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 Memb er States relating to making available on 
the market of non-automatic weighing instruments 
(Recast) 
(Text with EEA relevance)   
EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT OF THE PROPOSAL  
General context, reasons for and objectives of this proposal  
This proposal is presented in the framework of the implementation of the “goods package”  
adopted in 2008. It is part of  a package of proposals aligni ng ten product directives to 
Decision No 768/2008/EC  establishing a common framework for the marketing of products. 
Union (EU) harmonisation legislation ensuring th e free movement of products has contributed 
considerably to the completion and operation of the Single Market. It is based on a high level of protection and provides econom ic operators with the means to demonstrate conformity, 
thus ensuring free movement through trust in the products.  
Directive 2009/23/EC is an exam ple of that Union harmonisation legislation, ensuring the free 
movement of non-automatic weighing instruments.  It sets out essentia l requirements that non-
automatic weighing instruments must comply with  in order to be made available on the EU 
market. Manufacturers must demo nstrate that a non-automatic we ighing instrument has been 
designed and manufactured in compliance with the essential requirements and affix the CE 
marking.  
Experience with the implementation of Uni on harmonisation legislation has shown – on a 
cross-sector scale - certain weaknesses and inconsistencies in the implementation and 
enforcement of this legislation, leading to 
– 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 beco me more and more complex, as frequently 
several pieces of legisla tion apply simultaneously to one and the same product. 
Inconsistencies in these piece s of legislation make it increasingly difficult for economic 
operators and authorities to correctly interpret an d apply that legislation. 
To remedy these horizontal shortcomings in Union harmonisation legislation observed across 
several industrial sectors, 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 applica tion and enforcement. The New Legislative 
Framework (NLF) consists of tw o complementary instruments, Regulation (EC) No  
EN 3   EN 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 contro ls of products from th ird countries. Since 1 
January 2010 these rules apply di rectly in all Member States. 
The NLF Decision sets out a common framewor k for EU product harmonisation legislation. 
This framework consists of the provision s which are commonly used in EU product 
legislation (e.g. definitions, obligations of economic operators, notified bodies, safeguard 
mechanisms, etc). These common provisions ha ve been reinforced to ensure that the 
directives can be applied and enforced more ef fectively in practice. New elements, such as 
obligations on importers, have been introduced, which are crucial for improving the safety of 
products on the market.  
The provisions of the NLF Decision and those of the NLF Regulation are complementary and 
closely interlinked. The NLF Decision contains  the corresponding obligations for economic 
operators and notified bodies allowing market  surveillance authoriti es and authorities 
responsible for notified bodies to properly pe rform the tasks imposed on them by the NLF 
Regulation and to ensure an effective and cons istent enforcement of EU product legislation.  
However, unlike the NLF Regulation, the provis ions of the NLF Deci sion are not directly 
applicable. To ensure that all economic sect ors subject to Union ha rmonisation legislation 
benefit from the improvements of the NLF, th e provisions of the NLF Decision need to be 
integrated into the ex isting product legislation. 
A survey after the adoption of the goods packag e in 2008 showed that a majority of Union 
harmonisation legislation on products was due to be revised within the following 3 years, not 
only to address the problems observed throughout  all sectors but also for sector-specific 
reasons. Any such revision would automatically  include an alignment of the legislation 
concerned to the NLF Decision since Parlia ment, Council and Comm ission have committed 
themselves to use its provisions as much as po ssible in future legislation on products in order 
to further the utmost coheren ce of the regulatory framework..  
For a number of other Union harmonisation di rectives, including Di rective 2009/23/EC no 
revision for sector-specific probl ems had been envisaged within this timeframe. To ensure 
that the problems in relation to non-compliance and no tified bodies are neve rtheless addressed 
in these sectors, and for the sake of consistency of the overall regulatory environment on products, it was decided to alig n these directives w ithin a package to th e provisions of the 
NLF Decision. 
Consistency with other policies and objectives of the Union 
This initiative is in line with the Single Market Act
1, which has stressed the need to restore 
consumer confidence in the quality of products on the market and the importance of reinforcing market surveillance. 
                                                
 
1 Communication from the Commission to the European  Parliament, the Council, the Economic and 
Social Committee and the Committee of the Regions, COM(2011) 206 final.  
EN 4   EN Furthermore it supports the Commission’s polic y on Better Regulation and simplification of 
the regulatory environment. 
2. CONSULTATION OF INTEREST ED PARTIES AND IMPACT 
ASSESSMENT 
Consultation of interested parties 
The alignment of Directive 2009/23/EC to the NL F Decision has been discussed with national 
experts responsible for the implementation of this Directive and w ith other interested 
stakeholders as well as in bilateral meetings with 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 quest ionnaires for economic operators, 
authorities, notified bodies and users and the Commission servic es received 300 replies. The 
results are published at:  
http://ec.europa.eu/enterpri se/policies/single-market-goods /regulatory-policies-common-
rules-for-products/new-legislative-framework/index_en.htm  
In addition to the general cons ultation a specific SME consulta tion was carried out. 603 SMEs 
were consulted through the En terprise Europe Network in May/June 2010. The results are 
available at http://ec.europa.eu/ enterprise/policies/ single-market-goods/f iles/new-legislative-
framework/smes_statistics_en.pdf  
The consultation process revealed widespread su pport for the initiative. There is unanimity on 
the need to improve market surveillance and th e system for assessing and monitoring Notified 
Bodies. Authorities fully support the exercise b ecause it will strengthen the existing system 
and improve cooperation at EU level. Industry expects a more level playing field resulting 
from more effective actions agai nst products that do not comply with the legislation, as well 
as a simplification effect from the alignment of  legislation. Certain co ncerns were expressed 
on some obligations which are, however, indispen sable for increasing the efficiency of market 
surveillance. These measures wi ll not entail significant costs for industry, and the benefits 
resulting from improved market surveill ance should by far outweigh the costs.  
Collection and use of expertise 
The impact assessment for this implementati on package has largely built on the impact 
assessment carried out for the New Legislativ e Framework. In addition to the expertise 
collected and analysed in that context, furt her consultation of sector-specific experts and 
interest groups, as well as horizontal expert s active in the area of technical harmonisation, 
conformity assessment, accreditation and market surveillance, has taken place. 
Impact assessment  
Based on the information collected, the Commissi on carried out an impact assessment which 
examined and compared three options. 
Option 1 - No changes to  the current situation   
EN 5   EN This option proposes no changes to the current  directive and relies exclusively on certain 
improvements that can be expected from the NLF Regulation. 
Option 2 – Alignment to the NLF Deci sion by non-legislative measures 
Option 2 considers the possibility  of encouraging a voluntary ali gnment to the provisions set 
out in the NLF Decision by, e.g., presenting them  as best practices in guidance documents. 
Option 3 – Alignment to NLF Deci sion by legislative measures 
This option consists in integrating the provis ions of the NLF Decisi on into the existing 
directives. 
Option 3 was found to be the preferred option because – it will improve the competitiveness of comp anies 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 econom ic operators and notified bodies; for those 
who are already acting responsib ly, no extra costs or only neg ligible costs are expected; 
– it is considered more effective than option 2: du e to the lack of enforc eability of option 2 it 
is questionable that the positive impact s would materialise under that option; 
– options 1 and 2 do not provide answers to the pr oblem 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 le gislation and should therefor e be given a consistent 
meaning throughout that legislation. 
3.2. Obligations of economic operators  and traceability requirements 
The proposal clarifies the obligat ions of manufacturers and au thorised representatives and 
introduces obligations for impor ters and distributors. Importe rs must verify that the 
manufacturer has carried out the applicable conformity assessment procedure and has drawn 
up a technical documentation. They must also ma ke sure with the manufacturer that this 
technical documentation can be made availa ble to authorities upon request. Furthermore 
importers must verify that the 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 wher e this is not possible 
on the packaging or the accompanying documenta tion. Distributors must verify that the non-
automatic weighing instrument bears the CE ma rking, the name of th e manufacturer and of  
EN 6   EN the importer, if relevant, and that it is accompanied by the required documentation and 
instructions. 
Importers and distributors must cooperate w ith market surveillance authorities and take 
appropriate actions when they have s upplied non-compliant non-automatic weighing 
instruments.  
Enhanced traceability obligations  are introduced for all economic operators. Non-automatic 
weighing instruments have to bear the manuf acturer’s name and address and a number 
allowing to identify and link the non-automa tic weighing instrument  to its technical 
documentation. When a non-automatic weighing in strument is imported the importer’s name 
and address must also be on the non-automa tic 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 in strument 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 pro posal for a Regulation 
on European Standardisation
2 that sets out a horizontal legal framework for European 
standardisation. The proposal for the Regu lation contains inter alia provisions on 
standardisation requests from the Commission to the European Standardisation Organisations, 
on the procedure for objections to harmonised standards and on stakehol der 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 confor mity when standards only partially cover the 
essential requirements.  
3.4. Conformity assessment and CE marking 
Directive 2009/23/EC has selected the appropria te conformity assessment procedures which 
manufacturers have to apply in order to demonstrate that  their non-automatic weighing 
instruments comply with the essential requiremen ts. 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 Dir ective 2009/23/EC as th e intervention in cer tain cases of two 
notified bodies in the production  control phase. Furthermore,  the statistical verification 
provided for in Modules F and F1 of the NLF Deci sion 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]  
EN 7   EN 3.5. Notified Bodies 
The proposal reinforces the notification crite ria for notified bodies.  It clarifies that 
subsidiaries or subcontractors mu st also comply with the notif ication requirements. Specific 
requirements for notifying authorities are intro duced, and the procedure for notification of 
notified bodies is revised. The competence of a notified body must be demonstrated by an 
accreditation certificate. Where accr editation has not been used to evaluate the competence of 
a notified body, the notification must compri se the documentation demonstrating how the 
competence of that body has been evaluated. Member  States will have the possibility to object 
to a notification. 
3.6. Market surveillance and the safeguard clause procedure 
The proposal revises the existing safeguard cl ause procedure. It introduces a phase of 
information exchange between Member States, and specifies the steps to be taken by the authorities concerned, when a non-compliant no n-automatic weighing instrument is found. A 
real safeguard clause procedure – leading to  a Decision at Commissi on level on whether a 
measure is justified or not - is only launched wh en another Member State objects to a measure 
taken against a non-automatic weighing instrume nt. 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 Tr eaty on the Functioning of the European Union. 
Subsidiarity principle 
The internal market is a competence that is sh ared between the Union and the Member States. 
The subsidiarity principle aris es in particular with regard  to the newly added provisions 
aiming at the improvement of effective enfo rcement of Directive 2009/23/EC, namely, the 
importer and distributor obligations, the tr aceability provisions, the provisions on the 
assessment and notification of notified bodies, and the enhanced cooperation obligations in 
the context of the revised market su rveillance and safeguard procedures.  
Experience with the enforcement of the legislat ion has shown that measures taken at national 
level have led to divergent ap proaches and to a different tr eatment of economic operators 
inside the EU, which undermines the objective of th is directive. If actions are taken at national 
level to address the problems, this risks cr eating obstacles to the free movement of goods. 
Furthermore action at national level is limited to the territorial competence of a Member State. 
In view of the increasing internationalisation of  trade, the number of cross-border cases is 
constantly rising. Coordinated ac tion at EU level can much be tter achieve the objectives set, 
and will in particular render market surveillance  more effective. Hence it is more appropriate 
to take action at EU level. 
As regards the problem of inconsistencies thro ughout the directives, th is is a problem which 
can only be solved by the EU legislator. 
Proportionality   
EN 8   EN In accordance with the principle of proportiona lity, the proposed modifications do not go 
beyond what is necessary to achieve the objectives set.  
The new or modified obligations do not impos e unnecessary burdens an d costs on industry - 
especially on small and medium sized enterpri ses - or administrations . Where modifications 
have been identified to have negative impacts, the analysis of the impacts of the option serves 
to provide the most proportionate respons e to the problems identified. A number of 
modifications concern the improvement of cl arity of the existing Directive without 
introducing new requirements th at 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 r eadability of the amended text the 
technique of recasting has been chosen in line with the Interinstitutional Agreement of 28 
November 2001 on a more structured use of  the recasting technique for legal acts3.  
The changes made to the provisions of Direct ive 2009/23/EC concern: the definitions, the 
obligations of economic operators, the presum ption 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.  
EN 9   EN  
 
Ð 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 CO UNCIL OF THE EUROPEAN UNION, 
Having regard to the Treaty esta blishing the European Community  ⌦ on the Functioning of 
the European Union ⌫, and in particular Article 95  ⌦ 114 ⌫ thereof, 
Having regard to the proposal from the European Commission, 
After transmission of the draft legislative act to the national Parliaments,  Having regard to the opinion of the Eu ropean Economic and Social Committee
4, 
Acting in accordance with the or dinary legislative procedure, 
Whereas: 
 
Ð 2009/23/EC recital 1 (adapted) 
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 b een substantially 
amended6. In the interests of clarit y and rationality the said Di rective should be codified.  
                                                 
4 OJ C […], […], p. […]. 
5 OJ L 189, 20.7.1990, p. 1.  
6 See Annex VII, Part A.   
EN 10   EN  
Ø new 
(1) 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. 
(2) Regulation (EC) No 765/2008/EC of the Europe an Parliament and of  the Council of 9 
July 2008 setting out the requirements fo r accreditation and market surveillance 
relating to the marketing of products and repealing Regulation (EEC) No 339/938 lays 
down rules on the accreditation of conf ormity assessment bodies, provides a 
framework for the market surveillance of products and for controls on products from 
third countries, and lays down the gene ral principles of the CE marking. 
(3) Decision No 768/2008/EC of the European Par liament and of the Council of 9 July 
2008 on a common framework for the marketi ng of products and repealing Council 
Decision 93/465/EEC9 lays down a common framework of general principles and 
reference provisions intende d to apply across the le gislation harmonising the 
conditions for the marketing of products in order to provide a coherent basis for 
revision or recasts of that legislation. Directive 2009/23/EC should therefore be 
adapted to that Decision. 
 
Ð 2009/23/EC recital 2  
(4)  Member States have the res ponsibility of protecting the publ ic against incorrect results 
of weighing operations by m eans of non-automatic weighing instruments when used 
for certain categories of applications. 
 
Ð 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 s pecifying 
metrological and technical requirements, toge ther with inspection procedures before 
and after going into service. These mandato ry provisions do not necessarily lead to 
different levels of protec tion from one Member Stat e to another but do, by the ir 
disparity, impede trade within the Community.  
 
Ø new 
(5) Economic operators should be responsible  for the compliance of non-automatic 
weighing instruments, in relati on to their respective roles in the supply chain, so as to 
                                                 
7 OJ L 122, 16.5.2009, p. 6. 
8 OJ L 218, 13.8.2008, p. 30. 
9 OJ L 218, 13.8.2008, p. 82.  
EN 11   EN ensure a high level of protec tion of public interests, as health and safety and the 
protection of users, and to guarantee fair competition on the Union market. 
(6) All economic operators interv ening in the supply and dist ribution chain should take 
appropriate measures to ensure that th ey 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 propor tionate distribution of  obligations which 
correspond to the role of each operator in the supply and distribution process. 
(7) The manufacturer, having detailed knowledge  of the design and pr oduction process, is 
best placed to carry out the complete conf ormity assessment procedure. Conformity 
assessment should therefore remain the ob ligation of the manu facturer alone. 
(8) It is necessary to ensure that non-automa tic 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 conf ormity assessment procedures have been 
carried out and that product marking a nd documentation drawn up by manufacturers 
are available for inspection by the supervisory authorities. 
(9) The distributor makes a non-automatic weighi ng instrument available on the market 
after it has been placed on the market by the manufacturer or th e 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 inst rument on the market, every importer 
should indicate on the non-automatic weighing instrument his name and the address at 
which he can be contacted. Ex ceptions should be provided fo r in cases where the size 
or nature of the non-automatic weighing in strument 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 trademar k or modifies a non-automatic weighing 
instrument in such a way that compliance w ith 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 carri ed out by the competent national authorities, and should 
be prepared to participate actively, providing those auth orities with all necessary 
information relating to the non-automa tic weighing instrument concerned. 
(13) Ensuring traceability of a non-automatic we ighing instrument throughout the whole 
supply chain helps to make market survei llance simpler and more efficient. An 
efficient traceability system facilitates market  surveillance authorities' task of tracing  
EN 12   EN economic operators who made non-complia nt non-automatic weighing instruments 
available on the market. 
 
Ð 2009/23/EC recital 4 (adapted)  
Ö new 
(14) This Directive should set out  Ö be limited to the expression of  mandatory and  the 
essential requirements as regards metrol ogy 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,  Ö that are 
adopted in accordance with Regulation (EU) No [../..] of the European Parliament and 
of the Council of […..] on Eu ropean 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 inst ruments complying with those harmonised 
standards may be assumed to confor m 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 Eur opean Committee for Standardisation (CEN), 
the European Committee for Electrotechni cal Standardisation (Cenelec) and the 
European Telecommunicati ons 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 bod ies, signed on 28 March 2003 . 
 
Ø new 
(15) Regulation (EU) No [../..] [European Sta ndardisation] provides for a procedure for 
objections to harmonised standards where those standards do not entirely satisfy 
requirements of this Directive. 
 
Ð 2009/23/EC recital 5 (adapted) 
A series of Directives designed to remove technical barriers to trade in accordance 
with the principles established in th e Council Resolution of 7 May 1985 on a new 
approach to technical ha rmonisation and standards12 has been adopted; each of those 
Directives provides for th e affixing of the ‘CE’ c onformity marking. In its 
communication of 15 June 198913 on a global approach to certification and testing, 
                                                 
10 OJ L […], […], p. […]. 
11 OJ C 91, 16.4.2003, p. 7.  
12 OJ C 136, 4.6.1985, p. 1.  
13 OJ C 267, 19.10.1989, p. 3.   
EN 13   EN the Commission proposed that comm on 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 appr oved 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 basi c elements of the new approach which 
should be applied are the essential requi rements and the conformity assessment 
procedures.  
 
Ð 2009/23/EC recital 6 
(16) Assessment of conformity with the relevant  metrological and tech nical 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 b arriers to the free movement 
of the instruments, arrangements should be made for the mutual recognition of 
conformity assessment procedures by the Me mber States. To fac ilitate the mutual 
recognition of conformity assessment procedures, Community  procedures  should be 
set up, together with criteria  for the designation of the bodi es responsible for carrying 
out tasks pertaining to the conformity assessment procedures.  
 
Ø new 
(17) In order to enable economic operators to de monstrate and the competent authorities to 
ensure that non-automatic weighing instru ments 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 leve l of risk involved a nd the level of safety required. In order to 
ensure inter-sectoral coherence and to avoi d ad-hoc variants, c onformity assessment 
procedures should be chosen from among those modules.  
(18) Manufacturers should draw up an EU declara tion of conformity to provide detailed 
information on the conformity of the non- automatic weighing instrument with the 
requirements of  this Directive and of other releva nt Union harmonisation legislation. 
(19) The CE marking, indicating the conformity of a non-automatic weighing instrument, is 
the visible consequence of a whole proce ss comprising conformity assessment in a 
broad sense. General principl es governing the CE marking a nd 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” stic ker should be laid down in this Directive . 
                                                 
14 OJ C 10, 16.1.1990, p. 1.   
EN 14   EN  
Ø new 
(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.  
 
Ð 2009/23/EC recital 7 
It is therefore essential to ensure that such designated  bodies ensure a high level of 
quality throughout the Community.   
 
Ø new 
(21) Experience has shown that the criteria set out in Directive 2009/23/ EC that conformity 
assessment bodies have to fulfil to be notif ied to the Commission are not sufficient to 
ensure a uniformly high level of performan ce of notified bodies th roughout the Union. 
It is, however, essential that all notified bodies perform their functions to the same 
level and under conditions of fair competition. That requires the setting of obligatory 
requirements for conformity assessment bodies wishing to be notified in order to 
provide conformity assessment services. 
(22) In order to ensure a consis tent 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. 
(23) If a conformity assessment body demonstrates conformity with the criteria laid down 
in harmonised standards, it should be pres umed to comply w ith the corresponding 
requirements set out in this Directive. 
(24) The system set out in this Directive s hould be complemented by the accreditation 
system provided for in Regulation (EC)  No 765/2008. Since accreditation is an 
essential means of verifying the compet ence of conformity assessment bodies, it 
should also be used for th e purposes of notification. 
(25)  Transparent accreditation as provided fo r in Regulation (EC) No 765/2008, ensuring 
the necessary level of confid ence in conformity certificates , should be considered by 
the national public authorit ies throughout the Union as the preferred means of 
demonstrating the technical competence of  conformity assessment bodies. However, 
national authorities may consider that they  possess the appropriate means of carrying 
out this evaluation themselves. In such cases , in order to ensure the appropriate level 
of credibility of evaluations carried out  by other national authorities, they should 
provide the Commission and the other Member  States with the necessary documentary 
evidence demonstrating the compliance of th e conformity assessment bodies evaluated 
with the relevant regu latory requirements. 
(26) Conformity assessment bodies frequently subc ontract parts of their activities linked to 
the assessment of conformity or have recour se to a subsidiary. In  order to safeguard  
EN 15   EN 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 notifie d bodies in relation to the 
performance of conformity assessment tasks. Therefore, it is important that the 
assessment of the competence and the performance of bodies  to be notified and the 
monitoring of bodies alr eady notified cover also activities carried out by 
subcontractors and subsidiaries. 
(27) It is necessary to increase the efficiency a nd transparency of the notification procedure 
and, in particular, to adapt it to new technol ogies so as to enable online notification. 
(28) Since notified bodies may offer their services  throughout the Union, it is appropriate to 
give the other Member States and the Co mmission 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 co mpetence of conformity assessment bodies 
can be clarified before they start operating as notified bodies. 
(29) In the interests of competitiveness, it is  crucial that notified bodies apply the 
conformity assessment procedures without  creating unnecessary burdens for economic 
operators. For the same reason, and to ensu re equal treatment of  economic operators, 
consistency in the technical application of the conformity assessment procedures needs 
to be ensured. That can best be achie ved through appropriate  coordination and 
cooperation between notified bodies. 
(30) In order to ensure legal certainty, it is necessary to clarify that rules on Union market 
surveillance and control of products ente ring the Union market provided for in 
Regulation (EC) No 765/2008 apply to non-au tomatic 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 pro cessing 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 supplemen ted 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 Commissi on agree as to the justification of a 
measure taken by a Member State, no furt her involvement of the Commission should 
be required, except where non- compliance can be attributed to shortcomings of a 
harmonised standard.  
EN 16   EN (34) Member States should lay down rules on penalt ies applicable to infringements of the 
national provisions adopted pur suant to this Directive a nd 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-au tomatic 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 require ments providing a high level of protection 
of health and safety and other public inte rests 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 effect s, 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 Un ion. 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. 
 
Ð 2009/23/EC recital 8 
The presence on a non -automatic weighing instrument of the ‘CE’ conformity 
marking or of the s ticker bearing the letter ‘M’ s hould indicate th at 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.  
 
Ø new 
(37) The obligation to transpose this Directive in to 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 wh ich are unchanged arises 
under the earlier Directive. 
 
Ð 2009/23/EC recital 9 
(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. ,  
EN 17   EN  
Ð 2009/23/EC (adapted) 
HAVE ADOPTED THIS DIRECTIVE: 
CHAPTER 1 
SCOPE, PLACING ON THE MARKET AND FREE MOVEMENT  
⌦ GENERAL PROVISIONS ⌫ 
Article 1 
⌦ Scope ⌫ 
 
Ð 2009/23/EC (adapted) 
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: 
 (a)  
 (ai ) determination of mass for commercial transactions; 
 (bii ) determination of mass fo r the calculation of a toll, tariff, tax, bonus, 
penalty, remuneration, indemnity or similar type of payment; 
 (ciii ) determination of mass for the applicati on of laws or regulations or for an 
expert opinion given in court proceedings; 
 (div ) determination of mass in the practi ce 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 th an those listed in points  (a) ⌦ to (f) ⌫ .  
EN 18   EN  
Ð 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 interventi on of an operator during weighing; 
 
Ð 2009/23/EC 
3. ‘harmonised standard’: a technical specifi cation (European standard or harmonised 
document) adopted by the European Comm ittee for Standardisation (CEN), the 
European Committee for Electrotechnical Standa rdisation (Cenelec), or the European 
Telecommunications Standards Institute (ETS I), or by two or th ree 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 lay ing down a procedure 
for the provision of information in the fi eld of technical standards and regulations15 
and the general guidelines for cooperat ion between the Commission, the European 
Free Trade Association (EFTA) and those three bodies, signed on 28 Ma rch 2003.  
 
Ø new 
(3) ‘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; 
(4) ‘placing on the market’ means the first making available of an instrument on the 
Union market; 
(5) ‘manufacturer’ means any natural or legal person who manufactures an instrument or 
has an instrument designed or manufactur ed, and markets that instrument under his 
name or trademark; 
                                                 
15 OJ L 204, 21.7.1998, p. 37.   
EN 19   EN (6) ‘authorised representative’ means any natural or legal person established within the 
Union who has received a written mandate fr om a manufacturer to act on his behalf 
in relation to specified tasks; 
(7) ‘importer’ means any natural or legal person established within the Union who 
places an instrument from a third country on the Union market; 
(8) ‘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; 
(9) ‘economic operators’ means the manufact urer, the authorised representative, the 
importer and the distributor; 
(10) ‘technical specification’ means a document that prescribes technical requirements to 
be fulfilled by an instrument, process or service; 
(11) ‘harmonised standard’ means harmonised st andard as defined in Article 2(1)(c) of 
Regulation (EU) No […] [E uropean Standardisation]; 
(12) ‘accreditation’ means accreditation as defi ned in Article 2(10) of  Regulation (EC) No 
765/2008; 
(13) ‘national accreditation b ody’ means national accreditation body as defined in Article 
2(11) of Regulation (EC) No 765/2008; 
(14) ‘conformity assessment’ means the pro cess demonstrating whether the requirements 
of this Directive relating to an instrument have been fulfilled; 
(15) ‘conformity assessment body’ means a body  that performs conformity assessment 
activities including calib ration, testing, certification and inspection; 
(16) ‘recall’ means any measure aimed at achie ving the return of an instrument that has 
already been made available to the end user; 
(17) ‘withdrawal’ means any measure aimed at  preventing an instrument in the supply 
chain from being made available on the market; 
(18) ‘CE marking’ means a marking by whic h the manufacturer indicates that the 
instrument is in conformity with the applicable requirements set out in Union 
harmonisation legislation pr oviding for its affixing; 
(19) ‘Union harmonisation legi slation’ means any Union legislation harmonising the 
conditions for the marketing of products.  
EN 20   EN  
Ð 2009/23/EC (adapted) 
Article 3 
⌦ Making available on the mark et and putting into service ⌫ 
 
Ð 2009/23/EC 
Ö new 
1. Member States shall take all steps to en sure that only instruments that meet the 
requirements of this Directive may be placed  Ö made available  on the market. 
 
Ð 2009/23/EC (adapted) 
2. Member States shall take all steps to ensu re 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’ conform ity marking provided for 
in Article 11 . 
Article 14  
3. Member States shall take all steps to ensure that instrume nts 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 ⌫ 
 
Ð 2009/23/EC 
Ö new 
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 Ö and bear the CE marking and the inscriptions 
provided for in point 1 of Annex III  .   
EN 21   EN  
Ð 2009/23/EC 
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. 
 
Ð 2009/23/EC (adapted) 
Article 5 
⌦ Free movement ⌫ 
 
Ð 2009/23/EC  
Ö new 
1. Member States shall not impede the placing  Ö making available  on the market of 
instruments which meet the requirements of this Directive. 
2. Member States shall not impede the putting into service, for the uses referred to in 
points  (a) to (f)  of Article 1(2), of instruments which m eet the requirements of this Directive. 
 
Ø 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 shal l ensure that they have been designed and 
manufactured in accordance with the esse ntial 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), manufacturer s shall ensure that they bear the inscriptions provided for in 
point 2 of Annex III.  
EN 22   EN 2. For the instruments used for the applications listed in points (a) to (f) of Article 1(2), 
manufacturers shall draw up th e required technical documentati on 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 a pplicable 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 liste d in points (a) to (f ) of Article 1(2), 
manufacturers shall affix the inscriptions provided for in point 2 of Annex III. 
 
Ð 2009/23/EC (adapted) 
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, devi ces that have not been subject to conformity 
assessment as  referred to in Article 9 13, 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 . 
 
Ø new 
3. For the instruments used for the applications listed in points (a) to (f) of Article 1(2), 
manufacturers shall keep the technical documen tation 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 refere nce 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 dist ributors informed of any such monitoring. 
5. Manufacturers shall ensure that their instrume nts bear a type, batch or serial number or 
other element allowing their identi fication, as set out in Annex III. 
6. Manufacturers shall indicate their name, regi stered 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 th e manufacturer can be contacted. 
7. Manufacturers 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. 
8. Manufacturers who consider or have reason to  believe that an instrument which they 
have placed on the market is no t in conformity with  this Directive shal l immediately take the  
EN 23   EN necessary corrective measures to bring that in strument 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 eff ect, 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 info rmation and documentation necessary to demonstrate the 
conformity of the instrument, in a language wh ich 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 author ised representative's mandate. 
2. An authorised representative shall perform the tasks specified in the mandate received 
from the manufacturer. The mandate shall allow th e authorised representative to do at least 
the following: 
(a) keep the EU declaration of conform ity and the technical documentation at the 
disposal of national surveillance author ities for 10 years after the instrument 
has been placed on the market; 
(b) further to a reasoned request from a competent national authority, provide that 
authority with all the information and documentation necessary to demonstrate 
the conformity of an instrument; 
(c) 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  
EN 24   EN documents, and that the manufacturer has complie d 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 Articl e 1(2) is not in confor mity 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, wher e the instrument presen ts 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 inst rument bears the inscriptions provided 
for in point 2 of Annex III a nd that the manufacturer has complied with the requirements set 
out in Article 6(5) and (6).  
3. Importers shall indicate their name, register ed 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 inst rument used for the applications listed in 
points (a) to (f) of Article 1(2) is under thei r responsibility, storage or transport conditions do 
not jeopardise its compliance with the esse ntial requirements set out in Annex I. 
6. When deemed appropriate w ith 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. 
7. Importers who consider or have reason to be lieve that an instrument which they have 
placed on the market is not in conformity w ith this Directive shall immediately take the 
corrective measures necessary to bring that in strument into conformity, to withdraw it or 
recall it, if appropriate. Furthermore, where th e 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 eff ect, 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 dispos al of the market surveillance authorities and 
ensure that the technical documentation can be  made available to those authorities, upon 
request. 
9. Importers shall, further to a reasoned request from a competent national authority, 
provide it with all the info rmation and documentation necessary to demonstrate the 
conformity of an instrument in a language wh ich 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.   
EN 25   EN Article 9 [Article R5 of Decision No 768/2008/EC] 
Obligations of distributors 
1. When making an instrument available on th e market distributors shall act with due 
care in relation to the requirements of this Directive. 
2. Before making an instrument used for the ap plications listed in points (a) to (f) of 
Article 1(2) available on the ma rket, distributors shall verify th at 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 in formation in a language which can be easily 
understood by consumers and other end-users in th e 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 belie ve 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 co nformity. 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 app lications listed in points (a) to (f) of Article 
1(2) available on the market, distributors shall ve rify that the instrument bears the inscriptions 
provided for in point 2 of Annex III and that th e manufacturer and the importer have complied 
with the requirements set out in Article 6(5)  and (6)  and Article 8(3). 
3. Distributors shall ensure that, while an in strument used for the applications listed in 
points (a) to (f) of Article 1(2) is under thei r responsibility, storage or transport conditions do 
not jeopardise its compliance with the esse ntial requirements set out in Annex I. 
4. Distributors who consider or have reason to believe that an instrument which they 
have made available on the market is not in co nformity with this Directive shall make sure 
that the corrective measures necessary to bring th at instrument into conformity, to withdraw it 
or recall it, if appropriate, are taken. Furthe rmore, where the instrument presents a risk, 
distributors shall immediately inform the compet ent 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 info rmation and documentation necessary to demonstrate the 
conformity of an instrument. Th ey shall cooperate with that authority, at its request, on any 
action taken to eliminate the risks posed by inst ruments which they have made available on 
the market.   
EN 26   EN Article 10 [Article R6 of Decision No 768/2008/EC] 
Cases in which obligations of manufactu rers apply to importers and distributors 
An importer or distributor shall be consider ed a manufacturer for the purposes of this 
Directive and he shall be subject to the obliga tions of the manufacturer  under Article 6, where 
he places an instrument on the market under his name or trademar k or modifies an instrument 
already placed on the market in such a way th at 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 re quest, identify the following to  the market surveillance 
authorities: 
(a) any economic operator who has s upplied 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. 
 
Ð 2009/23/EC (adapted) 
CHAPTER 2 3 
CONFORMITY ASSESSME NT ⌦ OF INSTRUMENTS ⌫ 
 
Ð 2009/23/EC  
Article 6  
1. Member States shall presume conformity with  the essential requireme nts set out in Annex I 
in respect of instruments which comply with the relevant national standard s 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 .  
EN 27   EN Member States shall publish the refer ences of the national standard s referred to in paragraph 
1. 
 
Ø new 
Article 12 [Article R8 of Decision No 768/2008/EC] 
Presumption of conformity 
Instruments which are in conformity with harmoni sed 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 essent ial requirements covered by those standards or 
parts thereof, set out in Annex I. 
[Where a harmonised standard sa tisfies the requirements which it  covers and which are set out 
in Annex I or Article 23, the Commission shall publ ish the references of that standard in the 
Official Journal of the European Union .] 
 
Ð 2009/23/EC (adapted) 
Article 9 13 
⌦ Conformity assessment procedures ⌫ 
 
Ð 2009/23/EC 
1. The conformity of instruments to the essen tial requirements set out in Annex I may be 
certified by either of the following pro cedures as selected by the applicant: 
 
Ð 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 conform ity (guarantee of production 
qualit y) ⌦ 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 lo ad-measuring device of which does not use a 
spring to balance the load ⌦ . For those instruments not submitted to Module B, Module D1  
EN 28   EN 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 th e procedures referred  to in paragraph 1 
shall be drafted in an  ⌦ one of the ⌫ official languages of th e 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. 
 
Ð 2009/23/EC  
3. Where the instruments are subject to other Directives co vering other aspects and 
which also provide for the affixing of the ‘C E’ conformity marking, that marking shall 
indicate that the instruments in question are al so presumed to conform to the provisions of 
those other Directives.  
 Howev er, where one or more of the Directives  which apply to the instruments allow 
the manufacturer, durin g a transitional period, to choose wh ich arrangements to apply, the 
‘CE’ conformity marking shall indicate confor mity 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 consid ers that the harmonised standards referred to 
in Article 6(1) do not fully meet the esse ntial requirements set out in Annex I, the 
Commission or the Member St ate concerned shall bring the matter before the Standi ng 
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 info rm the Member States 
whether or not it is necessary to withdraw those standards from the publications referred to in 
Article 6(2).   
EN 29   EN  
Ø new 
Article 14 [Article R10 of Decision No 768/2008/EC] 
EU declaration of conformity 
1. The EU declaration of conformity shall state that the fulfilment of the essential 
requirements set out in Anne x I has been demonstrated. 
2. The EU declaration of conformity shall ha ve the model structure set out in Annex III 
of Decision No 768/2008/EC, shall contain the elements specified in the relevant modules set 
out in Annex II to this Directiv e 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 mo re than one Union act requiring an EU 
declaration of conformity, a single EU declaratio n of conformity shall be drawn up in respect 
of all such Union acts. That de claration shall contain the identification of the acts concerned 
including the publication references. 
4. By drawing up the EU declaration of c onformity, the manufacturer shall assume 
responsibility for the comp liance of the instrument. 
 
Ð 2009/23/EC  
Article 8  
1. Where a Member State considers th at 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 fo r which they are intended, it shall take all 
appropriate measu res to withdraw those instruments from th e market or to prohibit or restrict 
their being put into service and/or placed on the market.  
The Member State concerned sh all immediately inform the Comm ission of any such measure, 
indicating the reasons for its de cision, and in particular whether non -compliance is due to:  
 (a) failure to meet the essential requiremen ts set out in Annex I, where instruments 
do not meet the harmonised standard s referred to in Article 6(1);  
 (b) incorrect applica tion of the harmonised  standards referred to in Article 6(1);  
 (c) shortcomings in the harmonised standard s referred to in Article 6(1) themselves.  
2. The Commission shall enter into consultati on with the parties concerned as soon as 
possible.   
EN 30   EN After such consultation the Commis sion 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 shor tcomings in the standards, the Commis sion, after consulting 
the parties concerned, shall br ing the matter before the Committee within two months if the 
Member State which has taken the measures inte nds to maintain them, and shall subsequently 
initiate the procedures referred to in Article 7.  
3. Where an instrument which does not comp ly 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 Stat es 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 pro cedures 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 th e body no 
longer meets the criteria for designation referred  to in paragraph 2. It shall immediately 
inform the other Member States and the Comm ission thereof and withdraw the notification.   
EN 31   EN CHAPTER  3  
‘CE’ CONFORMITY MARKING AND INSCRIPTIONS  
 
Ø 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 Ar ticle 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 pr ovided for in point 1 of Annex III or the 
inscriptions provided for in poin t 2 of Annex III shall be affixe d visibly, legibly and indelibly 
to the instrument or to its data plate. 
2. The CE marking and/or the inscriptions sh all be affixed before the instrument is 
placed on the market. 
3. The CE marking shall be followed by the id entification number of the notified body 
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. 
4. The CE marking and the identification num ber referred to in paragraph 3 may be 
followed by a pictogram or any other mark  indicating a special risk or use. 
5. The CE marking and the identification numbe r referred to in paragraph 3 shall be 
followed by the sticker bearing the letter “M”, provided for in point 1.1(b) of Annex III.   
EN 32   EN  
Ð 2009/23/EC 
Article  11 
1. The ‘CE’ conformity marking and the require d supplementary data as described in Annex 
IV, point 1, shall be affixed in a clearly visible, easily le gible and indelible form to 
instruments for which EC conform ity 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 marki ngs which are likely to deceive thi rd parties 
as to the meaning and form of the ‘CE’ conf ormity marking shall be prohibited. Any other 
marking may be affixed to the in struments provided th at the visibility a nd legibility of the 
‘CE’ conformity marking is not thereby reduced.  
Article 12  
With out prejudice to Article 8:  
 (a) where a Member State establishes that  the ‘CE’ conformity marking has been 
affixed unduly, the manufacturer or his author ised representative established within 
the Community shall be obliged to make the instrument conform a s 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 t he placing on the market of the instrument in 
question or to ensure that it is withdraw n from the market in accordance with the 
procedures laid down in Article 8.  
 
Ð 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 clea rly visible and indelible form.  
EN 33   EN  
Ø 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 th e 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 monito ring 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 referr ed to in paragraph 1 to a b ody which is not a governmental 
entity, that body shall be a legal entity an d shall comply mutatis mutandis with the 
requirements laid down in Article 20(1) to (6). In addition it sh all have arrangements to cover 
liabilities arising out of its activities. 
4. The notifying authority shall take full re sponsibility for the tasks performed by the 
body referred to in paragraph 3. 
Article 20 [Article R15 of Decision No 768/2008/EC] 
Requirements relating to notifying authorities 
1. A notifying authority shall be established in  such a way that no conflict of interest 
with conformity assessment bodies occurs.  
EN 34   EN 2. A notifying authority shall be organised and operated so as to safeguard the objectivity 
and impartiality of its activities. 
3. A notifying authority shall be organised in such a way that each decision relating to 
notification of a conformity a ssessment body is taken by competent persons different from 
those who carried out the assessment. 
4. A notifying authority shall not offer or provide any activities that conformity 
assessment bodies perform or consultancy services on a commercial or competitive basis. 
5. A notifying authority shall safeguard the c onfidentiality of the information it obtains. 
6. A notifying authority shall have a suffici ent number of compet ent personnel at its 
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 a ssessment bodies and the monitori ng 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 
1. For the purposes of notification, a c onformity assessment body shall meet the 
requirements laid down in paragraphs 2 to 11. 
2. A conformity assessment body shall be esta blished under national law and have legal 
personality. 
3. A conformity assessment body shall be a third-party body i ndependent of the 
organisation or the instrument it assesses. 
A body belonging to a business association or professional federation representing 
undertakings involved in the de sign, manufacturing, provision, assembly, use or maintenance 
of instruments which it assesses, may, on conditi on that its independenc e and the absence of 
any conflict of interest are demons trated, be considered such a body. 
4. A conformity assessment body, its top level management and the personnel 
responsible for carrying out th e conformity assessm ent tasks shall not be the designer, 
manufacturer, supplier, installer,  purchaser, owner, user or maintainer of the instruments 
which they assess, nor the authorised representa tive of any of those pa rties. 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.  
EN 35   EN A conformity assessment body, its top level management and the personnel responsible for 
carrying out the conformity asse ssment tasks shall not be dir ectly involved in the design, 
manufacture or construction, th e marketing, installation, us e or maintenance of those 
instruments, or represent the pa rties engaged in those activities. They shall not engage in any 
activity that may c onflict with their independence of judge ment or integrity in relation to 
conformity assessment activities for which they are notified. This shall in particular apply to 
consultancy services. 
Conformity assessment bodies sh all ensure that th e activities of their subsidiaries or 
subcontractors do not affect the c onfidentiality, objectivity or impartiality of their conformity 
assessment activities. 
5. Conformity assessment bodies and their pe rsonnel shall carry out the conformity 
assessment activities with the highest degree of professional integr ity 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. 
6. A conformity assessment body shall be capab le of carrying out all the conformity 
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 conf ormity assessment body itself or on its behalf 
and under its responsibility. 
At all times and for each conformity asse ssment procedure and each kind or category of 
instruments in relation to which it has been no tified, a conformity assessment body shall have 
at its disposal the necessary: 
(a) personnel with technical knowledge and sufficient and appropriate experience 
to perform the conformity assessment tasks; 
(b) descriptions of procedures in accord ance with which conformity assessment is 
carried out, ensuring the transparency and the ability of reproduction of those 
procedures. It shall have appropriate policies and procedures in place that 
distinguish between tasks it carries out as a notifi ed body and other activities; 
(c) procedures for the performance of activ ities which take due account of the size 
of an undertaking, the sector  in which it operates, it s structure, the degree of 
complexity of the instrument technol ogy in question and the mass or serial 
nature of the production process. 
It shall have the means necessary to perform the technical and admini strative tasks connected 
with the conformity assessment activities in an appropriate manner and shall have access to 
all necessary equipment or facilities. 
7. The personnel responsible for carrying out conformity assessment activities shall have 
the following: 
(a) sound technical and vocational training covering all the conformity assessment 
activities in relation to  which the conformity assessment body has been 
notified;  
EN 36   EN (b) satisfactory knowledge of the requiremen ts of the assessments they carry out 
and adequate authority to carry out those assessments; 
(c) appropriate knowledge and understanding of the essential requirements set out 
in Annex I, of the applicable harm onised standards and of the relevant 
provisions of Union harmoni sation legislation and of  national legislation; 
(d) the ability to draw up certificates, records and reports demonstrating that 
assessments have been carried out. 
8. The impartiality of the conformity asse ssment bodies, their top level management and 
of the assessment pers onnel shall be guaranteed. 
The remuneration of the top level management  and assessment pers onnel 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 lia bility insurance unless liability is 
assumed by the State in accordance with national law, or the Memb er State itself is directly 
responsible for the conformity assessment. 
10. The personnel of a conformity assessm ent body shall observe professional secrecy 
with regard to all information obtained in ca rrying out their tasks und er Article 13 or any 
provision of national law giving effect to it, exce pt in relation to the competent authorities of 
the Member State in which its act ivities are carried out. Proprieta ry rights shall be protected. 
11. Conformity assessment bodies shall partic ipate in, or ensure that their assessment 
personnel are informed of, the relevant standa rdisation activities and the activities of the 
notified body coordination gr oup established under the re levant 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 subcontrac ting by notified bodies 
1. Where a notified body subcontracts specif ic tasks connected with conformity 
assessment or has recourse to a subsidiary, it  shall ensure that the subcontractor or the  
EN 37   EN subsidiary meets the requirements set out in  Article 22 and shall inform the notifying 
authority accordingly. 
2. Notified bodies shall take full responsibil ity for the tasks performed by subcontractors 
or subsidiaries wherever these are established. 
3. Activities may be subcontracted or carried out by a subsidiary only with the agreement 
of the client. 
4. Notified bodies shall keep at the disposal  of the notifying authority the relevant 
documents concerning the assessment of the qua lifications of the subcontractor or the 
subsidiary and the work carried  out by them under Article 13. 
Article 25 [Article R22 of Decision No 768/2008/EC] 
Application for notification 
1. A conformity assessment body shall submit an application for notification to the 
notifying authority of the Member State in which it is established. 
2. That application shall be accompanied by a description of the conformity assessment 
activities, the conformity assessment module or modules and the instrument or instruments for 
which that body claims to be competent, as we ll as by an accreditation certificate, where one 
exists, issued by a national accreditation body attesting that the conf ormity assessment body 
fulfils the requirements laid down in Article 22. 
3. Where the conformity assessment body c oncerned cannot provide  an accreditation 
certificate, it shall provide the notifying aut hority with all the documentary evidence 
necessary for the verification, recognition and re gular monitoring of its compliance with the 
requirements laid down in Article 22. 
Article 26 [Article R23 of Decision No 768/2008/EC] 
Notification procedure 
1. Notifying authorities may notify only conf ormity assessment bodies which have 
satisfied the requirements laid down in Article 22. 
2. They shall notify the Commission and the ot her Member States using the electronic 
notification tool developed and managed by the Commission. 
3. The notification shall include full details of the conformity assessment activities, the 
conformity assessment module or modules and 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  
EN 38   EN competence and the arrangements in place to ensure that that body will be monitored 
regularly and will continue to satisfy th e requirements laid down in Article 22. 
5. The body concerned may perform the activ ities of a notified body only where no 
objections are raised by the Commission or the other Member States within two weeks of a 
notification where an accreditati on certificate is used or within  two months of a notification 
where accreditation is not used. 
Only such a body shall be considered a notifie d body for the purposes of this Directive. 
6. The Commission and the othe r Member States shall be notified of any subsequent 
relevant changes to the notification.  
Article 27 [Article R24 of Decision No 768/2008/EC] 
Identification numbers and lists of notified bodies 
1. The Commission shall assign an iden tification number to a notified body. 
It shall assign a single such number even wh ere 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 identif ication 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 
1. Where a notifying authority has ascertained or has been informed that a notified body 
no longer meets the requirements laid down in Artic le 22, or that it is failing to fulfil its 
obligations, the notifying authority shall rest rict, suspend or withdraw notification as 
appropriate, depending on the seriousness of the fa ilure to meet those requirements or fulfil 
those obligations. It sh all immediately inform the Commi ssion 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 notifyi ng 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.  
EN 39   EN Article 29 [Article R26 of Decision No 768/2008/EC] 
Challenge of the competence of notified bodies 
1. The Commission shall investigate all cases  where it doubts, or doubt  is brought to its 
attention regarding, the competence of a no tified body or the continued fulfilment by a 
notified body of the requirem ents and responsibilities to which it is subject. 
2. The notifying Member State shall provide  the Commission, on request, with all 
information relating to the basis for the notificat ion or the maintenance of the competence of 
the body concerned. 
3. The Commission shall ensure that all sensi tive information obtained in the course of 
its investigations is treated confidentially. 
4. Where the Commission ascertains that a notified body does not meet or no longer 
meets the requirements for its notification, it  shall inform the notifying Member State 
accordingly and request it to take  the necessary corrective measures, including de-notification 
if necessary. 
Article 30 [Article R27 of Decision No 768/2008/EC] 
Operational obligations of notified bodies 
1. Notified bodies shall carry  out conformity assessments in accordance with the 
conformity assessment procedures provided for in Annex II. 
2. Conformity assessments shall be carried  out in a proportionate  manner, avoiding 
unnecessary burdens for economic  operators. Conformity asse ssment 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 complex ity of the instrument technology in question and 
the mass or serial nature of the production process. 
In so doing they shall nevert heless respect the degree of rigour  and the level of protection 
required for the compliance of the instrument with the provisions of this Directive. 
3. Where a notified body finds that the esse ntial requirements set out in Annex I or 
corresponding harmonised standards or technical  specifications have  not been met by a 
manufacturer, it shall re quire that manufacturer to take a ppropriate corrective measures and 
shall not issue a conformity certificate. 
4. Where, in the course of the monitori ng of conformity follo wing the issue of a 
certificate, a notified body finds that an instru ment no longer complies, it shall require the 
manufacturer to take appropria te corrective measures and sh all suspend or withdraw the 
certificate if necessary. 
5. Where corrective measures are not taken or do not have the required effect, the 
notified body shall restrict, suspend or withdraw any cer tificates, as appropriate.  
EN 40   EN Article 31  
Appeal against decisions of notified bodies 
Member States shall ensure that  an appeal procedur e 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 no tifying authority of the following: 
(a) any refusal, restriction, suspensi on 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 confor mity assessment activities; 
(d) on request, conformity assessment activ ities 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 bodi es 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 coope ration between bodies 
notified under this Directive are put in place and pr operly operated in the form of a sectoral or 
cross sectoral group or groups of notified bodies. 
Member States shall ensure that the bodies notifie d by them participate in the work of that or 
those group or groups, directly or by m eans of designated representatives.  
EN 41   EN CHAPTER 5 
UNION MARKET SURVEILLANCE, CONTROL OF 
INSTRUMENTS ENTERING THE UNION MARKET AND 
SAFEGUARD PROCEDURES 
Article 35 
Union market surveillance, control of instruments entering the Union market 
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 
1. Where the market surveillance authoritie s of one Member State have taken action 
pursuant to Article 20 of Regulation (EC) No 765/2008, or where they have sufficient reason 
to believe that an instrument covered by this Di rective presents a risk to the aspects of public 
interest protection covered by this Directive, th ey 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 th e market surveillance 
authorities. 
Where, in the course of that  evaluation, the market surveill ance 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 al l appropriate corrective action 
to bring the instrument into compliance with th ose requirements, to withdraw the instrument 
from the market, or to recall it within a reasonable period, comme nsurate with the nature of 
the risk, as they may prescribe. 
The market surveillance author ities 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 authori ties consider that non-compliance is not 
restricted to their national territory, they sh all 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 en sure that all appropriate co rrective action is taken in 
respect of all the instruments concerned that it has made av ailable on the market throughout 
the Union.  
EN 42   EN 4. Where the relevant economic operator does not  take adequate corrective action within 
the period referred to in the second subparagr aph of paragraph 1, the market surveillance 
authorities shall take all appropriate provis ional measures to prohibit or restrict the 
instrument's being made available on their natio nal 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 fo r the identification of  the non-compliant instrument, the origin 
of the instrument, the nature of the non-comp liance alleged and the risk involved, the nature 
and duration of the national measures taken an d the arguments put forward by the relevant 
economic operator. In particular, the market surv eillance authorities sha ll indicate whether the 
non-compliance is due to either of the following: 
(a) failure of the instrument to meet re quirements relating to the aspects of public 
interest protection laid down in this Directive; 
(b) shortcomings in the harmonised standards referred to in Article 12 conferring a 
presumption of conformity. 
6. Member States other than the Member St ate initiating the procedure shall without 
delay inform the Commission and the other Memb er 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 w ith the notified national measure, of their 
objections. 
7. Where, within two months of receipt of th e 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. 
8. Member States shall ensure that appropriate  restrictive measures are taken in respect 
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 ou t 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 le gislation, 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 releva nt economic operator or operators.  
EN 43   EN 2. If the national measure is considered justified, all Member States shall take the 
measures necessary to ensure that the non-compliant instrume nt is withdrawn from their 
market, and shall inform the Commission accordi ngly. If the national measure is considered 
unjustified, the Member State concer ned 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 
1. Where, having performed an evaluation under Article 36(1), a Member  State finds that 
although an instrument is in compliance with this  Directive, it presents a risk to aspects of 
public interest protection, it shall require th e relevant economic operator to take all 
appropriate measures to ensure that the inst rument concerned, when placed on the market, no 
longer presents that risk, to with draw the instrument from the mark et or to recall it within a 
reasonable period, commensurate with the natu re of the risk, as it may prescribe. 
2. The economic operator shall ensu re that corrective action is taken in respect of all the 
instruments concerned that he has made av ailable on the market throughout the Union. 
3. The Member State shall immediately info rm the Commission and the other Member 
States. That information shall include all availabl e details, in particular  the data necessary for 
the identification of the instrument concer ned, 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 in to consultation with the Member States 
and the relevant economic opera tor or operators and shall ev aluate the national measures 
taken. On the basis of the results of that ev aluation, the Commission shall decide whether the 
measure is justified or not, and where necessary, propose appropriate measures. 
5. The Commission shall address its decision to  all Member States and shall immediately 
communicate it to them and the releva nt economic operator or operators. 
Article 39 [Article R34 of Decision No 768/2008/EC] 
Formal non-compliance 
1. Without prejudice to Article 36, where a Member State makes one of the following 
findings, it shall require the re levant economic operator to put an end to the non-compliance 
concerned:  
EN 44   EN (a) the CE marking and/or the inscriptions provided for in Annex III have been 
affixed in violation of Article 30 of Re gulation (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 conf ormity has not been drawn up; 
(d) the EU declaration of conform ity 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 appropria te measures to restrict or pr ohibit the instrument being made 
available on the market or ensure that it is  recalled or withdrawn from the market. 
 
Ð 2009/23/EC (adapted) 
CHAPTER 4 6 
⌦ TRANSITIONAL AND  ⌫ FINAL PROVISIONS  
 
Ð 2009/23/EC 
Article 15  
Any de cision 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 dela y to the party concerne d, who shall at the same 
time be informed of the judicial remedies av ailable to him under the laws in force in the 
Member State in question and of the time limits to which such remedies are subject.  
 
Ø 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.  
EN 45   EN The penalties provided for shall be eff ective, 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 av ailable on the market and/or the putting into 
service of instruments covered by Directive 20 09/23/EC which are in c onformity with that 
Directive and which were pla ced on the market before [the  date set out in the second 
subparagraph of Article 42(1)].  
Certificates of conformity issued under Di rective 2009/23/EC shal l be valid under this 
Directive until [the date set out in the second subparagraph of Article 42(1)] unless they 
expire before that date. 
 
Ð  
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 provi sions and a correlation table between those 
provisions and this Directive. 
They shall apply those provisions from [day after the date set out in the first subparagraph]. 
When Member States adopt those provisions, they  shall contain a refere nce to this Directive 
or be accompanied by such a reference on the occas ion of their official publication. They shall 
also include a statement that references in existing laws, regulations  and administrative 
provisions to the Directive repealed by this Direc tive shall be construed as references to this 
directive. Member States shall determine how such reference is to be made and how that 
statement is to be formulated.  
EN 46   EN  
Ð 2009/23/EC  
Article 16  
2. Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 
 
Ð 2009/23/EC (adapted) 
Article 17 43 
⌦ 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 Stat es 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 . 
 
Ð 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 VIII IV. 
 
Ð 2009/23/EC (adapted) 
Article 18 44 
⌦ 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 appl y from [the date set out in 
the second subparagraph of Article 42(1)].  
EN 47   EN  
Ð 2009/23/EC 
Article 19 45 
This Directive is addressed to the Member States. 
Done at […], 
For the European Parliament For the Council 
The President The President 
EN 48   EN  
Ð 2009/23/EC (adapted) 
ANNEX I  
ESSENTIAL  REQUIREMENTS  
The terminology used is that of the Inte rnational Organisation  of Legal Metrology. 
Preliminary observation  
Where an instrument includes, or is connected to, more than one indica ting or printing device 
used for the applications listed in points  (a) to (f)  of Article 1(2), thos e devices which repeat 
the results of the weighing operation and whic h cannot influence the correct functioning of 
the instrument shall not be subject to the e ssential 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 part ies concerned by the 
measurement. However, in the case of instrument s used for direct sales to the public, display 
and printing devices for the vendor and the cust omer must fulfil the essential requirements. 
METROLOGICAL  REQUIREMENTS  
1. Units of mass 
The units of mass used shall be the legal un its within the meaning of Council Directive 
80/181/EEC of 20 December 1979 on the approximati on of the laws of the Member States 
relating to units of measurement16. 
Subject to compliance with this cond ition, 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 car at, 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.   
EN 49   EN (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 
I 0,001 g ≤ e 100 e 50 000 — 
0,001 g ≤ e ≤ 
0,05 g 20 e 100 100000 II 
0,1 g ≤ e 50 e 5000 100000 
0,1 g ≤ e ≤ 2 
g 20 e 100 10000 III 
5 g ≤ e 20 e 500 10000 
IIII 5 g ≤ e 10 e 100 1000 
 
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 interv al (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 thos e with auxiliary indicating devices: 
d = e. 2.2.3. For instruments with auxiliary indicati ng devices the following conditions apply: 
e = 1 × 10
k g,; 
d < e ≤ 10 d, .  
EN 50   EN 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 colu mn 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 cl asses 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 equi pped 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) > e i 
— its maximum capacity Max i with Max r = Max 
— its minimum capacity Min i with Min i = Max (i – 1) 
and Min 1 = Min 
 where: 
i = 1, 2, … r, 
i = partial weighing range number, 
r = the total number of partial weighing ranges. 
 
All capacities are capacities of net load, ir respective of the value of any tare used.  
EN 51   EN 3.3.3. The partial weighing ranges are classified according to Table 2. All partial weighing 
ranges shall fall into the same accur acy class, that class being the instrument’s accuracy class.  
Table 2  
Multi-interval instruments  
 i = 1, 2, … r 
 i = partial weighing range number  r = total number of pa rtial weighing ranges 
Class Verification scale 
interval (e) Minimum 
capacity (Min) Number of verifica tion scale intervals 
   Minimum value Minimum value17 
n = 
((Max i)/(e (i+1))) Maximum value 
n = ((Max i)/(e i)) 
I 0,001 g ≤ ei 100 e 1 50000 — 
0,001 g ≤ ei ≤ 
0,05 g 20 e 1 5000 100000 II 
0,1 g ≤ ei 50 e 1 5000 100000 
III 0,1 g ≤ ei 20 e 1 500 10000 
IIII 5 g ≤ ei 10 e 1 50 1000 
 
4. Accuracy 
4.1. On implementation of the proce dures laid down in Article 9 13, 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 sh all 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 
Class I Class II Class III Class IIII Maximum 
permissible error 
                                                 
17 For i = r, the corresponding column of  Table 1 applies, with e replaced by e r.  
EN 52   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 ±1,0 e 
200000 e < m 20000 e < m ≤ 
100000 e 2000 e < m ≤ 
10000 e 200 e < m ≤ 
1000 e ±1,5 e 
 
4.2. The maximum permissible errors in servi ce 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 accordan ce with other methods of balancing used. 
The weighing results shall be sufficiently insens itive 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 pow er 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 automatica lly 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 conditi ons 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 53   EN 7.6. Under other conditions the instruments shall ei ther continue to function correctly or be 
automatically put out of service. 
Design and construction  
8. General requirements 8.1. Design and construction of the instrument s shall be such that  the instruments will 
preserve their metrological qualities when properl y used and installed a nd when used in an 
environment for which they are intended. Th e value of the mass must be indicated. 
8.2. When exposed to disturban ces, electronic instruments sha ll not display the effects of 
significant faults, or shall automatically detect and indicate them. 
Upon automatic detection of a si gnificant fault, elec tronic instruments sha ll provide a visual 
or audible alarm that shall continue until th e 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 si gnificant durability error, electr onic instruments shall provide 
a visual or audible alarm that sh all continue until the user take s 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 sha ll not be adversely influenced. 
8.5. The instruments shall have no characteristics likely to fac ilitate fraudulent use, whereas 
possibilities for unintentional misuse shall be minimal. Components that may not be 
dismantled or adjusted by the user sh all be secured against such actions. 
8.6. Instruments shall be designed to permit rea dy execution of the statutory controls laid 
down by this Directive. 
9. Indication of weighing resu lts and other weight values 
The indication of the weighing results and other weight values shall be accurate, unambiguous 
and non-misleading and the indi cating 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 add ition of the symbol for the metric carat which 
shall be the symbol ‘ct’. 
Indication shall be impossibl e above the maximum capacity (Max), increased by 9 e.  
EN 54   EN An auxiliary indicating device is permitted only to  the right of the decimal mark. An extended 
indicating device may be used only temporaril y, 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 result s and other weight values 
Printed results shall be  correct, suitably iden tified and unambiguous. The printing shall be 
clear, legible, non-erasable and durable. 
11. Levelling 
When appropriate, instruments shall be fitted w ith a levelling device and a level indicator, 
sufficiently sensitive to allow proper installation. 
12. Zeroing 
Instruments may be equipped with zeroing device s. 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 devi ces and a preset tare device. The operation of 
the tare devices shall result in accurate zeroing and shal l ensure correct net weighing. The 
operation of the preset tare devi ce shall ensure corre ct 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 sh all show all essential information about the 
weighing operation and, in the case of price-i ndicating instruments, sh all 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 indicati ons 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 extende d indicating devices are not permitted.  
EN 55   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 requ irements of price indicating instruments for 
direct sale to the public, as far as applicable to the instrument in que stion. The printing of a 
price label shall be impossi ble below a minimum capacity. 
 
Ð 2009/23/EC 
ANNEX II  
CONFORMITY  ASSESSMENT  PROCEDURES  
 
Ð 2009/23/EC (adapted) 
1. ⌦ MODULE B : EU ⌫ EC-type examination  
 
Ð 2009/23/EC 
1.1. EC type -examination is the procedure whereby a notified body verifies and certifies that 
an instrument, representative of the productio n 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 represen tative 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 th e application has not been l odged 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 56   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 ma nufacturer meet the essential  requirements where the 
harmonised standards referred to in Ar ticle 6(1) have not been applied;  
1.3.4. perform or have performed the appropriate ex aminations 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 descripti on 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 periodica lly make available to all Membe r States the list of:  
– applications received for EC type -examination,  
– EC type -approval certificates issued,  
– applications for type -certificates refused,  
– additions and amendments relati ng to documents already issued.  
Each notified body shall moreover inform a ll the Member States fort hwith of withdrawals of 
EC type -approval certificates.  
Each Member State shall make this informati on 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 k eep the notified body that has issued the EC type -approval certificate 
informed of any modifica tion to the approved type.   
EN 57   EN Modifications to the approved type must receive additional approval from the notified body 
that issued the EC type -approval certificate where such cha nges 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.  
 
Ø new 
1.1. EU-type examination is the part of a confor mity 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 meet s the requirements of this Di rective that apply to it. 
1.2. EU-type examination may be carried out in any of the following manners: 
– examination of a specimen, representati ve of the production envisaged, of the 
complete instrument (production type); 
– assessment of the adequacy of the tec hnical design of the instrument through 
examination of the technical documentation and supporting evidence referred to in 
point 1.3, plus examination of specime ns, representative of the production 
envisaged, of one or more critical pa rts of the instrument (combination of 
production type and design type); 
– assessment of the adequacy of the tec hnical 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)  the name and address of the manufactu rer and, if the application is lodged by 
the authorised representative, his name and address as well; 
(b) a written declaration that the same a pplication has not been lodged with any 
other notified body; 
(c) the technical documentation. The tech nical documentation shall make it 
possible to assess the instrument's confor mity with the applicable requirements 
of this Directive and shall include an adequate analysis and assessment of the 
risk(s). The technical documentation sha ll specify the applicable requirements 
and cover, as far as relevant for the assessment, the design, manufacture and 
operation of the instrument. The t echnical documentation shall contain, 
wherever applicable, at l east the following elements: 
(i) a general descripti on of the instrument; 
(ii) conceptual design and manuf acturing drawings and schemes of 
components, sub-assemblies, circuits, etc.;  
EN 58   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 standa rds and/or other re levant technical 
specifications the references of wh ich 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 ha rmonised 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 ma de, examinations carried out, etc.; 
(vi) test reports; 
(d) the specimens representative of the production envisaged. The notified body 
may request further specimens if needed  for carrying out the test programme; 
(e) the supporting evidence for the adequacy of the technical design solution. This 
supporting evidence shall mention any doc uments that have been used, in 
particular where the relevant harm onised standards and/or technical 
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 manufactur er, or by another testing laboratory on his behalf 
and under his responsibility. 
1.4. The notified body shall: 
For the instrument: 
1.4.1. examine the technical documentation and s upporting evidence to asse ss the adequacy of 
the technical design of the instrument; 
For the specimen(s): 
1.4.2. verify that the specimen(s) have been ma nufactured in conformity  with the technical 
documentation, and identify the elements which ha ve been designed in accordance with the 
applicable provisions of the rele vant 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 te sts, 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 te sts, or have them carried out, to check 
whether, where the solutions in the releva nt harmonised standards and/or technical 
specifications have not been applied, the so lutions adopted by the manufacturer meet the 
corresponding essential require ments of this Directive; 
1.4.5. agree with the manufacturer on a location where the examinations and tests will be 
carried out.  
EN 59   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 rel ease the content of that report, in full or in 
part, only with the agreem ent of the manufacturer. 
1.6. Where the type meets the requirements of th is Directive, the notif ied body shall issue an 
EU-type examination certificate to the manufactu rer. The certificate shall contain the name 
and address of the manufacturer, the conclusion s of the examination, the conditions (if any) 
for its validity and the necessary data for iden tification of the approve d type. The certificate 
may have one or more annexes attached. 
The certificate and its a nnexes shall contain all relevant information to allow the conformity 
of manufactured instruments w ith 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 tw o 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 examinati on 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 no tified 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 conform ity of the instrument with the essential 
requirements of this Directive or the condi tions 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 in form its notifying authorit ies concerning the EU-type 
examination certificates and/or any additions thereto which it has issued or withdrawn, and 
shall, periodically or upon re quest, make available to its no tifying authorities the list of 
certificates and/or any additi ons thereto refused, suspende d or otherwise restricted. 
The Commission, the Member States and the ot her notified bodies may, on request, obtain a 
copy of the EU-type examinati on certificates and/or additions thereto. On request, the 
Commission and the Member St ates may obtain a copy of the technical documentation and 
the results of the examinations carried out by  the notified body. The not ified body shall keep a 
copy of the EU-type examination certificate, it s annexes and additions, as well as the 
technical file including the documentation subm itted 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 th e technical documentation at the disposal of the national 
authorities for 10 years af ter the instrument has b een placed on the market.  
EN 60   EN 1.10. The manufacturer's authorised representative may lodge the application referred to in 
point 1.3 and fulfil th e obligations set out in points 1.7 and 1.9, provided that they are 
specified in the mandate. 
 
Ð 2009/23/EC (adapted) 
2. EC declaration of type conformi ty (guarantee of production quality)  ⌦ MODULE D: 
Conformity to type based on quality assurance of the production process ⌫ 
 
Ð 2009/23/EC 
2.1. The EC declaration of type conformity (gua rantee of production qual ity) is the procedure 
whereby the manufacturer who satisfies the obligations of  point 2.2 declare s 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 wit hin 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 imple mented a quality system as specified in 
point 2.3 and shall be subject to EC surveillance as specified in point 2.4.  
2.3. Qu ality 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 conform ity 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 t he manufacturer shall be 
documented in a systematic and orderly manner in the form of written rules, procedures and 
instructions. This quality system documentati on shall ensure a prope r understanding of the 
quality programmes, plans, manuals and records.   
EN 61   EN It shall contain in particular an adequate description of:  
– the quality objectives and the organisational structure, responsibi lities and powers of 
the management with regard to product quality,  
– the manufacturing process, the quality control and assurance te chniques 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 pr oduct 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 refe rred 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 manufactur er 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 auth orised representative shall k eep the notified body that has 
approved the quality system informed of any updating of the quality assuran ce 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 th e approved quality system.  
2.4.2. The manufacturer shall grant the notif ied body access for inspection purposes to the 
manufacture, inspection, testing and st orage 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 repo rts and tests and calib ration 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 62   EN In addition, the notified body may carry out unscheduled visits  to the manufacturer. During 
such visits, the notified body may carry out fu ll or partial audits. It shall provide the 
manufacturer with a report on the visit,  and, where appropriate, an audit report.  
2.4.3. The notifie d body shall ensure that  the manufacturer maintains and applies the 
approved quality system.  
 
Ø new 
2.1. Conformity to type based on quality assuran ce of the production process is the part of a 
conformity assessment procedure whereby the ma nufacturer 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 w ith 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 fo r production, final instrument 
inspection and testing of the instruments conc erned 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) the name and address of the manufactu rer and, if the application is lodged by 
the authorised representative, his name and address as well; 
(b) a written declaration that the same application has not been lodged with any 
other notified body; 
(c) all relevant information for th e instrument category envisaged; 
(d) the documentation concerning the quality system; 
(e) the technical documentation of the a pproved type and a copy of the EU-type 
examination certificate. 
2.3.2. The quality system shall ensure that the in struments are in confor mity with the type 
described in the EU-type examination certificat e and comply with the requirements of this 
Directive that apply to them. 
All the elements, requirements and provisi ons adopted by the ma nufacturer shall be 
documented in a systematic and orderly manner in the form of written policies, procedures 
and instructions. The quality system documentati on shall permit a consistent interpretation of 
the quality programmes, plans, manuals and records. 
It shall, in particular, contai n an adequate description of:  
EN 63   EN (a) the quality objectives and the organi sational structure, responsibilities and 
powers of the management with regard to instrument quality; 
(b) the corresponding manufacturing, qua lity control and quality assurance 
techniques, processes and systematic actions that will be used; 
(c) the examinations and tests that will be carried out before, during and after 
manufacture, and the frequency with which they will be carried out;  
(d) the quality records, such as inspection reports and test data, calibration data, 
qualification reports on the personnel concerned, etc.; 
(e) the means of monitoring the achieveme nt of the required instrument quality 
and the effective operati on of the quality system. 
2.3.3. The notified body shall assess  the quality system to dete rmine whether it satisfies the 
requirements referred to in point 2.3.2. 
It shall presume conformity with those requireme nts in respect of the elements of the quality 
system that comply with th e corresponding specifica tions of the national standard that 
implements the relevant harmonised sta ndard 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 appli cable requirements of this Directive. The 
audit shall include an assessment visit to the manufacturer's premises. The auditing team shall 
review the technical docu mentation 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 complian ce of the instrument w ith those requirements. 
The decision shall be notified to the manuf acturer. The notification shall contain the 
conclusions of the audit and th e 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 a pproved 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 requ irements 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 respons ibility 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 th e approved quality system.  
EN 64   EN 2.4.2. The manufacturer shall, for assessment purposes, allow the notified body access to the 
manufacture, inspection, testi ng and storage sites and shall pr ovide 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 unexp ected visits to the manufacturer. During 
such visits the notified body may,  if necessary, carry out instru ment 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 repor t and, if tests have been carried out, with 
a test report. 
2.5. Conformity marking and d eclaration of conformity 
2.5.1. The manufacturer shall affix the CE marki ng 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 inst rument 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 c onformity for each instrument 
model and keep it at the dispos al 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 conf ormity shall be made availabl e 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 dis posal 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 no tified body referred to in points 2.3.5, 2.4.3 
and 2.4.4. 
2.7. Each notified body shall inform its notifyi ng 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, suspe nded or otherwise restricted. 
2.8. Authorised representative  
EN 65   EN 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 respons ibility, provided that they are 
specified in the mandate.  
3. MODULE D1: Quality assurance of the production process 
3.1. Quality assurance of the production proce ss is the conformity assessment procedure 
whereby the manufacturer fulfils the obliga tions laid down in points 3.2, 3.4 and 3.7, and 
ensures and declares on his sole responsibilit y that the instruments concerned satisfy the 
requirements of this Direc tive that apply to them. 
3.2. Technical documentation 
The manufacturer shall estab lish 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 tech nical documentation shall, 
wherever applicable, contain at least the following elements: 
(a) a general descripti on of the instrument; 
(b) conceptual design and manufacturing drawings and schemes of components, 
sub-assemblies, circuits, etc.; 
(c) descriptions and explanations ne cessary for the understanding of those 
drawings and schemes and the operation of the instrument; 
(d) a list of the harmonised standards and/or other releva nt technical specifications 
the references of which have been published in the Official Journal of the 
European Union,  applied in full or in part, an d descriptions of the solutions 
adopted to meet the essential requirem ents of this Directive where those 
harmonised standards have not been appl ied. In the event of partly applied 
harmonised standards, the technical documentation shall specify the parts 
which have been applied; 
(e) results of design calculations ma de, examinations carried out, etc.; 
(f) test reports. 
3.3. The manufacturer shall keep th e technical documentation at th e disposal of the relevant 
national authorities for 10 y ears after the instrument ha s been placed on the market. 
3.4. Manufacturing 
The manufacturer shall opera te an approved quality syst em for production, final product 
inspection and testing of the instruments conc erned as specified in point 3.5, and shall be 
subject to surveillance as  specified in point 3.6. 
3.5. Quality system  
EN 66   EN 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) the name and address of the manufactu rer and, if the application is lodged by 
the authorised representative, his name and address as well; 
(b) a written declaration that the same application has not been lodged with any 
other notified body; 
(c) all relevant information for th e 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 provisi ons adopted by the ma nufacturer shall be 
documented in a systematic and orderly manner in the form of written policies, procedures 
and instructions. The quality system documentati on shall permit a consistent interpretation of 
the quality programmes, plans, manuals and records. 
It shall, in particular, contai n an adequate description of: 
(a) the quality objectives and the organi sational structure, responsibilities and 
powers of the management with regard to instrument quality; 
(b) the corresponding manufacturing, qua lity control and quality assurance 
techniques, processes and systematic actions that will be used; 
(c) the examinations and tests that will be carried out before, during and after 
manufacture, and the frequency with which they will be carried out; 
(d) the quality records, such as inspection reports and test data, calibration data, 
qualification reports on the personnel concerned, etc.; 
(e) the means of monitoring the achieveme nt of the required instrument quality 
and the effective operati on of the quality system. 
3.5.3. The notified body shall assess  the quality system to dete rmine whether it satisfies the 
requirements referred to in point 3.5.2. 
It shall presume conformity with those requireme nts in respect of the elements of the quality 
system that comply with th e corresponding specifica tions of the national standard that 
implements the relevant harmonised sta ndard 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 appli cable requirements of this Directive. The  
EN 67   EN 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 re quirements 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 manuf acturer. The notification shall contain the 
conclusions of the audit and th e 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 a pproved 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 re quirements 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 respons ibility 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 th e approved quality system. 
3.6.2. The manufacturer shall, for assessment purposes, allow the notified body access to the 
manufacture, inspection, testi ng and storage sites and shall pr ovide 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 unexp ected visits to the manufacturer. During 
such visits the notified body may, if necessary, ca rry out product tests, or have them carried 
out, in order to verify that the quality syst em is functioning correc tly. 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 d eclaration of conformity 
3.7.1. The manufacturer shall affix the CE marki ng 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  
EN 68   EN 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 c onformity for each instrument 
model and keep it at the dispos al 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 conf ormity shall be made availabl e 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 dis posal 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 no tified body referred to in points 3.5.5, 3.6.3 
and 3.6.4. 
3.9. Each notified body shall inform its notifyi ng 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, suspe nded 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 a nd 3.8 may be fulfilled 
by his authorised representative , on his behalf and under his res ponsibility, provided that they 
are specified in the mandate. 
 
Ð 2009/23/EC (adapted) 
34. EC  ⌦ MODULE F: Conformity to  type based on product  ⌫ verification  
 
Ð 2009/23/EC 
3.1. EC verification is the procedure where by 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 appli cable, 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 applicab le, with the type as described in 
the EC type -examination certificate and with the requi rements of this Directive which apply 
to them. The manufacturer or hi s authorised representative established within the Community 
shall affix the ‘CE’ conformity marking to each instrument and draw up  a written declaration 
of conformity.   
EN 69   EN 3.3. The notified body shall carry out the appropriat e examinations and tests in order to check 
the conformity of the produc t to the requirements of th is 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 re lating to the design of 
the instrument, as set out in Annex III, must be accessible to the notifie d body should the 
latter so request.  
3.5. Verification by checking and testing of each instrument  
3.5.1. All instruments shall be indi vidually examined and appropriate  tests, as set out in the 
relevant harmonised standards refe rred to in Arti cle 6(1), or e quivalent tests, shall be carried 
out in order to verify their conformity, where ap plicable, 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 affi xed, its identification number on each 
instrument the conformity of which to requireme nts has been established, and shall draw up a 
written certificate of conformity relating to the tests carried out.  
3.5.3. The manufacturer or hi s authorised representativ e shall ensure that he is able to supply 
the notified body’s certificates of conformity on request.  
 
Ø 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 responsi bility that the instruments concerned, which 
have been subject to the provisi ons of point 4.3, are in conform ity with the type described in 
the EU-type examination certificate and satisfy th e requirements of this Directive that apply 
to them. 
4.2. Manufacturing 
The manufacturer shall take all measures necessa ry so that the manufacturing process and its 
monitoring ensure conformity of the manufactured instrument s 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 manuf acturer shall carry out appropriate examinations and tests 
in order to check the conformity of the instru ments with the approved type described in the 
EU-type examination certificate and with the ap propriate 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 examina tion and testing of every instrument  
EN 70   EN 4.4.1. All instruments shall be individually exam ined and appropriate tests set out in the 
relevant harmonised standard(s) an d/or technical specifications, or  equivalent tests, shall be 
carried out in order to  verify conformity with the appr oved type described in the EU-type 
examination certificate and with the appropr iate 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 identif ication 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 y ears after the instrument ha s been placed on the market. 
4.5. Conformity marking and d eclaration of conformity 
4.5.1. The manufacturer shall affix the CE marki ng 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 examina tion certificate and satisfies the applicable 
requirements of this Directive. 
4.5.2. The manufacturer shall draw up a written declaration of c onformity for each instrument 
model and keep it at the disposal of the nationa l 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 conf ormity shall be made availabl e 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 re sponsibility, the manufacturer may affix the 
notified body's identification number to the in struments 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 obliga tions laid down in points 5.2, 5.3, 5.6.1 and 5.7 
and ensures and declares on his sole responsibil ity that the instrument s 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  
EN 71   EN The manufacturer shall estab lish the technical documentation. The documentation shall make 
it possible to assess the instrument's conform ity 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 tech nical documentation shall, 
wherever applicable, contain at least the following elements: 
(a) a general descripti on of the instrument; 
(b) conceptual design and manufacturing drawings and schemes of components, 
sub-assemblies, circuits, etc.; 
(c) descriptions and explanations ne cessary for the understanding of those 
drawings and schemes and the operation of the instrument; 
(d) a list of the harmonised standards and/or other releva nt technical specifications 
the references of which have been published in the Official Journal of the 
European Union , applied in full or in part, an d descriptions of the solutions 
adopted to meet the essential requirem ents of this Directive where those 
harmonised standards have not been appl ied. In the event of partly applied 
harmonised standards, the technical documentation shall specify the parts 
which have been applied; 
(e) results of design calculations ma de, examinations carried out, etc.; 
(f) test reports. 
The manufacturer shall keep th e technical documentation at th e disposal of the relevant 
national authorities for 10 y ears after the instrument ha s been placed on the market. 
5.3. Manufacturing 
The manufacturer shall take all measures necessa ry 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 manuf acturer 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 confor mity 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 examina tion and testing of every instrument 
5.5.1. All instruments shall be individually examin ed and appropriate tests, set out in the 
relevant harmonised standards and/or technical specifications, or equiva lent tests, shall be 
carried out to verify conformity with the requir ements 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.  
EN 72   EN 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 identif ication 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 af ter the instrument has b een placed on the market. 
5.6. Conformity marking and d eclaration of conformity 
5.6.1. The manufacturer shall affix the CE marki ng 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 c onformity for each instrument 
model and keep it at the dispos al 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 conf ormity shall be made availabl e 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 re sponsibility, the manufacturer may affix the 
notified body's identification number to the in struments 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. 
 
Ð 2009/23/EC (adapted) 
46. EC  ⌦ MODULE G: Conformity based on ⌫ unit verification 
 
Ð 2009/23/EC 
4.1. EC unit verification is the procedure wher eby 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 requirem ents of this Directive that apply to it. The 
manufactu rer or his authorised representative shall affix the ‘CE’ conformity marking to the 
instrument and shall draw up a written declaration of conformity.   
EN 73   EN 4.2. The notified body shall examine th e instrument and carry out th e 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 requireme nts has been established, and shall draw up a 
written certificate of conformity concerning the tests carried out.  
4.3. The aim of the technical doc umentation relating to the desi gn of the instrument, as 
referre d to in Annex III, is to enable conformity w ith the requirements of this Directive to be 
assessed and the design, manufacture and operati on of the instrument to be understood. It 
must be accessible to the notified body.  
4.4. The manufacturer or his authori sed representative shall ensure  that he is able to supply 
the notified body’s certificates of conformity on request.  
 
Ø new 
6.1. Conformity based on unit verification is the conformity assessment procedure whereby 
the manufacturer fulfils the ob ligations laid down in points 6.2, 6.3 and 6.5, and ensures and 
declares on his sole responsibil ity that the instrument concer ned, which has be en 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 technica l documentation and make it available to the 
notified body referred to in point  6.4. The documentation shall ma ke it possible to assess the 
instrument's conformity with the relevant requir ements, 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 descripti on of the instrument; 
(b) conceptual design and manufacturing drawings and schemes of components, 
sub-assemblies, circuits, etc.; 
(c) descriptions and explanations ne cessary for the understanding of those 
drawings and schemes and the operation of the instrument; 
(d) a list of the harmonised standards and/or other releva nt technical specifications 
the references of which have been published in the Official Journal of the 
European Union , applied in full or in part, an d descriptions of the solutions 
adopted to meet the essential requirem ents of this Directive where those 
harmonised standards have not been appl ied. In the event of partly applied  
EN 74   EN harmonised standards, the technical documentation shall specify the parts 
which have been applied; 
(e) results of design calculations ma de, examinations carried out, etc.; 
(f) test reports. 
The manufacturer shall keep th e technical documentation at th e disposal of the relevant 
national authorities for 10 y ears after the instrument ha s been placed on the market. 
6.3. Manufacturing 
The manufacturer shall take all measures necessa ry so that the manufacturing process and its 
monitoring ensure conformity  of the manufactured instrument with the applicable 
requirements of this Directive. 
6.4. Verification 
A notified body chosen by the manufacturer shal l carry out appropriat e examinations and 
tests, set out in the relevant harmonised st andards and/or technical  specifications, or 
equivalent tests, to check the conformity of th e 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 cer tificate of conformity in resp ect of the examinations and 
tests carried out and shall affix its identification number to the approved in strument, 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 af ter the instrument has b een placed on the market. 
6.5. Conformity marking and d eclaration of conformity 
6.5.1. The manufacturer shall affix the CE marki ng and the inscriptions provided for in point 
1 of Annex III and, under the re sponsibility of the notified body referred to in point 6.4, the 
latter's identification number to each instrument  that satisfies the appl icable requirements of 
this Directive. 
6.5.2. The manufacturer shall draw up a written d eclaration of conformity  and keep it at the 
disposal of the national authorities for 10 year s after the instrument has been placed on the 
market. The declaration of conf ormity shall identify the instrument for which it has been 
drawn up. 
A copy of the declaration of conf ormity shall be made availabl e to the relevant authorities 
upon request. 
6.6. Authorised representative 
The manufacturer's obligations set out in poi nts 6.2 and 6.5 may be fulfilled by his authorised 
representative, on his behalf and under his respons ibility, provided that th ey are specified in 
the mandate.   
EN 75   EN  
Ð 2009/23/EC (adapted) 
57. Common provisions 
57.1. The EC declaration  of type conformity (guarant ee 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 manufactur er’s works or any other location if 
transport to the place of use does not require di smantling of the instrument, if the putting into 
service at the place of use does not require asse mbly 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 consid eration or if the instrument’s performance is 
insensitive to gravity varia tions. In all other cases, they  ⌦ it ⌫ shall be carried out at the 
place of use of the instrument. 
 
Ð 2009/23/EC 
57.2. If the instrument’s performance is sensitive to gravity variations the procedures referred 
to in point 5 7.1 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 shal l be carried out at th e 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 r ead 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 5 7.1, and where these two stages will be  carried out by different parties, 
an instrument which has undergone the firs t stage of the procedure shall bear the 
identification number of the notif ied body involved in that stage. 
57.2.2. The party which has carried out the first stag e of the procedure sha ll 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 stag e 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. 
 
Ð 2009/23/EC (adapted) 
57.2.3. A manufacturer who has opted for the EC decl aration of type confor mity (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 cont inue in the second stag e with EC verification  
⌦ Module F or F1 as appropriate ⌫ .  
EN 76   EN 57.2.4. The ‘CE’  ⌦ CE ⌫ conformity  marking shall be affixe d to the instrument on 
completion of the second stage,  along with the iden tification number of the notified body 
which took part in the second stage. 
 
Ð 2009/23/EC  
ANNEX III  
DESIGN  TECHNICAL  DOCUMENTATION  
The technical documentation must rende r 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 manuf acturing drawings and plans of components, sub -
assemblies, circuits, etc.,  
– descriptions and explanations necessary fo r 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 ma de 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.  
 
Ð 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:  
EN 77   EN (a) - the ‘CE’  ⌦ CE ⌫ conformity  marking comprising the ‘CE’ symbol  as 
described  ⌦ provided for ⌫ in Annex VI II 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 verif ication  ⌦ involved in the production 
control phase ⌫.; 
 
Ð 2009/23/EC 
 The abovementioned marking and inscriptions  shall be affixed to the instrument and 
distinctly grouped together;  
 
Ð 2009/23/EC (adapted) 
(b) a green sticker at leas t 12,5 mm × 12,5 mm square bear ing a capital letter ‘M’ 
printed in black; 
(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 in terval, 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: 
 
Ð 2009/23/EC 
(viii)  - serial number, ; 
(ix) - for instruments consisting of separate  but associated uni ts: identification 
mark on each unit, ; 
(x) - scale interval if it is different from e, in the form d = …, ;  
EN 78   EN (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. 
 
Ð 2009/23/EC (adapted) 
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 inst rument is in its regular operating position. 
 
Ð 2009/23/EC 
1.3. Where a data plate is used it shall be po ssible to seal the plat e 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 th e 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 inscrip tions 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 s tickers provided for in point 1.1(b). 
3. Restrictive use symbol specified in Article 13 17 
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.  
EN 79   EN  
Ð 2009/23/EC 
ANNEX V  
THE MINIMUM CRITERIA TO BE  APPLIED BY MEMBER S TATES WHEN DESIGNATI NG BODIES FOR 
THE CARRYING -OUT OF TASKS PERTAIN ING TO THE PROCEDURE S REFERRED TO IN 
ARTICLE 9 
1. The bodies shall have at their disposal th e necessary personnel, means and equipment.  
2. The personnel of the bodies sh all have technical competen ce and professional integrity.  
3. The bodies shall work independently of all ci rcles, groups or persons having a direct or 
indirect interest in non -automatic weighing instruments as regards the carrying -out of the 
tests, the prep aration of the reports, the issuing of th e 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 li ability insurance if  their civil liab ility 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.  
 
Ð 2009/23/EC  
ANNEX VI  
‘CE’  CONFORMITY  MARKING  
– The ‘CE’ conformity marking shall  consist of the initials ‘CE’ taking the following 
form:   
EN 80   EN 
 
– If the ‘CE’ conformity marking is reduced  or enlarged the proportions given in the 
above graduated drawing must be respected.  
– The var ious components of the ‘CE’ conformity  marking must have substantially the 
same vertical dimension, which may not be less than 5 mm.  
 
Ð 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  
(OJ L 220, 30.8.1993, p. 1)  Article 1, point 7, and Article 8 only  
 
PART  B 
List of time limits for transposit ion into national law and application  
(referred to in Art icle 17)   
EN 81   EN Directive  Time limit for transposition  Date of application  
90/384/EEC  30 June 1992  1 January 199318 
93/68/EEC  30 June 1994  1 January 199519 
 
Ð 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)  
Articl e 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 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.  
19 In accordance w ith 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’.   
EN 82   EN 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) a nd (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 10  Article 11  
Article 11  Article 12  
Article 12  Article 13  
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 16  
Article 15(5)  —  
— Article 17  
— Article 18  
Article 16  Article 19  
Annexes I to VI  Anne xes I to VI  
— Annex VII  
— Annex VIII  
⌦ Article 1(1) ⌫ ⌦ Article 1(1) ⌫  
EN 83   EN ⌦ 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(1) ⌫ 
⌦ Article 2(2) ⌫ ⌦ Article 2(2) ⌫ 
⌦ Article 2(3) ⌫  ⌦ ____ ⌫  
⌦ ____ ⌫  ⌦ Article 2(3) to (19) ⌫  
⌦ Article 3 ⌫ ⌦ Article 3 ⌫ 
⌦ Article 4 ⌫ ⌦ Article 4 ⌫ 
⌦ Article 5 ⌫ ⌦ Article 5 ⌫ 
⌦ Article 6 ⌫ ⌦ ____ ⌫ 
⌦ Article 7 ⌫ ⌦ ____ ⌫ 
⌦ Article 8 ⌫ ⌦ ____ ⌫ 
⌦ ____ ⌫ ⌦ Article 6 ⌫ 
⌦ ____ ⌫ ⌦ Article 7 ⌫ 
⌦ ____ ⌫ ⌦ Article 8 ⌫ 
⌦ ____ ⌫ ⌦ Article 9 ⌫ 
⌦ ____ ⌫ ⌦ Article 10 ⌫ 
⌦ ____ ⌫ ⌦ Article 11 ⌫ 
⌦ ____ ⌫ ⌦ Article 12 ⌫ 
⌦ Article 9(1), introductory wording ⌫ ⌦ Article 13(1), introductory  
EN 84   EN 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 13(2) ⌫ 
⌦ Article 9(3) ⌫ ⌦ _____ ⌫ 
⌦ Article 10 ⌫ ⌦ ____ ⌫ 
⌦ Article 11 ⌫ ⌦ ___ ⌫ 
⌦ Article 12 ⌫ ⌦ ____ ⌫ 
⌦ ____ ⌫ ⌦ Article 14 ⌫ 
⌦ ____ ⌫ ⌦ Article 15 ⌫ 
⌦ ____ ⌫ ⌦ Article 16 (1) to (4) ⌫ 
⌦ Article 13, first sentence ⌫ ⌦ 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 ⌫  
EN 85   EN ⌦ ____ ⌫ ⌦ Article 31 ⌫ 
⌦ ____ ⌫ ⌦ Article 32 ⌫ 
⌦ ____ ⌫ ⌦ Article 33 ⌫ 
⌦ ____ ⌫ ⌦ Article 34 ⌫ 
⌦ ____ ⌫ ⌦ Article 35 ⌫ 
⌦ ____ ⌫ ⌦ Article 36 ⌫ 
⌦ ____ ⌫ ⌦ Article 37 ⌫ 
⌦ ____ ⌫ ⌦ Article 38 ⌫ 
⌦ ____ ⌫ ⌦ Article 39 ⌫ 
⌦ ____ ⌫ ⌦ Article 40 ⌫ 
⌦ Article 14 ⌫ ⌦ Article 3(3) ⌫ 
⌦ Article 15 ⌫ ⌦ ____ ⌫ 
⌦ ____ ⌫ ⌦ Article 41 ⌫ 
⌦ ____ ⌫ ⌦ Article 42(1) ⌫ 
⌦ Article 16 ⌫ ⌦ Article 42(2) ⌫ 
⌦ Article 17 ⌫ ⌦ Article 43 ⌫ 
⌦ Article 18 ⌫ ⌦ Article 44, first 
subparagraph ⌫ 
⌦ ____ ⌫ ⌦ Article 44, second 
subparagraph ⌫ 
⌦ Article 19 ⌫ ⌦ Article 45 ⌫ 
⌦ Annex I ⌫ ⌦ Annex I ⌫ 
⌦ Annex II, point 1 ⌫ ⌦ ____ ⌫ 
⌦ ____ ⌫ ⌦ Annex II, point 1 ⌫ 
⌦ Annex II, point 2 ⌫ ⌦ ____ ⌫ 
⌦ ____ ⌫ ⌦ Annex II, point 2 ⌫ 
⌦ ____ ⌫ ⌦ Annex II, point 3 ⌫  
EN 86   EN ⌦ 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 III ⌫ 
⌦ Annex V ⌫ ⌦ ____ ⌫ 
⌦ Annex VI ⌫ ⌦ ____ ⌫ 
⌦ Annex VII ⌫ ⌦ ____ ⌫ 
⌦ Annex VIII ⌫ ⌦ ____ ⌫ 
⌦ ____ ⌫ ⌦ Annex IV ⌫