article 29 [Article R18 of Decision No 768/2008/EC] 
Presumption of conformity 
Where a conformity assessment body demonstrates its conformity with the criteria laid down 
in the relevant harmonised standards or parts thereof the references of which have been 
published in the Official Journal of the European Union  it shall be presumed to comply with 
the requirements set out in Article 28 in so far as the applicable harmonised standards cover 
those requirements. 
Article 30 [Article R20 of Decision No 768/2008/EC] 
Subsidiaries of and subcontrac ting by notified bodies 
1. Where a notified body subcontracts specif ic tasks connected with conformity 
assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or 
the subsidiary meets the requirements set out in Article 28 and shall inform the 
notifying authority accordingly. 
2. Notified bodies shall take full res ponsibility for the tasks performed by 
subcontractors or subsidiaries wh erever these are established. 
3. Activities may be subcontracted or carr ied out by a subsid iary only with the 
agreement of the client. 
4. Notified bodies shall keep at the disposal  of the notifying authority the relevant 
documents concerning the assessment of the qua lifications of the subcontractor or the 
subsidiary and the work carried  out by them under Article 24. EN 48   EN Article 31 [Article R22 of Decision No 768/2008/EC] 
Application for notification 
1. A conformity assessment body shall submit an application for notification to the 
notifying authority of the Member State in which it is established. 
2. That application shall be accompanied by a description of the conformity assessment 
activities, the conformity  assessment module or modules and the measuring 
instrument or measuring instruments for whic h that body claims to  be competent, as 
well as by an accreditation certificate, where one exists, issued by a national 
accreditation body attesting that the conformity assessment body fulfils the 
requirements laid down in Article 28. 
3. Where the conformity assessment body c oncerned cannot provide an accreditation 
certificate, it shall provide the notifying aut hority with all the documentary evidence 
necessary for the verification, recognition and regular monitoring of its compliance 
with the requirements laid down in Article 28. 
Article 32 [Article R23 of Decision No 768/2008/EC] 
Notification procedure 
1. Notifying authorities may notify only conf ormity assessment bodies which have 
satisfied the requirements laid down in Article 28. 
2. They shall notify the Commission and the ot her Member States us ing the electronic 
notification tool developed and managed by the Commission. 
3. The notification shall include full details of the conformity assessment activities, the 
conformity assessment module or modules and measuring instrument or measuring 
instruments concerned and the rele vant attestation of competence. 
4. Where a notification is not based on an accreditation certificate as referred to in 
Article 31(2), the notifying authority sh all provide the Commi ssion and the other 
Member States with documentary eviden ce which attests to the conformity 
assessment body's competence and the arrangements in place to ensure that that body 
will be monitored regularly and will continue to satisfy the requirements laid down in 
Article 28.  
5. The body concerned may perform the activ ities of a notified body only where no 
objections are raised by the Commission or  the other Member States within two 
weeks of a notification wher e an accreditation certificate is used or within two 
months of a notification wher e accreditation is not used. 
Only such a body shall be considered a notified body for the purposes of this 
Directive. 
6. The Commission and the othe r Member States shall be notified of any subsequent 
relevant changes to the notification. EN 49   EN Article 33 [Article R24 of Decision No 768/2008/EC] 
Identification numbers and lists of notified bodies 
1. The Commission shall assign an iden tification number to a notified body. 
It shall assign a single such  number even where the body is notified under several 
Union acts. 
2. The Commission shall make publicly avai lable the list of th e bodies notified under 
this Directive, including the identification numbers that have been allocated to them 
and the activities for which they have been notified. 
The Commission shall ensure that that list is kept up to date. 
Article 34 [Article R25 of Decision No 768/2008/EC] 
Changes to notifications 
1. Where a notifying authority has ascertained or has been informed that a notified body 
no longer meets the requirements  laid down in Article 28, or  that it is failing to fulfil 
its obligations, the notifying au thority shall restrict, suspe nd or withdraw notification 
as appropriate, depending on the seriou sness of the failure to meet those 
requirements or fulfil those obligations. It shall immediately inform the Commission 
and the other Member States accordingly. 
2. In the event of restriction, suspension or  withdrawal of notif ication, or where the 
notified body has ceased its activity, the notifying Member State shall take 
appropriate steps to ensure that the files of that body ar e either processed by another 
notified body or kept available for the re sponsible notifying and market surveillance 
authorities at their request. 
Article 35 [Article R26 of Decision No 768/2008/EC] 
Challenge of the competence of notified bodies 
1. The Commission shall investigate all cases  where it doubts, or doubt is brought to its 
attention regarding, the competence of a notified body or the c ontinued fulfilment by 
a notified body of the requirements and responsibilities to wh ich it is subject. 
2. The notifying Member State shall provi de the Commission, on request, with all 
information relating to the basis for the notification or the maintenance of the 
competence of the body concerned. 
3. The Commission shall ensure that all sensi tive information obtained in the course of 
its investigations is treated confidentially. EN 50   EN 4. Where the Commission ascertains that a notified body does not meet or no longer 
meets the requirements for its notification, it  shall inform the notifying Member State 
accordingly and request it to take the necessary corrective measures, including de-
notification if necessary. 
Article 36 [Article R27 of Decision No 768/2008/EC] 
Operational obligations of notified bodies 
1. Notified bodies shall carry out conform ity assessments in accordance with the 
conformity assessment procedures provided for in Annex II. 
2. Conformity assessments shall be carried out in a proportionate manner, avoiding 
unnecessary burdens for economic operators . Conformity assessment bodies shall 
perform their activities taking due account of th e size of an undert aking, the sector in 
which it operates, its structur e, the degree of complexity of the measuring instrument 
technology in question and the mass or seri al nature of the production process. 
In so doing they shall nevertheless respec t the degree of rigour and the level of 
protection required for the compliance of  the measuring instrument with the 
provisions of this Directive. 
3. Where a notified body finds that the essentia l requirements set out in Annex I and in 
the relevant instrument specific Annexe s or corresponding harmonised standards, 
normative documents or technical speci fications have not been met by a 
manufacturer, it shall require that manuf acturer to take appropriate corrective 
measures and shall not issue a conformity certificate. 
4. Where, in the course of the monitori ng of conformity following the issue of a 
certificate, a notified body finds that a meas uring instrument no longer complies, it 
shall require the manufacturer to take ap propriate corrective measures and shall 
suspend or withdraw the certificate if necessary. 
5. Where corrective measures are not taken or  do not have the required effect, the 
notified body shall restrict, suspend or withdraw any cer tificates, as appropriate. 
Article 37  
Appeal against decisions of notified bodies 
Member States shall ensure that an appeal pr ocedure against decisions of notified bodies is 
available. EN 51   EN Article 38 [Article R28 of Decision No 768/2008/EC] 
Information obligation on notified bodies 
1. Notified bodies shall inform the no tifying authority of the following: 
(a) any refusal, restriction, suspensi on or withdrawal of a certificate; 
(b) any circumstances affecting the scop e of and conditions for notification; 
(c) any request for information which they have received from market surveillance 
authorities regarding confor mity assessment activities; 
(d) on request, conformity assessment activ ities performed within the scope of 
their notification and a ny other activity performed, including cross-border 
activities and subcontracting. 
2. Notified bodies shall provide  the other bodies notified under this Directive carrying 
out similar conformity assessment activ ities covering the same measuring 
instruments with relevant information on issues relating to negative and, on request, 
positive conformity assessment results. 
Article 39 [Article R29 of Decision No 768/2008/EC] 
Exchange of experience 
The Commission shall provide for the organisation of exchange  of experience between the 
Member States' national authorities responsible for notification policy. 
Article 40 [Article R30 of Decision No 768/2008/EC] 
Coordination of notified bodies 
The Commission shall ensure that appropriate  coordination and coope ration between bodies 
notified under this Directive are put in place and pr operly operated in the form of a sectoral or 
cross sectoral group or groups of notified bodies. 
Member States shall ensure that the bodies notifie d by them participate in the work of that or 
those group or groups, directly or by m eans of designated representatives. EN 52   EN  
Ð 2004/22/EC (adapted) 
CHAPTER 5  
⌦ UNION MARKET SURVEILLANCE, CONTROL OF 
MEASURING INSTRUMENTS ENTERING THE UNION 
MARKET AND SAFEGUARD PROCEDURES ⌫ 
 
Ð 2004/22/EC 
Article 18  
Market surveillance and ad ministrative cooperation  
1. Member States shall take all appropriate m easures to ensure that measuring instruments  
that are subject to legal metrological control bu t do not comply with applicable provisions of 
this Directive are neither placed on the market nor put into use.  
2. The competent authorities of the Member States  shall assist each othe r in the fulfilment of  
their obligations to carry  out market surveillance.  
In particular, the competent authorities shall exchange:  
– information concerning the extent to which instruments they examine comply with 
the provisions of this Directive,  and the results of such examinat ions;  
– EC-type examination and design examination certificates and their annexes issued by 
notified bodies as well as additions, amendments and withdrawals relating to 
certificates already issued;  
– quality system approvals issued by notified bodies, as well as information on quality 
systems refused or withdrawn;  
– evaluation reports established by no tified bodies, when demanded by other 
authorities.  
3. The Member States shall ensure  that all necessary informati on relating to the certificates 
and quality system approvals is made available to bodies they have notified.  
4. Each Member State shall inform the othe r Member States and the Commission which 
competent authorities it has designated for such exchange of information.  EN 53   EN  
Ø new 
Article 41 
Union market surveillance, control of measur ing instruments entering the Union market 
Article 15(3) and Articles 16 to  29 of Regulation (EC) No 7 65/2008 shall apply to measuring 
instruments. 
Article 42 [Article R31 of Decision No 768/2008/EC] 
Procedure for dealing with measuring instrume nts presenting a risk at national level 
1. Where the market surveillance authoritie s of one Member Stat e have taken action 
pursuant to Article 20 of Regulation (EC) No 765/2008, or where they have 
sufficient reason to believe that a measur ing instrument covered by this Directive 
presents a risk to the aspects of public in terest protection covered by this Directive, 
they shall carry out an evaluation in rela tion to the measuring instrument concerned 
covering all the requirements laid down in this Directive. The relevant economic 
operators shall cooperate as necessary w ith the market surveillance authorities. 
Where, in the course of th at evaluation, the market surv eillance authorities find that 
the measuring instrument does not comply w ith the requirements laid down in this 
Directive, they shall without  delay require the relevant economic operator to take all 
appropriate corrective action to bring the measuring instrument into compliance with 
those requirements, to withdr aw the measuring instrument from the market, or to 
recall it within a reasonable period, commensura te with the nature of the risk, as they 
may prescribe. 
The market surveillance authorities sh all inform the relevant notified body 
accordingly. 
Article 21 of Regulation (EC) No 765/2008 shal l apply to the measur es referred to in 
the second subparagraph. 
2. Where the market surveillance authorities consider that non-compliance is not 
restricted to their national territory, they  shall inform the Commission and the other 
Member States of the results  of the evaluation and of th e actions which they have 
required the economic operator to take. 
3. The economic operator shall en sure that all appropriate co rrective action is taken in 
respect of all the measuring instruments c oncerned that it has made available on the 
market throughout the Union. 
4. Where the relevant economic operator doe s not take adequate corrective action 
within the period referred to  in the second subparagraph of paragraph 1, the market 
surveillance authorities shall take all appropr iate provisional measures to prohibit the EN 54   EN measuring instrument’s being made availabl e on their national market, to withdraw 
the measuring instrument from that market or to recall it. 
The market surveillance authorities sh all inform the Commission and the other 
Member States, without delay, of those measures. 
5. The information referred to in paragraph 4 shall include all available details, in 
particular the data necessary for the iden tification of the non-compliant measuring 
instrument, the origin of the measuring instrument, the nature of the  non-compliance 
alleged and the risk involved, the nature and duration of the national measures taken 
and the arguments put forward by the releva nt economic operator. In particular, the 
market surveillance authorities shall indica te whether the non-compliance is due to 
either of the following: 
(a) failure of the measuring instrument to  meet requirements relating to the aspects 
of public interest protection la id down in this Directive; 
(b) shortcomings in the harmonised standa rds or normative documents referred to 
in Article 14 conferring a presumption of conformity. 
6. Member States other than the Member St ate initiating the pro cedure shall without 
delay inform the Commission and the other Member States of any measures adopted 
and of any additional information at their disposal relating to the non-compliance of 
the measuring instrument concerned, and, in the event of disagreement with the 
notified national measure,  of their objections. 
7. Where, within two months of  receipt of the information referred to in paragraph 4, no 
objection has been raised by either a Member  State or the Commission in respect of a 
provisional measure taken by a Member St ate, that measure shall be deemed 
justified. 
8. Member States shall ensure that appropriate  restrictive measures are taken in respect 
of the measuring instrument concerned.  
Article 43 [Article R32 of Decision No 768/2008/EC] 
Union safeguard procedure 
1. Where, on completion of the procedure set out in Article 42(3) and (4), objections 
are raised against a measure taken by a Member State, or where the Commission 
considers a national measure to be contra ry to Union legisla tion, the Commission 
shall without delay enter into consultation with the Member States and the relevant 
economic operator or operators and shall eval uate the national measure. On the basis 
of the results of that evaluation, the Co mmission shall decide whether the national 
measure is justified or not. 
The Commission shall address its decisi on to all Member States and shall 
immediately communicate it to them and the relevant economic operator or 
operators. EN 55   EN 2. If the national measure is considered justified, all Member States shall take the 
measures necessary to ensure that th e non-compliant measuring instrument is 
withdrawn from their market, and shall in form the Commission accordingly. If the 
national measure is considered unjustified, the Member State concerned shall 
withdraw the measure. 
3. Where the national measure is considered  justified and the non-compliance of the 
measuring instrument is attributed to shortcomings in the harmonised standards 
referred to in Article 42(5)(b) of this Directive, the Commission shall apply the 
procedure provided for in Article 8 of Regulation (EU) No [….] [on European 
Standardisation]. 
 
Ð 2004/22/EC (adapted) 
(a)4. Should the Commission find that the  ⌦ Where the national measure ⌫ measure s 
taken by the Member State concerned are  ⌦ is considered ⌫ justified, it shall 
immediately inform that Member State ther eof, as well as the other Member States.  
 The competent Member State shall take appropriate action against any person who 
affixed the markings and shall inform the Commission and the other Member Stat es 
thereof.  
 If  ⌦ and ⌫ the non-compliance ⌦ of the measuring instrument ⌫ is attributed to 
shortcomings in the standards or  normative documents ⌦ referred to in Article 
42(5)(b) ⌫, the Commission shall, after consul ting the parties c oncerned, bring the 
matter as soon as possible before the appropriate Committee referred to  ⌦ apply the 
procedure provided for ⌫ in Articles  17 14 or 15 . 
 
Ø new 
Article  44 [Article R33 of Decision No 768/2008/EC] 
Compliant measuring instruments which presen t a risk to public in terest protection 
1. Where, having performed an evaluation unde r Article 42(1), a Member State finds 
that although a measuring instrument is in compliance with this Di rective, it presents 
a risk to aspects of public interest protection, it shall require the relevant economic 
operator to take all appropriate measures to ensure that the measuring instrument 
concerned, when placed on the market, no longer  presents that risk, to withdraw the 
measuring instrument from the market or  to recall it within a reasonable period, 
commensurate with the nature of the risk, as it may prescribe. 
2. The economic operator shall ensu re that corrective action is taken in respect of all the 
measuring instruments concerned that he  has made available on the market 
throughout the Union. EN 56   EN 3. The Member State shall immediately in form the Commission and the other Member 
States. That information shall include all available details, in particular the data 
necessary for the identification of the m easuring instrument concerned, the origin 
and the supply chain of the measuring instrument, the natu re of the risk involved and 
the nature and duration of the national measures taken. 
4. The Commission shall without delay enter in to consultation with the Member States 
and the relevant economic operator or ope rators and shall evaluate the national 
measures taken. On the basis of the result s of that evaluation, the Commission shall 
decide whether the measures are justif ied or not, and where necessary, propose 
appropriate measures. 
5. The Commission shall address its deci sion to all Member States and shall 
immediately communicate it to them and the relevant economic operator or 
operators. 
Article 45 [Article R34 of Decision No 768/2008/EC] 
Formal non-compliance 
1. Without prejudice to Artic le 42, where a Member State makes one of the following 
findings, it shall require the relevant economic operator to put an end to the 
non-compliance concerned: 
(a) the CE marking, the supplementary metrology marking or the identification 
number of the notified body, where that  body is involved in the production 
control phase, has been affixed in viol ation of Article 30 of Regulation (EC) 
No 765/2008 or of Article 23 of this Directive; 
(b) the CE marking, the supplementary metrology marking or the identification 
number of the notified body, where that  body is involved in the production 
control phase, has not been affixed; 
(c) the EU declaration of conformity has not been drawn up; 
(d) the EU declaration of conform ity has not been drawn up correctly; 
(e) technical documentation is eith er not available or not complete. 
2. Where the non-compliance referred to in paragraph 1 persists, the Member State 
concerned shall take all appropria te measures to restrict or pr ohibit the measuring instrument 
being made available on the market or ensure that  it is recalled or withdrawn from the market. 
 
Ð 2004/22/EC 
Article 19  
Safeguard clause  EN 57   EN 1. Where a M ember State establishes that all or pa rt of the measuring instruments of a 
particular model that bear th e ‘CE’ marking and the supplem entary metrology marking do not 
satisfy the essential requirements relating to  metrological performa nce set out in this 
Directive, when correctly installed and used  in accordance with the manufacturer's 
instructions, it shall take all appropriate measures to withdraw these instruments from the 
market, prohibit or restrict their further being placed on the market, or prohibit or restrict their 
further being used.  
When deciding on the above measures, the Member  State shall take account of the systematic 
or incidental nature of the non -compliance. Where the Member State has established that the 
non-compliance is of a systematic n ature, it shall immediately inform the Commission of the 
measures taken, indicating the reasons for its decision.  
2. The Commission shall enter into consultati on with the parties concerned as soon as 
possible.  
 
Ð 2004/22/EC (adapted) 
 (a) Sho uld the Commission find that the m easures taken by the Member State 
concerned are justified, it shall immediatel y inform that Member State thereof, as 
well as the other Member States.  
 The competent Member State shall ta ke appropriate action against any pe rson who 
affixed the markings and shall inform th e Commission and the other Member States 
thereof.  
 If the non -compliance is attributed to shortcom ings in the standards or normative 
documents, the Commission shall, afte r consulting the parties concerned, b ring the 
matter as soon as possible before the appropriate Committee referred to in Articles 
14 or 15.  
 
Ð 2004/22/EC  
 (b) Should the Commission find that the measures taken by the Member State 
concerned are not justif ied, it shall immediatel y inform that Member State thereof, as 
well as the manufacturer concerned or his authorised representative.  
The Commission shall ensure that the Member St ates are kept informed of the progress and 
outcome of the procedure.  
Article 20  
Unduly fixed markings  
1. Where a Member State establ ishes that the ‘CE’ marking and supplementary metrology 
marking have been affixed unduly, the manufacturer or his authorised representative shall be 
obliged:  EN 58   EN – to make the instrument conform as regards those provisions concernin g the ‘CE’ 
marking and supplementary metrology ma rking not covered by Article 19(1) and  
– to end the infringement under the co nditions imposed by the Member State.  
2. Should the infringement described above pe rsist, the Member State must take all 
appropriate  measures to restrict or prohibit the pl acing on the market of the instrument in 
question or to ensure that it is withdrawn from the market or prohibit or restrict its further use 
in accordance with the procedures laid down in Article 19.  
Article 21  
Decisi ons entailing refusal or restriction  
Any decision taken pursuant to this Directive en tailing the withdrawal from the market of a 
measuring instrument, or prohibiting or restricting the placing on the market or putting into 
use of an instrument, shall state  the exact grounds on which it is  based. The decision shall be 
notified forthwith to the party concerned, who shall at the same time be informed of the legal 
remedies available to him under the law of the Member State concerned and of the time limits 
to wh ich such remedies are subject.  
 
Ð 2004/22/EC (adapted) 
CHAPTER 6  
⌦ COMMITTEE AND DELEGATED ACTS ⌫ 
Article 15 46 
Measuring Instruments  Committee ⌦ procedure  ⌫ 
1. The Commission shall be assisted by the Measuring Instruments Committee. ⌦ That 
Committee shall be a committee within th e meaning of Regulation (EU) No 182/2011. ⌫ 
2. Where reference is made to this paragraph, Articles  3 and 7 of Decision 1999/468/EC  ⌦ 5 
of Regulation (EU) No 182/2011 ⌫ shall apply, having regard to  the provisions of Article 8 
thereof . 
 
Ø new 
3. Where the opinion of the committee is to be obtained by written proce dure, that procedure 
shall be terminated without result when, within  the time-limit for delivery of the opinion, the 
chair of the committee so decides or a simple  majority of committee members so request. EN 59   EN  
Ð 1137/2008  
3. Where reference is made to this paragraph, Article  5a(1) to (4) and Article  7 of Decision 
1999/468/EC shall apply, having regard  to the provisions of Article  8 thereof.  
 
Ð 2004/22/EC 
5. The Commission shall ensure that relevant information about envisaged measures, as 
referred to in Article 16, is made available to interested parties in due time.  
 
Ð 2004/22/EC (adapted) 
Article 16 47 
Functions of the Measuring Instruments Committee  ⌦ Amendments of Annexes  ⌫ 
 
Ø new 
The Commission shall be empowered to adopt de legated acts in acco rdance with Article 48 
concerning the amendments of the instru ment-specific Annexes III to XII.  
 
Ð 1137/2008  
(2.) At the request of a Memb er State or on its own initiative, the Commission may amend the 
instrument -specific Annexes (MI -001 to MI -010) iIn relation to the following: 
 (a) maximum permissible errors (MPEs) and accuracy classes;  (b) rated operating conditions;  (c) critical change values;  (d) disturbances. 
Those measures, designed to amend non -essential elements of this Directive, shall be adopted 
in accordance with the regulatory proce dure with scrutiny re ferred to in Article  15(3).  
 
Ð 2004/22/EC 
4. Member States may take appropriate measur es to consult interested parties at nati onal level 
about OIML work relating to the scope of this Directive.  EN 60   EN  
Ø new 
Article 48 
Exercise of the delegation 
1. The power to adopt delegated acts is conferred on the Commission subject to the 
conditions laid down in this Article. 
2. The delegation of power referred to  in Article 47 shall be conferred  for an 
indeterminate period of time from the [the date set out in the second subparagraph of 
Article 51]. 
3. The delegation of power referred to in Ar ticle 47 may be revoked at any time by the 
European Parliament or by the Council. A decision of revocation shall put an end to 
the delegation of the power specified in th at decision. It shall take effect the day 
following the publication of the decision in the Official Journal  of the European 
Union or at a later date specified therein. It  shall not affect the validity of any 
delegated acts alr eady in force.  
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council.  
5. A delegated act adopted pursu ant to Article 46 shall en ter into force only if no 
objection has been expressed either by th e European Parliament or the Council 
within a period of 2 months of notification of  that act to the European Parliament and 
the Council or if, before the expiry of that period, the European Parliament and the 
Council have both informed the Commi ssion that they will not object.  That period 
shall be extended by 2 months at the initia tive of the European Parliament or the 
Council. EN 61   EN  
Ð 2004/22/EC (adapted) 
CHAPTER 7  
⌦ TRANSITIONAL AND FINAL PROVISIONS ⌫ 
 
Ð 2004/22/EC 
Article 23  
Transitional provisions  
By way of derogation from Artic le 8(2), Member States shall permit, for measurement tasks 
for which they have prescribed the use of a legally controlled meas uring instrument, the 
placing on the market and putting into use of m easuring instruments that satisfy the rules 
applicable before 30 October 2006 until th e expiry of the validity of the type  approval of 
those measuring instruments or, in the case of a type approval of inde finite validity, for a 
period of a maximum of ten years from 30 October 2006.  
 
Ð 2006/96/EC  
For the purpose of this transition period, the monetary values for  Bulgaria and Romania 
according to point 4.8.1 of Chapter IV of the A nnex to Directive 71/348/EEC shall be fixed 
at: 
1 стотинка  (1 stotinka)  
1 new leu.  
 
Ø new 
Article 49  
Penalties 
Member States shall lay down rules on penalties applicable to infringements of the national 
provisions adopted pursuant to this  Directive and shall take all measures necessary to ensure 
that they are enforced. 
The penalties provided for shall be eff ective, proportionate and dissuasive. EN 62   EN Member States shall notify those provisions to  the Commission by [the date set out in the 
second subparagraph of Article 51] at the late st and shall notify to it without delay any 
subsequent amendment affecting them. 
Article 50  
Transitional provisions 
1. Member States shall not impede the ma king available on the market and/or the 
putting into use of measuring instrume nts covered by Directive 2004/22/EC which 
are in conformity with that Directive a nd which were placed on the market before 
[the date set out in the sec ond subparagraph of Article 51]. 
Certificates of conformity  issued under Dir ective 2004/22/EC shall be valid under 
this Directive until [the date  set out in the second subpa ragraph of Article 51] unless 
they expire before that date. 
2. The effects of Article 23 of Directiv e 2004/22/EC shall conti nue until 30 October 
2016. 
 
Ð 2004/22/EC (adapted) 
Article 24  
Transposition  
1. Member States shall adopt an d publish the laws, regulations  and administrative provisions 
necessary to comply with this Directive before 30 Apri l 2006. They shall forthwith inform the 
Commission thereof.  
When Member States adopt those measures, they shall contain a reference to this Directive or 
shall be accompanied by such a reference on th e occasion of their official publication. The 
methods of making such reference shall be laid down by the Member States.  
Member States shall apply thes e provisions from 30 October 2006.  
 
Ð  
Article 51 
Transposition 
1. Member States shall adopt and publish by [insert date – 2 years after adoption] at the 
latest the laws, regulations a nd administrative provisions necessa ry to comply with Articles 
4(5) to (22), 8, 9, 10, 11, 13, 14, [15], 20, 22, 23( 1), 23(3), 23(5), 23(6), 24, 25, 26, 27, 28, 29, EN 63   EN 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 49, 50 and Annex II. They shall 
forthwith communicate to the Commission the text  of those provisions and a correlation table 
between those provisions and this Directive. 
They shall apply those provisions from [day after the date set out in the first subparagraph]. 
When Member States adopt those provisions, they  shall contain a refere nce to this Directive 
or be accompanied by such a reference on the occas ion of their official publication. They shall 
also include a statement that references in existing laws, regulations  and administrative 
provisions to the Directive repealed by this Direc tive shall be construed as references to this 
Directive. Member States shall determine how such reference is to be made and how that 
statement is to be formulated.  
 
Ð 2004/22/EC (adapted) 
2. Member States shall communicate to the Commission the text of the ⌦ main ⌫ 
provisions of national law which they adopt in the field covered by this Directive. 
Article 22 52 
Repeals  
The follo wing Directives shall be repealed as from 30 October 2006 without prejudice to 
Article 23:  
– Council Directive 71/318/EEC of 26  July 1971 on the approximation of the laws of 
the Member States relating to gas meters20, 
– Directive 71/319/EEC of 26  July 1971 on t he approximation of the laws of the 
Member States relating to meters  for liquids other than water21; 
– Directive 71/348/EEC of 12  October 1971 on the approxima tion of the laws of the 
Member States relating to ancillary e quipment for meters for liquids other t han 
water22, 
– Directive 73/362/EEC of 19  November 1973 on the approximation of the laws of the 
Member States relating to ma terial measures of length23, 
– Directive 75/33/EEC of 17  December 1974 on the approximation of the laws of the 
Member States relating to c old water meters, as concer ns the meters defined in 
Annex MI -001 of this Directive24. 
                                                 
20 OJ L 202, 6.9.1971, p.  21. Directive as last amended by Co mmission Directive 82/623/EEC (OJ L 252, 
27.8.1982, p.  5). 
21 OJ L 202, 6.9.1971, p.  32. 
22 OJ L 239, 25.10.1971, p.  9. Directive as las t amended by the 1994 Act of Accession.  
23 OJ L 335, 5.12.1973, p.  56. Directive as last amended by Commission Directive 85/146/EEC (OJ L 54, 
23.2.1985, p.  29). EN 64   EN – Directive 75/410/EEC of 24  June 1975 on the approximati on of the laws of the 
Member States relating to con tinuous totalising weighing machines25, 
– Directive 76/891/EEC of 4  November 1976 on the approximation of the laws of the 
Member States relating to  electrical energy meters26, 
– Directive 77/95/EEC of 21  December 1976 on the approximation of the laws of the 
Member States relating to taximeters27, 
– Directive 77/313/EEC of 5  April 1977 on the approximation of the laws of the 
Member States relating to measuring systems for liquids other than water28, 
– Directive 78/1031/EEC of 5  December 1978 on the approxima tion of the laws of the 
Member States relating to automatic checkweighing and  weight grading machines29, 
– Directive 79/830/EEC of 11  September 1979 on the approximation of the laws of the 
Member States relating to hot -water meters30. 
 
Ø new 
Without prejudice to Article 50, Directive 2004/22 /EC as amended by the acts listed in Annex 
XIII is repealed with effect from [the date set out in the second subpa ragraph of Article 51], 
without prejudice to the obligatio ns of the Member States re lating to the time-limits for 
transposition into national law and application of  the Directives set out in Part B of Annex 
XIII.  
References to the repealed Directive shall be construed as references to this Directive and 
shall be read in accordance with the correlation table in Annex XIV. 
 
Ð 2004/22/EC  
Article 25  
Revision claus e 
The European Parliament and the Council invite  the Commission to report, before 30 April 
2011, on the implementation of this Directive, inte r alia, on the basis of reports provided by 
the Member States, and, where approp riate, to submit a proposal for am endments.  
                                                                                                                                                         
24 OJ L 14, 20.1.1975, p.  1. 
25 OJ L 183, 14.7.1975, p.  25. 
26 OJ L 336, 4.12.1976, p.  30. 
27 OJ L 2 6, 31.1.1977, p.  59. 
28 OJ L 105, 28.4.1977, p.  18. Directive as amended by Commission Directive 82/625/EEC (OJ L 252, 
27.8.1982, p.  10). 
29 OJ L 364, 27.12.1978, p.  1. 
30 OJ L 259, 15.10.1979, p.  1. EN 65   EN The European Parliament and Council invite the Commission to evaluate whether conformity 
assessment procedures for industrial products ar e properly applied and, where appropriate, to 
propose amendments in order to ensure consistent certification.  
 
Ð 2004/22/EC (adapted) 
Article 26 53 
Entry into force 
This Directive shall enter into force on the ⌦ twentieth ⌫ day following that of its 
publication in the Official Journal of the European Union . 
Articles 1, 2, 3, 4(1) to (4), 5, 6, 7, 16, 17, 18, 19, 21, 23(2), 23(4) and Annexes I, III, IV, V, 
VI, VII, VIII, IX, X, XI, XII shall apply from [the date set out in the second subparagraph of 
Article 51].  
 
Ð 2004/22/EC 
Article 27 54 
Addressees 
This Directive is addressed to the Member States. 
Done at […], 
For the European Parliament For the Council 
The President The PresidentEN 66   EN  
Ð 2004/22/EC 
ANNEX I  
ESSENTIAL REQUIREMENTS 
A measuring instrument shall pr ovide a high level of metrological  protection in order that any 
party affected can have confid ence in the result of measurem ent, and shall be designed and 
manufactured to a high level of  quality in respect of the measurement technology and security 
of the measurement data. 
 
Ð 2004/22/EC (adapted) 
The ⌦ essential ⌫ requirements that shall be met by measuring instruments are set out 
below and are supplemented, where appropriate,  by specific instrument requirements in 
Annexes MI -001 to MI -010 III to XII  that provide more detail  on certain aspects of the 
general requirements. 
The solutions adopted in the pursuit of the ⌦ essential ⌫ requirements shall take account of 
the intended use of the instrument and any foreseeable misuse thereof. 
 
Ð 2004/22/EC 
DEFINITIONS 
Measurand  The measurand is the particular quantity subject to measurement. 
Influence 
quantity  An influence quantity is a quantity that is not the measurand but that 
affects the result of measurement. 
Rated Operating Conditions  The rated operating conditions are the values for the measurand and 
influence quantities making up the normal working conditions of an instrument. 
Disturbance  An influence quantity having a value within the limits specified in the 
appropriate requirement  but outside the speci fied rated operating 
conditions of the measuring instrument. An influence quantity is a disturbance if for that influence quantity the rated operating conditions 
are not specified. 
Critical change value  The critical change value is the value at which the change in the 
measurement result is considered undesirable. 
Material Measure  A material measure is a device inte nded to reproduce or supply in a 
permanent manner during its use one or more known values of a given EN 67   EN quantity. 
Direct sales  A trading transaction is direct sales if: 
– the measurement result serves as the basis for the price to pay 
and; 
– at least one of the pa rties involved in the transaction related to 
measurement is a consumer or  any other party requiring a 
similar level of protection and; 
– all the parties in the transaction accept the measurement result 
at that time and place. 
Climatic environments  Climatic environments are the conditions in which measuring 
instruments may be used. To cope with climatic differences between the Member States, a range of temperature limits has been defined. 
Utility  A utility is regarded as a supp lier of electricity, gas, heat or water. 
 
Ð 2004/22/EC (adapted) 
⌦ ESSENTIAL ⌫ REQUIREMENTS 
 
Ð 2004/22/EC 
1. Allowable Errors 
1.1. Under rated operating conditions  and in the absence of a disturbance, the error of 
measurement shall not exceed the maximum perm issible error (MPE) value as laid down in 
the appropriate instrument-specific requirements. 
Unless stated otherwise in the instrument-speci fic annexes, MPE is expressed as a bilateral 
value of the deviation from th e true measurement value. 
1.2. Under rated operating conditions and in the presence of a disturbance, the performance 
requirement shall be as laid down in the a ppropriate instrument-specific requirements. 
Where the instrument is intended to be used in a specified permanent continuous 
electromagnetic field the permitted performance during the radiated electromagnetic field-amplitude modulated test shall be within MPE. 
1.3. The manufacturer shall specify the c limatic, mechanical and electromagnetic 
environments in which the instrument is intended to be used, power supply and other 
influence quantities likely to a ffect its accuracy, taking account of  the requirements laid down 
in the appropriate instrument-specific annexes. EN 68   EN 1.3.1. Climatic environments 
The manufacturer shall specify the upper temper ature limit and the lower temperature limit 
from any of the values in Table 1 unless otherwise specified in the Annexes MI -001 to MI -
010 III to XII , and indicate whether the instrument  is designed for condensing or non-
condensing humidity as well as the intended loca tion for the instrument, i.e. open or closed. 
Table 1 
 Temperature Limits 
Upper temperature limit 30 °C 40 °C 55 °C 70 °C 
Lower temperature limit 5 °C – 10 °C – 25 °C – 40 °C 
 
 1.3.2. (a) Mechanical environments are classifi ed into classes M1 to M3 as described 
below. 
M1  This class applies to instruments used in locations with vibration and shocks of 
low significance, e.g. for instruments fa stened to light supporting structures 
subject to negligible vibrations and shocks transmitted from local blasting or pile-driving activities, sl amming doors, etc. 
M2  This class applies to instruments used in locations with significant or high levels 
of vibration and shock, e.g. transmitted from machines and passing vehicles in 
the vicinity or adjacent to hea vy machines, conveyor belts, etc. 
M3  This class applies to instruments used  in locations where the level of vibration 
and shock is high and very high, e.g. for instruments mounted directly on machines, conveyor belts, etc. 
 
 (b) The following influence quantities shall be considered in relation with 
mechanical environments: 
– Vvibration; 
– Mmechanical shock. 
 1.3.3. (a) Electromagnetic environments are clas sified into classes E1, E2 or E3 as 
described below, unless otherwise laid dow n in the appropriate instrument-specific 
annexes. 
E1  This class applies to instruments used in locations with electromagnetic 
disturbances corresponding to those likely to be found in residential, commercial 
and light industrial buildings. 
E2  This class applies to instruments used in locations with electromagnetic 
disturbances corresponding to those li kely to be found in other industrial EN 69   EN buildings. 
E3  This class applies to instruments s upplied by the battery of a vehicle. Such 
instruments shall comply with the require ments of E2 and the following additional 
requirements: 
– voltage reductions caused by energisi ng the starter-motor circuits of 
internal combustion engines, 
– load dump transients occurring in the event of a discharg ed battery being 
disconnected while the engine is running. 
 
 (b) The following influence quantities shall be considered in relation with 
electromagnetic environments: 
– Vvoltage interruptions, ; 
– Sshort voltage reductions, ; 
– Vvoltage transients on supply lines and/or signal lines, ; 
– Eelectrostatic discharges, ; 
– Rradio frequency electromagnetic fields, ; 
– Cconducted radio frequency electromagnetic  fields on supply lines and/or 
signal lines, ; 
– Ssurges on supply lines a nd/or signal lines. 
1.3.4. Other influence quantitie s to be considered, where appropriate, are: 
– Vvoltage variation, ; 
– Mmains frequency variation, ; 
– Ppower frequency magnetic fields, ; 
– Aany other quantity likely to influence in  a significant way the accuracy of the 
instrument. 
 
Ð 2004/22/EC (adapted) 
1.4. When carrying out the tests as envisaged in this Directive, the following paragraphs  
points  ⌦ shall ⌫ apply: EN 70   EN  
Ð 2004/22/EC 
1.4.1. Basic rules for testing and the determination of errors 
Essential requirements specified in 1.1 and 1.2 sh all be verified for each relevant influence 
quantity. Unless otherwise specified in the a ppropriate instrument-specific annex, these 
essential requirements apply when each influenc e quantity is applied and its effect evaluated 
separately, all other influence quant ities being kept relatively cons tant at their reference value. 
Metrological tests shall be carried  out during or after the applic ation of the influence quantity, 
whichever condition corresponds to the normal opera tional status of the instrument when that 
influence quantity is likely to occur. 
1.4.2. Ambient humidity (a)
 According to the climatic operating environment in which the instrument is intended 
to be used either the damp heat-steady st ate (non-condensing) or damp heat cyclic 
(condensing) test may be appropriate. 
(b) The damp heat cyclic test is appropriat e where condensation is  important or when 
penetration of vapour will be  accelerated by the effect of breathing. In conditions 
where non-condensing humidity is a factor the damp-heat steady state is appropriate. 
2. Reproducibility 
The application of the same meas urand in a different location or  by a different user, all other 
conditions being the same, shall result in the close agreement of successive measurements. 
The difference between the measurement results sh all be small when compared with the MPE. 
3. Repeatability 
The application of the same m easurand under the same conditions of measurement shall result 
in the close agreement of su ccessive measurements. The difference between the measurement 
results shall be small when compared with the MPE. 
4. Discrimination and Sensitivity 
A measuring instrument shall be sufficiently sensitive and the discrimination threshold shall 
be sufficiently low for the intended measurement task. 
5. Durability 
A measuring instrument shall be designed to maintain an adequate  stability of its metrological 
characteristics over a period of time estimat ed by the manufacturer, provided that it is 
properly installed, maintained and used accordi ng to the manufacturer's instruction when in 
the environmental conditions for which it is intended. EN 71   EN 6. Reliability 
A measuring instrument shall be designed to redu ce as far as possible the effect of a defect 
that would lead to an inaccurate measurement result, unless th e presence of such a defect is 
obvious. 
7. Suitability 
7.1. A measuring instrument shall have no feature likely to facilitate fr audulent use, whereas 
possibilities for unintentional misuse shall be minimal. 
7.2. A measuring instrument shall be suitable  for its intended use taking account of the 
practical working conditions and shall not requ ire unreasonable demands of the user in order 
to obtain a correct measurement result. 
7.3. The errors of a utility measuring instrument  at flows or currents outside the controlled 
range shall not be unduly biased. 
7.4. Where a measuring instrument is designed  for the measurement of values of the 
measurand that are constant over time, the measur ing instrument shall be insensitive to small 
fluctuations of the value of the measur and, or shall take appropriate action. 
7.5. A measuring instrument shall be robust and its  materials of construction shall be suitable 
for the conditions in which it is intended to be used. 
7.6. A measuring instrument shall be designed so as to allow the control of the measuring 
tasks after the instrument has been placed on the market and put into use.  If necessary, special 
equipment or software for this control shall be part of the instrument. The test procedure shall 
be described in the operation manual. 
When a measuring instrument has associated so ftware which provides ot her functions besides 
the measuring function, the software that is cr itical for the metrological characteristics shall 
be identifiable and shall not  be inadmissibly influenced by the associated software. 
8. Protection against corruption 
8.1. The metrological characteristic s of a measuring instrument sh all not be influenced in any 
inadmissible way by the connection to it of anot her device, by any feature of the connected 
device itself or by any remote device that co mmunicates with the measuring instrument. 
8.2. A hardware component that is critical for me trological characteristic s shall be designed so 
that it can be secured. Secu rity measures foreseen shall provide for evidence of an 
intervention. 
8.3. Software that is critical fo r metrological characteristics sh all be identified as such and 
shall be secured. 
Software identification shall be easily provided by the measuring instrument. 
Evidence of an intervention shall be ava ilable for a reasonab le period of time. EN 72   EN 8.4. Measurement data, software that is cr itical for measurement characteristics and 
metrologically important parameters stored or transmitted shall be adequately protected against accidental or intentional corruption. 
8.5. For utility measuring instruments the display of the total quantity su pplied or the displays 
from which the total quantity supplied can be de rived, whole or partial reference to which is 
the basis for payment, shall not be  able to be reset during use. 
9. Information to be borne by and to accompany the instrument 
9.1. A measuring instrument shall bear the following inscriptions: 
(a)
 manufacturer's mark or name; 
(b) information in respect of its accuracy, 
 
Ð 2004/22/EC (adapted) 
plus ⌦ and ⌫ , when applicable: 
 
Ð 2004/22/EC 
(c) information in respect of the conditions of use; 
(d) measuring capacity; 
(e) measuring range; 
(f) identity marking; 
 
Ð 2004/22/EC (adapted) 
(g) number of the EC -type ⌦ EU-type ⌫ examination certificate or the EC  ⌦ EU ⌫ 
design examination certificate; 
 
Ð 2004/22/EC 
(h) information whether or not additional de vices providing metrological results comply 
with the provisions of this Directive on legal metrological control. 
9.2. An instrument of dimensions too small or of too sensitive a composition to allow it to 
bear the relevant information shall have  its packaging, if any, and the accompanying 
documents required by the provisions of  this Directive suitably marked. EN 73   EN 9.3. The instrument shall be accompanied by information on its operation, unless the 
simplicity of the measuring instrument makes this unnecessary. Information shall be easily 
understandable and shall include where relevant: 
(a) rated operating conditions; 
(b) mechanical and electromagnetic environment classes; 
(c) the upper and lower temperature limit, whet her condensation is possible or not, open 
or closed location; 
(d) instructions for installation, maintenan ce, repairs, permissible adjustments; 
(e) instructions for correct operation and any special conditions of use; 
(f) conditions for compatibility with interfaces, sub-assemblies or measuring 
instruments. 
9.4. Groups of identical measuring instruments used  in the same location or used for utility 
measurements do not necessarily requ ire individual instruction manuals. 
9.5. Unless specified otherwise in an instrument-specific a nnex, the scale interval for a 
measured value shall be in the form 1×10n, 2×10n, or 5×10n, where n is any integer or zero. 
The unit of measurement or its symbol shal l be shown close to the numerical value. 
9.6. A material measure shall be marked with a nominal value or a scale, accompanied by the 
unit of measurement used. 
 
Ð 2004/22/EC (adapted) 
9.7. The units of measurement used and their symbols shall be in accordance with the 
provisions of Community  ⌦ Union ⌫ legislation on units of measurement and their 
symbols. 
 
Ð 2004/22/EC 
9.8. All marks and inscriptions required under a ny requirement shall be  clear, non-erasable, 
unambiguous and non-transferable. 
10. Indication of result 
10.1. Indication of the result shall be by means of a display or hard copy. 
10.2. The indication of a ny result shall be clear and unambiguous and accompanied by such 
marks and inscriptions necessary to inform the user of the significance of the result. Easy 
reading of the presented result shall be perm itted under normal conditions of use. Additional 
indications may be shown pr ovided they cannot be confus ed with the metrologically 
controlled indications. EN 74   EN 10.3. In the case of hard copy the print or record shall also be  easily legible and non-erasable. 
10.4. A measuring instrument for di rect sales trading transactions  shall be designed to present 
the measurement result to both parties in the transaction when installed as intended. When critical in case of direct sale s, any ticket provided to the cons umer by an ancillary device not 
complying with the appropriate requireme nts of this Directive shall bear an
 appropriate 
restrictive information. 
10.5. Whether or not a measuring instrument in tended for utility measurement purposes can 
be remotely read it shall in any case be fi tted with a metrologically controlled display 
accessible without tools to the consumer. The r eading of this display is the measurement 
result that serves as the basis for the price to pay. 
11. Further processing of data to conclude the trading transaction 
11.1. A measuring instrument other than a uti lity measuring instrument shall record by a 
durable means the measurement result accompanie d by information to identify the particular 
transaction, when: 
(a) the measurement is non-repeatable and; 
(b) the measuring instrument is normally inte nded for use in the ab sence of one of the 
trading parties. 
11.2. Additionally, a durable proof of the measurement result and the information to identify 
the transaction shall be available on request  at the time the measurement is concluded. 
12. Conformity evaluation 
A measuring instrument shall be designed so as  to allow ready evaluation of its conformity 
with the appropriate requirements of this Directive. 
 
Ð 2004/22/EC (adapted) 
Ö new 
ANNEX AII 
⌦ 1. MODULE A : ⌫ DECLARATION OF CONFORMITY BASED ON  INTERNAL 
PRODUCTION CONTROL 
1. The ‘declaration of confor mity based on  iInternal production control’  is the conformity 
assessment procedure whereby the manufacturer fu lfils the obligations laid down in this 
Annex  points 2, 3 and 4,  and ensures and declares that the measuring instruments concerned 
satisfy the appropriate require ments of this Directive. 
2. TECHNICAL DOCUMENTATION  
2. The manufacturer shall establish the techni cal documentation as described in Article 10 19. 
The documentation shall enable  ⌦ make it possible to assess ⌫ asse ssment of the 
conformity of  the instrument  ⌦ instrument’s conformity to the relevant ⌫ with the EN 75   EN appropriate  requirements of this Directive  ⌦ , and ⌫ . It shall,  Ö include an adequate 
analysis and assessment of the risks.  Ö The technical documentation shall specify the 
applicable requirements and cover,  as far as relevant for such  ⌦ the ⌫ assessment, cover  
the design, manufacture and ope ration of the instrument. 
3. The manufacturer shall keep the technical do cumentation at the disposal of the national 
authorities for ten years after the la st instrument has been manufactured.  
3. MANUFACTURING  
4. The manufacturer shall ta ke all measures necessary ⌦ so that the manu facturing process 
and its monitoring ⌫ to ensure conformity  ⌦ compliance ⌫ of the manufactured 
instruments with the appropriate requirements  ⌦ technical documentation referred to in point 
2 and with the requirements ⌫ of this Directive  ⌦ the Directives that apply to it ⌫ . 
4. WRITTEN  ⌦ CONFORMITY MARKING AND  ⌫ DECLARATION OF CONFORMITY  
54.1. The manufacturer shall affix the ‘CE’  ⌦ CE ⌫ marking and the supplementary 
metrology marking to each measuring instrument that satisfies the appropriate requirements of this Directive. 
5
4.2. ⌦ The manufacturer shall draw up a ⌫ A ⌦ written ⌫ declaration of conformity is 
drawn up  for an instrument m odel and shall be kept  ⌦ keep it together with the technical 
documentation ⌫ at the disposal of the national authorities for ten years after the las t 
instrument has been manufactured  Ö placed on the market  . It ⌦ The declaration of 
conformity ⌫ shall identify the instrume nt for which it was drawn up. 
 
Ø new 
A copy of the declaration of conformity shall be  made available to th e relevant authorities 
upon request. 
 
Ð 2004/22/EC 
A copy of the declaration shall be supplied with  each measuring instrument that is placed on 
the market. However, this requirement may be interpreted as applying to a batch or 
consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. EN 76   EN 5. AUTHORISED REPRESENTATIVE  
 
Ð 2004/22/EC (adapted) 
Ö new 
6. The manufacturer's obligations contained in paragraphs 3 and 5.2  ⌦ set out in point 4 ⌫ 
may be fulfilled ⌦ by his authorised representative ⌫, on his behalf and under his 
responsibility, by his aut horised representative  Ö provided that they are specified in the 
mandate  . 
 
Ð 2004/22/EC 
Where the manufacturer is not established within the Community and where he does not have 
an authorised representative, the obligations contained in paragraphs  3 and 5.2 shall be the 
responsibility of the person who pl aces the instrument on the market.  
 
Ð 2004/22/EC (adapted) 
ANNEX A1  
⌦ 2. MODULE A2: ⌫ DECLARATION OF CONFORMITY BASED ON  
INTERNAL PRODUCTION CONTROL PLUS ⌦ SUPERVISED INSTRUMENT 
CHECKS AT RANDOM INTERVALS ⌫ PRODUCT TESTING BY A NOTIFIED 
BODY  
 
Ð 2004/22/EC 
1. ‘Declaration of co nformity based on internal producti on control plus product testing by a 
notified body’ is the conformity assessment pr ocedure whereby the manufacturer fulfils the 
obligations laid down in this Annex, and ensure s and declares that th e measuring instruments 
concerned satisfy the appropriate requirements of this Directive.  
 
Ø new 
1. Internal production control plus  supervised instrument checks at random intervals is the 
conformity assessment procedure whereby the ma nufacturer fulfils the obligations laid down 
in points 2, 3, 4, and 5, and ensures and declares on his sole responsibility that the measuring 
instruments concerned satisfy the requirement s of this Directive that apply to them. EN 77   EN  
Ð 2004/22/EC (adapted) 
Ö new 
2. TECHNICAL DOCUMENTATION  
2. The manufacturer shall establish the techni cal documentation as described in Article 10 19. 
The documentation shall enable  ⌦ make it possible to assess ⌫ assessment  of the 
⌦ instrument’s ⌫ conformity of the instrument  with the appropriate  ⌦ relevant ⌫ 
requirements Ö , and shall include an adequate an alysis and assessment of the risk(s)  of 
this Directive . It shall  ⌦ The technical documentation shall specify the applicable 
requirements and cover ⌫ , as far as relevant for such  ⌦ the ⌫ assessment, cover  the 
design, manufacture and operation of the instrument. 
3. The m anufacturer shall keep the technical docume ntation at the disposal of the national 
authorities for 10 years af ter the last instrument has been manufactured.  
3. MANUFACTURING  
4. The manufacturer shall ta ke all measures necessary ⌦ so that the manu facturing process 
and its monitoring ⌫ to ensure conformity  ⌦ compliance ⌫ of the manufactured 
instruments with the appropriate requirements  ⌦ technical documentation referred to in point 
2 and with the requirements ⌫ of this Directive  ⌦ the Directives that apply to them ⌫ . 
4. PRODUCT  ⌦ INSTRUMENT  ⌫ CHECKS  
5. A notified body, chosen by the manu facturer, shall carry out product  ⌦ instrument ⌫ 
checks or have them carried out in ap propriate intervals determined by it  ⌦ the body ⌫ , in 
order to verify the quality of th e internal checks of the product  ⌦ instrument ⌫, taking into 
account inter alia the technol ogical complexity of the inst ruments and the quantity of 
production. An adequate sample of the final products  ⌦ measuring instruments ⌫ , taken 
⌦ on site ⌫ by the notified  body before the placing on the ma rket, shall be examined and 
appropriate tests as identified by the rele vant document(s) referred to in Article 13  ⌦ parts of 
the harmonised standard, normative doc ument and/or techni cal specifications, ⌫ or 
equivalent tests, shall be carried out to chec k the conformity of the instruments with the 
appropriate  ⌦ relevant ⌫ requirements of this Directive.  In the absence of a relevant 
document, the notified body concerned shall decide  on the appropriate test s to be carried out. 
 
Ð 2004/22/EC 
In those cases where a relevant number of instruments in the sample do not conform to an 
acceptable quality level, the notified body shall take appropriate measures. EN 78   EN  
Ø new 
Where the tests are carried out by a notif ied body, the manufacturer shall, under the 
responsibility of the notified body, affix the notified body' s identification number during the 
manufacturing process. 
 
Ð 2004/22/EC (adapted) 
Ö new 
5. WRITTEN  ⌦ CONFORMITY MARKING AND  ⌫ DECLARATION OF CONFORMITY  
65.1. The manufacturer shall affix the ‘CE’  ⌦ CE ⌫ marking,  ⌦ and ⌫ the 
supplementary metrology marking and, under the responsibility of the notified body referred 
to in paragraph 5, the latter's identification number  ⌦ set out in this Directive ⌫ to each 
measuring  ⌦ individual ⌫ instrument that satisfies the appropriate  ⌦ applicable ⌫ 
requirements of this Directive. 
65.2. ⌦ The manufacturer shall draw up ⌫ Aa ⌦ written ⌫ declaration of conformity is 
drawn up  for each  ⌦ an ⌫ instrument model and shall be kept  ⌦ keep it together with the 
technical documentation ⌫ at the disposal of the national authorities for ten years after the 
last instrument has been manufactured  Ö placed on the market  . It ⌦ The declaration of 
conformity ⌫ shall identify the model of  the instrument ⌦ model ⌫ for which it was 
drawn up. 
 
Ø new 
A copy of the declaration of conformity shall be  made available to th e relevant authorities 
upon request. 
 
Ð 2004/22/EC 
A copy of the declaration shall be supplied with  each measuring instrument that is placed on 
the market. However, this requirement may be interpreted as applying to a batch or 
consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. 
6.
 Authorised representative 
 
Ð 2004/22/EC (adapted) 
Ö new 
7. The manufacturer's obligations contained in paragraphs 3 and 6.2  ⌦ set out in point 5 ⌫ 
may be fulfilled ⌦ by his authorised representative ⌫ , on his behalf and under his EN 79   EN responsibility, by his aut horised representative  Ö provided that they are specified in the 
mandate  . 
 
Ð 2004/22/EC 
Where the manufacturer is not established within the Community and w here he does not have 
an authorised representative, the obligations contained in paragraphs  3 and 6.2 shall be the 
responsibility of the person who pl aces the instrument on the market.  
 
Ð 2004/22/EC (adapted) 
3. ANNEX  ⌦ MODULE ⌫ B: ⌦ EU- ⌫ TYPE EXAMINATION 
1. ‘ ⌦ EU- ⌫ Ttype examination’ is the part of a c onformity assessment procedure whereby  
⌦ in which ⌫ a notified body examines the technical design of ⌦ an ⌫ a m easuring  
instrument and ensures and declares  ⌦ verifies and attests ⌫ that the technical design ⌦ of 
the instrument ⌫ meets the appropriate  requirements of this Directive ⌦ that apply to it ⌫ 
. 
2. ⌦ EU- ⌫ Ttype examination may be carried out in  either of the fo llowing manners.  
 
Ð 2004/22/EC 
The notified body decides on the appropriate manner and the specimens required: 
 
Ð 2004/22/EC (adapted) 
 (a) examination of a specimen, representative of the production envisaged, of 
the complete measuring instrument ⌦ (production type) ⌫ , 
 (b) e xamination of specimens, representative of the production envisaged, of 
one or more critical parts of  the measuring instrument, plus  assessment of the 
adequacy of the technical design of  the other parts of the measuring  instrument 
through examination of the technical documentation and supporting evidence 
referred to in paragraph  point  3, ⌦ plus examination of specimens, 
representative of the produc tion envisaged, of one or mo re critical parts of the 
instrument (combination of pr oduction type and design type) ⌫ ; 
 (c) assessment of the ad equacy of the technical design of the measuring  
instrument through examination of the technical documentation and supporting 
evidence referred to in paragraph  point  3, without examina tion of a specimen 
⌦ (design type) ⌫ . EN 80   EN 3. The ⌦ manufacturer ⌫ application for type examination  shall ⌦ lodge an application 
for EU-type examination ⌫ be lodged by the manufacturer  with a ⌦ single ⌫ notified 
body of his choice. 
 
Ð 2004/22/EC 
The application shall include: 
 
Ð 2004/22/EC (adapted) 
– the name and address of the manufacture r and, if the app lication is lodged by 
the authorised representative, his name and address in addition  ⌦ as well ⌫ ; 
 
Ð 2004/22/EC 
– a written declaration that the same app lication has not been lodged with any 
other notified body; 
 
Ð 2004/22/EC (adapted) 
Ö new 
– the technical documentation as described in Article 1019 . The ⌦ technical ⌫ 
documentation shall enable assessment of  ⌦ make it possible to assess ⌫ the 
⌦ instrument’s ⌫ conformity of the instrument  with the appropriate  
⌦ applicable ⌫ requirements of this Directive. It  ⌦ and ⌫ shall 
⌦ include an adequate analysis and assessment of the risk(s). The technical 
documentation shall specify the app licable requirements and cover, ⌫ as far 
as relevant for such  ⌦ the ⌫ assessment, cover  the design, manufacture and 
operation of the instrument; . 
⌦ The technical documentation shall in addition contain, wherever applicable: ⌫ 
– the specimens, representative of the production envisaged, . as required by  tThe 
notified body Ö may request further specimens if needed for carrying out the 
test programme  ; 
– the supporting evidence for the ade quacy of the technical design 
⌦ solution ⌫ of those parts of the measur ing instrument for which no 
specimens are required . This supporting evidence shall mention any relevant  
documents that have been applied  ⌦ used ⌫ , in particular where the relevant 
⌦ harmonised standards, normative ⌫ documents ⌦ and/or technical 
specifications ⌫ referred to in Article 13  have not been applied in full, . and 
⌦ The supporting evidence ⌫ shall include, where n ecessary, the results of 
tests carried out by the appropriate laboratory of the manufacturer, or by 
another testing laboratory on his be half and under his responsibility. EN 81   EN  
Ð 2004/22/EC 
4. The notified body shall: 
 
Ø new 
For the instrument: 
4.1. examine the technical documentation and s upporting evidence to a ssess the adequacy of 
the technical design of the instrument; 
 
Ð 2004/22/EC (adapted) 
For the specimen( s): 
4.12. examine the tec hnical documentation,  verify that the specimen( s) have been 
manufactured in conformity with it  ⌦ the technical documentation ⌫ and identify the 
elements which have been designed in accordance with the relevant  ⌦ applicable ⌫ 
provisions of the relevant ⌦ harmonised standards, normative ⌫ documents ⌦ and/or 
technical specifications ⌫ referred to in Article 13 , as well as the elements which have been 
designed without applying the rele vant provisions of those documents  ⌦ standards ⌫ ; 
4.23. carry out the  appropriate examinations and tests, or have them carried out, to check 
whether, where the manufacturer has chosen to apply the solutions in the relevant 
⌦ harmonised standards, normative ⌫ documents ⌦ and/or technical specifications ⌫ 
referred to in Article 13 , these have been applied correctly; 
4.34. carry out the  appropriate examinations and tests, or have them carried out, to check 
whether, where the manufacturer has chosen not to apply  the solutions in the relevant 
⌦ harmonised standards, normative ⌫ documents ⌦ and/or technical specifications have 
not been applied ⌫ referred to in Article 13 , the solutions adopted by the manufacturer meet 
the corresponding essential requi rements of this Directive; 
4.45. agree with the applicant  ⌦ manufacturer ⌫ on the location where the examinations 
and tests shall  ⌦ will ⌫ be carried out. 
 
Ð 2004/22/EC 
For the other parts of the measuring instrument: 
4.56. examine the technical documentation and supporting evidence to assess the adequacy of 
the technical design of the other pa rts of the measuring instrument. 
For the manufacturing process:  EN 82   EN 4.6. examine the technical documentation to assure  that the manufacturer has adequate means 
to ensure consistent production.  
 
Ð 2004/22/EC (adapted) 
5.1. The notified body shall draw up an evaluati on report that record s the activities as  
undertaken in accordance with paragraph  point  4 and their outcomes.  Without prejudice to 
Article 12(8)  ⌦ its obligations vis-à-vis, the notifying authorities ⌫ , the notified body shall 
release the content of this report, in full or in part, only with the agreement of the manufacturer. 
5.2
6. Where the technical design  ⌦ type ⌫ meets the requirements of this Directive that 
apply to the measuring instrument , the notified body shall issue an EC -type ⌦ EU-type ⌫ 
examination certificate to the manufacturer. The certificate shall contain the name and address 
of the manufacturer and, if  appropriate, of his au thorised representative , the conclusions of the 
examination, the  conditions (if any) for its validity and the necessary data for identification of 
the instrument  ⌦ approved type ⌫ . The certificate may have one or more annexes attached. 
The certificate and its annexes shal l contain all relevant information ⌦ to allow ⌫ for the 
conformity evaluation and  ⌦ of manufactured measuring in struments with the examined 
type to be evaluated and to allow for ⌫ in-service control. In particular, to allow the 
conformity of manufactured inst ruments to be evaluated with the examined type regarding the 
reproducibility of their metrologi cal performances, when they are properly adjusted using 
appropriate means, content shall include: 
 
Ð 2004/22/EC 
– the metrological characteristics of the type of instrument; 
– measures required for ensuring the inte grity of the instruments (sealing, 
identification of software, etc.); 
– information on other elements necessary for the identification of the 
instruments and to check their visu al external conformity to type; 
– if appropriate, any specific information necessary to verify the characteristics 
of manufactured instruments; 
– in the case of a sub-assembly, all necessary information to ensure the 
compatibility with other sub-assemblies or measuring instruments. 
The certificate shall have a validity of ten ye ars from the date of its issue, and may be 
renewed for subsequent pe riods of ten years each. EN 83   EN  
Ø new 
Where the type does not satisfy the applicable requirements of this Directive, the notified 
body shall refuse to issue an EU-type examina tion certificate and shall inform the applicant 
accordingly, giving detailed reasons for its refusal. 
7. The notified body shall keep itself apprised of  any changes in the generally acknowledged 
state of the art which indica te that the approved type may no longer comply with the 
applicable requirements of this Directive, a nd shall determine whethe r such changes require 
further investigation. If so, the notified body shall inform the manufacturer accordingly. 
 
Ð 2004/22/EC 
5.3. The notified body shall establish an evaluation report in this regard  and keep it at the 
disposal of the Member State that designated it.  
 
Ð 2004/22/EC (adapted) 
68. The manufacturer shall inform the notifie d body that holds the technical documentation 
concerning  the EC -type ⌦ relating to the EU-type ⌫ examination certificate of all 
modifications to the ⌦ approved type ⌫ instrument  that may affect the conformity of the 
instrument with the essential requirements or the conditions for validity of the certificate  
⌦ of this Directive ⌫ . Such modifications require add itional approval in the form of an 
addition to the original EC -type ⌦ EU-type ⌫ examination certificate. 
79. Each notified body shall imme diately inform the Member St ate that designa ted it about:  
⌦ its notifying authorities concerning the ⌫ 
EC-type ⌦ EU-type ⌫ examination certificates and ⌦ /or ⌫ annexes issued;  
⌦ any ⌫ additions and amendments rela ting to certificates already  ⌦ thereto which it 
has ⌫ issued.  
 
Ø new 
or withdrawn, and shall, periodically or upon request, make available to its notifying 
authorities the list of certific ates and/or any additions theret o refused, suspended or otherwise 
restricted. 
The Commission, the Member Stat es and the other notified bodi es may, on request, obtain a 
copy of the EU-type examination certificates and/or additions thereto. On request, the 
Commission and the Member St ates may obtain a copy of the technical documentation and 
the results of the examinations  carried out by the notified body. EN 84   EN  
Ð 2004/22/EC 
Each notified body shall immediately inform th e Member State that designated it of the 
withdrawal of an EC -type examination certificate.  
 
Ð 2004/22/EC (adapted) 
Ö new 
The notified body shall hold  ⌦ keep a copy of the EU-type examination certificate, its 
annexes and additions, as well as ⌫ the technical file including the documentation submitted 
by the manufacturer fo r a period up to the end  ⌦ until the expiry ⌫ of the validity of the 
certificate. 
89. The manufacturer shall keep a copy of the EC -type ⌦ EU-type ⌫ examination 
certificate, its annexes and additions ⌦ together ⌫ with the technical documentation ⌦ at 
the disposal of the national authorities ⌫ for 10 years after the last measuring  instrument has 
been manufactured  Ö placed on the market  . 
910. The manufacturer's authorised representative  may lodge the application referred to in 
paragraph  point  3 and carry out  ⌦ fulfil ⌫ the obligations mentioned in paragraphs 6 and 8  
⌦ set out in points 7 and 9, provided that  they are specified in the mandate ⌫ . Where the 
manufacturer is not established within th e Communities and where he does not have an 
authorised representative, the obligatio n to make the technical documentation a vailable on 
request shall be the responsibility of the person designated by the manufacturer.  
 
Ð 2004/22/EC (adapted) 
Ö new  
4. ANNEX  ⌦ MODULE ⌫ C: 
DECLARATION OF  CONFORMITY TO TYPE  BASED ON INTERNAL 
PRODUCTION CONTROL 
1. ‘Declaration of  cConformity to type based on internal production control’ is the part of a 
conformity assessment procedure whereby the ma nufacturer fulfils the obligations laid down 
in this Annex  points 2 and 3  and ensures and declares that the measuring instruments 
concerned are in conformity with the type as described in the EC -type ⌦ EU-type ⌫ 
examination certificate and satisfy the appropriate  requirements of this Directive ⌦ that 
apply to them ⌫ . 
2. Manufacturing 
2. The manufacturer shall take  all measures necessary to  ⌦ so that the manuf acturing process 
and its monitoring ⌫ ensure conformity of the manufactured ⌦ measuring ⌫ instruments 
with the ⌦ approved ⌫ type as  described in the EC -type ⌦ EU-type ⌫ examination 
certificate and with the appropriate  requirements of this Directive ⌦ that apply to them ⌫. EN 85   EN 3. Written  ⌦ Conformity marking and ⌫ declaration of conformity 
3.1. The manufacturer shall affix the ‘CE’  ⌦ CE ⌫ marking and the supplementary 
metrology marking ⌦ set out in this Directive ⌫ to each ⌦ individual ⌫ measuring  
instrument that is in conformity with the type as  described in the EC -type ⌦ EU-type ⌫ 
examination certificate and satisfies the ap propriate  ⌦ applicable ⌫ requirements of this 
Directive. 
3.2. ⌦ The manufacturer shall draw up ⌫ Aa ⌦ written ⌫ declaration of conformity is 
drawn up  for each  ⌦ an ⌫ instrument model and shall be kept  ⌦ keep it ⌫ at the disposal 
of the national authorities for 10 years after the last  instrument has been manufactured  
Ö placed on the market  . It  ⌦ The declaration of conformity ⌫ shall identify the 
instrument model for which it was drawn up. 
 
Ø new 
A copy of the declaration of conformity shall be  made available to th e relevant authorities 
upon request. 
 
Ð 2004/22/EC  
A copy of the declaration shall be supplied with  each measuring instrument that is placed on 
the market. However, this requirement may be interpreted as applying to a batch or 
consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. 
4.
 Authorised representative 
 
Ð 2004/22/EC (adapted) 
Ö new 
4. The manufacturer's obligati ons contained in paragraph 3.2  ⌦ set out in point 3 ⌫ may be 
fulfilled ⌦ by his authorised representative ⌫ , on his behalf and unde r his responsibility, 
by his authorised representative  Ö provided that they are specified in the mandate  . 
 
Ð 2004/22/EC 
Where the manufacturer is not established with in the Community and where he does not have 
an authorised representative , the obligation mentioned in  paragraph 3.2 shall be the 
responsibility of the person who places the in strument on the market.  EN 86   EN  
Ð 2004/22/EC (adapted) 
5. ANNEX  ⌦ MODULE ⌫ C12: 
DECLARATION OF  CONFORMITY TO TYPE  BASED ON INTERNAL 
PRODUCTION CONTROL PLUS PRODUCT  TESTING BY A NOTIFIED BODY  
⌦ SUPERVISED INSTRUMENT CHECKS AT RANDOM INTERVALS ⌫ 
1. ‘Declaration of  cConformity to type based on intern al production control plus product 
testing by a notified body’  ⌦ supervised instrument checks at random intervals ⌫ is the part 
of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid 
down in this Annex  points 2, 3 and 4,  and ensures and declares ⌦ on his sole 
responsibility ⌫ that the measuring instruments concerned are in conformity with the type as  
described in the EC -type ⌦ EU-type ⌫ examination certificate and satisfy the appropriate  
requirements of this Directive ⌦ that apply to them ⌫ . 
2. Manufacturing 
2. The manufacturer shall take  all measures necessary to  ⌦ so that the manuf acturing process 
and its monitoring ⌫ ensure conformity of the manufactured ⌦ measuring ⌫ instruments 
with the type as  described in the EC -type ⌦ EU-type ⌫ examination certificate and with the 
appropriate  requirements of this Directive. 
3. Product  ⌦ Instrument ⌫ checks 
3. A notified body, chosen by the manu facturer, shall carry out product  ⌦ instrument ⌫ 
checks or have them carried out in ap propriate intervals determined by it  ⌦ the body ⌫ , in 
order to verify the quality of th e internal checks of the product  ⌦ on the instrument ⌫ , 
taking into account inter alia  the technological complexity of the ⌦ measuring ⌫ 
instruments and the quantity of production. An adequate sample of the final products  
⌦ measuring instrument ⌫ , taken ⌦ on site ⌫ by the notified body be fore the placing on 
the market, shall be examined and appropriate tests, as identified by the relevant ⌦ parts of 
the harmonised standards, normative ⌫ documents ⌦ and/or technical specifications ⌫ 
referred to in Article 13 , or equivalent tests, shall be carrie d out to check the conformity of the 
product  ⌦ instrument ⌫ with the type as described in the EC -type ⌦ EU-type ⌫ 
examination certificate and the appropriate  ⌦ relevant ⌫ requirements of the  ⌦ this ⌫ 
Directive. In the absence of a rel evant document, the notified body concerned shall decide on 
the appropriate tests to be carried out.  
In those cases  wWhere a relevant number of instruments in the  sample does  not conform to an 
acceptable quality level, the notified body shall take appropriate measures. 
 
Ø new 
The acceptance sampling procedure to be applie d is intended to determine whether the 
manufacturing process of the in strument performs within acceptable limits, with a view to 
ensuring conformity of the instrument. EN 87   EN Where the tests are carried out by a notif ied body, the manufacturer shall, under the 
responsibility of the notified body, affix the notified body' s identification number during the 
manufacturing process. 
 
Ð 2004/22/EC (adapted) 
Ö new 
4. ⌦ Conformity marking and ⌫ Written  declaration of conformity 
4.1. The manufacturer shall affix the ‘CE’  ⌦ CE ⌫ marking, the supplementary metrology 
marking and, under the responsibility of the noti fied body referred to in paragraph 3, the 
latter's identification number,  ⌦ set out in this Directive ⌫ to each measuring  instrument 
that is in conformity with the type as  described in the EC -type ⌦ EU-type ⌫ examination 
certificate and satisfies the appropriate  ⌦ applicable ⌫ requirements of this Directive. 
4.2. ⌦ The manufacturer shall draw a up a written ⌫ a declaration of conformity is drawn 
up for each  ⌦ an ⌫ instrument model and shall be kept  ⌦ keep it ⌫ at the disposal of the 
national authorities for 10 years after the last  instrument has been manufactured  Ö placed on 
the market . It ⌦ The declaration of conformity ⌫ shall identify the model of  the 
instrument ⌦ model ⌫ for which it was  ⌦ has been ⌫ drawn up. 
 
Ø new 
A copy of the declaration of conformity shall be  made available to th e relevant authorities 
upon request. 
 
Ð 2004/22/EC 
A copy of the declaration shall be supplied with  each measuring instrument that is placed on 
the market. However, this requirement may be interpreted as applying to a batch or 
consignment rather than individual instruments in those cases where a large number of 
instruments is delivered to a single user. 
5. Authorised representative 
 
Ð 2004/22/EC (adapted) 
Ö new 
5. The manufacturer's obligati ons contained in paragraph 4.2  ⌦ set out in point 4 ⌫ may be 
fulfilled ⌦ by his authorised representative ⌫ , on his behalf and unde r his responsibility, 
by his authorised representative  Ö provided that they are specified in the mandate  . EN 88   EN  
Ð 2004/22/EC 
Where the manufacturer is not established with in the Community and where he does not have 
an authorised represen tative, the obligations mentione d in paragraph 4.2 shall be the 
responsibility of the person who pl aces the instrument on the market.  
 
Ð 2004/22/EC (adapted) 
6. ANNEX  ⌦ MODULE ⌫ D: 
DECLARATION OF  CONFORMITY TO TYPE BA SED ON QUALITY ASSURANCE 
OF THE PRODUCTION PROCESS 
1. ‘Declaration of  cConformity to type based on quality  assurance of the production process’  
is the part of a conformity assessment pr ocedure whereby the manufacturer fulfils the 
obligations laid down in this Annex  points 2 and 5,  and ensures and declares ⌦ on his sole 
responsibility ⌫ that the measuring instruments concerned are in conformity with the type as  
described in the EC -type ⌦ EU-type ⌫ examination certificate and satisfy the appropriate  
requirements of this Directive ⌦ that apply to them ⌫ . 
2. Manufacturing 
2. The manufacturer shall oper ate an approved quality syst em for production, final product  
⌦ instrument ⌫ inspection and testing of  the measuring instrument concerned as specified 
in paragraph  point  3 and shall be subject to survei llance as specified in paragraph  point  4. 
3. Quality system 
3.1. The manufacturer shall lodge an application for assessment of the  ⌦ his ⌫ quality 
system with a notified body of his choice ⌦ , for the measuring instruments concerned ⌫ . 
 
Ð 2004/22/EC 
The application shall include: 
 
Ø new 
– the name and address of the manufacture r and, if the app lication is lodged by 
the authorised representative, his name and address as well, 
– a written declaration that the same app lication has not been lodged with any 
other notified body, EN 89   EN  
Ð 2004/22/EC  
– all relevant information for the instrument category envisaged; 
– the documentation concerning the quality system; 
 
Ð 2004/22/EC (adapted) 
– the technical documentation of the approved type and a copy of the EC -type 
⌦ EU-type ⌫ examination certificate. 
 
Ð 2004/22/EC (adapted) 
Ö new 
3.2. The quality system shall ensure compliance of  ⌦ that the measuring ⌫ the instruments 
⌦ are in conformity ⌫ with the type as  described in the EC -type ⌦ EU-type ⌫ 
examination certificate and ⌦ comply with ⌫ the appropriate  requirements of this Directive 
⌦ that apply to them ⌫ . 
All the elements, requirements and provisi ons adopted by the manufacturer shall be 
documented in a systematic and orderly manner in  the form of written policies, procedures 
and instructions. This quality system documentation must  Ö shall  permit a consistent 
interpretation of the quality progra mmes, plans, manuals and records. 
It shall ⌦ , in particular, ⌫ contain in particular  an adequate description of: 
– the quality objectives and the organisational structure, responsibilities and 
powers of the management with regard to product  ⌦ instrument ⌫ quality; 
– the ⌦ corresponding ⌫ manufacturing, quality cont rol and quality assurance 
techniques, processes and systematic actions that will be used; 
– the examinations and test s that will be carried out  before, during, and after 
manufacture, and the frequency with which they will be carried out; 
– the quality records, such as inspection reports and test data, calibration data, 
qualification reports of  ⌦ on ⌫ the personnel concerned, etc; 
– the means to monitor  ⌦ of monitoring ⌫ the achievement of the required 
product  ⌦ instrument ⌫ quality and the effectiv e operation of the quality 
system. 
3.3. The notified body shall assess the quality system to determ ine whether it satisfies the 
requirements referred to in paragraph  point  3.2.  
It shall presume conformity with these  ⌦ those ⌫ requirements in respect of ⌦ the 
elements of the ⌫ a quality system that complies  ⌦ comply ⌫ with the corresponding EN 90   EN specifications of the national standard that impl ements the relevant harmonised standard, from 
the moment its references have been published  ⌦ and/or technical specifications ⌫ . 
In addition to experience in quality manage ment systems, the auditing team shall poss ess 
appropriate  ⌦ have at least one member with ⌫ experience ⌦ of evaluation ⌫ in the 
relevant ⌦ instrument ⌫ field of metrology  and instrument technology ⌦ concerned ⌫ , 
and knowledge of the applicable requirements of  this Directive. Th e evaluation procedure  
⌦ audit ⌫ shall include an inspection  ⌦ assessment ⌫ visit to the manufacturer's 
premises. 
 
Ø new 
The auditing team shall review the technical  documentation referred to in point 3.1, fifth 
indent, to verify the manufacturer's ability to  identify the relevant requirements of this 
Directive and to carry out the necessary examin ations with a view to  ensuring compliance of 
the instrument with those requirements. 
 
Ð 2004/22/EC (adapted) 
The decision shall be notified to the manuf acturer. The notification shall contain the 
conclusions of the examination  ⌦ audit ⌫ and the reasoned assessment decision. 
 
Ð 2004/22/EC 
3.4. The manufacturer shall undertake to fulfil the obl igations arising out of  the quality system 
as approved and to maintain it so th at it remains adequate and efficient. 
3.5. The manufacturer shall keep the notified body that has approved the quality system 
informed of any intended ch ange of the quality system. 
 
Ð 2004/22/EC (adapted) 
The notified body shall evaluate the modifications  ⌦ any ⌫ proposed ⌦ changes ⌫ and 
decide whether the changed  ⌦ modified ⌫ quality system will still  ⌦ continue to ⌫ 
satisfy the requirements referred to in paragra ph point  3.2 or whether a re-assessment is 
required  ⌦ necessary ⌫ . 
It shall notify its decision to  the manufacturer ⌦ of its decision ⌫ . The notification shall 
contain the conclusions of the examina tion and the reasoned  assessment decision. 
4. Surveillance under the respons ibility of the notified body 
4.1. The purpose of surveillance is to make sure that the manufacturer ⌦ duly ⌫ fulfils the 
obligations arising out of th e approved quality system. EN 91   EN 4.2. The manufacturer shall ⌦ , for assessment purposes, ⌫ allow the notified body 
entrance for inspection purposes  ⌦ access ⌫ to the locations of  manufacture, inspection, 
testing and storage ⌦ sites ⌫ , and shall provide it with all necessary information, in 
particular: 
 
Ð 2004/22/EC 
– the quality system documentation; 
 
Ð 2004/22/EC (adapted) 
Ö new  
– the quality records, such as inspection reports and test data, calibration data, 
qualification reports of  ⌦ on ⌫ the personnel concerned, etc. 
4.3. The notified body shall carry out periodic a udits to make sure that the manufacturer 
maintains and applies the quality system and shall provide ⌦ the manufacturer with ⌫ an 
audit report to the manufacturer . 
4.4. Additionally  ⌦ In addition, ⌫ the notified body may pay unexpected visits to the 
manufacturer. During such visits the notif ied body may, if necessary, carry out product  
⌦ instrument ⌫ tests, or have them carried out, ⌦ in order ⌫ to verify that the quality 
system is functioning correctly. It  ⌦ The notified body ⌫ shall provide the manufacturer 
with a visit report and, if tests have be en carried out, with a test report. 
5. Written  ⌦ Conformity marking and ⌫ declaration of conformity 
5.1. The manufacturer shall affix the ‘CE’  ⌦ CE ⌫ marking,  ⌦ and ⌫ the supplementary 
metrology marking ⌦ set out in this Directive, ⌫ and, under the res ponsibility of the 
notified body referred to in paragraph  point  3.1, the latter's identification number to each 
measuring  ⌦ individual ⌫ instrument that is in conformity with the type as described in the 
EC-type ⌦ EU-type ⌫ examination certificate and satisfies the appropriate  
⌦ applicable ⌫ requirements of this Directive. 
5.2. ⌦ The manufacturer shall draw up a written ⌫ A declaration of conformity is drawn up 
for each instrument model and shall be kept  ⌦ keep it ⌫ at the disposal of the national 
authorities for 10 years after the last  instrument has been manufactured  Ö placed on the 
market  . It  ⌦ The declaration of conformity ⌫ shall identify the ⌦ instrument ⌫ 
model of the instrument  for which it was  ⌦ has been ⌫ drawn up. 
 
Ø new 
A copy of the declaration of conformity shall be  made available to th e relevant authorities 
upon request. EN 92   EN  
Ð 2004/22/EC  
A copy of the declaration shall be supplied with  each measuring instrument that is placed on 
the market. However, this requirement may be interpreted as applying to a batch or 
consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. 
 
Ð 2004/22/EC (adapted) 
Ö new 
6. The manufacturer shall, for ⌦ a period ending at least ⌫ 10 years after the last  instrument 
has been manufactured  Ö placed on the market , keep at the dispos al of the national 
authorities: 
 
Ð 2004/22/EC (adapted) 
– the documentation referred to in paragraph  point  3.1, second indent;  
 
Ð 2004/22/EC 
– the change referred to in paragraph  point  3.5, as approved; 
– the decisions and reports from the notified body referred to in paragraphs  
points  3.5, 4.3 and 4.4. 
 
Ð 2004/22/EC 
7. Each notified body shall periodically make ava ilable to the Member St ate that designated it 
the list of quality system approvals issued or refused, and shall immediately inform the 
Member State that designated  it of the withdrawal of  a quality system approval.  
 
Ø new 
7. Each notified body shall immediately  inform its notifying authorities of quality system 
approvals issued or withdrawn, a nd shall, periodically or upon request, make available to its 
notifying authorities the list of quality system approvals refused, suspended or otherwise 
restricted. EN 93   EN  
Ð 2004/22/EC (adapted) 
Ö new  
8. Authorised representative 
8. The manufacturer's obligati ons contained in paragraphs  ⌦ set out in points ⌫ 3.1, 3.5, 
5.2 and 6 may be fulfilled ⌦ by his authorised representative ⌫ , on his behalf and under 
his responsibility, by his authorised representative  Ö provided that they are specified in the 
mandate  . 
7. ANNEX  ⌦ MODULE ⌫ D1: 
DECLARATION OF CONFORMITY BASED ON  QUALITY ASSURANCE OF THE 
PRODUCTION PROCESS 
1. ‘Declaration of conformity based on  qQuality assurance of the production process’  is the 
conformity assessment procedure whereby the ma nufacturer fulfils the obligations laid down 
in this Annex  points 2, 4, and 7,  and ensures and declares ⌦ on his sole responsibility ⌫ 
that the measuring instruments concerned satisfy the appropriate  requirements of this 
Directive ⌦ that apply to them ⌫ . 
2. Technical documentation 
2. The manufacturer shall establish the techni cal documentation as described in Article 10 19. 
The documentation shall enable assessme nt of  ⌦ make it possible to assess ⌫ the 
⌦ instrument’s ⌫ conformity of the instrument  with the appropriate  ⌦ relevant ⌫ 
requirements of this Directive. It  ⌦ , and shall include an adequate analysis and assessment 
of the risk(s). The technical documentation ⌫ shall ⌦ specify the applicable requirements 
and cover ⌫ , as far as relevant for such  ⌦ the ⌫ assessment, cover  the design ⌦ , 
manufacture ⌫ and operation of the instrument. 
3. The manufacturer shall keep the technical do cumentation at the disposal of the national 
authorities for 10 years after the last  instrument has been manufactured  Ö placed on the 
market  . 
4. Manufacturing 
4. The manufacturer shall oper ate an approved quality syst em for production, final product  
⌦ instrument ⌫ inspection and testing of the measuring instruments  concerned as specified 
in paragraph  point  5 and shall be subject to survei llance as specified in paragraph  point  6. 
5. Quality system 
5.1. The manufacturer shall lodge an application for assessment of the  ⌦ his ⌫ quality 
system with a notified body of his choice ⌦ , for the measuring instruments concerned ⌫ . 
 
Ð 2004/22/EC 
The application shall include: EN 94   EN  
Ø new 
– the name and address of the manufacture r and, if the app lication is lodged by 
the authorised representative, his name and address as well, 
– a written declaration that the same app lication has not been lodged with any 
other notified body, 
 
Ð 2004/22/EC  
– all relevant information for the instrument category envisaged; 
– the documentation concerning the quality system; 
– the technical documentation referred to in paragraph  point  2. 
 
Ð 2004/22/EC (adapted) 
Ö new 
5.2. The quality system shall ensure compliance of the ⌦ measuring ⌫ instruments with the 
appropriate  requirements of this Directive ⌦ that apply to them ⌫ . 
All the elements, requirements and provisi ons adopted by the manufacturer shall be 
documented in a systematic and orderly manner in  the form of written policies, procedures 
and instructions. This quality system documentation must  Ö shall  permit a consistent 
interpretation of the quality progra mmes, plans, manuals and records. 
It shall contain , in particular, ⌦ contain ⌫ an adequate description of: 
– the quality objectives and the organisational structure, responsibilities and 
powers of the management with regard to product  ⌦ instrument ⌫ quality; 
– the ⌦ corresponding ⌫ manufacturing, quality cont rol and quality assurance 
techniques, processes and systematic actions that will be used; 
 
Ð 2004/22/EC 
– the examinations and test s that will be carried out  before, during, and after 
manufacture, and the frequency with which they will be carried out; 
 
Ð 2004/22/EC (adapted) 
– the quality records, such as inspection reports and test data, calibration data, 
qualification reports of  ⌦ on ⌫ the personnel concerned, etc.; EN 95   EN – the means to monitor  ⌦ of monitoring ⌫ the achievement of the required 
product  ⌦ instrument ⌫ quality and the effectiv e operation of the quality 
system. 
5.3. The notified body shall assess the quality system to determ ine whether it satisfies the 
requirements referred to in paragraph  point  5.2.  
It shall presume conformity with these  ⌦ those ⌫ requirements in respect of ⌦ the 
elements of the ⌫ a quality system that complies  ⌦ comply ⌫ with the corresponding 
specifications of the national standard that implements the relevant harmonised standard, 
⌦ and/or technical specification ⌫ from the moment its refe rences have been published . 
In addition to experience in quality manageme nt systems, the auditing team shall possess 
appropriate  ⌦ have at least one member with ⌫ experience ⌦ of evaluation ⌫ in the 
relevant ⌦ instrument ⌫ field of metrology  and instrument technology ⌦ concerned ⌫ , 
and knowledge of the applicable requirements of  this Directive. Th e evaluation procedure  
⌦ audit ⌫ shall include an inspection  ⌦ assessment ⌫ visit to the manufacturer's 
premises. 
 
Ø new 
The auditing team shall review the technical docu mentation referred to in  point 2 in order to 
verify the manufacturer's ability to identify the relevant requirements of this Directive and to 
carry out the necessary examinations with a vi ew to ensuring compliance of the instrument 
with those requirements. 
 
Ð 2004/22/EC 
The decision shall be notified to the manuf acturer. The notification shall contain the 
conclusions of the examination a nd the reasoned assessment decision. 
5.4. The manufacturer shall undertake to fulfil the obl igations arising out of  the quality system 
as approved and to maintain it so th at it remains adequate and efficient. 
 
Ð 2004/22/EC (adapted) 
5.5. The manufacturer shall keep the notified body that has approved the quality system 
periodically  informed of any intended ch ange of the quality system. 
The notified body sha ll evaluate the  ⌦ any proposed ⌫ changes proposed  and decide 
whether the changed  ⌦ modified ⌫ quality system will still  ⌦ continue to ⌫ satisfy the 
requirements referred to in paragraph  ⌦ point ⌫ 5.2 or whether a re-assessment is required  
⌦ necessary ⌫ . 
It shall notify its decision to  the manufacturer ⌦ of its decision ⌫ . The notification shall 
contain the conclusions of the examina tion and the reasoned  assessment decision. EN 96   EN 6. Surveillance under the respons ibility of the notified body 
6.1. The purpose of surveillance is to make sure that the manufacturer ⌦ duly ⌫ fulfils the 
obligations arising out of th e approved quality system. 
6.2. The manufacturer shall ⌦ , for assessment purposes, ⌫ allow the notified body 
entrance for inspection purposes  ⌦ access ⌫ to the locations of  manufacture, inspection, 
testing and storage ⌦ sites ⌫ , and shall provide it with all necessary information, in 
particular: 
 
Ð 2004/22/EC 
– the quality system documentation; 
 
Ð 2004/22/EC (adapted) 
Ö new  
– the technical documentation referred to in paragraph  point  2; 
– the quality records, such as inspection reports and test data, calibration data, 
qualification reports of  ⌦ on ⌫ the personnel concerned, etc. 
6.3. The notified body shall carry out periodic a udits to make sure that the manufacturer 
maintains and applies the quality system and shall provide ⌦ the manufacturer with ⌫ an 
audit report to the manufacturer . 
6.4. Additionally  ⌦ In addition ⌫ , the notified body may pay un expected visits to the 
manufacturer. During such visits the notif ied body may, if necessary, carry out product  
⌦ instrument ⌫ tests, or have them carried out, ⌦ in order ⌫ to verify that the quality 
system is functioning correctly. It  ⌦ The notified body ⌫ shall provide the manufacturer 
with a visit report and, if tests have be en carried out, with a test report. 
7. Written  ⌦ Conformity marking and ⌫ declaration of conformity 
7.1. The manufacturer shall affix the ‘CE’  ⌦ CE ⌫ marking, the supplementary metrology 
marking ⌦ set out in this Directive, ⌫ and, under the responsibility of the notified body 
referred to in paragraph  ⌦ point ⌫ 5.1, the latter's identification number to each measuring  
instrument that satisfies the appropriate  ⌦ applicable ⌫ requirements of this Directive. 
7.2. A  ⌦ The manufacturer shall draw up a written ⌫ declaration of conformity is  drawn up  
for each instrument model and shall be kept  ⌦ keep it ⌫ at the disposal of the national 
authorities for 10 years after the last  instrument has been manufactured  Ö placed on the 
market  . It ⌦ The declaration of conformity ⌫ shall identify the model of  the instrument 
⌦ model ⌫ for which it was  ⌦ has been ⌫ drawn up. EN 97   EN  
Ø new 
A copy of the declaration of conformity shall be  made available to th e relevant authorities 
upon request. 
 
Ð 2004/22/EC 
A copy of the declaration shall be supplied with  each measuring instrument that is placed on 
the market. However, this requirement may be interpreted as applying to a batch or 
consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. 
 
Ð 2004/22/EC (adapted) 
Ö new  
8. The manufacturer shall, for ⌦ a period ending at least ⌫ 10 years after the last  instrument 
has been manufactured  Ö placed on the market  , keep at the disposal of the national 
authorities: 
– the documentation referred to in paragraph  point  5.1, second indent;  
– the change referred to in paragraph  point 5.5, as approved; 
– the decisions and reports from  ⌦ of ⌫ the notified body referred to in 
paragraph  point  5.5, 6.3 and 6.4. 
 
Ð 2004/22/EC 
9. Each not ified body shall periodically make available to the Member State that designated it 
the list of quality system approvals issued or refused, and shall immediately inform the 
Member State that designated it of the withdrawal of a quality system approval.  
 
Ø new 
9. Each notified body shall immediately inform its notifying authori ties of quality system 
approvals issued or withdrawn, a nd shall, periodically or upon request, make available to its 
notifying authorities the list of quality system approvals refused, suspended or otherwise 
restricted. EN 98   EN  
Ð 2004/22/EC (adapted) 
Ö new  
10. Authorised representative 
10. The manufacturer's obligati ons contained in paragraphs  ⌦ contained in points ⌫ 3, 5.1, 
5.5, 7.2  and 8 may be fulfilled ⌦ by his authorised representative ⌫ , on his behalf and 
under his responsibility, by his authorised representative  Ö provided that they are specified in 
the mandate  . 
8. ANNEX  ⌦ MODULE ⌫ E: 
DECLARATION OF  CONFORMITY TO TYPE BASED ON ⌦ INSTRUMENT ⌫ 
QUALITY ASSURANCE OF FINAL PR ODUCT INSPECTION AND TESTING  
1. ‘Declaration of  cConformity to type based on ⌦ instrument ⌫ quality assurance of final 
product inspection and testing’  is the  ⌦ that ⌫ part of a conformity assessment procedure 
whereby the manufacturer fulfils the obligations laid down in this Annex  points 2 and 5,  and 
ensures and declares ⌦ on his sole responsibility ⌫ that the measuring instruments 
concerned are in conformity with the type as described in the EC -type ⌦ EU-type ⌫ 
examination certificate and satisfy the appropriate  requirements of this Directive ⌦ that 
apply to them ⌫ . 
2. Manufacturing 
2. The manufacturer shall operate an approved quality system as specified in paragraph 3  for 
final product  ⌦ instrument ⌫ inspection and testing of the measuring instruments  
concerned ⌦ as specified in point 3 ⌫ and shall be subject to surveillance, as specified in 
paragraph  ⌦ point ⌫ 4. 
3. Quality system 
3.1. The manufacturer shall lodge an application for assessment of the  ⌦ his ⌫ quality 
system with a notified body of his choice ⌦ , for the measuring instruments concerned ⌫ . 
 
Ð 2004/22/EC 
The application shall include: 
 
Ø new 
– the name and address of the manufacture r and, if the app lication is lodged by 
the authorised representative, his name and address as well, 
– a written declaration that the same app lication has not been lodged with any 
other notified body, EN 99   EN  
Ð 2004/22/EC (adapted)  
– all relevant information for the instrument category envisaged; 
– the documentation concerning the quality system; 
– the technical documentation of the approved type and a copy of the EC -type 
⌦ EU-type ⌫ examination certificate. 
3.2. The quality system shall ensure compliance of the ⌦ measuring ⌫ instruments with the 
type as  described in the EC -type ⌦ EU-type ⌫ examination certificate and ⌦ with ⌫ the 
appropriate  ⌦ applicable ⌫ requirements of this Directive. 
All the elements, requirements and provisi ons adopted by the manufacturer shall be 
documented in a systematic and orderly manner in  the form of written policies, procedures 
and instructions. This quality system documentation must  ⌦ shall ⌫ permit a consistent 
interpretation of the quality progra mmes, plans, manuals and records. 
It shall ⌦ , in particular, ⌫ contain in particular  an adequate description of: 
 
Ð 2004/22/EC 
– the quality objectives and the organisational structure, responsibilities and 
powers of the management with  regard to product quality; 
– the examinations and tests that will  be carried out after manufacture; 
 
Ð 2004/22/EC (adapted) 
– the quality records, such as inspection reports and test data, calibration data, 
qualification reports of  ⌦ on ⌫ the personnel concerned, etc.; 
– the means to monitor  ⌦ of monitoring ⌫ the effective operation of the 
quality system. 
3.3. The notified body shall assess the quality system to determ ine whether it satisfies the 
requirements referred to in paragraph  point  3.2.  
It shall presume conformity with these  ⌦ those ⌫ requirements in respect of ⌦ the 
elements of the ⌫ a quality system that complies  ⌦ comply ⌫ with the corresponding 
specifications of the national standard that impl ements the relevant harmonised standard, from 
the moment its references have been published  ⌦ and/or technical specification ⌫ . 
In addition to experience in quality manageme nt systems, the auditing team shall possess 
appropriate  ⌦ have at least one member with ⌫ experience ⌦ of evaluation ⌫ in the 
relevant ⌦ instrument ⌫ field of metrology  and instrument technology ⌦ concerned ⌫ , 
and knowledge of the applicable requirements of  this Directive. Th e evaluation procedure  EN 100   EN ⌦ audit ⌫ shall include an inspection  ⌦ assessment ⌫ visit to the manufacturer's 
premises. 
 
Ø new 
The auditing team shall review the technical  documentation referred to in point 3.1, fifth 
indent, in order to verify the manufacturer's abi lity to identify the relevant requirements of 
this Directive and to carry out the necessary ex aminations with a view to ensuring compliance 
of the instrument with  those requirements. 
 
Ð 2004/22/EC (adapted) 
The decision shall be notified to the manuf acturer. The notificati on shall contain the 
conclusions of the examination  ⌦ audit ⌫ and the reasoned assessment decision. 
 
Ð 2004/22/EC 
3.4. The manufacturer shall undertake to fulfil the obl igations arising out of  the quality system 
as approved and to maintain it so th at it remains adequate and efficient. 
 
Ð 2004/22/EC (adapted) 
3.5. The manufacturer shall keep the notified body that has approved the quality system 
informed of any intended change of  ⌦ to ⌫ the quality system. 
The notified body sha ll evaluate the  ⌦ any proposed ⌫ changes proposed  and decide 
whether the changed  ⌦ modified ⌫ quality system will still  ⌦ continue to ⌫ satisfy the 
requirements referred to in paragraph  point  3.2 or whether a re-assessment is required  
⌦ necessary ⌫ . 
It shall notify its decision to  the manufacturer ⌦ of its decision ⌫ . The notification shall 
contain the conclusions of the examina tion and the reasoned  assessment decision. 
4. Surveillance under the respons ibility of the notified body 
4.1. The purpose of surveillance is to make sure that the manufacturer ⌦ duly ⌫ fulfils the 
obligations arising out of th e approved quality system. 
4.2. The manufacturer shall ⌦ , for assessment purposes, ⌫ allow the notified body 
entrance for inspectio n purposes to the locations of  ⌦ access to the manufacture, ⌫ 
inspection, testing and storage ⌦ sites ⌫ , and shall provide it with all necessary 
information, in particular: EN 101   EN  
Ð 2004/22/EC 
– the quality system documentation; 
 
Ð 2004/22/EC (adapted) 
Ö new 
– the quality records, such as inspection reports and test data, calibration data, 
qualification reports of  ⌦ on ⌫ the personnel concerned, etc. 
4.3. The notified body shall carry out periodic a udits to make sure that the manufacturer 
maintains and applies the quality system and shall provide an audit report to  the manufacturer 
⌦ with an audit report ⌫ . 
4.4. Ad ditionally  ⌦ In addition ⌫ , the notified body may pay un expected visits to the 
manufacturer. During such visits the notif ied body may, if necessary, carry out product  
⌦ instrument ⌫ tests, or have them carried out, ⌦ in order ⌫ to verify that the quality 
system is functioning correctly. It  ⌦ The notified body ⌫ shall provide the manufacturer 
with a visit report and, if tests have be en carried out, with a test report. 
5. Written  ⌦ Conformity marking and ⌫ declaration of conformity 
5.1. The manufacturer shall affix the ‘CE’  ⌦ CE ⌫ marking, the supplementary metrology 
marking ⌦ set out in this Directive, ⌫ and, under the responsibility of the notified body 
referred to in paragraph  point  3.1, the latter's identification number to each measuring  
⌦ individual ⌫ instrument that is in conformity with the type as  described in the EC -type 
⌦ EU-type ⌫ examination certificate and satisfies the appropriate  ⌦ applicable ⌫ 
requirements of this Directive. 
5.2. A  ⌦ The manufacturer shall draw up a written ⌫ declaration of conf ormity is drawn up  
for each instrument model and shall be kept  ⌦ keep ⌫ at the disposal  of the national 
authorities for 10 years after the last  instrument has been manufactur ed Ö placed on the 
market  . It ⌦ The declaration of conformity ⌫ shall identify the instrument model for 
which it was  ⌦ has been ⌫ drawn up.  
 
Ø new 
A copy of the declaration of conformity shall be  made available to th e relevant authorities 
upon request. 
 
Ð 2004/22/EC 
A copy of the declaration shall be supplied with  each measuring instrument that is placed on 
the market. However, this requirement may be interpreted as applying to a batch or EN 102   EN consignment rather than individual instruments in those cases where a large number of 
instruments is delivered to a single user. 
 
Ð 2004/22/EC (adapted) 
Ö new 
6. The manufacturer shall, for ⌦ a period ending at least ⌫ 10 years after the last  instrument 
has been manufactured  Ö placed on the market  , keep at the disposal of the national 
authorities: 
– the documentation referred to in the second indent of paragraph  point  3.1; 
– the change referred to in the second subparagraph of paragraph  point  3.5, as 
approved; 
– the decisions and reports from  ⌦ of ⌫ the notified body which are  referred to 
in paragraph  points  3.5, final subparagraph, paragraph  4.3 and paragraph  4.4. 
 
Ð 2004/22/EC 
7. Each notified body shall periodically make ava ilable to the Member St ate that designated it 
the list of quality system approvals  issued or refused, and shall immed iately inform the 
Member State that designated it of the withdrawal of a quality system approval.  
 
Ø new 
7. Each notified body shall immediately inform its notifying authori ties of quality system 
approvals issued or withdrawn, a nd shall, periodically or upon request, make available to its 
notifying authorities the list of quality system approvals refused, suspended or otherwise 
restricted. 
 
Ð 2004/22/EC (adapted) 
Ö new 
8. Authorised representative 
8. The manufacturer's obligati ons contained in paragraphs  ⌦ set out in points ⌫ 3.1, 3.5, 
5.2 and 6 may be fulfilled ⌦ by his authorised representative ⌫ , on his behalf and under 
his responsibility, by his authorised representative  Ö provided that they are specified in the 
mandate  . 
9. ANNEX  ⌦ MODULE ⌫ E1: 
DECLARATION OF CONFORMITY BASED ON  QUALITY ASSURANCE OF 
FINAL PRODUCT  ⌦ INSTRUMENT ⌫ INSPECTION AND TESTING EN 103   EN 1. ‘Declaration of conformity based on  qQuality assurance of final product  ⌦ instrument ⌫ 
inspection and testing’  is the conformity assessment procedure whereby the manufacturer 
fulfils the obligations laid down in this Annex  points 2, 4 and 7,  and ensures and declares 
⌦ on his sole responsibility ⌫ that the measuring instrument s concerned are in conformity 
with the appropriate  ⌦ satisfy the ⌫ requirements of this Directive ⌦ that apply to 
them ⌫ . 
2. Technical documentation 
2. The manufacturer shall establish the techni cal documentation as described in Article 10 19. 
The documentation shall enable assessment of  ⌦ make it possible to assess ⌫ the 
⌦ instrument’s ⌫ conformity of the instrument  with the appropriate  ⌦ relevant ⌫ 
requirements of this Directive  ⌦ , and shall include an adequate analysis and assessment of 
the risk(s) ⌫ . It  ⌦ The technical documentation ⌫ shall ⌦ specify the applicable 
requirements and cover ⌫ , as far as relevant for such  ⌦ the ⌫ assessment, cover  the 
design, manufacture and operation of the instrument. 
3. The manufacturer shall keep the technical  documentation at the disposal of the 
⌦ relevant ⌫ national authorities for 10 years after the last  instrument has been 
manufactured  Ö placed on the market  . 
4. Manufacturing 
4. The manufacturer shall operate an ap proved quality system for final product  
⌦ instrument ⌫ inspection and testing of the measuring instruments  concerned as specified 
in paragraph  point  5 and shall be subject to survei llance as specified in paragraph  point  6. 
5. Quality system 
5.1. The manufacturer shall lodge an application for assessment of the  ⌦ his ⌫ quality 
system with a  ⌦ the ⌫ notified body of his choice ⌦ , for the measuring instruments 
concerned ⌫ . 
 
Ð 2004/22/EC 
The application shall include: 
 
Ø new 
– the name and address of the manufacture r and, if the app lication is lodged by 
the authorised representative, his name and address as well, 
– a written declaration that the same app lication has not been lodged with any 
other notified body, EN 104   EN  
Ð 2004/22/EC 
– all relevant information for the instrument category envisaged; 
– the documentation concerning the quality system; 
 
Ð 2004/22/EC (adapted) 
Ö new 
– the technical documentation referred to in paragraph  point  2. 
5.2. The quality system shall ensure compliance of the ⌦ measuring ⌫ instruments with the 
appropriate  requirements of this Directive ⌦ that apply to them ⌫ . 
All the elements, requirements and provisi ons adopted by the manufacturer shall be 
documented in a systematic and orderly manner in  the form of written policies, procedures 
and instructions. This  ⌦ The ⌫ quality system documentation must  Ö shall  permit a 
consistent interpretation of the quality programmes, plans, manuals and records. 
This documentation  ⌦ It ⌫ shall ⌦ , in particular, ⌫ contain in particular  an adequate 
description of: 
– the quality objectives and the organisational structure, responsibilities and 
powers of the management with regard to product  ⌦ instrument ⌫ quality; 
– the examinations and tests that will  be carried out after manufacture; 
– the quality records, such as inspection reports and test data, calibration data, 
qualification reports of  ⌦ on ⌫ the personnel concerned, etc; 
– the means to monitor  ⌦ of monitoring ⌫ the effective operation of the 
quality system. 
5.3. The notified body shall assess the quality system to determ ine whether it satisfies the 
requirements referred to in paragraph  point  5.2.  
It shall presume conformity with these  ⌦ those ⌫ requirements in respect of ⌦ the 
elements of the ⌫ a quality system that complies  ⌦ comply ⌫ with the corresponding 
specifications of the national standard that impl ements the relevant harmonised standard, from 
the m oment its references have been published  ⌦ and/or technical specification ⌫ . 
In addition to experience in quality manageme nt systems, the auditing team shall possess 
appropriate  ⌦ have at least one member with ⌫ experience ⌦ of evaluation ⌫ in the 
relevant ⌦ instrument ⌫ field of metrology  and instrument technology, and knowledge of 
the applicable requirements of this Directive. The evaluation pr ocedure  ⌦ audit ⌫ shall 
include an inspection  ⌦ assessment ⌫ visit to the manufacturer's premises. EN 105   EN  
Ø new 
The auditing team shall review the technical docu mentation referred to in  point 2 in order to 
verify the manufacturer's ability to identify the relevant requirements of this Directive and to 
carry out the necessary examinations with a vi ew to ensuring compliance of the instrument 
with those requirements. 
 
Ð 2004/22/EC (adapted) 
The decision shall be notified to the manuf acturer. The notification shall contain the 
conclusions of the examination  ⌦ audit ⌫ and the reasoned assessment decision. 
 
Ð 2004/22/EC 
5.4. The manufacturer shall undertake to fulfil the obl igations arising out of  the quality system 
as approved and to maintain it so th at it remains adequate and efficient. 
5.5. The manufacturer shall keep the notified body that has approved the quality system 
informed of any intended ch ange of the quality system. 
 
Ð 2004/22/EC (adapted) 
The notified body shall evaluate the changes  ⌦ any ⌫ proposed ⌦ changes ⌫ and decide 
whether the changed  ⌦ modified ⌫ quality system will still  ⌦ continue to ⌫ satisfy the 
requirements referred to in paragraph  point  5.2 or whether a re-assessment is required  
⌦ necessary ⌫ . 
It shall notify its decisi on to  the manufacturer ⌦ of its decision ⌫ . The notification shall 
contain the conclusions of the examina tion and the reasoned  assessment decision. 
6. Surveillance under the respons ibility of the notified body 
6.1. The purpose ⌦ of surveillance ⌫ is to make sure that the manufacturer ⌦ duly ⌫ 
fulfils the obligations arising out  of the approved quality system. 
6.2. The manufacturer shall ⌦ , for assessment purposes, ⌫ allow the notified body 
entrance for inspection purposes to the locations of  ⌦ access to the manufacture, ⌫ 
inspection, testing and storage ⌦ sites ⌫ , and shall provide it with all necessary 
information, in particular: 
 
Ð 2004/22/EC 
– the quality system documentation; EN 106   EN  
Ð 2004/22/EC (adapted) 
Ö new 
– the technical documentation referred to in paragraph  point  2; 
– the quality records, such as inspection reports and test data, calibration data, 
qualification reports of  ⌦ on ⌫ the personnel concerned, etc. 
6.3. The notified body shall carry out periodic a udits to make sure that the manufacturer 
maintains and applies the quality system and shall provide an audit report to  the manufacturer 
⌦ with an audit report ⌫ . 
6.4. Additionally  ⌦ In addition ⌫ , the notified body may pay un expected visits to the 
manufacturer. During such visits the notif ied body may, if necessary, carry out product  
⌦ instrument ⌫ tests, or have them carried out, ⌦ in order ⌫ to verify that the quality 
system is functioning correctly. It  ⌦ The notified body ⌫ shall provide the manufacturer 
with a visit report and, if tests have be en carried out, with a test report. 
7. Written  ⌦ Conformity marking and ⌫ declaration of conformity 
7.1. The manufacturer shall affix the ‘CE’  ⌦ CE ⌫ marking, the supplementary metrology 
marking ⌦ set out in this Directive, ⌫ and, under the responsibility of the notified body 
referred to in paragraph  point  5.1, the latter's identification number to each measuring  
⌦ individual ⌫ instrument that satisfies the appropriate  ⌦ applicable ⌫ requirements of 
this Directive. 
7.2. A  ⌦ The manufacturer shall draw up a written ⌫ declaration of conf ormity is drawn up  
for each instrument model and shall be kept  ⌦ keep it ⌫ at the disposal of the national 
authorities for 10 years after the last  instrument has been manu factured  Ö placed on the 
market  . It ⌦ The declaration of conformity ⌫ shall identify the model of  the instrument 
⌦ model ⌫ for which it was  ⌦ has been ⌫ drawn up. 
 
Ø new 
A copy of the declaration of conformity shall be  made available to th e relevant authorities 
upon request. 
 
Ð 2004/22/EC 
A copy of the declaration shall be supplied with  each measuring instrument that is placed on 
the market. However, this requirement may be interpreted as applying to a batch or 
consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. EN 107   EN  
Ð 2004/22/EC (adapted) 
Ö new 
8. The manufacturer shall, for ⌦ a period ending at least ⌫ 10 years after the last  instrument 
has been manufactured  Ö placed on the market  , keep at the disposal of the national 
authorities: 
– the documentation referred to in paragraph  point  5.1, second indent;  
– the change referred to in paragraph  point  5.5, as approved; 
– the decisions and reports from the notified body referred to in paragraphs  
points  5.5, 6.3 and 6.4. 
 
Ð 2004/22/EC 
9. Each notified body shall periodically make ava ilable to the Member St ate that designated it 
the list of quality system approvals issued or refused, and shall immediately inform the 
Member State that designated it of the withdrawal  of a quality system approval.  
 
Ø new 
9. Each notified body shall immediately inform its notifying authori ties of quality system 
approvals issued or withdrawn, a nd shall, periodically or upon request, make available to its 
notifying authorities the list of quality system approvals refused, suspended or otherwise 
restricted. 
 
Ð 2004/22/EC (adapted) 
Ö new 
10. Authorised representative 
10. The manufacturer's obligati ons contained in paragraphs  ⌦ set out in points ⌫ 3, 5.1, 
5.5, 7.2  and 8 may be fulfilled ⌦ his authorised representative, ⌫ , on his behalf and under 
his responsibility, by his authorised representative  Ö provided that they are specified in the 
mandate  . 
10. ANNEX  ⌦ MODULE ⌫ F: 
DECLARATION OF  CONFORMITY TO TYPE  BASED ON PRODUCT 
VERIFICATION 
1. ‘Declaration of  cConformity to type based on product verification’  is the part of a 
conformity assessment procedure whereby the ma nufacturer fulfils the obligations laid down 
in this Annex  points 2, 5.1 and 6,  and ensures and declares ⌦ on his sole responsibility ⌫ 
that the measuring instruments ⌦ concerned, which ⌫ that  have been subjected  to the EN 108   EN provisions of paragraph  point  3, are in conformity with the type as descri bed in the EC -type 
⌦ EU-type ⌫ examination certificate and satisfy the appropriate  requirements of this 
Directive ⌦ that apply to them ⌫ . 
2. Manufacturing 
2. The manufacturer shall ta ke all measures necessary ⌦ so that the manu facturing process 
and its monitoring ⌫ to ensure conformity of the manufactured ⌦ measuring ⌫ 
instruments with the approved type as  described in the EC -type ⌦ EU-type ⌫ examination 
certificate and with  the appropriate  requirements of this Directive ⌦ that apply to them ⌫. 
3. Verification 
3. A notified body chosen by the manufacturer sha ll carry out the appropriate examinations 
and tests, or have them carried out, to check the conformity of the instru ments with the type as 
described in the EC -type ⌦ EU-type ⌫ examination certificate and the approporate 
requirements of this Directive. 
The examinations and tests to check the conformity ⌦ of the measuring instruments ⌫ with 
the metrological  ⌦ appropriate ⌫ requirements will  ⌦ shall ⌫ be carried out, at the 
choice of the manufacturer, either  by examination and testing of every instrument as specified 
in paragraph  point  4, or by examination and testing of the ⌦ measuring ⌫ instruments on a 
statistical basis as specified in paragraph  point  5. 
4. Verification of conformity w ith the metrological requirements  by examination and testing 
of every instrument. 
4.1. All ⌦ measuring ⌫ instruments shall be individually examined and appropriate tests as  
set out in the relevant ⌦ harmonised standard(s), normative ⌫ documents ⌦ and/or 
technical specifications ⌫ referred to in Article 13 , or equivalent tests, shall be carried out in 
order  to verify their  conformity with the ⌦ approved type described in the EU-type 
examination certificate a nd with the appropriate ⌫ metrological  requirements that apply to 
them  ⌦ of this Directive ⌫ .  
In the absence of a relevant  ⌦ harmonised standard or normative ⌫ document, the notified 
body concerned shall decide on the appr opriate tests to be carried out. 
 
Ð 2004/22/EC 
4.2. The notified body shall issue a certificate of conformity in respect of the examinations 
and tests carried out, and shall affix its identif ication number to each approved instrument or 
have it affixed under its responsibility. 
 
Ð 2004/22/EC (adapted) 
Ö new 
The manufacturer shall keep th e certificates of conformity available for inspection by the 
national authorities for 10 years after the certification of  the instrument Ö has been placed on 
the market  . EN 109   EN 5. Statistical verification of conformity with the metrological requirements . 
5.1. The manufacturer shall take all measures necessary in order  ⌦ so ⌫ that the 
manufacturing process ⌦ and its monitoring ensure ⌫ ensur es the homogeneity of each lot 
produced, and shall present his ⌦ measuring ⌫ instruments for verification in the form of 
homogeneous lots. 
5.2. A random sample shall be drawn  ⌦ taken ⌫ from each lot according to the 
requirements of paragraph 5.3  this Directive . All ⌦ measuring ⌫ instruments in the  
⌦ a ⌫ sample shall be individually ex amined and appropriate tests as  set out in the relevant 
⌦ harmonised standard(s), normative ⌫ document( s) referred to in Article 13  ⌦ and/or 
technical specifications ⌫ , or equivalent tests, ⌦ shall be carried out in order to ⌫ 
Ö verify their conformity with the type as de scribed in the EU-type examination certificate 
and to ensure  to establish  their conformity with the metrological  ⌦ applicable ⌫ 
requirements that apply to them shall be carried out  ⌦ of this Directive and ⌫ to determine 
whether the lot is accepted or rejected. In the absence of a relevant  ⌦ such harmonised 
standard or normative ⌫ document, the notified body concerned shall decide on the 
appropriate tests to be carried out. 
 
Ð 2004/22/EC 
5.3. The statistical procedure shall meet the following requirements: 
The statistical control will be based on at tributes. The sampling system shall ensure: 
– a level of quality corresponding to a pr obability of acceptance of 95 %, with a 
non-conformity of less than 1 %; 
– a limit quality corresponding to a probabi lity of acceptance of 5 %, with a non-
conformity of less than 7 %. 
 
Ð 2004/22/EC (adapted) 
Ö new 
5.4. If a lot is accepted, all ⌦ measuring ⌫ instruments of the lot are  Ö shall be 
considered  approved, except for those ⌦ measuring ⌫ instruments from the sample that 
were  ⌦ have been ⌫ found not to satisfy the tests. 
 
Ð 2004/22/EC 
The notified body shall issue a cert ificate of conformity in resp ect of the examinations and 
tests carried out, and shall affix its identificati on number to each approve d instrument or have 
it affixed under its responsibility. EN 110   EN  
Ð 2004/22/EC (adapted) 
Ö new 
The manufacturer shall keep th e certificates of conformity ⌦ at the disposal of ⌫ available 
for inspection by  the national authorities for 10 years after the certification of  the instrument 
Ö has been placed on the market  . 
 
Ð 2004/22/EC 
5.5. If a lot is rejected, the notified body shall take appropriate measures to prevent the 
placing on the market of that lot. In the event of frequent rejection of lots the notified body 
may suspend the statistical verifica tion and take appropriate measures. 
 
Ð 2004/22/EC (adapted) 
Ö new 
6. Written  ⌦ Conformity marking and ⌫ declaration of conformity 
6.1. The manufacturer shall affix the ‘CE’  ⌦ CE ⌫ marking and the supplementary 
metrology marking ⌦ set out in this Directive , and, under  the responsibility of the notified 
body referred to in point 3, the latter's identification number ⌫ to each measuring  
⌦ individual ⌫ instrument that is in conformity with the approved type ⌦ described in the 
EU-type examination certificate ⌫ and satisfies the appropriate  ⌦ applicable ⌫ 
requirements of this Directive. 
6.2. A  ⌦ The manufacturer shall draw up a written ⌫ declaration of conf ormity is drawn up  
for each instrument model and shall be kept  ⌦ keep it ⌫ at the disposal of the national 
authorities for 10 years after the last  instrument has been manufactured  Ö placed on the 
market  . It ⌦ The declaration of conformity ⌫ shall identify the model of  the instrument 
⌦ model ⌫ for which it was  ⌦ has been ⌫ drawn up. 
 
Ø new 
A copy of the declaration of conformity shall be  made available to th e relevant authorities 
upon request. 
 
Ð 2004/22/EC 
A copy of the declaration shall be supplied with  each measuring instrument that is placed on 
the market. However, this requirement may be interpreted as applying to a batch or 
consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. EN 111   EN  
Ð 2004/22/EC (adapted) 
Ö new 
If agreed upon b y the notified body referred to in paragraph  point  3 ⌦ agrees and under its 
responsibility ⌫ , the manufacturer shall  ⌦ may ⌫ also affix the notified body's 
identification number to the measuring inst ruments under the notifie d body's responsibility . 
7. The manufacturer may,  iIf agreed upon by  the notified body ⌦ agrees ⌫ and under its 
responsibility, ⌦ the manufacturer may ⌫ affix the notified body's identification number to 
the measuring instruments duri ng the manufactur ing process. 
8. Authorised representative 
8. The manufacturer's obligations may be fulfilled ⌦ by his authorised representative ⌫ , on 
his behalf and under his responsibilit y, by his authorised representative  Ö provided that they 
are specified in the mandate.  except for the  ⌦ An authorised representative may not fulfil 
the manufacturer's ⌫ obligations contained in paragraphs  ⌦ set out in points ⌫ 2 and 5.1. 
11. ANNEX  ⌦ MODULE ⌫ F1: 
DECLARATION OF  CONFORMITY BASED ON PRODUCT VERIFICATION 
1. ‘Declaration of  cConformity based on product verification’  is the conformity assessment 
procedure whereby the manufacturer fulfils the obligations laid down in this Annex  points 2, 
3, 6.1 and 7 and ensures and declares ⌦ on his sole responsibility ⌫ that the measuring 
instruments ⌦ concerned which ⌫ that have been subjected  to the provisions of paragraph 5  
point 4,  are in conformity with the appropriate  requirements of this Directive ⌦ that apply to 
them ⌫ . 
2. Technical documentation 
2. The manufacturer shall establish the techni cal documentation as described in Article 10 19. 
The documentation shall enable assessment  ⌦ make it possible to assess the instrument’s ⌫ 
of the  conformity of the instrument  with the appropriate  ⌦ relevant ⌫ requirements ⌦ , 
and shall include an adequate anal ysis and assessment of the risk(s) ⌫ of this Directive . It 
⌦ The technical documentation ⌫ shall ⌦ specify the applicab le requirements and 
cover ⌫ , as far as relevant for such  ⌦ the ⌫ assessment, co ver the design, manufacture 
and operation of the instrument. 
3. The manufacturer shall keep the technical  documentation at the disposal of the 
⌦ relevant ⌫ national authorities for 10 years after the last  instrument has been 
manufactured  Ö placed on the market  . 
3. Manufacturing 
4. The manufacturer shall ta ke all measures necessary ⌦ so that the manu facturing process 
and its monitoring ⌫ to ensure conformity of the manufactured ⌦ measuring ⌫ 
instruments with the appropriate  ⌦ applicable ⌫ requirements of this Directive. 
4. Verification EN 112   EN 5. A notified body chosen by the manufacturer sha ll carry out the appropriate examinations 
and tests, or have them carried out, to check the conformity of the ⌦ measuring ⌫ 
instruments with the appropriate  ⌦ applicable ⌫ requirements of this Directive. 
The examinations and tests to check the conformity with the metrological  ⌦ those ⌫ 
requirements will  ⌦ shall ⌫ be carried out, at the choice of the manufacturer, either by 
examination and testing of every inst rument as specified in paragraph 6  point 5 , or by 
examination and testing of the ⌦ measuring ⌫ instruments on a statistical basis as specified 
in paragraph 7  point 6 . 
65. Verification of conformity w ith the metrological requirements  by examination and testing 
of every instrument. 
65.1. All ⌦ measuring ⌫ instruments shall be individually  examined and appropriate tests, 
as set out in the relevant ⌦ harmonized standards, normative ⌫ documents ⌦ and/or 
technical specifications ⌫ referred to in Article 13 , or equivalent tests, shall be carried out to 
verify their conformity with the metrological  requirements that apply to them. In the absence 
of a relevant  ⌦ such a harmonised standard, normative ⌫ document ⌦ and/or technical 
specification ⌫ , the notified body concerned shall de cide on the appropriate tests to be 
carried out. 
 
Ð 2004/22/EC 
65.2. The notified body shall issue a certificate of conformity in respect of the examinations 
and tests carried out, and shall affix its identif ication number to each approved instrument or 
have it affixed under its responsibility. 
 
Ð 2004/22/EC (adapted) 
Ö new 
The manufacturer shall keep th e certificates of conformity ⌦ at the disposal of ⌫ available 
for inspection by  the national authorities for 10 years after the certification of  the instrument 
Ö has been placed on the market  . 
76. Statistical verification of conformity with the metrological requirements . 
76.1. The manufacturer shall take a ll measures necessary in order  ⌦ so ⌫ that the 
manufacturing process ensures the homogeneit y of each lot produced, and shall present his 
⌦ measuring ⌫ instruments for verification in the form of homogeneous lots. 
76.2. A random sample shall be drawn  ⌦ taken ⌫ from each lot according to the 
requirements of paragraph 7.3.  
6.3. All ⌦ measuring ⌫ instruments in the sample shall be individually examined and 
appropriate tests as  set out in the relevant ⌦ harmonised standards, normative ⌫ documents 
referred to in Article 13  ⌦ and/or technical specifications ⌫ , or equivalent tests, to 
establish their  conformity with the metrological  requirements that apply to them, shall be 
carried out to determine whether the lot is accep ted or rejected. In th e absence of a relevant  EN 113   EN ⌦ such harmonised standard, normative ⌫ document ⌦ and/or technical specification ⌫ , 
the notified body concerned shal l decide on the appropriate tests to be carried out. 
 
Ð 2004/22/EC 
7.36.4. The statistical procedure shall meet the following requirements: 
The statistical control will be based on at tributes. The sampling system shall ensure: 
– a level of quality corresponding to a pr obability of acceptance of 95 %, with a 
non-conformity of less than 1 %; 
– a limit quality corresponding to a probabi lity of acceptance of 5 %, with a non-
conformity of less than 7 %. 
 
Ð 2004/22/EC (adapted) 
Ö new 
7.46.5. If a lot is accepted,  all ⌦ measuring ⌫ instruments of the lot are  Ö shall be 
considered  approved, except for those ⌦ measuring ⌫ instruments from the sample that 
were  ⌦ have been ⌫ found not to satisfy the tests. 
 
Ð 2004/22/EC 
The notified body shall issue a cert ificate of conformity in resp ect of the examinations and 
tests carried out, and shall affix its identificati on number to each approve d instrument or have 
it affixed under its responsibility. 
 
Ð 2004/22/EC (adapted) 
Ö new 
The manufacturer shall keep the certificates of confor mity available for inspection by  ⌦ at 
the disposal of ⌫ the national authorities for 10 years after the certification of  the instrument 
Ö has been placed on the market  . 
7.5. If a lot is rejected, the notified body shall take appropriate measures to prevent the  
⌦ that lot from being placed ⌫ placing  on the market of that lot . In the event of frequent 
rejection of lots the notified body  may suspend the statistical ve rification and take appropriate 
measures. 
7. Written  ⌦ Conformity marking and ⌫ declaration of conformity 
87.1. The manufacturer shall affix the ‘CE’  ⌦ CE ⌫ marking and the supplementary 
metrology marking ⌦ set out in this Direct ive, and under the responsi bility of the notified 
body referred to in point 4, the latter's identification number ⌫ to each measuring  EN 114   EN ⌦ individual ⌫ instrument that satisfies the appropriate  ⌦ applicable ⌫ requirements of 
this Directive. 
87.2. A  ⌦ The manufacturer sh all draw up a written ⌫ declaration of conformity is drawn 
up for each instrument model and shall be kept  ⌦ keep it ⌫ at the disposal of the national 
authorities for 10 years after the last  instrument has been manufactured  Ö placed on the 
market  . It ⌦ The declaration of conformity ⌫ shall identify the model of  the instrument 
⌦ model ⌫ for which it was  ⌦ has been ⌫ drawn up. 
 
Ø new 
A copy of the declaration of conformity shall be  made available to th e relevant authorities 
upon request. 
 
Ð 2004/22/EC 
A copy of the declaration shall be supplied with  each measuring instrument that is placed on 
the market. However, this requirement may be interpreted as applying to a batch or 
consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. 
 
Ð 2004/22/EC (adapted) 
Ö new 
If agreed upon by  the notified body referred to in paragraph  point  5 ⌦ agrees and under its 
responsibility ⌫ , the manufacturer shall  ⌦ may ⌫ also affix the notified body's 
identification number to the measuring inst ruments under the notifie d body's responsibility . 
98. ⌦ If the notified body agrees  and under its responsibility, ⌫ Tthe manufacturer may, if 
agreed upon by the notified body and under its responsibility,  affix the notified body's 
identification number to the measuring inst ruments during the manu facturing process. 
9. Authorised representative 
10. The manufacturer's obligations may be fulfilled ⌦ by his authorised representative ⌫ , 
on his behalf and under his responsibil ity, by his authorised representative  Ö provided that 
they are specified in the mandate.  , ⌦ An authorised representative may not fulfil the 
manufacturer’s ⌫ except for the  obligations contained in paragraphs 4 and 7.1  ⌦ set out in 
points 3 and 6.1 ⌫ . 
12. ANNEX  ⌦ MODULE ⌫ G: 
DECLARATION OF  CONFORMITY BASED ON UNIT VERIFICATION 
1. ‘Declaration of  cConformity based on unit verification’  is the conformity assessment 
procedure whereby the manufacturer fulfils the obligations laid down in this Annex  points 2, 
3 and 5  and ensures and declares ⌦ on his sole responsibility ⌫ that a measuring  the EN 115   EN instrument ⌦ concerned, ⌫ that  ⌦ which ⌫ has been subjected  to the provisions of 
paragraph  point  4, is in conformity with the appropriate  requirements of this Directive ⌦ that 
apply to it ⌫ . 
2. Technical documentation 
The manufacturer shall establish the technical documentation as described in Article 10 19 and 
make it available to the notifie d body referred to in paragraph  point  4. The technical  
documentation shall enable assessment of the  ⌦ make it possible to assess the 
instrument's ⌫ conformity of the instrument  with the appropriate  ⌦ relevant ⌫ 
requirements of this Directive and  ⌦ , and shall include an ade quate analysis and assessment 
of the risk(s). The technical documentation ⌫ shall ⌦ specify the applicable requirements 
and cover ⌫ , as far as relevant for such  ⌦ the ⌫ assessment, cover  the design, 
manufacture and operation of the instrument. 
The manufacturer shall keep the technica l documentation at the disposal of the 
⌦ relevant ⌫ national authorities for ten years Ö after the instrument has been placed on 
the market  . 
3. Manufacturing 
3. The manufacturer shall ta ke all measures necessary ⌦ so that the manu facturing process 
and its monitoring ⌫ to ensure conformity of the ma nufactured instrument with the 
appropriate  ⌦ applicable ⌫ requirements of this Directive. 
4. Verification 
4. A notified body chosen by the manufacturer sha ll carry out the appropriate examinations 
and tests as  set out in the relevant ⌦ harmonised standards, normative ⌫ documents 
⌦ and/or technical specifications ⌫ referred to in Article 13 , or equivalent tests, to check 
the conformity of the instrument with the appropriate  ⌦ applicable ⌫ requirements of this 
Directive, or have them carri ed out. In the absence of ⌦ such ⌫ a relevant  ⌦ harmonised 
standard, normative ⌫ document ⌦ and/or technical specification ⌫ , the notified body 
concerned shall decide on the appr opriate tests to be carried out. 
 
Ð 2004/22/EC 
The notified body shall issue a cert ificate of conformity in resp ect of the examinations and 
tests carried out and affix its identification nu mber to the approved instrument, or have it 
affixed under its responsibility. 
 
Ð 2004/22/EC (adapted) 
Ö new 
The manufacturer shall keep th e certificates of conformity ⌦ at the disposal of ⌫ available 
for inspection by  the national authorities for 10 years after the certification of  the instrument 
Ö has been placed on the market  . 
5. Written  ⌦ Conformity marking and ⌫ declaration of conformity EN 116   EN 5.1. The manufacturer shall affix the ‘CE’  ⌦ CE ⌫ marking,  ⌦ and ⌫ the supplementary 
metrology marking ⌦ set out in this Directive ⌫ and, under the res ponsibility of the 
notified body referred to in paragraph  point  4, the latter's identification number to each 
measuring  instrument that satisfies the appro priate  ⌦ applicable ⌫ requirements of this 
Directive. 
5.2. ⌦ The manufacturer shall draw up a written ⌫ A declaration of conformity shall be 
drawn up  and kept  ⌦ keep it ⌫ at the disposal of the nation al authorities for 10 years after 
the instrument has been manufactured  Ö placed on the market  . It ⌦ The declaration of 
conformity ⌫ shall identify the instrument for which it was  ⌦ has been ⌫ drawn up. 
 
Ø new 
A copy of the declaration of conformity shall be  made available to th e relevant authorities 
upon request. 
 
Ð 2004/22/EC 
A copy of the declaration shall be su pplied with the measuring instrument. 
6. Authorised representative 
 
Ð 2004/22/EC (adapted) 
Ö new 
6. The manufacturer's obligati ons contained in paragraphs  ⌦ set out in points ⌫ 2 and 4.2  5 
may be fulfilled ⌦ by his authorised representative ⌫ , on his behalf and under his 
responsibility, by his aut horised representative  Ö provided that they are specified in the 
mandate  . 
13. ANNEX  ⌦ MODULE ⌫ H: 
DECLARATION OF  CONFORMITY BASED ON FULL QUALITY ASSURANCE 
1. ‘Declaration of  cConformity based on full quality assurance’  is the conformity assessment 
procedure whereby the manufacturer fulfils  the obligations laid down in this Ann ex points 2 
and 5,  and ensures and declares ⌦ on his sole responsibility ⌫ that the measuring 
instruments concerned satisfy the appropriate  requirements of this Directive ⌦ that apply to 
them ⌫ . 
2. Manufacturing 
2. The manufacturer shall operate  an approved qual ity system for design, manufacture and 
final product  ⌦ instrument ⌫ inspection and testing of the measuring instruments  
concerned as specified in paragraph  point  3, and shall be subject to surveillance as specified 
in paragraph  point  4. EN 117   EN 3. Quality system 
3.1. The manufacturer shall lodge an application for assessment of the  ⌦ his ⌫ quality 
system with a  ⌦ the ⌫ notified body of his choice ⌦ , for the measuring instruments 
concerned ⌫ . 
 
Ð 2004/22/EC 
The application shall include: 
all relevant information for th e instrument category envisaged;  
 
Ø new 
– the name and address of the manufacture r and, if the app lication is lodged by 
the authorised representative, his name and address as well, 
– the technical documentation for one m odel of each category of measuring 
instruments intended to be manufactur ed. The technical doc umentation shall, 
wherever applicable, contain at least the following elements: 
– a general description of the instrument, 
– conceptual design and manufacturing dr awings and schemes of components, 
sub-assemblies, circuits, etc., 
– descriptions and explanations nece ssary for the understanding of those 
drawings and schemes and the operation of the instrument, 
– a list of the harmonised standards, norma tive documents and/or other relevant 
technical specifications the references of which have been published in the 
Official Journal of the European Union , applied in full or in part, and 
descriptions of the solutions adopted to meet the essential requirements of this 
Directive where those standards have not been applied. In th e event of partly 
applied harmonised standards, the tec hnical documentation shall specify the 
parts which have been applied, 
– results of design calculations made , examinations carried out, etc., 
– test reports 
 
Ð 2004/22/EC (adapted) 
– the documentation concerning the quality system, ⌦ and ⌫ EN 118   EN  
Ø new 
– a written declaration that the same app lication has not been lodged with any 
other notified body. 
 
Ð 2004/22/EC (adapted) 
Ö new 
3.2. The quality system shall ensure compliance of the ⌦ measuring ⌫ instruments with the 
appropriate  requirements of this Directive ⌦ that apply to them ⌫ . 
All the elements, requirements and provisi ons adopted by the manufacturer shall be 
documented in a systematic and orderly manner in  the form of written policies, procedures 
and instructions. This quality system documentation must  ⌦ shall ⌫ permit a consistent 
interpretation of the quality progra mmes, plans, manuals and records.  
It shall ⌦ , in particular, ⌫ contain in particular  an adequate description of: 
– the quality objectives and the organisational structure, responsibilities and 
powers of the management with regard to design and produc t 
⌦ instrument ⌫ quality; 
– the technical design specifications, incl uding standards, that will be applied 
and, where the relevant ⌦ harmonised standards, normative ⌫ documents 
⌦ and/or technical specifications ⌫ referred to in Article 13  will not be 
applied in full, the means that will be used to ensure that the essential 
requirements of this Directive that apply to the ⌦ measuring ⌫ instruments 
will be met; 
– the design control and desi gn verification techniques, processes and systematic 
actions that will be used when designing the ⌦ measuring ⌫ instruments 
pertaining to the instru ment category covered; 
 
Ð 2004/22/EC 
– the corresponding manufacturing, quality control and quality assurance 
techniques, processes and systematic actions that will be used; 
 
Ð 2004/22/EC (adapted) 
– the examinations and tests that will be carried out before, during and after 
manufacture, and their  ⌦ the ⌫ frequency ⌦ with which they will be 
carried out ⌫ ; 
– the quality records, such as inspection reports and test data, calibration data, 
qualification reports of  ⌦ on ⌫ the personnel concerned, etc.; EN 119   EN – the means to monitor  ⌦ of monitoring ⌫ the achievement of the required 
design and product  ⌦ instrument ⌫ quality and the effective operation of the 
quality system. 
3.3. The notified body shall assess the quality system to determ ine whether it satisfies the 
requirements referred to in paragraph  point  3.2.  
It shall presume conformity with these  ⌦ those ⌫ requirements in respect of ⌦ the 
elements of the ⌫ a quality system that complies  ⌦ comply ⌫ with the corresponding 
specifications of the national standard that implements the relevant harmonised standard, 
⌦ and/or technical specification ⌫ from the moment its refe rences have been published . 
In addition to experience in quality manageme nt systems, the auditing team shall possess 
appropriate  ⌦ have at least one member ⌫ experienced  ⌦ as an assessor ⌫ in the 
relevant ⌦ instrument ⌫ field of metrology  and instrument technology ⌦ concerned ⌫ , 
and knowledge of the applicable requirements of  this Directive. Th e evaluation procedure  
⌦ audit ⌫ shall include an inspection  ⌦ assessment ⌫ visit to the manufacturer's 
premises. 
 
Ø new 
The auditing team shall review the technical documentation refe rred to in point 3.1, second 
indent, to verify the manufacturer 's ability to identify the a pplicable requirements of this 
Directive and to carry out the necessary examin ations with a view to  ensuring compliance of 
the instrument with those requirements. 
 
Ð 2004/22/EC (adapted) 
The decision  ⌦ manufacturer or his authorised representative ⌫ shall be notified to the 
manufacturer  ⌦ of the decision ⌫ . The notification shall cont ain the conclusions of the 
examination  ⌦ audit ⌫ and the reasoned assessment decision. 
 
Ð 2004/22/EC 
3.4. The manufacturer shall undertake to fulfil the obl igations arising out of  the quality system 
as approved and to maintain it so th at it remains adequate and efficient. 
 
Ð 2004/22/EC (adapted) 
3.5. The manufacturer shall keep the notified body that has approved the quality system 
informed of any intended change of  ⌦ to ⌫ the quality system. 
The notified body sha ll evaluate the  ⌦ any proposed ⌫ changes proposed  and decide 
whether the changed  ⌦ modified ⌫ quality system will still  ⌦ continue to ⌫ satisfy the EN 120   EN requirements referred to in paragraph  point  3.2 or whether a re-assessment is required  
⌦ necessary ⌫ . 
It shall notify ⌦ the manufacturer of ⌫ its decision to the manufacture r. The notification 
shall contain the conclusions of the examin ation and the reasoned assessment decision. 
 
Ð 2004/22/EC 
4. Surveillance under the respons ibility of the notified body 
 
Ð 2004/22/EC (adapted) 
4.1. The purpose of surveillance is to make sure that the manufacturer ⌦ duly ⌫ fulfils the 
obligations arising out of th e approved quality system. 
4.2. The manufacturer shall ⌦ , for assessment purposes, ⌫ allow the notified body 
entrance for inspection purposes  ⌦ access to the design, ⌫ to the locations of  manufacture, 
inspection, testing and storage ⌦ sites ⌫ , and shall provide it with all necessary 
information, in particular: 
 
Ð 2004/22/EC 
– the quality system documentation; 
 
Ð 2004/22/EC (adapted) 
Ö new 
– the quality records as foreseen  ⌦ provided for ⌫ by the design part of the 
quality system, such as results of analyses, calculations, tests, etc.; 
– the quality records as foreseen  ⌦ provided for ⌫ by the manufacturing part 
of the quality system, such as inspection reports and test da ta, calibration data, 
qualification reports of  ⌦ on ⌫ the personnel concerned, etc. 
4.3. The notified body shall carry out periodic a udits to make sure that the manufacturer 
maintains and applies the quality system and shall provide ⌦ the manufacturer with ⌫ an 
audit report to the manufacturer . 
4.4. Additionally  ⌦ In addition ⌫ , the notified body may pay un expected visits to the 
manufacturer. During such visits the no tified body may, if necessary, carry out prod uct 
⌦ instrument ⌫ tests, or have them carri ed out under its responsibility , ⌦ in order to check 
the proper functioning of ⌫ to verify that  the quality system is functioning correctly . It shall 
provide the manufacturer with a visit report and, if tests have been carried out, with a test 
report. EN 121   EN 5. Written  ⌦ Conformity marking and ⌫ declaration of conformity 
5.1. The manufacturer shall affix the ‘CE’  ⌦ CE ⌫ marking, the supplementary metrology 
marking ⌦ set out in this Directive ⌫ and, under the responsib ility of the notified body 
referred to in paragraph  point  3.1, the latter's identification number to each measuring  
⌦ individual ⌫ instrument that satisfies the appropriate  ⌦ applicable ⌫ requirements of 
this Directive. 
5.2. A  ⌦ The manufacturer shall draw a written ⌫ declaration of conformity is drawn up  
for an  ⌦ each ⌫ instrument model and shall be kept  ⌦ keep it ⌫ at the disposal of the 
national authorities for 10 years after the last  instrument has been manufactured  Ö placed on 
the market  . It ⌦ The declaration of conformity ⌫ shall identify the instrument model for 
which it was  ⌦ has been ⌫ drawn up. 
 
Ø new 
A copy of the declaration of conformity shall be  made available to th e relevant authorities 
upon request. 
 
Ð 2004/22/EC 
A copy of the declaration shall be supplied with  each measuring instrument that is placed on 
the market. However, this requirement may be interpreted as applying to a batch or 
consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. 
 
Ð 2004/22/EC (adapted) 
Ö new 
6. The manufacturer shall, for ⌦ a period ending at least ⌫ 10 years after the last  instrument 
has been manufactured  Ö placed on the market  , keep at the disposal of the national 
authorities: 
 
Ø new 
– the technical documentation referred to in point 3.1, 
 
Ð 2004/22/EC (adapted) 
– the documentation concerning the qualit y system referred to in paragraph  point  
3.1, second indent;  
– the change referred to in paragraph  point  3.5, as approved; EN 122   EN – the decisions and reports from  ⌦ of ⌫ the notified body referred to in 
paragraphs  points  3.5, 4.3 and 4.4. 
 
Ð 2004/22/EC 
7. Each notified body shall periodically make ava ilable to the Member St ate that designated it 
the list of quality system app rovals issued or refused, and shall immediately inform the 
Member State that designated it of the withdrawal of a quality system approval.  
 
Ø new 
7. Each notified body shall immediately inform its notifying authori ties of quality system 
approvals issued or withdrawn, a nd shall, periodically or upon request, make available to its 
notifying authorities the list of quality system approvals refused, suspended or otherwise 
restricted. 
 
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8. Authorised representative 
 
Ð 2004/22/EC (adapted) 
Ö new 
8. The manufacturer's obligati ons contained in paragraphs  points  3.1, 3.5, 5.2  and 6 may be 
fulfilled ⌦ by his authorised representative ⌫ , on his behalf and unde r his responsibility, 
by his authorised representative  Ö provided that they are specified in the mandate  . 
14. ANNEX  ⌦ MODULE ⌫ H1: 
DECLARATION OF  CONFORMITY BASED ON FULL QUALITY ASSURANCE 
PLUS DESIGN EXAMINATION 
1. ‘Declaration of  cConformity based on full quality assurance plus design examination’  is the 
conformity assessment procedure whereby the ma nufacturer fulfils the obligations laid down 
in this Annex  points 2 and 6,  and ensures and declares ⌦ on his sole responsibility ⌫ that 
the measuring instruments conc erned satisfy the appropriate  requirements of this Directive 
⌦ that apply to them ⌫ . 
2. Manufacturing 
2. The manufacturer shall operate  an approved qual ity system for design, manufacture and 
final product  ⌦ instrument ⌫ inspection and testing of the measuring instrument concerned 
as specified in paragraph  point  3, and shall be subject to surv eillance as specified in parag raph 
point  5.  EN 123   EN The adequacy of the technical desi gn of the measuring instruments  shall have been examined 
according  ⌦ in accordance ⌫ to the provisio ns of paragraph  with point  4. 
3. Quality system 
3.1. The manufacturer shall lodge an  application for assessment of  the quality system with a  
⌦ the ⌫ notified body of his choice ⌦ for the measuring instruments concerned ⌫ . 
 
Ð 2004/22/EC 
The application shall include: 
 
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– the name and address of the manufacture r and, if the app lication is lodged by 
the authorised representative, his name and address as well, 
 
Ð 2004/22/EC 
– all relevant information for the instrument category envisaged; 
– the documentation concerning the quality system, 
 
Ø new 
– a written declaration that the same app lication has not been lodged with any 
other notified body. 
 
Ð 2004/22/EC (adapted) 
3.2. The quality system shall ensure compliance of the ⌦ measuring ⌫ instruments with the 
appropriate  requirements of this Directive ⌦ that apply to them ⌫ . 
All the elements, requirements and provisi ons adopted by the manufacturer shall be 
documented in a systematic and orderly manner in  the form of written policies, procedures 
and instructions. This quality system documentation must  ⌦ shall ⌫ permit a consistent 
interpretation of the quality progra mmes, plans, manuals and records.  
It shall ⌦ , in particular, ⌫ contain in particular  an adequate description of: 
– the quality objectives and the organisational structure, responsibilities and 
powers of the management with regard to design and product  
⌦ instrument ⌫ quality; EN 124   EN – the technical design specifications, incl uding standards, that will be applied 
and, where the relevant ⌦ harmonised standards and/or technical 
specifications ⌫ documents referre d to in Article 13  will not be applied in 
full, the means that will be used to ensure that the essential requirements of this 
Directive that apply to the ⌦ measuring ⌫ instruments will be met; 
– the design control and desi gn verification techniques, processes and systematic 
actions that will be used when designing the ⌦ measuring ⌫ instruments 
pertaining to the instru ment category covered; 
 
Ð 2004/22/EC 
– the corresponding manufacturing, quality control and quality assurance 
techniques, processes and systematic actions that will be used; 
– the examinations and tests that will be carried out before, during and after 
manufacture, and the frequency with which they will be carried out; 
 
Ð 2004/22/EC (adapted) 
– the quality records, such as inspection reports and test data, calibration data, 
qualification reports of  ⌦ on ⌫ the personnel concerned, etc.; 
– the means to monitor  ⌦ of monitoring ⌫ the achievement of the required 
design and product  ⌦ instrument ⌫ quality and the effective operation of the 
quality system. 
3.3. The notified body shall assess the quality system to determ ine whether it satisfies the 
requirements referred to in paragraph  point  3.2. It shall presume conformity with these  
⌦ those ⌫ requirements in respect of ⌦ the elements of the ⌫ a quality system that 
complies  ⌦ comply ⌫ with the corresponding specifications  of the national standard that 
implements the relevant harmonised standard, ⌦ and/or technical specifications ⌫ from the 
moment its references have  been published in the Offi cial Journal . 
In addition to experience in quality manageme nt systems, the auditing team shall possess 
appropriate  ⌦ have at least one member ⌫ experienced  in the relevant ⌦ instrument ⌫ 
field of metr ology  and instrument technology ⌦ concerned ⌫ , and knowledge of the 
applicable requirements of this Directive. The evaluation procedure  ⌦ audit ⌫ shall include 
an inspection  ⌦ assessment ⌫ visit to the manufacturer's premises. 
The decision  ⌦ manufacturer or his authorised representative ⌫ shall be notified to the 
manufacturer  ⌦ of the decision ⌫ . The notification shall cont ain the conclusions of the 
examination  ⌦ audit ⌫ and the reasoned assessment decision. EN 125   EN  
Ð 2004/22/EC 
3.4. The manufacturer shall undertake to fulfil the obl igations arising out of  the quality system 
as approved and to maintain it so th at it remains adequate and efficient. 
3.5. The manufacturer shall keep the notified body that has approved the quality system 
informed of any intended ch ange of the quality system. 
 
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The notified body sha ll evaluate the  ⌦ any proposed ⌫ changes proposed  and decide 
whether the changed  ⌦ modified ⌫ quality system will still  ⌦ continue to ⌫ satisfy the 
requirements referred to in paragraph  point  3.2 or whether a re-assessment is required  
⌦ necessary ⌫ . 
It shall notify ⌦ the manufacturer of ⌫ its decision to the manufacturer . The notification 
shall contain the conclusions of the examin ation and the reasoned assessment decision. 
3.6. Each notified body shall periodically make ava ilable to the Member State that designated 
it the list  ⌦ immediately inform its notifying authorities ⌫ of quality system approvals 
issued or refused  Ö withdrawn  , and shall ⌦ periodically or upon request, make available 
to its notifying author ities the list of ⌫ immediately inform the Member State that designated 
it of the withdrawal of a  quality system approvals  Ö refused, suspended or otherwise 
restricted  . 
4. Design examination 
4.1. The manufacturer shall lodge an application for examination of the design with the 
notified body referred to in paragraph  point  3.1. 
4.2. The application shall enable  ⌦ make it possible to understand ⌫ understanding of  the 
design, manufacture and operation of the instrument, and shall enable assessm ent ⌦ to assess 
the ⌫ of conformity with the appropriate  requirements of this Directive ⌦ that apply to 
it ⌫ .  
 
Ð 2004/22/EC 
It shall include: 
– the name and address of the manufacturer; 
– a written declaration that the same app lication has not been lodged with any 
other notified body; EN 126   EN  
Ð 2004/22/EC (adapted) 
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– the technical documentation as described in Article 10 19. The documentation 
shall enable  ⌦ make it possible to ⌫ assessment  of the ⌦ instrument’s ⌫ 
conformity of the instrument  with the appropriate  ⌦ relevant ⌫ requirements 
⌦ , and shall include an adequate an alysis and assessment of the risk(s) ⌫ of 
this Directive . It shall, as far as relevant for such assessment, cover the design 
and operation of the instrument; 
– the supporting evidence for the adequ acy of the technical design. This 
⌦ supporting ⌫ evidence shall mention any documents that have been 
applied  ⌦ used ⌫ , in particular where the relevant ⌦ harmonised 
standards, normative ⌫ documents ⌦ and/or technical specifications ⌫ 
referred to in Article 13  have not been applied in full, and shall include, where 
necessary, the results of tests carried out by the appropriate laboratory of the 
manufacturer, or by anothe r testing laboratory on hi s behalf and under his 
responsibility. 
4.3. The notified body shall examine the app lication, and where the design meets the 
provisions of the Directive  ⌦ requirements of this Directive ⌫ that apply to the measuring  
instrument it shall issue an EC  ⌦ EU ⌫ design examination certific ate to the manufacturer. 
The certificate shall contain  ⌦ give ⌫ the name and address of the manufacturer, the 
conclusions of the examination, any conditions ⌦ (if any) ⌫ for its validity and the 
⌦ data ⌫ necessary data  for identification of the approved instrument  ⌦ design ⌫ . 
⌦ The certificate may have one or more annexes attached. ⌫ 
4.3.1. All relevant parts of the technical documen tation shall be annexed to the certificate.  
4.3.2.  The certificate or  Ö and  its annexes shall contain all relevant information for  ⌦ to 
allow the ⌫ conformity ⌦ of manufactured measuring in struments with the examined 
design to be evaluated ⌫ evaluation  and ⌦ to allow for ⌫ in-service control. It shall to 
allow the evaluation of conformity of the manuf actured instruments with the examined design 
regarding the reproducibility of  their metrological performa nces, when they are properly 
adjusted using appropriate means, including: 
 
Ð 2004/22/EC 
– the metrological characteristics of the design of the instrument; 
– measures required for ensuring the inte grity of the instruments (sealing, 
identification of software …); 
– information on other elements necessary fo r the identification of the instrument 
and to check its visual extern al conformity to the design; 
– if appropriate, any specific information necessary to verify the characteristics 
of manufactured instruments; EN 127   EN – in the case of a sub-assembly, all necessary information to ensure the 
compatibility with other sub-assemblies or measuring instruments. 
4.3.3.  The notified body shall establish an evaluation report in this regard and keep it at the 
disposal of the Member State that desi gnated it. Without prejudice to Article 12(8)  28(10) , the 
notified body shall release the content of this repo rt, in full or in part, only with the agreement 
of the manufacturer. 
The certificate shall have a validity of ten ye ars from the date of its issue, and may be 
renewed for subsequent pe riods of ten years each. 
 
Ð 2004/22/EC (adapted) 
Ö new 
If the manufacturer is denied  ⌦ Where the design does not  satisfy the applicable 
requirements of this Directive, the notified body shall refuse to issue ⌫ a design examination 
certificate, the notified body  ⌦ and ⌫ shall ⌦ inform the applicant accordingly, giving ⌫ 
provide  detailed reasons for the denial  ⌦ its refusal ⌫ . 
4.4. Ö The notified body shall keep itself appr ised of any changes in the generally 
acknowledged state of the art which indicate that the approved design may no longer comply 
with the applicable requirements of the legi slative instrument, and shall determine whether 
such changes require further investigation. If so, the notified body shall inform the 
manufacturer accordingly.  
The manufacturer shall k eep the notified body that has issued the ‘EC’  ⌦ EU ⌫ design 
examination certificate info rmed of any fundamental  modification to the approved design. 
Modifications to the approved design must r eceive additional approval from the notified body 
that issued the ‘EC’ design examination certificate where such changes  ⌦ that ⌫ may affect 
the conformity with the essential requirements of this Directive,  ⌦ or ⌫ the conditions for 
validity of the certificate.  or the prescribed conditions for use of the instrument. This  ⌦ Such 
modifications shall require ⌫ additional approval ⌦ – from the notified body that issued the 
EU design examination certificate – ⌫ is given  in the form of an addition to the original 
‘EC’  ⌦ EU ⌫ design examination certificate. 
4.5. Each notified body shall periodically make ava ilable to the Member State that designated 
it: ⌦ immediately inform its notifying authorities of the ⌫ ‘EC’  ⌦ EU ⌫ design 
examination certificates and annexes issued;  ⌦ and/or any ⌫ additions and amendments 
relating to certificates issued  Ö which it has issued or withdraw n, and shall, periodically or 
upon request, make available to its notifying aut horities the list of cer tificates and/or any 
additions thereto refused, suspe nded or otherwise restricted  . 
Each notified body shall immediately inform th e Member State that designated it of the 
withdrawal  of an EC design examination certificate.  EN 128   EN  
Ø new 
The Commission, the Member Stat es and the other notified bodi es may, on request, obtain a 
copy of the EU design examination certificates and/or additions thereto. On request, the 
Commission and the Member States may obtain a copy of the technical documentation and of 
the results of the examinations  carried out by the notified body. 
The notified body shall keep a c opy of the EU design examinati on certificate, its annexes and 
additions, as well as the technical file including the documentation submitted by the 
manufacturer until the expiry of  the validity of the certificate. 
 
Ð 2004/22/EC (adapted) 
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4.6. The manufacturer or his authorised representative  shall keep a copy of the ‘EC’  
⌦ EU ⌫ design examination certificate, its a nnexes and additions with the technical 
documentation ⌦ at the disposal of the national authorities ⌫ for 10 years after the last 
measurin g instrument has been manufactured  Ö placed on the market  . 
 
Ð 2004/22/EC 
Where neither the manufacturer nor his authorised  representative is established within the 
Community, the obligation to make the technical  documentation availabl e on request shall be 
the responsibility of  the person designated by the manufacturer.  
 
Ð 2004/22/EC (adapted) 
Ö new 
5. Surveillance under the respons ibility of the notified body 
5.1. The purpose of surveillance is to make sure that the manufacturer ⌦ duly ⌫ fulfils the 
obligations arising out of th e approved quality system. 
5.2. The manufacturer shall ⌦ , for assessment purposes, ⌫ allow the notified body 
entrance for inspection purposes  ⌦ access ⌫ to the locations of  design, manufacture, 
inspection, testing and storage ⌦ sites ⌫ , and shall provide it with all necessary 
information, in particular: 
– the quality system documentation; 
– the quality records as foreseen  ⌦ provided for ⌫ by the design part of the 
quality system, such as results of analyses, calculations, tests, etc; 
– the quality records as foreseen  ⌦ provided for ⌫ by the manufacturing part 
of the quality system, such as inspection reports and test da ta, calibration data, 
qualification reports of  ⌦ on ⌫ the personnel concerned, etc. EN 129   EN 5.3. The notified body shall carry out periodic a udits to make sure that the manufacturer 
maintains and applies the quality system and shall provide ⌦ the manufacturer with ⌫ an 
audit report to the manufacturer . 
5.4. Additionally  ⌦ In addition ⌫ , the notified body may pay un expected visits to the 
manufacturer. During such visits the notif ied body may, if necessary, carry out product  
⌦ instrument ⌫ tests, or have them ca rried out under its responsibi lity, ⌦ in order to check 
the proper function of ⌫ to verify that  the quality system is functioning correctly . It shall 
provide the manufacturer with a visit report and, if tests have been carried out, with a test 
report. 
6. Written ⌦ Conformity marking and ⌫ declaration of conformity 
6.1. The manufacturer shall affix the ‘CE’  ⌦ CE ⌫ marking,  and  the supplementary 
metrology marking ⌦ set out in this Directive, ⌫ and, under the res ponsibility of the 
notified body referred to in paragraph  point  3.1, the latter's identification number to each 
measuring  ⌦ individual ⌫ instrument that satisfies the appropriate  ⌦ applicable ⌫ 
requirements of this Directive. 
6.2. A  ⌦ The manufacturer shall draw up a written ⌫ declaration of conf ormity is drawn up  
for each instrument model and shall be kept  ⌦ keep it ⌫ at the disposal of the national 
authorities for 10 years after the last  instrument has been manufactured  Ö placed on the 
market  . It  ⌦ The declaration of conformity ⌫ shall identify the ⌦ instrument ⌫ 
model of the instrument  for which it was  ⌦ has been ⌫ drawn up and shall mention the 
number of the design examination certificate. 
 
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A copy of the declaration of conformity shall be  made available to th e relevant authorities 
upon request. 
 
Ð 2004/22/EC 
A copy of the declaration shall be supplied with  each measuring instrument that is placed on 
the market. However, this requirement may be interpreted as applying to a batch or 
consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user. 
 
Ð 2004/22/EC (adapted) 
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7. The manufacturer shall, for ⌦ a period ending at least ⌫ 10 years after the last  instrument 
has been manufactured  Ö placed on the market  , keep at the disposal of the national 
authorities: 
– the documentation ⌦ concerning the quality system ⌫ referred to in point  
3.1, second indent;  EN 130   EN  
Ð 2004/22/EC 
– the change referred to in paragraph  point  3.5, as approved; 
– the decisions and reports of the not ified body referred to in paragraphs  points  
3.5, 5.3 and 5.4. 
8. Authorised representative 
 
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8. The manufacturer's ⌦ authorised representative may lodge  the application referred to in 
points 4.1 and 4.2 and fulfil the ⌫ obligations contained i n paragraphs  ⌦ set out in 
points ⌫ 3.1, 3.5, 4.4, 4.6,  6.2 and 7 may be fulfilled , on his behalf and under his 
responsibility, by his aut horised representative  Ö provided that they are specified in the 
mandate  . 
 
Ð 2004/22/EC (adapted) 
ANNEX MI -001 III 
WATER METERS ⌦ (MI-001)  ⌫ 
 
Ð 2004/22/EC 
The relevant requirements of Annex I, the sp ecific requirements of this Annex and the 
conformity assessment procedures listed in this  Annex, apply to water meters intended for the 
measurement of volumes of clean, cold or heated  water in residential, commercial and light 
industrial use. 
DEFINITIONS 
Water Meter  An instrument designed to measure, memorise and display the 
volume at metering conditions of water passing through the 
measurement transducer. 
Minimum Flowrate (Q
1)  The lowest flowrate at which the water meter provides indications 
that satisfy the requirements c oncerning the maximum permissible 
errors (MPEs.) 
Transitional Flowrate (Q
2)  The transitional flowrate is the flowrate value occurring between the 
permanent and minimum flowrates, at which the flowrate range is divided into two zones, the ‘upper zone’ and the ‘low er zone’. Each EN 131   EN zone has a characteristic MPE. 
Permanent 
Flowrate (Q 3)  The highest flowrate at which the water meter operates in a 
satisfactory manner under normal cond itions of use, i.e. under steady 
or intermittent flow conditions. 
Overload Flowrate (Q
4)  The overload flowrate is the highe st flowrate at which the meter 
operates in a satisfactory manner fo r a short period of time without 
deteriorating. 
 
SPECIFIC  REQUIREMENTS 
Rated Operating Conditions 
The manufacturer shall specify the rated operatin g conditions for the instrument, in particular; 
1. The flowrate range of the water. The values for the flowrate range shall fulfil the following conditions: Q
3/Q1 ≥ 10 
Q2/Q1 = 1,6 
Q4/Q3 = 1,25 
For 5 years from the date of entry into force of this Directive the ratio Q 2/Q1 may be: 1,5, 2,5, 
4 or 6,3.  
2. The temperature range of the water. The values for the temperature range shall fulfil the following conditions: 
0,1 °C to at least 30 °C, or 30 °C to at least 90 °C. The meter may be designed to operate over both ranges. 3. The relative pressure range of  the water, the range being 0, 3 bar to at least 10 bar at Q
3. 
4. For the power supply: the nominal value of th e AC voltage supply and/or the limits of DC 
supply. 
MPE 
5. The MPE, positive or negative, on volumes delivered at flowrates between the transitional 
flowrate (Q 2) (included) and the overload flowrate (Q 4) is: 
2 % for water having a temperature ≤ 30 °C, EN 132   EN 3 % for water having a temperature > 30 °C. 
6. The MPE, positive or negative, on volumes delivered at flowrates between the minimum 
flowrate (Q 1) and the transitional flowrate (Q 2) (excluded) is 5 % for water having any 
temperature. 
 
Ð 2009/137/EC  
6a. The meter shall not exploit the MP E or systematically favour any party. 
 
Ð 2004/22/EC 
Permissible Effect of Disturbances 
7.1. Electromagnetic immunity 7.1.1. The effect of an electromagnetic disturba nce on a water meter shall be such that: 
– the change in the measurement result is no greater than the critical change value as 
defined in 8.1.4
 7.1.3 , or 
– the indication of the measurem ent result is such that it cannot be interpreted as a 
valid result, such as a momentary variati on that cannot be interpreted, memorised or 
transmitted as a measuring result. 
7.1.2. After undergoing an electromagnetic disturbance the water meter shall: 
– recover to operate within MPE, and 
– have all measurement functions safeguarded, and 
– allow recovery of all measurement data present just before the disturbance. 
7.1.3. The critical change value is the smaller of the two following values: 
– the volume corresponding to half of the ma gnitude of the MPE in the upper zone on 
the measured volume; 
– the volume corresponding to the MPE on th e volume corresponding to one minute at 
flowrate Q 3. 
7.2. Durability 
After an appropriate test, taking into account the period of time estimated by the 
manufacturer, has been performed, the fo llowing criteria shall be satisfied: 
7.2.1. The variation of the measurement result afte r the durability test, when compared with 
the initial measurement result, shall not exceed: 
– 3 % of the metered volume between Q 1 included and Q 2 excluded; EN 133   EN – 1,5 % of the metered volume between Q 2 included and Q 4 included. 
7.2.2. The error of indication for the volume metere d after the durability te st shall not exceed: 
– ± 6 % of the metered volume between Q 1 included and Q 2 excluded; 
– ± 2,5 % of the metered volume between Q 2 included and Q 4 included for water 
meters intended to meter water with a temperature between 0,1 °C and 30 °C, 
– ± 3,5 % of the metered volume between Q 2 included and Q 4 included for water 
meters intended to meter water with a temperature between 30 °C and 90 °C. 
Suitability 
8.1. The meter shall be able to be installed to  operate in any positi on unless clearly marked 
otherwise. 
8.2. The manufacturer shall specify whether the me ter is designed to measure reverse flow. In 
such a case, the reverse flow volume shall either  be subtracted from the cumulated volume or 
shall be separately recorded. The same MPE sh all apply to both forward and reverse flow. 
Water meters not designed to measure reverse flow shall either prevent reverse flow or shall 
withstand an accidental reverse flow without any deterioration or change in metrological 
properties. 
Units of Measurement 
9. Metered volume shall be displayed in cubic metres. 
Putting into Use 
 
Ð 2004/22/EC (adapted) 
10. The Member State shall ensure that the requirements under 1, 2 and 3 are determined by 
the distributor  ⌦ utility ⌫ or the person legally designated fo r installing the meter, so that 
the meter is appropriate for the accurate measur ement of consumption that is foreseen or 
foreseeable. 
 
Ð 2004/22/EC 
CONFORMITY  ASSESSMENT 
The conformity assessment proce dures referred to in Article 9 18 that the manufacturer can 
choose between are: 
B + F or B + D or H1. EN 134   EN  
Ð 2004/22/EC (adapted) 
ANNEX MI -002 IV 
GAS METERS AND VOLUME CONVERSION DEVICES ⌦ (MI-002) ⌫ 
 
Ð 2004/22/EC 
The relevant requirements of Annex I, the sp ecific requirements of this Annex and the 
conformity assessment procedures listed in this Annex, apply to gas meters and volume conversion devices defined below,  intended for residential, co mmercial and light industrial 
use. 
DEFINITIONS 
Gas meter  An instrument designed to  measure, memorise and display the 
quantity of fuel gas (volume or mass) that has passed it. 
Conversion device  A device fitted to a gas meter that automatically converts the 
quantity measured at metering cond itions into a quantity at base 
conditions. 
Minimum flowrate (Q
min)  The lowest flowrate at which the gas meter provides indications that 
satisfy the requirements regarding maximum permissible error (MPE.) 
Maximum flowrate (Q
max)  The highest flowrate at which the gas meter provides indications that 
satisfy the requirements regarding MPE. 
Transitional flowrate (Q
t)  The transitional flowrate is the flowrate occurring between the 
maximum and minimum flowrates at  which the flowrate range is 
divided into two zones, the ‘upper zone’ and the ‘low er zone’. Each 
zone has a characteristic MPE. 
Overload Flowrate (Q
r)  The overload flowrate is the highe st flowrate at which the meter 
operates for a short period of  time without deteriorating. 
Base conditions  The specified conditions to  which the measured quantity of fluid is 
converted. 
 
PART  I — SPECIFIC  REQUIREMENTS  — GAS  METERS 
1. Rated operating conditions 
The manufacturer shall specify the rated operating conditions of  the gas meter, taking into 
account: EN 135   EN 1.1. The flowrate range of the gas shall fulfil at least the following conditions: 
Class Q max/Qmin Q max/Qt Q r/Qmax 
1,5 ≥150 ≥10 1,2 
1,0 ≥20 ≥5 1,2 
 
1.2. The temperature range of the gas, with a minimum range of 40 °C. 
1.3. The fuel/gas related conditions 
The gas meter shall be designed for the range of  gases and supply pressures of the country of 
destination. In particular th e manufacturer shall indicate: 
– the gas family or group; 
– the maximum operating pressure. 
1.4. A minimum temperature range of 50 °C for the climatic environment. 
1.5. The nominal value of the AC voltage supply and/or the limits of DC supply. 
2. Maximum permissible error (MPEs) 
2.1. Gas meter indicating the volume  at metering conditions or mass 
Table 1 
Class 1,5 1,0 
Qmin ≤ Q < Q t 3 % 2 % 
Qt ≤ Q ≤ Qmax 1,5 % 1 % 
 
Ð 2009/137/EC  
The gas meter shall not exploit the MPEs  or systematically favour any party. 
 
Ð 2004/22/EC 
2.2. For a gas meter with temperature conversion,  which only indicates the converted volume, 
the MPE of the meter is increased by 0,5 % in  a range of 30 °C extending symmetrically 
around the temperature specified by the manuf acturer that lies betw een 15 °C and 25 °C. 
Outside this range, an additional increase of 0,5 % is permitted in each interval of 10 °C. EN 136   EN 3. Permissible effect of disturbances 
3.1. Electromagnetic immunity 3.1.1. The effect of an electromagnetic dist urbance on a gas meter or volume conversion 
device shall be such that: 
– the change in the measurement result is no greater than the critical change value as 
defined in 3.1.3, or 
– the indication of the measurem ent result is such that it cannot be interpreted as a 
valid result, such as a momentary variati on that cannot be interpreted, memorised or 
transmitted as a measuring result. 
3.1.2. After undergoing a disturba nce, the gas meter shall: 
– recover to operate within MPE, and 
– have all measurement functions safeguarded, and 
– allow recovery of all measurement data present just before the disturbance. 
3.1.3. The critical change value is the smaller of the two following values: 
– the quantity corresponding to half of the ma gnitude of the MPE in the upper zone on 
the measured volume; 
– the quantity corresponding to the MPE on the quantity corresponding to one minute 
at maximum flowrate. 
3.2. Effect of upstream-downstream flow disturbances 
Under installation conditions specified by th e manufacturer, the effect of the flow 
disturbances shall not exceed one third of the MPE. 
4. Durability 
After an appropriate test, taking into account the period of time estimated by the 
manufacturer, has been performed, the fo llowing criteria shall be satisfied: 
4.1. Class 1,5 meters 
4.1.1. The variation of the measurement result afte r the durability test when compared with 
the initial measurement result for the flow rates in the range Q
t to Q max-shall not exceed the 
measurement result by more than 2 %. 
4.1.2. The error of indication afte r the durability test shall not exceed twice the MPE in 
paragraph 2. 
4.2. Class 1,0 meters 
4.2.1. The variation of the measurement result afte r the durability test when compared with 
the initial measurement result shall not ex ceed one-third of the MPE in paragraph 2. EN 137   EN 4.2.2. The error of indication after the durability test shall not exceed the MPE in paragraph 2. 
5. Suitability 
5.1. A gas meter powered from the mains (AC or  DC) shall be provided with an emergency 
power supply device or other m eans to ensure, during a failure of the principal power source, 
that all measuring functions are safeguarded. 
5.2. A dedicated power source shall have a lifetime of at least five years. After 90 % of its 
lifetime an appropriate warning shall be shown. 
5.3. An indicating device shall have a sufficient number of digits to ensure that the quantity 
passed during 8000 hours at Q max does not return the digits  to their initial values. 
5.4. The gas meter shall be able to be installe d to operate in any pos ition declared by the 
manufacturer in its in stallation instruction. 
5.5. The gas meter shall have a test element, whic h shall enable tests to be carried out in a 
reasonable time. 
5.6. The gas meter shall respect the MPE in any fl ow direction or only in one flow direction 
clearly marked. 
6. Units 
Metered quantity shall be displayed in cubic metre, or in kilogram. 
PART  II — SPECIFIC  REQUIREMENTS  — VOLUME  CONVERSION  DEVICES 
 
Ð 2004/22/EC (adapted) 
A volume conversion device constitutes a sub-asse mbly according to Article 4, definition (b), 
second indent  ⌦ when it is together with a measuring instrument with which it is 
compatible ⌫ . 
 
Ð 2004/22/EC 
For a volume conversion device, the essential requirements for the gas meter shall apply, if 
applicable. In addition, the follo wing requirements shall apply: 
7. Base conditions for converted quantities 
The manufacturer shall specify the base  conditions for converted quantities. 
8. MPE 
– 0,5 % at ambient temperature 20 °C ± 3 °C, ambient humidity 60 % ± 15 %, nominal 
values for power supply; EN 138   EN – 0,7 % for temperature conversion devi ces at rated operating conditions; 
– 1 % for other conversion devices at rated operating conditions. 
Note:  
 The error of the gas meter is not taken into account. 
 
Ð 2009/137/EC  
The volume conversion device sha ll not exploit the MPEs or sy stematically favour any party. 
 
Ð 2004/22/EC 
9. Suitability 
9.1. An electronic conversion device shall be capable of detecting when it is operating outside 
the operating range(s) stated by the manufacturer for parameters that are relevant for 
measurement accuracy. In such a case, the conversion device must stop integrating the 
converted quantity, and may totalise separate ly the converted quantity for the time it is 
operating outside the operating range(s). 
9.2. An electronic conversion device shall be capab le to display all relevant data for the 
measurement without additional equipment. 
PART  III — PUTTING  INTO  USE  AND  CONFORMITY  ASSESSMENT 
Putting into use 
 10. (a) Where a Member State imposes measur ement of residential use, it sh all allow 
such measurement to be performed by means of any Class 1,5 meter, and by Class 1,0 meters which have a Q
max/Qmin ratio equal or greater than 150. 
 (b) Where a Member State imposes m easurement of commercial and/or light 
industrial use, it shal l allow such measurement to be performed by any Class 1,5 
meter. 
 
Ð 2004/22/EC (adapted) 
 (c) As regards the requirements under para graphs 1.2 and 1.3, Member States shall 
ensure that the properties be  determined by the distributor  ⌦ utility ⌫ or the 
person legally designated for installing the mete r, so that the meter is appropriate for 
the accurate measurement of consumption that is foreseen or foreseeable. EN 139   EN  
Ð 2004/22/EC 
CONFORMITY  ASSESSMENT 
The conformity assessment proce dures referred to in Article 9 18 that the manufacturer can 
choose between are 
 
Ð 2004/22/EC (adapted) 
B + F oder  ⌦ or ⌫ B + D or H1. 
ANNEX MI -003 V 
ACTIVE ELECTRICAL ENERGY METERS ⌦ (MI-003) ⌫ 
 
Ð 2004/22/EC 
The relevant requirements of Annex I, the sp ecific requirements of this Annex and the 
conformity assessment procedures listed in th is Annex, apply to active electrical energy 
meters intended for residential, co mmercial and light industrial use. 
Note:  
 Electrical energy meters may be used in  combination with external instrument 
transformers, depending upon the measurem ent technique applied. However, this 
Annex covers only electrical energy mete rs but not instrument transformers. 
DEFINITIONS 
An active electrical energy meter is a device which measures the active electrical energy 
consumed in a circuit. 
I = the electrical current flowing through the meter; 
In = the specified reference current for which the transformer operated meter has 
been designed; 
Ist = the lowest declared value of I at wh ich the meter register s active electrical 
energy at unity power factor (polyph ase meters with balanced load); 
Imin = the value of I above which the error lies within maximum permissible errors 
(MPEs) (polyphase meters with balanced load); 
Itr = the value of I above which the error lies within the smallest MPE 
corresponding to the class index of the meter; EN 140   EN Imax = the maximum value of I for which the error lies within the MPEs; 
U = the voltage of the electricity supplied to the meter; 
Un = the specified reference voltage; 
f = the frequency of the voltage supplied to the meter; 
fn = the specified reference frequency; 
PF = power factor = cos φ = the cosine of the phase difference φ between I and U. 
 
SPECIFIC  REQUIREMENTS 
1. Accuracy 
The manufacturer shall sp ecify the class index of the meter.  The class indices are defined as: 
Class A, B and C. 
2. Rated operating conditions 
The manufacturer shall specify the rated opera ting conditions of the meter; in particular: 
The values of f n, U n, In, Ist, Imin, Itr and I max that apply to the meter. For the current values 
specified, the meter shall satisfy the conditions given in Table 1; 
Table 1 
 Class A Class B Class C 
For direct-connected meters    
Ist ≤ 0,05 · Itr ≤ 0,04 · Itr ≤ 0,04 · Itr 
Imin ≤ 0,5 · Itr ≤ 0,5 · Itr ≤ 0,3 · Itr 
Imax ≥ 50 · Itr ≥ 50 · Itr ≥ 50 · Itr 
For transformer-operated meters    
Ist ≤ 0,06 · Itr ≤ 0,04 · Itr ≤ 0,02 · Itr 
Imin ≤ 0,4 · Itr ≤ 0,2 · Itr31 ≤ 0,2 · Itr 
In = 20 · Itr = 20 · Itr = 20 · Itr 
Imax ≥ 1,2 · In ≥ 1,2 · In ≥ 1,2 · In 
                                                 
31 For Class B electromechanical meters I min ≤ 0,4 · Itr shall apply. EN 141   EN  
The voltage, frequency and power factor ranges within which the meter shall satisfy the MPE 
requirements are specified in Ta ble 2. These ranges shall recogni se the typical characteristics 
of electricity supplied by public distribution systems. 
The voltage and frequency ranges shall be at least: 
0,9 · Un ≤ U ≤ 1,1 · Un 
0,98 · fn ≤ f ≤ 1,02 · fn 
power factor range at least from cos φ = 0,5 inductive to cos φ = 0,8 capacitive. 
3. MPEs 
The effects of the various measurands and in fluence quantities (a, b, c,…) are evaluated 
separately, all other measurands and influence qu antities being kept relatively constant at their 
reference values. The error of measurement, that  shall not exceed the MPE stated in Table 2, 
is calculated as: 
Error of measurement = 2√(a2 + b2 + c2 …) 
When the meter is operating under varying-load  current, the percentage errors shall not 
exceed the limits given in Table 2. 
Table 2 
MPEs in percent at rated operating conditions and defined load curren t levels and operating 
temperature 
 Operating 
temperatures Operating 
temperatures Operating 
temperatures Operating 
temperatures 
+ 5 °C 
… + 30 °C - 10 °C … + 5 °C 
or 
+ 30 °C … 
+ 40 °C - 25 °C … -
 10 °C 
or 
+ 40 °C … 
+ 55 °C - 40 °C … -
 25 °C 
or 
+ 55 °C … 
+ 70 °C Meter class 
A B C A B C A B C A B C 
Single phase 
meter; 
polyphase 
meter if 
operating 
with 
balanced 
loads             EN 142   EN Imin ≤ I < I tr 3,5 2 1 5 2,5 1,3 7 3,5 1,7 9 4 2 
Itr ≤ I ≤ Imax 3,5 2 0,7 4,5 2,5 1 7 3,5 1,3 9 4 1,5 
Polyphase 
meter if 
operating 
with single 
phase load             
Itr ≤ I ≤ Imax, 
see exception below 4 2,5 1 5 3 1,3 7 4 1,7 9 4,5 2 
 
 For electromechanical polyphase meters th e current range for single-phase load is 
limited to 5I tr ≤ I ≤ Imax 
When a meter operates in different temperatur e ranges the relevant MPE values shall apply. 
 
Ð 2009/137/EC 
The meter shall not exploit the MPEs or systematically favour any party. 
 
Ð 2004/22/EC 
4. Permissible effect of disturbances 
4.1. General As electrical energy meters ar e directly connected to the main s supply and as mains current is 
also one of the measurands, a special electrom agnetic environment is used for electricity 
meters. 
The meter shall comply with the electrom agnetic environment E2 and the additional 
requirements in 4.2 and 4.3. 
The electromagnetic environment and permissible effects reflect the situ ation that there are 
disturbances of long duration wh ich shall not affect the accuracy  beyond the critical change 
values and transient disturbances, which ma y cause a temporary degradation or loss of 
function or performance but from which the me ter shall recover and shall not affect the 
accuracy beyond the criti cal change values. 
When there is a foreseeable high risk due to lightning or where overhead supply networks are 
predominant, the metrological characteri stics of the meter shall be protected. EN 143   EN 4.2. Effect of disturbances of long duration 
Table 3 
Critical change values for di sturbances of long duration 
Critical change values in 
percent for meters of class Disturbance 
A B C 
Reversed phase sequence 1,5 1,5 0,3 
Voltage unbalance (only applicab le to polyphase meters) 4 2 1 
Harmonic contents in the current circuits32 1 0,8 0,5 
DC and harmonics in the current circuit33 6 3 1,5 
Fast transient bursts 6 4 2 
Magnetic fields; HF (radiated RF) electromagnetic field; 
Conducted disturbances intr oduced by radio-frequency 
fields; and Oscillatory waves immunity 3 2 1 
 
4.3. Permissible effect of trans ient electromagnetic phenomena 
4.3.1. The effect of an electromagnetic disturbance on an electrical energy meter shall be such 
that during and immediat ely after a disturbance 
– any output intended for testing the accuracy  of the meter does not produce pulses or 
signals corresponding to an energy of mo re than the critical change value 
and in reasonable time after the disturbance the meter shall 
– recover to operate within the MPE limits, and 
– have all measurement functions safeguarded, and 
– allow recovery of all measurement data present prior to the disturbance, and 
– not indicate a change in the re gistered energy of more than the critical change value. 
The critical change value in kWh is m · Un · Imax · 10-6 
(m being the number of measuring elements of the meter, U n in Volts and I max in Amps). 
                                                 
32 In the case of electromechanical electricity meters, no critical cha nge values are defined for harmonic 
contents in the current circuits and for DC and harmonics in the current circuit. 
33 In the case of electromechanical electricity meters, no critical cha nge values are defined for harmonic 
contents in the current circuits and for DC and harmonics in the current circuit. EN 144   EN 4.3.2. For overcurrent the critical change value is 1,5 %. 
5. Suitability 
5.1. Below the rated operating voltage the positive error of the meter shall not exceed 10 %. 
5.2. The display of the total energy shall have a sufficient number of di gits to ensure that 
when the meter is operated for 4000 hours at full load (I = I max, U = U n and PF = 1) the 
indication does not return to its initial value and shall not be able to be reset during use. 
5.3. In the event of loss of electri city in the circuit, the amounts of electrical energy measured 
shall remain available for reading du ring a period of at  least 4 months. 
5.4. Running with no load 
When the voltage is applied with no current flowi ng in the current circuit (current circuit shall 
be open circuit), the meter shall not register energy at any voltage between 0,8 · Un and 1,1 
Un. 
5.5. Starting 
The meter shall start and continue to register at U n, PF = 1 (polyphase meter with balanced 
loads) and a current which is equal to I st. 
6. Units 
The electrical energy measured shall be displayed in  kilowatt-hours or in megawatt-hours. 
7. Putting into use 
 (a) Where a Member State imposes measurem ent of residential use, it shall allow 
such measurement to be performed by mean s of any Class A meter. For specified 
purposes the Member State is authoris ed to require any Class B meter. 
 (b) Where a Member State imposes m easurement of commercial and/or light 
industrial use, it shall allo w such measurement to be performed by any Class B 
meter. For specified purposes the Member State is authorised to require any Class C meter. 
 
Ð 2004/22/EC (adapted) 
 (c) The Member State shall ensure that  the current range be determined by the 
distributo r ⌦ utility ⌫ or the person legally designated for installing the meter, so 
that the meter is appropriate for the accurate measurement of consumption that is foreseen or foreseeable. EN 145   EN  
Ð 2004/22/EC 
CONFORMITY  ASSESSMENT 
The conformity assessment proce dures referred to in Article 9 18 that the manufacturer can 
choose between are: 
B + F or B + D or H1. 
 
Ð 2004/22/EC (adapted) 
ANNEX MI -004 VI 
HEAT METERS ⌦ (MI-004)  ⌫ 
 
Ð 2004/22/EC 
The relevant requirements of Annex I, th e specific requirements and the conformity 
assessment procedures listed in this Annex, appl y to heat meters defined below, intended for 
residential, commercial a nd light industrial use. 
DEFINITIONS 
A heat meter is an instrument designed to measur e the heat which, in a heat exchange circuit, 
is given up by a liquid calle d the heat-conveying liquid. 
A heat meter is either a complete instrument or a combined instrument consisting of the sub-
assemblies, flow sensor, temper ature sensor pair, and calculato r, as defined in Article 4(b 2), 
or a combination thereof 
θ = the temperature of th e heat-conveying liquid; 
θin = the value of θ at the inlet of the heat exchange circuit; 
θout = the value of θ at the outlet of the heat exchange circuit; 
∆θ = the temperature difference θin — θout with ∆θ ≥ 0; 
θmax = the upper limit of θ for the heat meter to function correctly within the MPEs; 
θmin = the lower limit of θ for the heat meter to function correctly within the MPEs; 
∆θmax = the upper limit of ∆θ for the heat meter to function correctly within the 
MPEs; 
∆θmin = the lower limit of ∆θ for the heat meter to function correctly within the EN 146   EN MPEs; 
q = the flow rate of the heat conveying liquid; 
qs = the highest value of q that is permitted for short periods of time for the heat 
meter to function correctly; 
qp = the highest value of q that is permitted permanently for the heat meter to 
function correctly; 
qi = the lowest value of q that is permitted for the heat meter to function 
correctly; 
P = the thermal power of the heat exchange; 
Ps = the upper limit of P that is permitted for the heat meter to function correctly. 
 
SPECIFIC  REQUIREMENTS 
1. Rated operating conditions 
The values of the rated operating conditions shal l be specified by the manufacturer as follows: 
1.1. For the temperature of the liquid: θmax, θmin, 
– for the temperature differences: ∆θmax, ∆θmin, 
 subject to the following restrictions: ∆θmax/∆θmin ≥ 10; ∆θmin = 3 K or 5 K or 10 K. 
1.2. For the pressure of the liquid: The maximum positive internal pressure that the heat meter 
can withstand permanently at the upper limit of the temperature. 
1.3. For the flow rates of the liquid: q s, qp, qi, where the values of q p and q i are subject to the 
following restriction: q p/qi ≥ 10. 
1.4. For the thermal power: P s. 
2. Accuracy classes 
The following accuracy classes are defined for heat meters: 1, 2, 3. 
3. MPEs applicable to complete heat meters 
The maximum permissible relative errors applicab le to a complete heat meter, expressed in 
percent of the true value fo r each accuracy class, are: 
– For class 1: E = E f + E t + E c, with E f, Et, Ec according to paragraphs 7.1 to 7.3. 
– For class 2: E = E f + E t + E c, with E f, Et, Ec according to paragraphs 7.1 to 7.3. 
– For class 3: E = E f + E t + E c, with E f, Et, Ec according to paragraphs 7.1 to 7.3. EN 147   EN  
Ð 2009/137/EC  
The complete heat meter shall not exploit the MPEs or systematically favour any party. 
 
Ð 2004/22/EC 
4. Permissible influences of electromagnetic disturbances 
4.1. The instrument shall not be influenced by static magnetic fields and by electromagnetic 
fields at mains frequency. 
4.2. The influence of an electromagnetic disturba nce shall be such that the change in the 
measurement result is not greater than the cri tical change value as laid down in requirement 
4.3 or the indication of the measurement result is such that it cannot be interpreted as a valid 
result. 
4.3. The critical change value for a complete heat  meter is equal to the absolute value of the 
MPE applicable to that heat meter (see paragraph 3). 
5. Durability 
After an appropriate test, taking into account the period of time estimated by the 
manufacturer, has been performed, the fo llowing criteria shall be satisfied: 
5.1. Flow sensors: The variation of the measur ement result after the durability test, when 
compared with the initial measurement result, shall not exceed the crit ical change value. 
5.2. Temperature sensors: The variation of the measurement result after the durability test, 
when compared with the initial meas urement result, shall not exceed 0,1 °C. 
6. Inscriptions on a heat meter 
– Accuracy class 
– Limits of flow rate 
– Limits of temperature 
– Limits of temperature difference 
– Place of the flow sensor inst allation: flow or return 
– Indication of the di rection of flow 
7. Sub-assemblies 
The provisions for sub-assemblies may apply to sub-assemblies manufactured by the same or 
different manufacturers. Where a heat meter consists of sub-assemblies, the essential 
requirements for the heat meter apply to the sub-assemblies as releva nt. In addition, the 
following apply: EN 148   EN 7.1. The relative MPE of the flow sensor, expressed in %, for accuracy classes: 
– Class 1: E f = (1 + 0,01 q p/q), but not more than 5 %, 
– Class 2: E f = (2 + 0,02 q p/q), but not more than 5 %, 
– Class 3: E f = (3 + 0,05 q p/q), but not more than 5 %, 
where the error E f relates the indicated value to the true  value of the relatio nship between flow 
sensor output signal and the mass or the volume. 
7.2. The relative MPE of the temperature sensor pair, expressed in %: – E
t = (0,5 + 3 · ∆θmin/∆θ), 
where the error E t relates the indicated value to the tr ue value of the relationship between 
temperature sensor pair output  and temperature difference. 
7.3. The relative MPE of the ca lculator, expressed in %: 
– Ec = (0,5 + ∆θmin/∆θ), 
where the error E c relates the value of the heat indicat ed to the true value of the heat. 
7.4. The critical change value fo r a sub-assembly of a heat me ter is equal to the respective 
absolute value of the MPE applicable to th e sub-assembly (see paragraphs 7.1, 7.2 or 7.3). 
7.5. Inscriptions on the sub-assemblies 
Accuracy class 
Limits of flow rate 
Limits of temperature 
Nominal meter factor (e.g. lit res/pulse) or corresponding output 
signal Flow sensor: 
Indication of the di rection of flow 
Type identification (e.g. Pt 100) 
Limits of temperature Temperature sensor pair: 
Limits of temperature difference 
Calculator: Type of temperature sensors 
– Limits of temperature 
– Limits of temperature difference 
– Required nominal meter factor (e.g. litres/pulse) or EN 149   EN corresponding input signal coming from the flow sensor 
– Place of the flow sensor inst allation: flow or return 
 
PUTTING  INTO  USE 
 8. (a) Where a Member State imposes measur ement of residential use, it shall allow 
such measurement to be performed by means of any Class 3 meter. 
 (b) Where a Member State imposes m easurement of commercial and/or light 
industrial use, it is authorised to require any Class 2 meter. 
 
Ð 2004/22/EC (adapted) 
 (c) As regards the requirements under pa ragraphs 1.1 to 1.4, Me mber States shall 
ensure that the properties be  determined by the distributor  ⌦ utility ⌫ or the 
person legally designated for installing the mete r, so that the meter is appropriate for 
the accurate measurement of consumption that is foreseen or foreseeable. 
 
Ð 2004/22/EC 
CONFORMITY  ASSESSMENT 
The conformity assessment proce dures referred to in Article 9 18 that the manufacturer can 
choose between are: 
B + F or B + D or H1. 
 
Ð 2004/22/EC (adapted) 
ANNEX MI -005 VII 
MEASURING SYSTEMS FOR THE CONTINUOUS AND DYNAMIC 
MEASUREMENT OF QUANTITIES OF  LIQUIDS OTHER THAN WATER  ⌦ (MI-
005) ⌫ 
 
Ð 2004/22/EC 
The relevant essential requireme nts of Annex I, the specific requirements of this Annex and 
the conformity assessment procedures listed in this Annex, apply to measuring systems 
intended for the continuous and dynamic measurem ent of quantities (volumes or masses) of EN 150   EN liquids other than water. If appr opriate, the terms ‘volume, and L’ in this Anne x can be read 
as: ‘mass and kg’. 
DEFINITIONS 
Meter  An instrument designed to  measure continuously, memorise and 
display the quantity at meteri ng conditions of liquid flowing 
through the measurement transducer  in a closed, fully charged 
conduit. 
Calculator  A part of a meter that receives the output signals from the 
measurement transducer(s) and possibly, from associated measuring instruments and displays the measurement results. 
Associated measuring instrument  An instrument connected to the calculator for measuring certain 
quantities which are characteristic of the liquid, with a view to 
make a correction and/or conversion. 
Conversion Device  A part of the cal culator which by taking account of the 
characteristics of the liquid (tem perature, density, etc.) measured 
using associated measuring instruments, or stored in a memory, automatically converts: 
– the volume of the liquid measured at metering conditions 
into a volume at base cond itions and/or into mass, or 
– the mass of the liquid measured at metering conditions 
into a volume at metering c onditions and/or into a volume 
at base conditions 
Note:  
 A conversion device includes the relevant associated 
measuring instruments. 
Base conditions  The specified conditions to which the measured quantity of liquid 
at metering conditions is converted. 
Measuring System  A system that comprises th e meter itself and all devices required to 
ensure correct measurement or inte nded to facilitate the measuring 
operations. 
Fuel dispenser  A measuring system inte nded for the refuelling of motor vehicles, 
small boats and small aircraft. 
Self-service arrangement  An arrangement that allows the customer to use a measuring 
system for the purpose of obtaining liquid for his own use. 
Self-service device  A specific device that is  part of a self-ser vice arrangement and 
which allows one of more measuring systems to perform in this self-service arrangement. EN 151   EN Minimum measured 
quantity (MMQ)  The smallest quantity of liquid for which the measurement is 
metrologically acceptable for the measuring system. 
Direct indication  The indi cation, either volume or mass, corresponding to the 
measure and that the meter is physically capable  of measuring. 
Note:  
 The direct indication may be converted into another 
quantity using a conversion device. 
Interruptible/non interruptible  A measuring system is considered  as interruptible /non interruptible 
when the liquid flow can/cannot be stopped easily and rapidly. 
Flowrate range  The range between the minimum flowrate (Q min) and maximum 
flowrate (Q max). 
 
SPECIFIC  REQUIREMENTS 
1. Rated operating conditions 
The manufacturer shall specify the rated operatin g conditions for the instrument, in particular; 
1.1. The flowrate range The flowrate range is subject  to the following conditions: 
 (i) the flowrate range of a measuring system shall be within the flowrate range of 
each of its elements, in particular the meter. 
 (ii) meter and measuring system: 
Table 1 
Specific measuring system Characteristic of 
liquid Minimum ratio of 
Qmax : Q min 
Not Liquefied gases 10 : 1 Fuel dispensers 
Liquefied gases 5 : 1 
Measuring system Cryogenic liquids 5 : 1 
Measuring systems on pipeline and systems 
for loading ships All liquids Suitable for use 
All other measuring systems All liquids 4 : 1 
 EN 152   EN 1.2. The properties of the liquid to be measured by the instrume nt by specifying the name or 
type of the liquid or its relevant  characteristics, for example: 
– Temperature range; 
– Pressure range; 
– Density range; 
– Viscosity range. 
1.3. The nominal value of the AC voltage suppl y and/or limits of the DC voltage supply. 
1.4. The base conditions for converted values. 
Note: 
 
Ð 2004/22/EC (adapted) 
 Paragraph 1.4 is without prej udice to the Member States' ob ligations to require use of 
a temperature of either 15 °C in accordance with Article 3(1 )12(2)  of Council 
Directive 92/81/EEC  2003/96/EC  of 19 October 1992  27 October 2003  on the 
harmonisation of the structures of excise duties on mineral oils  ⌦ restructuring the 
Community framework for the taxation of energy products and electricity ⌫34 or, 
for heavy fuel oils, LPG and methane, a nother temperature pu rsuant to Article 3(2) 
of that Directive . 
 
Ð 2004/22/EC 
2. Accuracy classification and m aximum permissible errors (MPEs) 
2.1. For quantities equal to or greater th an 2 litres the MP E on indications is: 
Table 2 
 Accuracy Class 
 0,3 0,5 1,0 1,5 2,5 
Measuring systems (A) 0,3% 0,5% 1,0% 1,5% 2,5% 
Meters (B) 0,2% 0,3% 0,6% 1,0% 1,5% 
 
2.2. For quantities less than two litr es the MPE on indications is: 
                                                 
34 OJ L 316, 31.10.1992, p. 12. Directive abolished by Directive 2003/96/EC ( OJ L 283, 31.10.2003, p. 
51). EN 153   EN Table 3 
Measured volume V MPE 
V < 0,1 L 4 × value in Table 2, applied to 0,1 L 
0,1 L ≤ V < 0,2 L 4 × value in Table 2 
0,2 L ≤ V < 0,4 L 2 × value in Table 2, applied to 0,4 L 
0,4 L ≤ V < 1 L 2 × value in Table 2 
1 L ≤ V < 2 L Value in Table 2, applied to 2 L 
 
2.3. However, no matter what the measured quan tity may be, the magnitude of the MPE is 
given by the greater of the following two values: 
– the absolute value of the MPE given in Table 2 or Table 3, 
– the absolute value of the MPE fo r the minimum measured quantity (E min). 
2.4.1. For minimum measured quantities greater than or equal to 2 litres the following 
conditions apply: 
Condition 1  
Emin shall fulfil the condition: E min ≥ 2 R, where R is the smallest scale interval of the 
indication device. 
Condition 2  
Emin is given by the formula: E min = (2MMQ) × (A/100), where: 
– MMQ is the minimum measured quantity, 
– A is the numerical value specified in line A of Table 2. 
2.4.2. For minimum measured quantities of le ss than two litres, the above mentioned 
condition 1 applies and E min is twice the value specified in Table 3, and related to line A of 
Table 2. 
2.5. Converted indication 
In the case of a converted indication the MPEs are as in line A of Table 2. 
2.6. Conversion devices 
MPEs on converted indications due to a convers ion device are equal to ± (A — B), A and B 
being the values specified in Table 2. 
Parts of conversion devices that  can be tested separately EN 154   EN  (a) Calculator  
 MPEs on quantities of liquid indications  applicable to calculation, positive or 
negative, are equal to one-tenth of the MPEs as defined in line A of Table 2. 
 (b) Associated measuring instruments  
 Associated measuring instruments shall have an accuracy at least as good as the 
values in Table 4: 
Table 4 
Accuracy classes of the measuring system MPE on Measurements 
0,3 0,5 1,0 1,5 2,5 
Temperature ± 0,3 °C ± 0,5 °C ± 1,0 °C 
Pressure Less than 1 MPa: ± 50 kPa 
From 1 to 4 MPa: ± 5 % Over 4 MPa: ± 200 kPa 
Density ± 1 kg/m3 ± 2 kg/m3 ± 5 kg/m3 
  These values apply to the indication of the characteristic quantities of the liquid 
displayed by the conversion device. 
 c) Accuracy for calculating function  
 The MPE for the calculation of each charac teristic quantity of the liquid, positive or 
negative, is equal to two fifths  of the value fixed in (b). 
2.7. The requirement (a) in paragraph 2.6 applie s to any calculation, not only conversion. 
 
Ð 2009/137/EC  
2.8. The measuring system shall not exploit th e MPEs or systematically favour any party. 
 
Ð 2004/22/EC  
3. Maximum permissible effect of disturbances 
3.1. The effect of an electromagnetic disturbanc e on a measuring system shall be one of the 
following; EN 155   EN – the change in the measurement result is not greater than the critical change value as 
defined in paragraph 3.2, or 
– the indication of the measurement result s hows a momentary varia tion that cannot be 
interpreted, memorised or transmitted as a measuring result. Furthermore, in the case of an interruptible system, this can also  mean the impossibility to perform any 
measurement, or 
– the change in the measurement result is great er than the critical change value, in 
which case the measuring system shall permit the retrieval of the measuring result just before the critical change va lue occurred and cut off the flow. 
3.2. The critical change value is  the greater of MPE/5 for a pa rticular measured quantity or 
E
min. 
4. Durability 
After an appropriate test, taking into account the period of time estimated by the 
manufacturer, has been performed, the fo llowing criterion sha ll be satisfied: 
The variation of the measurement result after the durability test, when compared with the 
initial measurement result, shall not exceed the va lue for meters specified in line B of table 2. 
5. Suitability 
5.1. For any measured quantity relating to the sa me measurement, the i ndications provided by 
various devices shall not deviat e one from another by more th an one scale interval where 
devices have the same scale interval. In th e case where the devices have different scale 
intervals, the deviation shall not be more than that of the greatest scale interval. 
However, in the case of a self-service arrangeme nt the scale intervals of the main indicating 
device on the measuring system and the scale inte rvals of the self-service device shall be the 
same and results of measurement shall not deviate one from another. 
5.2. It shall not be possible to divert the meas ured quantity in normal conditions of use unless 
it is readily apparent. 
5.3. Any percentage of air or gas not easily detectable in the liqui d shall not lead to a variation 
of error greater than: 
– 0,5 % for liquids other than potable liqui ds and for liquids of a viscosity not 
exceeding 1 mPa.s, or 
– 1 % for potable liquids and for liquids  of a viscosity ex ceeding 1 mPa.s. 
However, the allowed variation shall never be smaller than 1 % of MMQ. This value applies 
in the case of air or gas pockets. 
5.4. Instruments for direct sales 
5.4.1. A measuring system for direct sales sha ll be provided with means for resetting the 
display to zero. EN 156   EN It shall not be possible to divert the measured quantity. 
5.4.2. The display of the quantity on which the transaction is based shall be permanent until 
all parties in the transaction have  accepted the measurement result. 
5.4.3. Measuring systems for direct sales shall be interruptible. 
5.4.4. Any percentage of air or gas in the liquid sh all not lead to a vari ation of error greater 
than the values specified in paragraph 5.3. 
5.5. Fuel Dispensers 
5.5.1. Displays on fuel dispensers shall not be  capable of being reset to zero during a 
measurement. 
5.5.2. The start of a new measurement shall be i nhibited until the display has been reset to 
zero. 
5.5.3. Where a measuring system is fitted with a price display, the difference between the 
indicated price and the price calculated from th e unit price and the indicated quantity shall not 
exceed the price corresponding to E min. However this difference need not be less than the 
smallest monetary value. 
6. Power supply failure 
A measuring system shall either be provided w ith an emergency power supply device that will 
safeguard all measuring functions during the fa ilure of the main power supply device or be 
equipped with means to save and display the data  present in order to permit the conclusion of 
the transaction in progress and with means to stop  the flow at the moment of the failure of the 
main power supply device. 
7. Putting into use 
Table 5 
Accuracy Class Types of Measuring system 
0,3 Measuring systems on pipeline 
0,5 All measuring systems if not differently  stated elsewhere in this Table, in 
particular: 
– fuel dispensers (not for liquefied gases), 
– measuring systems on road tankers for liquids of low viscosity 
(< 20 mPa.s) 
– measuring systems for (un)loading ships and rail and road 
tankers35 
                                                 
35 However, Member States may require measuring systems of accuracy class 0,3 or 0,5 when used for the 
levying of duties on mineral oils when ( un)loading ships and rail and road tankers. EN 157   EN – measuring systems for milk 
– measuring systems for refuelling aircraft 
Measuring systems for liquefied gases under pressure measured at a 
temperature equal to or above – 10 °C 1,0 
Measuring systems normally in clas s 0,3 or 0,5 but used for liquids 
– whose temperature is less than - 10 °C or greater than 50 °C 
– whose dynamic viscosity is higher than 1000 mPa.s 
– whose maximum volumetric flowrate  is not higher than 20 L/h 
Measuring systems for liquefied carbon dioxide 1,5 
Measuring systems for liquefied gases under pressure measured at a 
temperature below – 10 °C (o ther than cryogenic liquids) 
2,5 measuring systems for cryogenic liq uids (temperature below – 153 °C) 
 
Note:  
 However, the manufacturer may specify a better accuracy for a certain type of 
measuring system. 
8. Units of measurement 
The metered quantity shall be displayed in millil itres, cubic centimetres, litres, cubic metres, 
grams, kilograms or tonnes. 
CONFORMITY  ASSESSMENT 
The conformity assessment proce dures referred to in Article 9 18 that the manufacturer can 
choose between are: 
B + F or B + D or H1 or G. 
 
Ð 2004/22/EC (adapted) 
ANNEX MI -006 VIII  
AUTOMATIC WEIGHING INSTRUMENTS ⌦ (MI-006) ⌫ EN 158   EN  
Ð 2004/22/EC 
The relevant essential requireme nts of Annex I, the specific requirements of this Annex and 
the conformity assessment proce dures listed in Chapter I of this Annex, apply to automatic 
weighing instruments defined below, intended to determine the mass of a body by using the 
action of gravity on that body. 
DEFINITIONS 
Automatic weighing 
instrument  An instrument that determines  the mass of a product without 
the intervention of an operato r and follows a predetermined 
programme of automatic proce sses characteristic of the 
instrument. 
Automatic catchweigher  An automatic wei ghing instrument that determines the mass 
of pre-assembled discrete loads (for example prepackages) or single loads of loose material. 
Automatic checkweigher  An automatic catchweigher that subdivides articles of 
different mass into two or more subgroups according to the value of the difference of their mass and a nominal set-point. 
Weight labeller  An automatic catchweigher that labels individual articles 
with the weight value. 
Weight/price labeller  An automatic catchweigher that labels individual articles 
with the weight value, and price information. 
Automatic gravimetric filling instrument  An automatic weighing instrument that fills containers with 
a predetermined and virtually constant mass of product from bulk. 
Discontinuous totaliser 
(totalising hopper 
weigher)  An automatic weighing instrument that determines the mass 
of a bulk product by dividing it into discrete loads. The 
mass of each discrete load is  determined in sequence and 
summed. Each discrete load is then delivered to bulk. 
Continuous totaliser  An automatic we ighing instrument that continuously 
determines the mass of a bulk product on a conveyor belt, without systematic subdivision of the product and without interrupting the movement of the conveyor belt. 
Rail-weighbridge  An automatic weighing instrument having a load receptor 
inclusive of rails for conveying railway vehicles. 
 EN 159   EN SPECIFIC  REQUIREMENTS 
CHAPTER I — Requirements common to all ty pes of automatic weighing instruments 
1. Rated Operating Conditions The manufacturer shall specify the rated opera ting conditions for the instrument as follows: 
1.1. For the measurand: The measuring range in terms of its maximum and minimum capacity. 1.2. For the electrical su pply influence quantities: 
In case of AC voltage 
supply : the nominal AC voltage supply, or the AC voltage limits. 
In case of DC voltage 
supply : the nominal and minimum DC voltage supply, or the DC 
voltage limits. 
 
1.3. For the mechanical and climatic influence quantities: The minimum temperature range is 30 °C unless specified otherwise in the following chapters 
of this Annex. 
The mechanical environment classes according to  Annex I, paragraph 1.3.2 are not applicable. 
For instruments which are used under special mech anical strain, e.g. inst ruments incorporated 
into vehicles, the manufacturer shall defi ne the mechanical conditions of use. 
1.4. For other influence quan tities (if applicable): 
The rate(s) of operation. The characteristics of the product(s) to be weighed. 
2. Permissible effect of disturbanc es - Electromagnetic environment 
The required performance and the critical change  value are given in the relevant Chapter of 
this Annex for each type of instrument. 
3. Suitability 
3.1. Means shall be provided to limit the effects of tilt, loading and rate of operation such that 
maximum permissible errors (MPEs) ar e not exceeded in normal operation. 
3.2. Adequate material handling facilities shall be  provided to enable the instrument to respect 
the MPEs during normal operation. 
3.3. Any operator control interface shall be clear and effective. 3.4. The integrity of the displa y (where present) shall be verifiable by the operator. EN 160   EN 3.5. Adequate zero setting capability shall be provi ded to enable the inst rument to respect the 
MPEs during normal operation. 
3.6. Any result outside the measurement range shall be identified as such, where a printout is 
possible. 
4. Conformity assessment 
The conformity assessment proce dures referred to in Article 9 18 that the manufacturer can 
choose between are: 
For mechanical systems: B + D or B + E or B + F or D1 or F1 or G or H1. For electromechanical instruments: B + D or B + E or B + F or G or H1. For electronic systems or systems containing software: B + D or B + F or G or H1. 
CHAPTER II — Automatic Catchweighers 
1. Accuracy Classes 1.1. Instruments are divided into primary categories designated by: 
X or Y as specified by the manufacturer. 1.2. These primary categories are further divided into four accuracy classes: 
XI, XII, XIII & XIV and Y(I), Y(II), Y(a) & Y(b) which shall be specified by the manufacturer. 
2. Category X Instruments 
 
Ð 2004/22/EC (adapted) 
2.1. Category X applies to instruments used to check prepackages made up in accordance with 
the requirements of Council Di rective 75/106/EEC of 19 Decembe r 1974 on the 
approximation of the laws of the Me mber States relating to the making -up by volume of EN 161   EN certain prepackaged liquids36 and of Council Directive 76/211/ EEC of 20 January 1976 on the 
approximation of the laws of the Member Stat es relating to the making-up by weight or by 
volume of certain prepackaged products37 applicable to prepackages. 
 
Ð 2004/22/EC 
2.2. The accuracy classes are supplemented by a factor (x) that quantifies the maximum 
permissible standard deviation as specified in paragraph 4.2. 
The manufacturer shall sp ecify the factor (x), where (x) shall be ≤ 2 and in the form 1 × 10k, 
2 × 10k or 5 × 10k, where k is a negative whole number or zero. 
3. Category Y Instruments 
Category Y applies to all ot her automatic catchweighers. 
4. MPE 
4.1. Mean error Category X / MPE Category Y instruments 
Table 1 
Net Load (m) in verification scale intervals (e) Maxim
um 
permiss
ible 
mean 
error Maxim
um 
permis
sible 
error 
XI Y(I) XII Y(II) XIII Y(a) XIV Y(b) X Y 
0 < m ≤ 50000 0 < m ≤ 5000 0 < m ≤ 500 0 < m ≤ 50 ± 0,5 e ± 1 e 
50000 < m ≤ 200
000 5000 < m ≤ 200
00 500 < m ≤ 2000 50 < m ≤ 200 ± 1,0 e ± 1,5 e 
200000 < m 20000 < m ≤ 10
0000 2000 < m ≤ 100
00 200 < m ≤ 100
0 ± 1,5 e ± 2 e 
 
4.2. Standard deviation Maximum permissible value for the standard deviation of a class X (x) instrument is the result 
of the multiplication of the factor (x) by the value in Table 2 below. 
                                                
 
36 OJ L 42, 15.2.1975, p. 1. Directive as last amended by Directive 89/676/ EEC (OJ L 398, 30.12.1989, p. 
18). 
37 OJ L 46, 21.2.1976, p. 1. Directive as last amended by the EEA Agreement.  EN 162   EN Table 2 
Net Load (m) Maximum permissible standard deviation for class X(1) 
m ≤ 50 g 0,48 % 
50 g < m ≤ 100 g 0,24 g 
100 g < m ≤ 200 g 0,24 % 
200 g < m ≤ 300 g 0,48 g 
300 g < m ≤ 500 g 0,16 % 
500 g < m ≤ 1000 g 0,8 g 
1000 g < m ≤ 
10000 g 0,08 % 
10000 g < m ≤ 
15000 g 8 g 
15000 g < m 0,053 % 
 For class XI and XII (x) shall be less than 1. 
 For class XIII (x) shall be not greater than 1.  For class XIV (x) shall be greater than 1. 4.3. Verification scale interval — single interval instruments 
Table 3 
Accuracy classes Verification scale 
interval Number of verifica tion scale intervals 
n = Max/e 
   Minimum Maximum 
XI Y(I) 0,001 g ≤ e 50000 — 
0,001 g ≤ e ≤ 0,05 g 100 100000 XII Y(II) 
0,1 g ≤ e 5000 100000 
0,1 g ≤ e ≤ 2 g 100 10000 XIII Y(a) 
5 g ≤ e 500 10000 
XIV Y(b) 5 g ≤ e 100 1000 
 EN 163   EN 4.4. Verification scale interval — multi-interval instruments 
Table 4 
Accuracy 
classes Verification scale 
interval Number of verification s cale intervals n = Max/e 
   Minimum value38 
n = Max i/e(i+1) Maximum value 
n = Max i/ei 
XI Y(I) 0,001 g ≤ ei 50000 — 
0,001 g ≤ ei ≤ 0,05 g 5000 100000 XII Y(II) 
0,1 g ≤ ei 5000 100000 
XIII Y(a) 0,1 g ≤ ei 500 10000 
XIV Y(b) 5 g ≤ ei 50 1000 
 Where: 
i = 1, 2, … r 
i = partial weighing range 
r = total number of partial ranges 
5. Measurement Range 
In specifying the measurement range for class Y instruments the manufacturer shall take 
account that the minimum capac ity shall not be less than: 
class Y(I) : 100 e 
class Y(II) : 20 e for 0,001 g ≤ e ≤ 0,05 g, and 50 
e for 0,1 g ≤ e 
class Y(a) : 20 e 
class Y(b) : 10 e 
Scales used for grading, e.g. postal scales and 
garbage weighers : 5 e 
 
                                                 
38 For i = r the corresponding column of  Table 3 applies with e replaced by e r. EN 164   EN 6. Dynamic Setting 
6.1. The dynamic setting facility shall operate within a load range specified by the 
manufacturer. 
6.2. When fitted, a dynamic setting facility that  compensates for the dynamic effects of the 
load in motion shall be inhibited from operatin g outside the load range, and shall be capable 
of being secured. 
7. Performance Under Influence Factors And Electromagnetic Disturbances 
7.1. The MPEs due to influence factors are: 
7.1.1. For category X instruments: – For automatic operation; as specified in Tables 1, and 2, 
– For static weighing in non-automatic operation; as specified in Table 1. 
7.1.2. For category Y instruments – For each load in automatic operation; as specified in Table 1, 
– For static weighing in non-au tomatic operation; as specified for category X in 
Table 1. 
7.2. The critical change value due  to a disturbance is one verification scale interval. 
7.3. Temperature range: – For class XI and Y(I) the minimum range is 5° C, 
– For class XII and Y(II) the minimum range is 15° C. 
CHAPTER III — Automatic Gravim etric Filling Instruments 
1. Accuracy classes 1.1. The manufacturer shall specify both the reference accuracy class Ref(x) and the 
operational accuracy class(es) X(x). 
1.2. An instrument type is designated a referen ce accuracy class, Ref(x), corresponding to the 
best possible accuracy for instruments of the type. After installation, individual instruments 
are designated for one or more ope rational accuracy classes, X(x) , having taken account of the 
specific products to be weighed. The class designation factor (x) shall be ≤ 2, and in the form 
1 × 10
k, 2 × 10k or 5 × 10k where k is a negative whole number or zero. 
1.3. The reference accuracy class, Ref(x)  is applicable for static loads. 
1.4. For the operational accuracy class X(x), X is a regime relating accuracy to load weight 
and (x) is a multiplier for the limits of error specified for class X(1) in 2.2. EN 165   EN 2. MPE 
2.1. Static weighing error 
2.1.1. For static loads under rated operating co nditions, the MPE for reference accuracy class 
Ref(x), shall be 0,312 of the maximum permissible deviation of each fill from the average; as 
specified in Table 5; multiplied by the class designation factor (x). 
2.1.2. For instruments where the fill may be made up from more than one load (e.g. 
cumulative or selective combination weighers) th e MPE for static loads shall be the accuracy 
required for the fill as specified  in 2.2 (i.e. not the sum of th e maximum permissible deviation 
for the individual loads). 
2.2. Deviation from average fill 
Table 5 
Value of the mass, m (g), of the fills Maxi mum permissible deviation of each fill from 
theaverage  the average  for class X(1) 
m ≤ 50 7,2 % 
50 < m ≤ 100 3,6 g 
100 < m ≤ 200 3,6 % 
200 < m ≤ 300 7,2 g 
300 < m ≤ 500 2,4 % 
500 < m ≤ 1000 12 g 
1000 < m ≤ 10000 1,2 % 
10000 < m ≤ 15000 120 g 
15000 < m 0,8 % 
Note:  
 The calculated deviation of each fill from the average may be adjusted to take 
account for the effect of material particle size. 
2.3. Error relative to pre- set value (setting error) 
For instruments where it is possible to pre-se t a fill weight; the maximum difference between 
the pre-set value and the average mass of th e fills shall not exceed 0,312 of the maximum 
permissible deviation of each fill from the average, as specified in Table 5. 
3. Performance Under Influence Factor And Electromagnetic Disturbance 
3.1. The MPE due to influence factors sha ll be as specified in paragraph 2.1. EN 166   EN 3.2. The critical change value due to  a disturbance is a change of  the static weight indication 
equal to the MPE as specified in paragraph 2.1 calculated for the rated minimum fill, or a 
change that would give equivalent effect on the fill in the case of instruments where the fill 
consists of multiple loads. The calculated critic al change value shall be rounded to the next 
higher scale interval (d). 
3.3. The manufacturer shall specify the value of the rated minimum fill. 
CHAPTER IV — Discontinuous Totalisers 
1. Accuracy Classes Instruments are divided into four accuracy classes as follows: 0,2, 0,5, 1, 2. 
2. MPEs 
Table 6 
Accuracy class MPE of totalised load 
0,2 ± 0,10 % 
0,5 ± 0,25 % 
1 ± 0,50 % 
2 ± 1,00 % 
3. Totalisation scale interval 
The totalisation scale interval (d t) shall be in the range: 
0,01 % Max ≤ dt ≤ 0,2 % Max 
4. Minimum Totalised Load ( Σmin) 
The minimum totalised load ( Σmin) shall be not less than the load  at which the MPE is equal to 
the totalisation scale interval (d t) and not less than the minimum load as specified by the 
manufacturer. 
5. Zero Setting 
Instruments that do not tare weigh after each discharge shall have a zero setting device. 
Automatic operation shall be inhibi ted if zero indication varies by: 
– 1 d t on instruments with automatic zero setting device; 
– 0,5 d t on instruments with a semi-automatic, or non-automatic, zero setting device. 
6. Operator Interface 
Operator adjustments and reset function shal l be inhibited during automatic operation. EN 167   EN 7. Printout 
On instruments equipped with a printing device, th e reset of the total shall be inhibited until 
the total is printed. The printout of the total shall occur if automatic operation is interrupted. 
8. Performance under influence fact ors and electromagne tic disturbances 
8.1. The MPEs due to influence factors shall be as specified in Table 7. 
Table 7 
Load (m) in totalisation scale intervals 
(dt) MPE 
0 < m ≤ 500 ± 0,5 d t 
500 < m ≤ 2000 ± 1,0 d t 
2000 < m ≤ 10000 ± 1,5 d t 
8.2. The critical change value due to a disturba nce is one totalisation scale interval for any 
weight indication and any stored total. 
CHAPTER V — Continuous Totalisers 
1. Accuracy classes Instruments are divided into three accuracy classes as follows: 0,5, 1, 2. 
2. Measurement Range 
2.1. The manufacturer shall specify the measur ement range, the ratio between the minimum 
net load on the weighing unit and the maximu m capacity, and the minimum totalised load. 
2.2. The minimum totalised load Σ
min shall not be less than 
800 d for class 0,5, 400 d for class 1, 200 d for class 2. Where d is the totalisation scale interval of the general totalisation device. 
3. MPE 
Table 8 
Accuracy class MPE for totalised load 
0,5 ± 0,25 % 
1 ± 0,5 % EN 168   EN 2 ± 1,0 % 
4. Speed of the belt 
The speed of the belt shall be specified by th e manufacturer. For singl e-speed beltweighers, 
and variable-speed beltweighers  having a manual speed setting control, the speed shall not 
vary by more than 5 % of the nominal value. Th e product shall not have a different speed than 
the speed of the belt. 
5. General Totalisation Device 
It shall not be possible to reset th e general totalisation device to zero. 
6. Performance under influence fact ors and electromagne tic disturbances 
6.1. The MPE due to influence factor , for a load not less than the Σmin, shall be 0,7 times the 
appropriate value specified in Table 8, rounded to the nearest to talisation scale interval (d). 
6.2. The critical change value due to a disturbance shall be 0,7 times the appropriate value 
specified in Table 8, for a load equal to Σmin, for the designated class of the beltweigher; 
rounded up to the next higher tota lisation scale interval (d). 
CHAPTER VI — Automatic Rail Weighbridges 
1. Accuracy classes Instruments are divided into f our accuracy classes as follows: 
0,2, 0,5, 1, 2. 
2. MPE 
2.1. The MPEs for weighing-in-motion of a single wagon or a total train are shown in table 9. 
Table 9 
Accuracy class MPE 
0,2 ± 0,1 % 
0,5 ± 0,25 %
1 ± 0,5 % 
2 ± 1,0 % 
2.2. The MPEs for the weight of coupled or uncoupled wagons weighing-in-motion shall be 
one of the following values, whichever is the greatest: 
– the value calculated according to Table 9, rounded to the neares t scale interval; EN 169   EN – the value calculated according to Table 9, rounded to the nearest scale interval for a 
weight equal to 35 % of the maximum wagon weight (as inscribed on the descriptive 
markings); 
– one scale interval (d). 
2.3. The MPEs for the weight of train weighi ng-in-motion shall be one of the following 
values, whichever is the greatest: 
– the value calculated according to Table 9, rounded to the neares t scale interval; 
– the value calculated according to Table 9, for the weight of a single wagon equal to 
35 % of the maximum wagon weight (as in scribed on the descriptive markings) 
multiplied by the number of reference wagons  (not exceeding 10) in the train, and 
rounded to the nearest scale interval; 
– one scale interval (d) for each wagon in the train, but not exceeding 10 d. 
2.4. When weighing coupled wagons; the errors of not more than 10 % of the weighing results 
taken from one or more passes of the train may exceed the appropriate MPE given in paragraph 2.2, but shall not exceed twice the MPE. 
3. Scale interval (d) 
The relationship between the accuracy class and the scale interval shal l be as specified in 
Table 10. 
Table 10 
Accuracy class Scale interval (d) 
0,2 d ≤ 50 kg 
0,5 d ≤ 100 kg 
1 d ≤ 200 kg 
2 d ≤ 500 kg 
4. Measurement range 
4.1. The minimum capacity shall not be less than 1 t, and not gr eater than the value of the 
result of the minimum wagon weight divi ded by the number of partial weighings. 
4.2. The minimum wagon weight shall not be less than 50 d. 
5. Performance under influence fact or and electromagnetic disturbance 
5.1. The MPE due to an influence factor shall be as specified in Table 11. 
Table 11 
Load (m) in verification scale intervals (d) MPE EN 170   EN 0 < m ≤ 500 ± 0,5 d 
500 < m ≤ 2000 ± 1,0 d 
2000 < m ≤ 10000 ± 1,5 d 
 
5.2. The critical change value due to a disturbance is one scale interval. 
 
Ð 2004/22/EC (adapted) 
ANNEX MI -007 IX 
TAXIMETERS ⌦ (MI-007) ⌫ 
 
Ð 2004/22/EC 
The relevant requirements of Annex 1 I, the specific requirements of this Annex and the 
conformity assessment procedures listed  in this Annex apply to taximeters. 
DEFINITIONS 
Taximeter 
A device that works together with a signal generator39 to make a measuring instrument. 
This device measures duration, calculates distan ce on the basis of a signal delivered by the 
distance signal generator. Additiona lly, it calculates and displays the fare to be paid for a trip 
on the basis of the calculated distance a nd/or the measured duration of the trip. 
Fare 
The total amount of money due for a trip based on a fixed initial hire fee and/or the length 
and/or the duration of the tr ip. The fare does not include a supplement charged for extra 
services. 
Cross-over speed 
The speed value found by division of a tim e tariff value by a distance tariff value. 
Normal calculation mode S (s ingle application of tariff) 
Fare calculation based on appl ication of the time tariff be low the cross-over speed and 
application of the distance ta riff above the cross-over speed. 
                                                 
39 The distance signal generator is outside the scope of this Directive. EN 171   EN Normal calculation mode D (double application of tariff) 
Fare calculation based on simultaneous applicat ion of time tariff and distance tariff over the 
whole trip. 
Operating position 
The different modes in which a taximeter fulf ils the different parts of its functioning. The 
operating positions are distinguish ed by the following indications: 
‘For Hire’ : The operating position in which the fare calculation is disabled 
‘Hired’ : The operating position in which the fare calculation takes place on the basis 
of a possible initial charge and a tariff for distance travelled and/or time of 
the trip 
‘Stopped’ : The operating position in which the fare due for the trip is indicated and at 
least the fare calculation ba sed on time is disabled. 
DESIGN  REQUIREMENTS 
1. The taximeter shall be designed to calculate the distance and to measure the duration of a 
trip. 
2. The taximeter shall be designed to calculat e and display the fare, incrementing in steps 
equal to the resolution fixed by the Member State in the operation position ‘Hired’. The 
taximeter shall also be designed to display the final value for the trip in the operating position 
‘Stopped’. 
3. A taximeter shall be able to apply the nor mal calculation modes S and D. It shall be 
possible to choose between these cal culation modes by a secured setting. 
4. A taximeter shall be able to supply the fo llowing data through an appropriate secured 
interface(s): 
– operation position: ‘For Hire’, ‘Hired’ or ‘Stopped’; 
– totaliser data according to paragraph 15.1; 
– general information: constant of the distance signal genera tor, date of securing, taxi 
identifier, real time, identification of the tariff; 
– fare information for a trip : total charged, fare , calculation of the fare, supplement 
charge, date, start time, fini sh time, distance travelled; 
– tariff(s) information: parameters of tariff(s). 
National legislation may require certain devices to be connect ed to the interface(s) of a 
taximeter. Where such a device is required; it sh all be possible, by secured setting, to inhibit 
automatically the operation of the taximeter for reasons of the non-presence or improper functioning of the required device. EN 172   EN 5. If relevant, it shall be possibl e to adjust a taximeter for the constant of the distance signal 
generator to which it is to be conn ected and to secure the adjustment. 
RATED  OPERATING  CONDITIONS 
6.1. The mechanical environment class that applies is M3. 
6.2. The manufacturer shall specify the rated operating conditions for the instrument, in 
particular: 
– a minimum temperature range of 80 °C for the climatic environment; 
– the limits of the DC power supply for which the instrument has been designed. 
MAXIMUM  PERMISSIBLE  ERRORS  (MPE S) 
7. The MPE, excluding any errors due to appl ication of the taximeter in a taxi, are: 
– For the time elapsed: ± 0,1 % 
 minimum value of mpe: 0,2s; – For the distance travelled: ± 0,2 % 
 minimum value of mpe: 4 m; – For the calculation of the fare: ± 0,1 % 
 minimum, including rounding: corresponding to the least significant digit of the fare 
indication. 
PERMISSIBLE
 EFFECT  OF DISTURBANCES 
8. Electromagnetic immunity 
8.1. The electromagnetic class that applies is E3. 
8.2. The MPE laid down in paragraph 7 shall also be respected in  the presence of an 
electromagnetic disturbance. 
POWER  SUPPLY  FAILURE 
9. In case of a reduction of the voltage supply to a value below the lower operating limit as 
specified by the manufacturer, the taximeter shall: 
– continue to work correctly or resume its correct func tioning without loss of data 
available before the voltage drop if the voltage drop is temporary, i.e. due to 
restarting the engine; EN 173   EN – abort an existing measurement and return to  the position ‘For Hire’ if the voltage 
drop is for a longer period. 
OTHER  REQUIREMENTS 
10. The conditions for the compatibility between the taximeter and the distance signal 
generator shall be specified by th e manufacturer of the taximeter. 
11. If there is a supplement charge for an extra service, entered by the driver on manual 
command, this shall be excluded from the fare displayed. However, in that case a taximeter 
may display temporarily the value of the fare including the supplementary charge. 
12. If the fare is calculated according to ca lculation mode D a taximeter may have an 
additional display mode in which only the total distance and duration of the trip are displayed 
in real time. 
13. All values displayed for the passenger shall be  suitably identified. These values as well as 
their identification shall be  clearly readable under dayl ight and night conditions. 
14.1. If the fare to be paid or the measures to be taken against fraudulent use can be affected 
by the choice of functionality from a pre-programmed setting or by free data setting, it shall be possible to secure the instru ment settings and data entered. 
14.2. The securing possibilitie s available in a taximeter shall be  such that separate securing of 
the settings is possible. 
14.3. The provisions in paragraph 8.3 of Annex I apply also to the tariffs. 
15.1. A taximeter shall be fitted w ith non-resettable totalisers for all of the following values: 
– The total distance travelled by the taxi; 
– The total distance travelled when hired; 
– The total number of hirings; 
– The total amount of money charged as supplements; 
– The total amount of money charged as fare. 
The totalised values shall incl ude the values saved according to paragraph 9 under conditions 
of loss of power supply. 
15.2. If disconnected from power, a taximeter shall allow the totali sed values to be stored for 
one year for the purpose of reading out the va lues from the taximeter to another medium. 
15.3. Adequate measures shall be taken to preven t the display of totalised values from being 
used to deceive passengers. 
16. Automatic change of tariffs is allowed due to the: – distance of the trip; EN 174   EN – duration of the trip; 
– time of the day; 
– date; 
– day of the week. 
17. If properties of the taxi are important for th e correctness of the taximeter, the taximeter 
shall provide means to secure the connection of  the taximeter to the taxi in which it is 
installed. 
18. For the purpose of testing after installatio n, the taximeter shall be equipped with the 
possibility to test separately the accuracy of time and distance measurement and the accuracy 
of the calculation. 
19. A taximeter and its installati on instructions specified by th e manufacturer sh all be such 
that, if installed according to the manufacturer's instructions , fraudulent alterations of the 
measurement signal representing the distan ce travelled are sufficiently excluded. 
20. The general essential requirement dealing with  fraudulent use shall be fulfilled in such a 
way that the interests of the customer, the driver, the driver's employer and the fiscal 
authorities are protected. 
21. A taximeter shall be designed so that it can respect the MPEs without adjustment during a 
period of one year of normal use. 
22. The taximeter shall be equipp ed with a real -timeclock by means of which the time of the 
day and the date are kept, one or both can be  used for automatic change of tariffs. The 
requirements for the real-time clock are: 
– The timekeeping shall have an accuracy of 0,02 %; 
– The correction possibility of the clock sha ll be not more than 2 minutes per week. 
Correction for summer and wintertime  shall be performed automatically; 
– Correction, automatic or manually, du ring a trip shall be prevented. 
23. The values of distance travelled and tim e elapsed, when displayed or printed in 
accordance with this Directive,  shall use the following units: 
Distance travelled: 
 
Ð 2004/22/EC (adapted) 
– in the United Kingdom and Ireland: until the da te which will be fixed by these 
Member States according to Article  (1)(b) of Directive 80/181/EEC:  kilometres or 
miles; EN 175   EN  
Ð 2004/22/EC 
– in all other Member States: kilometres. 
Time elapsed: – seconds, minutes or hours, as may be suitable; keeping in mind the necessary 
resolution and the need to prevent misunderstandings. 
CONFORMITY
 ASSESSMENT 
The conformity assessment proce dures referred to in Article 9 18 that the manufacturer can 
choose between are: 
B + F or B + D or H1. 
 
Ð 2004/22/EC (adapted) 
ANNEX MI -008 X 
MATERIAL MEASURES ⌦ (MI-008) ⌫ 
 
Ð 2004/22/EC 
CHAPTER  I — MATERIAL MEASURES OF LENGTH  
The relevant essential requireme nts of Annex I, the specific requirements of this Annex and 
the conformity assessment procedures listed in th is chapter, apply to material measures of 
length defined below. However, th e requirement for the supply of  a copy of declarations of 
conformity may be interpreted as applying to  a batch or consignment rather than each 
individual instruments . 
DEFINITIONS Material measure of 
length  An instrument comprising scale marks whose distances are 
given in legal units of length. 
 
SPECIFIC REQUIREMENTS 
Reference Conditions 1.1. For tapes of length equal to or greater than five metres, the maximum permissible errors 
(MPEs) are to be met when a tractive force of fifty newtons or other force values as specified EN 176   EN by the manufacturer and marked on the tape acco rdingly, or in the case of rigid or semi-rigid 
measures no tractive force is needed, is applied. 
1.2. The reference temperature is 20 °C unless otherwise specified by the manufacturer and 
marked on the measure accordingly. 
MPEs 
2. The MPE, positive or negative in mm, between two non-consecu tive scale marks is 
(a + bL), where: 
– L is the value of the length rounded up to the next whole metre; and 
– a and b are given in Table 1 below. 
When a terminal interval is bounded by a surface, the MPE for any distance beginning at this 
point is increased by the va lue c given in Table 1. 
Table 1 
Accuracy Class a (mm) b c (mm) 
I 0,1 0,1 0,1 
II 0,3 0,2 0,2 
III 0,6 0,4 0,3 
D — special class for dipping tapes40 
Up to and including 30 m41 1,5 zero zero 
S — special class for tank strapping tapes 
For each 30 m length when the tape is supported on a flat surface 1,5 zero zero 
Dip tapes may also be of Cla sses I or II in which case for any length between two scale 
marks, one of which is on the sinker and the other on the tape, the mpe is ± 0,6 mm when application of the formula give s a value of less than 0,6 mm. 
The MPE for the length between consecutive scale marks, and the maximum permissible 
difference between two consecutive inte rvals, are given in Table 2 below. 
Table 2 
MPE or difference in millimetres according to accuracy class Length i of the interval 
I II III 
                                                 
40 Applies to the tape/dip weight combinations. 
41 If the nominal tape length exceeds 30 m, an additi onal mpe of 0,75 mm shall be permitted for each 
30 m of tape length. EN 177   EN i ≤ 1 mm 0,1 0,2 0,3 
1 mm < i ≤ 1 cm 0,2 0,4 0,6 
Where a rule is of the folding type, the jointin g shall be such as not to cause any errors, 
supplementary to those above, exceeding: 0,3 mm for Class II, and 0,5 mm for Class III. 
Materials 
3.1. Materials used for material measures sha ll be such that length variations due to 
temperature excursions up to ± 8 °C about th e reference temperature do not exceed the MPE. 
This does not apply to Class S and Class D m easures where the manufacturer intends that 
thermal expansion corrections shall be appl ied to observed readings where necessary. 
3.2. Measures made from material whose dimensi ons may alter materially when subjected to a 
wide range of relative humidity, may onl y be included in Classes II or III. 
Markings 
4. The nominal value shall be marked on the measure. Millimetre scales shall be numbered 
every centimetre and measures with a scale interval greater than 2 cm shall have all scale marks numbered. 
CONFORMITY ASSESSMENT 
The conformity assessment proce dures referred to in Article 9
18 that the manufacturer can 
choose between are: 
F 1 or D1 or B + D or H or G. 
CHAPTER  II — CAPACITY SERVING MEASURES  
The relevant essential requirements of Anne x I, and the specific requirements and the 
conformity assessment procedures listed in this  chapter, apply to capa city serving measures 
defined below. However, the requirement fo r the supply of a copy of declarations of 
conformity may be interpreted as applying to  a batch or consignment rather than each 
individual instrument. Also, the requirement for the instrument to bear information in respect 
of its accuracy shall not apply. 
DEFINITIONS Capacity 
serving measure  A capacity measure (such as a drinki ng glass, jug or thimble measure) 
designed to determine a specified vo lume of a liquid (other than a 
pharmaceutical product) which is so ld for immediate consumption. 
Line measure  A capacity serving measure ma rked with a line to indicate nominal 
capacity. 
Brim measure  A capacity serving measure for which the internal volume is equal to 
the nominal capacity. EN 178   EN Transfer 
measure  A capacity serving measure from whic h it is intended that the liquid is 
decanted prior to consumption. 
Capacity  The capacity is the internal volume for brim measures or internal 
volume to a filling mark for line measures. 
SPECIFIC REQUIREMENTS 
1. Reference Conditions 1.1. Temperature: the reference temperatur e for measurement of capacity is 20 °C. 
1.2. Position for correct indication:  free standing on a level surface. 
2. MPEs 
Table 1 
 Line Brim 
Transfer measures   
< 100 ml ± 2 ml – 0 
+ 4 ml 
≥ 100 ml ± 3 % – 0 
+ 6 % 
Serving measures   
< 200 ml ± 5 % – 0 
+ 10 % 
≥ 200 ml ± ( 5 ml + 2,5
 %) – 0 
+ 10 ml + 5 % 
3. Materials 
Capacity serving measures shall be made of  material which is sufficiently rigid and 
dimensionally stable to maintain capacity within the MPE. 
4. Shape 
4.1. Transfer measures shall be designed so that a change of contents e qual to the MPE causes 
a change in level of at least 2 mm at the brim or filling mark. 
4.2. Transfer measures shall be designed so that the complete discharge of the liquid being 
measured will not be impeded. EN 179   EN 5. Marking 
5.1. The nominal capacity declared shall be cl early and indelibly marked on the measure. 
5.2. Capacity serving measures may also be mark ed with up to three clearly distinguishable 
capacities, none of whic h shall lead to confusion one to the other. 
5.3. All filling marks shall be sufficiently clear and durable to ensure that MPEs are not 
exceeded in use. 
CONFORMITY ASSESSMENT 
The conformity assessment proce dures referred to in Article 9 18 that the manufacturer can 
choose between are: 
A1A2 or F1 or D1 or E1 or  B + E or B + D or H. 
 
Ð 2004/22/EC (adapted) 
ANNEX MI -009 XI 
DIMENSIONAL MEASURING INSTRUMENTS ⌦ (MI-009) ⌫ 
 
Ð 2004/22/EC 
The relevant essential requireme nts of Annex I, the specific requirements of this Annex and 
the conformity assessment proce dures listed in this Annex, a pply to dimensional measuring 
instruments of the types defined below. 
DEFINITIONS 
Length measuring 
instrument  A length measuring instrument serves for the determination 
of the length of rope-type ma terials (e.g. textiles, bands, 
cables) during feed motion of the product to be measured. 
Area Measuring Instruments  An area measuring instrument serves for the determination 
of the area of irregular shaped objects, e.g. for leather. 
Multi-dimensional Measuring Instruments  A multi-dimensional measuring instrument serves for the 
determination of the edge lengt h (length, height, width) of 
the smallest enclosing recta ngular parallelepiped of a 
product. EN 180   EN CHAPTER  I — REQUIREMENTS COMMON TO ALL DIMENSIONAL MEASURING 
INSTRUMENTS  
Electromagnetic immunity 
1. The effect of an electromagnetic disturban ce on a dimensional measuring instrument shall 
be such that: 
– the change in measurement result is no gr eater than the critical change value as 
defined in paragraph 2.3 ; or 
– it is impossible to perform any measurement; or 
– there are momentary variations in the measurement result that cannot be interpreted, 
memorised or transmitted as a measuring result; or 
– there are variations in the measurement re sult severe enough to be noticed by all 
those interested in the measurement result. 
2. The critical change value is  equal to one scale interval. 
CONFORMITY  ASSESSMENT 
The conformity assessment proce dures referred to in Article 9 18 that the manufacturer can 
choose between are: 
For mechanical or electr omechanical instruments: 
F1 or E1 or D1 or B + F or B + E or B + D or H or H1 or G. 
For electronic instruments or instruments containing software: 
B + F or B + D or H1 or G. 
CHAPTER  II — LENGTH MEASURING INSTRUMENTS  
Characteristics of the product to be measured 
1. Textiles are characterised by the characteristic factor K. This factor takes the stretchability 
and force per unit area of the product measured  into account and is defined by the following 
formula: 
K = ε · (G A + 2,2 N/m2), where 
ε is the relative elongation of a cloth specimen 1 m wide  at a tensile force of 
10 N, 
GA is the weight force per unit area of a cloth specimen in N/m2. EN 181   EN Operating conditions 
2.1. Range Dimensions and K-factor, where applicable, w ithin the range specified by the manufacturer 
for the instrument. The ranges of K-factor are given in Table 1: 
Table 1 
Group Range of K Product 
I 0 < K < 2 × 10-2 N/m2 low stretchability 
II 2 × 10-2 N/m2 < K < 8 × 10-
2 N/m2 medium stretchability 
III 8 × 10-2 N/m2 < K < 24 × 10-
2 N/m2 high stretchability 
IV 24 × 10-2 N/m2 < K very high stretchability 
2.2. Where the measured object is not transporte d by the measuring instrument, its speed must 
be within the range specified by th e manufacturer for the instrument. 
2.3. If the measurement result depends on the thickness, the surface condition and the kind of 
delivery (e.g. from a big roll or from a pile ), corresponding limitations  are specified by the 
manufacturer. 
MPEs 
3. Instrument 
Table 2 
Accuracy class MPE 
I 0,125 %, but not less than 
0,005 L m 
II 0,25 %, but not less than 0,01 L m 
III 0,5 %, but not less than 0,02 L m 
Where L m is the minimum measurable length, that is  to say the smallest length specified by 
the manufacturer for which the inst rument is intended to be used. 
The true length value of the different types of materials should be measured using suitable 
instruments (e.g. tapes of length). Thereby, the ma terial which is going to be measured should 
be laid out on a suitable underlay (e.g. a suitable tabl e) straight and unstretched. EN 182   EN Other requirements 
4. The instruments must ensure that the produc t is measured unstretched according to the 
intended stretchability for which the instrument is designed. 
CHAPTER  III — AREA MEASURING INSTRUMENTS  
Operating conditions 
1.1. Range Dimensions within the range specified by the manufacturer for the instrument. 
1.2. Condition of the product 
The manufacturer shall specify the limitations of the instruments due to the speed, and 
thickness of the surface conditions if relevant, of the product. 
MPEs 
2. Instrument The MPE is 1,0 %, but not less than 1 dm
2. 
Other requirements 
3. Presentation of the product In the case of pulling back or stopping the product, it should not  be possible to have an error 
of measurement or the display must be blanked. 
4. Scale interval 
The instruments must have a scale interval of 1,0 dm
2. In addition, it must be possible to have 
a scale interval of 0,1 dm2 for testing purposes. 
CHAPTER  IV — MULTIDIMENSIONAL MEASURING INSTRUMENTS  
Operating conditions 
1.1. Range Dimensions within the range specified by the manufacturer for the instrument. 
1.2. Minimum dimension 
The lower limit of the minimum dimension for a ll values of the scale interval is given in 
Table 1. 
Table 1 EN 183   EN Scale interval (d) Minimum dimension (min) 
(lower limit) 
d ≤ 2 cm 10 d 
2 cm < d ≤ 10 cm 20 d 
10 cm < d 50 d 
1.3. Speed of the product 
The speed must be within the range specified by the manufacturer for the instrument. 
MPE 
2. Instrument: The MPE is ± 1,0 d. 
 
Ð 2004/22/EC (adapted) 
ANNEX MI -010 XII 
EXHAUST GAS ANALYSERS ⌦ (MI-010) ⌫ 
 
Ð 2004/22/EC 
The relevant requirements of Annex I, the sp ecific requirements of this Annex and the 
conformity assessment procedures listed in this Annex, apply to  exhaust gas analysers defined 
below intended for inspection and professiona l maintenance of motor vehicles in use. 
DEFINITIONS 
Exhaust 
gas analyser  An exhaust gas analyser is a measuri ng instrument that serves to determine 
the volume fractions of specified com ponents of the exhaust gas of a motor 
vehicle engine with spark ignition at  the moisture level of the sample 
analysed. 
These gas components are carbon monoxide (CO), carbon dioxide (CO
2), 
oxygen (O 2) and hydrocarbons (HC). 
The content of hydrocarbons has to be  expressed as concentration of n-
hexane (C 6H14), measured with near-inf rared absorption techniques. 
The volume fractions of the gas compone nts are expressed as a percentage 
(% vol) for CO, CO 2 and O 2 and in parts per million (ppm vol). EN 184   EN Moreover, an exhaust gas analyser ca lculates the lambda value from the 
volume fractions of the components of the exhaust gas. 
Lambda  Lambda is a dimensionless value re presentative of the burning efficiency of 
an engine in terms of air/fuel ratio in  the exhaust gases. It is determined 
with a reference standardised formula. 
SPECIFIC  REQUIREMENTS 
Instrument Classes 
1. Two classes (0 and I) are be ing defined for exhaust gas anal ysers. The relevant minimum 
measuring ranges for these classes are shown in Table 1. 
Table 1 
Classes and measuring ranges 
Parameter Classes 0 and I 
CO fraction from 0 to 5 % vol 
CO 2 fraction from 0 to 16 % vol 
HC fraction from 0 to 2000 ppm vol 
O2 fraction from 0 to 21 % vol 
λ from 0,8 to 1,2 
Rated operating conditions 
2. The values of the operating conditions sha ll be specified by the manufacturer as follows: 
2.1. For the climatic and mechan ical influence quantities: 
– A minimum temperature range of 35 °C for the climatic environment; 
– The mechanical environment class that applies is M1. 
2.2. For the electrical powe r influence quantities: 
– The voltage and frequency range  for the AC voltage supply; 
– The limits of the DC voltage supply. 
2.3. For the ambient pressure: 
– The minimum and the maximum values of th e ambient pressure are for both classes: 
pmin ≤ 860 hPa, p max ≥ 1060 hPa. EN 185   EN Maximum permissible errors (MPEs) 
3. The MPEs are defined as follows: 
3.1. For each of the fractions measured, th e maximum error value permitted under rated 
operating conditions according to paragraph 1.1 of Annex I is th e greater of the two values 
shown in Table 2. Absolute values are expresse d in % vol or ppm vol, percentage values are 
percent of the true value. 
Table 2 
MPEs 
Parameter Class 0 Class I 
CO fraction ± 0,03 % vol 
± 5 % ± 0,06 % vol 
± 5 % 
CO 2 fraction ± 0,5 % vol 
± 5 % ± 0,5 % vol 
± 5 % 
HC fraction ± 10 ppm vol 
± 5 % ± 12 ppm vol 
± 5 % 
O2 fraction ± 0,1 % vol 
± 5 % ± 0,1 % vol 
± 5 % 
3.2. The MPE on lambda calculation is 0,3 %. Th e conventional true va lue is calculated 
according to the formula defined in point 5.3.7.3 of Annex I of Directive 98/69/EC of the European
 Parliament  and the Council relating to measures  to be taken against air pollution by 
emissions from motor vehicles a nd amending Council Directive 70/220/EEC42. 
For this purpose, the values displayed by the instrument are used for calculation. 
Permissible effect of disturbances 
4. For each of the volume fractions measured by the instrument, the critical change value is 
equal to the MPE for the parameter concerned. 
5. The effect of an electromagnetic disturbance shall be such that: 
– either the change in the measurement result  is not greater than the critical change 
value laid down in paragraph 4; 
– or the presentation of the measurement resu lt is such that it cannot be taken for a 
valid result. 
                                                 
42 OJ L 350, 28.12.1998, p. 17. EN 186   EN Other requirements 
6. The resolution shall be equal to or of one or der of magnitude higher than the values shown 
in Table 3. 
Table 3 
Resolution 
 CO CO 2 O 2 HC 
Class 0 and class I 0,01 % vol 0,1 % vol 43 1 ppm vol 
The lambda value shall be disp layed with a resolution of 0,001. 
7. The standard deviation of 20 measurements shall not be greater than one third of the 
modulus of the MPE for each applicable gas volume fraction. 
8. For measuring CO, CO 2 and HC, the instrument, including the specified gas handling 
system, must indicate 95 % of the final value as determined with calibration gases within 15 
seconds after changing from a gas with zero content, e.g. fresh air. For measuring O 2, the 
instrument under similar conditions must indi cate a value differing less than 0,1 % vol from 
zero within 60 seconds after changing fr om fresh air to an oxygen-free gas. 
9. The components in the exhaust gas, other than  the components whose va lues are subject to 
the measurement, shall not affect the measur ement results by more than the half of the 
modulus of the MPEs when those components are present in the following maximum volume 
fractions: 
6 % vol CO, 16 % vol CO
2, 
10 % vol O 2, 
5 % vol H 2, 
0,3 % vol NO, 2000 ppm vol HC (as n-hexane), water vapor up to saturation. 10. An exhaust gas analyser shall have an adju stment facility that provides operations for 
zero-setting, gas calibration and internal adjust ment. The adjustment facility for zero-setting 
and internal adjustment shall be automatic. 
11. For automatic or semi-automatic adjustment facilities, the instrume nt shall be unable to 
make a measurement as long as the adjustments have not been made. 
                                                
 
43 0,01 % vol for measurand values below or equal to 4 % vol, otherwise 0,1 % vol. EN 187   EN 12. An exhaust gas analyser shall detect hydroc arbon residues in the ga s handling system. It 
shall not be possible to carry out a measurement if the hydro carbon residues, present before 
any measurement, exceeds  20 ppm vol. 
13. An exhaust gas analyser shall have a device for automatically recognising any 
malfunctioning of the sensor of the oxygen channel due to wear or a break in the connecting 
line. 
14. If the exhaust gas analyser is capable to operate with di fferent fuels (e.g. petrol or 
liquefied gas), there shall be the possibility to select the suitable coefficients for the Lambda 
calculation without ambiguity conc erning the appropriate formula. 
CONFORMITY  ASSESSMENT 
The conformity assessment proce dures referred to in Article 9 18 that the manufacturer can 
choose between are: 
B + F or B + D or H1. 
 
Ï 
ANNEX XIII  
PART  A 
Repealed Directive with list of its successive amendments  
(referred to in Article 52) 
Directive 2004/22/EC of the European Parliament and 
of the Council 
(OJ L 135, 30.4.2004, p. 1)  
Council Directive 2006/96/EC 
(OJ L 363, 20.12.2006, p. 81)  
Commission Directive 2009/137/EC 
(OJ L 294, 11.11.2009, p. 7)  
 
PART  B 
List of time limits for transposit ion into national law and application  EN 188   EN (referred to in Article 19) 
Directive Time limit for transposition Date of application 
2004/22/EC 30 April 2006 30 October 2006 
2006/96/EC   
2009/137/EC 1 December 2010 1 June 2011 
 
Ï 
ANNEX XIV  
CORRELATION TABLE  
Directive 2004/22/EC This Directive 
  
Article 1 Article 2(1) 
Article 2  Article 3 
Article 3 first paragraph Article 1 
Article 3 second para graph Article 2(2) 
Article 4  Article 4(1) to (5) 
___ Article 4(6) to (22) 
Article 5 Article 5 
Article 6(1) Article 6 
Article 6(2) ___ 
Articles 7(1) Article 21 
Article 7(2) Article 23(4) 
Article 7(3) ___ 
Article 7(4) ___ 
Article 8 Article 7 
___ Article 8 
___ Article 9 EN 189   EN ___ Article 10 
___ Article 11 
___ Article 12 
___ Article 13 
___ [Article 15] 
Article 9 Article 18 
Article 10 Article 19 
Article 11(1) ___ 
Article 11(2) first subparagraph ___ 
Article 11(2) second subparagraph Article 24(2) 
Article 12 ___ 
Article 13(1) ___ 
Article 13(2) ___ 
___ Article 14(1) 
___ Article 14(2) 
Article 13(3) Article 14(3) 
Article 13(4) Article 14(4) 
Article 14 ___ 
Article 15(1) Article 46(1) 
Article 15(2) Article 46(2) 
Article 15(3) ___ 
Article 15(4) ___ 
Article 15(5) ___ 
Article 16(1) Article 16 
Article 16(2) Article 47 
Article 16(3) Article 17 
Article 16(4) ___ EN 190   EN Article 17(1) ___ 
Article 17(2) Article 22 second subparagraph 
Article 17(3)  
Article 17(4) first subparagraph Article 23(2) 
Article 17(4) second subparagraph ___ 
Article 17(5) ___ 
Article 18 ___ 
___ Article 20 
___ Article 22 first subparagraph 
___ Article 23(1) 
___ Article 23(3) 
___ Article 23(5) second subparagraph 
___ Article 23(5) third subparagraph 
___ Article 23(6) 
___ Article 24 
___ Article 25 
___ Article 26 
___ Article 27 
___ Article 28 
___ Article 29 
___ Article 30 
___ Article 31 
___ Article 32 
___ Article 33 
___ Article 34 
___ Article 35 
___ Article 36 EN 191   EN ___ Article 37 
___ Article 38 
___ Article 39 
___ Article 40 
Article 19(1) ___ 
Article 19(2)(a) first subparagraph ___ 
Article 19(2)(a) second subparagraph ___ 
Article 19(2)(a) third su bparagraph Article 43(4) 
Article 19(2)(b) ___ 
Article 20 ___ 
Article 21 ___ 
Article 22 ___ 
Article 23 ___ 
___ Article 41 
___ Article 42 
___ Article 43(1) 
___ Article 43(2) 
___ Article 43(3) 
___ Article 44 
___ Article 45 
___ Article 48 
___ Article 49 
___ Article 50 
Article 24 ___ 
___ Article 51 
Article 25 ___ 
___ Article 52 EN 192   EN Article 26 Article 53 first subparagraph 
___ Article 53 second subparagraph 
Article 27 Article 54 
Annex I Annex I 
Annex A Annex II, point 1 
Annex A1 Annex II, point 2 
Annex B Annex II, point 3 
Annex C Annex II, point 4 
Annex C1 Annex II, point 5 
Annex D Annex II, point 6 
Annex D1 Annex II, point 7  
Annex E Annex II, point 8  
Annex E1 Annex II, point 9 
Annex F Annex II, point 10 
Annex F1 Annex II, point 11 
Annex G Annex II, point 12 
Annex H Annex II, point 13 
Annex H1 Annex II, point 14 
Annex MI-001 Annex III 
Annex MI-002 Annex IV 
Annex MI-003 Annex V 
Annex MI-004 Annex VI 
Annex MI-005 Annex VII 
Annex MI-006 Annex VIII 
Annex MI-007 Annex IX 
Annex MI-008 Annex X 
Annex MI-009 Annex XI EN 193   EN Annex MI-010 Annex XII 
___ Annex XIII 
___ Annex XIV