Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the harmonisation of the laws of the Member States relating to electromagnetic compatibility
Date: 2011-11-21
Institutions: European Commission
Subjects: approximation of laws, electro-magnetic equipment, free movement of goods, harmonisation of standards, market supervision, marketing, product safety, single market

EUROPEAN COMMISSION 

Brussels, 21.11.2011 
COM(2011) 765 final 

2011/0351 (COD) 

NEW LEGISLATIVE FRAMEWORK (NLF) ALIGNMENT PACKAGE 
(Implementation of the Goods Package) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on the harmonisation of the laws of the Member States relating to electromagnetic 
compatibility 

(Recast) 

(Text with EEA relevance) 

 
 
  
 
EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

General context, reasons for and objectives of this proposal  

This proposal is presented in the framework of the implementation of the “goods package” 
adopted  in  2008.  It  is  part  of  a  package  of  proposals  aligning  ten  product  directives  to 
Decision No 768/2008/EC establishing a common framework for the marketing of products. 

Union (EU) harmonisation legislation ensuring the free movement of products has contributed 
considerably to the completion and operation of the Single Market. It is based on a high level 
of  protection  and  provides  economic  operators  with  the  means  to  demonstrate  conformity, 
thus ensuring free movement through trust in the products.  

Directive  2004/108/EC  is  an  example  of  that  Union  harmonisation  legislation,  ensuring  the 
free movement of apparatus. It sets out essential electromagnetic compatibility requirements 
that  apparatus  must  comply  with  in  order  to  be  made  available  on  the  EU  market.  These 
essential requirements also apply to fixed installations. Manufacturers must demonstrate that 
an  apparatus  has  been  designed  and  manufactured  in  compliance  with  the  essential 
requirements and affix the CE marking. The responsible persons for fixed installations must 
also guarantee that fixed installations comply with the essential requirements.  

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

–  the  presence  of  non-compliant  or  dangerous  products  on  the  market  and  consequently  a 

certain lack of trust in CE marking 

–  competitive  disadvantages  for  economic  operators  complying  with  the  legislation  as 

opposed to those circumventing the rules 

–  unequal  treatment  in  the  case  of  non-compliant  products  and  distortion  of  competition 

amongst economic operators due to different enforcement practices 

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

authorities 

–  problems with the quality of certain notified bodies 

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

legislation  apply  simultaneously 

to  one  and 

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

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765/2008  on  accreditation  and  market  surveillance  and  Decision  No  768/2008/EC 
establishing a common framework for the marketing of products. 

The  NLF  Regulation  has  introduced  rules  on  accreditation  (a  tool  for  the  evaluation  of 
competence  of  conformity  assessment  bodies)  and  requirements  for  the  organisation  and 
performance  of  market  surveillance  and  controls  of  products  from  third  countries.  Since  1 
January 2010 these rules apply directly in all Member States. 

The NLF Decision sets out a common framework for EU product harmonisation legislation. 
This  framework  consists  of  the  provisions  which  are  commonly  used  in  EU  product 
legislation  (e.g.  definitions,  obligations  of  economic  operators,  notified  bodies,  safeguard 
mechanisms,  etc).  These  common  provisions  have  been  reinforced  to  ensure  that  the 
directives  can  be  applied  and  enforced  more  effectively  in  practice.  New  elements,  such  as 
obligations on importers, have been introduced, which are crucial for improving the safety of 
products on the market.  

The provisions of the NLF Decision and those of the NLF Regulation are complementary and 
closely  interlinked.  The  NLF  Decision  contains  the  corresponding  obligations  for  economic 
operators  and  notified  bodies  allowing  market  surveillance  authorities  and  authorities 
responsible  for  notified  bodies  to  properly  perform  the  tasks  imposed  on  them  by  the  NLF 
Regulation and to ensure an effective and consistent enforcement of EU product legislation.  

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

A survey after  the adoption  of  the  goods package  in  2008  showed  that  a  majority  of  Union 
harmonisation legislation on products was due to be revised within the following 3 years, not 
only  to  address  the  problems  observed  throughout  all  sectors  but  also  for  sector-specific 
reasons.  Any  such  revision  would  automatically  include  an  alignment  of  the  legislation 
concerned to the NLF Decision since Parliament, Council and Commission have committed 
themselves to use its provisions as much as possible in future legislation on products in order 
to further the utmost coherence of the regulatory framework.  

For a number of other Union harmonisation directives, including Directive 2004/108/EC no 
revision  for  sector-specific  problems  had  been  envisaged  within  this  timeframe.  To  ensure 
that the problems in relation to non-compliance and notified bodies are nevertheless addressed 
in  these  sectors,  and  for  the  sake  of  consistency  of  the  overall  regulatory  environment  on 
products,  it  was  decided  to  align  these  directives  within  a  package  to  the  provisions  of  the 
NLF Decision. 

Consistency with other policies and objectives of the Union 

This initiative is in line with the Single Market Act1, which has stressed the need to restore 
consumer  confidence  in  the  quality  of  products  on  the  market  and  the  importance  of 
reinforcing market surveillance. 

1 

Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  Economic  and 
Social Committee and the Committee of the Regions, COM(2011) 206 final. 

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Furthermore it supports the Commission’s policy on Better Regulation and simplification of 
the regulatory environment. 

2. 

CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

Consultation of interested parties 

The  alignment  of  Directive  2004/108/EC  to  the  NLF  Decision  has  been  discussed  with 
national experts responsible for the implementation of this Directive, the notified body group, 
the  administrative  cooperation  group  as  well  as  in  bilateral  meetings  with  industry 
associations. 

From June to October 2010 a public consultation was organised that comprised all the sectors 
involved in this initiative. It consisted of four targeted questionnaires for economic operators, 
authorities, notified bodies and users and the Commission services received 300 replies. The 
results are published at:  

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

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

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

Collection and use of expertise 

The  impact  assessment  for  this  implementation  package  has  largely  built  on  the  impact 
assessment  carried  out  for  the  New  Legislative  Framework.  In  addition  to  the  expertise 
collected  and  analysed  in  that  context,  further  consultation  of  sector-specific  experts  and 
interest  groups,  as  well  as  horizontal  experts  active  in  the  area  of  technical  harmonisation, 
conformity assessment, accreditation and market surveillance, has taken place. 

Impact assessment  

Based on the information collected, the Commission carried out an impact assessment which 
examined and compared three options. 

Option 1 - No changes to the current situation 

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This  option  proposes  no  changes  to  the  current  directive  and  relies  exclusively  on  certain 
improvements that can be expected from the NLF Regulation. 

Option 2 – Alignment to the NLF Decision by non-legislative measures 

Option 2 considers the possibility of encouraging a voluntary alignment to the provisions set 
out in the NLF Decision by, e.g., presenting them as best practices in guidance documents. 

Option 3 – Alignment to NLF Decision by legislative measures 

This  option  consists  in  integrating  the  provisions  of  the  NLF  Decision  into  the  existing 
directives. 

Option 3 was found to be the preferred option because 

–  it  will  improve  the  competitiveness  of  companies  and  notified  bodies  taking  their 

obligations seriously, as opposed to those cheating on the system; 

–  it  will  improve  the  functioning  of  the  internal  market  by  ensuring  equal  treatment  of  all 

economic operators, notably importers and distributors, as well as notified bodies; 

–  it  does  not  entail  significant  costs  for  economic  operators  and  notified  bodies;  for  those 
who are already acting responsibly, no extra costs or only negligible costs are expected; 

–  it is considered more effective than option 2: due to the lack of enforceability of option 2 it 

is questionable that the positive impacts would materialise under that option; 

–  options 1 and 2 do not provide answers to the problem of inconsistencies in the regulatory 
framework  and  therefore  have  no  positive  impact  on  the  simplification  of  the  regulatory 
environment. 

3. 

MAIN ELEMENTS OF THE PROPOSAL 

3.1. 

Horizontal definitions 

The  proposal  introduces  harmonised  definitions  of  terms  which  are  commonly  used 
throughout  Union  harmonisation  legislation  and  should  therefore  be  given  a  consistent 
meaning throughout that legislation.  

3.2. 

Obligations of economic operators and traceability requirements 

The  proposal  clarifies  the  obligations  of  manufacturers  and  authorised  representatives  and 
introduces  obligations  for  importers  and  distributors.  Importers  must  verify  that  the 
manufacturer has carried out the applicable conformity assessment procedure and has drawn 
up  a  technical  documentation.  They  must  also  make  sure  with  the  manufacturer  that  this 
technical  documentation  can  be  made  available  to  authorities  upon  request.  Furthermore 
importers  must  verify  that  apparatus  are  correctly  marked  and  accompanied  by  the  required 
documentation.  They  must  keep  a  copy  of  the  Declaration  of  conformity  and  indicate  their 
name  and  address  on  the  product,  or  where  this  is  not  possible  on  the  packaging  or  the 
accompanying  documentation. Distributors must  verify  that apparatus  bear the CE marking, 

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the name of the manufacturer and of the importer, if relevant, and that it is accompanied by 
the required documentation and instructions. 

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

Enhanced  traceability  obligations  are  introduced  for  all  economic  operators.  Apparatus 
have to bear the manufacturer’s name and address and a number allowing to identify and link 
the  apparatus  to  its  technical  documentation.  When  an  apparatus  is  imported  the  importer’s 
name and address must also be on the apparatus. Furthermore every economic operator must 
be able to identify towards authorities the economic operator who has supplied him with an 
apparatus or to whom he has supplied an apparatus. 

3.3. 

Harmonised standards 

Compliance  with  harmonised  standards  provides  a  presumption  of  conformity  with  the 
essential requirements. On 1 June 2011 the Commission adopted a proposal for a Regulation 
on  European  Standardisation2  that  sets  out  a  horizontal  legal  framework  for  European 
standardisation.  The  proposal  for  the  Regulation  contains  inter  alia  provisions  on 
standardisation requests from the Commission to the European Standardisation Organisations, 
on the procedure for objections to harmonised standards and on  stakeholder participation in 
the  standardisation  process.  Consequently  the  provisions  of  Directive  2004/108/EC  which 
cover the same aspects have been deleted in this proposal for reasons of legal certainty.  

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

3.4. 

Conformity assessment and CE marking 

Directive 2004/108/EC has selected the appropriate conformity assessment procedures which 
manufacturers  have  to  apply  in  order  to  demonstrate  that  their  apparatus  comply  with  the 
essential requirements. The proposal aligns these procedures to their updated versions set out 
in the NLF Decision maintaining certain specific elements, regarding to the electromagnetic 
compatibility  conformity  assessment.  The  Directive  also  introduces  a  model  for  the  EU 
Declaration of conformity. 

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 to apparatus have been inserted in 
this proposal. 

3.5. 

Notified Bodies 

The  proposal  reinforces  the  notification  criteria  for  notified  bodies.  It  clarifies  that 
subsidiaries or subcontractors must also comply with  the notification requirements. Specific 
requirements  for  notifying  authorities  are  introduced,  and  the  procedure  for  notification  of 

2 

COM(2011)  315  final:  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. 

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notified  bodies  is  revised.  The  competence  of  a  notified  body  must  be  demonstrated  by  an 
accreditation certificate. Where accreditation has not been used to evaluate the competence of 
a  notified  body,  the  notification  must  comprise  the  documentation  demonstrating  how  the 
competence of that body has been evaluated. Member States will have the possibility to object 
to a notification. 

3.6.  Market surveillance and the safeguard clause procedure 

The  proposal  revises  the  existing  safeguard  clause  procedure.  It  introduces  a  phase  of 
information  exchange  between  Member  States,  and  specifies  the  steps  to  be  taken  by  the 
authorities  concerned,  when  a  non-compliant  apparatus  is  found.  A  real  safeguard  clause 
procedure – leading to a Decision at Commission level on whether a measure is justified or 
not  -  is  only  launched  when  another  Member  State  objects  to  a  measure  taken  against  an 
apparatus. Where there is no disagreement on the restrictive measure taken, all Member States 
must take the appropriate action on their territory. 

4. 

LEGAL ELEMENTS OF THE PROPOSAL 

Legal basis 

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

Subsidiarity principle 

The internal market is a competence that is shared between the Union and the Member States. 
The  subsidiarity  principle  arises  in  particular  with  regard  to  the  newly  added  provisions 
aiming  at  the  improvement  of  effective  enforcement  of  Directive  2004/108/EC  namely,  the 
importer  and  distributor  obligations,  the  traceability  provisions,  the  provisions  on  the 
assessment  and  notification  of  notified  bodies,  and  the  enhanced  cooperation  obligations  in 
the context of the revised market surveillance and safeguard procedures.  

Experience with the enforcement of the legislation has shown that measures taken at national 
level  have  led  to  divergent  approaches  and  to  a  different  treatment  of  economic  operators 
inside  the  EU,  which  undermines  the  objective  of  this  directive.  If  actions  are  taken  at 
national level to address the problems, this risks creating obstacles to the free movement of 
goods.  Furthermore  action  at  national  level  is  limited  to  the  territorial  competence  of  a 
Member  State.  In  view  of  the  increasing  internationalisation  of  trade,  the  number  of  cross-
border cases is constantly rising. Coordinated action at EU level can much better achieve the 
objectives  set,  and  will  in  particular  render  market  surveillance  more  effective.  Hence  it  is 
more appropriate to take action at EU level. 

As regards the problem of inconsistencies throughout the directives, this is a problem which 
can only be solved by the EU legislator. 

Proportionality 

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

The new or modified obligations do not impose unnecessary burdens and costs on industry - 
especially on small and medium sized enterprises - or administrations. Where modifications 

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have been identified to have negative impacts, the analysis of the impacts of the option serves 
to  provide  the  most  proportionate  response  to  the  problems  identified.  A  number  of 
modifications  concern  the  improvement  of  clarity  of  the  existing  Directive  without 
introducing new requirements that entail added cost.  

Legislative technique used 

The  alignment  to  the  NLF  Decision  requires  a  number  of  substantive  amendments  to  the 
provisions  of  Directive  2004/108/EC.  To  ensure  the  readability  of  the  amended  text  the 
technique  of  recasting  has  been  chosen  in  line  with  the  Interinstitutional  Agreement  of  28 
November 2001 on a more structured use of the recasting technique for legal acts3.  

The  changes  made  to  the  provisions  of  Directive  2004/108/EC  concern:  the  definitions,  the 
obligations  of  economic  operators,  the  presumption  of  conformity  provided  by  harmonised 
standards,  the  declaration  of  conformity,  CE  marking,  notified  bodies,  the  safeguard  clause 
procedure and the conformity assessment procedures. 

The  proposal  does  not  change  the  scope  of  Directive  2004/108/EC  and  the  essential 
requirements.  

5. 

BUDGETARY IMPLICATIONS 

This proposal does not have any implications for the EU budget. 

6. 

ADDITIONAL INFORMATION 

Repeal of existing legislation 

The adoption of the proposal will lead to repeal of Directive 2004/108/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, p. 1. 

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(cid:208) 2004/108 (adapted) 

2011/0351 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on theapproximation ⌦ harmonisation ⌫ of the laws of the Member States relating to 
electromagnetic compatibilityand repealing Directive 89/336/EEC 

(Recast) 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, ⌦ on the Functioning of 
the European Union, ⌫ and in particular Article 95 ⌦ 114 ⌫ thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national Parliaments, 

Having regard to the opinion of the European Economic and Social Committee4, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(cid:208) 2004/108 recital 1 (adapted) 

Council Directive 89/336/EEC of 3 May 1989 on the approximation of laws of the Member 
States relating to electromagnetic compatibility5 has been the subject of a review under 
the initiative known as Simpler Legislation for the Internal Market (SLIM). Both the 
SLIM  process  and  a  subsequent  in-depth  consultation  have  revealed  the  need  to 
complete, reinforce and clarify the framework established by Directive 89/336/EEC. 

4 
5 

OJ C 220, 16.9.2003, p. 13. 
OJ L 139, 23.5.1989, p. 19. Directive as last amended by Directive 93/68/EEC (OJ L 220, 30.8.1993, 
p. 1). 

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(cid:216) new  

(1) 

(2) 

(3) 

A  number  of  substantive  changes  are  to  be  made  to  Directive  2004/108/EC  of  the 
European Parliament and of the Council of 15 December 2004 on the approximation 
of  the  laws  of  the  Member  States  relating  to  electromagnetic  compatibility  and 
repealing  Directive  89/336/EEC6.  In  the  interests  of  clarity,  that  Directive  should  be 
recast. 

Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 
2008 setting out the requirements for accreditation and market surveillance relating to 
the marketing of products and repealing Regulation (EEC) No 339/937 lays down rules 
on  the  accreditation  of  conformity  assessment  bodies,  provides  a  framework  for  the 
market surveillance of products and for controls on products from third countries, and 
lays down the general principles of the CE marking. 

Decision  No  768/2008/EC  of  the  European  Parliament  and  of  the  Council  of  9  July 
2008  on  a  common  framework  for  the  marketing of products, and repealing Council 
Decision  93/465/EEC8  lays  down  a  common  framework  of  general  principles  and 
reference  provisions  intended  to  apply  across  the  legislation  harmonising  the 
conditions  for  the  marketing  of  products  in  order  to  provide  a  coherent  basis  for 
revision  or  recasts  of  that  legislation.  Directive  2004/108/EC  should  therefore  be 
adapted to that Decision. 

(cid:208) 2004/108 recital 2 

(4)  Member States are responsible for ensuring that radiocommunications, including radio 
broadcast  reception  and  the  amateur  radio  service  operating  in  accordance  with 
International  Telecommunication  Union  (ITU)  radio  regulations,  electrical  supply 
networks and telecommunications networks, as well as equipment connected thereto, 
are protected against electromagnetic disturbance. 

(cid:208) 2004/108 recital 3 (adapted) 

(5) 

electromagnetic 
Provisions  of  national 
disturbanceshould  ⌦ need  to ⌫  be  harmonised  in  order  to  guarantee  the  free 
movement  of  electrical  and  electronic  apparatus  without  lowering  justified  levels  of 
protection in the Member States. 

ensuring  protection 

against 

law 

6 
7 
8 

OJ L 390, 31.12.2004, p. 24 
OJ L 218, 13.8.2008, p. 30. 
OJ L 218, 13.8.2008, p. 82. 

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(6) 

Protection against electromagnetic disturbance requires obligations to be imposed on 
the  various  economic  operators.  Those  obligations  should  be  applied  in  a  fair  and 
effective way in order to achieve such protection. 

(cid:208) 2004/108 recital 4 

The electromagnetic compatibility of equipment should be regulated with a view to ensuring 
the functioning of the internal market, that is to say, of an area without internal frontiers in 
which the free movement of goods, persons, services and capital is assured. 

(cid:208) 2004/108 recital 5 

(7) 

(8) 

(cid:208) 2004/108 recital 6 (adapted) 

The  equipment  covered  by  this  Directive  should  include  both  apparatus  and  fixed 
installations. However, separate provision should be made for each. This is so because, 
whereas  apparatus  as  such  may  move  freely  within  the  ⌦ Union ⌫  Community, 
fixed  installations  on  the  other  hand  are  installed  for  permanent  use  at  a  predefined 
location,  as  assemblies  of  various  types  of  apparatus  and,  where  appropriate,  other 
devices. The composition and function of such installations correspond in most cases 
to the particular needs of their operators. 

(cid:208) 2004/108 recital 7 (adapted) 

Radio equipment and telecommunications terminal equipment should not be covered 
by  this  Directive  since  they  are  already  regulated  by  Directive  1999/5/EC  of  the 
European  Parliament  and  of  the  Council  of  9  March  1999  on  radio  equipment  and 
telecommunications 
their 
conformity9.  The  electromagnetic  compatibility  requirements  in  both  Directives 
achieve the same level of protection. 

the  mutual  recognition  of 

terminal  equipment  and 

(9) 

Aircraft or equipment intended to be fitted into aircraft should not be covered by this 
Directive,  since  they  are  already  subject  to  special  Community  ⌦ Union ⌫  or 
international rules governing electromagnetic compatibility. 

(cid:208) 2004/108 recital 8 (adapted) 

9 

OJ  L  91,  7.4.1999,  p.  10.  Directive  as  amended  by  Regulation  (EC)  No  1882/2003  (OJ  L  284, 
31.10.2003, p. 1). 

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(10)  This  Directive  need  not  regulate  equipment  which  is  inherently  benign  in  terms  of 

electromagnetic compatibility. 

(cid:208) 2004/108 recital 9 

(11)  This Directive should not deal with the safety of equipment, since that is dealt with by 

separate Community ⌦ Union ⌫ or national legislation. 

(cid:208) 2004/108 recital 10 (adapted) 

(12)  Where  this  Directive  regulates  apparatus,  it  should  refer  to  finished  apparatus 
commercially  available  for  the  first  time  on  the  Community  ⌦ placed  on  the ⌫ 
market.  Certain  components  or  sub-assemblies  should,  under  certain  conditions,  be 
considered to be apparatus if they are made available to the end-user. 

(cid:208) 2004/108 recital 11 (adapted) 

(cid:208) 2004/108 recital 12 (adapted) 

The principles on which this Directive is based are those set out in the Council Resolution of 
7 May  1985  on  a  new  approach  to  technical  harmonization  and  standards10.  In  accordance 
with  that  approach,  the  design  and  manufacture  of  equipment  is  subject  to  essential 
requirements  in  relation  to  electromagnetic  compatibility.  Those  requirements  are  given 
technical  expression  by  harmonised  European  standards,  to  be  adopted  by  the  various 
European standardisation bodies, European Committee for Standardisation (CEN), European 
Committee 
and  European 
Telecommunications  Standards  Institute  (ETSI).  CEN,  CENELEC  and  ETSI  are  recognised 
as  the  competent  institutions  in  the  field  of  this  Directive  for  the  adoption  of  harmonised 
standards,  which  they  draw  up  in  accordance  with  the  general  guidelines  for  cooperation 
between 
in 
Directive 98/34/EC  of  the  European  Parliament  and  of  the  Council  of  22  June  1998  laying 
down  a  procedure  for  the  provision  of  information  in  the  field  of  technical  standards  and 
regulations and of rules on Information Society services11. 

the  Commission,  and  with 

for  Electro-technical 

themselves  and 

Standardisation 

the  procedure 

(CENELEC) 

laid  down 

Harmonised  standards  reflect  the  generally  acknowledged  state  of  the  art  as  regards 
electromagnetic compatibility matters in the European Union. It is thus in the interest of the 
functioning of the internal market to have standards for the electromagnetic compatibility of 

(cid:208) 2004/108 recital 13 (adapted) 

10 
11 

OJ C 136, 4.6.1985, p. 1. 
OJ L 204, 21.7.1998, p. 37. Directive as last amended by the 2003 Act of Accession. 

EN 

12 

   EN 

 
 
 
 
 
 
                                                 
equipment  which  have  been  harmonised  at  Community  level.  Once  the  reference  to  such  a 
standard has been published in the Official Journal of the European Union, compliance with 
it should raise a presumption of conformity with the relevant essential requirements, although 
other  means  of  demonstrating  such  conformity  should  be  permitted.  Compliance  with  a 
harmonised standard means conformity with its provisions and demonstration thereof by the 
methods the harmonised standard describes or refers to. 

(cid:208) 2004/108 recital 14 

(13)  Manufacturers  of  equipment  intended  to  be  connected  to  networks  should  construct 
such  equipment  in  a  way  that  prevents  networks  from  suffering  unacceptable 
degradation  of  service  when  used  under  normal  operating  conditions.  Network 
operators  should  construct  their  networks  in  such  a  way  that  manufacturers  of 
equipment liable to be connected to networks do not suffer a disproportionate burden 
in  order  to  prevent  networks  from  suffering  an  unacceptable  degradation  of  service. 
The European standardisation organisations should take due account of that objective 
(including the cumulative effects of the relevant types of electromagnetic phenomena) 
when developing harmonised standards. 

(cid:208) 2004/108 recital 15 (adapted) 

It  should  be  possible  to  place  apparatus  on  the  market  or  put  it  into  service  only  if  the 
manufacturers  concerned  have  established  that  such  apparatus  has  been  designed  and 
manufactured in conformity with the requirements of this Directive. Apparatus placed on the 
market  should  bear  the  ‘CE’  marking  attesting  to  compliance  with  this  Directive.  Although 
conformity assessment should be the responsibility of the manufacturer, without any need to 
involve an independent conformity assessment body, manufacturers should be free to use the 
services of such a body. 

(cid:216) new 

(14)  Economic operators should be responsible for the compliance of products, in relation 
to their respective roles in the supply chain, so as to ensure a high level of protection 
of public interests, and the protection of end-users, and to guarantee fair competition 
on the Union market. 

(15)  All  economic  operators  intervening  in  the  supply  and  distribution  chain  should  take 
appropriate measures to ensure that they only make available on the market products 
which are in conformity with this Directive. It is necessary to provide for a clear and 
proportionate distribution of obligations which correspond to the role of each operator 
in the supply and distribution process. 

(16)  The manufacturer, having detailed knowledge of the design and production process, is 
best  placed  to  carry  out  the  complete  conformity  assessment  procedure.  Conformity 
assessment should therefore remain the obligation of the manufacturer alone. 

EN 

13 

   EN 

 
 
 
 
(17) 

It is necessary to ensure that products 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 
products.  Provision  should  therefore  be  made  for  importers  to  make  sure  that  the 
products they place on the market comply with the requirements of this Directive and 
that  they  do  not  place  on  the  market  products  which  do  not  comply  with  such 
requirements  or  present a  risk. Provision should also be made for  importers  to make 
sure  that  conformity  assessment  procedures  have  been  carried  out  and  that  product 
marking and documentation drawn up by manufacturers are available for inspection by 
the supervisory authorities. 

(18)  The distributor makes a product available on the market after it has been placed on the 
market by the manufacturer or the importer and should act with due care to ensure that 
its handling of the product does not adversely affect the compliance of the product. 

(19)  When placing a product on the market, every importer should indicate on the product 
his name and the address at which he can be contacted. Exceptions should be provided 
for  in  cases  where  the  size  or  nature  of  the  product  does  not  allow  it.  This  includes 
cases  where  the  importer  would  have  to  open  the  packaging  to  put  his  name  and 
address on the product. 

(20)  Any economic operator that either places a product on the market under his own name 
or  trademark  or  modifies  a  product  in  such  a  way  that  compliance  with  the 
requirements  of  this  Directive  may  be  affected  should  be  considered  to  be  the 
manufacturer and should assume the obligations of the manufacturer. 

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

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

(cid:208) 2004/108 recital 18 (adapted) 

(23)  Fixed 

including 

installations, 

large  machines  and  networks,  may  generate 
electromagnetic disturbance, or be affected by it. There may be an interface between 
fixed  installations  and  apparatus,  and  the  electromagnetic  disturbances  produced  by 
fixed  installations  may  affect  apparatus,  and  vice  versa.  In  terms  of  electromagnetic 
compatibility, it is irrelevant whether the electromagnetic disturbance is produced by 
apparatus  or  by  a  fixed  installation.  Accordingly,  fixed  installations  and  apparatus 
should be subject to a coherent and comprehensive regime of essential requirements. It 
should  be  possible  to  use  harmonised  standards  for  fixed  installations  in  order  to 
demonstrate conformity with the essential requirements covered by such standards. 

EN 

14 

   EN 

 
 
(cid:216) new 

(24)  This  Directive  should  be  limited  to  the  expression  of  the  essential  requirements.  In 
order  to  facilitate  conformity  assessment  with  those  requirements  it  is  necessary  to 
provide  for  presumption  of  conformity  for  equipment  which  is  in  conformity  with 
harmonised standards that are adopted in accordance with Regulation (EU) No [../..] of 
the European Parliament and of the Council of […..] on European Standardisation and 
amending  Council  Directives  89/686/EEC  and  93/15/EEC  and  Directives  94/9/EC, 
94/25/EC,  95/16/EC,  97/23/EC,  98/34/EC,  2004/22/EC,  2007/23/EC,  2009/105/EC 
and  2009/23/EC  of  the  European  Parliament  and  of  the  Council12  for  the  purpose  of 
expressing detailed technical specifications of those requirements. 

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

(26) 

In order to enable economic operators to demonstrate and the competent authorities to 
ensure  that  products  made  available  on  the  market  conform  to  the  essential 
requirements  it  is  necessary  to  provide  for  conformity  assessment  procedures. 
Decision No 768/2008/EC establishes modules for conformity assessment procedures, 
which  include  procedures  from  the  least  to  the  most  stringent,  in  proportion  to  the 
level of risk involved and the level of safety required. In order to ensure inter-sectoral 
coherence and to avoid ad-hoc variants, conformity assessment procedures should be 
chosen from among those modules. 

(27)  The conformity assessment obligation should require the manufacturer to perform an 
electromagnetic compatibility assessment of apparatus, based on relevant phenomena, 
in  order  to  determine  whether  or  not  it  meets  the  protection  requirements  under  this 
Directive. 

(cid:208) 2004/108 recital 16 

(cid:208) 2004/108 recital 17 

(28)  Where  apparatus  is  capable  of  taking  different  configurations,  the  electromagnetic 
compatibility  assessment  should  confirm  whether  the  apparatus  meets  the  protection 
requirements  in  the  configurations  foreseeable  by  the  manufacturer  as  representative 
of  normal  use  in  the  intended  applications;.  iIn  such  cases  it  should  be  sufficient  to 
perform an assessment on the basis of the configuration most likely to cause maximum 
disturbance and the configuration most susceptible to disturbance. 

12 

OJ L […], […], p. […] 

EN 

15 

   EN 

 
 
 
 
                                                 
(cid:208) 2004/108 recital 20 

(29) 

It  is  not  pertinent  to  carry  out  the  conformity  assessment  of  apparatus  placed  on  the 
market  for  incorporation  into  a  given  fixed  installation,  and  otherwise  not 
commercially  available,  in  isolation  from  the  fixed  installation  into  which  it  is  to  be 
incorporated.  Such  apparatus  should  therefore  be  exempted  from  the  conformity 
assessment  procedures  normally  applicable  to  apparatus.  However,  such  apparatus 
should  not  be  permitted  to  compromise  the  conformity  of  the  fixed  installation  into 
which  it  is  incorporated.  Should  apparatus  be  incorporated  into  more  than  one 
identical 
compatibility 
characteristics of these installations should be sufficient to ensure exemption from the 
conformity assessment procedure. 

electromagnetic 

installation, 

identifying 

fixed 

the 

(cid:216) new 

(30)  Manufacturers  should  draw  up  an  EU  declaration  of  conformity  to  provide  detailed 
information on the conformity of an apparatus with the requirements of this Directive 
and of the other relevant Union harmonisation legislation.  

(31)  The CE marking, indicating the conformity of a product, is the visible consequence of 
a  whole  process  comprising  conformity  assessment  in  a  broad  sense.  General 
principles  governing  the  CE  marking  are  set  out  in  Regulation  (EC)  No  765/2008. 
Rules governing the affixing of the CE marking should be laid down in this Directive. 

(32)  Due  to  their  specific  characteristics,  fixed  installations  need  not  be  subject  to 
theaffixation ⌦ affixing ⌫ of the ‘CE’ marking or to the ⌦ EU ⌫ declaration of 
conformity. 

(cid:208) 2004/108 recital 19 (adapted) 

(cid:216) new 

(33)  One  of  the  conformity  assessment  procedures  set  out  in  this  Directive  requires  the 
intervention  of  conformity  assessment  bodies,  which  are  notified  by  the  Member 
States to the Commission. 

(34)  Experience  has  shown  that  the  criteria  set  out  in  Directive  2004/108/EC  that 
conformity assessment bodies have to fulfil to be notified to the Commission are not 
sufficient  to  ensure  a  uniformly  high  level  of  performance  of  notified  bodies 
throughout  the  Union.  It  is,  however,  essential  that  all  notified  bodies  perform  their 
functions to the same level and under conditions of fair competition. That requires the 
setting  of  obligatory  requirements  for  conformity  assessment  bodies  wishing  to  be 
notified in order to provide conformity assessment services. 

EN 

16 

   EN 

 
 
 
 
 
(35) 

(36) 

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

If a conformity assessment body demonstrates conformity with the criteria laid down 
in  harmonised  standards,  it  should  be  presumed  to  comply  with  the  corresponding 
requirements set out in this Directive. 

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

(38)  Transparent  accreditation  as  provided  for  in  Regulation  (EC)  No  765/2008,  ensuring 
the necessary level of confidence in conformity certificates, should be considered by 
the  national  public  authorities  throughout  the  Union  as  the  preferred  means  of 
demonstrating  the  technical  competence  of  conformity  assessment  bodies.  However, 
national authorities may consider that they possess the appropriate means of carrying 
out this evaluation themselves. In such cases, in order to ensure the appropriate level 
of  credibility  of  evaluations  carried  out  by  other  national  authorities,  they  should 
provide the Commission and the other Member States with the necessary documentary 
evidence demonstrating the compliance of the conformity assessment bodies evaluated 
with the relevant regulatory requirements. 

(39)  Conformity assessment bodies frequently subcontract parts of their activities linked to 
the  assessment  of  conformity  or  have  recourse  to  a  subsidiary.  In  order  to  safeguard 
the level of protection required for the products to be placed on the Union market, it is 
essential  that  conformity  assessment  subcontractors  and  subsidiaries  fulfil  the  same 
requirements  as  notified  bodies  in  relation  to  the  performance  of  conformity 
assessment tasks. Therefore, it is important that the assessment of the competence and 
the performance of bodies to be notified and the monitoring of bodies already notified 
cover also activities carried out by subcontractors and subsidiaries. 

(40) 

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

(41)  Since notified bodies may offer their services throughout the Union, it is appropriate to 
give the other Member States and the Commission the opportunity to raise objections 
concerning  a  notified  body.  It  is  therefore  important  to  provide  for  a  period  during 
which any doubts or concerns as to the competence of conformity assessment bodies 
can be clarified before they start operating as notified bodies. 

(42) 

In  the  interests  of  competitiveness,  it  is  crucial  that  notified  bodies  apply  the 
conformity assessment procedures without creating unnecessary burdens for economic 
operators. For the same reason, and to ensure equal treatment of economic operators, 
consistency in the technical application of the conformity assessment procedures needs 
to  be  ensured.  That  can  best  be  achieved  through  appropriate  coordination  and 
cooperation between notified bodies. 

(43) 

In order to ensure legal certainty, it is necessary to clarify that rules on Union market 
surveillance  and  control  of  products  entering  the  Union  market  provided  for  in 

EN 

17 

   EN 

 
Regulation  (EC)  No  765/2008  apply  to  equipment  covered  by  this  Directive.  This 
Directive should not prevent Member States from choosing the competent authorities 
to carry out those tasks. 

(44)  Directive  2004/108/EC  already  provides  for  a  safeguard  procedure.  In  order  to 
increase  transparency  and  to  reduce  processing  time,  it  is  necessary  to  improve  the 
existing  safeguard  clause  procedure,  with  a  view  to  making  it  more  efficient  and 
drawing on the expertise available in Member States. 

(45)  The  existing  system  should  be  supplemented  by  a  procedure  under  which  interested 
parties  are  informed  of  measures  intended  to  be  taken  with  regard  to  products 
presenting  a  risk  to  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 products. 

(46)  Where  the  Member  States  and  the  Commission  agree  as  to  the  justification  of  a 
measure taken by a Member State, no further involvement of the Commission should 
be  required,  except  where  non-compliance  can  be  attributed  to  shortcomings  of  a 
harmonised standard. 

(47)  The Member States should lay down rules on penalties applicable to infringements of 
the  national  provisions  adopted  pursuant  to  this  Directive  and  ensure  that  they  are 
implemented. Those penalties should be effective, proportionate and dissuasive. 

(48) 

It is necessary to provide for transitional arrangements that allow making available on 
the  market  and  putting  into  service  of  apparatus  that  has  already  been  placed  on  the 
market in accordance with Directive 2004/108/EC. 

(cid:208) 2004/108 recital 22 (adapted) 

(49)  Since the objective of this Directive, namely to ensure the functioning of the internal 
market  by  requiring  equipment  to  comply  with  an  adequate  level  of  electromagnetic 
compatibility, cannot be sufficiently achieved by Member States and can therefore, by 
reason of its scale and effects, be better achieved at Community ⌦ Union ⌫ level, 
the Community ⌦ Union ⌫ may adopt measures, in accordance with the principle of 
subsidiarity  as  set  out  in  Article  5  of  the  Treaty  ⌦ on  European  Union ⌫  .  In 
accordance  with  the  principle  of  proportionality,  as  set  out  in  that  Article,  this 
Directive does not go beyond what is necessary in order to achieve that objective. 

(50)  The obligation to transpose this Directive into national law should be confined to those 
provisions  which  represent  a  substantive  change  as  compared  with  Directive 
2004/108/EC. The obligation to transpose the provisions which are unchanged arises 
under Directive 2004/108/EC. 

(cid:216) new 

EN 

18 

   EN 

 
 
 
(51)  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 
Directive 2004/108/EC set out in Annex V. 

A transitional period is necessary in order to ensure that manufacturers and other concerned 
parties are able to adapt to the new regulatory regime. 

(cid:208) 2004/108 recital 21 (adapted) 

HAVE ADOPTED THIS DIRECTIVE: 

(cid:208) 2004/108 (adapted) 

CHAPTER 1I 

GENERAL PROVISIONS 

Article 1 

Subject matter and scope 

1.This Directive regulates the electromagnetic compatibility of equipment. It aims to ensure 
the  functioning  of  the  internal  market  by  requiring  equipment  to  comply  with  an  adequate 
level of electromagnetic compatibility.  

(cid:208) 2004/108  

(cid:208) 2004/108 (adapted) 

Article 2 

⌦ Scope ⌫ 

1. This Directive applies ⌦ shall apply ⌫ to equipment as defined in Article 23. 

2. This Directive shall not apply to ⌦ the following ⌫ : 

EN 

19 

   EN 

 
 
 
 
 
(a) 

(b) 

(c) 

equipment covered by Directive 1999/5/EC; 

(cid:208) 2004/108  

aeronautical  products,  parts  and  appliances  as  referred  to  in  Regulation  (EC)  No 
1592/2002  216/2008  of  the  European  Parliament  and  of  the  Council13  of  15  July 
2002  on  common  rules  in  the  field  of  civil  aviation  and  establishing  a  European 
Aviation Safety Agency14; 

(cid:208) 2004/108 (adapted) 

in 

framework  of 

radio equipment used by radio amateurs within the meaning of the Radio Regulations 
adopted 
International 
the 
Telecommunication  Union ⌫ 
ITU 
⌦ International  Telecommunication  Union ⌫15,  unless  the  equipment  is  available 
commercially.;  Kits  of  components  to  be  assembled  by  radio  amateurs  and 
commercial  equipment  modified  by  and  for  the  use  of  radio  amateurs  are  not 
regarded as commercially available equipment. 

and  ⌦ the ⌫  Convention  of 

the  Constitution  ⌦ of 

the 

the 

(d) 

3.  This  Directive  shall  not  apply  to  equipment  the  inherent  nature  of  the  physical 
characteristics of which is such that: 

(ai) 

it is incapable of generating or contributing to electromagnetic emissions which 
exceed  a  level  allowing  radio  and  telecommunication  equipment  and  other 
equipment to operate as intended; and 

(cid:208) 2004/108 

(bii)  it  will  operate  ⌦ operates ⌫  without  unacceptable  degradation  in  the 
presence  of  the  electromagnetic  disturbance  normally  consequent  upon  its 
intended use. 

(cid:208) 2004/108 (adapted) 

⌦ For the purposes of point (c) of the first subparagraph, kits of components to be assembled 
by radio amateurs and commercial equipment modified by and for the use of radio amateurs 
are not regarded as commercially available equipment. ⌫ 

13 
14 

15 

OJ L 79, 19.3.2008, p. 1 
OJ L 240, 7.9.2002, p. 1. Regulation as amended by Commission Regulation (EC) No 1701/2003 (OJ L 
243, 27.9.2003, p. 5). 
Constitution and Convention of the International Telecommunication Union adopted by the Additional 
Plenipotentiary  Conference  (Geneva,  1992)  as  amended  by  the  Plenipotentiary  Conference  (Kyoto, 
1994). 

EN 

20 

   EN 

 
 
 
 
 
                                                 
43. Where, for the equipment referred to in paragraph 1, the essential requirements referred to 
⌦ set  out ⌫  in  Annex I  are  wholly  or  partly  laid  down  more  specifically  by  other 
⌦ Union ⌫ Community directives, this Directive shall not apply, or shall cease to apply, to 
that  equipment  in  respect  of  such  requirements  from  the  date  of  implementation  of  those 
directives. 

54.  This  Directive  shall  not  affect  the  application  of  ⌦ Union ⌫  Community  or  national 
legislation regulating the safety of equipment. 

(cid:208) 2004/108 (adapted) 

Article32 [Article R1 of Decision No 768/2008/EC] 

Definitions  

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

(cid:208) 2004/108 (adapted) 

(a1) 

‘equipment’ means any apparatus or fixed installation; 

(cid:208) 2004/108  

(b2) 

(c3) 

(d4) 

‘apparatus’ means any finished appliance or combination thereof made commercially 
available as a single functional unit, intended for the end user and liable to generate 
electromagnetic disturbance, or the performance of which is liable to be affected by 
such disturbance;  

‘fixed installation’ means a particular combination of several types of apparatus and, 
where  applicable,  other  devices,  which  are  assembled,  installed  and  intended  to  be 
used permanently at a predefined location;  

‘electromagnetic  compatibility’  means  the  ability  of  equipment  to  function 
satisfactorily  in  its  electromagnetic  environment  without  introducing  intolerable 
electromagnetic disturbances to other equipment in that environment; 

(e5) 

‘electromagnetic  disturbance’  means  any  electromagnetic  phenomenon  which  may 
degrade  the  performance  of  equipment⌦ ,  including, ⌫  .  An  electromagnetic 
disturbance  may  be  electromagnetic  noise,  an  unwanted  signal  or  a  change  in  the 
propagation medium itself; 

(cid:208) 2004/108 (adapted)  

EN 

21 

   EN 

 
 
 
 
 
(cid:208) 2004/108  

(f6) 

‘immunity’  means  the  ability  of  equipment  to  perform  as  intended  without 
degradation in the presence of an electromagnetic disturbance; 

(g7) 

‘safety purposes’ means the purposes of safeguarding human life or property; 

(h8) 

‘electromagnetic environment’ means all electromagnetic phenomena observable in a 
given location.; 

(9) 

(10) 

(11) 

(12) 

(13) 

(14) 

(15) 

(16) 

(17) 

(18) 

(19) 

(cid:216) new 

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

'placing  on  the  market'  means  the  first  making available of apparatus on the Union 
market; 

'manufacturer' means any natural or legal person who manufactures apparatus or has 
apparatus  designed  or  manufactured,  and  markets  that  apparatus  under  his  name  or 
trademark; 

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

'importer' means any natural or legal person established within the Union who places 
apparatus from a third country on the Union market; 

'distributor'  means  any  natural  or  legal  person  in  the  supply  chain,  other  than  the 
manufacturer or the importer, who makes apparatus available on the market; 

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

'technical specification' means a document that prescribes technical requirements to 
be fulfilled by the equipment; 

'harmonised  standard'  means  harmonised  standard  as  defined  in  Article  2(1)(c)  of 
Regulation (EU) No [../..] [on European Standardisation]; 

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

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

EN 

22 

   EN 

 
 
 
(20) 

(21) 

(22) 

(23) 

(24) 

'conformity  assessment'  means  the  process  demonstrating  whether  the  requirements 
relating to an apparatus have been fulfilled; 

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

'recall'  means  any  measure  aimed  at  achieving  the  return  of  apparatus  that  has 
already been made available to the end user; 

'withdrawal'  means  any  measure  aimed  at  preventing  apparatus  in  the  supply  chain 
from being made available on the market; 

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

(25) 

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

2. For the purposes of this Directive ⌦ point (2) of the first subparagraph ⌫ the following 
shall be deemed to be ⌦ considered ⌫ an apparatus within the meaning of paragraph 1(b) : 

(cid:208) 2004/108 (adapted) 

(cid:208) 2004/108 (adapted) 
(cid:214) new 

(a)‘components’ or ‘sub-assemblies’ intended for incorporation into an apparatus by 
the  end  user,  which  are  liable  to  generate  electromagnetic  disturbance,  or  the 
performance of which is liable to be affected by such disturbance;  

(b)‘mobile  installations’  defined  as  a  combination  of  apparatus  and,  where 
applicable, other devices, intended to be moved and operated in a range of locations.  

Article 43 

Placing (cid:214) Making available  on the market and/or putting into service 

Member States shall take all appropriate measures to ensure that equipment is placed (cid:214) made 
available  on the market and/or put into service only if it complies with the requirements of 
this Directive when properly installed, maintained and used for its intended purpose. 

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Article 54 

Free movement of equipment 

1. Member States shall not impede, for reasons relating to electromagnetic compatibility, the 
placing (cid:214) making available  on the market and/or the putting into service in their territory 
of equipment which complies with this Directive. 

2. The requirements of this Directive shall not prevent the application in any Member State of 
the following special measures concerning the putting into service or use of equipment: 

(a)  measures  to  overcome  an  existing  or  predicted  electromagnetic  compatibility 
problem at a specific site; 

(b) measures taken for safety reasons to protect public telecommunications networks 
or  receiving  or  transmitting  stations  when  used  for  safety  purposes  in  well-defined 
spectrum situations. 

Without prejudice to Directive 98/34/EC, Member States shall notify those special measures 
to the Commission and to the other Member States. 

The special measures which have been accepted shall be published by the Commission in the 
Official Journal of the European Union. 

3. Member States shall not create any obstacles to the display and/or demonstration at trade 
fairs, exhibitions or similar events of equipment which does not comply with this Directive, 
provided that a visible sign clearly indicates that such equipment may not be placed (cid:214) made 
available   on  the  market  and/or  put  into  service  until  it  has  been  brought  into  conformity 
with this Directive. Demonstration may only take place provided that adequate measures are 
taken to avoid electromagnetic disturbances. 

Article 65 

Essential requirements 

The  equipment  referred  to  in  Article  1  shall  meet  the  essential  requirements  set  out  in 
Annex I. 

(cid:208) 2004/108 (adapted) 

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(cid:216) new  

CHAPTER 2 

OBLIGATIONS OF ECONOMIC OPERATORS 

Article 7 [Article R2 of Decision No 768/2008/EC] 

Obligations of manufacturers 

1. When placing their apparatus on the market and/or putting them into service, manufacturers 
shall ensure that they have been designed and manufactured in accordance with the essential 
requirements set out in Annex I. 

2.  Manufacturers  shall  draw  up  the  technical  documentation  referred  to  in  Annex  II  and 
Annex III and carry out the conformity assessment procedure referred to in Article 15 or have 
it carried out. 

Where  compliance  of  apparatus  with  the  applicable  requirements  has  been  demonstrated  by 
that procedure, manufacturers shall draw up an EU declaration of conformity and affix the CE 
marking. 

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

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

5. Manufacturers shall ensure that their apparatus bear a type, batch or serial number or other 
element  allowing  their  identification,  or,  where  the  size  or  nature  of  the  apparatus  does  not 
allow  it,  that  the  required  information  is  provided  on  the  packaging  or  in  a  document 
accompanying the apparatus. 

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

7.  Manufacturers  shall  ensure  that  the  apparatus  is  accompanied  by  instructions  and  other 
information  referred  to  in  Article  18  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  apparatus  which  they  have 
placed  on  the  market  and/or  put  into  service  is  not  in  conformity  with  this  Directive  shall 

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

9.  Manufacturers  shall,  further  to  a  reasoned  request  from  a  competent  national  authority, 
provide  it  with  all  the  information  and  documentation  necessary  to  demonstrate  the 
conformity of the apparatus, in a language which can be easily understood by that authority. 
They shall cooperate with that authority, at its request, on any action taken to eliminate the 
risks posed by apparatus which they have placed on the market and/or put into service. 

Article 8 [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 7(1) and the drawing up of technical documentation shall 
not form part of the authorised representative's mandate. 

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

(a) keep the EU declaration of conformity and the technical documentation at the disposal of 
national  surveillance  authorities  for  10  years  after  the  apparatus  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  the 
apparatus; 

(c) cooperate with the competent national authorities, at their request, on any action taken to 
eliminate the risks posed by the apparatus covered by the authorised representative's mandate. 

Article 9 [Article R4 of Decision No 768/2008/EC] 

1. Importers shall place only compliant apparatus on the market.  

Obligations of importers 

2.  Before  placing  apparatus  on  the  market  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 apparatus bears the 
CE  marking  and  is  accompanied  by  the  required  documents,  and  that  the  manufacturer  has 
complied with the requirements set out in Article 7(5) and (6). 

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

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

4.  Importers  shall  ensure  that  the  apparatus  is  accompanied  by  instructions  and  other 
information  referred  to  in  Article  18  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  apparatus  is  under  their  responsibility,  storage  or 
transport conditions do not jeopardise its compliance with the essential requirements set out in 
Annex I. 

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

7. Importers shall, for 10 years after the apparatus has been placed on the market, keep a copy 
of the EU declaration of conformity at the disposal of the market surveillance authorities and 
ensure  that  the  technical  documentation  can  be  made  available  to  those  authorities,  upon 
request. 

8. Importers shall, further to a reasoned request from a competent national authority, provide 
it  with  all  the  information  and  documentation  necessary  to  demonstrate  the  conformity  of 
apparatus  in  a  language  which  can  be  easily  understood  by  that  authority.  They  shall 
cooperate with that authority, at its request, on any action taken to eliminate the risks posed 
by apparatus which they have placed on the market. 

Article 10 [Article R5 of Decision No 768/2008/EC] 

Obligations of distributors 

1.  When  making  apparatus  available  on  the  market  distributors  shall  act  with  due  care  in 
relation to the requirements of this Directive. 

2. Before making apparatus available on the market distributors shall verify that the apparatus 
bears the CE marking, that it is accompanied by the required documents and by instructions 
and other information referred to in Article 18 in a language which can be easily understood 
by consumers and other end-users in the Member State in which the apparatus is to be made 
available  on  the  market  and/or  to  be  put  into  service,  and  that  the  manufacturer  and  the 
importer have complied with the requirements set out in Article 7(5) and (6) and Article 9(3). 

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

3.  Distributors  shall  ensure  that,  while  apparatus  is  under  their  responsibility,  storage  or 
transport conditions do not jeopardise its compliance with the essential requirements set out in 
Annex I. 

4. Distributors who consider or have reason to believe that apparatus which they have made 
available  on  the  market  is  not  in  conformity  with  the  requirements  of  this  Directive  shall 
make sure that the corrective measures necessary to bring that apparatus into conformity, to 
withdraw it or recall it, if appropriate, are taken. Furthermore, where the apparatus presents a 
risk, distributors shall immediately inform the competent national authorities of the Member 
States in which they made the apparatus available to that effect, giving details, in particular, 
of the non-compliance and of any corrective measures taken. 

5.  Distributors  shall,  further  to  a  reasoned  request  from  a  competent  national  authority, 
provide  it  with  all  the  information  and  documentation  necessary  to  demonstrate  the 
conformity  of  the  apparatus.  They  shall  cooperate  with  that  authority,  at  its  request,  on  any 
action taken to eliminate the risks posed by apparatus which they have made available on the 
market. 

Article 11 [Article R6 of Decision No 768/2008/EC] 

Cases in which obligations of manufacturers apply to importers and distributors 

An  importer  or  distributor  shall  be  considered  a  manufacturer  for  the  purposes  of  this 
Directive and he shall be subject to the obligations of the manufacturer under Article 7, where 
he places apparatus on the market under his name or trademark or modifies apparatus already 
placed on the market in such a way that compliance with the requirements of this Directive 
may be affected. 

Article 12 [Article R7 of Decision No 768/2008/EC] 

Identification of economic operators 

Economic  operators  shall,  on  request,  identify  the  following  to  the  market  surveillance 
authorities:  

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

(b) any economic operator to whom they have supplied apparatus. 

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 apparatus and for a period of 
10 years after they have supplied the apparatus. 

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(cid:208) 2004/108 (adapted) 

CHAPTER 3III 

⌦ CONFORMITY OF EQUIPMENT ⌫ 

Article 613 [Article R8 of Decision No 768/2008/EC] 

Harmonised standards ⌦ Presumption of conformity ⌫  

1. ‘Harmonised standard’ means a technical specification adopted by a recognised European 
standardisation  body  under  a  mandate  from  the  Commission  in  conformity  with  the 
procedures  laid  down  in  Directive  98/34/EC  for  the  purpose  of  establishing  a  European 
requirement. Compliance with a ‘harmonised standard’ is not compulsory. 

(cid:208) 2004/108 

(cid:208) 2004/108 (adapted) 

2.  The  compliance  of  eEquipment  ⌦ which  is  in  conformity ⌫  with  the  relevant 
harmonised standards ⌦ or parts thereof the ⌫ whose references ⌦ of which ⌫ have been 
published  in  the  Official  Journal  of  the  European  Union  shall ⌦ be  presumed  to  be  in ⌫ 
raise  a  presumption,  on  the  part  of  the  Member  States,  of  conformity  with  the  essential 
requirements ⌦ covered by those standards or parts thereof, set out ⌫ referred to in Annex I 
to which such standards relate. This presumption of conformity is limited to the scope of the 
harmonised  standard(s)  applied  and  the  relevant  essential  requirements  covered  by  such 
harmonised standard(s). 

3. Where a Member State or the Commission considers that a harmonised standard does not 
entirely  satisfy  the  essential  requirements  referred  to  in  Annex  I,  it  shall  bring  the  matter 
before the Standing Committee set up by Directive 98/34/EC (hereinafter ‘the Committee’), 
stating its reasons. The Committee shall deliver an opinion without delay. 

4. Upon receipt of the Committee's opinion, the Commission shall take one of the following 
decisions with regard to the references to the harmonised standard concerned: 

(a) not to publish; 

(b) to publish with restrictions; 

(c) to maintain the reference in the Official Journal of the European Union; 

(d) to withdraw the reference from the Official Journal of the European Union. 

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The Commission shall inform the Member States of its decision without delay. 

[Where a harmonised standard satisfies the requirements which it covers and which are set out 
in Annex I or Article 24, the Commission shall publish the references of those standards in 
the Official Journal of the European Union.] 

(cid:216) new 

(cid:208) 2004/108 (adapted) 

Article 147 

Conformity assessment procedure for apparatus 

Compliance of apparatus with the essential requirements referred to ⌦ set out ⌫ in Annex I 
shall be demonstrated by means of the procedure ⌦ either of the following procedures ⌫: 
described  in  Annex  II  (internal  production  control).  However,  at  the  discretion  of  the 
manufacturer or of his authorised representative in the Community, the procedure described 
in Annex III may also be followed. 

⌦ (a) internal production control set out in Annex II; ⌫ 

⌦ (b)  EU  type  examination  that  is  followed  by  Conformity  to  type  based  on  internal 
production control set out in Annex III. ⌫ 

(cid:208) 2004/108  

Article 8 

‘CE’ marking 

1.  Apparatus  whose  compliance  with  this  Directive  has  been  established  by  means  of  the 
procedure laid down in Article 7 shall bear the ‘CE’ marking which attests to that fact. The 
affixing of the ‘CE’ marking shall be the responsibility of the manufacturer or his authorised 
representative  in  the  Community.  The  ‘CE’  marking  shall  be  affixed  in  accordance  with 
Annex V 

2. Member States shall take the necessary measures to prohibit the affixing to the apparatus, 
or to its packaging, or to the instructions for its use, of marks which are likely to mislead third 
parties in relation to the meaning and/or graphic form of the ‘CE’ marking 

3. Any other mark may be affixed to the apparatus, its packaging, or the instructions for its 
use,  provided  that  neither  the  visibility  nor  the  legibility  of  the  ‘CE’  marking  is  thereby 
impaired 

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4. Without prejudice to Article 10, if a competent authority establishes that the ‘CE’ marking 
has been unduly affixed, the manufacturer or his authorised representative in the Community 
shall  bring  the  apparatus  into  conformity  with  the  provisions  concerning  the  ‘CE’  marking 
under conditions imposed by the Member State concerned 

(cid:216) new  

Article 15 [Article R10 of Decision No 768/2008/EC] 

EU declaration of conformity 

1.  The  EU  declaration  of  conformity  shall  state  that  the  fulfilment  of  the  essential 
requirements set out in Annex I has been demonstrated. 

2. The EU declaration of conformity shall have the model structure set out in Annex IV to this 
Directive  and  it  shall  be  continuously  updated.  It  shall  be  translated  into  the  language  or 
languages  required  by  the  Member  State  in  which  market  the  apparatus  is  placed  or  made 
available.  

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

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

Article 16 [Article R11 of Decision No 768/2008/EC] 

General principles of the CE marking 

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

Article 17 [Article R12 of Decision No 768/2008/EC] 

Rules and conditions for affixing the CE marking 

1. The CE marking shall be affixed visibly, legibly and indelibly to the apparatus or to its data 
plate. Where that is not possible or not warranted on account of the nature of the apparatus, it 
shall be affixed to the packaging and to the accompanying documents.  

2. The CE marking shall be affixed before the apparatus is placed on the market. 

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(cid:208) 2004/108 (adapted) 

Article 189 

Other marks and information 

(cid:208) 2004/108  

1.  Each  apparatus  shall  be  identified  in  terms  of  type,  batch,  serial  number  or  any  other 
information allowing for the identification of the apparatus. 

2. Each apparatus shall be accompanied by the name and address of the manufacturer and, if 
he  is  not  established  within  the  Community,  the  name  and  address  of  his  authorised 
representative or of the person in the Community responsible for placing the apparatus on the 
Community market. 

(cid:208) 2004/108 (adapted) 

13. The manufacturer shall provide information on any specific precautions that must be taken 
when the apparatus is assembled, installed, maintained or used, in order to ensure that, when 
put  into  service,  the  apparatus  is  in  conformity  with  the  protection  ⌦ essential ⌫ 
requirements set out in Annex I, point 1 of Annex I. 

24. Apparatus for which compliance with the protection ⌦ essential ⌫ requirements ⌦ set 
out  in  point  1  of  Annex  I ⌫  is  not  ensured  in  residential  areas  shall  be  accompanied  by  a 
clear  indication  of  this  ⌦ such ⌫  restriction  of  use,  where  appropriate  also  on  the 
packaging. 

35. The information required to enable apparatus to be used in accordance with the intended 
purpose of the apparatus shall be contained ⌦ included ⌫ in the instructions accompanying 
the apparatus. 

(cid:208) 2004/108  

Article 10 

Safeguards 

1. Where a Member State ascertains that apparatus bearing the ‘CE’ marking does not comply 
with the requirements of this Directive, it shall take all appropriate measures to withdraw the 
apparatus from the market, to prohibit its placing on the market or its putting into service, or 
to restrict the free movement thereof. 

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2.  The  Member  State  concerned  shall  immediately  inform  the  Commission  and  the  other 
Member  States  of  any  such  measure,  indicating  the  reasons  and  specifying,  in  particular, 
whether non-compliance is due to: 

(a)  failure  to  satisfy  the  essential  requirements  referred  to  in  Annex  I,  where  the 
apparatus does not comply with the harmonised standards referred to in Article 6; 

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

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

3. The Commission shall consult the parties concerned as soon as possible, following which it 
shall inform the Member States whether or not it finds the measure to be justified. 

4. Where the measure referred to in paragraph 1 is attributed to a shortcoming in harmonised 
standards, the Commission, after consulting the parties, shall, if the Member State concerned 
intends  to  uphold  the  measure,  bring  the  matter  before  the  Committee  and  initiate  the 
procedure laid down in Article 6(3) and (4). 

5.  Where  the  non-compliant  apparatus  has  been  subject  to  the  conformity  assessment 
procedure referred to in Annex III, the Member State concerned shall take appropriate action 
in respect of the author of the statement referred to in Annex III, point 3, and shall inform the 
Commission and the other Member States accordingly. 

Article 11 

Decisions to withdraw, prohibit or restrict the free movement of apparatus 

1.  Any  decision  taken  pursuant  to  this  Directive  to  withdraw  apparatus  from  the  market, 
prohibit  or  restrict  its  placing  on  the  market  or  its  putting  into  service,  or  restrict  the  free 
movement thereof, shall state the exact grounds on which it is based. Such decisions shall be 
notified without delay to the party concerned, who shall at the same time be informed of the 
remedies available to him under the national law in force in the Member State in question and 
of the time limits to which such remedies are subject. 

2.  In  the  event  of  a  decision  as  referred  to  in  paragraph  1,  the  manufacturer,  his  authorised 
representative, or any other interested party shall have the opportunity to put forward his point 
of  view  in  advance,  unless  such  consultation  is  not  possible  because  of  the  urgency  of  the 
measure to be taken as justified in particular with respect to public interest requirements. 

Article 12 

Notified bodies 

1.  Member  States  shall  notify  the  Commission  of  the  bodies  which  they  have  designated  to 
carry  out  the  tasks  referred  to  in  Annex  III.  When  determining  the  bodies  to  be  designated, 
Member States shall apply the criteria laid down in Annex VI. 

Such notification shall state whether the bodies are designated to carry out the tasks referred 
to in Annex III for all apparatus covered by this Directive, and/or the essential requirements 

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referred to in Annex I or whether the scope of designation is limited to certain specific aspects 
and/or categories of apparatus. 

2. Bodies which comply with the assessment criteria established by the relevant harmonised 
standards shall be presumed to comply with the criteria set out in Annex VI covered by such 
harmonised standards. The Commission shall publish in the Official Journal of the European 
Union the references of those standards. 

3.  The  Commission  shall  publish  in  the  Official  Journal  of  the  European  Union  a  list  of 
notified bodies. The Commission shall ensure that the list is kept up to date. 

4. If a Member State finds that a notified body no longer meets the criteria listed in Annex VI, 
it  shall  inform  the  Commission  and  the  other  Member  States  accordingly.  The  Commission 
shall withdraw the reference to that body from the list referred to in paragraph 3. 

(cid:208) 2004/108 (adapted) 
(cid:214) new 

FIXED INSTALLATIONS 

Article 1913 

Fixed installations 

1.  Apparatus  which  has  been  placed  (cid:214) made  available   on  the  market  and  which  may  be 
incorporated into  a  fixed installation is ⌦ shall  be ⌫ subject to all  relevant provisions for 
apparatus set out in this Directive. 

However, the provisions ⌦ requirements ⌫ of Articles 5, 7, 8 and 9 ⌦ 6 to 11 and Articles 
15  to  18 ⌫  shall  not  be  compulsory  in  the  case  of  apparatus  which  is  intended  for 
incorporation  into  a  given  ⌦ particular ⌫  fixed  installation  and  is  otherwise  not 
commercially ⌦ made ⌫ available ⌦ on the market ⌫.  

In  such  cases,  the  accompanying  documentation  shall  identify  the  fixed  installation  and  its 
electromagnetic compatibility characteristics and shall indicate the precautions to be taken for 
the incorporation of the apparatus into the fixed installation in order not to compromise the 
conformity  of  that  installation.  It  shall  furthermore  ⌦ also ⌫  include  the  information 
referred to in Articles 9(1) and (2) 7(5), 7(6) and 9(3). 

2. Where there are indications of non-compliance of the fixed installation, in particular, where 
there  are  complaints  about  disturbances  being  generated  by  the  installation,  the  competent 
authorities of the Member State concerned may request evidence of compliance of the fixed 
installation, and, when appropriate, initiate an assessment. 

(cid:208) 2004/108  

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(cid:208) 2004/108 (adapted) 

Where  non-compliance  is  established,  the  competent  authorities  may  impose  appropriate 
measures to bring the fixed installation into compliance with the protection ⌦ essential ⌫ 
requirements set out in Annex I, point 1. 

3. Member States shall set out the necessary provisions for identifying the person or persons 
responsible  for  the  establishment  of  compliance  of  a  fixed  installation  with  the  relevant 
essential requirements. 

(cid:216) new 

CHAPTER 4 

NOTIFICATION OF CONFORMITY ASSESSMENT BODIES  

Article 20 [Article R13 of Decision No 768/2008/EC] 

Notification of Notified Bodies 

Member States shall notify the Commission and the other Member States of bodies authorised 
to carry out third-party conformity assessment tasks under this Directive. 

Article 21 [Article R14 of Decision No 768/2008/EC] 

Notifying authorities 

1. Member States shall designate a notifying authority that shall be responsible for setting up 
and carrying out the necessary procedures for the assessment and notification of conformity 
assessment  bodies  and  the  monitoring  of  notified  bodies,  including  compliance  with  Article 
26. 

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

3. Where the notifying authority delegates or otherwise entrusts the assessment, notification 
or  monitoring  referred  to  in  paragraph  1  to  a  body  which  is  not  a  governmental  entity,  that 
body  shall  be  a  legal  entity  and  shall  comply  mutatis  mutandis  with  the  requirements  laid 
down in Article 22 (1) to (6). In addition it shall have arrangements to cover liabilities arising 
out of its activities. 

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4.  The  notifying  authority  shall  take  full  responsibility  for  the  tasks  performed  by  the  body 
referred to in paragraph 3. 

Article 22 [Article R15 of Decision No 768/2008/EC] 

Requirements relating to notifying authorities 

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

2. A notifying authority shall be 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  assessment  body  is  taken  by  competent  persons  different  from 
those who carried out the assessment. 

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

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

6. A notifying authority shall have a sufficient number of competent personnel at its disposal 
for the proper performance of its tasks. 

Article 23 [Article R16 of Decision No 768/2008/EC] 

Information obligation on notifying authorities 

Member  States  shall  inform  the  Commission  of  their  procedures  for  the  assessment  and 
notification  of  conformity  assessment  bodies  and  the  monitoring  of  notified  bodies,  and  of 
any changes thereto. 

The Commission shall make that information publicly available. 

Article 24 [Article R17 of Decision No 768/2008/EC] 

Requirements relating to notified bodies 

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

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

3. A conformity assessment body shall be a third-party body independent of the organisation 
or the apparatus it assesses. 

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A  body  belonging  to  a  business  association  or  professional  federation  representing 
undertakings involved in the design, manufacturing, provision, assembly, use or maintenance 
of apparatus which it assesses, may, on condition that its independence and the absence of any 
conflict of interest are demonstrated, be considered such a body. 

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

A  conformity  assessment  body,  its  top  level  management  and  the  personnel  responsible  for 
carrying  out  the  conformity  assessment  tasks  shall  not  be  directly  involved  in  the  design, 
manufacture  or  construction,  the  marketing,  installation,  use  or  maintenance  of  those 
apparatus,  or  represent  the  parties  engaged  in  those  activities.  They  shall  not  engage  in  any 
activity  that  may  conflict  with  their  independence  of  judgement  or  integrity  in  relation  to 
conformity assessment activities for which they are notified. This shall in particular apply to 
consultancy services. 

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

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

6.  A  conformity  assessment  body  shall  be  capable  of  carrying  out  all  the  conformity 
assessment  tasks  assigned  to  it  by  Annex  III  and  in  relation  to  which  it  has  been  notified, 
whether those tasks are carried out by the conformity assessment body itself or on its behalf 
and under its responsibility.  

At  all  times  and  for  each  conformity  assessment  procedure  and  each  kind  or  category  of 
apparatus in relation to which it has been notified, a conformity assessment body shall have at 
its disposal the necessary: 

(a) personnel with technical knowledge and sufficient and appropriate experience to perform 
the conformity assessment tasks; 

(b) descriptions of procedures in accordance with which conformity assessment is carried out, 
ensuring  the  transparency  and  the  ability  of  reproduction  of  those  procedures.  It  shall  have 
appropriate policies and procedures in place that distinguish between tasks it carries out as a 
notified body and other activities; 

(c)  procedures  for  the  performance  of  activities  which  take  due  account  of  the  size  of  an 
undertaking,  the  sector  in  which  it  operates,  its  structure,  the  degree  of  complexity  of  the 
apparatus technology in question and the mass or serial nature of the production process. 

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It shall have the means necessary to perform the technical and administrative tasks connected 
with the conformity assessment activities in an appropriate manner and shall have access to 
all necessary equipment or facilities. 

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

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

(b) satisfactory knowledge of the requirements 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 harmonised standards and of the relevant provisions of Union harmonisation 
legislation and national legislation; 

(d) the ability to draw up certificates, records and reports demonstrating that assessments have 
been carried out. 

8. The impartiality  of  the  conformity assessment bodies,  their top level management and of 
the assessment personnel shall be guaranteed. 

The  remuneration  of  the  top  level  management  and  assessment  personnel  of  a  conformity 
assessment body shall not depend on the number of assessments carried out or on the results 
of those assessments. 

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

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

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

Article 25 [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 

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the requirements set out in Article 24 in so far as the applicable harmonised standards cover 
those requirements. 

Article 26 [Article R20 of Decision No 768/2008/EC] 

Subsidiaries of and subcontracting by notified bodies 

1. Where a notified body subcontracts specific tasks connected with conformity assessment or 
has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the 
requirements set out in Article 24 and shall inform the notifying authority accordingly. 

2. Notified bodies shall take full responsibility 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 qualifications of the subcontractor or the subsidiary and the 
work carried out by them under Annex III. 

Article 27 [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 apparatus or apparatuses for 
which that body claims to be competent, as well as by an accreditation certificate, where one 
exists, issued by a national accreditation body attesting that the conformity assessment body 
fulfils the requirements laid down in Article 24. 

3.  Where  the  conformity  assessment  body  concerned  cannot  provide  an  accreditation 
certificate,  it  shall  provide  the  notifying  authority  with  all  the  documentary  evidence 
necessary for the verification, recognition and regular monitoring of its compliance with the 
requirements laid down in Article 24. 

Article 28 [Article R23 of Decision No 768/2008/EC] 

Notification procedure 

1.  Notifying  authorities  may  notify  only  conformity  assessment  bodies  which  have  satisfied 
the requirements laid down in Article 24. 

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2.  They  shall  notify  the  Commission  and  the  other  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  apparatus  or  apparatuses  concerned  and  the 
relevant attestation of competence. 

4.  Where  a  notification  is  not  based  on  an  accreditation  certificate  as  referred  to  in  Article 
27(2), the notifying authority shall provide the Commission and the other Member States with 
documentary evidence which attests to the conformity assessment body's competence and the 
arrangements in place to ensure that that body will be monitored regularly and will continue 
to satisfy the requirements laid down in Article 24. 

5. The body concerned may perform the activities of a notified body only where no objections 
are raised by the Commission or the other Member States within two weeks of a notification 
where  an  accreditation  certificate  is  used  or  within  two  months  of  a  notification  where 
accreditation is not used. 

Only such a body shall be considered a notified body for the purposes of this Directive.  

6. The Commission and the other Member States shall be notified of any subsequent relevant 
changes to the notification. 

Article 29 [Article R24 of Decision No 768/2008/EC] 

Identification numbers and lists of notified bodies 

1. The Commission shall assign an identification number to a notified body. 

It shall assign a single such number even where the body is notified under several Union acts. 

2.  The  Commission  shall  make  publicly  available  the  list  of  the  bodies  notified  under  this 
Directive,  including  the  identification  numbers  that  have  been  allocated  to  them  and  the 
activities for which they have been notified. 

The Commission shall ensure that that list is kept up to date. 

Article 30 [Article R25 of Decision No 768/2008/EC] 

Changes to notifications 

1. Where a notifying authority has ascertained or has been informed that a notified body no 
longer  meets  the  requirements  laid  down  in  Article  24,  or  that  it  is  failing  to  fulfil  its 
obligations,  the  notifying  authority  shall  restrict,  suspend  or  withdraw  notification  as 
appropriate, depending on the seriousness of the failure to meet those requirements or fulfil 
those obligations. It shall immediately inform the Commission and the other Member States 
accordingly. 

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2. In the event of restriction, suspension or withdrawal of notification, or where the notified 
body has ceased its activity, the notifying Member State shall take appropriate steps to ensure 
that the files of that body are either processed by another notified body or kept available for 
the responsible notifying and market surveillance authorities at their request. 

Article 31 [Article R26 of Decision No 768/2008/EC] 

Challenge of the competence of notified bodies 

1.  The  Commission  shall  investigate  all  cases  where  it  doubts,  or  doubt  is  brought  to  its 
attention  regarding,  the  competence  of  a  notified  body  or  the  continued  fulfilment  by  a 
notified body of the requirements 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  notification  or  the  maintenance  of  the  competence  of  the  body 
concerned. 

3.  The  Commission  shall  ensure  that  all  sensitive  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 32 [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 procedure provided for in Annex III. 

2.  Conformity  assessments  shall  be  carried  out  in  a  proportionate  manner,  avoiding 
unnecessary burdens for economic operators. 

Conformity assessment bodies shall perform their activities taking due account of the size of 
an undertaking, the sector in which it operates, its structure, the degree of complexity of the 
apparatus technology in question and the mass or serial nature of the production process. 

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

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

4. Where, in the course of the monitoring of conformity following the issue of a certificate, a 
notified body finds that an apparatus no longer complies, it shall require the manufacturer to 

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41 

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take  appropriate  corrective  measures  and  shall  suspend  or  withdraw  the  certificate  if 
necessary. 

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

Article 33 

Appeal against decisions of notified bodies 

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

Article 34 [Article R28 of Decision No 768/2008/EC] 

Information obligation on notified bodies 

1. Notified bodies shall inform the notifying authority of the following: 

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

(b) any circumstances affecting the scope of and conditions for notification; 

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

(d)  on  request,  conformity  assessment  activities  performed  within  the  scope  of  their 
notification  and  any  other  activity  performed,  including  cross-border  activities  and 
subcontracting. 

2.  Notified  bodies  shall  provide  the  other  bodies  notified  under  this  Directive  carrying  out 
similar  conformity  assessment  activities  covering  the  same  apparatus  with  relevant 
information  on  issues  relating  to  negative  and,  on  request,  positive  conformity  assessment 
results. 

Article 35[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. 

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Article 36 [Article R30 of Decision No 768/2008/EC] 

Coordination of notified bodies 

The Commission shall ensure that appropriate coordination and cooperation between bodies 
notified under this Directive are put in place and properly operated in the form of a sectoral 
group of notified bodies. 

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

CHAPTER 5 

UNION MARKET SURVEILLANCE AND CONTROL OF 
APPARATUS ENTERING THE UNION MARKET AND 
SAFEGUARD PROCEDURES 

Union market surveillance and control of apparatus entering the Union market 

Article 37 

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

Article 38 [Article R31 of Decision No 768/2008/EC] 

Procedure for dealing with apparatus presenting a risk at national level 

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

Where,  in  the  course  of  that  evaluation,  the  market  surveillance  authorities  find  that  the 
apparatus  does  not  comply  with  the  requirements  laid  down  in  this  Directive,  they  shall 
without delay require the relevant economic operator to take all appropriate corrective action 
to  bring  the  apparatus  into  compliance  with  those  requirements,  to  withdraw  the  apparatus 
from the market, or to recall it within a reasonable period, commensurate with the nature of 
the risk, as they may prescribe. 

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

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

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

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

4. Where the relevant economic operator does not take adequate corrective action within the 
period  referred  to  in  the  second  subparagraph  of  paragraph  1,  the  market  surveillance 
authorities shall take all appropriate provisional measures to prohibit or restrict the apparatus's 
being made available on their national market, to withdraw the apparatus from that market or 
to recall it. 

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

5. The information referred to in paragraph 4 shall include all available details, in particular 
the  data  necessary  for  the  identification  of  the  non-compliant  apparatus,  the  origin  of  the 
apparatus,  the  nature  of  the  non-compliance  alleged  and  the  risk  involved,  the  nature  and 
duration  of  the  national  measures  taken  and  the  arguments  put  forward  by  the  relevant 
economic operator. In particular, the market surveillance authorities shall indicate whether the 
non-compliance is due to either of the following reasons: 

(a)  failure  of  the  apparatus  to  meet  the  requirements  relating  to  aspects  of  public  interest 
protection covered by 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  State  initiating  the  procedure  shall  without  delay 
inform  the  Commission  and  the  other  Member  States  of  any  measures  adopted  and  of  any 
additional  information  at  their  disposal  relating  to  the  non-compliance  of  the  apparatus 
concerned,  and,  in  the  event  of  disagreement  with  the  notified  national  measure,  of  their 
objections. 

7.  Where,  within  2  months  of  receipt  of  the  information  referred  to  in  paragraph  4,  no 
objection  has  been  raised  by  either  a  Member  State  or  the  Commission  in  respect  of  a 
provisional measure taken by a Member State, that measure shall be deemed justified. 

8. Member States shall ensure that appropriate restrictive measures are taken in respect of the 
apparatus concerned without delay. 

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Article 39 [Article R32 of Decision No 768/2008/EC] 

Union safeguard procedure 

1.  Where,  on  completion  of  the  procedure  set  out  in  Article  38(3)  and  (4),  objections  are 
raised  against  a  measure  taken  by  a  Member  State,  or  where  the  Commission  considers  a 
national  measure  to  be  contrary  to  Union  legislation,  the  Commission  shall  without  delay 
enter  into  consultation  with  the  Member  States  and  the  relevant  economic  operator  or 
operators  and  shall  evaluate  the  national  measure.  On  the  basis  of  the  results  of  that 
evaluation, the Commission shall decide whether the national measure is justified or not. 

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

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

3. Where the national measure is considered justified and the non-compliance of the apparatus 
is attributed to shortcomings in the harmonised standards referred to in Article 38(5)(b) of this 
Directive, the Commission shall apply the procedure provided for in Article [8] of Regulation 
(EU) No [../..] [on European Standardisation]. 

Article 40 [Article R34 of Decision No 768/2008/EC] 

Formal non-compliance 

1.  Without  prejudice  to  Article  38,  where  a  Member  State  makes  one  of  the  following 
findings, it shall require the relevant economic operator to put an end to the non-compliance 
concerned: 

(a)  the  CE  marking  has  been  affixed  in  violation  of  Article  30  of  Regulation  (EC)  No 
765/2008 or of Article 17 of this Directive; 

(b) the CE marking has not been affixed; 

(c) the EU declaration of conformity has not been drawn up; 

(d) the EU declaration of conformity has not been drawn up correctly; 

(e) technical documentation is either not available or not complete. 

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

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(cid:208) 2004/108 (adapted) 

CHAPTER IV6 

⌦ TRANSITIONAL AND⌫ FINAL PROVISIONS 

(cid:216) new 

Article 41 

Penalties 

Member States shall lay down rules on penalties applicable to infringements of the national 
provisions adopted pursuant to this Directive and shall take all measures necessary to ensure 
that they are enforced.  

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

Member  States  shall  notify  those  provisions  to  the  Commission  by  [the  date  set  out  in  the 
second  subparagraph  of  Article  43(1)]  at  the  latest  and  shall  notify  it  without  delay  of  any 
subsequent amendment affecting them. 

(cid:208) 2004/108 (adapted) 
(cid:214) new 

Article 4215 

Transitional provisions 

Member States shall not impede the placing (cid:214) making available  on the market and/or the 
putting  into  service  of  equipment  which  is  in  compliance  with  the  provisions  of  Directive 
89/336/EEC and which was placed on the market before 20 July 2009 (cid:214) covered by Directive 
2004/108/EC which is in conformity with that Directive and which was placed on the market 
before [the date set out in the second subparagraph of Article 43(1)]  . 

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(cid:208) 2004/108 (adapted) 

Article 4316 

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 this 
Directive ⌦ Article 3 first subparagraph points (9) to (25), Article 4, Article 5(1), Articles 7 
to 12, Articles 15 to 17, Article 19 (1) first subparagraph, Articles 20 to 42, and Annexes II, 
III and IV. ⌫ by 20 January 2007. They shall forthwith inform ⌦ communicate to ⌫ the 
Commission  thereof  ⌦ the  text  of  those  provisions  and  a  correlation  table  between  those 
provisions and this Directive ⌫. 

They shall apply those provisions as from 20 July 2007 ⌦ [day after date mentioned in first 
subparagraph] ⌫. 

When Member States adopt those provisions, they shall contain a reference to this Directive 
or shall be accompanied by such reference on the occasion of their official publication. The 
methods of making such reference shall be laid down by Member States. ⌦They shall also 
include a statement that references in existing laws, regulations and administrative provisions 
to the directive  repealed by  this Directive shall be construed as references to this Directive. 
Member States shall determine how such reference is to be made and how that statement is to 
be formulated. ⌫ 

2.  Member  States  shall  communicate  to  the  Commission  the  texts  of  the  ⌦ main ⌫ 
provisions of national law which they adopt in the field covered by this Directive. 

Article 4414 

Repeal 

Directive 89/336/EEC 2004/108/EC is hereby repealed as from 20 July 2007 ⌦ with effect 
from [the date set out in the second subparagraph of Article 43(1)], without prejudice to the 
obligations of the Member States relating to the time-limit for transposition into national law 
and application of the said Directive set out in Annex V. ⌫ 

References  to ⌦ the repealed ⌫ Directive 89/336/EEC shall be construed as references to 
this Directive and should ⌦ shall ⌫ be read in accordance with the correlation table set out 
in Annex VII. 

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Article 4517 

Entry into force 

This  Directive  shall  enter  into  force  on  the  twentieth  day  after  ⌦ following  that  of ⌫  its 
publication in the Official Journal of the European Union. 

Article 1, Article 2, Article 3 first subparagraph, points (1) to (8) and second subparagraph, 
Article 5(2) and (3), Article 6, Article 13 first subparagraph, Article 19 (3) and Annex I shall 
apply from [the date set out in the second subparagraph of Article 43(1)]. 

(cid:208) 

(cid:208) 2004/108 

Article 4618 

Addressees 

This Directive is addressed to the Member States. 

Done at […], 

For the European Parliament 
The President 

For the Council 
The President

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(cid:208) 2004/108 (adapted) 

ANNEX I 

ESSENTIAL REQUIREMENTS REFERRED TO IN ARTICLE 5 

1. PROTECTION ⌦ ESSENTIAL ⌫ REQUIREMENTS 

Equipment shall be so designed and manufactured, having regard to the state of the art, as to 
ensure that: 

(cid:208) 2004/108 

(a) the electromagnetic disturbance generated does not exceed the level above which 
radio  and  telecommunications  equipment  or  other  equipment  cannot  operate  as 
intended; 

(b) it has a level of immunity to the electromagnetic disturbance to be expected in its 
intended  use  which  allows  it  to  operate  without  unacceptable  degradation  of  its 
intended use. 

2. SPECIFIC REQUIREMENTS FOR FIXED INSTALLATIONS 

Installation and intended use of components 

(cid:208) 2004/108 (adapted) 

A fixed installation shall be installed applying good engineering practices and respecting the 
information  on  the  intended  use  of  its  components,  with  a  view  to  meeting  the  protection 
⌦ essential ⌫ requirements set out in Ppoint 1. Those good engineering practices shall be 
documented and the documentation shall be held by the person(s) responsible at the disposal 
of the relevant national authorities for inspection purposes for as long as the fixed installation 
is in operation. 

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(cid:208) 2004/108 (adapted) 

ANNEX II 

CONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN 
ARTICLE 7 

(INTERNAL PRODUCTION CONTROL) 

(cid:208) 2004/108 

1.  The  manufacturer  shall  perform  an  electromagnetic  compatibility  assessment  of  the 
apparatus,  on  the  basis  of  the  relevant  phenomena,  with  a  view  to  meeting  the  protection 
requirements  set  out  in  Annex I,  point  1.  The  correct  application  of  all  the  relevant 
harmonised  standards  whose  references  have  been  published  in  the  Official  Journal  of  the 
European Union shall be equivalent to the carrying out of the electromagnetic compatibility 
assessment. 

2. The electromagnetic compatibility assessment shall take into account all normal intended 
operating  conditions.  Where  the  apparatus  is  capable  of  taking  different  configurations,  the 
electromagnetic  compatibility  assessment  shall  confirm  whether  the  apparatus  meets  the 
protection  requirements  set  out  in  Annex  I,  point  1,  in  all  the  possible  configurations 
identified by the manufacturer as representative of its intended use. 

3.  In  accordance  with  the  provisions  set  out  in  Annex  IV,  the  manufacturer  shall  draw  up 
technical  documentation  providing  evidence  of  the  conformity  of  the  apparatus  with  the 
essential requirements of this Directive. 

4.  The  manufacturer  or  his  authorised  representative  in  the  Community  shall  hold  the 
technical documentation at the disposal of the competent authorities for at least ten years after 
the date on which such apparatus was last manufactured. 

5. The compliance of apparatus with all relevant essential requirements shall be attested by an 
EC declaration of  conformity issued  by the manufacturer or his authorised representative in 
the Community. 

6.  The  manufacturer  or  his  authorised  representative  in  the  Community  shall  hold  the 
EC declaration  of  conformity  at  the  disposal  of  the  competent  authorities  for  a  period  of  at 
least ten years after the date on which such apparatus was last manufactured. 

7.  If  neither  the  manufacturer  nor  his  authorised  representative  is  established  within  the 
Community,  the  obligation  to  hold  the  EC  declaration  of  conformity  and  the  technical 
documentation  at  the  disposal  of  the  competent  authorities  shall  lie  with  the  person  who 
places the apparatus on the Community market. 

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8.  The  manufacturer  must  take  all  measures  necessary  to  ensure  that  the  products  are 
manufactured in accordance with the technical documentation referred to in point 3 and with 
the provisions of this Directive that apply to them. 

9.  The  technical  documentation  and  the  EC  declaration  of  conformity  shall  be  drawn  up  in 
accordance with the provisions set out in Annex IV. 

(cid:216) new 

1.  Internal  production  control  is  the  conformity  assessment  procedure  whereby  the 
manufacturer performs an electromagnetic compatibility assessment of the apparatus, on the 
basis of the relevant phenomena, with a view to meeting the essential requirements set out in 
point 1 of Annex I and fulfils the obligations laid down in points 2, 3 and 4, and ensures and 
declares on his sole responsibility that the apparatus concerned satisfy the requirements of this 
Directive. 

The  electromagnetic  compatibility  assessment  shall  take  into  account  all  normal  intended 
operating  conditions.  Where  the  apparatus  is  capable  of  taking  different  configurations,  the 
electromagnetic  compatibility  assessment  shall  confirm  whether  the  apparatus  meets  the 
essential  requirements  set  out  in  point  1  of  Annex  I  in  all  the  possible  configurations 
identified by the manufacturer as representative of its intended use. 

The correct application of all the relevant harmonised standards whose references have been 
published  in  the  Official  Journal  of the  European  Union  shall  be  equivalent  to  the  carrying 
out of the electromagnetic compatibility assessment. 

2. Technical documentation 

The manufacturer shall establish the technical documentation. The documentation shall make 
it possible to assess the apparatus conformity to 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  apparatus.  The 
technical documentation shall, wherever applicable, contain at least the following elements: 

— a general description of the apparatus; 

—  a  list  of  the  harmonised  standards  and/or  other  relevant  technical  specifications  the 
references  of  which  have  been  published  in  the  Official  Journal  of  the  European  Union, 
applied  in  full  or  in  part,  and  descriptions  of  the  solutions  adopted  to  meet  the  essential 
requirements of this Directive where those harmonised standards have not been applied. In the 
event  of  partly  applied  harmonised  standards,  the  technical  documentation  shall  specify  the 
parts which have been applied; 

— results of design calculations made, examinations carried out, etc; and 

— test reports. 

3. Manufacturing 

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The manufacturer shall take all measures necessary so that the manufacturing process and its 
technical 
monitoring  ensure  compliance  of 
documentation referred to in point 2 and with the requirements of the legislative instruments 
that apply to them. 

the  manufactured  apparatus  with 

the 

4. CE marking and EU declaration of conformity 

4.1.  The  manufacturer  shall  affix  the  CE  marking to each individual apparatus that satisfies 
the applicable requirements of this Directive. 

4.2. The manufacturer shall draw up a written EU declaration of conformity for an apparatus 
model  and  keep  it  together  with  the  technical  documentation  at  the  disposal  of  the  national 
authorities for 10 years after the apparatus has been placed on the market. The declaration of 
conformity shall identify the apparatus for which it has been drawn up. 

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

5. Authorised representative 

The  manufacturer's  obligations  set  out  in  point  4  may  be  fulfilled  by  his  authorised 
representative, on his behalf and under his responsibility, provided that they are specified in 
the mandate. 

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(cid:208) 2004/108 

ANNEX III 

CONFORMITY ASSESSMENT PROCEDURE REFERRED TO IN 
ARTICLE 7 

1. This procedure consists of applying Annex II, completed as follows: 

2.  The  manufacturer  or  his  authorised  representative  in  the  Community  shall  present  the 
technical documentation to the notified body referred to in Article 12 and request the notified 
body  for  an  assessment  thereof.  The  manufacturer  or  his  authorised  representative  in  the 
Community  shall  specify  to  the  notified  body  which  aspects  of  the  essential  requirements 
must be assessed by the notified body. 

3.  The  notified  body  shall  review  the  technical  documentation  and  assess  whether  the 
technical documentation properly demonstrates that the requirements of the Directive that it is 
to  assess  have  been  met.  If  the  compliance  of  the  apparatus  is  confirmed,  the  notified  body 
shall issue a statement to the manufacturer or his authorised representative in the Community 
confirming the compliance of the apparatus. That statement shall be limited to those aspects 
of the essential requirements which have been assessed by the notified body. 

4.  The  manufacturer  shall  add  the  statement  of  the  notified  body  to  the  technical 
documentation. 

(cid:216) new 

Part A 

EU-TYPE EXAMINATION 

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

2. EU-type examination shall be carried out by assessment of the  adequacy of the technical 
design  of  the  apparatus  through  examination  of  the  technical  documentation  and  supporting 
evidence referred to in point 3, without examination of a specimen (design type). It may be 
restricted to some aspects of the essential requirements as specified by the manufacturer or his 
authorised representative in the Union. 

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

The application shall include: 

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the  name  and  address  of  the  manufacturer  and,  if  the  application  is  lodged  by  the 

(a) 
authorised representative, his name and address as well; 

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

(b) 
notified body; 

(c) 
the  technical  documentation.  The  technical  documentation  shall  make  it  possible  to 
assess the apparatus conformity with the applicable requirements of this Directive and shall 
include an adequate analysis and assessment of the risk(s). The technical documentation shall 
specify  the  applicable  requirements  and  cover,  as  far  as  relevant  for  the  assessment,  the 
design,  manufacture  and  operation  of  the  apparatus.  The  technical  documentation  shall 
contain, wherever applicable, at least the following elements: 

(i) 

a general description of the apparatus; 

(ii) 
a list of the harmonised standards and/or other relevant technical specifications 
the references of which have been published in the Official Journal of the European 
Union, applied in full or in part, and descriptions of the solutions adopted to meet the 
essential requirements of this Directive where those harmonised standards have not 
been  applied.  In  the  event  of  partly  applied  harmonised  standards,  the  technical 
documentation shall specify the parts which have been applied; 

(iii) 

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

(iv) 

test reports; 

(d) 
the  supporting  evidence  for  the  adequacy  of  the  technical  design  solution.  This 
supporting evidence shall mention any documents that have been used, in particular where the 
relevant  harmonised  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 manufacturer, or by another testing laboratory on his behalf and 
under his responsibility. 

4.  The  notified  body  shall  examine  the  technical  documentation  and  supporting  evidence  to 
assess the adequacy of the technical design of the apparatus. 

5. The notified body shall draw up an evaluation report that records the activities undertaken 
in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à vis 
the notifying authorities, the notified body shall release the content of that report, in full or in 
part, only with the agreement of the manufacturer. 

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

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

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Where  the  type  does  not  satisfy  the  applicable  requirements  of  this  Directive,  the  notified 
body shall refuse to issue an EU-type examination certificate and shall inform the applicant 
accordingly, giving detailed reasons for its refusal. 

7. The notified body shall keep itself apprised of any changes in the generally acknowledged 
state  of  the  art  which  indicate  that  the  approved  type  may  no  longer  comply  with  the 
applicable requirements of this Directive, and shall determine whether such changes require 
further investigation. If so, the notified body shall inform the manufacturer accordingly. 

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

8.  Each  notified  body  shall  inform  its  notifying  authorities  concerning  the  EU-type 
examination  certificates  and/or  any  additions  thereto  which  it  has  issued  or  withdrawn,  and 
shall,  periodically  or  upon  request,  make  available  to  its  notifying  authorities  the  list  of 
certificates and/or any additions thereto refused, suspended or otherwise restricted. 

Each notified body shall inform the other notified bodies concerning the EU-type examination 
certificates  and/or  any  additions  thereto  which  it  has  refused,  withdrawn,  suspended  or 
otherwise  restricted,  and,  upon  request,  concerning  the  certificates  and/or  additions  thereto 
which it has issued.  

The Commission, the Member States and the other notified bodies may, on request, obtain a 
copy  of  the  EU-type  examination  certificates  and/or  additions  thereto.  On  request,  the 
Commission  and  the  Member  States  may  obtain  a  copy  of  the  technical  documentation  and 
the results of the examinations carried out by the notified body. The notified body shall keep a 
copy  of  the  EU-type  examination  certificate,  its  annexes  and  additions,  as  well  as  the 
technical file including the documentation submitted by the manufacturer, until the expiry of 
the validity of the certificate. 

9. The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and 
additions together with the technical documentation at the disposal of the national authorities 
for 10 years after the apparatus has been placed on the market. 

10.  The  manufacturer's  authorised  representative  may  lodge  the  application  referred  to  in 
point 3 and fulfill the obligations set out in points 7 and 9, provided that they are specified in 
the mandate. 

Part B 

CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL 

1.  Conformity  to  type  based  on  internal  production  control  is  the  part  of  a  conformity 
assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 
and 3, and ensures and declares that the apparatus concerned are in conformity with the type 
described in the EU-type examination certificate and satisfy the requirements of this Directive 
that apply to them. 

2. Manufacturing 

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

3. CE marking and EU declaration of conformity 

3.1.  The  manufacturer  shall  affix  the  required  CE  marking  set  out  in  this  Directive  to  each 
individual apparatus that is in conformity with the type described in the EU-type examination 
certificate and satisfies the applicable requirements of this Directive.  

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

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

4. Authorised representative 

The  manufacturer's  obligations  set  out  in  point  3  may  be  fulfilled  by  his  authorised 
representative, on his behalf and under his responsibility, provided that they are specified in 
the mandate. 

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(cid:208) 2004/108 (adapted) 

ANNEX IV 

TECHNICAL DOCUMENTATION AND EC ⌦ EU ⌫ DECLARATION 
OF CONFORMITY 

(cid:208) 2004/108 

1. TECHNICAL DOCUMENTATION 

The technical documentation must enable the conformity of the apparatus with the essential 
requirements  to  be  assessed.  It  must  cover  the  design  and  manufacture  of  the  apparatus,  in 
particular: 

– 

– 

– 

– 

a general description of the apparatus; 

evidence of compliance with the  harmonised standards, if any, applied in full or in 
part; 

where  the  manufacturer  has  not  applied  harmonised  standards,  or  has  applied  them 
only  in  part,  a  description  and  explanation  of  the  steps  taken  to  meet  the  essential 
requirements  of  the  Directive,  including  a  description  of  the  electromagnetic 
compatibility assessment set out in Annex II, point 1, results of design calculations 
made, examinations carried out, test reports, etc.; 

a statement from the notified body, when the procedure referred to in Annex III has 
been followed. 

2. EC DECLARATION OF CONFORMITY 

The EC declaration of conformity must contain, at least, the following: 

– 

– 

– 

– 

– 

a reference to this Directive, 

an identification of the apparatus to which it refers, as set out in Article 9(1), 

the  name  and  address  of  the  manufacturer  and,  where  applicable,  the  name  and 
address of his authorised representative in the Community, 

a dated reference to the specifications under which conformity is declared to ensure 
the conformity of the apparatus with the provisions of this Directive, 

the date of that declaration, 

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– 

the identity and signature of the person empowered to bind the manufacturer or his 
authorised representative. 

1. No … (unique identification of the apparatus): 

2. Name and address of the manufacturer or his authorised representative: 

(cid:216) new 

3. This declaration of conformity is issued under the sole responsibility of the manufacturer 
(or installer): 

4. Object of the declaration (identification of apparatus allowing traceability. It may include a 
photograph, where appropriate): 

5.  The  object  of  the  declaration  described  above  is  in  conformity  with  the  relevant  Union 
harmonisation legislation:  

6. References to the relevant harmonised standards used, including the date of the standard, or 
references  to  the  specifications,  including  the  date  of  the  specification,  in  relation  to  which 
conformity is declared: 

7.  Where  applicable,  the  notified  body  ...  (name,  number)  …  performed  …  (description  of 
intervention) … and issued the certificate: … 

8. Additional information: 

Signed for and on behalf of: ………………………………… 

(place and date of issue): 

(name, function) (signature): 

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(cid:208) 2004/108 (adapted) 

ANNEX V 

‘CE’ MARKING REFERRED TO IN ARTICLE 8 

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

The ‘CE’ marking must have a height of at least 5 mm. If the ‘CE’ marking is reduced or 
enlarged the proportions given in the above graduated drawing must be respected. 

The  ‘CE’  marking  must  be  affixed  to  the  apparatus  or  to  its  data  plate.  Where  this  is  not 
possible or not warranted on account of the nature of the apparatus, it must be affixed to the 
packaging, if any, and to the accompanying documents. 

Where the apparatus is the subject of other Directives covering other aspects and which also 
provide for the ‘CE’ marking, the latter shall indicate that the apparatus also conforms with 
those other Directives. 

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

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(cid:208) 2004/108 

ANNEX VI 

CRITERIA FOR THE ASSESSMENT OF THE BODIES TO BE 
NOTIFIED 

1. The bodies notified by the Member States shall fulfil the following minimum conditions: 

(a) availability of personnel and of the necessary means and equipment; 

(b) technical competence and professional integrity of personnel; 

(c)  independence  in  preparing  the  reports  and  performing  the  verification  function 
provided for in this Directive; 

(d) independence of staff and technical personnel in relation to all interested parties, 
groups or persons directly or indirectly concerned with the equipment in question; 

(e) maintenance of professional secrecy by personnel; 

(f)  possession  of  civil  liability  insurance  unless  such  liability  is  covered  by  the 
Member State under national law. 

2.  Fulfilment  of  the  conditions  laid  down  in  point  1  shall  be  verified  at  intervals  by  the 
competent authorities of the Member State. 

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(cid:208) 

ANNEX V 

LIST OF TIME-LIMITS FOR TRANSPOSITION INTO NATIONAL LAW AND 
APPLICATION 
(REFERRED TO IN ARTICLE 44) 

Directive 

Time-limit for 
transposition 

Date of application 

2004/108/EC 

20.1.2007 

20.7.2007 

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(cid:208) 2004/108 (adapted) 

ANNEX VII 

CORRELATION TABLE 

Directive 89/336/EEC 
⌦2004/108/EC⌫ 

This Directive 

Article 1, point 1 

Article 2(1)(a), (b) and (c) 

Article 1, point 2 

Article 2(1)(e) 

Article 1, point 3 

Article 2(1)(f) 

Article 1, point 4 

Article 2(1)(d) 

Article 1, points 5 and 6 

- 

Article 2(1) 

Article 2(2) 

Article 2(3) 

Article 3 

Article 4 

Article 5 

Article 6 

Article 7(1)(a) 

Article 7(1)(b) 

Article 7(2). 

Article 7(3) 

Article 8(1) 

Article 8(2) 

Article 9(1) 

Article 9(2) 

Article 9(3) 

Article 1(1) 

Article 1(4) 

Article 1(2) 

Article 3 

Article 5 and Annex I 

Article 4(1) 

Article 4(2) 

Article 6(1) and (2) 

- 

- 

- 

Article 6(3) and (4) 

- 

Article 10(1) and (2) 

Article 10(3) and (4) 

Article 10(5) 

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Article 9(4) 

Article 10(3) 

Article 10(1), first sub-
paragraph 

Article 7, Annexes II and III 

Article 10(1), second sub-
paragraph 

Article 8 

Article 10(2) 

Article 10(3) 

Article 10(4) 

Article 10(5) 

Article 10(6) 

Article 11 

Article 12 

Article 13 

Article 7, Annexes II and III 

- 

- 

Article 7, Annexes II and III 

Article 12 

Article 14 

Article 16 

Article 18 

Annex I, point 1 

Annex IV, point 2 

Annex I, point 2 

Annex II 

Annex V 

Annex VI 

Annex III, last paragraph 

Article 9(5) 

⌦ Article 1(1) ⌫ 

⌦ Article 1 and Article 
2(1) ⌫ 

⌦ Article 1(2) ⌫ 

⌦ Article 2(2) ⌫ 

⌦ Article 1(3) ⌫ 

⌦ Article 2(2)(d) ⌫ 

⌦ Article 1(4) ⌫ 

⌦ Article 2(3) ⌫ 

⌦ Article 1(5) ⌫ 

⌦ Article 2(4) ⌫ 

⌦ Article 2(1)(a) ⌫ 

⌦ Article 3(1) ⌫ 

⌦ Article 2(1)(b) ⌫ 

⌦ Article 3(2) ⌫ 

⌦ Article 2(1)(c) ⌫ 

⌦ Article 3(3) ⌫ 

⌦ Article 2(1)(d) ⌫ 

⌦ Article 3(4) ⌫ 

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⌦ Article 2(1)(e) ⌫ 

⌦ Article 3(5) ⌫ 

⌦ Article 2(1)(f) ⌫ 

⌦ Article 3(6) ⌫ 

⌦ Article 2(1)(g) ⌫ 

⌦ Article 3(7) ⌫ 

⌦ Article 2(1)(h) ⌫ 

⌦ Article 3(8) ⌫ 

⌦ Article 2(2) ⌫ 

⌦ Article 
paragraph ⌫ 

3, 

last 

⌦ Article 3 ⌫ 

⌦ Article 4 ⌫ 

⌦ Article 4 ⌫ 

⌦ Article 5 ⌫ 

⌦ Article 5 ⌫ 

⌦ Article 6 ⌫ 

⌦ Article 6 ⌫ 

⌦ Article 13 ⌫ 

⌦ Article 7 ⌫ 

⌦ Article 14 ⌫ 

⌦ Article 8 ⌫ 

⌦ Article 16 and Article 
17 ⌫ 

⌦ Article 9(1) ⌫ 

⌦ Article 7(5) ⌫ 

⌦ Article 9(2) ⌫ 

⌦ Article 7(6) ⌫ 

⌦ Article 9(3) ⌫ 

⌦ Article 18(1) ⌫ 

⌦ Article 9(4) ⌫ 

⌦ Article 18(2) ⌫ 

⌦ Article 9(5) ⌫ 

⌦ Article 18(3) ⌫ 

⌦ Article 10 and Article 11 ⌫  ⌦ Article 37, Article 38, 

and Article 39⌫ 

⌦ Article 12 and Annex VI ⌫  ⌦ Chapter IV ⌫ 

⌦ Article 13 ⌫ 

⌦ Article 19 ⌫ 

⌦ Article 14 ⌫ 

⌦ Article 44 ⌫ 

⌦ Article 15 ⌫ 

⌦ Article 42 ⌫ 

⌦ Article 16 ⌫ 

⌦ Article 43 ⌫ 

⌦ Article 17 ⌫ 

⌦ Article 45 ⌫ 

⌦ Article 18 ⌫ 

⌦ Article 46 ⌫ 

⌦ Annex I ⌫ 

⌦ Annex I ⌫ 

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⌦ Annex II ⌫ 

⌦ Annex II ⌫ 

⌦ Annex III ⌫ 

⌦ Annex III ⌫ 

⌦ Annex IV ⌫ 

⌦ Annex IV ⌫ 

⌦ Annex V ⌫ 

⌦ Article 16 and Article 
17 ⌫ 

⌦ Annex VI ⌫ 

⌦ Chapter 4 ⌫ 

⌦ Annex VII ⌫ 

⌦ Annex VI ⌫ 

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