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
Date: 2011-11-21
Institutions: European Commission
Subjects: EC conformity marking, market supervision, marketing standard, measuring equipment, metrology, technical standard

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 Member States relating to making available on 
the market of measuring instruments  

(Recast) 

(Text with EEA relevance) 

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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  aligning  ten  product  directives  to 
Decision No 768/2008/EC establishing a common framework for the marketing of products. 

Union (EU) harmonisation legislation ensuring the 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  economic  operators  with  the  means  to  demonstrate  conformity, 
thus ensuring free movement through trust in the products.  

Directive 2004/22 EC is an example 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  instrument  has  been  designed  and  manufactured  in 
compliance  with  the  essential  requirements  and  affix  the  CE  marking  and  the  M 
supplementary metrology marking.  

Experience  with  the  implementation  of  Union  harmonisation  legislation  has  shown  –  on  a 
cross-sector  scale  -  certain  weaknesses  and  inconsistencies  in  the  implementation  and 
enforcement of this legislation, leading to 

(1) 

(2) 

(3) 

(4) 

the  presence  of  non-compliant  or  dangerous  products  on  the  market  and 
consequently a certain lack of trust in CE marking 

competitive disadvantages for economic operators complying with the legislation as 
opposed to those circumventing the rules 

unequal  treatment  in  the  case  of  non-compliant  products  and  distortion  of 
competition amongst economic operators due to different enforcement practices 

differing  practices  in  the  designation  of  conformity  assessment  bodies  by  national 
authorities 

(5) 

problems with the quality of certain notified bodies 

Furthermore the regulatory environment has become more and more complex, as frequently 
the  same  product. 
several  pieces  of 
Inconsistencies  in  these  pieces  of  legislation  make  it  increasingly  difficult  for  economic 
operators and authorities to correctly interpret and apply that legislation. 

legislation  apply  simultaneously 

to  one  and 

To remedy these horizontal shortcomings in Union harmonisation legislation observed across 
several industrial sectors, the “New Legislative Framework” was adopted in 2008 as part of 
the  goods  package.  Its  objective  is  to  strengthen  and  complete  the  existing  rules  and  to 
improve  practical  aspects  of  their  application  and  enforcement.  The  New  Legislative 
Framework (NLF) consists of two complementary instruments, Regulation (EC) No 765/2008 

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on  accreditation  and  market  surveillance  and  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  controls  of  products  from  third  countries.  Since  1 
January 2010 these rules apply directly in all Member States. 

The NLF Decision sets out a common framework for EU product harmonisation legislation. 
This  framework  consists  of  the  provisions  which  are  commonly  used  in  EU  product 
legislation  (e.g.  definitions,  obligations  of  economic  operators,  notified  bodies,  safeguard 
mechanisms,  etc).  These  common  provisions  have  been  reinforced  to  ensure  that  the 
directives  can  be  applied  and  enforced  more  effectively  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  authorities  and  authorities 
responsible  for  notified  bodies  to  properly  perform  the  tasks  imposed  on  them  by  the  NLF 
Regulation and to ensure an effective and consistent enforcement of EU product legislation.  

However,  unlike  the  NLF  Regulation,  the  provisions  of  the  NLF  Decision  are  not  directly 
applicable.  To  ensure  that  all  economic  sectors  subject  to  Union  harmonisation  legislation 
benefit  from  the  improvements  of  the  NLF,  the  provisions  of  the  NLF  Decision  need  to  be 
integrated into the existing product legislation. 

A  survey  after  the  adoption  of  the  goods  package  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 Parliament, Council and Commission have committed 
themselves to use its provisions as much as possible in future legislation on products in order 
to further the utmost coherence of the regulatory framework.  

For  a  number  of  other  Union  harmonisation  directives,  including  Directive  2004/22/EC  no 
revision  for  sector-specific  problems  had  been  envisaged  within  this  timeframe.  To  ensure 
that the problems in relation to non-compliance and notified bodies are nevertheless addressed 
in  these  sectors,  and  for  the  sake  of  consistency  of  the  overall  regulatory  environment  on 
products,  it  was  decided  to  align  these  directives  within  a  package  to  the  provisions  of  the 
NLF Decision. 

Consistency with other policies and objectives of the Union 

This initiative is in line with the Single Market Act1, 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. 

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Furthermore it supports the Commission’s policy 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 NLF Decision has been discussed with national 
experts  responsible  for  the  implementation  of  this  Directive  and  with  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 questionnaires for economic operators, 
authorities, notified bodies and users and the Commission services received 300 replies. The 
results are published at:  

http://ec.europa.eu/enterprise/policies/single-market-goods/regulatory-policies-common-
rules-for-products/new-legislative-framework/index_en.htm 

In addition to the general consultation a specific SME consultation was carried out. 603 SMEs 
were  consulted  through  the  Enterprise  Europe  Network  in  May/June  2010.  The  results  are 
available  at  http://ec.europa.eu/enterprise/policies/single-market-goods/files/new-legislative-
framework/smes_statistics_en.pdf 

The consultation process revealed widespread support for the initiative. There is unanimity on 
the need to improve market surveillance and the system for assessing and monitoring Notified 
Bodies.  Authorities  fully  support  the  exercise  because  it  will  strengthen  the  existing  system 
and  improve  cooperation  at  EU  level.  Industry  expects  a  more  level  playing  field  resulting 
from more effective actions against products that do not comply with the legislation, as well 
as a simplification effect from the alignment of legislation. Certain concerns were expressed 
on some obligations which are, however, indispensable for increasing the efficiency of market 
surveillance.  These  measures  will  not  entail  significant  costs  for  industry,  and  the  benefits 
resulting from improved market surveillance should by far outweigh the costs.  

Collection and use of expertise 

The  impact  assessment  for  this  implementation  package  has  largely  built  on  the  impact 
assessment  carried  out  for  the  New  Legislative  Framework.  In  addition  to  the  expertise 
collected  and  analysed  in  that  context,  further  consultation  of  sector-specific  experts  and 
interest  groups,  as  well  as  horizontal  experts  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 evaluation report external experts2 have estimated that Directive 2004/22/EC 
applies  to  around  345  million  units  of  measuring  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: 
consultation/public-consultation-files/evaluation_report_by_cses_en.pdf 

http://ec.europa.eu/enterprise/sectors/legal-metrology-and-prepack/public-

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where most authorities recognise that their effort 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 evaluation and is generally supported by stakeholders as 
regards its analysis. 

The  weaknesses  remarked  in  market  surveillance  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 Commission 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 Decision by non-legislative measures 

Option 2 considers the possibility of encouraging a voluntary alignment 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 Decision by legislative measures 

This  option  consists  in  integrating  the  provisions  of  the  NLF  Decision  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 internal 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 economic 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 

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–  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 definitions which are commonly used throughout Union 
harmonisation legislation in order to harmonise their meaning throughout that legislation. 

3.2. 

Obligations of economic operators and traceability requirements 

The  proposal  clarifies  the  obligations  of  manufacturers  and  authorised  representatives  and 
introduces  obligations  for  importers  and  distributors.  Importers  must  verify  that  the 
manufacturer has carried out the applicable conformity assessment procedure and has drawn 
up  a  technical  documentation.  They  must  also  make  sure  with  the  manufacturer  that  this 
technical  documentation  can  be  made  available  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  product,  or  where  this  is  not  possible  on  the 
packaging  or  the  accompanying  documentation.  Distributors  must  verify  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 the required documentation and instructions. 

Importers  and  distributors  must  cooperate  with  market  surveillance  authorities  and  take 
appropriate actions when they have supplied non-compliant measuring instruments. 

Enhanced  traceability  obligations  are  introduced  for  all  economic  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 proposal for a Regulation 
on  European  Standardisation4  that  sets  out  a  horizontal  legal  framework  for  European 
standardisation.  The  proposal  for  the  Regulation  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 stakeholder 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  

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provision conferring presumption of conformity to harmonised standards has been modified to 
clarify  the  extent  of  the  presumption  of  conformity  when  standards  only  partially  cover  the 
essential requirements.  

3.4. 

Conformity assessment and CE marking 

Directive  2004/22/EC  has  selected  the  appropriate  conformity  assessment  procedures  which 
manufacturers have to apply in order to demonstrate that their measuring instruments comply 
with  the  essential  requirements.  The  proposal  aligns  these  procedures  to  their  updated 
versions  set  out  in  the  NLF  Decision.  It  also  keeps  some  sector  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 inserted in this proposal. 

3.5. 

Notified Bodies 

The  proposal  reinforces  the  notification  criteria  for  notified  bodies.  It  clarifies  that 
subsidiaries or subcontractors must  also  comply  with  the  notification requirements. Specific 
requirements  for  notifying  authorities  are  introduced,  and  the  procedure  for  notification  of 
notified  bodies  is  revised.  The  competence  of  a  notified  body  must  be  demonstrated  by  an 
accreditation certificate. Where accreditation has not been used to evaluate the competence of 
a  notified  body,  the  notification  must  comprise  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  clause  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 measuring 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  another  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 the appropriate action on their territory. 

3.7. 

Comitology and Delegated acts 

The provisions on the operation of the Measuring Instruments Committee have been adapted 
to the new rules on delegated acts laid down in Article 290 of the Treaty on the Functioning 
of the EU and to the new provisions on implementing acts laid down in Regulation (EU) No 
182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the 
rules and general principles concerning mechanisms for control by the Member States of the 
Commission's exercise of implementing powers5. 

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). 

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4. 

LEGAL ELEMENTS OF THE PROPOSAL 

Legal basis 

The proposal is based on Article 114 of the Treaty on the Functioning of the European Union. 

Subsidiarity principle 

The internal market is a competence that is shared between the Union and the Member States. 
The  subsidiarity  principle  arises  in  particular  with  regard  to  the  newly  added  provisions 
aiming  at  the  improvement  of  effective  enforcement  of  Directive  2004/22/EC,  namely,  the 
importer  and  distributor  obligations,  the  traceability  provisions,  the  provisions  on  the 
assessment  and  notification  of  notified  bodies,  and  the  enhanced  cooperation  obligations  in 
the context of the revised market surveillance and safeguard procedures.  

Experience with the enforcement of the legislation has shown that measures taken at national 
level  have  led  to  divergent  approaches  and  to  a  different  treatment  of  economic  operators 
inside the EU, which undermines the objective of this directive. If actions are taken at national 
level  to  address  the  problems,  this  risks  creating  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 action at EU level can much better 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 throughout the directives, this is a problem which 
can only be solved by the EU legislator. 

Proportionality 

In  accordance  with  the  principle  of  proportionality,  the  proposed  modifications  do  not  go 
beyond what is necessary to achieve the objectives set.  

The new or modified obligations do not impose unnecessary burdens and costs on industry - 
especially on small and medium sized enterprises - 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  response  to  the  problems  identified.  A  number  of 
modifications  concern  the  improvement  of  clarity  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  readability  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  Directive  2004/22/EC  concern:  the  definitions,  the 
obligations  of  economic  operators,  the  presumption  of  conformity  provided  by  harmonised 

6 

OJ C 77, 28.3.2002. 

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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.

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(cid:208) 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 COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing 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 European Economic and Social Committee7, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(cid:208) 2004/22/EC recital 1 (adapted) 

A number of measuring instruments are  covered by specific Directives, adopted on 
the basis of Council Directive 71/316/EEC of 26 July 1971 on the approximation of 
the  laws  of  the  Member  States  relating  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 
8 

OJ C […], […], p. […]. 
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)   

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reflecting the spirit of the Council Resolution of 7 May 1985 on a new approach to 
technical harmonisation and standards9. 

(cid:216) new 

(1) 

(2) 

(3) 

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 should be recast in the interests of clarity. 

Regulation (EC) No 765/2008/EC of the European Parliament and of the Council of 9 
July  2008  setting  out  the  requirements  for  accreditation  and  market  surveillance 
relating to the marketing of products and repealing Regulation (EEC) No 339/9311 lays 
down  rules  on  the  accreditation  of  conformity  assessment  bodies,  provides  a 
framework for the market surveillance of products and for controls on products from 
third countries, and lays down the general principles of the CE marking. 

Decision  No  768/2008/EC  of  the  European  Parliament  and  of  the  Council  of  9  July 
2008  on  a  common  framework  for  the  marketing  of  products  and  repealing  Council 
Decision  93/465/EEC12  lays  down  a  common  framework  of  general  principles  and 
reference  provisions  intended  to  apply  across  the  legislation  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. 

(cid:208) 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  consumer,  of  levying  taxes  and  duties  and  of 
fair trading, which directly and indirectly affect the daily life of citizens in many ways, 
may require the use of legally controlled measuring instruments. 

(5) 

Legal  metrological  control  should  not  lead  to  barriers  to  the  free  movement  of 
measuring  instruments.  The  provisions  concerned  should  be  the  same  in  all  Member 
States and proof of conformity accepted throughout the Community ⌦ Union ⌫ . 

(cid:208) 2004/22/EC recital 3 (adapted) 

9 
10 
11 
12 

OJ C 136, 4.6.1985, p. 1. 
OJ L 135, 30.4.2004, p. 1. 
OJ L 218, 13.8.2008, p. 30. 
OJ L 218, 13.8.2008, p. 82. 

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(6) 

Legal  metrological  control 
requires  conformity  with  specified  performance 
requirements.  The  performance  requirements  that  the  measuring  instruments  must 
meet  should  provide  a  high  level  of  protection.  The  conformity  assessment  should 
provide a high level of confidence. 

(cid:208) 2004/22/EC recital 4 

(7)  Member  States  should  as  a  general  rule  prescribe  legal  metrological  control.  Where 
legal  metrological  control  is  prescribed,  only  measuring  instruments  complying  with 
common performance requirements should be used. 

(cid:208) 2004/22/EC recital 5 

(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  covered  by  this  Directive, 
should be applicable only to the extent that this will not cause unfair competition. 

(cid:208) 2004/22/EC recital 6 (adapted) 

The responsibilities of the manufacturer for compliance with the requirements of this 
Directive should be specifically stated. 

(cid:208) 2004/22/EC recital 7 

(cid:208) 2004/22/EC recital 8 (adapted) 

(9) 

is  particularly  sensitive 

The  performance  of  measuring 
the 
instruments 
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 and repealing Directive 89/336/EEC13 should therefore 
not apply. 

to 

13 

OJ L 390, 31.12.2004, p. 24.  

EN 

11 

   EN 

 
 
 
 
 
                                                 
(cid:208) 2004/22/EC recital 17 (adapted) 
(cid:214) new 

(10)  (cid:214) In  order  to  ensure  the  free  circulation  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 with the provisions of this Directive. 

(11)  Member  States  should  take  appropriate  action  to  prevent  non-complying  measuring 
instruments  from  being  placed  on  the  market  and/or  put  into  use.  Adequate 
cooperation  between  the  competent  authorities  of  the  Member  States  is  therefore 
necessary to ensure a Community-wide ⌦ Union-wide ⌫ effect of this objective. 

(cid:208) 22/2004 recital 18 (adapted) 

(cid:216) new 

(12)  Economic  operators  should  be  responsible  for  the  compliance  of  measuring 
instruments, in relation to their respective roles in the supply chain, so as to ensure a 
high level of protection of public interests, such as health and safety and the protection 
of users, and to guarantee fair competition on the Union market. 

(13)  All  economic  operators  intervening  in  the  supply  and  distribution  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  distribution  of  obligations  which  correspond  to  the  role  of 
each operator in the supply and distribution process. 

(14)  The manufacturer, having detailed knowledge of the design and production process, is 
best  placed  to  carry  out  the  complete  conformity  assessment  procedure.  Conformity 
assessment should therefore remain the obligation of the manufacturer 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 manufacturers 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 present a risk. Provision 
should  also  be  made  for  importers  to  make  sure  that  the  conformity  assessment 
procedures have been carried out and that product marking and documentation drawn 
up by manufacturers are available for inspection 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  measuring instrument does not  adversely affect the 
compliance of the measuring instrument.  

EN 

12 

   EN 

 
 
 
(17)  When  placing  a  measuring  instrument  on  the  market,  every  importer  should  indicate 
on the measuring instrument his name and the 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 carried out by competent national authorities, and should be 
prepared  to  participate  actively,  providing  those  authorities  with  all  necessary 
information relating to the measuring instrument concerned. 

(20)  Ensuring  traceability  of  a  measuring  instrument  throughout  the  whole  supply  chain 
helps to make market surveillance simpler and more efficient. An efficient traceability 
system  facilitates  market  surveillance  authorities'  task  of  tracing  economic  operators 
who made non compliant measuring instruments available on the market. 

(cid:208) 2004/22/EC recital 9 (adapted) 
(cid:214) 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. Provisions to remove technical barriers to trade 
should follow the Council Resolution of 7 May 1985 on a new approach to technical 
harmonisation and standards. (cid:214) In order to facilitate conformity assessment with those 
requirements  it  is  necessary  to  provide  for presumption  of  conformity  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  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  Council14  for  the  purpose  of  expressing  detailed  technical 
specifications of those requirements.  

(22)  Regulation  (EU)  No  […/…]  [on  European  Standardisation]  provides  for  a  procedure 
for  objections  to  harmonised  standards  where  those  standards  do  not  entirely  satisfy 
requirements of this Directive. 

(cid:216) new 

14 

OJ L […], […], p. […]. 

EN 

13 

   EN 

 
 
                                                 
(cid:208) 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  the  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. 

(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. 

(cid:208) 2004/22/EC recital 13 

(cid:216) new 

(25) 

In order to enable economic operators to demonstrate and the competent authorities to 
ensure  that  measuring  instruments  made  available  on  the  market  comply  with  the 
essential requirements it is necessary to provide 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, conformity assessment procedures should be 
chosen from among those modules. However, it is necessary to adapt those modules in 
order to reflect specific aspects of metrological control.  

(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 instrument, the exercise of conformity assessment 
should be undertaken independently of the instrument concerned. 

(cid:208) 2004/22/EC recital 14 (adapted) 

(cid:208) 2004/22/EC recital 15 

(27)  The state of the art in measurement technology is subject to constant evolution which 
may  lead  to  changes  in  the  needs  for  conformity  assessments.  Therefore,  for  each 
category  of  measurement  and,  where  appropriate,  sub-assemblies,  there  must  be  an 
appropriate  procedure  or  a  choice  between  different  procedures  of  equivalent 
stringency. The procedures adopted are as required by Council Decision 93/465/EEC 
of  22 July  1993  concerning  the  modules  for  the  various  phases  of  the  conformity 

EN 

14 

   EN 

 
 
 
 
 
assessment  procedures  and  the  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. 

(cid:216) new 

(28)  Manufacturers  should  draw  up  an  EU  declaration  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 metrology marking, indicating the conformity 
of a measuring instrument, are the visible consequence of a whole process comprising 
conformity assessment in a broad sense. General principles governing the CE marking 
and  its  relationship  to  other  markings  are  set  out  in  Regulation (EC)  No  765/2008. 
Rules  governing  the  affixing  of  the  CE  marking  and  the  supplementary  metrology 
marking should be laid down in this Directive. 

(cid:208) 2004/22/EC recital 10 (adapted) 
(cid:214) new 

(30) 

In order to take account of differences in climatic conditions or of different levels of 
consumer  protection  that  may  apply  at  national  level,  ⌦ it  is  necessary  to 
establish ⌫  essential  requirements  may  give  rise 
the  establishment  of 
environmental or accuracy classes (cid:214) as essential requirements  . 

to 

(cid:208) 2004/22/EC recital 11 

In order to ease the task of proving conformity with the essential requirements and to 
enable conformity to be assessed, it is desirable to have harmonised standards. Such 
harmonised  standards  are  drawn  up  by  private-law  bodies  and  should  retain  their 
status  as  non-mandatory  texts.  To  this  end,  the  European  Committee  for 
for  Electrotechnical 
Standardisation 
Standardisation  (CENELEC)  and  the  European  Telecommunications  Standards 
Institute  (ETSI)  are  recognised  as  the  competent  bodies  for  the  adoption  of 
harmonised  standards  in  accordance  with  the  general  guidelines  on  cooperation 
between  the  Commission  and  the  European  Standardisation  bodies  signed  on 
13 November 1984. 

the  European  Committee 

(CEN), 

15 

OJ L 220, 30.8.1993, p. 23. 

EN 

15 

   EN 

 
 
 
                                                 
(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. 

(cid:216) new 

(cid:208) 2004/22/EC recital 16 (adapted) 

Continued  development  in  measurement  technology  as  well  as  concerns  expressed 
by  stakeholders  about  certification,  stress  the  need  to  ensure  consistent  conformity 
assessment  procedures  for  industrial  products,  as  requested  by  the  Council 
Resolution adopted on 10 November 200316. 

(cid:216) new 

(32)  Experience has shown that the criteria set out in Directive 2004/22/EC that conformity 
assessment bodies have to fulfil to be notified to the Commission are not sufficient to 
ensure a uniformly high level of performance of notified bodies throughout 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. Those 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  and  other  bodies  involved  in  the  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  presumed  to  comply  with  the  corresponding 
requirements set out in this Directive. 

(35)  The  system  set  out  in  this  Directive  should  be  complemented  by  the  accreditation 
system  provided  for  in  Regulation  (EC)  No  765/2008.  Since  accreditation  is  an 
essential  means  of  verifying  the  competence  of  conformity  assessment  bodies,  it 
should also be used for the purposes of notification. 

(36)  Transparent  accreditation  as  provided  for  in  Regulation  (EC)  No  765/2008,  ensuring 
the necessary level of confidence in conformity certificates, should be considered by 
the  national  public  authorities  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 

16 

   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 the conformity assessment bodies evaluated 
with the relevant regulatory requirements. 

(37)  Conformity assessment bodies frequently subcontract parts of their activities linked to 
the  assessment  of  conformity  or  have  recourse  to  a  subsidiary.  In  order  to  safeguard 
the  level  of  protection  required  for  the  measuring  instruments  to  be  placed  on  the 
Union  market,  it  is  essential  that  conformity  assessment  subcontractors  and 
subsidiaries  fulfil  the  same  requirements  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  already  notified  cover  also  activities  carried  out  by 
subcontractors and subsidiaries. 

(38) 

(39) 

It is necessary to increase the efficiency and transparency of the notification procedure 
and, in particular, to adapt it to new technologies so as to enable online notification. 

 Since notified bodies may offer their services 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. 

Member States should not impede the placing on the market 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. 

(cid:208) 22/2004 recital 17 (adapted) 

(cid:208) 22/2004 recital 18 

Member  States  should  take  appropriate  action  to  prevent  non-complying  measuring 
instruments  from  being  placed  on  the  market  and/or  put  into  use.  Adequate 
cooperation  between  the  competent  authorities  of  the  Member  States  is  therefore 
necessary to ensure a Community-wide effect of this objective. 

(cid:216) 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 ensure equal treatment of economic operators, 
consistency in the technical application of the conformity assessment procedures needs 
to  be  ensured.  That  can  best  be  achieved  through  appropriate  coordination  and 
cooperation between notified bodies. 

EN 

17 

   EN 

 
 
 
 
 
(41) 

In order to ensure legal certainty, it is necessary to clarify that rules on Union market 
surveillance  and  control  of  products  entering  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  supplemented  by  a  procedure  under  which  interested 
parties  are  informed  of  measures  intended  to  be  taken  with  regard  to  measuring 
instruments  presenting  a  risk  to  the  aspects  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 respect 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 further involvement of the Commission should 
be  required,  except  where  non-compliance  can  be  attributed  to  shortcomings  of  a 
harmonised standard. 

Manufacturers  should  be  informed  of  the  grounds  on  which  negative  decisions  in 
respect of their products were taken, and of the legal remedies available to them. 

(cid:208) 2004/22/EC recital 19 

Manufacturers should be offered the possibility to exercise the rights obtained before 
the entry into force of this Directive, during a reasonable transitional period. 

(cid:208) 2004/22/EC recital 20 

(45)  National specifications concerning the appropriate national requirements in use should 

not interfere with the provisions of this Directive on ‘putting into use’. 

(cid:208) 2004/22/EC recital 21 

EN 

18 

   EN 

 
 
 
The measures necessary for 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 implementing powers conferred on the Commission17. 

(cid:208) 2004/22/EC recital 22 (adapted)  

The  activity  of  the  Measuring  Instruments  Committee  should  include  proper 
consultations with representatives of interested parties. 

(cid:208) 2004/22/EC recital 23 

(cid:208) 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, 

(cid:216) new 

(46) 

It is necessary to provide for transitional arrangements that allow making available on 
the market and putting into use measuring instruments that have already been placed 
on the market in accordance 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  for  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 February 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  internationally  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  conformity  with  the  applicable  essential 
requirements.  

17 
18 

OJ L 184, 17.7.1999, p. 23. 
OJ L 55, 28.2.2011, p. 13. 

EN 

19 

   EN 

 
 
 
 
                                                 
(50) 

In  order  to  take  into  account  the  developments  in  the  measurement  technology,  the 
power to adopt acts in accordance with Article 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 importance that the Commission 
carry  out  appropriate  consultations  during  its  preparatory  work,  including  at  expert 
level. 

(51)  The  Commission,  when  preparing  and  drawing-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, namely to ensure that measuring instruments on 
the  market  fulfil  the  requirements  providing  a  high  level  of  protection  of  the  public 
interests covered by this Directive while guaranteeing the functioning of the internal 
market  cannot  be  sufficiently  achieved  by  the  Member  States  and  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 into national law should be confined to those 
provisions which represent a substantive change 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, 

HAVE ADOPTED THIS DIRECTIVE: 

CHAPTER 1 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

⌦ GENERAL PROVISIONS ⌫ 

Article 31 

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  (cid:214) made 

EN 

20 

   EN 

 
available  on the market and/or put into use for those ⌦ the measuring ⌫ tasks mentioned 
⌦ referred to ⌫ in Article 23(1). 

Article 12 

Scope 

This Directive applies to the ⌦ measuring instruments ⌫ devices and systems with a 
1. 
measuring  function  defined  in  the  instrument-specific  aAnnexes  III  to  XII  ⌦ ,  hereinafter 
instrument-specific Annexes, ⌫ concerning water meters (MI-001), gas meters and volume 
conversion devices (MI-002), active electrical energy meters (MI-003), heat meters (MI-004), 
measuring  systems  for  continuous  and  dynamic  measurement  of  quantities  of  liquids  other 
then  water  (MI-005),  automatic  weighing  instruments  (MI-006),  taximeters  (MI-007), 
material  measures  (MI-008),  dimensional  measuring  instruments  (MI-009)  and  exhaust  gas 
analysers (MI-010). 

2. 
This  Directive  is  a  specific  Directive  in  respect  of  requirements  for  electromagnetic 
immunity  in  the  sense  of  Article  21(24)  of  Directive  2004/108/EC  89/336/EEC.  Directive 
2004/108/EC 89/336/EEC continues to apply with regard to emission requirements. 

(cid:208) 2004/22/EC  

(cid:208) 2004/22/EC (adapted) 

Article 23 

⌦ Optionality ⌫ 

Member States may prescribe the use of measuring instruments mentioned in Article 1 
1. 
for  measuring  tasks  for  reasons  of  public  interest,  public  health,  public  safety,  public  order, 
protection of the environment, protection of consumers, levying of taxes and duties and fair 
trading, where they consider it justified. 

Where Member States do not prescribe such use, they shall communicate the reasons 

2. 
therefore to the Commission and the other Member States. 

(cid:208) 2004/22/EC 

EN 

21 

   EN 

 
 
 
(cid:208) 2004/22/EC (adapted) 

Article 4 

Definitions 

For the purposes of this Directive ⌦ the following definitions apply ⌫ : 

(cid:208) 2004/22/EC 

(a1)  ‘measuring  instrument’  means  any  device  or  system  with  a  measurement 

function that is covered by Articles 1 and 32(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 application of a measuring instrument, for reasons of 
public  interest,  public  health,  public  safety,  public  order,  protection  of  the 
environment, levying of taxes and duties, protection of the consumers and fair 
trading; 

(cid:208) 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 end user, whether for reward or free 
of charge; 

(6) 

‘making available on the market‘ means any supply of a measuring instrument 
for  distribution  or  use  on  the  Union  market  in  the  course  of  a  commercial 
activity, whether in return for payment or free of charge;  

(cid:216) new 

EN 

22 

   EN 

 
 
 
 
(f7)  ‘putting into use’ means the first use of an instrument intended for the end user 

for the purposes for which it was intended; 

(cid:208) 2004/22/EC 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

(d8)  ‘manufacturer’  means  a ⌦ any ⌫  natural  or  legal  person  responsible  for  the 
conformity  of  the  (cid:214) who  manufactures  a  measuring  instrument  or  has  a   
measuring instrument (cid:214) designed or manufactured, and  with this Directive 
with  a  view  to  either  placing  it  on  the  market  (cid:214) markets  that  measuring 
instrument   under  his  own  name  (cid:214)  or  trademark   and/or  putting 
⌦ puts ⌫ it into use for his own purposes; 

(cid:208) 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; 

(cid:216) 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  legal  person  in  the  supply  chain,  other  than 
the manufacturer or the importer, who makes 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  document 

that  prescribes 

technical 

requirements to be fulfilled by a measuring instrument; 

(cid:208) 2004/22/EC 
(cid:214) new 

(h14)  ‘harmonised  standard’  means  (cid:214) 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 

23 

   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 European standards organisations ; 

(cid:216) new 

(15)  ‘accreditation’  means  accreditation  as  defined  in  Article  2(10)  of  Regulation 

(EC) no 765/2008; 

(16)  ‘national  accreditation  body’  means  national  accreditation  body  as  defined  in 

Article 2(11) of Regulation (EC) no 765/2008; 

(17)  "conformity  assessment"  means  the  process  demonstrating  whether  the 
requirements  of  this  Directive  relating  to  a  measuring  instrument  have  been 
fulfilled; 

(18)  "conformity  assessment  body"  means  a  body  that  performs  conformity 
assessment activities including calibration, testing, certification 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 aimed at preventing a measuring instrument 

in the supply chain from being made available on the market; 

(21)  "CE  marking"  means  a  marking  by  which the manufacturer indicates that the 
measuring instrument is in conformity with the applicable requirements set out 
in the Union harmonisation legislation providing for its affixing; 

(22)  "Union  harmonisation  legislation"  means  any  Union  legislation  harmonising 

the conditions for the marketing of products. 

(cid:208) 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 

24 

   EN 

 
 
                                                 
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. 

(cid:208) 2004/22/EC (adapted) 

Sub-assemblies and measuring instruments may be assessed independently and separately for 
the purpose of establishing conformity. 

(cid:208) 2004/22/EC 

Article 6 

Essential requirements and assessment of conformity 

1. A measuring instrument shall meet the essential requirements laid down ⌦ set out ⌫ in 
Annex I and in the relevant instrument-specific Annex. 

(cid:208) 2004/22/EC (adapted) 

(cid:208) 2004/22/EC  
(cid:214) new 

Member States may require, if it is needed for correct use of the instrument, the information 
referred  to  in  point  9  of  Annex  I  or  in  the  relevant  instrument-specific  aAnnexes  to  be 
provided  in  the  official  language(s)  of  the  Member  State  in  which  the  instrument  is  placed 
(cid:214) made available  on the market. 

2. The conformity of a measuring instrument with the essential requirements shall be assessed 
in accordance with Article 9. 

(cid:208) 2004/22/EC (adapted) 

Article 87 

Placing ⌦ Making available ⌫ on the market and putting into use 

1.  Member  States  shall  not  impede  for  reasons  covered  by  this  Directive  the  placing 
(cid:214) making available  on the market and/or putting into use of any measuring instrument that 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

EN 

25 

   EN 

 
 
 
 
 
 
carries  the  ‘CE’  ⌦ CE ⌫  marking  and  supplementary  metrology  marking  in  accordance 
with Article 723. 

2. Member States shall take all appropriate measures to ensure that measuring instruments be 
placed  (cid:214) are  made  available   on  the  market  and/or  put  into  use  only  if  they  satisfy  the 
requirements of this Directive. 

(cid:208) 2004/22/EC (adapted) 

3.  A  Member  State  may  require  a  measuring  instrument  to  satisfy  provisions  governing  its 
putting  into  use  that  are  justified  by  local  climatic  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. 

4. When different accuracy classes are defined for a measuring instrument: 

(cid:208) 2004/22/EC 

(a)  the  instrument-specific  aAnnexes  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. 

(cid:208) 2004/22/EC (adapted) 
(cid:214) 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,  exhibitions,  demonstrations,  etc. ⌦ or  similar  events ⌫  ,  Member  States 
shall  not  prevent  the  showing  of ⌦  measuring ⌫  instruments  not  in  conformity  with  this 
Directive,  provided  that  a  visible  sign  clearly  indicates  their  non-conformity  and  their  non-
availability  for  placing  (cid:214) making  available   on  the  market  and/or  putting  into  use  until 
⌦ they are ⌫ brought into conformity. 

EN 

26 

   EN 

 
 
 
 
 
(cid:216) new 

CHAPTER 2 

OBLIGATIONS OF ECONOMIC OPERATORS 

Article 8 [Article R2 of Decision No 768/2008/EC] 

Obligations of manufacturers 

1. 

2. 

3. 

4. 

5. 

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. 

Manufacturers  shall  draw  up  the  required  technical  documentation  referred  to  in 
Article 19 and carry out the relevant 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 that procedure, manufacturers shall draw up 
an  EU  declaration  of  conformity  and  affix  the  CE  marking  and  the  supplementary 
metrology marking. 

Manufacturers  shall  keep  the  technical  documentation  and  the  EU  declaration  of 
conformity  for  10  years  after  the  measuring  instrument  has  been  placed  on  the 
market. 

Manufacturers  shall  ensure  that  procedures  are  in  place  for  series  production  to 
remain in conformity. Changes in measuring instrument design or characteristics and 
changes  in  the  harmonised  standards,  normative  documents  or  in  technical 
specifications  by  reference  to  which  conformity  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  testing  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 distributors informed of any such monitoring. 

Manufacturers  shall  ensure  that  their  measuring  instruments  bear  a  type,  batch  or 
serial  number  or  other  element  allowing  their  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 

27 

   EN 

 
6. 

7. 

8. 

9. 

Manufacturers  shall  indicate  their  name,  registered  trade  name  or  registered  trade 
mark and the address at which they can be contacted 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. 

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. 

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  corrective  measures  to  bring  that  measuring 
instrument  into  conformity,  to  withdraw  it  or  recall  it,  if  appropriate.  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. 

Manufacturers  shall,  further  to  a  reasoned  request  from  a  competent  national 
authority,  provide  it  with  all  the  information  and  documentation  necessary  to 
demonstrate the conformity of the 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 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) and the drawing up of technical documentation shall 
not form part of the authorised representative's mandate. 

2. 
An authorised representative shall perform the tasks specified in the mandate received 
from  the  manufacturer.  The  mandate  shall  allow  the  authorised  representative  to  do  at  least 
the following: 

(a) 

(b) 

keep the EU declaration of conformity and the technical documentation at the 
disposal  of  national  surveillance  authorities  for  10  years  after  the  measuring 
instrument has been placed on the market; 

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 

28 

   EN 

(c) 

cooperate  with  the  competent  national  authorities,  at  their  request,  on  any 
action taken to eliminate the risks posed by measuring instruments covered by 
their mandate. 

Article 10 [Article R4 of Decision No 768/2008/EC] 

Obligations of importers 

Importers shall place only compliant measuring instruments on the Union market. 

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  manufacturer.  They  shall  ensure  that  the 
manufacturer  has  drawn  up  the  technical  documentation,  that  the  measuring 
instrument  bears  the  CE  marking  and  the  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  requirements  set  out  in  Annex  I  and  in  the 
relevant instrument specific 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 authorities to that effect. 

Importers  shall  indicate  their  name,  registered  trade  name  or  registered  trade  mark 
and  the  address  at  which  they  can  be  contacted  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. 

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 determined by the Member State concerned. 

Importers  shall  ensure 
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.  

that,  while  a  measuring 

instrument 

is  under 

When deemed appropriate with regard to the performance of a measuring instrument, 
importers  shall  carry  out  sample  testing  of  marketed  measuring  instruments, 
investigate,  and,  if  necessary,  keep  a  register  of  complaints,  of  non-conforming 
measuring instruments and measuring instrument recalls, and shall keep distributors 
informed of such monitoring. 

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  appropriate.  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 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

EN 

29 

   EN 

8. 

9. 

1. 

2. 

3. 

4. 

measuring instrument available to that effect, giving details, in particular, of the non-
compliance and of any corrective measures taken. 

Importers shall, for 10 years 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. 

Importers  shall,  further  to  a  reasoned  request  from  a  competent  national  authority, 
provide it with all the information and documentation necessary 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 

When  making  a  measuring  instrument  available  on  the  market  and/or  put  into  use, 
distributors shall act with due care in relation to the requirements of this Directive. 

Before  making  a  measuring  instrument  available  on  the  market  and/or  putting  a 
measuring instrument into use distributors shall verify that the measuring instrument 
bears  the  CE  marking  and  the  supplementary  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  requirements  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 use, until it has been brought 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. 

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. 

Distributors  who  consider  or  have  reason  to  believe  that  a  measuring  instrument 
which  they  have  made  available  on  the  market 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 measuring instrument presents a risk, distributors 

EN 

30 

   EN 

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. 

5. 

Distributors shall, further to a reasoned request from a competent national authority, 
provide it with all the information and documentation necessary to demonstrate the 
conformity of a measuring instrument. They shall cooperate with that 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 manufacturers apply to importers and distributors 

An importer or distributor shall be considered a manufacturer for the purposes of this 
Directive  and  he  shall  be  subject  to  the  obligations  of  the  manufacturer  under 
Article 8, where he places a measuring instrument on the market under his name or 
trademark  or  modifies  a  measuring  instrument  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  request,  identify  the  following  to  the  market  surveillance 
authorities, for 10 years: 

(a) 

any economic operator who has supplied 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 

31 

   EN 

(cid:208) 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 ⌫ 

(cid:208) 2004/22/EC 

1.  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  elements  of  the  national  standards  implementing  the  European 
harmonised standard for that measuring instrument that correspond 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  national 
standards referred to in the first subparagraph, Member States shall presume conformity with 
the essential requirements corresponding to the elements of the national standards with which 
the instrument complies. 

Member  States  shall  publish  the  references  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  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 normative document referred to 
in  the  first  subparagraph,  Member  States  shall  presume  conformity  with  the  essential 
requirements corresponding to the normative elements with which the instrument complies. 

Member States shall publish the references of the normative document referred to in the first 
subparagraph. 

EN 

32 

   EN 

 
 
1. 

2. 

3. 

4. 

(cid:216) new 

Measuring instruments which are in conformity 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. 

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. 

(cid:208) 2004/22/EC (adapted) 

A  manufacturer  may  choose  to  use  any  technical  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  solutions  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. 

(cid:208) 2004/22/EC 

Member  States  shall  presume  compliance  with  the  appropriate  tests  mentioned  in 
point (i) of Article 1019(3) if the corresponding test programme 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. 

(cid:216) new 

[Article 15] 

[Where a harmonised standard satisfies 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 

33 

   EN 

 
 
 
 
(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

Article 16 

Functions of the Measuring Instruments Committee ⌦ Publication of the references of 
normative documents ⌫ 

(cid:214) Where a normative document satisfies the requirements which it covers and which 
1. 
are  set  out  in  Annex  I  and  in  the  relevant  instrument  specific  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 Article 15(2), may take any appropriate measure 
to: 

(a) 

(b) 

identify  normative  documents  drawn  up  by  OIML  and,  in  a  list,  indicate  the  parts 
thereof  compliance  with  which  gives  rise  to  a  presumption  of  conformity  with  the 
corresponding essential requirements of this Directive; 

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. 

(cid:208) 2004/22/EC (adapted)  

Article 17 

⌦ Withdrawal of the references of normative documents ⌫ 

3.  Where  ⌦ When ⌫  a  Member  State  or  the  Commission  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 so.  

The Commission, acting in accordance with the 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. 

Those decisions shall be adopted in accordance with the examination procedure referred to in 
Article 46(2).  

(cid:216) new 

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(cid:208) 2004/22/EC (adapted) 

Article 918 

Conformity assessment ⌦ procedures ⌫ 

(cid:208) 2004/22/EC 

Conformity  assessment  of  a  measuring  instrument  with  the  relevant  essential  requirements 
shall  be  carried  out  by  the  application,  at  the  choice  of  the  manufacturer,  of  one  of  the 
conformity assessment procedures listed in the instrument-specific aAnnex. The manufacturer 
shall provide, where appropriate, technical documentation for specific instruments or groups 
of instruments as set out in Article 10. 

The conformity assessment modules making up the procedures are described ⌦ set out ⌫ in 
Annexes A to H1 Annex II. 

(cid:208) 2004/22/EC (adapted) 

Records  and  correspondence  relating  to  conformity  assessment  shall  be  drawn  up  in  the 
official language(s) of the Member State where the notified body carrying out the Conformity 
assessment procedures is established, or in a language accepted by that body. 

(cid:208) 2004/22/EC 

Article 1019 

Technical Documentation 

1.  The  technical  documentation  shall  render  the  design,  manufacture  and  operation  of  the 
measuring  instrument  intelligible  and  shall  permit  an  assessment  of  its  conformity  with  the 
appropriate requirements of this Directive. 

2.  The  technical  documentation  shall  be  sufficiently  detailed  to  ensure ⌦ compliance  with 
the following requirements ⌫ : 

(cid:208) 2004/22/EC (adapted) 

(a) 

the definition of the metrological characteristics,; 

(cid:208) 2004/22/EC 

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(b) 

the  reproducibility  of  the  metrological  performances  of  produced  instruments 
when properly adjusted using appropriate intended means, and; 

(cid:208) 2004/22/EC (adapted) 

(c) 

the integrity of the instrument. 

3.  The  technical  documentation  shall  include  insofar  as  relevant  for  assessment  and 
identification of the type and/or instrument ⌦ include the following information ⌫: 

(a) a general description of the instrument; 

(cid:208) 2004/22/EC 

(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  description  of  the  electronic  devices  with  drawings,  diagrams, 
flow  diagrams  of  the  logic  and  general  software  information  explaining  their 
characteristics and operation; 

(e) descriptions and explanations necessary for the understanding of paragraphs (b), 
(c) and (d), including the operation of the instrument; 

(f)  a  list  of  the  standards  and/or  normative  documents  referred  to  in  Article  1314, 
applied in full or in part; 

(g) descriptions of the solutions adopted to meet the essential requirements where the 
standards  and/or  normative  documents  referred  to  in  Article  1314  have  not  been 
applied; 

(h) results of design calculations, examinations, etc; 

(i) the appropriate test results, where necessary, to demonstrate that the type and/or 
instruments comply with ⌦ the following ⌫ : 

(cid:208) 2004/22/EC (adapted) 

–  the  requirements  of  this  Directive  under  declared  rated  operating  conditions  and 

under specified environmental disturbances, 

(cid:208) 2004/22/EC 

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–  the  durability  specifications  for  gas-,  water-,  heat-meters  as  well  as  for  liquids 

other than water. 

(j)  the  ⌦ EU-type ⌫  EC-type  examination  certificates  or  ⌦ EU ⌫  EC  design 
examination certificates in respect of instruments containing parts identical to those 
in the design. 

(cid:208) 2004/22/EC (adapted) 

4. The manufacturer shall specify where seals and markings have been applied. 

5.  The  manufacturer  shall  indicate  the  conditions  for  compatibility  with  interfaces  and  sub-
assemblies, where relevant. 

(cid:208) 2004/22/EC 

(cid:208) 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  carry  out  the  tasks  pertaining  to  the 
conformity  assessment  modules  referred  to  in  Article  9,  together  with  the  identification 
numbers given to them by the Commission in accordance with paragraph 4 of this Article, the 
kind(s)  of  measuring  instrument  for  which  each  body  has  been  designated  and  in  addition, 
where  relevant,  the  instrument  accuracy  classes,  the  measuring  range,  the  measurement 
technology, and any other instrument characteristic limiting the scope of the notification. 

2.  Member  States  shall  apply  the  criteria  set  out  in  Article  12  for  the  designation  of  such 
bodies. Bodies that meet the criteria laid down in the national standards which transpose the 
relevant  harmonised  standards,  the  references  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 notification if it finds that the body no longer meets those criteria. 

It  shall  forthwith  inform  the  other  Member  States  and  the  Commission  of  any  such 
withdrawal. 

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4.  Each  of  the  bodies  to  be  notified  shall  be  given  an  identification  number  by  the 
Commission.  The  Commission  shall  publish  the  list  of  notified  bodies,  together  with  the 
information  in  respect  of  the  scope  of  the  notification  referred  to  in  paragraph  1,  in  the 
Official Journal of the European Union, C series, and shall ensure that the list is kept up to 
date. 

Article 12 

Criteria to be satisfied by designated bodies 

Member States shall apply the following criteria for 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, installer or user of the measuring instruments 
that they inspect, nor the authorised representative of any of them. In addition, they 
may not be directly involved in the design, manufacture, marketing or maintenance 
of  the  instruments,  nor  represent  the  parties  engaged  in  these  activities.  The 
preceding  criterion  does  not,  however,  preclude  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  results  of  their  conformity  assessment, 
especially  from  persons  or  groups  of  persons  with  an  interest  in  the  results  of  the 
assessments. 

3.  The  conformity  assessment  shall  be  carried  out  with  the  highest  degree  of 
professional integrity and requisite competence in the field of metrology. Should the 
body subcontract specific tasks, it shall first ensure that the subcontractor meets the 
requirements of this Directive, and in particular of this Article. The body shall keep 
the  relevant  documents  assessing  the  subcontractor's  qualifications  and  the  work 
carried out by him under this Directive 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 those tasks are carried out by the body itself or 
on  its  behalf  and  under  its  responsibility.  It  shall  have  at  its  disposal  the  necessary 
staff  and  shall  have  access  to  the  necessary  facilities  for  carrying  out  in  a  proper 
manner the technical and administrative tasks entailed in conformity 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  governing  the  tasks  which  it  carries  out, 
and adequate experience of such tasks; 

the  requisite  ability  to  draw  up  the  certificates,  records  and  reports 
demonstrating that the tasks have been carried out. 

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6.  The  impartiality  of  the  body,  its  director  and  staff  shall  be  guaranteed.  The 
remuneration of the body shall not depend 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 insurance if its civil liability is not covered 
by the Member State 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 considers 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 without delay. 

In  the  light  of  the  Committee's  opinion,  the  Commission  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 third subparagraph of Article 13(1). 

(cid:216) new 

Article 20 [Article R10 of Decision No 768/2008/EC] 

EU declaration of conformity 

1. 

2. 

3. 

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. 

The EU declaration of conformity shall have the model structure set out in Annex III 
of  Decision No 768/2008/EC,  shall  contain  the  elements  specified  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. 

Where a measuring instrument is subject to more than one Union 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, including the publication references. 

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4. 

By  drawing  up  the  EU  declaration  of  conformity,  the  manufacturer  shall  assume 
responsibility for the compliance of the measuring instrument. 

(cid:208) 2004/22/EC (adapted) 

Article 721 

Conformity marking 

1. The conformity of a measuring instrument with all the provisions of this Directive shall be 
indicated  by  the  presence  on  it  of  the  ‘CE’  ⌦ CE ⌫  marking  and  the  supplementary 
metrology marking as specified in Article 1722. 

2. The ‘CE’ marking and supplementary metrology marking shall be affixed by, or under the 
responsibility of, the manufacturer. These markings may be affixed to the instrument during 
the fabrication process, if justified.  

(cid:208) 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  and  legibility  of  the  ‘CE’  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  affixing  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  consists  of  the  symbol  ‘CE’  according  to  the 
design  laid  down  in  paragraph  I.B(d)  of  the  Annex  to  Decision  93/465/EEC.  The  ‘CE’ 
marking shall be at least 5 mm high. 

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 rectangle. The height of the rectangle shall 

(cid:208) 2004/22/EC (adapted) 

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40 

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be  equal  to  the  height  of  the  ‘CE’  marking.  The  supplementary  metrology  marking  shall 
immediately follow the ‘CE’ marking. 

3.  The  identification  number  of  the  notified  body  concerned  referred  to  in  Article  11,  if 
prescribed  by  the  conformity  assessment  procedure,  shall  follow  the  ‘CE’  marking  and 
supplementary metrology marking. 

(cid:208) 2004/22/EC 

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 device. 

(cid:208) 2004/22/EC (adapted) 

(cid:208) 2004/22/EC  

When  a  measuring  instrument  is  too  small  or  too  sensitive  to  carry  the  ‘CE’  marking  and 
supplementary metrology marking, the markings 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  notified  body  concerned  shall  be  indelible  or  self  destructive 
upon removal. All markings shall be clearly visible or easily accessible. 

(cid:216) new 

Article 22 [Article R11 of Decision No 768/2008/EC] 

General principles of the CE marking and of the supplementary metrology marking 

The CE marking shall be subject to the general principles set out in Article 30 of Regulation 
(EC) No 765/2008. 

17.2. 

The supplementary metrology marking shall consist 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 immediately follow the ‘CE’ marking. 

(cid:208) 2004/22/EC (adapted)  

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(cid:216) 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 metrology marking shall be affixed visibly, 
legibly and indelibly to the measuring 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. 

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. 

(cid:208) 2004/22/EC 

3. 

The  CE  marking  and  the  supplementary  metrology  marking  shall  be  affixed  before 
the measuring instrument is placed on the market. 

(cid:216) new 

(cid:208) 2004/22/EC (adapted) 

2.4. 

The ‘CE’ ⌦ CE ⌫ marking and supplementary metrology marking shall be affixed 
by, or under the responsibility of, the manufacturer. These markings may be affixed 
to the instrument during the fabrication process, if justified. 

5. 

The supplementary metrology marking shall immediately follow the ‘CE’ ⌦ CE ⌫ 
marking.  

(cid:216) new 

The CE marking and the supplementary metrology 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 manufacturer or his authorised representative. 

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6. 

The  CE  marking,  the  supplementary  metrology  marking  and,  where  applicable,  the 
identification number referred to in paragraph 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 CONFORMITY ASSESSMENT BODIES 

Article 24 [Article R13 of Decision No 768/2008/EC] 

Notification 

1. 
Member  States  shall  notify  the  Commission  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  kind(s)  of  measuring  instrument(s)  for  which 
each  body  has  been  designated  and,  where  relevant,  the  instrument  accuracy  classes,  the 
measuring  range,  the  measurement  technology,  and  any  other  instrument  characteristic 
limiting the scope of the notification. 

2. 
If  a  Member  State  has  not  introduced  national  legislation  for  tasks  mentioned  under 
⌦ referred  to  in ⌫  Article  23,  it  shall  retain  the  right  to  designate  and  notify  a  body  for 
tasks relating to that ⌦ the measuring ⌫ instrument ⌦ concerned ⌫ . 

(cid:208) 2004/22/EC (adapted) 

(cid:216) new 

Article 25 [Article R14 of Decision No 768/2008/EC] 

Notifying authorities 

1. 

2. 

Member  States  shall  designate  a  notifying  authority  that  shall  be  responsible  for 
setting  up  and  carrying  out  the  necessary  procedures  for  the  assessment  and 
notification of conformity assessment bodies and the monitoring of notified bodies, 
including compliance with the provisions of Article 30. 

Member  States  may  decide  that  the  assessment  and  monitoring  referred  to  in 
paragraph 1 shall be carried out by a national accreditation body within the meaning 
of and in accordance with Regulation (EC) No 765/2008. 

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3. 

4. 

1. 

2. 

3. 

4. 

5. 

6. 

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  shall  comply  mutatis 
mutandis with the requirements laid down in Article 26(1) to (6). In addition it shall 
have arrangements to cover liabilities arising out of its activities. 

The  notifying  authority  shall  take  full  responsibility  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 

A  notifying  authority  shall  be  established  in  such  a  way  that  no  conflict  of  interest 
with conformity assessment bodies occurs. 

A  notifying  authority  shall  be  organised  and  operated  so  as  to  safeguard  the 
objectivity and impartiality of its activities. 

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. 

A  notifying  authority  shall  not  offer  or  provide  any  activities  that  conformity 
assessment bodies perform or consultancy services on a commercial or competitive 
basis. 

A notifying authority shall safeguard the confidentiality of the information it obtains. 

A  notifying  authority  shall  have  a  sufficient  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  assessment  bodies  and  the  monitoring  of  notified  bodies,  and  of 
any changes thereto. 

The Commission shall make that information publicly available. 

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1. 

2. 

3. 

4. 

Article 28 [Article R17 of Decision No 768/2008/EC] 

Requirements relating to notified bodies 

For  the  purposes  of  notification,  a  conformity  assessment  body  shall  meet  the 
requirements laid down in paragraphs 2 to 11. 

A conformity assessment body shall be established under national law and have legal 
personality. 

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,  manufacturing,  provision,  assembly,  use  or 
maintenance  of  measuring  instruments which it assesses, may, on condition that its 
independence  and  the  absence  of  any  conflict  of  interest  are  demonstrated,  be 
considered such a body. 

A  conformity  assessment  body,  its  top  level  management  and  the  personnel 
responsible  for  carrying  out  the  conformity  assessment  tasks  shall  not  be  the 
designer,  manufacturer,  supplier,  installer,  purchaser,  owner,  user  or  maintainer  of 
the  measuring  instruments  which  they  assess,  nor  the  authorised  representative  of 
any  of  those  parties.  This  shall  not  preclude  the  use  of  assessed  measuring 
instruments that are necessary for the operations 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  tasks  shall  not  be  directly 
involved in the design, manufacture or construction, the marketing, installation, use 
or maintenance of  those measuring  instruments, 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, preclude the possibility of exchanges of 
technical  information  between  the  manufacturer  and  the  body  for  the  purposes  of 
conformity assessment.  

Conformity assessment bodies shall ensure that the activities of their subsidiaries or 
subcontractors  do  not  affect  the  confidentiality,  objectivity  or  impartiality  of  their 
conformity assessment activities. 

5. 

Conformity  assessment  bodies  and  their  personnel  shall  carry  out  the  conformity 
assessment  activities  with  the  highest  degree  of  professional  integrity  and  the 
requisite  technical  competence  in  the  specific  field  and  shall  be  free  from  all 
pressures  and  inducements,  particularly  financial,  which  might  influence  their 
judgement  or  the  results  of  their  conformity  assessment  activities,  especially  as 
regards persons or groups of persons with an interest in the results of those activities. 

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6. 

A  conformity  assessment  body  shall  be  capable  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 assessment procedure and each kind or category 
of  measuring  instruments  in  relation  to  which  it  has  been  notified,  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 accordance 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 notified body and other activities; 

(c) 

procedures for the performance of activities which take due account of the size 
of  an  undertaking,  the  sector  in  which  it  operates,  its  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  necessary to perform  the technical and administrative tasks 
connected  with  the  conformity  assessment  activities  in  an  appropriate  manner  and 
shall have access to all necessary equipment or facilities. 

7. 

The  personnel  responsible  for  carrying  out  conformity  assessment  activities  shall 
have the following: 

(a) 

(b) 

(c) 

sound technical and vocational training covering all the conformity assessment 
activities  in  relation  to  which  the  conformity  assessment  body  has  been 
notified; 

satisfactory  knowledge  of  the  requirements  of  the  assessments  they  carry  out 
and adequate authority to carry out those assessments; 

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 documents and of the relevant provisions 
of Union harmonisation legislation 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. 

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9. 

10. 

11. 

Conformity  assessment  bodies  shall  take  out  liability  insurance  unless  liability  is 
assumed by the State in accordance with national law, or the Member State itself is 
directly responsible for the conformity assessment. 

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. 

Conformity  assessment  bodies  shall  participate  in,  or  ensure  that  their  assessment 
personnel are informed of, the relevant standardisation activities and the activities of 
the  notified  body  coordination  group  established  under  the  relevant  Union 
harmonisation legislation and apply as general guidance the administrative decisions 
and documents produced as a result 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 subcontracting by notified bodies 

1. 

2. 

3. 

4. 

Where  a  notified  body  subcontracts  specific  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. 

the 
Notified  bodies  shall 
subcontractors or subsidiaries wherever these are established. 

take  full  responsibility  for 

tasks  performed  by 

Activities  may  be  subcontracted  or  carried  out  by  a  subsidiary  only  with  the 
agreement of the client. 

Notified  bodies  shall  keep  at  the  disposal  of  the  notifying  authority  the  relevant 
documents concerning the assessment of the qualifications of the subcontractor or the 
subsidiary and the work carried out by them under Article 24. 

EN 

47 

   EN 

1. 

2. 

3. 

1. 

2. 

3. 

4. 

5. 

Article 31 [Article R22 of Decision No 768/2008/EC] 

Application for notification 

A  conformity  assessment  body  shall  submit  an  application  for  notification  to  the 
notifying authority of the Member State in which it is established. 

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 which 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. 

Where  the  conformity  assessment  body  concerned  cannot  provide  an  accreditation 
certificate, it shall provide the notifying authority 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 

Notifying  authorities  may  notify  only  conformity  assessment  bodies  which  have 
satisfied the requirements laid down in Article 28. 

They shall notify the Commission and the other Member States using the electronic 
notification tool developed and managed by the Commission. 

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 relevant attestation of competence. 

Where  a  notification  is  not  based  on  an  accreditation  certificate  as  referred  to  in 
Article 31(2),  the  notifying  authority  shall  provide  the  Commission  and  the  other 
Member  States  with  documentary  evidence  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. 

The  body  concerned  may  perform  the  activities  of  a  notified  body  only  where  no 
objections  are  raised  by  the  Commission  or  the  other  Member  States  within  two 
weeks  of  a  notification  where  an  accreditation  certificate  is  used  or  within  two 
months of a notification where 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  other  Member  States  shall  be  notified  of  any  subsequent 
relevant changes to the notification. 

EN 

48 

   EN 

Article 33 [Article R24 of Decision No 768/2008/EC] 

Identification numbers and lists of notified bodies 

1. 

The Commission shall assign an identification 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 available the list of the 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 

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 authority shall restrict, suspend or withdraw notification 
as  appropriate,  depending  on  the  seriousness  of  the  failure  to  meet  those 
requirements or fulfil those obligations. It shall immediately inform the Commission 
and the other Member States accordingly. 

In  the  event  of  restriction,  suspension  or  withdrawal  of  notification,  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 are either processed by another 
notified body or kept available for the responsible 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 

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 continued fulfilment by 
a notified body of the requirements and responsibilities to which it is subject. 

The  notifying  Member  State  shall  provide  the  Commission,  on  request,  with  all 
information  relating  to  the  basis  for  the  notification  or  the  maintenance  of  the 
competence of the body concerned. 

The Commission shall ensure that all sensitive information obtained in the course of 
its investigations is treated confidentially. 

1. 

2. 

1. 

2. 

3. 

EN 

49 

   EN 

4. 

1. 

2. 

3. 

4. 

5. 

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 

Notified  bodies  shall  carry  out  conformity  assessments  in  accordance  with  the 
conformity assessment procedures provided for in Annex II. 

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 the size of an undertaking, the sector in 
which it operates, its structure, the degree of complexity of the measuring instrument 
technology in question and the mass or serial nature of the production process. 

In  so  doing  they  shall  nevertheless  respect  the  degree  of  rigour  and  the  level  of 
protection  required  for  the  compliance  of  the  measuring  instrument  with  the 
provisions of this Directive. 

Where a notified body finds that the essential requirements set out in Annex I and in 
the  relevant  instrument  specific  Annexes  or  corresponding  harmonised  standards, 
normative  documents  or  technical  specifications  have  not  been  met  by  a 
manufacturer,  it  shall  require  that  manufacturer  to  take  appropriate  corrective 
measures and shall not issue a conformity certificate. 

Where,  in  the  course  of  the  monitoring  of  conformity  following  the  issue  of  a 
certificate, a notified body finds that a measuring instrument no longer complies, it 
shall  require  the  manufacturer  to  take  appropriate  corrective  measures  and  shall 
suspend or withdraw the certificate if necessary. 

Where  corrective  measures  are  not  taken  or  do  not  have  the  required  effect,  the 
notified body shall restrict, suspend or withdraw any certificates, as appropriate. 

Article 37  

Appeal against decisions of notified bodies 

Member  States  shall  ensure  that  an  appeal  procedure  against  decisions  of  notified  bodies  is 
available. 

EN 

50 

   EN 

Article 38 [Article R28 of Decision No 768/2008/EC] 

Information obligation on notified bodies 

1. 

Notified bodies shall inform the notifying authority of the following: 

(a) 

any refusal, restriction, suspension or withdrawal of a certificate; 

(b) 

any circumstances affecting the scope of and conditions for notification; 

(c) 

any request for information which they have received from market surveillance 
authorities regarding conformity assessment activities; 

(d)  on  request,  conformity  assessment  activities  performed  within  the  scope  of 
their  notification  and  any  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  activities  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 cooperation between bodies 
notified under this Directive are put in place and properly operated in the form of a sectoral or 
cross sectoral group or groups of notified bodies. 

Member States shall ensure that the bodies notified by them participate in the work of that or 
those group or groups, directly or by means of designated representatives. 

EN 

51 

   EN 

(cid:208) 2004/22/EC (adapted) 

CHAPTER 5 

⌦ UNION MARKET SURVEILLANCE, CONTROL OF 
MEASURING INSTRUMENTS ENTERING THE UNION 
MARKET AND SAFEGUARD PROCEDURES ⌫ 

(cid:208) 2004/22/EC 

Article 18 

Market surveillance and administrative cooperation 

1.  Member  States  shall  take  all  appropriate  measures  to  ensure  that  measuring  instruments 
that are subject to legal metrological control but 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 other 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 examinations; 

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  notified  bodies,  when  demanded  by  other 
authorities. 

3.  The  Member  States  shall  ensure  that  all  necessary  information  relating  to  the  certificates 
and quality system approvals is made available to bodies they have notified. 

4.  Each  Member  State  shall  inform  the  other  Member  States  and  the  Commission  which 
competent authorities it has designated for such exchange of information. 

EN 

52 

   EN 

 
 
(cid:216) new 

Article 41 

Union market surveillance, control of measuring instruments entering the Union market 

Article 15(3) and Articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to measuring 
instruments. 

Article 42 [Article R31 of Decision No 768/2008/EC] 

Procedure for dealing with measuring instruments presenting a risk at national level 

1. 

2. 

3. 

4. 

Where  the  market  surveillance  authorities  of  one  Member  State  have  taken  action 
pursuant  to  Article 20  of  Regulation (EC)  No  765/2008,  or  where  they  have 
sufficient  reason  to  believe  that  a  measuring  instrument  covered  by  this  Directive 
presents a risk to the aspects of public interest protection covered by this Directive, 
they shall carry out an evaluation in relation to the measuring instrument concerned 
covering  all  the  requirements  laid  down  in  this  Directive.  The  relevant  economic 
operators shall cooperate as necessary with the market surveillance authorities. 

Where, in the course of that evaluation, the market surveillance authorities find that 
the  measuring  instrument  does  not  comply  with  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  withdraw  the  measuring  instrument  from  the  market,  or  to 
recall it within a reasonable period, commensurate with the nature of the risk, as they 
may prescribe. 

The  market  surveillance  authorities  shall  inform  the  relevant  notified  body 
accordingly. 

Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in 
the second subparagraph. 

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  the  actions  which  they  have 
required the economic operator to take. 

The economic operator shall ensure that all appropriate corrective action is taken in 
respect of all the measuring instruments concerned that it has made available on the 
market throughout the Union. 

Where  the  relevant  economic  operator  does  not  take  adequate  corrective  action 
within the period referred to in the second subparagraph of paragraph 1, the market 
surveillance authorities shall take all appropriate provisional measures to prohibit the 

EN 

53 

   EN 

 
5. 

6. 

7. 

8. 

1. 

measuring instrument’s being made available on their national market, to withdraw 
the measuring instrument from that market or to recall it. 

The  market  surveillance  authorities  shall  inform  the  Commission  and  the  other 
Member States, without delay, of those measures. 

The  information  referred  to  in  paragraph 4  shall  include  all  available  details,  in 
particular  the  data  necessary  for  the  identification  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 relevant economic operator. In particular, the 
market  surveillance  authorities  shall  indicate  whether  the  non-compliance  is  due  to 
either of the following: 

(a) 

(b) 

failure of the measuring instrument to meet requirements relating to the aspects 
of public interest protection laid down in this Directive; 

shortcomings in the harmonised standards or normative documents referred to 
in Article 14 conferring a presumption of conformity. 

Member  States  other  than  the  Member  State  initiating  the  procedure  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. 

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  State,  that  measure  shall  be  deemed 
justified. 

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 

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  contrary  to  Union  legislation,  the  Commission 
shall without delay enter into consultation with the Member States and the relevant 
economic operator or operators and shall evaluate the national measure. On the basis 
of  the  results  of  that  evaluation,  the  Commission  shall  decide  whether  the  national 
measure is justified or not. 

The  Commission  shall  address  its  decision  to  all  Member  States  and  shall 
immediately  communicate  it  to  them  and  the  relevant  economic  operator  or 
operators. 

EN 

54 

   EN 

2. 

3. 

If  the  national  measure  is  considered  justified,  all  Member  States  shall  take  the 
measures  necessary  to  ensure  that  the  non-compliant  measuring  instrument  is 
withdrawn  from  their  market,  and  shall  inform  the  Commission  accordingly.  If  the 
national  measure  is  considered  unjustified,  the  Member  State  concerned  shall 
withdraw the measure. 

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]. 

(a)4. 

Should  the  Commission  find  that  the ⌦ Where  the  national  measure ⌫  measures 
taken  by  the  Member  State  concerned  are  ⌦ is  considered ⌫  justified,  it  shall 
immediately inform that Member State thereof, as well as the other Member States. 

(cid:208) 2004/22/EC (adapted) 

The  competent  Member  State  shall  take  appropriate  action  against  any  person  who 
affixed the markings and shall inform the Commission and the other Member States 
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 consulting the parties concerned, bring the 
matter as soon as possible before the appropriate Committee referred to ⌦ apply the 
procedure provided for ⌫ in Articles 17 14 or 15. 

(cid:216) new 

Article 44 [Article R33 of Decision No 768/2008/EC] 

Compliant measuring instruments which present a risk to public interest protection 

1. 

2. 

Where,  having  performed  an  evaluation  under  Article 42(1),  a  Member  State  finds 
that although a measuring instrument is in compliance with this Directive, 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. 

The economic operator shall ensure 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 

55 

   EN 

 
 
 
 
3. 

4. 

5. 

1. 

The Member State shall immediately inform the Commission and the other Member 
States.  That  information  shall  include  all  available  details,  in  particular  the  data 
necessary  for  the  identification  of  the  measuring  instrument  concerned,  the  origin 
and the supply chain of the measuring instrument, the nature of the risk involved and 
the nature and duration of the national measures taken. 

The Commission shall without delay enter into consultation with the Member States 
and  the  relevant  economic  operator  or  operators  and  shall  evaluate  the  national 
measures taken. On the basis of the results of that evaluation, the Commission shall 
decide  whether  the  measures  are  justified  or  not,  and  where  necessary,  propose 
appropriate measures. 

The  Commission  shall  address  its  decision  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 

Without prejudice to Article 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  violation  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 conformity has not been drawn up correctly; 

(e) 

technical documentation is either not available or not complete. 

2. 
Where  the  non-compliance  referred  to  in  paragraph  1  persists,  the  Member  State 
concerned shall take all appropriate measures to restrict or prohibit the measuring instrument 
being made available on the market or ensure that it is recalled or withdrawn from the market. 

(cid:208) 2004/22/EC 

Article 19 

Safeguard clause 

56 

   EN 

EN 

 
1.  Where  a  Member  State  establishes  that  all  or  part  of  the  measuring  instruments  of  a 
particular model that bear the ‘CE’ marking and the supplementary metrology marking do not 
satisfy  the  essential  requirements  relating  to  metrological  performance  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 nature, it shall immediately inform the Commission of the 
measures taken, indicating the reasons for its decision. 

2.  The  Commission  shall  enter  into  consultation  with  the  parties  concerned  as  soon  as 
possible. 

(cid:208) 2004/22/EC (adapted) 

(a)  Should  the  Commission  find  that  the  measures  taken  by  the  Member  State 
concerned  are  justified,  it  shall  immediately  inform  that  Member  State  thereof,  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 States 
thereof. 

If  the  non-compliance  is  attributed  to  shortcomings  in  the  standards  or  normative 
documents,  the  Commission  shall,  after  consulting  the  parties  concerned,  bring  the 
matter as soon  as possible before the  appropriate  Committee  referred  to in  Articles 
14 or 15. 

(b)  Should  the  Commission  find  that  the  measures  taken  by  the  Member  State 
concerned are not justified, it shall immediately inform that Member State thereof, as 
well as the manufacturer concerned or his authorised representative. 

(cid:208) 2004/22/EC  

The Commission shall ensure that the Member States are kept informed of the progress and 
outcome of the procedure. 

Article 20 

Unduly fixed markings 

1.  Where  a  Member  State  establishes  that  the  ‘CE’  marking  and  supplementary  metrology 
marking have been affixed unduly, the manufacturer or his authorised representative shall be 
obliged: 

EN 

57 

   EN 

 
 
 
 
 
 
– 

– 

to  make  the  instrument  conform  as  regards  those  provisions  concerning  the  ‘CE’ 
marking and supplementary metrology marking not covered by Article 19(1) and 

to end the infringement under the conditions imposed by the Member State. 

2.  Should  the  infringement  described  above  persist,  the  Member  State  must  take  all 
appropriate  measures  to  restrict  or  prohibit  the  placing  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 

Decisions entailing refusal or restriction 

Any decision taken pursuant to this Directive entailing 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 which such remedies are subject. 

(cid:208) 2004/22/EC (adapted) 

CHAPTER 6 

⌦ COMMITTEE AND DELEGATED ACTS ⌫ 

Article 1546 

Measuring Instruments Committee ⌦ procedure ⌫ 

1.  The  Commission  shall  be  assisted  by  the  Measuring  Instruments  Committee.  ⌦ That 
Committee shall be a committee within the 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. 

3. Where the opinion of the committee is to be obtained by written procedure, 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. 

(cid:216) new 

EN 

58 

   EN 

 
 
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. 

(cid:208) 1137/2008  

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. 

(cid:208) 2004/22/EC 

(cid:208) 2004/22/EC (adapted) 

Article 1647 

Functions of the Measuring Instruments Committee ⌦ Amendments of Annexes ⌫ 

The Commission shall be empowered to adopt delegated acts in accordance with Article 48 
concerning the amendments of the instrument-specific Annexes III to XII.  

(cid:216) new 

(2.) At the request of a Member 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; 

(cid:208) 1137/2008  

(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 procedure with scrutiny referred to in Article 15(3). 

4. Member States may take appropriate measures to consult interested parties at national level 
about OIML work relating to the scope of this Directive. 

(cid:208) 2004/22/EC 

EN 

59 

   EN 

 
 
 
 
 
 
 
 
 
 
(cid:216) new 

Article 48 

Exercise of the delegation 

1. 

2. 

3. 

4. 

5. 

The  power  to  adopt  delegated  acts  is  conferred  on  the  Commission  subject  to  the 
conditions laid down in this Article. 

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]. 

The delegation of power referred to in Article 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  that  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 already in force.  

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council.  

A  delegated  act  adopted  pursuant  to  Article  46  shall  enter  into  force  only  if  no 
objection  has  been  expressed  either  by  the  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  Commission  that  they  will  not  object.  That  period 
shall  be  extended  by  2  months  at  the  initiative  of  the  European  Parliament  or  the 
Council. 

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(cid:208) 2004/22/EC (adapted) 

CHAPTER 7 

⌦ TRANSITIONAL AND FINAL PROVISIONS ⌫ 

(cid:208) 2004/22/EC 

Article 23 

Transitional provisions 

By way of derogation from Article 8(2), Member States shall permit, for measurement tasks 
for  which  they  have  prescribed  the  use  of  a  legally  controlled  measuring  instrument,  the 
placing  on  the  market  and  putting  into  use  of  measuring  instruments  that  satisfy  the  rules 
applicable  before  30  October  2006  until  the  expiry  of  the  validity  of  the  type  approval  of 
those  measuring  instruments  or,  in  the  case  of  a  type  approval  of  indefinite  validity,  for  a 
period of a maximum of ten years from 30 October 2006. 

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 Annex to Directive 71/348/EEC shall be fixed 
at: 

(cid:208) 2006/96/EC  

1 стотинка (1 stotinka) 

1 new leu. 

(cid:216) 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 effective, proportionate and dissuasive. 

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Member  States  shall  notify  those  provisions  to  the  Commission  by  [the  date  set  out  in  the 
second  subparagraph  of  Article  51]  at  the  latest  and  shall  notify  to  it  without  delay  any 
subsequent amendment affecting them. 

Article 50 

Transitional provisions 

1. 

Member  States  shall  not  impede  the  making  available  on  the  market  and/or  the 
putting  into  use  of  measuring  instruments  covered  by  Directive  2004/22/EC  which 
are  in  conformity  with  that  Directive  and  which  were  placed  on  the  market  before 
[the date set out in the second subparagraph of Article 51]. 

Certificates  of  conformity  issued  under  Directive  2004/22/EC  shall  be  valid  under 
this Directive until [the date set out in the second subparagraph of Article 51] unless 
they expire before that date. 

2. 

The  effects  of  Article  23  of  Directive  2004/22/EC  shall  continue  until  30  October 
2016. 

(cid:208) 2004/22/EC (adapted) 

Article 24 

Transposition 

1. Member States shall adopt and publish the laws, regulations and administrative provisions 
necessary to comply with this Directive before 30 April 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  the  occasion  of  their  official  publication.  The 
methods of making such reference shall be laid down by the Member States. 

Member States shall apply these provisions from 30 October 2006. 

(cid:208)  

Article 51 

Transposition 

1.  Member  States  shall  adopt  and  publish  by  [insert  date  –  2  years  after  adoption]  at  the 
latest the  laws,  regulations  and  administrative  provisions  necessary  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, 

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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 reference to this Directive 
or be accompanied by such a reference on the occasion 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 Directive 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.  

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. 

(cid:208) 2004/22/EC (adapted) 

Article 2252 

Repeals 

The  following  Directives  shall  be  repealed  as  from  30  October  2006  without  prejudice  to 
Article 23: 

– 

– 

– 

– 

– 

20 

21 
22 
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  the  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  approximation  of  the  laws  of  the 
Member  States  relating  to  ancillary  equipment  for  meters  for  liquids  other  than 
water22, 

Directive 73/362/EEC of 19 November 1973 on the approximation of the laws of the 
Member States relating to material measures of length23, 

Directive 75/33/EEC of 17 December 1974 on the approximation of the laws of the 
Member  States  relating  to  cold  water  meters,  as  concerns  the  meters  defined  in 
Annex MI-001 of this Directive24. 

OJ L 202, 6.9.1971, p. 21. Directive as last amended by Commission Directive 82/623/EEC (OJ L 252, 
27.8.1982, p. 5). 
OJ L 202, 6.9.1971, p. 32. 
OJ L 239, 25.10.1971, p. 9. Directive as last amended by the 1994 Act of Accession. 
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). 

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– 

– 

– 

– 

– 

– 

Directive  75/410/EEC  of  24 June  1975  on  the  approximation  of  the  laws  of  the 
Member States relating to continuous 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 approximation 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. 

(cid:216) 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 subparagraph of Article 51], 
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  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. 

(cid:208) 2004/22/EC  

Article 25 

Revision clause 

The  European  Parliament  and  the  Council  invite  the  Commission  to  report,  before  30  April 
2011, on the implementation of this Directive, inter alia, on the basis of reports provided by 
the Member States, and, where appropriate, to submit a proposal for amendments. 

24 
25 
26 
27 
28 

29 
30 

OJ L 14, 20.1.1975, p. 1. 
OJ L 183, 14.7.1975, p. 25. 
OJ L 336, 4.12.1976, p. 30. 
OJ L 26, 31.1.1977, p. 59. 
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). 
OJ L 364, 27.12.1978, p. 1. 
OJ L 259, 15.10.1979, p. 1. 

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The European Parliament and Council invite the Commission to evaluate whether conformity 
assessment procedures for industrial products are properly applied and, where appropriate, to 
propose amendments in order to ensure consistent certification. 

(cid:208) 2004/22/EC (adapted) 

Article 2653 

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].  

(cid:208) 2004/22/EC 

Article 2754 

Addressees 

This Directive is addressed to the Member States. 

Done at […], 

For the European Parliament 
The President 

For the Council 
The President

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(cid:208) 2004/22/EC 

ANNEX I 

ESSENTIAL REQUIREMENTS 

A measuring instrument shall provide a high level of metrological protection in order that any 
party  affected  can  have  confidence  in  the  result  of  measurement,  and  shall  be  designed  and 
manufactured to a high level of quality in respect of the measurement technology and security 
of the measurement data. 

(cid:208) 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. 

(cid:208) 2004/22/EC 

DEFINITIONS 

Measurand 

The measurand is the particular quantity subject to measurement. 

Influence 
quantity 

Rated Operating 
Conditions 

Disturbance 

  An influence quantity is a quantity that is not the measurand but that 

affects the result of measurement. 

The rated operating conditions are the values for the measurand and 
influence quantities making up the normal working conditions of an 
instrument. 

  An influence quantity having a value within the limits specified in the 
appropriate requirement but outside the specified 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 intended to reproduce or supply in a 

permanent manner during its use one or more known values of a given 

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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 parties 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 supplier of electricity, gas, heat or water. 

⌦ ESSENTIAL ⌫ REQUIREMENTS 

(cid:208) 2004/22/EC (adapted) 

1. Allowable Errors 

(cid:208) 2004/22/EC 

1.1.  Under  rated  operating  conditions  and  in  the  absence  of  a  disturbance,  the  error  of 
measurement shall not exceed the maximum permissible error (MPE) value as laid down in 
the appropriate instrument-specific requirements. 

Unless  stated  otherwise  in  the  instrument-specific  annexes,  MPE  is  expressed  as  a  bilateral 
value of the deviation from the 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 appropriate 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. 

the  climatic,  mechanical  and  electromagnetic 
1.3.  The  manufacturer  shall  specify 
environments  in  which  the  instrument  is  intended  to  be  used,  power  supply  and  other 
influence quantities likely to affect its accuracy, taking account of the requirements laid down 
in the appropriate instrument-specific annexes. 

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1.3.1. Climatic environments 

The  manufacturer  shall  specify  the  upper  temperature  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 location 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 classified into classes M1 to M3 as described 
below. 

This class applies to instruments used in locations with vibration and shocks of 
low significance, e.g. for instruments fastened to light supporting structures 
subject to negligible vibrations and shocks transmitted from local blasting or pile-
driving activities, slamming doors, etc. 

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 heavy machines, conveyor belts, etc. 

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  classified  into  classes  E1,  E2  or  E3  as 
described  below,  unless  otherwise  laid  down  in  the  appropriate  instrument-specific 
annexes. 

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. 

This class applies to instruments used in locations with electromagnetic 
disturbances corresponding to those likely to be found in other industrial 

M1 

M2 

M3 

E1 

E2 

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buildings. 

E3 

This class applies to instruments supplied by the battery of a vehicle. Such 
instruments shall comply with the requirements of E2 and the following additional 
requirements: 

– 

– 

voltage  reductions  caused  by  energising  the  starter-motor  circuits  of 
internal combustion engines, 

load dump transients occurring in the event of a discharged 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 and/or signal lines. 

1.3.4. Other influence quantities 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. 

1.4.  When  carrying  out  the  tests  as  envisaged  in  this  Directive,  the  following  paragraphs 
points ⌦ shall ⌫ apply: 

(cid:208) 2004/22/EC (adapted) 

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1.4.1. Basic rules for testing and the determination of errors 

(cid:208) 2004/22/EC 

Essential  requirements  specified  in  1.1  and  1.2  shall  be  verified  for  each  relevant  influence 
quantity.  Unless  otherwise  specified  in  the  appropriate  instrument-specific  annex,  these 
essential requirements apply when each influence quantity is applied and its effect evaluated 
separately, all other influence quantities being kept relatively constant at their reference value. 

Metrological tests shall be carried out during or after the application of the influence quantity, 
whichever condition corresponds to the normal operational status of the instrument when that 
influence quantity is likely to occur. 

1.4.2. Ambient humidity 

(a) 

(b) 

According to the climatic operating environment in which the instrument is intended 
to  be  used  either  the  damp  heat-steady  state  (non-condensing)  or  damp  heat  cyclic 
(condensing) test may be appropriate. 

The  damp  heat  cyclic  test  is  appropriate  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 measurand 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 shall be small when compared with the MPE. 

3. Repeatability 

The application of the same measurand under the same conditions of measurement shall result 
in the close agreement of successive 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  estimated  by  the  manufacturer,  provided  that  it  is 
properly  installed,  maintained  and  used  according  to  the  manufacturer's  instruction  when  in 
the environmental conditions for which it is intended. 

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6. Reliability 

A measuring instrument shall be designed to reduce as far as possible the effect of a defect 
that would lead to an inaccurate measurement result, unless the presence of such a defect is 
obvious. 

7. Suitability 

7.1. A measuring instrument shall have no feature likely to facilitate fraudulent 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 require 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 measuring instrument shall be insensitive to small 
fluctuations of the value of the measurand, 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 software which provides other functions besides 
the measuring function, the software that is critical 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 characteristics of a measuring instrument shall not be influenced in any 
inadmissible way by the connection to it of another device, by any feature of the connected 
device itself or by any remote device that communicates with the measuring instrument. 

8.2. A hardware component that is critical for metrological characteristics shall be designed so 
that  it  can  be  secured.  Security  measures  foreseen  shall  provide  for  evidence  of  an 
intervention. 

8.3.  Software  that  is  critical  for  metrological  characteristics  shall  be  identified  as  such  and 
shall be secured. 

Software identification shall be easily provided by the measuring instrument. 

Evidence of an intervention shall be available for a reasonable period of time. 

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8.4.  Measurement  data,  software  that  is  critical  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 supplied or the displays 
from which the total quantity supplied can be derived, 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) 

(b) 

manufacturer's mark or name; 

information in respect of its accuracy, 

plus ⌦ and ⌫ , when applicable: 

(cid:208) 2004/22/EC (adapted) 

information in respect of the conditions of use; 

(cid:208) 2004/22/EC 

measuring capacity; 

measuring range; 

identity marking; 

(c) 

(d) 

(e) 

(f) 

(g) 

number of the EC-type ⌦ EU-type ⌫ examination certificate or the EC ⌦ EU ⌫ 
design examination certificate; 

(cid:208) 2004/22/EC (adapted) 

(cid:208) 2004/22/EC 

(h) 

information whether or not additional devices 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. 

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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) 

(b) 

(c) 

(d) 

(e) 

(f) 

rated operating conditions; 

mechanical and electromagnetic environment classes; 

the upper and lower temperature limit, whether condensation is possible or not, open 
or closed location; 

instructions for installation, maintenance, repairs, permissible adjustments; 

instructions for correct operation and any special conditions of use; 

conditions 
instruments. 

for  compatibility  with 

interfaces,  sub-assemblies  or  measuring 

9.4.  Groups  of  identical  measuring  instruments  used in the same location or used for utility 
measurements do not necessarily require individual instruction manuals. 

9.5.  Unless  specified  otherwise  in  an  instrument-specific  annex,  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 shall 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. 

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. 

(cid:208) 2004/22/EC (adapted) 

9.8. All marks and inscriptions required under any  requirement shall  be clear, non-erasable, 
unambiguous and non-transferable. 

(cid:208) 2004/22/EC 

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 any 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 permitted under normal conditions of use. Additional 
indications  may  be  shown  provided  they  cannot  be  confused  with  the  metrologically 
controlled indications. 

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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 direct 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 sales, any ticket provided to the consumer by an ancillary device not 
complying  with  the  appropriate  requirements  of  this  Directive  shall  bear  an  appropriate 
restrictive information. 

10.5. Whether or not a measuring instrument intended for utility measurement purposes can 
be  remotely  read  it  shall  in  any  case  be  fitted  with  a  metrologically  controlled  display 
accessible  without  tools  to  the  consumer.  The  reading  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  utility  measuring  instrument  shall  record  by  a 
durable means the measurement result accompanied by information to identify the particular 
transaction, when: 

(a) 

(b) 

the measurement is non-repeatable and; 

the measuring instrument  is  normally  intended for use in the absence 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. 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

ANNEX AII 

⌦ 1. MODULE A: ⌫ DECLARATION OF CONFORMITY BASED ON INTERNAL 
PRODUCTION CONTROL 

1.  The  ‘declaration  of  conformity  based  on  iInternal  production  control’  is  the  conformity 
assessment  procedure  whereby  the  manufacturer  fulfils  the  obligations  laid  down  in  this 
Annex points 2, 3 and 4, and ensures and declares that the measuring instruments concerned 
satisfy the appropriate requirements of this Directive. 

2. TECHNICAL DOCUMENTATION 

2. The manufacturer shall establish the technical documentation as described in Article 1019. 
The  documentation  shall  enable  ⌦ make  it  possible  to  assess ⌫  assessment  of  the 
conformity  of  the  instrument  ⌦ instrument’s  conformity  to  the  relevant ⌫  with  the 

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appropriate  requirements  of  this  Directive  ⌦ ,  and ⌫  .  It  shall,  (cid:214) include  an  adequate 
analysis  and  assessment  of  the  risks.   (cid:214) 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  national 
authorities for ten years after the last instrument has been manufactured. 

3. MANUFACTURING 

4. The manufacturer shall take all measures necessary ⌦ so that the manufacturing 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. 

54.2. ⌦ The manufacturer shall draw up a ⌫ A ⌦ written ⌫ declaration of conformity is 
drawn  up  for  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  (cid:214) placed  on  the  market   .  It  ⌦ The  declaration  of 
conformity ⌫ shall identify the instrument for which it was drawn up. 

A  copy  of  the  declaration  of  conformity  shall  be  made  available  to  the  relevant  authorities 
upon request. 

(cid:216) new 

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. 

(cid:208) 2004/22/EC 

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5. AUTHORISED REPRESENTATIVE 

(cid:208) 2004/22/EC (adapted) 
(cid:214) 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  authorised  representative  (cid:214) provided  that  they  are  specified  in  the 
mandate  . 

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 places the instrument on the market. 

(cid:208) 2004/22/EC 

(cid:208) 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 

1. ‘Declaration of conformity based on internal production control plus product testing by a 
notified  body’  is  the  conformity  assessment  procedure  whereby  the  manufacturer  fulfils  the 
obligations laid down in this Annex, and ensures and declares that the measuring instruments 
concerned satisfy the appropriate requirements of this Directive. 

(cid:208) 2004/22/EC 

1.  Internal  production  control  plus  supervised  instrument  checks  at  random  intervals  is  the 
conformity assessment procedure whereby the manufacturer 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 requirements of this Directive that apply to them. 

(cid:216) new 

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(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

2. TECHNICAL DOCUMENTATION 

2. The manufacturer shall establish the technical documentation as described in Article 1019. 
The  documentation  shall  enable  ⌦ make  it  possible  to  assess ⌫  assessment  of  the 
⌦ instrument’s ⌫  conformity  of  the  instrument  with  the  appropriate  ⌦ relevant ⌫ 
requirements  (cid:214) ,  and  shall  include  an  adequate  analysis  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  manufacturer  shall  keep  the  technical  documentation  at  the  disposal  of  the  national 
authorities for 10 years after the last instrument has been manufactured. 

3. MANUFACTURING 

4. The manufacturer shall take all measures necessary ⌦ so that the manufacturing 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  manufacturer,  shall  carry  out  product  ⌦ instrument ⌫ 
checks or have them carried out in appropriate intervals determined by it ⌦ the body ⌫ , in 
order to verify the quality of the internal checks of the product ⌦ instrument ⌫, taking into 
account  inter  alia  the  technological  complexity  of  the  instruments  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 market, shall be examined and 
appropriate tests as identified by the relevant document(s) referred to in Article 13 ⌦ parts of 
the  harmonised  standard,  normative  document  and/or  technical  specifications,  ⌫  or 
equivalent  tests,  shall  be  carried  out  to  check  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 tests to be carried out. 

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. 

(cid:208) 2004/22/EC 

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Where  the  tests  are  carried  out  by  a  notified  body,  the  manufacturer  shall,  under  the 
responsibility of the notified body, affix the notified body's identification number during the 
manufacturing process. 

(cid:216) new 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

5. WRITTEN ⌦ CONFORMITY MARKING AND ⌫ DECLARATION OF CONFORMITY 

65.1.  The  manufacturer  shall  affix 
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. 

the  ‘CE’  ⌦ CE ⌫  marking,  ⌦ and ⌫ 

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 (cid:214) placed on the market  . It ⌦ The declaration of 
conformity ⌫  shall  identify  the  model  of  the  instrument  ⌦ model ⌫  for  which  it  was 
drawn up. 

A  copy  of  the  declaration  of  conformity  shall  be  made  available  to  the  relevant  authorities 
upon request. 

(cid:216) new 

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. 

(cid:208) 2004/22/EC 

6. Authorised representative 

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 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

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responsibility,  by  his  authorised  representative  (cid:214) provided  that  they  are  specified  in  the 
mandate  . 

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  6.2  shall  be  the 
responsibility of the person who places the instrument on the market. 

(cid:208) 2004/22/EC 

(cid:208) 2004/22/EC (adapted) 

3. ANNEX ⌦ MODULE ⌫ B: ⌦ EU- ⌫ TYPE EXAMINATION 

1. ‘ ⌦ EU- ⌫ Ttype examination’ is the part of a conformity assessment procedure whereby 
⌦ in  which ⌫  a  notified  body  examines  the  technical  design  of  ⌦ an ⌫  a  measuring 
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 following manners.  

The notified body decides on the appropriate manner and the specimens required: 

(cid:208) 2004/22/EC 

(cid:208) 2004/22/EC (adapted) 

(a) examination of a specimen, representative of the production envisaged, of 
the complete measuring instrument ⌦ (production type) ⌫ , 

(b)  examination  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 production envisaged, of one or more critical parts of the 
instrument (combination of production type and design type) ⌫ ; 

(c)  assessment  of  the  adequacy  of  the  technical  design  of  the  measuring 
instrument through examination of the technical documentation and supporting 
evidence referred to in paragraph point 3, without examination of a specimen 
⌦ (design type) ⌫ . 

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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. 

The application shall include: 

(cid:208) 2004/22/EC 

– 

the name and address of the manufacturer and, if the application is lodged by 
the authorised representative, his name and address in addition ⌦ as well ⌫ ; 

(cid:208) 2004/22/EC (adapted) 

– 

a  written  declaration  that  the  same  application  has  not  been  lodged  with  any 
other notified body; 

(cid:208) 2004/22/EC 

(cid:208) 2004/22/EC (adapted) 
(cid:214) 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 
this  Directive.  It  ⌦ and ⌫  shall 
⌦ applicable ⌫  requirements  of 
⌦ 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;. 

⌦ The technical documentation shall in addition contain, wherever applicable: ⌫ 

– 

– 

the specimens, representative of the production envisaged,. as required by tThe 
notified body (cid:214) may request further specimens if needed for carrying out the 
test programme  ; 

for 

the 

the  adequacy  of 

the  supporting  evidence 
technical  design 
⌦ solution ⌫  of  those  parts  of  the  measuring  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  necessary,  the  results  of 
tests  carried  out  by  the  appropriate  laboratory  of  the  manufacturer,  or  by 
another testing laboratory on his behalf and under his responsibility. 

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4. The notified body shall: 

For the instrument: 

(cid:208) 2004/22/EC 

(cid:216) new 

4.1. examine the technical documentation and supporting evidence to assess the adequacy of 
the technical design of the instrument; 

(cid:208) 2004/22/EC (adapted) 

For the specimen(s): 

4.12.  examine  the  technical  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 relevant 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 requirements of this Directive; 

4.45.  agree  with  the  applicant  ⌦ manufacturer ⌫  on  the  location  where  the  examinations 
and tests shall ⌦ will ⌫ be carried out. 

For the other parts of the measuring instrument: 

(cid:208) 2004/22/EC 

4.56. examine the technical documentation and supporting evidence to assess the adequacy of 
the technical design of the other parts of the measuring instrument. 

For the manufacturing process: 

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4.6. examine the technical documentation to assure that the manufacturer has adequate means 
to ensure consistent production. 

(cid:208) 2004/22/EC (adapted) 

5.1.  The  notified  body  shall  draw  up  an  evaluation  report  that  records  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. 

5.26.  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 authorised 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 shall contain all relevant information ⌦ to allow ⌫ for the 
conformity  evaluation  and  ⌦ of  manufactured  measuring  instruments  with  the  examined 
type  to  be  evaluated  and  to  allow  for  ⌫  in-service  control.  In  particular,  to  allow  the 
conformity of manufactured instruments to be evaluated with the examined type regarding the 
reproducibility  of  their  metrological  performances,  when  they  are  properly  adjusted  using 
appropriate means, content shall include: 

– 

– 

– 

– 

– 

the metrological characteristics of the type of instrument; 

(cid:208) 2004/22/EC 

measures  required  for  ensuring  the  integrity  of  the  instruments  (sealing, 
identification of software, etc.); 

information  on  other  elements  necessary  for  the  identification  of  the 
instruments and to check their visual 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  years  from  the  date  of  its  issue,  and  may  be 
renewed for subsequent periods of ten years each. 

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(cid:216) new 

Where  the  type  does  not  satisfy  the  applicable  requirements  of  this  Directive,  the  notified 
body shall refuse to issue an EU-type examination 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  indicate  that  the  approved  type  may  no  longer  comply  with  the 
applicable requirements of this Directive, and shall determine whether such changes require 
further investigation. If so, the notified body shall inform the manufacturer accordingly. 

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. 

(cid:208) 2004/22/EC 

(cid:208) 2004/22/EC (adapted) 

68.  The  manufacturer  shall  inform  the  notified  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  additional  approval  in  the  form  of  an 
addition to the original EC-type ⌦ EU-type ⌫ examination certificate. 

79. Each notified body shall immediately inform the Member State that designated it about: 
⌦ its notifying authorities concerning the ⌫ 

EC-type ⌦ EU-type ⌫ examination certificates and ⌦ /or ⌫ annexes issued; 

⌦ any ⌫  additions  and  amendments  relating  to  certificates  already  ⌦ thereto  which  it 
has ⌫ issued. 

(cid:216) new 

or  withdrawn,  and  shall,  periodically  or  upon  request,  make  available  to  its  notifying 
authorities the list of certificates and/or any additions thereto refused, suspended or otherwise 
restricted. 

The Commission, the Member States and the other notified bodies may, on request, obtain a 
copy  of  the  EU-type  examination  certificates  and/or  additions  thereto.  On  request,  the 
Commission  and  the  Member  States  may  obtain  a  copy  of  the  technical  documentation  and 
the results of the examinations carried out by the notified body. 

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Each  notified  body  shall  immediately  inform  the  Member  State  that  designated  it  of  the 
withdrawal of an EC-type examination certificate. 

(cid:208) 2004/22/EC 

(cid:208) 2004/22/EC (adapted) 
(cid:214) 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 for 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 (cid:214) 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  the  Communities  and  where  he  does  not  have  an 
authorised  representative,  the  obligation  to  make  the  technical  documentation  available  on 
request shall be the responsibility of the person designated by the manufacturer. 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

4. ANNEX ⌦ MODULE ⌫ C: 

DECLARATION  OF  CONFORMITY  TO  TYPE  BASED  ON 
PRODUCTION CONTROL 

INTERNAL 

1. ‘Declaration of cConformity to type based on internal production control’ is the part of a 
conformity assessment procedure whereby the manufacturer 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 manufacturing 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 ⌫. 

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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  appropriate  ⌦ 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 
(cid:214) placed  on  the  market   .  It  ⌦ The  declaration  of  conformity ⌫  shall  identify  the 
instrument model for which it was drawn up. 

A  copy  of  the  declaration  of  conformity  shall  be  made  available  to  the  relevant  authorities 
upon request. 

(cid:216) new 

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. 

(cid:208) 2004/22/EC 

4. Authorised representative 

4. The manufacturer's obligations contained in paragraph 3.2 ⌦ set out in point 3 ⌫ may be 
fulfilled ⌦ by his authorised representative ⌫ , on his behalf and under his responsibility, 
by his authorised representative (cid:214) provided that they are specified in the mandate  . 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

Where the manufacturer is not established within 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 instrument on the market. 

(cid:208) 2004/22/EC 

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(cid:208) 2004/22/EC (adapted) 

5. ANNEX ⌦ MODULE ⌫ C12: 

INTERNAL 
DECLARATION  OF  CONFORMITY  TO  TYPE  BASED  ON 
PRODUCTION  CONTROL  PLUS  PRODUCT  TESTING  BY  A  NOTIFIED  BODY 
⌦ SUPERVISED INSTRUMENT CHECKS AT RANDOM INTERVALS ⌫ 

1.  ‘Declaration  of  cConformity  to  type  based  on  internal  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 manufacturing 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  manufacturer,  shall  carry  out  product  ⌦ instrument ⌫ 
checks or have them carried out in appropriate intervals determined by it ⌦ the body ⌫ , in 
order  to  verify  the  quality  of  the  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 before 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 carried 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 relevant 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. 

The  acceptance  sampling  procedure  to  be  applied  is  intended  to  determine  whether  the 
manufacturing  process  of  the  instrument  performs  within  acceptable  limits,  with  a  view  to 
ensuring conformity of the instrument. 

(cid:216) new 

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Where  the  tests  are  carried  out  by  a  notified  body,  the  manufacturer  shall,  under  the 
responsibility of the notified body, affix the notified body's identification number during the 
manufacturing process. 

(cid:208) 2004/22/EC (adapted) 
(cid:214) 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  notified  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 (cid:214) 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. 

A  copy  of  the  declaration  of  conformity  shall  be  made  available  to  the  relevant  authorities 
upon request. 

(cid:216) new 

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. 

(cid:208) 2004/22/EC 

5. Authorised representative 

5. The manufacturer's obligations contained in paragraph 4.2 ⌦ set out in point 4 ⌫ may be 
fulfilled ⌦ by his authorised representative ⌫ , on his behalf and under his responsibility, 
by his authorised representative (cid:214) provided that they are specified in the mandate  . 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

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Where the manufacturer is not established within the Community and where he does not have 
an  authorised  representative,  the  obligations  mentioned  in  paragraph  4.2  shall  be  the 
responsibility of the person who places the instrument on the market. 

(cid:208) 2004/22/EC 

(cid:208) 2004/22/EC (adapted) 

6. ANNEX ⌦ MODULE ⌫ D: 

DECLARATION OF CONFORMITY TO TYPE BASED 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  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  for  production,  final  product 
⌦ instrument ⌫ inspection and testing of the measuring instrument concerned as specified 
in paragraph 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 ⌫ . 

The application shall include: 

(cid:208) 2004/22/EC 

(cid:216) new 

– 

– 

the name and address of the manufacturer and, if the application is lodged by 
the authorised representative, his name and address as well, 

a  written  declaration  that  the  same  application  has  not  been  lodged  with  any 
other notified body, 

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– 

– 

– 

all relevant information for the instrument category envisaged; 

the documentation concerning the quality system; 

(cid:208) 2004/22/EC 

the  technical  documentation  of  the  approved  type  and  a  copy  of  the  EC-type 
⌦ EU-type ⌫ examination certificate. 

(cid:208) 2004/22/EC (adapted) 

(cid:208) 2004/22/EC (adapted) 
(cid:214) 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  provisions  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  (cid:214) shall   permit  a  consistent 
interpretation of the quality programmes, 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 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; 

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  effective  operation  of  the  quality 
system. 

3.3.  The  notified  body  shall  assess  the  quality  system  to  determine  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 

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specifications of the national standard that implements the relevant harmonised standard, from 
the moment its references have been published ⌦ and/or technical specifications ⌫ . 

In  addition  to  experience  in  quality  management  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.  The  evaluation  procedure 
⌦ audit ⌫  shall  include  an  inspection  ⌦ assessment ⌫  visit  to  the  manufacturer's 
premises. 

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 examinations with a view to ensuring compliance of 
the instrument with those requirements. 

(cid:216) new 

The  decision  shall  be  notified  to  the  manufacturer.  The  notification  shall  contain  the 
conclusions of the examination ⌦ audit ⌫ and the reasoned assessment decision. 

(cid:208) 2004/22/EC (adapted) 

(cid:208) 2004/22/EC 

3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system 
as approved and to maintain it so that it remains adequate and efficient. 

3.5.  The  manufacturer  shall  keep  the  notified  body  that  has  approved  the  quality  system 
informed of any intended change of the quality system. 

(cid:208) 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  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 examination and the reasoned assessment decision. 

4. Surveillance under the responsibility of the notified body 

4.1. The purpose of surveillance is to make sure that the manufacturer ⌦ duly ⌫ fulfils the 
obligations arising out of the approved quality system. 

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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: 

– 

the quality system documentation; 

(cid:208) 2004/22/EC 

(cid:208) 2004/22/EC (adapted) 
(cid:214) 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  audits  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  notified  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 been 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  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 
appropriate 
⌦ applicable ⌫ requirements of this Directive. 

certificate 

satisfies 

and 

the 

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  (cid:214) 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. 

A  copy  of  the  declaration  of  conformity  shall  be  made  available  to  the  relevant  authorities 
upon request. 

(cid:216) new 

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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. 

(cid:208) 2004/22/EC 

6. The manufacturer shall, for ⌦ a period ending at least ⌫ 10 years after the last instrument 
has  been  manufactured  (cid:214) placed  on  the  market ,  keep  at  the  disposal  of  the  national 
authorities: 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

– 

the documentation referred to in paragraph point 3.1, second indent; 

(cid:208) 2004/22/EC (adapted) 

– 

– 

the change referred to in paragraph point 3.5, as approved; 

(cid:208) 2004/22/EC 

the  decisions  and  reports  from  the  notified  body  referred  to  in  paragraphs 
points 3.5, 4.3 and 4.4. 

7. Each notified 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. 

(cid:208) 2004/22/EC 

7.  Each  notified  body  shall  immediately  inform  its  notifying  authorities  of  quality  system 
approvals issued or withdrawn, and shall, periodically or upon request, make available to its 
notifying  authorities  the  list  of  quality  system  approvals  refused,  suspended  or  otherwise 
restricted. 

(cid:216) new 

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(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

8. Authorised representative 

8.  The  manufacturer's  obligations  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  (cid:214) 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 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  instruments  concerned  satisfy  the  appropriate  requirements  of  this 
Directive ⌦ that apply to them ⌫ . 

2. Technical documentation 

2. The manufacturer shall establish the technical documentation as described in Article 1019. 
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. 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  documentation  at  the  disposal  of  the  national 
authorities  for  10  years  after  the  last  instrument  has  been  manufactured  (cid:214) placed  on  the 
market  . 

4. Manufacturing 

4.  The  manufacturer  shall  operate  an  approved  quality  system  for  production,  final  product 
⌦ instrument ⌫ inspection and testing of the measuring instruments concerned as specified 
in paragraph point 5 and shall be subject to surveillance 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 ⌫ . 

The application shall include: 

(cid:208) 2004/22/EC 

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(cid:216) new 

the name and address of the manufacturer and, if the application is lodged by 
the authorised representative, his name and address as well, 

a  written  declaration  that  the  same  application  has  not  been  lodged  with  any 
other notified body, 

(cid:208) 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. 

– 

– 

– 

– 

– 

(cid:208) 2004/22/EC (adapted) 
(cid:214) 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  provisions  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  (cid:214) shall   permit  a  consistent 
interpretation of the quality programmes, 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 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; 

(cid:208) 2004/22/EC 

– 

the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data, 
qualification reports of ⌦ on ⌫ the personnel concerned, etc.; 

(cid:208) 2004/22/EC (adapted) 

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– 

the  means  to  monitor  ⌦ of  monitoring ⌫  the  achievement  of  the  required 
product  ⌦ instrument ⌫  quality  and  the  effective  operation  of  the  quality 
system. 

5.3.  The  notified  body  shall  assess  the  quality  system  to  determine  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 references have been published. 

In  addition  to  experience  in  quality  management  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.  The  evaluation  procedure 
⌦ audit ⌫  shall  include  an  inspection  ⌦ assessment ⌫  visit  to  the  manufacturer's 
premises. 

The auditing team shall review the technical documentation 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  view  to  ensuring  compliance  of  the  instrument 
with those requirements. 

(cid:216) new 

(cid:208) 2004/22/EC 

The  decision  shall  be  notified  to  the  manufacturer.  The  notification  shall  contain  the 
conclusions of the examination and the reasoned assessment decision. 

5.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system 
as approved and to maintain it so that it remains adequate and efficient. 

(cid:208) 2004/22/EC (adapted) 

5.5.  The  manufacturer  shall  keep  the  notified  body  that  has  approved  the  quality  system 
periodically informed of any intended change of the quality system. 

The  notified  body  shall  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 examination and the reasoned assessment decision. 

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6. Surveillance under the responsibility 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  ⌦ access ⌫  to  the  locations  of  manufacture,  inspection, 
testing  and  storage  ⌦ sites ⌫  ,  and  shall  provide  it  with  all  necessary  information,  in 
particular: 

– 

the quality system documentation; 

(cid:208) 2004/22/EC 

(cid:208) 2004/22/EC (adapted) 
(cid:214) 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  audits  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  unexpected  visits  to  the 
manufacturer.  During  such  visits  the  notified  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 been 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  (cid:214) 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. 

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A  copy  of  the  declaration  of  conformity  shall  be  made  available  to  the  relevant  authorities 
upon request. 

(cid:216) new 

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. 

(cid:208) 2004/22/EC 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

8. The manufacturer shall, for ⌦ a period ending at least ⌫ 10 years after the last instrument 
has  been  manufactured  (cid:214) 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 point5.5, as approved; 

the  decisions  and  reports  from  ⌦ of ⌫  the  notified  body  referred  to  in 
paragraph point 5.5, 6.3 and 6.4. 

9. Each notified 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. 

(cid:208) 2004/22/EC 

9.  Each  notified  body  shall  immediately  inform  its  notifying  authorities  of  quality  system 
approvals issued or withdrawn, and shall, periodically or upon request, make available to its 
notifying  authorities  the  list  of  quality  system  approvals  refused,  suspended  or  otherwise 
restricted. 

(cid:216) new 

EN 

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(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

10. Authorised representative 

10. The manufacturer's obligations 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 (cid:214) provided that they are specified in 
the mandate  . 

8. ANNEX ⌦ MODULE ⌫ E: 

DECLARATION  OF  CONFORMITY  TO  TYPE  BASED  ON  ⌦ INSTRUMENT ⌫ 
QUALITY ASSURANCE OF FINAL PRODUCT 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 ⌫ . 

The application shall include: 

(cid:208) 2004/22/EC 

(cid:216) new 

– 

– 

the name and address of the manufacturer and, if the application is lodged by 
the authorised representative, his name and address as well, 

a  written  declaration  that  the  same  application  has  not  been  lodged  with  any 
other notified body, 

EN 

98 

   EN 

 
 
 
– 

– 

– 

all relevant information for the instrument category envisaged; 

the documentation concerning the quality system; 

(cid:208) 2004/22/EC (adapted) 

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  provisions  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 programmes, plans, manuals and records. 

It shall ⌦ , in particular, ⌫ contain in particular an adequate description of: 

– 

– 

– 

– 

(cid:208) 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; 

(cid:208) 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  determine  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, from 
the moment its references have been published ⌦ and/or technical specification ⌫ . 

In  addition  to  experience  in  quality  management  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.  The  evaluation  procedure 

EN 

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⌦ audit ⌫  shall  include  an  inspection  ⌦ assessment ⌫  visit  to  the  manufacturer's 
premises. 

The  auditing  team  shall  review  the  technical  documentation  referred  to  in  point  3.1,  fifth 
indent,  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 view to ensuring compliance 
of the instrument with those requirements. 

(cid:216) new 

The  decision  shall  be  notified  to  the  manufacturer.  The  notification  shall  contain  the 
conclusions of the examination ⌦ audit ⌫ and the reasoned assessment decision. 

(cid:208) 2004/22/EC (adapted) 

3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system 
as approved and to maintain it so that it remains adequate and efficient. 

(cid:208) 2004/22/EC 

(cid:208) 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  shall  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 examination and the reasoned assessment decision. 

4. Surveillance under the responsibility of the notified body 

4.1. The purpose of surveillance is to make sure that the manufacturer ⌦ duly ⌫ fulfils the 
obligations arising out of the approved quality system. 

4.2.  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: 

EN 

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– 

the quality system documentation; 

(cid:208) 2004/22/EC 

(cid:208) 2004/22/EC (adapted) 
(cid:214) 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  audits  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.  Additionally  ⌦ In  addition ⌫  ,  the  notified  body  may  pay  unexpected  visits  to  the 
manufacturer.  During  such  visits  the  notified  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 been 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 conformity 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  manufactured  (cid:214) placed  on  the 
market   .  It  ⌦ The  declaration  of  conformity ⌫  shall  identify  the  instrument  model  for 
which it was ⌦ has been ⌫ drawn up.  

A  copy  of  the  declaration  of  conformity  shall  be  made  available  to  the  relevant  authorities 
upon request. 

(cid:216) new 

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 

(cid:208) 2004/22/EC 

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consignment  rather  than  individual  instruments  in  those  cases  where  a  large  number  of 
instruments is delivered to a single user. 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

6. The manufacturer shall, for ⌦ a period ending at least ⌫ 10 years after the last instrument 
has  been  manufactured  (cid:214) 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. 

7. Each notified 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. 

(cid:208) 2004/22/EC 

7.  Each  notified  body  shall  immediately  inform  its  notifying  authorities  of  quality  system 
approvals issued or withdrawn, and shall, periodically or upon request, make available to its 
notifying  authorities  the  list  of  quality  system  approvals  refused,  suspended  or  otherwise 
restricted. 

(cid:216) new 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

8. Authorised representative 

8.  The  manufacturer's  obligations  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  (cid:214) 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 

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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 instruments 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 technical documentation as described in Article 1019. 
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 (cid:214) placed on the market  . 

4. Manufacturing 

4.  The  manufacturer  shall  operate  an  approved  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 surveillance 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 ⌫ . 

The application shall include: 

(cid:208) 2004/22/EC 

(cid:216) new 

– 

– 

the name and address of the manufacturer and, if the application is lodged by 
the authorised representative, his name and address as well, 

a  written  declaration  that  the  same  application  has  not  been  lodged  with  any 
other notified body, 

EN 

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– 

– 

all relevant information for the instrument category envisaged; 

the documentation concerning the quality system; 

(cid:208) 2004/22/EC 

(cid:208) 2004/22/EC (adapted) 
(cid:214) 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  provisions  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  (cid:214) 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  determine  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, from 
the moment its references have been published ⌦ and/or technical specification ⌫ . 

In  addition  to  experience  in  quality  management  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  procedure  ⌦ audit ⌫  shall 
include an inspection ⌦ assessment ⌫ visit to the manufacturer's premises. 

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The auditing team shall review the technical documentation 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  view  to  ensuring  compliance  of  the  instrument 
with those requirements. 

(cid:216) new 

The  decision  shall  be  notified  to  the  manufacturer.  The  notification  shall  contain  the 
conclusions of the examination ⌦ audit ⌫ and the reasoned assessment decision. 

(cid:208) 2004/22/EC (adapted) 

(cid:208) 2004/22/EC 

5.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system 
as approved and to maintain it so that it remains adequate and efficient. 

5.5.  The  manufacturer  shall  keep  the  notified  body  that  has  approved  the  quality  system 
informed of any intended change of the quality system. 

(cid:208) 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 decision to the manufacturer ⌦ of its decision ⌫ . The notification shall 
contain the conclusions of the examination and the reasoned assessment decision. 

6. Surveillance under the responsibility 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: 

– 

the quality system documentation; 

(cid:208) 2004/22/EC 

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(cid:208) 2004/22/EC (adapted) 
(cid:214) 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  audits  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  unexpected  visits  to  the 
manufacturer.  During  such  visits  the  notified  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 been 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 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  (cid:214) 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. 

A  copy  of  the  declaration  of  conformity  shall  be  made  available  to  the  relevant  authorities 
upon request. 

(cid:216) new 

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. 

(cid:208) 2004/22/EC 

EN 

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   EN 

 
 
 
(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

8. The manufacturer shall, for ⌦ a period ending at least ⌫ 10 years after the last instrument 
has  been  manufactured  (cid:214) 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. 

9. Each notified 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. 

(cid:208) 2004/22/EC 

9.  Each  notified  body  shall  immediately  inform  its  notifying  authorities  of  quality  system 
approvals issued or withdrawn, and shall, periodically or upon request, make available to its 
notifying  authorities  the  list  of  quality  system  approvals  refused,  suspended  or  otherwise 
restricted. 

(cid:216) new 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

10. Authorised representative 

10.  The  manufacturer's  obligations  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  (cid:214) 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 manufacturer 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 

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provisions of paragraph point 3, 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 ⌦ so that the manufacturing 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 shall carry out the appropriate examinations 
and tests, or have them carried out, to check the conformity of the instruments 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 with 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  and  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 appropriate tests to be carried out. 

4.2.  The  notified  body  shall  issue  a certificate  of  conformity  in  respect  of  the  examinations 
and tests carried out, and shall affix its identification number to each approved instrument or 
have it affixed under its responsibility. 

(cid:208) 2004/22/EC 

The  manufacturer  shall  keep  the  certificates  of  conformity  available  for  inspection  by  the 
national authorities for 10 years after the certification of the instrument (cid:214) has been placed on 
the market  . 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

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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 ⌫ ensures 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 examined 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 ⌫ 
(cid:214) verify  their  conformity  with  the  type  as  described  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. 

5.3. The statistical procedure shall meet the following requirements: 

The statistical control will be based on attributes. The sampling system shall ensure: 

(cid:208) 2004/22/EC 

– 

– 

a level of quality corresponding to a probability of acceptance of 95 %, with a 
non-conformity of less than 1 %; 

a limit quality corresponding to a probability of acceptance of 5 %, with a non-
conformity of less than 7 %. 

5.4.  If  a  lot  is  accepted,  all  ⌦ measuring ⌫  instruments  of  the  lot  are  (cid:214) shall  be 
considered  approved, except for those ⌦ measuring ⌫ instruments from the sample that 
were ⌦ have been ⌫ found not to satisfy the tests. 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

The  notified  body  shall  issue  a  certificate  of  conformity  in  respect  of  the  examinations  and 
tests carried out, and shall affix its identification number to each approved instrument or have 
it affixed under its responsibility. 

(cid:208) 2004/22/EC 

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The manufacturer shall keep the certificates of conformity ⌦ at the disposal of ⌫ available 
for inspection by the national authorities for 10 years after the certification of the instrument 
(cid:214) has been placed on the market  . 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

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 verification and take appropriate measures. 

(cid:208) 2004/22/EC 

(cid:208) 2004/22/EC (adapted) 
(cid:214) 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 
the  appropriate  ⌦ applicable ⌫ 
EU-type  examination  certificate ⌫  and  satisfies 
requirements of this Directive. 

6.2. 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  (cid:214) 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. 

A  copy  of  the  declaration  of  conformity  shall  be  made  available  to  the  relevant  authorities 
upon request. 

(cid:216) new 

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. 

(cid:208) 2004/22/EC 

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(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

If agreed upon by 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 instruments under the notified 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 during the manufacturing process. 

8. Authorised representative 

8. The manufacturer's obligations may be fulfilled ⌦ by his authorised representative ⌫ , on 
his behalf and under his responsibility, by his authorised representative (cid:214) 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 technical documentation as described in Article 1019. 
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  analysis  and  assessment  of  the  risk(s) ⌫  of  this  Directive. 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 (cid:214) placed on the market  . 

3. Manufacturing 

4. The manufacturer shall take all measures necessary ⌦ so that the manufacturing process 
and  its  monitoring ⌫  to  ensure  conformity  of  the  manufactured  ⌦ measuring ⌫ 
instruments with the appropriate ⌦ applicable ⌫ requirements of this Directive. 

4. Verification 

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5. A notified  body  chosen  by the manufacturer shall 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  instrument  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 with 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  decide  on  the  appropriate  tests  to  be 
carried out. 

65.2. The notified body shall issue a certificate of conformity in respect of the examinations 
and tests carried out, and shall affix its identification number to each approved instrument or 
have it affixed under its responsibility. 

(cid:208) 2004/22/EC 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

The manufacturer shall keep the certificates of conformity ⌦ at the disposal of ⌫ available 
for inspection by the national authorities for 10 years after the certification of the instrument 
(cid:214) has been placed on the market  . 

76. Statistical verification of conformity with the metrological requirements. 

76.1.  The  manufacturer  shall  take  all  measures  necessary  in  order  ⌦ so ⌫  that  the 
manufacturing  process  ensures  the  homogeneity  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 accepted or rejected. In the absence of a relevant 

EN 

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⌦ such harmonised standard, normative ⌫ document ⌦ and/or technical specification ⌫ , 
the notified body concerned shall decide on the appropriate tests to be carried out. 

7.36.4. The statistical procedure shall meet the following requirements: 

The statistical control will be based on attributes. The sampling system shall ensure: 

(cid:208) 2004/22/EC 

– 

– 

a level of quality corresponding to a probability of acceptance of 95 %, with a 
non-conformity of less than 1 %; 

a limit quality corresponding to a probability of acceptance of 5 %, with a non-
conformity of less than 7 %. 

7.46.5.  If  a  lot  is  accepted,  all  ⌦ measuring ⌫  instruments  of  the  lot  are  (cid:214) shall  be 
considered  approved, except for those ⌦ measuring ⌫ instruments from the sample that 
were ⌦ have been ⌫ found not to satisfy the tests. 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

The  notified  body  shall  issue  a  certificate  of  conformity  in  respect  of  the  examinations  and 
tests carried out, and shall affix its identification number to each approved instrument or have 
it affixed under its responsibility. 

(cid:208) 2004/22/EC 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

The manufacturer shall keep the certificates of conformity available for inspection by ⌦ at 
the disposal of ⌫ the national authorities for 10 years after the certification of the instrument 
(cid:214) 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 verification 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  Directive,  and  under  the  responsibility  of  the  notified 
body  referred  to  in  point  4,  the  latter's  identification  number ⌫  to  each  measuring 

EN 

113 

   EN 

 
 
 
 
⌦ individual ⌫ instrument that satisfies the appropriate ⌦ applicable ⌫  requirements  of 
this Directive. 

87.2. 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  (cid:214) 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. 

A  copy  of  the  declaration  of  conformity  shall  be  made  available  to  the  relevant  authorities 
upon request. 

(cid:216) new 

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. 

(cid:208) 2004/22/EC 

(cid:208) 2004/22/EC (adapted) 
(cid:214) 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 instruments under the notified 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 instruments during the manufacturing process. 

9. Authorised representative 

10. The manufacturer's obligations may be fulfilled ⌦ by his authorised representative ⌫ , 
on  his  behalf  and  under  his  responsibility,  by  his  authorised  representative  (cid:214) 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 

114 

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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 1019 and 
make  it  available  to  the  notified  body  referred  to  in  paragraph  point  4.  The  technical 
documentation  shall  enable  assessment  of 
the 
the  appropriate  ⌦ relevant ⌫ 
instrument's ⌫  conformity  of 
requirements of this Directive and ⌦ , 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. 

instrument  with 

the  ⌦ make 

it  possible 

to  assess 

the 

The  manufacturer  shall  keep 
the 
⌦ relevant ⌫  national  authorities  for  ten  years  (cid:214) after  the  instrument  has  been  placed  on 
the market  . 

technical  documentation  at 

the  disposal  of 

the 

3. Manufacturing 

3. The manufacturer shall take all measures necessary ⌦ so that the manufacturing process 
and  its  monitoring ⌫  to  ensure  conformity  of  the  manufactured  instrument  with  the 
appropriate ⌦ applicable ⌫ requirements of this Directive. 

4. Verification 

4. A notified  body  chosen  by the manufacturer shall 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 carried out. In the absence of ⌦ such ⌫ a relevant ⌦ harmonised 
standard,  normative ⌫  document  ⌦ and/or  technical  specification ⌫  ,  the  notified  body 
concerned shall decide on the appropriate tests to be carried out. 

The  notified  body  shall  issue  a  certificate  of  conformity  in  respect  of  the  examinations  and 
tests  carried  out  and  affix  its  identification  number  to  the  approved  instrument,  or  have  it 
affixed under its responsibility. 

(cid:208) 2004/22/EC 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

The manufacturer shall keep the certificates of conformity ⌦ at the disposal of ⌫ available 
for inspection by the national authorities for 10 years after the certification of the instrument 
(cid:214) has been placed on the market  . 

5. Written ⌦ Conformity marking and ⌫ declaration of conformity 

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5.1. 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  paragraph  point  4,  the  latter's  identification  number  to  each 
measuring  instrument  that  satisfies  the  appropriate  ⌦ 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 national authorities for 10 years after 
the instrument has been manufactured (cid:214) placed on the market  . It ⌦ The declaration of 
conformity ⌫ shall identify the instrument for which it was ⌦ has been ⌫ drawn up. 

A  copy  of  the  declaration  of  conformity  shall  be  made  available  to  the  relevant  authorities 
upon request. 

(cid:216) new 

A copy of the declaration shall be supplied with the measuring instrument. 

(cid:208) 2004/22/EC 

6. Authorised representative 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

6. The manufacturer's obligations 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  authorised  representative  (cid:214) 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 Annex 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  quality  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. 

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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 ⌫ . 

The application shall include: 

all relevant information for the instrument category envisaged; 

(cid:208) 2004/22/EC 

(cid:216) new 

the name and address of the manufacturer and, if the application is lodged by 
the authorised representative, his name and address as well, 

the  technical  documentation  for  one  model  of  each  category  of  measuring 
instruments  intended  to  be  manufactured.  The  technical  documentation  shall, 
wherever applicable, contain at least the following elements: 

a general description of the instrument, 

conceptual  design  and  manufacturing  drawings  and  schemes  of  components, 
sub-assemblies, circuits, etc., 

descriptions  and  explanations  necessary  for  the  understanding  of  those 
drawings and schemes and the operation of the instrument, 

a list of the harmonised standards, normative 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 the event  of  partly 
applied  harmonised  standards,  the  technical  documentation  shall  specify  the 
parts which have been applied, 

results of design calculations made, examinations carried out, etc., 

test reports 

– 

– 

– 

– 

– 

– 

– 

– 

– 

the documentation concerning the quality system, ⌦ and ⌫ 

(cid:208) 2004/22/EC (adapted) 

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– 

a  written  declaration  that  the  same  application  has  not  been  lodged  with  any 
other notified body. 

(cid:216) new 

(cid:208) 2004/22/EC (adapted) 
(cid:214) 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  provisions  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 programmes, 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 
to  design  and  product 
⌦ instrument ⌫ quality; 

the  management  with 

regard 

the  technical  design  specifications,  including  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 design verification techniques, processes and systematic 
actions  that  will  be  used  when  designing  the  ⌦ measuring ⌫  instruments 
pertaining to the instrument category covered; 

– 

the  corresponding  manufacturing,  quality  control  and  quality  assurance 
techniques, processes and systematic actions that will be used; 

(cid:208) 2004/22/EC 

(cid:208) 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.; 

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– 

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  determine  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 references have been published. 

In  addition  to  experience  in  quality  management  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.  The  evaluation  procedure 
⌦ audit ⌫  shall  include  an  inspection  ⌦ assessment ⌫  visit  to  the  manufacturer's 
premises. 

The  auditing  team  shall  review  the  technical  documentation  referred  to  in  point  3.1,  second 
indent,  to  verify  the  manufacturer's  ability  to  identify  the  applicable  requirements  of  this 
Directive and to carry out the necessary examinations with a view to ensuring compliance of 
the instrument with those requirements. 

(cid:216) new 

The  decision  ⌦ manufacturer  or  his  authorised  representative ⌫  shall  be  notified  to  the 
manufacturer  ⌦ of  the  decision ⌫  .  The  notification  shall  contain  the  conclusions  of  the 
examination ⌦ audit ⌫ and the reasoned assessment decision. 

(cid:208) 2004/22/EC (adapted) 

3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system 
as approved and to maintain it so that it remains adequate and efficient. 

(cid:208) 2004/22/EC 

(cid:208) 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  shall  evaluate  the  ⌦ any  proposed ⌫  changes  proposed  and  decide 
whether the changed ⌦ modified ⌫ quality system will still ⌦ continue to ⌫ satisfy the 

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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 examination and the reasoned assessment decision. 

4. Surveillance under the responsibility of the notified body 

(cid:208) 2004/22/EC 

(cid:208) 2004/22/EC (adapted) 

4.1. The purpose of surveillance is to make sure that the manufacturer ⌦ duly ⌫ fulfils the 
obligations arising out of the 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: 

– 

the quality system documentation; 

(cid:208) 2004/22/EC 

(cid:208) 2004/22/EC (adapted) 
(cid:214) 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 data, calibration data, 
qualification reports of ⌦ on ⌫ the personnel concerned, etc. 

4.3.  The  notified  body  shall  carry  out  periodic  audits  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  notified  body  may,  if  necessary,  carry  out  product 
⌦ instrument ⌫ tests, or have them carried 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. 

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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 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 (cid:214) placed on 
the market  . It ⌦ The declaration of conformity ⌫ shall identify the instrument model for 
which it was ⌦ has been ⌫ drawn up. 

A  copy  of  the  declaration  of  conformity  shall  be  made  available  to  the  relevant  authorities 
upon request. 

(cid:216) new 

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. 

(cid:208) 2004/22/EC 

6. The manufacturer shall, for ⌦ a period ending at least ⌫ 10 years after the last instrument 
has  been  manufactured  (cid:214) placed  on  the  market   ,  keep  at  the  disposal  of  the  national 
authorities: 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

– 

the technical documentation referred to in point 3.1, 

(cid:216) new 

(cid:208) 2004/22/EC (adapted) 

– 

– 

the documentation concerning the quality system referred to in paragraph point 
3.1, second indent; 

the change referred to in paragraph point 3.5, as approved; 

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– 

the  decisions  and  reports  from  ⌦ of ⌫  the  notified  body  referred  to  in 
paragraphs points 3.5, 4.3 and 4.4. 

7. Each notified 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. 

(cid:208) 2004/22/EC 

7.  Each  notified  body  shall  immediately  inform  its  notifying  authorities  of  quality  system 
approvals issued or withdrawn, and shall, periodically or upon request, make available to its 
notifying  authorities  the  list  of  quality  system  approvals  refused,  suspended  or  otherwise 
restricted. 

(cid:216) new 

8. Authorised representative 

(cid:208) 2004/22/EC 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

8. The manufacturer's obligations contained in paragraphs 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 (cid:214) 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 manufacturer fulfils the obligations laid down 
in this Annex points 2 and 6, 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  quality  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 surveillance as specified in paragraph 
point 5.  

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The adequacy of the technical design of the measuring instruments shall have been examined 
according ⌦ in accordance ⌫ to the provisions 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 ⌫ . 

The application shall include: 

(cid:208) 2004/22/EC 

(cid:216) new 

– 

the name and address of the manufacturer and, if the application is lodged by 
the authorised representative, his name and address as well, 

– 

– 

– 

all relevant information for the instrument category envisaged; 

the documentation concerning the quality system, 

(cid:208) 2004/22/EC 

a  written  declaration  that  the  same  application  has  not  been  lodged  with  any 
other notified body. 

(cid:216) new 

(cid:208) 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  provisions  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 programmes, plans, manuals and records.  

It shall ⌦ , in particular, ⌫ contain in particular an adequate description of: 

– 

the  quality  objectives  and  the  organisational  structure,  responsibilities  and 
to  design  and  product 
powers  of 
⌦ instrument ⌫ quality; 

the  management  with 

regard 

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– 

– 

– 

– 

– 

– 

the 

the  technical  design  specifications,  including  standards,  that  will  be  applied 
technical 
and,  where 
specifications ⌫  documents  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; 

relevant  ⌦ harmonised 

standards  and/or 

the design control and design verification techniques, processes and systematic 
actions  that  will  be  used  when  designing  the  ⌦ measuring ⌫  instruments 
pertaining to the instrument category covered; 

(cid:208) 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; 

(cid:208) 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  determine  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 Official Journal. 

In  addition  to  experience  in  quality  management  systems,  the  auditing  team  shall  possess 
appropriate ⌦ have  at  least  one  member ⌫  experienced  in  the  relevant ⌦ instrument ⌫ 
field  of  metrology  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  contain  the  conclusions  of  the 
examination ⌦ audit ⌫ and the reasoned assessment decision. 

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(cid:208) 2004/22/EC 

3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system 
as approved and to maintain it so that it remains adequate and efficient. 

3.5.  The  manufacturer  shall  keep  the  notified  body  that  has  approved  the  quality  system 
informed of any intended change of the quality system. 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

The  notified  body  shall  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 examination and the reasoned assessment decision. 

3.6. Each notified body shall periodically make available to the Member State that designated 
it  the  list  ⌦ immediately  inform  its  notifying  authorities ⌫  of  quality  system  approvals 
issued or refused (cid:214) withdrawn  , and shall ⌦ periodically or upon request, make available 
to its notifying authorities the list of ⌫ immediately inform the Member State that designated 
it  of  the  withdrawal  of  a  quality  system  approvals  (cid:214) 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 assessment ⌦ to assess 
the ⌫  of  conformity  with  the  appropriate  requirements  of  this  Directive  ⌦ that  apply  to 
it ⌫ .  

It shall include: 

(cid:208) 2004/22/EC 

– 

– 

the name and address of the manufacturer; 

a  written  declaration  that  the  same  application  has  not  been  lodged  with  any 
other notified body; 

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(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

– 

– 

the technical documentation as described in Article 1019. 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 analysis 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  adequacy  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  another  testing  laboratory  on  his  behalf  and  under  his 
responsibility. 

4.3.  The  notified  body  shall  examine  the  application,  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 certificate 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 documentation shall be annexed to the certificate. 

4.3.2. The certificate or (cid:214) and  its annexes shall contain all relevant information for ⌦ to 
allow  the ⌫  conformity  ⌦ of  manufactured  measuring  instruments  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 manufactured instruments with the examined design 
regarding  the  reproducibility  of  their  metrological  performances,  when  they  are  properly 
adjusted using appropriate means, including: 

– 

– 

– 

– 

the metrological characteristics of the design of the instrument; 

(cid:208) 2004/22/EC 

measures  required  for  ensuring  the  integrity  of  the  instruments  (sealing, 
identification of software …); 

information on other elements necessary for the identification of the instrument 
and to check its visual external conformity to the design; 

if  appropriate,  any  specific  information  necessary  to  verify  the  characteristics 
of manufactured instruments; 

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– 

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 designated it. Without prejudice to Article 12(8) 28(10), the 
notified body shall release the content of this report, in full or in part, only with the agreement 
of the manufacturer. 

The  certificate  shall  have  a  validity  of  ten  years  from  the  date  of  its  issue,  and  may  be 
renewed for subsequent periods of ten years each. 

(cid:208) 2004/22/EC (adapted) 
(cid:214) 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.  (cid:214) The  notified  body  shall  keep  itself  apprised  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  legislative  instrument,  and  shall  determine  whether 
such  changes  require  further  investigation.  If  so,  the  notified  body  shall  inform  the 
manufacturer accordingly.  

The  manufacturer  shall  keep  the  notified  body  that  has  issued  the  ‘EC’  ⌦ EU ⌫  design 
examination  certificate  informed  of  any  fundamental  modification  to  the  approved  design. 
Modifications to the approved design must receive 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 available 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 (cid:214) which it has issued  or withdrawn, and shall, periodically or 
upon  request,  make  available  to  its  notifying  authorities  the  list  of  certificates  and/or  any 
additions thereto refused, suspended or otherwise restricted  . 

Each  notified  body  shall  immediately  inform  the  Member  State  that  designated  it  of  the 
withdrawal of an EC design examination certificate. 

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(cid:216) new 

The Commission, the Member States and the other notified bodies 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 copy of the EU design examination 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. 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

4.6.  The  manufacturer  or  his  authorised  representative  shall  keep  a  copy  of  the  ‘EC’ 
⌦ EU ⌫  design  examination  certificate,  its  annexes  and  additions  with  the  technical 
documentation  ⌦ at  the  disposal  of  the  national  authorities ⌫  for  10  years  after  the  last 
measuring instrument has been manufactured (cid:214) placed on the market  . 

Where  neither  the  manufacturer  nor  his  authorised  representative  is  established  within  the 
Community, the obligation to make the technical documentation available on request shall be 
the responsibility of the person designated by the manufacturer. 

(cid:208) 2004/22/EC 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

5. Surveillance under the responsibility of the notified body 

5.1. The purpose of surveillance is to make sure that the manufacturer ⌦ duly ⌫ fulfils the 
obligations arising out of the 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 data, calibration data, 
qualification reports of ⌦ on ⌫ the personnel concerned, etc. 

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5.3.  The  notified  body  shall  carry  out  periodic  audits  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  unexpected  visits  to  the 
manufacturer.  During  such  visits  the  notified  body  may,  if  necessary,  carry  out  product 
⌦ instrument ⌫ tests, or have them carried out under its responsibility, ⌦ 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  responsibility  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 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  (cid:214) 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. 

A  copy  of  the  declaration  of  conformity  shall  be  made  available  to  the  relevant  authorities 
upon request. 

(cid:216) new 

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. 

(cid:208) 2004/22/EC 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

7. The manufacturer shall, for ⌦ a period ending at least ⌫ 10 years after the last instrument 
has  been  manufactured  (cid:214) 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; 

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– 

– 

the change referred to in paragraph point 3.5, as approved; 

(cid:208) 2004/22/EC 

the decisions and reports of the notified body referred to in paragraphs points 
3.5, 5.3 and 5.4. 

8. Authorised representative 

(cid:208) 2004/22/EC (adapted) 
(cid:214) new 

8.  The  manufacturer's ⌦ authorised  representative  may  lodge  the  application  referred  to  in 
points  4.1  and  4.2  and  fulfil  the ⌫  obligations  contained  in  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  authorised  representative  (cid:214) provided  that  they  are  specified  in  the 
mandate  . 

(cid:208) 2004/22/EC (adapted) 

ANNEX MI-001 III 

WATER METERS ⌦ (MI-001) ⌫ 

The  relevant  requirements  of  Annex  I,  the  specific  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. 

(cid:208) 2004/22/EC 

DEFINITIONS 

Water Meter 

Minimum 
Flowrate (Q1) 

Transitional 
Flowrate (Q2) 

An instrument designed to measure, memorise and display the 
volume at metering conditions of water passing through the 
measurement transducer. 

The lowest flowrate at which the water meter provides indications 
that satisfy the requirements concerning the maximum permissible 
errors (MPEs.) 

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 ‘lower zone’. Each 

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zone has a characteristic MPE. 

Permanent 
Flowrate (Q3) 

Overload 
Flowrate (Q4) 

The highest flowrate at which the water meter operates in a 
satisfactory manner under normal conditions of use, i.e. under steady 
or intermittent flow conditions. 

The overload flowrate is the highest flowrate at which the meter 
operates in a satisfactory manner for a short period of time without 
deteriorating. 

SPECIFIC REQUIREMENTS 

Rated Operating Conditions 

The manufacturer shall specify the rated operating conditions for the instrument, in particular; 

1. The flowrate range of the water. 

The values for the flowrate range shall fulfil the following conditions: 

Q3/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 Q2/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 Q3. 

4. For the power supply: the nominal value of the 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 (Q2) (included) and the overload flowrate (Q4) is: 

2 % for water having a temperature ≤ 30 °C, 

EN 

131 

   EN 

 
 
 
3 % for water having a temperature > 30 °C. 

6. The MPE, positive or negative, on volumes  delivered  at  flowrates between the minimum 
flowrate  (Q1)  and  the  transitional  flowrate  (Q2)  (excluded)  is  5 %  for  water  having  any 
temperature. 

6a. The meter shall not exploit the MPE or systematically favour any party. 

(cid:208) 2009/137/EC  

Permissible Effect of Disturbances 

7.1. Electromagnetic immunity 

(cid:208) 2004/22/EC 

7.1.1. The effect of an electromagnetic disturbance 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  measurement  result  is  such  that  it  cannot  be  interpreted  as  a 
valid result, such as a momentary variation 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 magnitude of the MPE in the upper zone on 
the measured volume; 

the volume corresponding to the MPE on the volume corresponding to one minute at 
flowrate Q3. 

7.2. Durability 

After  an  appropriate  test,  taking  into  account  the  period  of  time  estimated  by  the 
manufacturer, has been performed, the following criteria shall be satisfied: 

7.2.1. The variation of the measurement result after the durability test, when compared with 
the initial measurement result, shall not exceed: 

– 

3 % of the metered volume between Q1 included and Q2 excluded; 

EN 

132 

   EN 

 
 
– 

1,5 % of the metered volume between Q2 included and Q4 included. 

7.2.2. The error of indication for the volume metered after the durability test shall not exceed: 

– 

– 

– 

± 6 % of the metered volume between Q1 included and Q2 excluded; 

± 2,5 %  of  the  metered  volume  between  Q2  included  and  Q4  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  Q2  included  and  Q4  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 position unless clearly marked 
otherwise. 

8.2. The manufacturer shall specify whether the meter 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 shall 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 

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 for installing the meter, so that 
the  meter  is  appropriate  for  the  accurate  measurement  of  consumption  that  is  foreseen  or 
foreseeable. 

(cid:208) 2004/22/EC (adapted) 

(cid:208) 2004/22/EC 

CONFORMITY ASSESSMENT 

The  conformity  assessment  procedures  referred  to  in  Article  918  that  the  manufacturer  can 
choose between are: 

B + F or B + D or H1. 

EN 

133 

   EN 

 
 
(cid:208) 2004/22/EC (adapted) 

ANNEX MI-002 IV 

GAS METERS AND VOLUME CONVERSION DEVICES ⌦ (MI-002) ⌫ 

The  relevant  requirements  of  Annex  I,  the  specific  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,  commercial  and  light  industrial 
use. 

(cid:208) 2004/22/EC 

DEFINITIONS 

Gas meter 

Conversion 
device 

Minimum 
flowrate (Qmin) 

Maximum 
flowrate (Qmax) 

Transitional 
flowrate (Qt) 

Overload 
Flowrate (Qr) 

Base conditions 

An instrument designed to measure, memorise and display the 
quantity of fuel gas (volume or mass) that has passed it. 

A device fitted to a gas meter that automatically converts the 
quantity measured at metering conditions into a quantity at base 
conditions. 

The lowest flowrate at which the gas meter provides indications that 
satisfy the requirements regarding maximum permissible error 
(MPE.) 

The highest flowrate at which the gas meter provides indications that 
satisfy the requirements regarding MPE. 

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 ‘lower zone’. Each 
zone has a characteristic MPE. 

The overload flowrate is the highest flowrate at which the meter 
operates for a short period of time without deteriorating. 

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 

134 

   EN 

 
 
 
 
 
 
 
 
 
 
1.1. The flowrate range of the gas shall fulfil at least the following conditions: 

Class 

Qmax/Qmin 

Qmax/Qt 

Qr/Qmax 

1,5 

1,0 

≥150 

≥20 

≥10 

≥5 

1,2 

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 the 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 < Qt  3 % 

2 % 

Qt ≤ Q ≤ Qmax  1,5 %  1 % 

The gas meter shall not exploit the MPEs or systematically favour any party. 

(cid:208) 2009/137/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  manufacturer  that  lies  between  15 °C  and  25 °C. 
Outside this range, an additional increase of 0,5 % is permitted in each interval of 10 °C. 

(cid:208) 2004/22/EC 

EN 

135 

   EN 

 
 
 
3. Permissible effect of disturbances 

3.1. Electromagnetic immunity 

3.1.1.  The  effect  of  an  electromagnetic  disturbance  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  measurement  result  is  such  that  it  cannot  be  interpreted  as  a 
valid result, such as a momentary variation that cannot be interpreted, memorised or 
transmitted as a measuring result. 

3.1.2. After undergoing a disturbance, 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 magnitude 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  the  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 following criteria shall be satisfied: 

4.1. Class 1,5 meters 

4.1.1.  The  variation  of  the  measurement  result  after  the  durability  test  when  compared  with 
the initial measurement result for the flow rates in the range Qt to Qmax-shall not exceed the 
measurement result by more than 2 %. 

4.1.2.  The  error  of  indication  after  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  after  the  durability  test  when  compared  with 
the initial measurement result shall not exceed one-third of the MPE in paragraph 2. 

EN 

136 

   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 means 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 Qmax does not return the digits to their initial values. 

5.4.  The  gas  meter  shall  be  able  to  be  installed  to  operate  in  any  position  declared  by  the 
manufacturer in its installation instruction. 

5.5.  The  gas  meter  shall  have  a  test  element,  which  shall  enable  tests  to  be  carried  out  in  a 
reasonable time. 

5.6. The gas meter shall respect the MPE in any flow 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 

A volume conversion device constitutes a sub-assembly according to Article 4, definition (b), 
second  indent  ⌦ when  it  is  together  with  a  measuring  instrument  with  which  it  is 
compatible ⌫ . 

(cid:208) 2004/22/EC (adapted) 

For a volume conversion device, the essential requirements  for the  gas  meter shall apply, if 
applicable. In addition, the following requirements shall apply: 

(cid:208) 2004/22/EC 

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 

137 

   EN 

 
 
0,7 % for temperature conversion devices 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. 

The volume conversion device shall not exploit the MPEs or systematically favour any party. 

(cid:208) 2009/137/EC  

9. Suitability 

(cid:208) 2004/22/EC 

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  separately  the  converted  quantity  for  the  time  it  is 
operating outside the operating range(s). 

9.2.  An  electronic  conversion  device  shall  be  capable  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 measurement of residential use, it shall allow 
such measurement to be performed by means of any Class 1,5 meter, and by Class 
1,0 meters which have a Qmax/Qmin ratio equal or greater than 150. 

(b)  Where  a  Member  State  imposes  measurement  of  commercial  and/or  light 
industrial  use,  it  shall  allow  such  measurement  to  be  performed  by  any  Class  1,5 
meter. 

(cid:208) 2004/22/EC (adapted) 

(c) As regards the requirements under paragraphs 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 meter, so that the meter is appropriate for 
the accurate measurement of consumption that is foreseen or foreseeable. 

EN 

138 

   EN 

 
 
 
 
 
 
 
(cid:208) 2004/22/EC 

CONFORMITY ASSESSMENT 

The  conformity  assessment  procedures  referred  to  in  Article  918  that  the  manufacturer  can 
choose between are 

B + F oder ⌦ or ⌫ B + D or H1. 

(cid:208) 2004/22/EC (adapted) 

ANNEX MI-003 V 

ACTIVE ELECTRICAL ENERGY METERS ⌦ (MI-003) ⌫ 

The  relevant  requirements  of  Annex  I,  the  specific  requirements  of  this  Annex  and  the 
conformity  assessment  procedures  listed  in  this  Annex,  apply  to  active  electrical  energy 
meters intended for residential, commercial and light industrial use. 

(cid:208) 2004/22/EC 

Note: 

Electrical  energy  meters  may  be  used  in  combination  with  external  instrument 
transformers,  depending  upon  the  measurement  technique  applied.  However,  this 
Annex covers only electrical energy meters but not instrument transformers. 

DEFINITIONS 

An  active  electrical  energy  meter  is  a  device  which  measures  the  active  electrical  energy 
consumed in a circuit. 

I 

In 

Ist 

Imin 

Itr 

= 

= 

= 

= 

= 

the electrical current flowing through the meter; 

the specified reference current for which the transformer operated meter has 
been designed; 

the lowest declared value of I at which the meter registers active electrical 
energy at unity power factor (polyphase meters with balanced load); 

the value of I above which the error lies within maximum permissible errors 
(MPEs) (polyphase meters with balanced load); 

the value of I above which the error lies within the smallest MPE 
corresponding to the class index of the meter; 

EN 

139 

   EN 

 
 
 
 
Imax 

U 

Un 

f 

fn 

PF 

= 

= 

= 

= 

= 

= 

the maximum value of I for which the error lies within the MPEs; 

the voltage of the electricity supplied to the meter; 

the specified reference voltage; 

the frequency of the voltage supplied to the meter; 

the specified reference frequency; 

power factor = cosφ = the cosine of the phase difference φ between I and U. 

SPECIFIC REQUIREMENTS 

1. Accuracy 

The manufacturer shall specify 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 operating conditions of the meter; in particular: 

The  values  of  fn,  Un,  In,  Ist,  Imin,  Itr  and  Imax  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 

Imin 

Imax 

For transformer-operated meters 

Ist 

Imin 

In 

Imax 

≤ 0,05 · Itr  ≤ 0,04 · Itr 

≤ 0,04 · Itr 

≤ 0,5 · Itr 

≤ 0,5 · Itr 

≤ 0,3 · Itr 

≥ 50 · Itr 

≥ 50 · Itr 

≥ 50 · Itr 

≤ 0,06 · Itr  ≤ 0,04 · Itr 

≤ 0,02 · Itr 

≤ 0,4 · Itr 

≤ 0,2 · Itr

31  ≤ 0,2 · Itr 

= 20 · Itr 

= 20 · Itr 

= 20 · Itr 

≥ 1,2 · In 

≥ 1,2 · In 

≥ 1,2 · In 

31 

For Class B electromechanical meters Imin ≤ 0,4 · Itr shall apply. 

EN 

140 

   EN 

 
 
 
 
 
 
 
 
                                                 
The voltage, frequency and power factor ranges within which the meter shall satisfy the MPE 
requirements are specified in Table 2. These ranges shall recognise 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 cosφ = 0,5 inductive to cosφ = 0,8 capacitive. 

3. MPEs 

The  effects  of  the  various  measurands  and  influence  quantities  (a,  b,  c,…)  are  evaluated 
separately, all other measurands and influence quantities 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 current levels and operating 
temperature 

Operating 
temperatures 

Operating 
temperatures 

Operating 
temperatures 

Operating 
temperatures 

Meter class 

+ 5 °C 
… + 30 °C 

- 10 °C … + 5 °C 

or 

+ 30 °C … 
+ 40 °C 

- 25 °C … -
 10 °C 

- 40 °C … -
 25 °C 

or 

or 

+ 40 °C … 
+ 55 °C 

+ 55 °C … 
+ 70 °C 

A 

B 

C 

A 

B 

C 

A 

B 

C 

A 

B 

C 

Single phase 
meter; 
polyphase 
meter if 
operating 
with 
balanced 
loads 

EN 

141 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Imin ≤ I < Itr 

3,5 

Itr ≤ I ≤ Imax 

3,5 

2 

2 

1 

5 

2,5 

1,3 

0,7 

4,5 

2,5 

1 

7 

7 

3,5 

1,7 

3,5 

1,3 

9 

9 

4 

4 

2 

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  the  current  range  for  single-phase  load  is 
limited to 5Itr ≤ I ≤ Imax 

When a meter operates in different temperature ranges the relevant MPE values shall apply. 

The meter shall not exploit the MPEs or systematically favour any party. 

(cid:208) 2009/137/EC 

4. Permissible effect of disturbances 

4.1. General 

(cid:208) 2004/22/EC 

As electrical energy meters are directly connected to the mains supply and as mains current is 
also  one  of  the  measurands,  a  special  electromagnetic  environment  is  used  for  electricity 
meters. 

The  meter  shall  comply  with  the  electromagnetic  environment  E2  and  the  additional 
requirements in 4.2 and 4.3. 

The  electromagnetic  environment  and  permissible  effects  reflect  the  situation  that  there  are 
disturbances of long duration which shall not affect the accuracy beyond the critical change 
values  and  transient  disturbances,  which  may  cause  a  temporary  degradation  or  loss  of 
function  or  performance  but  from  which  the  meter  shall  recover  and  shall  not  affect  the 
accuracy beyond the critical change values. 

When there is a foreseeable high risk due to lightning or where overhead supply networks are 
predominant, the metrological characteristics of the meter shall be protected. 

EN 

142 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4.2. Effect of disturbances of long duration 

Table 3 

Critical change values for disturbances of long duration 

Disturbance 

Reversed phase sequence 

Voltage unbalance (only applicable to polyphase meters) 

Harmonic contents in the current circuits32 

DC and harmonics in the current circuit33 

Fast transient bursts 

Magnetic fields; HF (radiated RF) electromagnetic field; 
Conducted disturbances introduced by radio-frequency 
fields; and Oscillatory waves immunity 

Critical change values in 
percent for meters of class 

A 

B 

C 

1,5 

4 

1 

6 

6 

3 

1,5 

2 

0,8 

3 

4 

2 

0,3 

1 

0,5 

1,5 

2 

1 

4.3. Permissible effect of transient electromagnetic phenomena 

4.3.1. The effect of an electromagnetic disturbance on an electrical energy meter shall be such 
that during and immediately after a disturbance 

– 

any output intended for testing the accuracy of the meter does not produce pulses or 
signals corresponding to an energy of more 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 registered 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, Un in Volts and Imax in Amps). 

32 

33 

In the case of electromechanical electricity meters, no critical change values are defined for harmonic 
contents in the current circuits and for DC and harmonics in the current circuit. 
In the case of electromechanical electricity meters, no critical change values are defined for harmonic 
contents in the current circuits and for DC and harmonics in the current circuit. 

EN 

143 

   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  digits  to  ensure  that 
when  the  meter  is  operated  for  4000  hours  at  full  load  (I = Imax,  U = Un  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 electricity in the circuit, the amounts of electrical energy measured 
shall remain available for reading during a period of at least 4 months. 

5.4. Running with no load 

When the voltage is applied with no current flowing 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  Un,  PF = 1  (polyphase  meter  with  balanced 
loads) and a current which is equal to Ist. 

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  measurement  of  residential  use,  it  shall  allow 
such  measurement  to  be  performed  by  means  of  any  Class  A  meter.  For  specified 
purposes the Member State is authorised to require any Class B meter. 

(b)  Where  a  Member  State  imposes  measurement  of  commercial  and/or  light 
industrial  use,  it  shall  allow  such  measurement  to  be  performed  by  any  Class  B 
meter. For specified purposes the Member State is authorised to require any Class C 
meter. 

(cid:208) 2004/22/EC (adapted) 

(c)  The  Member  State  shall  ensure  that  the  current  range  be  determined  by  the 
distributor ⌦ 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 

144 

   EN 

 
 
 
 
(cid:208) 2004/22/EC 

CONFORMITY ASSESSMENT 

The  conformity  assessment  procedures  referred  to  in  Article  918  that  the  manufacturer  can 
choose between are: 

B + F or B + D or H1. 

(cid:208) 2004/22/EC (adapted) 

ANNEX MI-004 VI 

HEAT METERS ⌦ (MI-004) ⌫ 

The  relevant  requirements  of  Annex  I,  the  specific  requirements  and  the  conformity 
assessment procedures listed in this Annex, apply to heat meters defined below, intended for 
residential, commercial and light industrial use. 

(cid:208) 2004/22/EC 

DEFINITIONS 

A heat meter is an instrument designed to measure the heat which, in a heat exchange circuit, 
is given up by a liquid called the heat-conveying liquid. 

A heat meter is either a complete instrument or a combined instrument consisting of the sub-
assemblies, flow sensor, temperature sensor pair, and calculator, as defined in Article 4(b2), 
or a combination thereof 

θ 

θin 

θout 

∆θ 

θmax 

θmin 

∆θmax 

= 

= 

= 

= 

= 

= 

= 

the temperature of the heat-conveying liquid; 

the value of θ at the inlet of the heat exchange circuit; 

the value of θ at the outlet of the heat exchange circuit; 

the temperature difference θin — θout with ∆θ ≥ 0; 

the upper limit of θ for the heat meter to function correctly within the MPEs; 

the lower limit of θ for the heat meter to function correctly within the MPEs; 

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 

145 

   EN 

 
 
 
q 

qs 

qp 

qi 

P 

Ps 

= 

= 

= 

= 

= 

= 

MPEs; 

the flow rate of the heat conveying liquid; 

the highest value of q that is permitted for short periods of time for the heat 
meter to function correctly; 

the highest value of q that is permitted permanently for the heat meter to 
function correctly; 

the lowest value of q that is permitted for the heat meter to function 
correctly; 

the thermal power of the heat exchange; 

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 shall 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: qs, qp, qi, where the values of qp and qi are subject to the 
following restriction: qp/qi ≥ 10. 

1.4. For the thermal power: Ps. 

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  applicable  to  a  complete  heat  meter,  expressed  in 
percent of the true value for each accuracy class, are: 

– 

– 

– 

EN 

For class 1: E = Ef + Et + Ec, with Ef, Et, Ec according to paragraphs 7.1 to 7.3. 

For class 2: E = Ef + Et + Ec, with Ef, Et, Ec according to paragraphs 7.1 to 7.3. 

For class 3: E = Ef + Et + Ec, with Ef, Et, Ec according to paragraphs 7.1 to 7.3. 

146 

   EN 

 
 
The complete heat meter shall not exploit the MPEs or systematically favour any party. 

(cid:208) 2009/137/EC  

4. Permissible influences of electromagnetic disturbances 

(cid:208) 2004/22/EC 

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  disturbance  shall  be  such  that  the  change  in  the 
measurement result is not greater than the critical 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 following criteria shall be satisfied: 

5.1.  Flow  sensors:  The  variation  of  the  measurement  result  after  the  durability  test,  when 
compared with the initial measurement result, shall not exceed the critical change value. 

5.2.  Temperature  sensors:  The  variation  of  the  measurement  result  after  the  durability  test, 
when compared with the initial measurement 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 installation: flow or return 

Indication of the direction 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  relevant.  In  addition,  the 
following apply: 

EN 

147 

   EN 

 
 
7.1. The relative MPE of the flow sensor, expressed in %, for accuracy classes: 

– 

– 

– 

Class 1: Ef = (1 + 0,01 qp/q), but not more than 5 %, 

Class 2: Ef = (2 + 0,02 qp/q), but not more than 5 %, 

Class 3: Ef = (3 + 0,05 qp/q), but not more than 5 %, 

where the error Ef relates the indicated value to the true value of the relationship between flow 
sensor output signal and the mass or the volume. 

7.2. The relative MPE of the temperature sensor pair, expressed in %: 

– 

Et = (0,5 + 3 · ∆θmin/∆θ), 

where  the  error  Et  relates  the  indicated  value  to  the  true  value  of  the  relationship  between 
temperature sensor pair output and temperature difference. 

7.3. The relative MPE of the calculator, expressed in %: 

– 

Ec = (0,5 + ∆θmin/∆θ), 

where the error Ec relates the value of the heat indicated to the true value of the heat. 

7.4.  The  critical  change  value  for  a  sub-assembly  of  a  heat  meter  is  equal  to  the  respective 
absolute value of the MPE applicable to the sub-assembly (see paragraphs 7.1, 7.2 or 7.3). 

7.5. Inscriptions on the sub-assemblies 

Flow sensor: 

Accuracy class 

Limits of flow rate 

Limits of temperature 

Nominal meter factor (e.g. litres/pulse) or corresponding output 
signal 

Indication of the direction of flow 

Temperature sensor pair: 

Type identification (e.g. Pt 100) 

Limits of temperature 

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 

148 

   EN 

corresponding input signal coming from the flow sensor 

– 

Place of the flow sensor installation: flow or return 

PUTTING INTO USE 

8. (a) Where a Member State imposes measurement of residential use, it shall allow 
such measurement to be performed by means of any Class 3 meter. 

(b)  Where  a  Member  State  imposes  measurement  of  commercial  and/or  light 
industrial use, it is authorised to require any Class 2 meter. 

(cid:208) 2004/22/EC (adapted) 

(c)  As  regards  the  requirements  under  paragraphs  1.1  to  1.4,  Member  States  shall 
ensure  that  the  properties  be  determined  by  the  distributor  ⌦ 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. 

(cid:208) 2004/22/EC 

CONFORMITY ASSESSMENT 

The  conformity  assessment  procedures  referred  to  in  Article  918  that  the  manufacturer  can 
choose between are: 

B + F or B + D or H1. 

(cid:208) 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) ⌫ 

The relevant essential requirements 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 measurement of quantities (volumes or masses) of 

(cid:208) 2004/22/EC 

EN 

149 

   EN 

 
 
 
 
 
 
 
 
liquids other than water. If appropriate, the terms ‘volume, and L’ in this Annex can be read 
as: ‘mass and kg’. 

DEFINITIONS 

Meter 

  An instrument designed to measure continuously, memorise and 
display the quantity at metering 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 calculator which by taking account of the 

characteristics of the liquid (temperature, 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 conditions and/or into mass, or 

the  mass  of  the  liquid  measured  at  metering  conditions 
into a volume at metering conditions 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 the meter itself and all devices required to 
ensure correct measurement or intended to facilitate the measuring 
operations. 

Fuel dispenser 

  A measuring system intended 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-service arrangement and 
which allows one of more measuring systems to perform in this 
self-service arrangement. 

EN 

150 

   EN 

 
 
Minimum measured 
quantity (MMQ) 

The smallest quantity of liquid for which the measurement is 
metrologically acceptable for the measuring system. 

Direct indication 

The indication, 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 (Qmin) and maximum 
flowrate (Qmax). 

SPECIFIC REQUIREMENTS 

1. Rated operating conditions 

The manufacturer shall specify the rated operating 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 : Qmin 

Fuel dispensers 

Not Liquefied gases  10 : 1 

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 

151 

   EN 

 
 
 
 
 
 
 
 
1.2. The properties of the liquid to be measured by the instrument 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 supply and/or limits of the DC voltage supply. 

1.4. The base conditions for converted values. 

Note: 

(cid:208) 2004/22/EC (adapted) 

Paragraph 1.4 is without prejudice to the Member States' obligations 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, another temperature pursuant to Article 3(2) 
of that Directive. 

2. Accuracy classification and maximum permissible errors (MPEs) 

2.1. For quantities equal to or greater than 2 litres the MPE on indications is: 

(cid:208) 2004/22/EC 

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 litres 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 

152 

   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  quantity  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 for the minimum measured quantity (Emin). 

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:  Emin ≥ 2 R,  where  R  is  the  smallest  scale  interval  of  the 
indication device. 

Condition 2 

Emin is given by the formula: Emin = (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  less  than  two  litres,  the  above  mentioned 
condition 1 applies and Emin 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 conversion 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 

153 

   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 

MPE on Measurements 

Accuracy classes of the measuring system 

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 characteristic 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 applies to any calculation, not only conversion. 

2.8. The measuring system shall not exploit the MPEs or systematically favour any party. 

(cid:208) 2009/137/EC  

3. Maximum permissible effect of disturbances 

(cid:208) 2004/22/EC  

3.1. The effect of an electromagnetic disturbance on a measuring system shall be one of the 
following; 

EN 

154 

   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 shows a momentary variation 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  greater  than  the  critical  change  value,  in 
which  case  the  measuring  system  shall  permit  the  retrieval  of  the  measuring  result 
just before the critical change value occurred and cut off the flow. 

3.2. The critical change value is the greater of MPE/5 for a particular measured quantity or 
Emin. 

4. Durability 

After  an  appropriate  test,  taking  into  account  the  period  of  time  estimated  by  the 
manufacturer, has been performed, the following criterion shall be satisfied: 

The  variation  of  the  measurement  result  after  the  durability  test,  when  compared  with  the 
initial measurement result, shall not exceed the value for meters specified in line B of table 2. 

5. Suitability 

5.1. For any measured quantity relating to the same measurement, the indications provided by 
various  devices  shall  not  deviate  one  from  another  by  more  than  one  scale  interval  where 
devices  have  the  same  scale  interval.  In  the  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 arrangement the scale intervals of the main indicating 
device on the measuring system and the scale intervals 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 measured quantity in normal conditions of use unless 
it is readily apparent. 

5.3. Any percentage of air or gas not easily detectable in the liquid shall not lead to a variation 
of error greater than: 

– 

– 

0,5 %  for  liquids  other  than  potable  liquids  and  for  liquids  of  a  viscosity  not 
exceeding 1 mPa.s, or 

1 % for potable liquids and for liquids of a viscosity exceeding 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  shall  be  provided  with  means  for  resetting  the 
display to zero. 

EN 

155 

   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 shall not lead to a variation 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  inhibited  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 the unit price and the indicated quantity shall not 
exceed  the  price  corresponding  to  Emin.  However  this  difference  need  not  be  less  than  the 
smallest monetary value. 

6. Power supply failure 

A measuring system shall either be provided with an emergency power supply device that will 
safeguard  all  measuring  functions  during  the  failure  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 

0,5 

Measuring systems on pipeline 

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 

156 

   EN 

                                                 
– 

– 

measuring systems for milk 

measuring systems for refuelling aircraft 

1,0 

Measuring systems for liquefied gases under pressure measured at a 
temperature equal to or above – 10 °C 

Measuring systems normally in class 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 

1,5 

Measuring systems for liquefied carbon dioxide 

Measuring systems for liquefied gases under pressure measured at a 
temperature below – 10 °C (other than cryogenic liquids) 

2,5 

measuring systems for cryogenic liquids (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 millilitres, cubic centimetres, litres, cubic metres, 
grams, kilograms or tonnes. 

CONFORMITY ASSESSMENT 

The  conformity  assessment  procedures  referred  to  in  Article  918  that  the  manufacturer  can 
choose between are: 

B + F or B + D or H1 or G. 

(cid:208) 2004/22/EC (adapted) 

ANNEX MI-006 VIII 

AUTOMATIC WEIGHING INSTRUMENTS ⌦ (MI-006) ⌫ 

EN 

157 

   EN 

 
 
 
The relevant essential requirements of Annex I, the specific requirements of this Annex and 
the  conformity  assessment  procedures  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. 

(cid:208) 2004/22/EC 

DEFINITIONS 

Automatic weighing 
instrument 

Automatic catchweigher 

Automatic checkweigher 

An instrument that determines the mass of a product without 
the intervention of an operator and follows a predetermined 
programme of automatic processes characteristic of the 
instrument. 

An automatic weighing instrument that determines the mass 
of pre-assembled discrete loads (for example prepackages) 
or single loads of loose material. 

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 

Discontinuous totaliser 
(totalising hopper 
weigher) 

Continuous totaliser 

An automatic weighing instrument that fills containers with 
a predetermined and virtually constant mass of product from 
bulk. 

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. 

An automatic weighing 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 

158 

   EN 

 
 
 
 
 
 
 
 
 
 
 
SPECIFIC REQUIREMENTS 

CHAPTER I — Requirements common to all types of automatic weighing instruments 

1. Rated Operating Conditions 

The manufacturer shall specify the rated operating 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 supply influence quantities: 

In case of AC voltage 
supply 

In case of DC voltage 
supply 

: 

: 

the nominal AC voltage supply, or the AC voltage limits. 

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 mechanical strain, e.g. instruments incorporated 
into vehicles, the manufacturer shall define the mechanical conditions of use. 

1.4. For other influence quantities (if applicable): 

The rate(s) of operation. 

The characteristics of the product(s) to be weighed. 

2. Permissible effect of disturbances - 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) are 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 display (where present) shall be verifiable by the operator. 

EN 

159 

   EN 

 
3.5. Adequate zero setting capability shall be provided to enable the instrument 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  procedures  referred  to  in  Article  918  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 

2.1. Category X applies to instruments used to check prepackages made up in accordance with 
the  requirements  of  Council  Directive  75/106/EEC  of  19  December  1974  on  the 
approximation  of  the  laws  of  the  Member  States  relating  to  the  making-up  by  volume  of 

(cid:208) 2004/22/EC (adapted) 

EN 

160 

   EN 

 
certain prepackaged liquids36 and of Council Directive 76/211/EEC of 20 January 1976 on the 
approximation  of  the  laws  of  the  Member  States  relating  to  the  making-up  by  weight  or  by 
volume of certain prepackaged products37 applicable to prepackages. 

(cid:208) 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 specify 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 other 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 

37 

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). 
OJ L 46, 21.2.1976, p. 1. Directive as last amended by the EEA Agreement. 

EN 

161 

   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 

10000 g < m ≤ 
15000 g 

0,08 % 

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 verification scale intervals 
n = Max/e 

Minimum 

Maximum 

XI 

Y(I) 

0,001 g ≤ e 

50000 

XII 

Y(II) 

0,001 g ≤ e ≤ 0,05 g 

100 

0,1 g ≤ e 

XIII 

Y(a) 

0,1 g ≤ e ≤ 2 g 

5 g ≤ e 

XIV 

Y(b) 

5 g ≤ e 

EN 

5000 

100 

500 

100 

162 

— 

100000 

100000 

10000 

10000 

1000 

   EN 

 
 
 
 
 
 
 
4.4. Verification scale interval — multi-interval instruments 

Table 4 

Accuracy 
classes 

Verification scale 
interval 

Number of verification scale intervals n = Max/e 

Minimum value38 

Maximum value 

n = Maxi/e(i+1) 

n = Maxi/ei 

XI 

XII 

Y(I) 

0,001 g ≤ ei 

50000 

Y(II) 

0,001 g ≤ ei ≤ 0,05 g 

5000 

0,1 g ≤ ei 

XIII 

Y(a) 

0,1 g ≤ ei 

XIV 

Y(b) 

5 g ≤ ei 

Where: 

5000 

500 

50 

— 

100000 

100000 

10000 

1000 

i 

i 

r 

= 

= 

= 

1, 2, … r 

partial weighing range 

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 capacity shall not be less than: 

class Y(I) 

class Y(II) 

class Y(a) 

class Y(b) 

Scales used for grading, e.g. postal scales and 
garbage weighers 

: 

: 

: 

: 

: 

100 e 

20 e for 0,001 g ≤ e ≤ 0,05 g, and 50 
e for 0,1 g ≤ e 

20 e 

10 e 

5 e 

38 

For i = r the corresponding column of Table 3 applies with e replaced by er. 

EN 

163 

   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 operating 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-automatic  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 Gravimetric 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 reference 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 operational 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 × 10k, 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 

164 

   EN 

2. MPE 

2.1. Static weighing error 

2.1.1. For static loads under rated operating conditions, 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) the MPE for static loads shall be the accuracy 
required for the fill as specified in 2.2 (i.e. not the sum of the maximum permissible deviation 
for the individual loads). 

2.2. Deviation from average fill 

Table 5 

Value of the mass, m (g), of the fills 

Maximum permissible deviation of each fill from 
theaverage the average for class X(1) 

m ≤ 50 

50 < m ≤ 100 

100 < m ≤ 200 

200 < m ≤ 300 

300 < m ≤ 500 

500 < m ≤ 1000 

1000 < m ≤ 10000 

10000 < m ≤ 15000 

15000 < m 

Note: 

7,2 % 

3,6 g 

3,6 % 

7,2 g 

2,4 % 

12 g 

1,2 % 

120 g 

0,8 % 

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-set a fill weight; the maximum difference between 
the  pre-set  value  and  the  average  mass  of  the  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 shall be as specified in paragraph 2.1. 

EN 

165 

   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 critical 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 

0,5 

1 

2 

± 0,10 % 

± 0,25 % 

± 0,50 % 

± 1,00 % 

3. Totalisation scale interval 

The totalisation scale interval (dt) 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  (dt)  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 inhibited if zero indication varies by: 

– 

– 

1 dt on instruments with automatic zero setting device; 

0,5 dt on instruments with a semi-automatic, or non-automatic, zero setting device. 

6. Operator Interface 

Operator adjustments and reset function shall be inhibited during automatic operation. 

EN 

166 

   EN 

7. Printout 

On instruments equipped with a printing device, the 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 factors and electromagnetic 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 

500 < m ≤ 2000 

2000 < m ≤ 10000 

± 0,5 dt 

± 1,0 dt 

± 1,5 dt 

8.2.  The  critical  change  value  due  to  a  disturbance  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 measurement range, the ratio between the minimum 
net load on the weighing unit and the maximum capacity, and the minimum totalised load. 

2.2. The minimum totalised load Σmin 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 

1 

± 0,25 % 

± 0,5 % 

167 

EN 

   EN 

2 

± 1,0 % 

4. Speed of the belt 

The speed of the belt shall be specified by the manufacturer. For single-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. The product shall not have a different speed than 
the speed of the belt. 

5. General Totalisation Device 

It shall not be possible to reset the general totalisation device to zero. 

6. Performance under influence factors and electromagnetic 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 totalisation 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 totalisation scale interval (d). 

CHAPTER VI — Automatic Rail Weighbridges 

1. Accuracy classes 

Instruments are divided into four 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 

0,5 

1 

2 

± 0,1 % 

± 0,25 %

± 0,5 % 

± 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 nearest scale interval; 

EN 

168 

   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  weighing-in-motion  shall  be  one  of  the  following 
values, whichever is the greatest: 

– 

– 

the value calculated according to Table 9, rounded to the nearest 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  inscribed  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  shall  be  as  specified  in 
Table 10. 

Table 10 

Accuracy class 

Scale interval (d) 

0,2 

0,5 

1 

2 

d ≤ 50 kg 

d ≤ 100 kg 

d ≤ 200 kg 

d ≤ 500 kg 

4. Measurement range 

4.1.  The  minimum  capacity  shall  not  be  less  than  1 t,  and  not  greater  than  the  value  of  the 
result of the minimum wagon weight divided by the number of partial weighings. 

4.2. The minimum wagon weight shall not be less than 50 d. 

5. Performance under influence factor 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 

169 

   EN 

0 < m ≤ 500 

500 < m ≤ 2000 

2000 < m ≤ 10000 

± 0,5 d 

± 1,0 d 

± 1,5 d 

5.2. The critical change value due to a disturbance is one scale interval. 

(cid:208) 2004/22/EC (adapted) 

ANNEX MI-007 IX 

TAXIMETERS ⌦ (MI-007) ⌫ 

The  relevant  requirements  of  Annex  1I,  the  specific  requirements  of  this  Annex  and  the 
conformity assessment procedures listed in this Annex apply to taximeters. 

(cid:208) 2004/22/EC 

DEFINITIONS 

Taximeter 

A device that works together with a signal generator39 to make a measuring instrument. 

This  device  measures  duration,  calculates  distance  on  the  basis  of  a  signal  delivered  by  the 
distance signal generator. Additionally, it calculates and displays the fare to be paid for a trip 
on the basis of the calculated distance and/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  trip.  The  fare  does  not  include  a  supplement  charged  for  extra 
services. 

Cross-over speed 

The speed value found by division of a time tariff value by a distance tariff value. 

Normal calculation mode S (single application of tariff) 

Fare  calculation  based  on  application  of  the  time  tariff  below  the  cross-over  speed  and 
application of the distance tariff above the cross-over speed. 

39 

The distance signal generator is outside the scope of this Directive. 

EN 

170 

   EN 

 
 
 
                                                 
Normal calculation mode D (double application of tariff) 

Fare calculation based on simultaneous application of time tariff and distance tariff over the 
whole trip. 

Operating position 

The  different  modes  in  which  a  taximeter  fulfils  the  different  parts  of  its  functioning.  The 
operating positions are distinguished by the following indications: 

‘For Hire’ 

‘Hired’ 

: 

: 

The operating position in which the fare calculation is disabled 

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 based 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  calculate  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  normal  calculation  modes  S  and  D.  It  shall  be 
possible to choose between these calculation modes by a secured setting. 

4.  A  taximeter  shall  be  able  to  supply  the  following  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 generator, 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, finish time, distance travelled; 

tariff(s) information: parameters of tariff(s). 

National  legislation  may  require  certain  devices  to  be  connected  to  the  interface(s)  of  a 
taximeter. Where such a device is required; it shall 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 

171 

   EN 

5. If relevant, it shall be possible to adjust a taximeter for the constant of the distance signal 
generator to which it is to be connected 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 (MPES) 

7. The MPE, excluding any errors due to application 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  functioning  without  loss  of  data 
available  before  the  voltage  drop  if  the  voltage  drop  is  temporary,  i.e.  due  to 
restarting the engine; 

EN 

172 

   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 the 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  calculation  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 daylight 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 instrument settings and data entered. 

14.2. The securing possibilities 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 with 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 include 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 totalised values to be stored for 
one year for the purpose of reading out the values from the taximeter to another medium. 

15.3. Adequate measures shall be taken to prevent 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 

173 

   EN 

– 

– 

– 

– 

duration of the trip; 

time of the day; 

date; 

day of the week. 

17. If properties of the taxi are important for the  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  installation,  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  installation  instructions  specified  by  the  manufacturer  shall  be  such 
that,  if  installed  according  to  the  manufacturer's  instructions,  fraudulent  alterations  of  the 
measurement signal representing the distance 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 equipped 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  shall  be  not  more  than  2  minutes  per  week. 
Correction for summer and wintertime shall be performed automatically; 

Correction, automatic or manually, during a trip shall be prevented. 

23.  The  values  of  distance  travelled  and  time  elapsed,  when  displayed  or  printed  in 
accordance with this Directive, shall use the following units: 

Distance travelled: 

– 

in  the  United  Kingdom  and  Ireland:  until  the  date  which  will  be  fixed  by  these 
Member  States  according  to  Article  (1)(b)  of  Directive  80/181/EEC:  kilometres  or 
miles; 

(cid:208) 2004/22/EC (adapted) 

EN 

174 

   EN 

 
– 

in all other Member States: kilometres. 

Time elapsed: 

(cid:208) 2004/22/EC 

– 

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  procedures  referred  to  in  Article  918  that  the  manufacturer  can 
choose between are: 

B + F or B + D or H1. 

(cid:208) 2004/22/EC (adapted) 

ANNEX MI-008 X 

MATERIAL MEASURES ⌦ (MI-008) ⌫ 

(cid:208) 2004/22/EC 

CHAPTER I — MATERIAL MEASURES OF LENGTH 

The relevant essential requirements of Annex I, the specific requirements of this Annex and 
the  conformity  assessment  procedures  listed  in  this  chapter,  apply  to  material  measures  of 
length defined  below. However,  the 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 

175 

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by the manufacturer and marked on the tape accordingly, 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-consecutive  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 value c given in Table 1. 

Table 1 

Accuracy Class 

a (mm) 

b 

c (mm) 

I 

II 

III 

D — special class for dipping tapes40 

Up to and including 30 m41 

0,1 

0,3 

0,6 

1,5 

0,1 

0,1 

0,2 

0,2 

0,4 

0,3 

zero 

zero 

S — special class for tank strapping tapes 

1,5 

zero 

zero 

For each 30 m length when the tape is supported on a flat surface 

Dip  tapes  may  also  be  of  Classes  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 gives 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 intervals, are given in Table 2 below. 

Table 2 

Length i of the interval 

MPE or difference in millimetres according to accuracy class

I 

II 

III 

40 
41 

Applies to the tape/dip weight combinations. 
If  the  nominal  tape  length  exceeds  30 m,  an  additional  mpe  of  0,75 mm  shall  be  permitted  for  each 
30 m of tape length. 

EN 

176 

   EN 

                                                 
i ≤ 1 mm 

1 mm < i ≤ 1 cm 

0,1 

0,2 

0,2 

0,4 

0,3 

0,6 

Where  a  rule  is  of  the  folding  type,  the  jointing  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  shall  be  such  that  length  variations  due  to 
temperature excursions up to ± 8 °C about the reference temperature do not exceed the MPE. 
This  does  not  apply  to  Class  S  and  Class  D  measures  where  the  manufacturer  intends  that 
thermal expansion corrections shall be applied to observed readings where necessary. 

3.2. Measures made from material whose dimensions may alter materially when subjected to a 
wide range of relative humidity, may only 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  procedures  referred  to  in  Article  918  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  Annex  I,  and  the  specific  requirements  and  the 
conformity  assessment  procedures  listed  in  this  chapter,  apply  to  capacity  serving  measures 
defined  below.  However,  the  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 instrument. Also, the requirement for the instrument to bear information in respect 
of its accuracy shall not apply. 

DEFINITIONS 

Capacity 
serving 
measure 

Line measure 

A capacity measure (such as a drinking glass, jug or thimble measure) 
designed to determine a specified volume of a liquid (other than a 
pharmaceutical product) which is sold for immediate consumption. 

A capacity serving measure marked 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 

177 

   EN 

 
 
 
Transfer 
measure 

Capacity 

A capacity serving measure from which it is intended that the liquid is 
decanted prior to consumption. 

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 temperature 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 equal 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 

178 

   EN 

 
 
 
 
 
 
 
5. Marking 

5.1. The nominal capacity declared shall be clearly and indelibly marked on the measure. 

5.2. Capacity serving measures may also be marked with up to three clearly distinguishable 
capacities, none of which 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  procedures  referred  to  in  Article  918  that  the  manufacturer  can 
choose between are: 

A1A2 or F1 or D1 or E1 or B + E or B + D or H. 

(cid:208) 2004/22/EC (adapted) 

ANNEX MI-009 XI 

DIMENSIONAL MEASURING INSTRUMENTS ⌦ (MI-009) ⌫ 

The relevant essential requirements of Annex I, the specific requirements of this Annex and 
the  conformity  assessment  procedures  listed  in  this  Annex,  apply  to  dimensional  measuring 
instruments of the types defined below. 

(cid:208) 2004/22/EC 

DEFINITIONS 

Length measuring 
instrument 

A length measuring instrument serves for the determination 
of the length of rope-type materials (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 length (length, height, width) of 
the smallest enclosing rectangular parallelepiped of a 
product. 

EN 

179 

   EN 

 
 
 
 
 
CHAPTER  I  —  REQUIREMENTS  COMMON  TO  ALL  DIMENSIONAL  MEASURING 

INSTRUMENTS 

Electromagnetic immunity 

1. The effect of an electromagnetic disturbance on a dimensional measuring instrument shall 
be such that: 

– 

– 

– 

– 

the  change  in  measurement  result  is  no  greater  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  result  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  procedures  referred  to  in  Article  918  that  the  manufacturer  can 
choose between are: 

For mechanical or electromechanical 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 · (GA + 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 

180 

   EN 

Operating conditions 

2.1. Range 

Dimensions  and  K-factor,  where  applicable,  within  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 

II 

III 

IV 

0 < K < 2 × 10-2 N/m2 

low stretchability 

2 × 10-2 N/m2 < K < 8 × 10-
2 N/m2 

8 × 10-2 N/m2 < K < 24 × 10-
2 N/m2 

medium stretchability 

high stretchability 

24 × 10-2 N/m2 < K 

very high stretchability 

2.2. Where the measured object is not transported by the measuring instrument, its speed must 
be within the range specified by the 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 

II 

III 

0,125 %, but not less than 
0,005 Lm 

0,25 %, but not less than 0,01 Lm 

0,5 %, but not less than 0,02 Lm 

Where Lm is the minimum measurable length, that is to say the smallest length specified by 
the manufacturer for which the instrument 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 material which is going to be measured should 
be laid out on a suitable underlay (e.g. a suitable table) straight and unstretched. 

EN 

181 

   EN 

Other requirements 

4.  The  instruments  must  ensure  that  the  product  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 dm2. 

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 dm2. 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  all  values  of  the  scale  interval  is  given  in 
Table 1. 

EN 

Table 1 

182 

   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. 

(cid:208) 2004/22/EC (adapted) 

ANNEX MI-010 XII 

EXHAUST GAS ANALYSERS ⌦ (MI-010) ⌫ 

The  relevant  requirements  of  Annex  I,  the  specific  requirements  of  this  Annex  and  the 
conformity assessment procedures listed in this Annex, apply to exhaust gas analysers defined 
below intended for inspection and professional maintenance of motor vehicles in use. 

(cid:208) 2004/22/EC 

DEFINITIONS 

Exhaust 
gas 
analyser 

An exhaust gas analyser is a measuring instrument that serves to determine 
the volume fractions of specified components 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 (CO2), 
oxygen (O2) and hydrocarbons (HC). 

The content of hydrocarbons has to be expressed as concentration of n-
hexane (C6H14), measured with near-infrared absorption techniques. 

The volume fractions of the gas components are expressed as a percentage 
(% vol) for CO, CO2 and O2 and in parts per million (ppm vol). 

EN 

183 

   EN 

 
 
 
Moreover, an exhaust gas analyser calculates the lambda value from the 
volume fractions of the components of the exhaust gas. 

Lambda 

Lambda is a dimensionless value representative 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 being defined for exhaust gas analysers. 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 

CO2 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 shall be specified by the manufacturer as follows: 

2.1. For the climatic and mechanical 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 power 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 the ambient pressure are for both classes: 
pmin ≤ 860 hPa, pmax ≥ 1060 hPa. 

EN 

184 

   EN 

 
Maximum permissible errors (MPEs) 

3. The MPEs are defined as follows: 

3.1.  For  each  of  the  fractions  measured,  the  maximum  error  value  permitted  under  rated 
operating  conditions  according  to  paragraph  1.1  of  Annex  I  is  the  greater  of  the  two  values 
shown in Table 2. Absolute values are expressed 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 

± 0,06 % vol 

± 5 % 

± 5 % 

CO2 fraction 

± 0,5 % vol 

± 0,5 % vol 

± 5 % 

± 5 % 

HC fraction 

± 10 ppm vol 

± 12 ppm vol 

± 5 % 

± 5 % 

O2 fraction 

± 0,1 % vol 

± 0,1 % vol 

± 5 % 

± 5 % 

3.2.  The  MPE  on  lambda  calculation  is  0,3 %.  The  conventional  true  value  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 and 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: 

– 

– 

42 

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  result  is  such  that  it  cannot  be  taken  for  a 
valid result. 

OJ L 350, 28.12.1998, p. 17. 

EN 

185 

   EN 

                                                 
Other requirements 

6. The resolution shall be equal to or of one order of magnitude higher than the values shown 
in Table 3. 

Table 3 

Resolution 

CO 

CO2 

O2 

HC 

Class 0 and class I 

0,01 % vol  0,1 % vol 

43 

1 ppm vol 

The lambda value shall be displayed 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,  CO2  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  O2,  the 
instrument under similar conditions must indicate a value differing less than 0,1 % vol from 
zero within 60 seconds after changing from fresh air to an oxygen-free gas. 

9. The components in the exhaust gas, other than the components whose values are subject to 
the  measurement,  shall  not  affect  the  measurement  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 CO2, 

10 % vol O2, 

5 % vol H2, 

0,3 % vol NO, 

2000 ppm vol HC (as n-hexane), 

water vapor up to saturation. 

10.  An  exhaust  gas  analyser  shall  have  an  adjustment  facility  that  provides  operations  for 
zero-setting, gas calibration and internal adjustment. The adjustment facility for zero-setting 
and internal adjustment shall be automatic. 

11.  For  automatic  or  semi-automatic  adjustment  facilities,  the  instrument  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 

186 

   EN 

 
                                                 
12. An exhaust gas analyser shall detect hydrocarbon residues in the gas handling system. It 
shall not be possible to carry out a measurement if the hydrocarbon 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  different  fuels  (e.g.  petrol  or 
liquefied gas), there shall be the possibility to select the suitable coefficients for the Lambda 
calculation without ambiguity concerning the appropriate formula. 

CONFORMITY ASSESSMENT 

The  conformity  assessment  procedures  referred  to  in  Article  918  that  the  manufacturer  can 
choose between are: 

B + F or B + D or H1. 

(cid:207) 

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 transposition into national law and application 

EN 

187 

   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 

(cid:207) 

ANNEX XIV 

CORRELATION TABLE 

Directive 2004/22/EC 

This Directive 

Article 1 

Article 2  

Article 3 first paragraph 

Article 3 second paragraph 

Article 4  

___ 

Article 5 

Article 6(1) 

Article 6(2) 

Articles 7(1) 

Article 7(2) 

Article 7(3) 

Article 7(4) 

Article 8 

___ 

___ 

Article 2(1) 

Article 3 

Article 1 

Article 2(2) 

Article 4(1) to (5) 

Article 4(6) to (22) 

Article 5 

Article 6 

___ 

Article 21 

Article 23(4) 

___ 

___ 

Article 7 

Article 8 

Article 9 

EN 

188 

   EN 

 
 
 
 
 
___ 

___ 

___ 

___ 

___ 

Article 9 

Article 10 

Article 11(1) 

Article 11(2) first subparagraph 

Article 10 

Article 11 

Article 12 

Article 13 

[Article 15] 

Article 18 

Article 19 

___ 

___ 

Article 11(2) second subparagraph 

Article 24(2) 

Article 12 

Article 13(1) 

Article 13(2) 

___ 

___ 

Article 13(3) 

Article 13(4) 

Article 14 

Article 15(1) 

Article 15(2) 

Article 15(3) 

Article 15(4) 

Article 15(5) 

Article 16(1) 

Article 16(2) 

Article 16(3) 

Article 16(4) 

___ 

___ 

___ 

Article 14(1) 

Article 14(2) 

Article 14(3) 

Article 14(4) 

___ 

Article 46(1) 

Article 46(2) 

___ 

___ 

___ 

Article 16 

Article 47 

Article 17 

___ 

EN 

189 

   EN 

Article 17(1) 

Article 17(2) 

Article 17(3) 

___ 

Article 22 second subparagraph 

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 

190 

   EN 

 
___ 

___ 

___ 

___ 

Article 19(1) 

Article 19(2)(a) first subparagraph 

Article 19(2)(a) second subparagraph 

Article 37 

Article 38 

Article 39 

Article 40 

___ 

___ 

___ 

Article 19(2)(a) third subparagraph 

Article 43(4) 

Article 19(2)(b) 

Article 20 

Article 21 

Article 22 

Article 23 

___ 

___ 

___ 

___ 

___ 

___ 

___ 

___ 

___ 

___ 

Article 24 

___ 

Article 25 

___ 

___ 

___ 

___ 

___ 

___ 

Article 41 

Article 42 

Article 43(1) 

Article 43(2) 

Article 43(3) 

Article 44 

Article 45 

Article 48 

Article 49 

Article 50 

___ 

Article 51 

___ 

Article 52 

EN 

191 

   EN 

Article 26 

___ 

Article 27 

Annex I 

Annex A 

Annex A1 

Annex B 

Annex C 

Annex C1 

Annex D 

Annex D1 

Annex E 

Annex E1 

Annex F 

Annex F1 

Annex G 

Annex H 

Annex H1 

Annex MI-001 

Annex MI-002 

Annex MI-003 

Annex MI-004 

Annex MI-005 

Annex MI-006 

Annex MI-007 

Annex MI-008 

Annex MI-009 

Article 53 first subparagraph 

Article 53 second subparagraph 

Article 54 

Annex I 

Annex II, point 1 

Annex II, point 2 

Annex II, point 3 

Annex II, point 4 

Annex II, point 5 

Annex II, point 6 

Annex II, point 7  

Annex II, point 8  

Annex II, point 9 

Annex II, point 10 

Annex II, point 11 

Annex II, point 12 

Annex II, point 13 

Annex II, point 14 

Annex III 

Annex IV 

Annex V 

Annex VI 

Annex VII 

Annex VIII 

Annex IX 

Annex X 

Annex XI 

EN 

192 

   EN 

Annex MI-010 

___ 

___ 

Annex XII 

Annex XIII 

Annex XIV 

EN 

193 

   EN