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 non-automatic weighing instruments
Date: 2011-11-21
Institutions: European Commission
Subjects: approximation of laws, free movement of goods, harmonisation of standards, market supervision, marketing, measuring equipment, metrology, product safety, single market

EUROPEAN COMMISSION 

Brussels, 21.11.2011 
COM(2011) 766 final 

2011/0352 (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 non-automatic weighing instruments 

(Recast) 
(Text with EEA relevance) 

 
 
  
 
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 2009/23/EC is an example of that Union harmonisation legislation, ensuring the free 
movement of non-automatic weighing instruments. It sets out essential requirements that non-
automatic weighing instruments must comply with in order to be made available on the EU 
market. Manufacturers must demonstrate that a non-automatic weighing instrument has been 
designed  and  manufactured  in  compliance  with  the  essential  requirements  and  affix  the  CE 
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 

–  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 

–  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 

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765/2008  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  2009/23/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 
ASSESSMENT 

Consultation of interested parties 

INTERESTED 

PARTIES  AND 

IMPACT 

The alignment of Directive 2009/23/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 the European weighing instruments 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. 

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 

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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; 

–  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  introduces  harmonised  definitions  of  terms  which  are  commonly  used 
throughout  Union  harmonisation  legislation  and  should  therefore  be  given  a  consistent 
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 non-automatic weighing instruments are correctly marked and 
accompanied  by  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 the non-
automatic  weighing  instrument  bears  the  CE  marking,  the  name  of  the  manufacturer  and  of 

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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  non-automatic  weighing 
instruments.  

Enhanced traceability obligations are introduced for all economic operators. Non-automatic 
weighing  instruments  have  to  bear  the  manufacturer’s  name  and  address  and  a  number 
allowing  to  identify  and  link  the  non-automatic  weighing  instrument  to  its  technical 
documentation. When a non-automatic weighing instrument is imported the importer’s name 
and  address  must  also  be  on  the  non-automatic  weighing  instruments.  Furthermore  every 
economic operator must be able to identify towards authorities the economic operator who has 
supplied him with a non-automatic weighing instrument or to whom he has supplied a non-
automatic weighing 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  Standardisation2  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 Organisations, 
on the procedure  for  objections to  harmonised standards and on stakeholder participation in 
the  standardisation  process.  Consequently  the  provisions  of  Directive  2009/23/EC  which 
cover the same aspects have been deleted in this proposal for reasons of legal certainty. The 
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  2009/23/EC  has  selected  the  appropriate  conformity  assessment  procedures  which 
manufacturers  have  to  apply  in  order  to  demonstrate  that  their  non-automatic  weighing 
instruments comply with the essential requirements. The proposal aligns these procedures to 
their  updated  versions  set  out  in  the  NLF  Decision.  It  keeps  some  sector  specific  elements 
already  provided  for  in  Directive  2009/23/EC  as  the  intervention  in  certain  cases  of  two 
notified  bodies  in  the  production  control  phase.  Furthermore,  the  statistical  verification 
provided for in Modules F and F1 of the NLF Decision has not been kept, as it is not relevant 
for the non-automatic weighing instruments sector.  

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 non-automatic 
weighing instruments have been inserted in this proposal. 

2 

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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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 non-automatic weighing 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  non-automatic  weighing  instrument.  Where  there  is  no  disagreement  on  the 
restrictive  measure  taken,  all  Member  States  must  take  the  appropriate  action  on  their 
territory. 

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  2009/23/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 

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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  2009/23/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 acts3.  

The  changes  made  to  the  provisions  of  Directive  2009/23/EC  concern:  the  definitions,  the 
obligations  of  economic  operators,  the  presumption  of  conformity  provided  by  harmonised 
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  2009/23/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 2009/23/EC. 

European Economic Area 

The proposal concerns the EEA and should therefore be extended to the European Economic 
Area. 

3 

OJ C 77, 28.3.2002. 

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(cid:208) 2009/23/EC (adapted)  

2011/0352 (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 non-automatic weighing 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 Committee4, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

Council  Directive  90/384/EEC  of  20  June  1990  on  the  harmonisation  of  the  laws  of  the 
Member  States  relating  to  non-automatic  weighing  instruments5  has  been  substantially 
amended6. In the interests of clarity and rationality the said Directive should be codified.  

(cid:208) 2009/23/EC recital 1 (adapted) 

4 
5 
6 

OJ C […], […], p. […]. 
OJ L 189, 20.7.1990, p. 1. 
See Annex VII, Part A. 

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(cid:216) new 

(1) 

(2) 

(3) 

A  number  of  substantive  changes  are  to  be  made  to  Directive  2009/23/EC  of  the 
European Parliament and of the Council of 23 April 2009 on non-automatic weighing 
instruments7. In the interests of clarity, that Directive should be recast. 

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 339/938 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/EEC9  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  2009/23/EC  should  therefore  be 
adapted to that Decision. 

(4) 

 Member States have the responsibility of protecting the public against incorrect results 
of  weighing  operations  by  means  of  non-automatic  weighing  instruments  when  used 
for certain categories of applications. 

(cid:208) 2009/23/EC recital 2  

(cid:208) 2009/23/EC recital 3 (adapted) 

In  each  Member  State,  mandatory  provisions  fix  in  particular  the  necessary 
performance  requirements  of  non-automatic  weighing  instruments  by  specifying 
metrological and technical requirements, together with inspection procedures before 
and after going into service. These mandatory provisions do not necessarily lead to 
different  levels  of  protection  from  one  Member  State  to  another  but  do,  by  their 
disparity, impede trade within the Community. 

(5) 

Economic  operators  should  be  responsible  for  the  compliance  of  non-automatic 
weighing instruments, in relation to their respective roles in the supply chain, so as to 

(cid:216) new 

7 
8 
9 

OJ L 122, 16.5.2009, p. 6. 
OJ L 218, 13.8.2008, p. 30. 
OJ L 218, 13.8.2008, p. 82. 

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(6) 

(7) 

(8) 

ensure  a  high  level  of  protection  of  public  interests,  as  health  and  safety  and  the 
protection of users, and to guarantee fair competition on the Union market. 

All  economic  operators  intervening  in  the  supply  and  distribution  chain  should  take 
appropriate  measures  to  ensure  that  they  only  make  available  on  the  market  non-
automatic  weighing  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. 

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. 

It is necessary to ensure that non-automatic weighing instruments from third countries 
entering  the  Union  market  comply  with  the  requirements  of  this  Directive,  and  in 
particular 
that  appropriate  assessment  procedures  have  been  carried  out  by 
manufacturers  with  regard  to  those  non-automatic  weighing  instruments.  Provision 
should therefore be made for importers to make sure that the non-automatic weighing 
instruments they place on the market comply with the requirements of this Directive 
and that they do  not place on the market  non-automatic weighing 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. 

(9) 

The  distributor  makes  a  non-automatic  weighing  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 non-automatic weighing instrument 
does not adversely affect the compliance of the instrument.  

(10)  When  placing  a  non-automatic  weighing  instrument  on  the  market,  every  importer 
should indicate on the non-automatic weighing 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  non-automatic  weighing  instrument  does  not  allow  it.  This  includes 
cases  where  the  importer  should  have  to  open  the  packaging  to  put  his  name  and 
address on the instrument.  

(11) 

 Any economic operator that either places a non-automatic weighing instrument on the 
market  under  his  own  name  or  trademark  or  modifies  a  non-automatic  weighing 
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. 

(12)  Distributors  and  importers,  being  close  to  the  market  place,  should  be  involved  in 
market surveillance tasks carried out by the competent national authorities, and should 
be  prepared  to  participate  actively,  providing  those  authorities  with  all  necessary 
information relating to the non-automatic weighing instrument concerned. 

(13)  Ensuring  traceability  of  a  non-automatic  weighing  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 

EN 

11 

   EN 

 
economic  operators  who  made  non-compliant  non-automatic  weighing  instruments 
available on the market. 

(cid:208) 2009/23/EC recital 4 (adapted)  
(cid:214) new 

(14)  This Directive should set out (cid:214) be limited to the expression of  mandatory and the 
essential  requirements  as  regards  metrology  and  performance  in  relation  to  non-
automatic  weighing  instruments.  ⌦  In  order  ⌫  Tto  facilitate  proof  of  conformity 
⌦ assessment ⌫ with the essential ⌦ those ⌫ requirements, it is necessary to have 
⌦ provide  for  presumption  of  conformity  for  non-automatic  weighing  instruments 
which are in conformity with ⌫ harmonised standards at European level, (cid:214) 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  Council10  for  the  purpose  of  expressing  detailed  technical 
specifications of those requirements,  in particular as to the metrological, design and 
construction  characteristics,  so  that  instruments  complying  with  those  harmonised 
standards may be assumed to conform to the essential requirements. These standards, 
harmonised at European level, are drawn up by private bodies and must remain non-
mandatory texts. For that purpose the European Committee for Standardisation (CEN), 
the  European  Committee  for  Electrotechnical  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  guidelines11  for  cooperation  between  the  Commission,  the  European  Free 
Trade Association (EFTA) and those three bodies, signed on 28 March 2003. 

(15)  Regulation  (EU)  No  [../..]  [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 

(cid:208) 2009/23/EC recital 5 (adapted) 

A  series  of  Directives  designed  to  remove  technical  barriers  to  trade  in  accordance 
with  the  principles  established  in  the  Council  Resolution  of  7  May  1985  on  a  new 
approach to technical harmonisation and standards12 has been adopted; each of those 
Directives  provides  for  the  affixing  of  the  ‘CE’  conformity  marking.  In  its 
communication of 15 June 198913 on a global approach to certification and testing, 

10 
11 
12 
13 

OJ L […], […], p. […]. 
OJ C 91, 16.4.2003, p. 7. 
OJ C 136, 4.6.1985, p. 1. 
OJ C 267, 19.10.1989, p. 3. 

EN 

12 

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the  Commission  proposed  that  common  rules  be  drawn  up  concerning  a  ‘CE’ 
conformity marking with a single design. In its Resolution of 21 December 1989 on a 
global  approach  to  conformity  assessment14,  the  Council  approved  as  a  guiding 
principle the adoption of a consistent approach such as this with regard to the use of 
the  ‘CE’  conformity  marking.  The  two  basic  elements  of  the  new  approach  which 
should  be  applied  are  the  essential  requirements  and  the  conformity  assessment 
procedures. 

(cid:208) 2009/23/EC recital 6 

(16)  Assessment  of  conformity  with  the  relevant  metrological  and  technical  provisions  is 
necessary  to  provide  effective  protection  for  users  and  third  parties.  The  existing 
conformity assessment procedures differ from one Member State to another. To avoid 
multiple assessments of conformity, which are in effect barriers to the free movement 
of  the  instruments,  arrangements  should  be  made  for  the  mutual  recognition  of 
conformity  assessment  procedures  by  the  Member  States.  To  facilitate  the  mutual 
recognition  of  conformity  assessment  procedures,  Community procedures  should  be 
set up, together with criteria for the designation of the bodies responsible for carrying 
out tasks pertaining to the conformity assessment procedures. 

(cid:216) new 

(17) 

In order to enable economic operators to demonstrate and the competent authorities to 
ensure  that  non-automatic  weighing  instruments  made  available  on  the  market 
conform  to  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.  

(18)  Manufacturers  should  draw  up  an  EU  declaration  of  conformity  to  provide  detailed 
information  on  the  conformity  of  the  non-automatic  weighing  instrument  with  the 
requirements of this Directive and of other relevant Union harmonisation legislation. 

(19)  The CE marking, indicating the conformity of a non-automatic weighing instrument, is 
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. Together with the CE marking, 
the  manufacturer  should  affix the  sticker  bearing  the  letter  ‘M’.  Rules  governing  the 
affixing of the CE marking and the “M” sticker should be laid down in this Directive. 

14 

OJ C 10, 16.1.1990, p. 1. 

EN 

13 

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(20)  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 

It is therefore essential to ensure that such designated bodies ensure a high level of 
quality throughout the Community.  

(cid:208) 2009/23/EC recital 7 

(cid:216) new 

(21)  Experience has shown that the criteria set out in Directive 2009/23/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. 

(22) 

(23) 

In  order  to  ensure  a  consistent  level  of  conformity  assessment  quality,  it  is  also 
necessary to set requirements for notifying authorities and other bodies involved in the 
assessment, notification and monitoring of notified bodies. 

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. 

(24)  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. 

(25) 

 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 
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. 

(26)  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 

EN 

14 

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the  level  of  protection  required  for  the  non-automatic  weighing  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. 

(27) 

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. 

(28)  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. 

(29) 

(30) 

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. 

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  non-automatic  weighing  instruments  covered 
by this Directive. This Directive should not prevent Member States from choosing the 
competent authorities to carry out those tasks.  

(31)  Directive  2009/23/EC  already  provides  for  a  safeguard  procedure  allowing  the 
Commission  to  examine  the  justification  for  a  measure  taken  by  a  Member  State 
against non-automatic weighing instruments it considers being non-compliant. In order 
to increase transparency and to reduce processing time, it is necessary to improve the 
existing  safeguard  clause  procedure,  with  a  view  to  making  it  more  efficient  and 
drawing on expertise available in Member States. 

(32)  The  existing  system  should  be  supplemented  by  a  procedure  under  which  interested 
parties  are  informed  of  measures  intended  to  be  taken  with  regard  to  non-automatic 
weighing instruments presenting a risk to the health and safety of persons or to other 
aspects  of  public  interest  protection.  It  should  also  allow  market  surveillance 
authorities,  in  cooperation  with  the  relevant  economic  operators,  to  act  at  an  earlier 
stage in respect of such non-automatic weighing instruments. 

(33)  Where  the  Member  States  and  the  Commission  agree  as  to  the  justification  of  a 
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. 

EN 

15 

   EN 

 
(34)  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. 

(35) 

It is necessary to provide for transitional arrangements that allow making available on 
the  market  and  putting  into  service  non-automatic  weighing  instruments  that  have 
already been placed on the market in accordance with Directive 2009/23/EC. 

(36)  Since  the  objective  of  this  Directive,  namely  to  ensure  that  non-automatic  weighing 
instruments on the market fulfil the requirements providing a high level of protection 
of  health  and  safety  and  other  public  interests  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. 

(cid:208) 2009/23/EC recital 8 

The  presence  on  a  non-automatic  weighing  instrument  of  the  ‘CE’  conformity 
marking  or  of  the  sticker  bearing  the  letter  ‘M’  should  indicate  that  there  is  a 
presumption  that  it  satisfies  the  provisions  of  this  Directive  and  therefore  make  it 
unnecessary to repeat the assessments of conformity already carried out. 

(37)  The obligation to transpose this Directive into national law should be confined to those 
provisions  which  represent  a  substantive  change  as  compared  with  Directive 
2009/23/EC.  The  obligation  to  transpose  the  provisions  which  are  unchanged  arises 
under the earlier Directive. 

(cid:216) new 

(38)  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 VII, Part B of Annex VII to Directive 2009/23/EC., 

(cid:208) 2009/23/EC recital 9 

EN 

16 

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HAVE ADOPTED THIS DIRECTIVE: 

CHAPTER 1 

(cid:208) 2009/23/EC (adapted) 

SCOPE, PLACING ON THE MARKET AND FREE MOVEMENT 

⌦ GENERAL PROVISIONS ⌫ 

Article 1 

⌦ Scope ⌫ 

1. This Directive shall apply to all non-automatic weighing instruments. 

2.  For  the  purposes  of  this  Directive,  the  following  categories  of  use  of  non-automatic 
weighing instruments shall be distinguished: 

(cid:208) 2009/23/EC (adapted) 

(a) 

(ai) determination of mass for commercial transactions; 

(bii)  determination  of  mass  for  the  calculation  of  a  toll,  tariff,  tax,  bonus, 
penalty, remuneration, indemnity or similar type of payment; 

(ciii) determination of mass for the application of laws or regulations or for an 
expert opinion given in court proceedings; 

(div)  determination  of  mass  in  the  practice  of  medicine  for  weighing  patients 
for the purposes of monitoring, diagnosis and medical treatment; 

(ev)  determination  of  mass  for  making  up  medicines  on  prescription  in  a 
pharmacy  and  determination  of  mass  in  analyses  carried  out  in  medical  and 
pharmaceutical laboratories; 

(fvi) determination of price on the basis of mass for the purposes of direct sales 
to the public and the making-up of prepackages; 

(gb) all applications other than those listed in points (a) ⌦ to (f) ⌫ . 

EN 

17 

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(cid:208) 2009/23/EC (adapted) 

Article 2 

⌦ Definitions ⌫ 

For the purposes of this Directive, the following definitions shall apply: 

(1.) 

‘weighing  instrument’:  ⌦ means ⌫  a  measuring  instrument  serving  to  determine 
the  mass  of  a  body  by  using  the  action  of  gravity  on  that  body.  A  weighing 
instrument  may  also  ⌦ or  serving ⌫  serve  to  determine  other  mass-related 
magnitudes, quantities, parameters or characteristics; 

(2.) 

‘non-automatic  weighing  instrument’  or  ‘instrument’:  ⌦ means ⌫  a  weighing 
instrument requiring the intervention of an operator during weighing; 

3. 

(3) 

(4) 

(5) 

(cid:208) 2009/23/EC 

‘harmonised  standard’:  a  technical  specification  (European  standard  or  harmonised 
document)  adopted  by  the  European  Committee  for  Standardisation  (CEN),  the 
European Committee for Electrotechnical Standardisation (Cenelec), or the European 
Telecommunications Standards Institute (ETSI), or by two or three of those bodies, 
upon  a  remit  from  the  Commission  in  accordance  with  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 regulations15 
and  the  general  guidelines  for  cooperation  between  the  Commission,  the  European 
Free Trade Association (EFTA) and those three bodies, signed on 28 March 2003. 

(cid:216) new 

‘making available on the market’ means any supply of an 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; 

‘placing  on  the  market’  means  the  first  making  available  of  an  instrument  on  the 
Union market; 

‘manufacturer’ means any natural or legal person who manufactures an instrument or 
has an instrument designed or manufactured, and markets that instrument under his 
name or trademark; 

15 

OJ L 204, 21.7.1998, p. 37. 

EN 

18 

   EN 

 
 
 
 
                                                 
(6) 

(7) 

(8) 

(9) 

(10) 

(11) 

(12) 

(13) 

(14) 

(15) 

(16) 

(17) 

(18) 

‘authorised representative’ means any natural or legal person established within the 
Union who has received a written mandate from a manufacturer to act on his behalf 
in relation to specified tasks; 

‘importer’  means  any  natural  or  legal  person  established  within  the  Union  who 
places an instrument from a third country on the Union market; 

‘distributor’  means  any  natural  or  legal  person  in  the  supply  chain,  other  than  the 
manufacturer or the importer, who makes an instrument available on the market; 

‘economic  operators’  means  the  manufacturer,  the  authorised  representative,  the 
importer and the distributor; 

‘technical specification’ means a document that prescribes technical requirements to 
be fulfilled by an instrument, process or service; 

‘harmonised  standard’  means  harmonised  standard  as  defined  in  Article  2(1)(c)  of 
Regulation (EU) No […] [European Standardisation]; 

‘accreditation’ means accreditation as defined in Article 2(10) of Regulation (EC) No 
765/2008; 

‘national accreditation body’ means national accreditation body as defined in Article 
2(11) of Regulation (EC) No 765/2008; 

‘conformity assessment’ means the process demonstrating whether the requirements 
of this Directive relating to an instrument have been fulfilled; 

‘conformity  assessment  body’  means  a  body  that  performs  conformity  assessment 
activities including calibration, testing, certification and inspection; 

‘recall’ means any measure aimed at achieving the return of an instrument that has 
already been made available to the end user; 

‘withdrawal’  means  any  measure  aimed  at  preventing  an  instrument  in  the  supply 
chain from being made available on the market; 

‘CE  marking’  means  a  marking  by  which  the  manufacturer  indicates  that  the 
instrument  is  in  conformity  with  the  applicable  requirements  set  out  in  Union 
harmonisation legislation providing for its affixing; 

(19) 

‘Union  harmonisation  legislation’  means  any  Union  legislation  harmonising  the 
conditions for the marketing of products. 

EN 

19 

   EN 

 
(cid:208) 2009/23/EC (adapted) 

Article 3 

⌦ Making available on the market and putting into service ⌫ 

Member  States  shall  take  all  steps  to  ensure  that  only  instruments  that  meet  the 

1. 
requirements of this Directive may be placed (cid:214) made available  on the market. 

(cid:208) 2009/23/EC 
(cid:214) new 

2. 
Member States shall take all steps to ensure that instruments may not be brought into 
service  for  the  uses  referred  to  in  points  (a)  to  (f)  of  Article  1(2)  unless  they  meet  the 
requirements of this Directive and accordingly bear the ‘CE’ conformity marking provided for 
in Article 11. 

(cid:208) 2009/23/EC (adapted) 

Article 14 

3. 
Member  States  shall  take  all  steps  to  ensure  that  instruments  bearing  the  ‘CE’ 
conformity marking attesting conformity with the requirements of this Directive continue to 
conform to those ⌦ the ⌫ requirements ⌦ of this Directive ⌫ . 

Article 4 

⌦ Essential requirements ⌫ 

Instruments used for the applications listed in points (a) to (f) of Article 1(2) must satisfy the 
essential  requirements  set  out  in  Annex  I  (cid:214) and  bear  the  CE  marking  and  the  inscriptions 
provided for in point 1 of Annex III  .  

(cid:208) 2009/23/EC 
(cid:214) new 

EN 

20 

   EN 

 
 
 
 
 
In cases where the instrument includes, or is connected to, devices which are not used for the 
applications listed in points (a) to (f) of Article 1(2), such devices shall not be subject to those 
essential requirements. 

(cid:208) 2009/23/EC 

(cid:208) 2009/23/EC (adapted) 

Article 5 

⌦ Free movement ⌫ 

(cid:208) 2009/23/EC  
(cid:214) new 

Member States shall not impede the placing (cid:214) making available  on the market of 

1. 
instruments which meet the requirements of this Directive. 

Member  States  shall  not  impede  the  putting  into  service,  for  the  uses  referred  to  in 

2. 
points (a) to (f) of Article 1(2), of instruments which meet the requirements of this Directive. 

(cid:216) new 

CHAPTER 2 

OBLIGATIONS OF ECONOMIC OPERATORS 

Article 6 [Article R2 of Decision No 768/2008/EC] 

Obligations of manufacturers 

1. 
When placing on the market their instruments used for the applications listed in points 
(a)  to  (f)  of  Article  1(2),  manufacturers  shall  ensure  that  they  have  been  designed  and 
manufactured in accordance with the essential requirements set out in Annex I. 

When placing on the market their instruments not used for the applications listed in points (a) 
to (f) of Article 1(2), manufacturers shall ensure that they bear the inscriptions provided for in 
point 2 of Annex III. 

EN 

21 

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2. 
For the instruments used for the applications listed in points (a) to (f) of Article 1(2), 
manufacturers shall draw up the required technical documentation and carry out the relevant 
conformity assessment procedure referred to in Article 14 or have it carried out. 

Where compliance of the instrument with the applicable requirements has been demonstrated 
by that procedure, manufacturers shall draw up an EU declaration of conformity and affix the 
CE marking and the inscriptions provided for in point 1 of Annex III. 

For  the  instruments  not  used  for  the  applications  listed  in  points  (a)  to  (f)  of  Article  1(2), 
manufacturers shall affix the inscriptions provided for in point 2 of Annex III. 

Where an instrument which is used for any of the applications referred to in points (a) to (f) of 
Article  1(2)  includes,  or  is  connected  to,  devices  that  have  not  been  subject  to  conformity 
assessment  as  referred  to  in  Article  913,  each  of  those  devices  shall  bear  the  symbol 
restricting its use as defined ⌦ provided for ⌫ in point 3 of by Annex IV III, point 3. 

(cid:208) 2009/23/EC (adapted) 

(cid:216) new 

For the instruments used for the applications listed in points (a) to (f) of Article 1(2), 
3. 
manufacturers shall keep the technical documentation and the EU declaration of conformity 
for 10 years after the instrument has been placed on the market. 

4. 
Manufacturers shall ensure that procedures are in place for series production to remain 
in conformity. Changes in instrument design or characteristics and changes in the harmonised 
standards or in technical specifications by reference to which conformity of an instrument is 
declared shall be adequately taken into account. 

When  deemed  appropriate  with  regard  to  the  performance  presented  by  an  instrument, 
manufacturers  shall  carry  out  sample  testing  of  instruments  made  available  on  the  market, 
investigate,  and,  if  necessary,  keep  a  register  of  complaints,  of  non-conforming  instruments 
and instrument recalls, and shall keep distributors informed of any such monitoring. 

Manufacturers shall ensure that their instruments bear a type, batch or serial number or 

5. 
other element allowing their identification, as set out in Annex III. 

6. 
Manufacturers  shall  indicate  their  name,  registered  trade  name  or  registered  trade 
mark and the address at which they can be contacted on the instrument or, where that is not 
possible, on its packaging or in a document accompanying the instrument. The address must 
indicate a single point at which the manufacturer can be contacted. 

Manufacturers  shall  ensure  that  the  instrument  is  accompanied  by  instructions  and 
7. 
information in a language which can be easily understood by consumers and other end-users, 
as determined by the Member State concerned. 

Manufacturers who consider or have reason to believe that an instrument which they 
8. 
have placed on the market is not in conformity with this Directive shall immediately take the 

EN 

22 

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necessary  corrective  measures  to  bring  that  instrument  into  conformity,  to  withdraw  it  or 
recall it, if appropriate. Furthermore, where the instrument presents a risk, manufacturers shall 
immediately  inform  the  competent  national  authorities  of  the  Member  States  in  which  they 
made  the  instrument  available  to  that  effect,  giving  details,  in  particular,  of  the  non-
compliance and of any corrective measures taken. 

9. 
Manufacturers shall, further to a reasoned request from a competent national authority, 
provide  it  with  all  the  information  and  documentation  necessary  to  demonstrate  the 
conformity of the 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 instruments which they have placed on the market. 

Article 7 [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 6(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) 

(c) 

keep the EU declaration of conformity and the technical documentation at the 
disposal  of  national  surveillance  authorities  for  10  years  after  the  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 an instrument; 

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

Article 8 [Article R4 of Decision No 768/2008/EC] 

Obligations of importers 

1. 

Importers shall place only compliant instruments on the Union market. 

2. 
Before placing on the market an instrument used for the applications listed in points 
(a)  to  (f)  of  Article  1(2),  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  instrument  bears  the  CE  marking,  the 
inscriptions  provided  for  in  point  1  of  Annex  III  and  is  accompanied  by  the  required 

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documents, and that the manufacturer has complied with the requirements set out in Article 
6(5) and (6). 

Where  an  importer  considers  or  has  reason  to  believe  that  an  instrument  used  for  the 
applications  listed  in  points  (a)  to  (f)  of  Article  1(2)  is  not  in  conformity  with  the  essential 
requirements set out in Annex I, he shall not place the instrument on the market until it has 
been brought into conformity. Furthermore, where the instrument presents a risk, the importer 
shall inform the manufacturer and the market surveillance authorities to that effect. 

Before placing on the market an instrument not used for the applications listed in points (a) to 
(f) of Article 1(2), importers shall ensure that the instrument bears the inscriptions provided 
for in point 2 of Annex III and that the manufacturer has complied with the requirements set 
out in Article 6(5) and (6). 

3. 
Importers shall indicate their name, registered trade name or registered trade mark and 
the address at which they can be contacted on the instrument or, where that is not possible, on 
its packaging or in a document accompanying the instrument. 

4. 
Importers  shall  ensure  that  the  instrument  is  accompanied  by  instructions  and 
information in a language which can be easily understood by consumers and other end-users, 
as determined by the Member State concerned. 

5. 
Importers  shall  ensure  that,  while  an  instrument  used  for  the  applications  listed  in 
points (a) to (f) of Article 1(2) is under their responsibility, storage or transport conditions do 
not jeopardise its compliance with the essential requirements set out in Annex I. 

6. 
When deemed appropriate with regard to the performance of an instrument, importers 
shall carry out sample testing of instruments made available on the market, investigate, and, if 
necessary,  keep  a  register  of  complaints,  of  non-conforming  instruments  and  instrument 
recalls, and shall keep distributors informed of such monitoring. 

Importers who consider or have reason to believe that an instrument which they have 
7. 
placed  on  the  market  is  not  in  conformity  with  this  Directive  shall  immediately  take  the 
corrective  measures  necessary  to  bring  that  instrument  into  conformity,  to  withdraw  it  or 
recall  it,  if  appropriate.  Furthermore,  where  the  instrument  presents  a  risk,  importers  shall 
immediately  inform  the  competent  national  authorities  of  the  Member  States  in  which  they 
made  the  instrument  available  to  that  effect,  giving  details,  in  particular,  of  the  non-
compliance and of any corrective measures taken. 

8. 
For the instruments used for the applications listed in points (a) to (f) of Article 1(2), 
importers shall, for 10 years after the 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, 
9. 
provide  it  with  all  the  information  and  documentation  necessary  to  demonstrate  the 
conformity of an 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 instruments which they have placed on the market.  

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Article 9 [Article R5 of Decision No 768/2008/EC] 

Obligations of distributors 

When  making  an  instrument  available  on  the  market  distributors  shall  act  with  due 

1. 
care in relation to the requirements of this Directive. 

2. 
Before  making  an  instrument  used  for  the  applications  listed  in  points  (a)  to  (f)  of 
Article 1(2) available on the market, distributors shall verify that the instrument bears the CE 
marking, the inscriptions provided for in point 1 of Annex III, that it is accompanied by the 
required  documents  and  by  instructions  and  information  in  a  language  which  can  be  easily 
understood by consumers and other end-users in the Member State in which the instrument is 
to be made available on the market, and that the manufacturer and the importer have complied 
with the requirements set out in Article 6(5) and (6) and Article 8(3). 

Where a distributor considers or has reason to believe that an instrument is not in conformity 
with the essential requirements set out in Annex I, he shall not make the instrument available 
on  the  market  until  it  has  been  brought  into  conformity.  Furthermore,  where  the  instrument 
presents a risk, the distributor shall inform the manufacturer or the importer to that effect as 
well as the market surveillance authorities. 

Before making an instrument not used for the applications listed in points (a) to (f) of Article 
1(2) available on the market, distributors shall verify that the instrument bears the inscriptions 
provided for in point 2 of Annex III and that the manufacturer and the importer have complied 
with the requirements set out in Article 6(5) and (6) and Article 8(3). 

Distributors  shall  ensure  that,  while  an  instrument  used  for  the  applications  listed  in 
3. 
points (a) to (f) of Article 1(2) is under their responsibility, storage or transport conditions do 
not jeopardise its compliance with the essential requirements set out in Annex I. 

Distributors  who  consider  or  have  reason  to  believe  that  an  instrument  which  they 
4. 
have  made  available  on  the  market  is  not  in  conformity  with  this  Directive  shall  make  sure 
that the corrective measures necessary to bring that instrument into conformity, to withdraw it 
or  recall  it,  if  appropriate,  are  taken.  Furthermore,  where  the  instrument  presents  a  risk, 
distributors shall immediately inform the competent national authorities of the Member States 
in which they made the 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 an instrument. They shall cooperate with that authority, at its request, on any 
action taken to eliminate the risks posed by instruments which they have made available on 
the market.  

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Article 10 [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 6, where 
he places an instrument on the market under his name or trademark or modifies an instrument 
already  placed  on  the  market  in  such  a  way  that  compliance  with  the  requirements  of  this 
Directive may be affected. 

Article 11 [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: 

(a) any economic operator who has supplied them with an instrument; 

(b) any economic operator to whom they have supplied an 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 instrument and for a period of 
10 years after they have supplied the instrument. 

(cid:208) 2009/23/EC (adapted) 

CHAPTER 23 

CONFORMITY ASSESSMENT ⌦ OF INSTRUMENTS ⌫ 

(cid:208) 2009/23/EC  

Article 6 

1. Member States shall presume conformity with the essential requirements set out in Annex I 
in respect of instruments which comply with the relevant national standards implementing the 
harmonised standards that meet those requirements. 

2.  The  Commission  shall  publish  the  references  of  the  harmonised  standards  referred  to  in 
paragraph 1 in the Official Journal of the European Union. 

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Member States shall publish the references of the national standards referred to in paragraph 
1. 

(cid:216) new 

Article 12 [Article R8 of Decision No 768/2008/EC] 

Presumption of conformity 

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. 

[Where a harmonised standard satisfies the requirements which it covers and which are set out 
in Annex I or Article 23, the Commission shall publish the references of that standard in the 
Official Journal of the European Union.] 

(cid:208) 2009/23/EC (adapted) 

Article 913 

⌦ Conformity assessment procedures ⌫ 

1.  The  conformity  of  instruments  to  the  essential  requirements  set  out  in  Annex  I  may  be 
certified by either of the following procedures as selected by the applicant: 

(cid:208) 2009/23/EC 

(cid:208) 2009/23/EC (adapted) 

(a) EC type examination ⌦ Module B ⌫ as referred to ⌦ set out ⌫ in point 1 of Annex II, 
point  1,  followed  either  by  the  EC  declaration  of  type  conformity  (guarantee  of  production 
quality) ⌦ Module D ⌫ as referred to ⌦ set out ⌫ in point 2 of Annex II, point 2, or by 
the EC verification ⌦ Module F ⌫ as referred to ⌦ set out ⌫ in point 4 of Annex II, point 
3. 

However,  EC  type  examination  ⌦ Module  B ⌫  shall  not  be  compulsory  for  instruments 
which do not use electronic devices and the load-measuring device of which does not use a 
spring to balance the load ⌦ . For those instruments not submitted to Module B, Module D1 

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as  set  out  in  point  3  of  Annex  II  or  Module  F1  as  set  out  in  point  5  of  Annex  II  shall 
apply ⌫; 

(b) EC unit verification ⌦ Module G ⌫ as referred to ⌦ set out ⌫ in point 6 of Annex II, 
point 4. 

2.  The  documents  and  correspondence  relating  to  the  procedures  referred  to  in  paragraph  1 
shall be drafted in an ⌦ one of the ⌫ official languages of the Member State where the said 
⌦ those ⌫  procedures  are  carried  out,  or  in  a  language  accepted  by  the  body  notified  in 
accordance with Article 10(1)18. 

(cid:208) 2009/23/EC  

3. 
Where  the  instruments  are  subject  to  other  Directives  covering  other  aspects  and 
which  also  provide  for  the  affixing  of  the  ‘CE’  conformity  marking,  that  marking  shall 
indicate  that  the  instruments  in  question  are  also  presumed  to  conform  to  the  provisions  of 
those other Directives. 

However, where one or more of the Directives which apply to the instruments allow 
the  manufacturer,  during  a  transitional  period,  to  choose  which  arrangements  to  apply,  the 
‘CE’  conformity  marking  shall  indicate  conformity  only  to  the  Directives  applied  by  the 
manufacturer. In this case, particulars of publication in the Official Journal of the European 
Union  of  the  Directives  applied  must  be  given  in  the  documents,  notices  or  instructions 
required by the Directives and accompanying such instruments. 

Article 7 

Where a Member State or the Commission considers that the harmonised standards referred to 
in  Article  6(1)  do  not  fully  meet  the  essential  requirements  set  out  in  Annex  I,  the 
Commission  or  the  Member  State  concerned  shall  bring  the  matter  before  the  Standing 
Committee  set  up  under  Article  5  of  Directive  98/34/EC,  hereinafter  referred  to  as  ‘the 
Committee’, 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 those standards from the publications referred to in 
Article 6(2). 

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(cid:216) new 

Article 14 [Article R10 of Decision No 768/2008/EC] 

EU declaration of conformity 

The  EU  declaration  of  conformity  shall  state  that  the  fulfilment  of  the  essential 

1. 
requirements set out in Annex I has been demonstrated. 

The EU declaration of conformity shall have the model structure set out in Annex III 
2. 
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  instrument  is 
placed or made available. 

3. 
Where  an  instrument  is  subject  to  more  than  one  Union  act  requiring  an  EU 
declaration of conformity, a single EU declaration of conformity shall be drawn up in respect 
of all such Union acts. That declaration shall contain the identification of the acts concerned 
including the publication references. 

By  drawing  up  the  EU  declaration  of  conformity,  the  manufacturer  shall  assume 

4. 
responsibility for the compliance of the instrument. 

(cid:208) 2009/23/EC  

Article 8 

1.  Where  a  Member  State  considers  that  instruments  bearing  the  ‘CE’  conformity  marking 
referred to in Annex II, points 2, 3 and 4, do not meet the requirements of this Directive when 
properly  installed  and  used  for  the  purposes  for  which  they  are  intended,  it  shall  take  all 
appropriate measures to withdraw those instruments from the market or to prohibit or restrict 
their being put into service and/or placed on the market. 

The Member State concerned shall immediately inform the Commission of any such measure, 
indicating the reasons for its decision, and in particular whether non-compliance is due to: 

(a) failure to meet the essential requirements set out in Annex I, where instruments 
do not meet the harmonised standards referred to in Article 6(1); 

(b) incorrect application of the harmonised standards referred to in Article 6(1); 

(c) shortcomings in the harmonised standards referred to in Article 6(1) themselves. 

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

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After  such  consultation  the  Commission  shall  immediately  inform  the  Member  State  which 
took the action of the result. Should it find that the measure is justified it shall immediately 
inform the other Member States. 

If the decision is attributed to shortcomings in the standards, the Commission, after consulting 
the parties concerned, shall bring the matter before the Committee within two months if the 
Member State which has taken the measures intends to maintain them, and shall subsequently 
initiate the procedures referred to in Article 7. 

3.  Where  an  instrument  which  does  not  comply  bears  the  ‘CE’  conformity  marking,  the 
competent  Member  State  shall  take  appropriate  action  against  whomsoever  has  affixed  the 
marking and shall inform the Commission and the other Member States thereof. 

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

Article 10 

1.  Member  States  shall  notify  the  Commission  and  the  other  Member  States  of  the  bodies 
which they have appointed to carry out the procedures referred to in Article 9 together with 
the specific tasks which these bodies have been appointed to carry out and the identification 
numbers assigned to them beforehand by the Commission. 

The  Commission  shall  publish  in  the  Official  Journal  of  the  European  Union  a  list  of  the 
notified  bodies  and  their  identification  numbers  and  the  tasks  for  which  they  have  been 
notified. The Commission shall ensure that this list is kept up to date. 

2. Member States shall apply the minimum criteria set out in Annex V for the designation of 
bodies. Bodies which satisfy the criteria fixed by the relevant harmonised standards shall be 
presumed to satisfy the criteria set out in that Annex. 

3. A Member State which has designated a body shall cancel the designation if the body no 
longer  meets  the  criteria  for  designation  referred  to  in  paragraph  2.  It  shall  immediately 
inform the other Member States and the Commission thereof and withdraw the notification. 

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CHAPTER 3  

‘CE’ CONFORMITY MARKING AND INSCRIPTIONS 

(cid:216) new 

Article 15 [Article R11 of Decision No 768/2008/EC] 

General principles of the CE marking 

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

Article 16 [Article R12 of Decision No 768/2008/EC] 

Rules and conditions for affixing the CE marking and of the inscriptions 

1. 
The  CE  marking  and  the  inscriptions  provided  for  in  point  1  of  Annex  III  or  the 
inscriptions provided for in point 2 of Annex III shall be affixed visibly, legibly and indelibly 
to the instrument or to its data plate. 

The  CE  marking  and/or  the  inscriptions  shall  be  affixed  before  the  instrument  is 

2. 
placed on the market. 

The CE marking shall be followed by the identification number of the notified body 

3. 
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. 

The  CE  marking  and  the  identification  number  referred  to  in  paragraph  3  may  be 

4. 
followed by a pictogram or any other mark indicating a special risk or use. 

The  CE  marking  and  the  identification  number  referred  to  in  paragraph  3  shall  be 

5. 
followed by the sticker bearing the letter “M”, provided for in point 1.1(b) of Annex III.  

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(cid:208) 2009/23/EC 

Article 11 

1. The ‘CE’ conformity marking and the required supplementary data as described in Annex 
IV,  point  1,  shall  be  affixed  in  a  clearly  visible,  easily  legible  and  indelible  form  to 
instruments for which EC conformity has been established. 

2. The inscriptions referred to in Annex IV, point 2 shall be affixed in a clearly visible, easily 
legible and indelible form to all other instruments. 

3. 
The affixing on the instruments of markings which are likely to deceive third parties 
as  to  the  meaning  and  form  of  the  ‘CE’  conformity  marking  shall  be  prohibited.  Any  other 
marking  may  be  affixed  to  the  instruments  provided  that  the  visibility  and  legibility  of  the 
‘CE’ conformity marking is not thereby reduced. 

Without prejudice to Article 8: 

Article 12 

(a)  where  a  Member  State  establishes  that  the  ‘CE’  conformity  marking  has  been 
affixed unduly, the manufacturer or his authorised representative established within 
the  Community  shall  be  obliged  to  make  the  instrument  conform  as  regards  the 
provisions  concerning  the  ‘CE’  conformity  marking  and  to  end  the  infringement 
under the conditions imposed by the Member State; 

(b)  where  non-conformity  continues,  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  in  accordance  with  the 
procedures laid down in Article 8. 

(cid:208) 2009/23/EC (adapted) 

Article 17 

⌦ Restrictive use symbol ⌫ 

That ⌦ The ⌫ symbol ⌦ referred to in the fourth subparagraph of Article 6(2) ⌫ shall be 
affixed to the devices in a clearly visible and indelible form. 

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(cid:216) new 

CHAPTER 4 

NOTIFICATION OF CONFORMITY ASSESSMENT BODIES 

Article 18 [Article R13 of Decision No 768/2008/EC] 

Notification 

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. 

Article 19 [Article R14 of Decision No 768/2008/EC] 

Notifying authorities 

1. 
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 Article 24. 

2. 
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. 

3. 
Where  the  notifying  authority  delegates  or  otherwise  entrusts  the  assessment, 
notification or monitoring referred to in paragraph 1 to a body which is not a governmental 
entity,  that  body  shall  be  a  legal  entity  and  shall  comply  mutatis  mutandis  with  the 
requirements laid down in Article 20(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 

4. 
body referred to in paragraph 3. 

Article 20 [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 

1. 
with conformity assessment bodies occurs. 

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A notifying authority shall be organised and operated so as to safeguard the objectivity 

2. 
and impartiality of its activities. 

3. 
A notifying authority shall be organised in  such a way that each decision relating to 
notification  of  a  conformity  assessment  body  is  taken  by  competent  persons  different  from 
those who carried out the assessment. 

A  notifying  authority  shall  not  offer  or  provide  any  activities  that  conformity 

4. 
assessment bodies perform or consultancy services on a commercial or competitive basis. 

5. 

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 

6. 
disposal for the proper performance of its tasks. 

Article 21 [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. 

Article 22 [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 

1. 
requirements laid down in paragraphs 2 to 11. 

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

2. 
personality. 

A  conformity  assessment  body  shall  be  a  third-party  body  independent  of  the 

3. 
organisation or the 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 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 
4. 
responsible  for  carrying  out  the  conformity  assessment  tasks  shall  not  be  the  designer, 
manufacturer,  supplier,  installer,  purchaser,  owner,  user  or  maintainer  of  the  instruments 
which  they  assess,  nor  the  authorised  representative  of  any  of  those  parties.  This  shall  not 
preclude  the  use  of  assessed  instruments  that  are  necessary  for  the  operations  of  the 
conformity assessment body or the use of such instruments for personal purposes. 

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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 
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. 

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. 

Conformity  assessment  bodies  and  their  personnel  shall  carry  out  the  conformity 
5. 
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. 

A  conformity  assessment  body  shall  be  capable  of  carrying  out  all  the  conformity 
6. 
assessment  tasks  assigned  to  it  by  Article  13  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 
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  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. 

The personnel responsible for carrying out conformity assessment activities shall have 

7. 
the following: 

(a) 

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

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(b) 

(c) 

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,  of  the  applicable  harmonised  standards  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. 

The impartiality of the conformity assessment bodies, their top level management and 

8. 
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. 

9. 
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. 

10. 
The  personnel  of  a  conformity  assessment  body  shall  observe  professional  secrecy 
with  regard  to  all  information  obtained  in  carrying  out  their  tasks  under  Article  13  or  any 
provision of national law giving effect to it, except in relation to the competent authorities of 
the Member State in which its activities are carried out. Proprietary rights shall be protected. 

11. 
Conformity  assessment  bodies  shall  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 23 [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 22 in so far as the applicable harmonised standards cover 
those requirements. 

Article 24 [Article R20 of Decision No 768/2008/EC] 

Subsidiaries of and subcontracting by notified bodies 

Where  a  notified  body  subcontracts  specific  tasks  connected  with  conformity 
1. 
assessment  or  has  recourse  to  a  subsidiary,  it  shall  ensure  that  the  subcontractor  or  the 

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subsidiary  meets  the  requirements  set  out  in  Article  22  and  shall  inform  the  notifying 
authority accordingly. 

Notified bodies shall take full responsibility for the tasks performed by subcontractors 

2. 
or subsidiaries wherever these are established. 

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

3. 
of the client. 

4. 
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 13. 

Article 25 [Article R22 of Decision No 768/2008/EC] 

Application for notification 

A  conformity  assessment  body  shall  submit  an  application  for  notification  to  the 

1. 
notifying authority of the Member State in which it is established. 

2. 
That application shall be accompanied by a description of the conformity assessment 
activities, the conformity assessment module or modules and the instrument or 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 22. 

3. 
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 22. 

Article 26 [Article R23 of Decision No 768/2008/EC] 

Notification procedure 

Notifying  authorities  may  notify  only  conformity  assessment  bodies  which  have 

1. 
satisfied the requirements laid down in Article 22. 

They  shall  notify  the  Commission  and  the  other  Member  States  using  the  electronic 

2. 
notification tool developed and managed by the Commission. 

3. 
The notification shall include full details of the conformity assessment activities, the 
conformity assessment module or modules and instrument or instruments concerned and the 
relevant attestation of competence. 

4. 
Where  a  notification  is  not  based  on  an  accreditation  certificate  as  referred  to  in 
Article  25(2),  the  notifying  authority  shall  provide  the  Commission  and  the  other  Member 
States  with  documentary  evidence  which  attests  to  the  conformity  assessment  body's 

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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 22. 

5. 
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. 

The  Commission  and  the  other  Member  States  shall  be  notified  of  any  subsequent 

6. 
relevant changes to the notification.  

Article 27 [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 28 [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 
1. 
no  longer  meets  the  requirements  laid  down  in  Article  22,  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. 

2. 
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. 

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Article 29 [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 
1. 
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 
2. 
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 

3. 
its investigations is treated confidentially. 

Where  the  Commission  ascertains  that  a  notified  body  does  not  meet  or  no  longer 
4. 
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 30 [Article R27 of Decision No 768/2008/EC] 

Operational obligations of notified bodies 

Notified  bodies  shall  carry  out  conformity  assessments  in  accordance  with  the 

1. 
conformity assessment procedures provided for in Annex II. 

2. 
Conformity  assessments  shall  be  carried  out  in  a  proportionate  manner,  avoiding 
unnecessary  burdens  for  economic  operators.  Conformity  assessment  bodies  shall  perform 
their  activities  taking  due  account  of  the  size  of  an  undertaking,  the  sector  in  which  it 
operates, its structure, the degree of complexity of the 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 instrument with the provisions of this Directive. 

Where  a  notified  body  finds  that  the  essential  requirements  set  out  in  Annex  I  or 
3. 
corresponding  harmonised  standards  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. 

4. 
Where,  in  the  course  of  the  monitoring  of  conformity  following  the  issue  of  a 
certificate,  a  notified  body  finds  that  an  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 

5. 
notified body shall restrict, suspend or withdraw any certificates, as appropriate. 

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Article 31  

Appeal against decisions of notified bodies 

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

Article 32 [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  instruments  with  relevant 
information  on  issues  relating  to  negative  and,  on  request,  positive  conformity  assessment 
results. 

Article 33 [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 34 [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. 

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CHAPTER 5 

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

Union market surveillance, control of instruments entering the Union market 

Article 35 

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

Article 36 [Article R31 of Decision No 768/2008/EC] 

Procedure for dealing with instruments presenting a risk at national level 

Where  the  market  surveillance  authorities  of  one  Member  State  have  taken  action 
1. 
pursuant to Article 20 of Regulation (EC) No 765/2008, or where they have sufficient reason 
to believe that an 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  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 
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 instrument into compliance with those requirements, to withdraw the 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. 

2. 
Where  the  market  surveillance  authorities  consider  that  non-compliance  is  not 
restricted to their national territory, they shall inform the Commission and the other Member 
States  of  the  results  of  the  evaluation  and  of  the  actions  which  they  have  required  the 
economic operator to take. 

3. 
The  economic  operator  shall  ensure  that  all  appropriate  corrective  action  is  taken  in 
respect of all the instruments concerned that it has made available on the market throughout 
the Union. 

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4. 
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  or  restrict  the 
instrument's being made available on their national market, to withdraw the 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. 

5. 
The  information  referred  to  in  paragraph  4  shall  include  all  available  details,  in 
particular the data necessary for the identification of the non-compliant instrument, the origin 
of the 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 instrument to meet requirements relating to the aspects of public 
interest protection laid down in this Directive; 

shortcomings in the harmonised standards referred to in Article 12 conferring a 
presumption of conformity. 

6. 
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 instrument 
concerned,  and,  in  the  event  of  disagreement  with  the  notified  national  measure,  of  their 
objections. 

7. 
Where, within two months of receipt of the information referred to in paragraph 4, no 
objection  has  been  raised  by  either  a  Member  State  or  the  Commission  in  respect  of  a 
provisional measure taken by a Member State, that measure shall be deemed justified. 

Member States shall ensure that appropriate restrictive measures are taken in respect 

8. 
of the instrument concerned without delay.  

Article 37 [Article R32 of Decision No 768/2008/EC] 

Union safeguard procedure 

1. 
Where, on completion of the procedure set out in Article 36(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. 

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42 

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2. 
If  the  national  measure  is  considered  justified,  all  Member  States  shall  take  the 
measures  necessary  to  ensure  that  the  non-compliant  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. 

3. 
Where  the  national  measure  is  considered  justified  and  the  non-compliance  of  the 
instrument  is  attributed  to  shortcomings  in  the  harmonised  standards  referred  to  in  Article 
36(5)(b) of this Directive, the Commission shall apply the procedure provided for in Article 8 
of Regulation (EU) No […] [on European Standardisation].  

Article 38 [Article R33 of Decision No 768/2008/EC] 

Compliant instruments which present a risk 

Where, having performed an evaluation under Article 36(1), a Member State finds that 
1. 
although  an  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 instrument concerned, when placed on the market, no 
longer presents that risk, to withdraw the 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 

2. 
instruments concerned that he has made available on the market throughout the Union. 

3. 
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  instrument  concerned,  the  origin  and  the  supply  chain  of  the 
instrument,  the  nature  of  the  risk  involved  and  the  nature  and  duration  of  the  national 
measures taken. 

4. 
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 
measure is justified or not, and where necessary, propose appropriate measures. 

The Commission shall address its decision to all Member States and shall immediately 

5. 
communicate it to them and the relevant economic operator or operators. 

Article 39 [Article R34 of Decision No 768/2008/EC] 

Formal non-compliance 

Without  prejudice  to  Article  36,  where  a  Member  State  makes  one  of  the  following 
1. 
findings, it shall require the relevant economic operator to put an end to the non-compliance 
concerned: 

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(a) 

the  CE  marking  and/or  the  inscriptions  provided  for  in  Annex  III  have  been 
affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 
16 of this Directive; 

(b) the CE marking and/or the inscriptions provided for in Annex III have 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 instrument being made 
available on the market or ensure that it is recalled or withdrawn from the market. 

(cid:208) 2009/23/EC (adapted) 

CHAPTER 46 

⌦ TRANSITIONAL AND ⌫ FINAL PROVISIONS 

(cid:208) 2009/23/EC 

Article 15 

Any decision taken pursuant to this Directive and resulting in restrictions on the putting into 
service of an instrument shall state the exact grounds on which it is based. 

Such a decision shall be notified without delay to the party concerned, who shall at the same 
time  be  informed  of  the  judicial  remedies  available  to  him  under  the  laws  in  force  in  the 
Member State in question and of the time limits to which such remedies are subject. 

(cid:216) new 

Article 40  

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. 

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The penalties provided for shall be effective, proportionate and dissuasive. 

Member  States  shall  notify  those  provisions  to  the  Commission  by  [the  date  set  out  in  the 
second  subparagraph  of  Article  42(1)] at  the  latest  and  shall  notify  to  it  without  delay  any 
subsequent amendment affecting them. 

Article 41 

Transitional provisions  

Member  States  shall  not  impede  the  making  available  on  the  market  and/or  the  putting  into 
service  of  instruments  covered  by  Directive  2009/23/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 42(1)].  

Certificates  of  conformity  issued  under  Directive  2009/23/EC  shall  be  valid  under  this 
Directive  until  [the  date  set  out  in  the  second  subparagraph  of  Article  42(1)]  unless  they 
expire before that date. 

(cid:208)  

Article 42 

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 
2(3) to (19), 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 
30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41 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. 

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(cid:208) 2009/23/EC  

Article 16 

Member States shall communicate to the Commission the text of the main provisions 

2. 
of national law which they adopt in the field covered by this Directive. 

(cid:208) 2009/23/EC (adapted) 

Article 1743 

⌦ Repeal ⌫ 

Directive 90/384/EEC 2009/23/EC as amended by the Directive listed in Annex VII, Part A, 
is repealed ⌦ from the date set out in the second subparagraph of Article 42(1) ⌫, 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 VII, Part B of Annex VII 
to Directive 2009/23/EC. 

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 VIIIIV. 

(cid:208) 2009/23/EC 

(cid:208) 2009/23/EC (adapted) 

Article 1844 

⌦ 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(1) and (2), 3, 4, 5, 17 and Annexes I and III shall apply from [the date set out in 
the second subparagraph of Article 42(1)]. 

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(cid:208) 2009/23/EC 

Article 1945 

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) 2009/23/EC (adapted) 

ANNEX I 

ESSENTIAL REQUIREMENTS 

The terminology used is that of the International Organisation of Legal Metrology. 

Preliminary observation 

Where an instrument includes, or is connected to, more than one indicating or printing device 
used for the applications listed in points (a) to (f) of Article 1(2), those devices which repeat 
the  results  of  the  weighing  operation  and  which  cannot  influence  the  correct  functioning  of 
the  instrument  shall  not  be  subject  to  the  essential  requirements  if  the  weighing  results  are 
printed  or  recorded  correctly  and  indelibly  by  a  part  of  the  instrument  which  meets  the 
essential  requirements  and  the  results  are  accessible  to  both  parties  concerned  by  the 
measurement. However, in the case of instruments used for direct sales to the public, display 
and printing devices for the vendor and the customer must fulfil the essential requirements. 

METROLOGICAL REQUIREMENTS 

1. Units of mass 

The  units  of  mass  used  shall  be  the  legal  units  within  the  meaning  of  Council  Directive 
80/181/EEC  of  20  December  1979  on  the  approximation  of  the  laws  of  the  Member  States 
relating to units of measurement16. 

Subject to compliance with this condition, the following units are permitted: 

(a) - SI units: kilogram, microgram, milligram, gram, tonne,; 

(b) - imperial unit: troy ounce, if weighing precious metals,; 

(c) - other non-SI unit: metric carat, if weighing precious stones. 

For  instruments  that  make  use  of  the  imperial  unit  of  mass  referred  to  above,  the  relevant 
essential  requirements  specified  below  shall  be  converted  to  that  unit,  using  simple 
interpolation. 

2. Accuracy classes 

2.1. The following accuracy classes have been defined: 

(a) 

I special 

(b) 

II high 

16 

OJ L 39, 15.2.1980, p. 40. 

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(c) 

III medium 

(d) 

IIII ordinary 

The specifications of these classes are given in Table 1. 

Table 1 

Accuracy classes 

Class 

Verification scale 
interval (e) 

Minimum capacity 
(Min) 

Number of verification scale 
intervals 

n = ((Max)/(e)) 

minimum value 

minimum value  maximum value 

0,001 

g ≤ e 

100 e 

50 000 

— 

0,001 

0,1 

0,1 

5 

5 

g ≤ e ≤ 
0,05 g 

g ≤ e 

g ≤ e ≤ 2 
g 

g ≤ e 

g ≤ e 

20 e 

50 e 

20 e 

20 e 

10 e 

100 

5000 

100 

500 

100 

100000 

100000 

10000 

10000 

1000 

I 

II 

III 

IIII 

The minimum capacity is reduced to 5 e for instruments in classes II and III for determining a 
conveying tariff. 

2.2. Scale intervals 

2.2.1. The actual scale interval (d) and the verification scale interval (e) shall be in the form: 

1 × 10k, 2 × 10k, or 5 × 10k mass units, 

k being any integer or zero. 

2.2.2. For all instruments other than those with auxiliary indicating devices: 

d = e. 

2.2.3. For instruments with auxiliary indicating devices the following conditions apply: 

e = 1 × 10k g,; 

d < e ≤ 10 d,. 

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except ⌦ Those  conditions  do  not  apply ⌫  for  instruments  of  class  I  with  d  <  10–4  g,  for 
which e = 10–3 g. 

3. Classification 

3.1. Instruments with one weighing range 

Instruments equipped with an auxiliary indicating device shall belong to class I or class II. For 
these instruments the minimum capacity lower limits for these two classes are obtained from 
Table 1 by replacement in column 3 of the verification scale interval (e) by the actual scale 
interval (d). 

If d < 10–4 g, the maximum capacity of class I may be less than 50000 e. 

3.2. Instruments with multiple weighing ranges 

Multiple weighing ranges are permitted, provided they are clearly indicated on the instrument. 
Each individual weighing range is classified according to point 3.1. If the weighing ranges fall 
into  different  accuracy  classes  the  instrument  shall  comply  with  the  severest  of  the 
requirements that apply for the accuracy classes in which the weighing ranges fall. 

3.3. Multi-interval instruments 

3.3.1. Instruments with one weighing range may have several partial weighing ranges (multi-
interval instruments). 

Multi-interval instruments shall not be equipped with an auxiliary indicating device. 

3.3.2. Each partial weighing range i of multi-interval instruments is defined by: 

— its verification scale interval 
ei 

with e(i + 1) > ei 

— its maximum capacity Maxi 

with Maxr = Max 

— its minimum capacity Mini 

with Mini = Max (i – 1) 

and Min1 = Min 

where: 

i 

i 

r 

= 

= 

= 

1, 2, … r, 

partial weighing range number, 

the total number of partial weighing ranges. 

All capacities are capacities of net load, irrespective of the value of any tare used. 

EN 

50 

   EN 

 
 
 
3.3.3.  The  partial  weighing  ranges  are  classified  according  to  Table  2.  All  partial  weighing 
ranges shall fall into the same accuracy class, that class being the instrument’s accuracy class.  

Table 2 

Multi-interval instruments 

i 

i 

r 

= 

= 

= 

1, 2, … r 

partial weighing range number 

total number of partial weighing ranges 

Class 

Verification scale 
interval (e) 

Minimum 
capacity (Min) 

Number of verification scale intervals 

Minimum value  Minimum value17 

Maximum value 

n = 
((Maxi)/(e(i+1))) 

n = ((Maxi)/(ei)) 

I 

II 

III 

IIII 

0,001 

g ≤ ei 

100 e1 

0,001 

g ≤ ei ≤ 
0,05 g 

20 e1 

0,1 

0,1 

5 

g ≤ ei 

50 e1 

g ≤ ei 

20 e1 

g ≤ ei 

10 e1 

50000 

5000 

5000 

500 

50 

— 

100000 

100000 

10000 

1000 

4. Accuracy 

4.1.  On  implementation  of  the  procedures  laid  down  in  Article  913,  the  error  of  indication 
shall not exceed the maximum permissible error of indication as shown in Table 3. In case of 
digital indication the error of indication shall be corrected for the rounding error. 

The maximum permissible errors apply to the net value and tare value for all possible loads, 
excluding preset tare values. 

Table 3 

Maximum permissible errors 

Load 

Maximum 
permissible error 

Class I 

Class II 

Class III 

Class IIII 

17 

For i = r, the corresponding column of Table 1 applies, with e replaced by er. 

EN 

51 

   EN 

 
 
 
 
 
 
 
 
                                                 
0 ≤ m ≤ 50000 e  0 ≤ m ≤ 5000 e 

0 ≤ m ≤ 500 e 

0 ≤ m ≤ 50 e 

±0,5 e 

50000 e < m ≤ 
200000 e 

5000 e < m ≤ 
20000 e 

500 e < m ≤ 
2000 e 

50 e < m ≤ 
200 e 

200000 e < m 

20000 e < m ≤ 
100000 e 

2000 e < m ≤ 
10000 e 

200 e < m ≤ 
1000 e 

±1,0 e 

±1,5 e 

4.2.  The  maximum  permissible  errors  in  service  are  twice  the  maximum  permissible  errors 
fixed in Section 4.1. 

5.  Weighing  results  of  an  instrument  shall  be  repeatable,  and  shall  be  reproducible  by  the 
other indicating devices used and in accordance with other methods of balancing used. 

The weighing results shall be sufficiently insensitive to changes in the position of the load on 
the load receptor. 

6. The instrument shall react to small variations in the load. 

7. Influence quantities and time 

7.1.  Instruments  of  classes  II,  III  and  IIII,  liable  to  be  used  in  a  tilted  position,  shall  be 
sufficiently insensitive to the degree of tilting that can occur in normal use. 

7.2.  The  instruments  shall  meet  the  metrological  requirements  within  the  temperature  range 
specified by the manufacturer. The value of this range shall be at least equal to: 

(a) 

- 5 °C for an instrument in class I,; 

(b) 

- 15 °C for an instrument in class II,; 

(c) 

- 30 °C for an instrument in class III or IIII. 

In the absence of a manufacturer’s specification, the temperature range of – 10 °C to + 40 °C 
applies. 

7.3.  Instruments  operated  from  a  mains  power  supply  shall  meet  the  metrological 
requirements under conditions of power supply within the limits of normal fluctuation. 

Instruments operated from battery power shall indicate whenever the voltage drops below the 
minimum  required  value  and  shall  under  those  circumstances  either  continue  to  function 
correctly or be automatically put out of service. 

7.4. Electronic instruments, except those in class I and in class II if e is less than 1 g, shall 
meet  the  metrological  requirements  under  conditions  of  high  relative  humidity  at  the  upper 
limit of their temperature range. 

7.5. Loading an instrument in class II, III or IIII for a prolonged period of time shall have a 
negligible  influence  on  the  indication  at  load  or  on  the  zero  indication  immediately  after 
removal of the load. 

EN 

52 

   EN 

 
 
7.6.  Under  other  conditions  the  instruments  shall  either  continue  to  function  correctly  or  be 
automatically put out of service. 

Design and construction 

8. General requirements 

8.1.  Design  and  construction  of  the  instruments  shall  be  such  that  the  instruments  will 
preserve  their  metrological  qualities  when  properly  used  and  installed  and  when  used  in  an 
environment for which they are intended. The value of the mass must be indicated. 

8.2.  When  exposed  to  disturbances,  electronic  instruments  shall  not  display  the  effects  of 
significant faults, or shall automatically detect and indicate them. 

Upon automatic detection of a significant fault, electronic instruments shall provide a visual 
or  audible  alarm  that  shall  continue  until  the  user  takes  corrective  action  or  the  fault 
disappears. 

8.3. The requirements of points 8.1 and 8.2 shall be met on a lasting basis during a period of 
time that is normal in view of the intended use of such instruments. 

Digital  electronic  devices  shall  always  exercise  adequate  control  of  the  correct  operation  of 
the measuring process, of the indicating device, and of all data storage and data transfer. 

Upon automatic detection of a significant durability error, electronic instruments shall provide 
a visual or audible alarm that shall continue until the user takes corrective action or the error 
disappears. 

8.4. When external equipment is connected to an electronic instrument through an appropriate 
interface the metrological qualities of the instrument shall not be adversely influenced. 

8.5. The instruments shall have no characteristics likely to facilitate fraudulent use, whereas 
possibilities  for  unintentional  misuse  shall  be  minimal.  Components  that  may  not  be 
dismantled or adjusted by the user shall be secured against such actions. 

8.6.  Instruments  shall  be  designed  to  permit  ready  execution  of  the  statutory  controls  laid 
down by this Directive. 

9. Indication of weighing results and other weight values 

The indication of the weighing results and other weight values shall be accurate, unambiguous 
and  non-misleading  and  the  indicating  device  shall  permit  easy  reading  of  the  indication 
under normal conditions of use. 

The names and symbols of the units referred to in point 1 of this Annex shall comply with the 
provisions of Directive 80/181/EEC with the addition of the symbol for the metric carat which 
shall be the symbol ‘ct’. 

Indication shall be impossible above the maximum capacity (Max), increased by 9 e. 

EN 

53 

   EN 

 
An auxiliary indicating device is permitted only to the right of the decimal mark. An extended 
indicating  device  may  be  used  only  temporarily,  and  printing  shall  be  inhibited  during  its 
functioning. 

Secondary  indications  may  be  shown,  provided  that  they  cannot  be  mistaken  for  primary 
indications. 

10. Printing of weighing results and other weight values 

Printed  results  shall  be  correct,  suitably  identified  and  unambiguous.  The  printing  shall  be 
clear, legible, non-erasable and durable. 

11. Levelling 

When  appropriate,  instruments  shall  be  fitted  with  a  levelling  device  and  a  level  indicator, 
sufficiently sensitive to allow proper installation. 

12. Zeroing 

Instruments may be equipped with zeroing devices. The operation of these devices shall result 
in accurate zeroing and shall not cause incorrect measuring results. 

13. Tare devices and preset tare devices 

The instruments may have one or more tare devices and a preset tare device. The operation of 
the  tare  devices  shall  result  in  accurate  zeroing  and  shall  ensure  correct  net  weighing.  The 
operation  of  the  preset  tare  device  shall  ensure  correct  determination  of  the  calculated  net 
value. 

14. Instruments for direct sales to the public, with a maximum capacity not greater than 100 
kg: additional requirements 

Instruments  for  direct  sale  to  the  public  shall  show  all  essential  information  about  the 
weighing  operation  and,  in  the  case  of  price-indicating  instruments,  shall  clearly  show  the 
customer the price calculation of the product to be purchased. 

The price to pay, if indicated, shall be accurate. 

Price-computing  instruments  shall  display  the  essential  indications  long  enough  for  the 
customer to read them properly. 

Price-computing instruments may perform functions other than per-article weighing and price 
computation  only  if  all  indications  related  to  all  transactions  are  printed  clearly  and 
unambiguously and are conveniently arranged on a ticket or label for the customer. 

Instruments shall bear no characteristics that can cause, directly or indirectly, indications the 
interpretation of which is not easy or straightforward. 

Instruments  shall  safeguard  customers  against  incorrect  sales  transactions  due  to  their 
malfunctioning. 

Auxiliary indicating devices and extended indicating devices are not permitted. 

EN 

54 

   EN 

 
Supplementary devices are permitted only if they cannot lead to fraudulent use. 

Instruments similar to those normally used for direct sales to the public which do not satisfy 
the requirements of this Section must carry near to the display the indelible marking ‘Not to 
be used for direct sale to the public’. 

15. Price labelling instruments 

Price  labelling  instruments  shall  meet  the  requirements  of  price  indicating  instruments  for 
direct sale to the public, as far as applicable to the instrument in question. The printing of a 
price label shall be impossible below a minimum capacity. 

(cid:208) 2009/23/EC 

ANNEX II 

CONFORMITY ASSESSMENT PROCEDURES 

1. ⌦ MODULE B : EU ⌫ EC-type examination  

(cid:208) 2009/23/EC (adapted) 

(cid:208) 2009/23/EC 

1.1. EC type-examination is the procedure whereby a notified body verifies and certifies that 
an  instrument,  representative  of  the  production  envisaged,  meets  the  requirements  of  this 
Directive. 

1.2. The application for EC type-examination shall be lodged with a single notified body by 
the manufacturer or his authorised representative established within the Community. 

The application shall include: 

– 

– 

– 

the  name  and  address  of  the  manufacturer  and,  if  the  application  is  lodged  by  the 
authorised representative, his name and address in addition, 

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

the design documentation, as described in Annex III. 

The applicant shall place at the disposal of the notified body an instrument, representative of 
the production envisaged, hereinafter the ‘type’. 

EN 

55 

   EN 

 
 
 
 
1.3. The notified body shall: 

1.3.1.  examine  the  design  documentation  and  verify  that  the  type  has  been  manufactured  in 
accordance with that documentation; 

1.3.2.  agree  with  the  applicant  on  the  location  where  the  examinations  and/or  tests  shall  be 
carried out; 

1.3.3. perform or have performed the appropriate examinations and/or tests to check whether 
the  solutions  adopted  by  the  manufacturer  meet  the  essential  requirements  where  the 
harmonised standards referred to in Article 6(1) have not been applied; 

1.3.4. perform or have performed the appropriate examinations and/or tests to check whether, 
where the manufacturer has chosen to apply the relevant standards, these standards have been 
applied effectively, thereby assuring conformity with the essential requirements. 

1.4.  Where  the  type  complies  with  the  provisions  of  this  Directive,  the  notified  body  shall 
issue  an  EC  type-approval  certificate  to  the  applicant.  The  certificate  shall  contain  the 
conclusions  of  the  examination,  conditions  (if  any)  for  its  validity,  the  necessary  data  for 
identification of the approved instrument and, if relevant, a description of its functioning. All 
the relevant technical elements such as drawings and layouts shall be annexed to the EC type-
approval certificate. 

The certificate shall have a validity period of 10 years from the date of its issue, and may be 
renewed for subsequent periods of 10 years each. 

In  the  event  of  fundamental  changes  to  the  design  of  the  instrument,  e.g.  as  a  result  of  the 
application of new techniques, the validity of the certificate may be limited to two years and 
extended by three years. 

1.5. Each notified body shall periodically make available to all Member States the list of: 

– 

– 

– 

– 

applications received for EC type-examination, 

EC type-approval certificates issued, 

applications for type-certificates refused, 

additions and amendments relating to documents already issued. 

Each notified body shall moreover inform all the Member States forthwith of withdrawals of 
EC type-approval certificates. 

Each Member State shall make this information available to the bodies which it has notified. 

1.6. The other notified bodies may receive a copy of the certificates together with the annexes 
to them. 

1.7. The applicant shall keep the notified body that has issued the EC type-approval certificate 
informed of any modification to the approved type. 

EN 

56 

   EN 

 
Modifications to the approved type must receive additional approval from the notified body 
that issued the EC type-approval certificate where such changes influence conformity with the 
essential requirements of this Directive or the prescribed conditions for use of the instrument. 
This additional approval is given in the form of an addition to the original EC type-approval 
certificate. 

(cid:216) new 

1.1. EU-type examination is the part of a conformity assessment procedure in which a notified 
body examines the technical design of an instrument and verifies and attests that the technical 
design of the instrument meets the requirements of this Directive that apply to it. 

1.2. EU-type examination may be carried out in any of the following manners: 

–  examination  of  a  specimen,  representative  of  the  production  envisaged,  of  the 

complete instrument (production type); 

–  assessment  of  the  adequacy  of  the  technical  design  of  the  instrument  through 
examination of the technical documentation and supporting evidence referred to in 
point  1.3,  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); 

–  assessment  of  the  adequacy  of  the  technical  design  of  the  instrument  through 
examination of the technical documentation and supporting evidence referred to in 
point 1.3, without examination of a specimen (design type). 

1.3.  The  manufacturer  shall  lodge  an  application  for  EU-type  examination  with  a  single 
notified body of his choice. 

The application shall include: 

(a) 

(b) 

(c) 

 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; 

the  technical  documentation.  The  technical  documentation  shall  make  it 
possible to assess the instrument's conformity with the applicable requirements 
of this Directive 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  the  assessment,  the  design,  manufacture  and 
operation  of  the  instrument.  The  technical  documentation  shall  contain, 
wherever applicable, at least the following elements: 

(i) 

a general description of the instrument; 

(ii) 

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

EN 

57 

   EN 

 
 
(iii)  descriptions  and  explanations  necessary  for  the  understanding  of  those 

drawings and schemes and the operation of the instrument; 

(iv)  a  list  of  the  harmonised  standards  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  harmonised  standards  have  not  been 
applied.  In  the  event  of  partly  applied  harmonised  standards,  the 
technical documentation shall specify the parts which have been applied; 

(v) 

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

(vi) 

test reports; 

the  specimens  representative  of  the  production  envisaged.  The  notified  body 
may request further specimens if needed for carrying out the test programme; 

the supporting evidence for the adequacy of the technical design solution. This 
supporting  evidence  shall  mention  any  documents  that  have  been  used,  in 
technical 
particular  where 
specifications  have  not  been  applied  in  full.  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. 

relevant  harmonised  standards  and/or 

the 

(d) 

(e) 

1.4. The notified body shall: 

For the instrument: 

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

For the specimen(s): 

1.4.2.  verify  that  the  specimen(s)  have  been  manufactured  in  conformity  with  the  technical 
documentation, and identify  the elements which have been designed in  accordance  with  the 
applicable provisions of the relevant harmonised standards and/or technical specifications, as 
well  as  the  elements  which  have  been  designed  without  applying  the  relevant  provisions  of 
those standards; 

1.4.3.  carry  out  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 and/or technical specifications, these have been applied correctly; 

1.4.4.  carry  out  appropriate  examinations  and  tests,  or  have  them  carried  out,  to  check 
whether,  where  the  solutions  in  the  relevant  harmonised  standards  and/or  technical 
specifications  have  not  been  applied,  the  solutions  adopted  by  the  manufacturer  meet  the 
corresponding essential requirements of this Directive; 

1.4.5.  agree  with  the  manufacturer  on  a  location  where  the  examinations  and  tests  will  be 
carried out. 

EN 

58 

   EN 

 
1.5. The notified body shall draw up an evaluation report that records the activities undertaken 
in accordance with point 1.4 and their outcomes. Without prejudice to its obligations vis-à-vis 
the notifying authorities, the notified body shall release the content of that report, in full or in 
part, only with the agreement of the manufacturer. 

1.6. Where the type meets the requirements of this Directive, the notified body shall issue an 
EU-type  examination  certificate  to  the  manufacturer.  The  certificate  shall  contain  the  name 
and address of the manufacturer, the conclusions of the examination, the conditions (if any) 
for its validity and the necessary data for identification of the approved type. The certificate 
may have one or more annexes attached. 

The certificate and its annexes shall contain all relevant information to allow the conformity 
of  manufactured  instruments  with  the  examined  type  to  be  evaluated  and  to  allow  for  in-
service control.  

The certificate shall have a validity period of ten years from the date of its issue, and may be 
renewed for subsequent periods of ten years each. In the event of fundamental changes to the 
design of the instrument, e.g. as a result of the application of new techniques, the validity of 
the certificate may be limited to two years and extended by three years. 

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. 

1.7.  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.  The  manufacturer  shall  inform  the  notified  body  that  holds  the  technical 
documentation  relating  to  the  EU-type  examination  certificate  of  all  modifications  to  the 
approved  type  that  may  affect  the  conformity  of  the  instrument  with  the  essential 
requirements  of  this  Directive  or  the  conditions  for  validity  of  the  certificate.  Such 
modifications shall require additional approval in the form of an addition to the original EU-
type examination certificate. 

1.8.  Each  notified  body  shall  inform  its  notifying  authorities  concerning  the  EU-type 
examination  certificates  and/or  any  additions  thereto  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. 

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. The notified body shall 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, until the expiry of 
the validity of the certificate. 

1.9. The manufacturer shall keep a copy of the 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 instrument has been placed on the market. 

EN 

59 

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1.10.  The  manufacturer's  authorised  representative  may  lodge  the  application  referred  to  in 
point  1.3  and  fulfil  the  obligations  set  out  in  points  1.7  and  1.9,  provided  that  they  are 
specified in the mandate. 

2. EC declaration of type conformity (guarantee of production quality) ⌦ MODULE D: 

Conformity to type based on quality assurance of the production process ⌫ 

(cid:208) 2009/23/EC (adapted) 

(cid:208) 2009/23/EC 

2.1. The EC declaration of type conformity (guarantee of production quality) is the procedure 
whereby  the  manufacturer  who  satisfies  the  obligations  of  point  2.2  declares  that  the 
instruments concerned are, where applicable, in conformity with the type as described in the 
EC type-approval certificate and that they satisfy the requirements of this Directive. 

The  manufacturer  or  his  authorised  representative  established  within  the  Community  shall 
affix  the  ‘CE’  conformity  marking  to  each  instrument  and  the  inscriptions  provided  for  in 
Annex IV and shall draw up a written declaration of conformity. 

The  ‘CE’  conformity  marking  shall  be  accompanied  by  the  identification  number  of  the 
notified body responsible for the EC surveillance referred to in point 2.4. 

2.2.  The  manufacturer  shall  have  adequately  implemented  a  quality  system  as  specified  in 
point 2.3 and shall be subject to EC surveillance as specified in point 2.4. 

2.3. Quality system 

2.3.1. The manufacturer shall lodge an application for approval of his quality system with a 
notified body. 

The application shall include: 

– 

– 

an undertaking to carry out the obligations arising from the approved quality system, 

an  undertaking  to  maintain  the  approved  quality  system  to  ensure  its  continuing 
suitability and effectiveness. 

The  manufacturer  shall  make  available  to  the  notified  body  all  relevant  information,  in 
particular  the  quality  system’s  documentation  and  the  design  documentation  of  the 
instrument. 

2.3.2.  The  quality  system  shall  ensure  conformity  of  the  instruments  with  the  type  as 
described in the EC type-approval certificate and with the requirement(s) 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 rules, procedures and 
instructions.  This  quality  system  documentation  shall  ensure  a  proper  understanding  of  the 
quality programmes, plans, manuals and records. 

EN 

60 

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It shall contain in particular an adequate description of: 

– 

– 

– 

– 

the quality objectives and the organisational structure, responsibilities and powers of 
the management with regard to product quality, 

the  manufacturing  process,  the  quality  control  and  assurance  techniques  and  the 
systematic measures 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  means  to  monitor  the  achievement  of  the  required  product  quality  and  the 
effective operation of the quality system. 

2.3.3. The notified body shall examine and evaluate the quality system to determine whether 
it satisfies the requirements referred to in point 2.3.2. It shall presume conformity with these 
requirements  in  respect  of  quality  systems  that  implement  the  corresponding  harmonised 
standard. 

It  shall  notify  its  decision  to  the  manufacturer  and  inform  the  other  notified  bodies  thereof. 
The notification to the manufacturer shall contain the conclusions of the examination and, in 
the event of refusal, the justification for the decision. 

2.3.4. The manufacturer or his authorised representative shall keep the notified body that has 
approved  the  quality  system  informed  of  any  updating  of  the  quality  assurance  system  in 
relation to changes brought about by, e.g. new technologies and new quality concepts. 

2.3.5. Any notified body that withdraws approval of a quality system shall so inform the other 
notified bodies. 

2.4. EC surveillance 

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

2.4.2.  The  manufacturer  shall  grant  the  notified  body  access  for  inspection  purposes  to  the 
manufacture, inspection, testing and storage premises and shall provide it with all necessary 
information, in particular: 

– 

– 

– 

the quality system documentation, 

the design documentation, 

the quality records, e.g. the inspection reports and tests and calibration data, reports 
on the qualifications of the personnel concerned, etc. 

The notified body shall periodically carry out audits in order to ensure that the manufacturer 
is maintaining and applying the quality system; it shall provide the manufacturer with an audit 
report. 

EN 

61 

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In addition, the  notified body may carry  out unscheduled visits to the manufacturer. During 
such  visits,  the  notified  body  may  carry  out  full  or  partial  audits.  It  shall  provide  the 
manufacturer with a report on the visit, and, where appropriate, an audit report. 

2.4.3.  The  notified  body  shall  ensure  that  the  manufacturer  maintains  and  applies  the 
approved quality system. 

(cid:216) new 

2.1. Conformity 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 points 2.2 and 2.5, and ensures and declares on his sole responsibility that the instruments 
concerned  are  in  conformity  with  the  type  described  in  the  EU-type  examination  certificate 
and satisfy the requirements of this Directive that apply to them. 

2.2. Manufacturing 

The  manufacturer  shall  operate  an  approved  quality  system  for  production,  final  instrument 
inspection  and  testing  of  the  instruments  concerned  as  specified  in  point  2.3,  and  shall  be 
subject to surveillance as specified in point 2.4. 

2.3. Quality system 

2.3.1. The manufacturer shall lodge an application for assessment of his quality system with 
the notified body of his choice, for the instruments concerned. 

The application shall include: 

(a) 

(b) 

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; 

(c) 

all relevant information for the instrument category envisaged; 

(d) 

the documentation concerning the quality system; 

(e) 

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

2.3.2.  The  quality  system  shall  ensure  that  the  instruments  are  in  conformity  with  the  type 
described  in  the  EU-type  examination  certificate  and  comply  with  the  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. The quality system documentation shall permit a consistent interpretation of 
the quality programmes, plans, manuals and records. 

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

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(a) 

(b) 

(c) 

(d) 

(e) 

the  quality  objectives  and  the  organisational  structure,  responsibilities  and 
powers of the management with regard to 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 on the personnel concerned, etc.; 

the  means  of  monitoring  the  achievement  of  the  required  instrument  quality 
and the effective operation of the quality system. 

2.3.3. The notified body shall assess the quality system to determine whether it satisfies the 
requirements referred to in point 2.3.2. 

It shall presume conformity with those requirements in respect of the elements of the quality 
system  that  comply  with  the  corresponding  specifications  of  the  national  standard  that 
implements the relevant harmonised standard and/or technical specifications. 

In addition to experience in quality management systems, the auditing team shall have at least 
one  member  with  experience  of  evaluation  in  the  relevant  instrument  field  and  instrument 
technology  concerned,  and  knowledge  of  the  applicable  requirements  of  this  Directive.  The 
audit shall include an assessment visit to the manufacturer's premises. The auditing team shall 
review the technical documentation referred to in point 2.3.1(e) 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. 

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

2.3.4.  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. 

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

The  notified  body  shall  evaluate  any  proposed  changes  and  decide  whether  the  modified 
quality system will continue to satisfy the requirements referred to in point 2.3.2 or whether a 
reassessment is necessary. 

It shall notify the manufacturer of its decision. The notification shall contain the conclusions 
of the examination and the reasoned assessment decision. 

2.4. Surveillance under the responsibility of the notified body 

2.4.1.  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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2.4.2. The manufacturer shall, for assessment purposes, allow the notified body access to the 
manufacture,  inspection,  testing  and  storage  sites  and  shall  provide  it  with  all  necessary 
information, in particular: 

(a) 

the quality system documentation; 

(b) 

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

2.4.3.  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. 

2.4.4.  In  addition,  the  notified  body  may  pay  unexpected  visits  to  the  manufacturer.  During 
such  visits  the  notified  body  may,  if  necessary,  carry  out  instrument  tests,  or  have  them 
carried  out,  in  order  to  verify  that  the  quality  system  is  functioning  correctly.  The  notified 
body shall provide the manufacturer with a visit report and, if tests have been carried out, with 
a test report. 

2.5. Conformity marking and declaration of conformity 

2.5.1. The manufacturer shall affix the CE marking and the inscriptions provided for in point 
1 of Annex III, and, under the responsibility of the notified body referred to in point 2.3.1, the 
latter's identification number to each individual instrument that is in conformity with the type 
described in the EU-type examination certificate and satisfies the applicable requirements of 
this Directive. 

2.5.2. The manufacturer shall draw up a written declaration of conformity for each instrument 
model and keep it at the disposal of the national authorities for 10 years after the instrument 
has  been  placed  on  the  market.  The  declaration  of  conformity  shall  identify  the  instrument 
model for which it has been drawn up. 

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

2.6. The manufacturer shall, for a period ending at least 10 years after the instrument has been 
placed on the market, keep at the disposal of the national authorities: 

(a) 

the documentation referred to in point 2.3.1; 

(b) 

the change referred to in point 2.3.5, as approved; 

(c) 

the decisions and reports of the notified body referred to in points 2.3.5, 2.4.3 
and 2.4.4. 

2.7.  Each  notified  body  shall  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. 

2.8. Authorised representative 

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The manufacturer's obligations set out in points 2.3.1, 2.3.5, 2.5 and 2.6 may be fulfilled by 
his authorised representative, on his behalf and under his responsibility, provided that they are 
specified in the mandate.  

3. MODULE D1: Quality assurance of the production process 

3.1.  Quality  assurance  of  the  production  process  is  the  conformity  assessment  procedure 
whereby  the  manufacturer  fulfils  the  obligations  laid  down  in  points  3.2,  3.4  and  3.7,  and 
ensures  and  declares  on  his  sole  responsibility  that  the  instruments  concerned  satisfy  the 
requirements of this Directive that apply to them. 

3.2. Technical documentation 

The manufacturer shall establish the technical documentation. The documentation shall make 
it  possible  to  assess  the  instrument’s  conformity  with  the  relevant  requirements,  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  the  assessment,  the 
design,  manufacture  and  operation  of  the  instrument.  The  technical  documentation  shall, 
wherever applicable, contain at least the following elements: 

(a) 

a general description of the instrument; 

(b) 

(c) 

(d) 

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 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 
harmonised  standards  have  not  been  applied.  In  the  event  of  partly  applied 
harmonised  standards,  the  technical  documentation  shall  specify  the  parts 
which have been applied; 

(e) 

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

(f) 

test reports. 

3.3. The manufacturer shall keep the technical documentation at the disposal of the relevant 
national authorities for 10 years after the instrument has been placed on the market. 

3.4. Manufacturing 

The  manufacturer  shall  operate  an  approved  quality  system  for  production,  final  product 
inspection  and  testing  of  the  instruments  concerned  as  specified  in  point  3.5,  and  shall  be 
subject to surveillance as specified in point 3.6. 

3.5. Quality system 

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3.5.1. The manufacturer shall lodge an application for assessment of his quality system with 
the notified body of his choice, for the instruments concerned. 

The application shall include: 

(a) 

(b) 

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; 

(c) 

all relevant information for the instrument category envisaged; 

(d) 

the documentation concerning the quality system; 

(e) 

the technical documentation referred to in point 3.2. 

3.5.2. The quality system shall ensure compliance of the instruments with the 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. The quality system documentation shall permit a consistent interpretation of 
the quality programmes, plans, manuals and records. 

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

(a) 

(b) 

(c) 

(d) 

(e) 

the  quality  objectives  and  the  organisational  structure,  responsibilities  and 
powers of the management with regard to 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 on the personnel concerned, etc.; 

the  means  of  monitoring  the  achievement  of  the  required  instrument  quality 
and the effective operation of the quality system. 

3.5.3. The notified body shall assess the quality system to determine whether it satisfies the 
requirements referred to in point 3.5.2. 

It shall presume conformity with those requirements in respect of the elements of the quality 
system  that  comply  with  the  corresponding  specifications  of  the  national  standard  that 
implements the relevant harmonised standard and/or technical specification. 

In addition to experience in quality management systems, the auditing team shall have at least 
one  member  with  experience  of  evaluation  in  the  relevant  instrument  field  and  instrument 
technology  concerned,  and  knowledge  of  the  applicable  requirements  of  this  Directive.  The 

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audit shall include an assessment visit to the manufacturer's premises. The auditing team shall 
review  the  technical  documentation  referred  to  in  point  3.2  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. 

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

3.5.4.  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. 

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

The  notified  body  shall  evaluate  any  proposed  changes  and  decide  whether  the  modified 
quality system will continue to satisfy the requirements referred to in point 3.5.2 or whether 
reassessment is necessary. 

It shall notify the manufacturer of its decision. The notification shall contain the conclusions 
of the examination and the reasoned assessment decision. 

3.6. Surveillance under the responsibility of the notified body 

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

3.6.2. The manufacturer shall, for assessment purposes, allow the notified body access to the 
manufacture,  inspection,  testing  and  storage  sites  and  shall  provide  it  with  all  necessary 
information, in particular: 

(a) 

the quality system documentation; 

(b) 

the technical documentation referred to in point 3.2; 

(c) 

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

3.6.3.  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. 

3.6.4.  In  addition,  the  notified  body  may  pay  unexpected  visits  to  the  manufacturer.  During 
such visits the notified body may, if necessary, carry out product tests, or have them carried 
out, in order to verify that the quality system is functioning correctly. The notified body shall 
provide  the  manufacturer  with  a  visit  report  and,  if  tests  have  been  carried  out,  with  a  test 
report. 

3.7. Conformity marking and declaration of conformity 

3.7.1. The manufacturer shall affix the CE marking and the inscriptions provided for in point 
1 of Annex III, and, under the responsibility of the notified body referred to in point 3.5.1, the 

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latter's  identification  number  to  each  individual  instrument  that  satisfies  the  applicable 
requirements of this Directive. 

3.7.2. The manufacturer shall draw up a written declaration of conformity for each instrument 
model and keep it at the disposal of the national authorities for 10 years after the instrument 
has  been  placed  on  the  market.  The  declaration  of  conformity  shall  identify  the  instrument 
model for which it has been drawn up. 

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

3.8. The manufacturer shall, for a period ending at least 10 years after the instrument has been 
placed on the market, keep at the disposal of the national authorities: 

(a) 

the documentation referred to in point 3.5.1; 

(b) 

the change referred to in point 3.5.5, as approved; 

(c) 

the decisions and reports of the notified body referred to in points 3.5.5, 3.6.3 
and 3.6.4. 

3.9.  Each  notified  body  shall  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. 

3.10. Authorised representative 

The manufacturer's obligations set out in points 3.3, 3.5.1, 3.5.5, 3.7 and 3.8 may be fulfilled 
by his authorised representative, on his behalf and under his responsibility, provided that they 
are specified in the mandate. 

34. EC ⌦ MODULE F: Conformity to type based on product ⌫ verification 

(cid:208) 2009/23/EC (adapted) 

(cid:208) 2009/23/EC 

3.1.  EC  verification  is  the  procedure  whereby  the  manufacturer  or  his  authorised 
representative  established  within  the  Community  ensures  and  declares  that  the  instruments 
which have been checked in accordance with point 3.3 are, where applicable, in conformity 
with  the  type  described  in  the  EC  type-examination  certificate  and  that  they  satisfy  the 
requirements of this Directive. 

3.2.  The  manufacturer  shall  take  all  necessary  measures  in  order  that  the  manufacturing 
process ensures conformity of the instruments, where applicable, with the type as described in 
the EC type-examination certificate and with the requirements of this Directive which apply 
to them. The manufacturer or his authorised representative established within the Community 
shall affix the ‘CE’ conformity marking to each instrument and draw up a written declaration 
of conformity. 

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3.3. The notified body shall carry out the appropriate examinations and tests in order to check 
the conformity of the product to the requirements of this Directive by examination and testing 
of every instrument, as specified in point 3.5. 

3.4. For instruments not subject to EC type-approval, the documents relating to the design of 
the  instrument,  as  set  out  in  Annex  III,  must  be  accessible  to  the  notified  body  should  the 
latter so request. 

3.5. Verification by checking and testing of each instrument 

3.5.1. All instruments shall be individually examined and appropriate tests, as set out in the 
relevant harmonised standards referred to in Article 6(1), or equivalent tests, shall be carried 
out in order to verify their conformity, where applicable, with the type as described in the EC 
type-examination certificate and the requirements of this Directive. 

3.5.2. The notified body shall affix, or cause to be affixed, its identification number on each 
instrument the conformity of which to requirements has been established, and shall draw up a 
written certificate of conformity relating to the tests carried out. 

3.5.3. The manufacturer or his authorised representative shall ensure that he is able to supply 
the notified body’s certificates of conformity on request. 

(cid:216) new 

4.1. Conformity to type based on product verification is the part of a conformity assessment 
procedure whereby the manufacturer fulfils the obligations laid down in points 4.2, 4.5.1 and 
4.6, and ensures and declares on his sole responsibility that the instruments concerned, which 
have been subject to the provisions of point 4.3, are in conformity with the type described in 
the EU-type examination certificate and satisfy the requirements of this Directive that apply 
to them. 

4.2. Manufacturing 

The manufacturer shall take all measures necessary so that the manufacturing process and its 
monitoring  ensure  conformity  of  the  manufactured  instruments  with  the  approved  type 
described in the EU-type examination certificate and with the requirements of this Directive 
that apply to them. 

4.3. Verification 

A notified body chosen by the manufacturer shall carry out appropriate examinations and tests 
in order to check the conformity of the instruments with the approved type described in the 
EU-type examination certificate and with the appropriate requirements of this Directive. 

The  examinations  and  tests  to  check  the  conformity  of  the  instruments  with  the  appropriate 
requirements shall be carried out by examination and testing of every instrument as specified 
in point 4.4. 

4.4. Verification of conformity by examination and testing of every instrument 

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4.4.1.  All  instruments  shall  be  individually  examined  and  appropriate  tests  set  out  in  the 
relevant  harmonised  standard(s)  and/or  technical  specifications,  or  equivalent  tests,  shall  be 
carried  out  in  order  to  verify  conformity  with  the  approved  type  described  in  the  EU-type 
examination certificate and with the appropriate requirements of this Directive. 

In the absence of such a harmonised standard, the notified body concerned shall decide on the 
appropriate tests to be carried out. 

4.4.2. 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. 

The  manufacturer  shall  keep  the  certificates  of  conformity  available  for  inspection  by  the 
national authorities for 10 years after the instrument has been placed on the market. 

4.5. Conformity marking and declaration of conformity 

4.5.1. The manufacturer shall affix the CE marking and the inscriptions provided for in point 
1 of Annex III, and, under the responsibility of the notified body referred to in point 4.3, the 
latter's  identification  number  to  each  individual  instrument  that  is  in  conformity  with  the 
approved  type  described  in  the  EU-type  examination  certificate  and  satisfies  the  applicable 
requirements of this Directive. 

4.5.2. The manufacturer shall draw up a written declaration of conformity for each instrument 
model and keep it at the disposal of the national authorities, for 10 years after the instrument 
has  been  placed  on  the  market.  The  declaration  of  conformity  shall  identify  the  instrument 
model for which it has been drawn up. 

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

If  the  notified  body  referred  to  in  point  4.3  agrees  and  under  its  responsibility,  the 
manufacturer may also affix the notified body's identification number to the instruments. 

4.6.  If  the  notified  body  agrees  and  under  its  responsibility,  the  manufacturer  may  affix  the 
notified body's identification number to the instruments during the manufacturing process. 

4.7. Authorised representative 

The manufacturer's obligations may be fulfilled by his authorised representative, on his behalf 
and under his  responsibility,  provided  that they are  specified  in  the  mandate.  An  authorised 
representative may not fulfil the manufacturer's obligations set out in points 4.2 and 4.5.1. 

5. MODULE F1: Conformity based on product verification 

5.1.  Conformity  based  on  product  verification  is  the  conformity  assessment  procedure 
whereby  the  manufacturer  fulfils  the  obligations  laid  down  in  points  5.2,  5.3,  5.6.1  and  5.7 
and ensures and declares on his sole responsibility that the instruments concerned, which have 
been  subject  to  the  provisions  of  point  5.4,  are  in  conformity  with  the  requirements  of  this 
Directive that apply to them. 

5.2. Technical documentation 

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The manufacturer shall establish the technical documentation. The documentation shall make 
it  possible  to  assess  the  instrument's  conformity  with  the  relevant  requirements,  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  the  assessment,  the 
design,  manufacture  and  operation  of  the  instrument.  The  technical  documentation  shall, 
wherever applicable, contain at least the following elements: 

(a) 

a general description of the instrument; 

(b) 

(c) 

(d) 

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 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 
harmonised  standards  have  not  been  applied.  In  the  event  of  partly  applied 
harmonised  standards,  the  technical  documentation  shall  specify  the  parts 
which have been applied; 

(e) 

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

(f) 

test reports. 

The  manufacturer  shall  keep  the  technical  documentation  at  the  disposal  of  the  relevant 
national authorities for 10 years after the instrument has been placed on the market. 

5.3. Manufacturing 

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

5.4. Verification 

A notified body chosen by the manufacturer shall carry out appropriate examinations and tests 
to check the conformity of the instruments with the applicable requirements of this Directive. 

The examinations and tests to check the conformity with those requirements shall be carried 
out by examination and testing of every instrument as specified in point 5.5. 

5.5. Verification of conformity by examination and testing of every instrument 

5.5.1.  All  instruments  shall  be  individually  examined  and  appropriate  tests,  set  out  in  the 
relevant  harmonised  standards  and/or  technical  specifications,  or  equivalent  tests,  shall  be 
carried out to verify conformity with the requirements that apply to them. In the absence of 
such  a harmonised standard  and/or technical specification the  notified  body concerned shall 
decide on the appropriate tests to be carried out. 

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5.5.2. 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. 

The  manufacturer  shall  keep  the  certificates  of  conformity  at  the  disposal  of  the  national 
authorities for 10 years after the instrument has been placed on the market. 

5.6. Conformity marking and declaration of conformity 

5.6.1. The manufacturer shall affix the CE marking and the inscriptions provided for in point 
1 of Annex III, and, under the responsibility of the notified body referred to in point 5.4, the 
latter's  identification  number  to  each  individual  instrument  that  satisfies  the  applicable 
requirements of this Directive. 

5.6.2. The manufacturer shall draw up a written declaration of conformity for each instrument 
model and keep it at the disposal of the national authorities for 10 years after the instrument 
has  been  placed  on  the  market.  The  declaration  of  conformity  shall  identify  the  instrument 
model for which it has been drawn up. 

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

If  the  notified  body  referred  to  in  point  5.5  agrees  and  under  its  responsibility,  the 
manufacturer may also affix the notified body's identification number to the instruments. 

5.7.  If  the  notified  body  agrees  and  under  its  responsibility,  the  manufacturer  may  affix  the 
notified body's identification number to the instruments during the manufacturing process. 

5.8. Authorised representative 

The manufacturer's obligations may be fulfilled by his authorised representative, on his behalf 
and under his  responsibility,  provided  that they are  specified  in  the  mandate.  An  authorised 
representative may not fulfil the manufacturer's obligations set out in points 5.3 and 5.6.1. 

46. EC ⌦ MODULE G: Conformity based on ⌫ unit verification 

(cid:208) 2009/23/EC (adapted) 

(cid:208) 2009/23/EC 

4.1.  EC  unit  verification  is  the  procedure  whereby  the  manufacturer  or  his  authorised 
representative  established  within  the  Community  ensures  and  declares  that  the  instrument, 
generally  designed  for  a  specific  application,  which  has  been  issued  with  the  certificate 
referred  to  in  point  4.2  conforms  to  the  requirements  of  this  Directive  that  apply  to  it.  The 
manufacturer or his authorised representative shall affix the ‘CE’ conformity marking to the 
instrument and shall draw up a written declaration of conformity. 

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4.2. The notified body shall examine the instrument and carry out the appropriate tests, as set 
out  in  the  relevant  harmonised  standard(s)  referred  to in  Article  6(1),  or  equivalent  tests,  in 
order to ensure its conformity with the relevant requirements of this Directive. 

The  notified  body  shall  affix,  or  cause  to  be  affixed,  its  identification  number  to  the 
instrument the conformity of which to requirements has been established, and shall draw up a 
written certificate of conformity concerning the tests carried out. 

4.3.  The  aim  of  the  technical  documentation  relating  to  the  design  of  the  instrument,  as 
referred to in Annex III, is to enable conformity with the requirements of this Directive to be 
assessed  and  the  design,  manufacture  and  operation  of  the  instrument  to  be  understood.  It 
must be accessible to the notified body. 

4.4.  The  manufacturer  or  his  authorised representative shall ensure that he is able to supply 
the notified body’s certificates of conformity on request. 

(cid:216) new 

6.1.  Conformity  based  on  unit  verification  is  the  conformity  assessment  procedure  whereby 
the manufacturer fulfils the obligations laid down in points 6.2, 6.3 and 6.5, and ensures and 
declares  on  his  sole  responsibility  that  the  instrument  concerned,  which  has  been  subject  to 
the provisions of point 6.4, is in conformity with the requirements of this Directive that apply 
to it. 

6.2. Technical documentation 

The  manufacturer  shall  establish  the  technical  documentation  and  make  it  available  to  the 
notified body referred to in point 6.4. The documentation shall make it possible to assess the 
instrument's conformity with the relevant requirements, 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  the  assessment,  the  design,  manufacture  and 
operation of the instrument. 

The  technical  documentation  shall,  wherever  applicable,  contain  at  least  the  following 
elements: 

(a) 

a general description of the instrument; 

(b) 

(c) 

(d) 

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 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 
harmonised  standards  have  not  been  applied.  In  the  event  of  partly  applied 

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harmonised  standards,  the  technical  documentation  shall  specify  the  parts 
which have been applied; 

(e) 

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

(f) 

test reports. 

The  manufacturer  shall  keep  the  technical  documentation  at  the  disposal  of  the  relevant 
national authorities for 10 years after the instrument has been placed on the market. 

6.3. Manufacturing 

The manufacturer shall take all measures necessary so that the manufacturing process and its 
monitoring  ensure  conformity  of 
the  applicable 
the  manufactured 
requirements of this Directive. 

instrument  with 

6.4. Verification 

A  notified  body  chosen  by  the  manufacturer  shall  carry  out  appropriate  examinations  and 
tests,  set  out  in  the  relevant  harmonised  standards  and/or  technical  specifications,  or 
equivalent tests, to check the conformity of the instrument with the applicable requirements of 
this Directive, or have them carried out. In the absence of such a harmonised standard 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 shall affix its identification number to the approved instrument, or have it 
affixed under its responsibility. 

The  manufacturer  shall  keep  the  certificates  of  conformity  at  the  disposal  of  the  national 
authorities for 10 years after the instrument has been placed on the market. 

6.5. Conformity marking and declaration of conformity 

6.5.1. The manufacturer shall affix the CE marking and the inscriptions provided for in point 
1 of Annex III and, under the responsibility of the notified body referred to in point 6.4, the 
latter's identification number to each instrument that satisfies the applicable requirements of 
this Directive. 

6.5.2. The manufacturer shall draw up a written declaration of conformity and keep it at the 
disposal  of  the  national  authorities  for  10  years  after  the  instrument  has  been  placed  on  the 
market.  The  declaration  of  conformity  shall  identify  the  instrument  for  which  it  has  been 
drawn up. 

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

6.6. Authorised representative 

The manufacturer's obligations set out in points 6.2 and 6.5 may be fulfilled by his authorised 
representative, on his behalf and under his responsibility, provided that they are specified in 
the mandate.  

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(cid:208) 2009/23/EC (adapted) 

57. Common provisions 

57.1.  The  EC  declaration  of  type  conformity  (guarantee  of  production  quality),  the  EC 
verification, and the EC unit verification ⌦ conformity assessment according to Module D, 
D1,  F,  F1  or  G ⌫  may  be  carried  out  at  the  manufacturer’s  works  or  any  other  location  if 
transport to the place of use does not require dismantling of the instrument, if the putting into 
service  at  the  place  of  use  does  not  require  assembly  of  the  instrument  or  other  technical 
installation work likely to affect the instrument’s performance, and if the gravity value at the 
place of putting into service is taken into consideration or if the instrument’s performance is 
insensitive  to  gravity  variations.  In  all  other  cases,  they ⌦ it ⌫  shall  be  carried  out  at  the 
place of use of the instrument. 

(cid:208) 2009/23/EC 

57.2. If the instrument’s performance is sensitive to gravity variations the procedures referred 
to  in  point  57.1  may  be  carried  out  in  two  stages,  with  the  second  stage  comprising  all 
examinations and tests of which the outcome is gravity-dependent, and the first stage all other 
examinations  and  tests.  The  second  stage  shall  be  carried  out  at  the  place  of  use  of  the 
instrument. If a Member State has established gravity zones on its territory the expression ‘at 
the  place  of  use  of  the  instrument’  may  be  read  as  ‘in  the  gravity  zone  of  use  of  the 
instrument’. 

57.2.1. Where a manufacturer has opted for execution in two stages of one of the procedures 
mentioned in point 57.1, and where these two stages will be carried out by different parties, 
an  instrument  which  has  undergone  the  first  stage  of  the  procedure  shall  bear  the 
identification number of the notified body involved in that stage. 

57.2.2. The party which has carried out the first stage of the procedure shall issue for each of 
the instruments a certificate containing the data necessary for identification of the instrument 
and specifying the examinations and tests that have been carried out. 

The  party  which  carries  out  the  second  stage  of  the  procedure  shall  carry  out  those 
examinations and tests that have not yet been carried out. 

The  manufacturer  or  his  authorised  representative  shall  ensure  that  he  is  able  to  supply  the 
notified body’s certificates of conformity on request. 

57.2.3. A manufacturer who has opted for the EC declaration of type conformity (guarantee of 
production  quality)  ⌦ Module  D  or  D1 ⌫  in  the  first  stage  may  either  use  this  same 
procedure in the second stage or decide to continue in the second stage with EC verification 
⌦ Module F or F1 as appropriate ⌫ . 

(cid:208) 2009/23/EC (adapted) 

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57.2.4.  The  ‘CE’  ⌦  CE  ⌫  conformity  marking  shall  be  affixed  to  the  instrument  on 
completion  of  the  second  stage,  along  with  the  identification  number  of  the  notified  body 
which took part in the second stage. 

(cid:208) 2009/23/EC  

ANNEX III 

DESIGN TECHNICAL DOCUMENTATION 

The  technical  documentation  must  render  the  design,  manufacture  and  operation  of  the 
product  intelligible  and  enable  an  assessment  to  be  made  of  its  conformity  with  the 
requirements of this Directive. 

The documentation shall include in so far as relevant for assessment: 

– 

– 

– 

– 

– 

– 

– 

a general description of the type, 

conceptual  designs  and  manufacturing  drawings  and  plans  of  components,  sub-
assemblies, circuits, etc., 

descriptions and explanations necessary for the understanding of the above, including 
the operation of the instrument, 

a list of the harmonised standards referred to in Article 6(1), applied in full or in part, 
and  descriptions  of  the  solutions  adopted  to  meet  the  essential  requirements  where 
the harmonised standards referred to in Article 6(1) have not been applied, 

results of design calculations made and of examinations, etc., 

test reports, 

the  EC  type-approval  certificates  and  the  results  of  relevant  tests  on  instruments 
containing parts identical to those in the design. 

(cid:208) 2009/23/EC (adapted) 

ANNEX IVIII 

‘CE’⌦ CE ⌫ CONFORMITY MARKING AND INSCRIPTIONS 

1. Instruments subject to the EC ⌦ EU ⌫ conformity assessment procedure 

1.1. These instruments must bear: 

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(a) 

- 

-  the  ‘CE’  ⌦  CE  ⌫  conformity  marking  comprising  the  ‘CE’  symbol  as 
described ⌦ provided for ⌫ in Annex VIII of Regulation (EC) No 765/2008, 
⌦ followed by ⌫  

the  identification  number(s)  of  the  notified  body/bodies  that  has/have  carried 
out  the  EC  surveillance  or  the  EC  verification ⌦ involved  in  the  production 
control phase ⌫.; 

The abovementioned marking and inscriptions shall be affixed to the instrument and 
distinctly grouped together; 

(cid:208) 2009/23/EC 

(b) 

a green sticker at least 12,5 mm × 12,5 mm square bearing a capital letter ‘M’ 
printed in black; 

(cid:208) 2009/23/EC (adapted) 

(c) 

the following inscriptions: 

(i) 

-  the  number  of  the  EC  type-approval  ⌦ EU-type  examination ⌫ 
certificate, where appropriate,; 

(ii) 

- the manufacturer’s mark or name,; 

(iii)  - the accuracy class, enclosed in an oval or in two horizontal lines joined 

by two half circles,; 

(iv)  - maximum capacity, in the form Max …,; 

(v) 

- minimum capacity, in the form Min …,; 

(vi)  - verification scale interval, in the form e = …,; 

(vii)  - the last two digits of the year in which the ‘CE’ ⌦ CE ⌫ conformity 

marking was affixed,; 

plus, ⌦ and ⌫ when applicable: 

(viii)  - serial number,; 

(cid:208) 2009/23/EC 

(ix)  - for instruments consisting of separate but associated units: identification 

mark on each unit,; 

(x) 

- scale interval if it is different from e, in the form d = …,; 

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(xi)  - maximum additive tare effect, in the form T = + …,; 

(xii)  - maximum subtractive tare effect if it is different from Max, in the form 

T = – …,; 

(xiii)  - tare interval if it is different from d, in the form dT = …,; 

(xiv)  - maximum safe load if it is different from Max, in the form Lim …,; 

(xv)  - the special temperature limits, in the form … °C/… °C,; 

(xvi)  - ratio between load receptor and load. 

1.2.  The  instruments  shall  have  adequate  facilities  for  the  affixing  of  the  ‘CE’  ⌦ CE ⌫ 
conformity  marking  and/or  inscriptions.  These  shall  be  such  that  it  shall  be  impossible  to 
remove  the  marking  and  inscriptions  without  damaging  them,  and  that  the  marking  and 
inscriptions shall be visible when the instrument is in its regular operating position. 

(cid:208) 2009/23/EC (adapted) 

(cid:208) 2009/23/EC 

1.3.  Where  a  data  plate  is  used  it  shall  be  possible  to  seal  the  plate  unless  it  cannot  be 
removed without being destroyed. If the data plate is sealable it shall be possible to apply a 
control mark to it. 

1.4. The inscriptions Max, Min, e, and d, shall also be shown near the display of the result if 
they are not already located there. 

1.5. Each load measuring device which is connected or can be connected to one or more load 
receptors shall bear the relevant inscriptions relating to the said load receptors. 

2. Other Instruments  

The other instruments must bear: 

– 

– 

the manufacturer’s mark or name,; 

maximum capacity, in the form Max …. 

Those instruments may not bear the stickers provided for in point 1.1(b). 

3. Restrictive use symbol specified in Article 1317 

That symbol shall be constituted by a capital letter ‘M’ printed in black on a red background 
at least 25 mm × 25 mm square with two intersecting diagonals forming a cross. 

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(cid:208) 2009/23/EC 

ANNEX V 

THE MINIMUM CRITERIA TO BE APPLIED BY MEMBER STATES WHEN DESIGNATING BODIES FOR 
THE  CARRYING-OUT  OF  TASKS  PERTAINING  TO  THE  PROCEDURES  REFERRED  TO  IN 
ARTICLE 9 

1. The bodies shall have at their disposal the necessary personnel, means and equipment. 

2. The personnel of the bodies shall have technical competence and professional integrity. 

3.  The  bodies  shall  work  independently  of  all  circles,  groups  or  persons  having  a  direct  or 
indirect  interest  in  non-automatic  weighing  instruments  as  regards  the  carrying-out  of  the 
tests, the preparation of the reports, the issuing of the certificates and the surveillance required 
by this Directive. 

4. The personnel of the bodies shall respect professional confidentiality. 

5. The bodies shall take out a civil liability insurance if their civil liability is not covered by 
the State under national law. 

The  fulfilment  of  the  conditions  under  points  1  and  2  shall  be  periodically  verified  by  the 
Member States. 

(cid:208) 2009/23/EC  

ANNEX VI 

‘CE’ CONFORMITY MARKING 

– 

The ‘CE’ conformity marking shall consist of the initials ‘CE’ taking the following 
form: 

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– 

– 

If the ‘CE’ conformity marking is reduced or enlarged the proportions given in the 
above graduated drawing must be respected. 

The various components of the ‘CE’ conformity marking must have substantially the 
same vertical dimension, which may not be less than 5 mm. 

(cid:208) 2009/23/EC (adapted) 

ANNEX VII 

PART A 

Repealed Directive with its amendment 

(referred to in Article 17) 

Council Directive 90/384/EEC  

(OJ L 189, 20.7.1990, p. 1) 

Council Directive 93/68/EEC 

Article 1, point 7, and Article 8 only 

(OJ L 220, 30.8.1993, p. 1) 

PART B 

List of time limits for transposition into national law and application 

(referred to in Article 17) 

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Directive 

Time limit for transposition  Date of application 

90/384/EEC 

30 June 1992 

93/68/EEC 

30 June 1994 

1 January 199318 

1 January 199519 

(cid:208) 2009/23/EC (adapted) 

ANNEX VIIIIV 

CORRELATION TABLE 

Directive 90/384/EEC ⌦ 2009/23/EC ⌫ 

This Directive 

Recital 5, last sentence 

Article 2, point (3) 

Article 1(1), first subparagraph 

Article 2, point (1) 

Article 1(1), second subparagraph 

Article 2, point (2) 

Article 1(1), third subparagraph 

Article 1(1) 

Article 1(2), introductory wording 

Article 1(2), introductory wording 

Article 1(2), point (a)(1) 

Article 1(2), point (a)(i) 

Article 1(2), point (a)(2) 

Article 1(2), point (a)(ii) 

Article 1(2), point (a)(3) 

Article 1(2), point (a)(iii) 

Article 1(2), point (a)(4) 

Article 1(2), point (a)(iv) 

Article 1(2), point (a)(5) 

Article 1(2), point (a)(v) 

Article 1(2), point (a)(6) 

Article 1(2), point (a)(vi) 

Article 1(2), point (b) 

Article 1(2), point (b) 

Article 2 

Article 3 

Article 3 

Article 4 

18 

19 

In accordance with Article 15(3) of Directive 90/384/EEC Member States shall permit, during a period 
of  10  years  from  the  date  on  which  they  apply  the  laws,  regulations  and  administrative  provisions 
adopted by the Member States in order to transpose that Directive into national law, the placing on the 
market and/or putting into service of instruments which conform to the rules in force before 1 January 
1993. 
In accordance with Article 14(2) of Directive 93/68/EEC: ‘Until 1 January 1997, Member States shall 
allow  the  placing  on  the  market  and  the  bringing  into  service  of  products  which  comply  with  the 
marking arrangements in force before 1 January 1995’. 

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Article 4 

Article 5 

Article 5 

Article 6 

Article 6, first paragraph, first sentence 

Article 7, first paragraph 

Article 6, first paragraph, second sentence  Article 7, second paragraph 

Article 6, second paragraph 

Article 7, third paragraph 

Article 7 

Article 8 

Article 8(1) and (2) 

Article 9(1) and (2) 

Article 8(3), point (a) 

Article 9(3), first subparagraph 

Article 8(3), point (b) 

Article 9(3), second subparagraph 

Article 9 

Article 10 

Article 11 

Article 12 

Article 13 

Article 10 

Article 11 

Article 12 

Article 13 

Article 14 

Article 14, first sentence 

Article 15, first paragraph 

Article 14, second sentence 

Article 15, second paragraph 

Article 15(1) to (3) 

Article 15(4) 

Article 15(5) 

— 

— 

Article 16 

Annexes I to VI 

— 

— 

— 

Article 16 

— 

Article 17 

Article 18 

Article 19 

Annexes I to VI 

Annex VII 

Annex VIII 

⌦ Article 1(1) ⌫ 

⌦ Article 1(1) ⌫ 

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⌦ Article 1(2), introductory wording ⌫  ⌦ Article 1(2), introductory 

wording ⌫ 

⌦ Article 1(2), point (a)(i) ⌫ 

⌦ Article 1(2), point (a) ⌫ 

⌦ Article 1(2), point (a)(ii) ⌫ 

⌦ Article 1(2), point (b) ⌫ 

⌦ Article 1(2), point (a)(iii) ⌫ 

⌦ Article 1(2), point (c) ⌫ 

⌦ Article 1(2), point (a)(iv) ⌫ 

⌦ Article 1(2), point (d) ⌫ 

⌦ Article 1(2), point (a)(v) ⌫ 

⌦ Article 1(2), point (e) ⌫ 

⌦ Article 1(2), point (a)(vi) ⌫ 

⌦ Article 1(2), point (f) ⌫ 

⌦ Article 1(2), point (b) ⌫ 

⌦ Article 1(2), point (g) ⌫ 

⌦ Article 2(1) ⌫ 

⌦ Article 2(2) ⌫ 

⌦ Article 2(1) ⌫ 

⌦ Article 2(2) ⌫ 

⌦ Article 2(3) ⌫  

⌦ ____ ⌫  

⌦ ____ ⌫  

⌦ Article 3 ⌫ 

⌦ Article 4 ⌫ 

⌦ Article 5 ⌫ 

⌦ Article 6 ⌫ 

⌦ Article 7 ⌫ 

⌦ Article 8 ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ Article 2(3) to (19) ⌫  

⌦ Article 3 ⌫ 

⌦ Article 4 ⌫ 

⌦ Article 5 ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ Article 6 ⌫ 

⌦ Article 7 ⌫ 

⌦ Article 8 ⌫ 

⌦ Article 9 ⌫ 

⌦ Article 10 ⌫ 

⌦ Article 11 ⌫ 

⌦ Article 12 ⌫ 

⌦ Article 9(1), introductory wording ⌫  ⌦ Article 13(1), introductory 

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wording ⌫ 

⌦ Article 9(1), point (a) ⌫ 

⌦ Article 13(1), point (a) ⌫ 

⌦ Article 9(1), point (b) ⌫ 

⌦ Article 13(1), point (b) ⌫ 

⌦ Article 9(2) ⌫ 

⌦ Article 9(3) ⌫ 

⌦ Article 10 ⌫ 

⌦ Article 11 ⌫ 

⌦ Article 12 ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ Article 13, first sentence ⌫ 

⌦ Article 13(2) ⌫ 

⌦ _____ ⌫ 

⌦ ____ ⌫ 

⌦ ___ ⌫ 

⌦ ____ ⌫ 

⌦ Article 14 ⌫ 

⌦ Article 15 ⌫ 

⌦ Article 16 (1) to (4) ⌫ 

⌦ Article 6(2) fourth 
subparagraph ⌫ 

⌦ Article 13, second sentence ⌫ 

⌦ Article 17 ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ Article 18 ⌫ 

⌦ Article 19 ⌫ 

⌦ Article 20 ⌫ 

⌦ Article 21 ⌫ 

⌦ Article 22 ⌫ 

⌦ Article 23 ⌫ 

⌦ Article 24 ⌫ 

⌦ Article 25 ⌫ 

⌦ Article 26 ⌫ 

⌦ Article 27 ⌫ 

⌦ Article 28 ⌫ 

⌦ Article 29 ⌫ 

⌦ Article 30 ⌫ 

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⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ Article 14 ⌫ 

⌦ Article 15 ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ Article 16 ⌫ 

⌦ Article 17 ⌫ 

⌦ Article 18 ⌫ 

⌦ ____ ⌫ 

⌦ Article 19 ⌫ 

⌦ Annex I ⌫ 

⌦ Article 31 ⌫ 

⌦ Article 32 ⌫ 

⌦ Article 33 ⌫ 

⌦ Article 34 ⌫ 

⌦ Article 35 ⌫ 

⌦ Article 36 ⌫ 

⌦ Article 37 ⌫ 

⌦ Article 38 ⌫ 

⌦ Article 39 ⌫ 

⌦ Article 40 ⌫ 

⌦ Article 3(3) ⌫ 

⌦ ____ ⌫ 

⌦ Article 41 ⌫ 

⌦ Article 42(1) ⌫ 

⌦ Article 42(2) ⌫ 

⌦ Article 43 ⌫ 

⌦ Article 44, first 
subparagraph ⌫ 

⌦ Article 44, second 
subparagraph ⌫ 

⌦ Article 45 ⌫ 

⌦ Annex I ⌫ 

⌦ Annex II, point 1 ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ Annex II, point 1 ⌫ 

⌦ Annex II, point 2 ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ Annex II, point 2 ⌫ 

⌦ Annex II, point 3 ⌫ 

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⌦ Annex II, point 3 ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ Annex II, point 4 ⌫ 

⌦ Annex II, point 5 ⌫ 

⌦ Annex II, point 4 ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ Annex II, point 6 ⌫ 

⌦ Annex II, point 5 ⌫ 

⌦ Annex II, point 7 ⌫ 

⌦ Annex III ⌫ 

⌦ Annex IV ⌫ 

⌦ Annex V ⌫ 

⌦ Annex VI ⌫ 

⌦ Annex VII ⌫ 

⌦ Annex VIII ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ Annex III ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ ____ ⌫ 

⌦ Annex IV ⌫ 

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