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 Me mber States relating to electromagnetic 
compatibility 
(Recast) 
(Text with EEA relevance) 
  
EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT OF THE PROPOSAL  
General context, reasons for and objectives of this proposal  
This proposal is presented in the framework of the implementation of the “goods package”  
adopted in 2008. It is part of  a package of proposals aligni ng ten product directives to 
Decision No 768/2008/EC  establishing a common framework for the marketing of products. 
Union (EU) harmonisation legislation ensuring th e free movement of products has contributed 
considerably to the completion and operation of the Single Market. It is based on a high level 
of protection and provides ec onomic 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 le gislation, ensuring the 
free movement of apparatus. It  sets out essential electroma gnetic compatibility requirements 
that apparatus must comply with in order to  be made available on the EU market. These 
essential requirements also apply to fixed inst allations. Manufacturers must demonstrate that 
an apparatus has been designed and manufact ured in compliance with the essential 
requirements and affix the CE ma rking. The responsible persons for fixed installations must 
also guarantee that fixed installations comply with the essential requirements.  
Experience with the implementation of Uni on harmonisation legislation has shown – on a 
cross-sector scale - certain weaknesses and inconsistencies in the implementation and 
enforcement of this legislation, leading to 
– the presence of non-compliant or dangerous products on the market and consequently a 
certain lack of trust in CE marking 
– competitive disadvantages for economic operators complying with the legislation as 
opposed to those circumventing the rules 
– unequal treatment in the case of non-compliant  products and distortion of competition 
amongst economic operators due to different enforcement practices 
– differing practices in the designation of conformity assessment bodies by national 
authorities 
– problems with the quality of certain notified bodies 
Furthermore the regulatory environment has beco me more and more complex, as frequently 
several pieces of legislation apply simu ltaneously to one and the same product. 
Inconsistencies in these pieces of legisla tion make it increasingly difficult for economic 
operators and authorities to correctly interpret an d apply that legislation. 
To remedy these horizontal shortcomings in Union harmonisation legi slation 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 applicat ion and enforcement. The New Legislative 
Framework (NLF) consists of two complementary instruments, Regulation (EC) No  
EN 3   EN 765/2008  on accreditation and market surveillance and Decision No 768/2008/EC 
establishing a common framework for the marketing of products . 
The NLF Regulation has introduced rules on accr editation (a tool for the evaluation of 
competence of conformity assessment bodies) and requirements for the organisation and performance of market surveillance and contro ls of products from third countries. Since 1 
January 2010 these rules apply di rectly in all Member States. 
The NLF Decision sets out a common framewor k for EU product harmonisation legislation. 
This framework consists of the provision s which are commonly used in EU product 
legislation (e.g. definitions, obligations of economic operators, notified bodies, safeguard 
mechanisms, etc). These common provisions ha ve been reinforced to ensure that the 
directives can be applied and enforced more ef fectively in practice. New elements, such as 
obligations on importers, have b een introduced, which are crucia l 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 D ecision contains the corresponding obligations for economic 
operators and notified bodies allowing market  surveillance authoriti es and authorities 
responsible for notified bodies to properly perform the tasks imposed on them by the NLF 
Regulation and to ensure an effective and cons istent enforcement of EU product legislation.  
However, unlike the NLF Regulation, the provis ions of the NLF Deci sion are not directly 
applicable. To ensure that a ll economic sectors subject to Union harmonisation legislation 
benefit from the improvements of the NLF, the provisions of the NLF D ecision need to be 
integrated into the ex isting product legislation. 
A survey after the adoption of the goods packag e in 2008 showed that a majority of Union 
harmonisation legislation on products  was due to be revised with in the following 3 years, not 
only to address the problems observed throughout  all sectors but also for sector-specific 
reasons. Any such revision would automatically  include an alignment of the legislation 
concerned to the NLF Decision since Parlia ment, Council and Commission have committed 
themselves to use its provisions as much as po ssible in future legislation on products in order 
to further the utmost coheren ce of the regulatory framework.  
For a number of other Union harmonisation di rectives, including Directive 2004/108/EC no 
revision for sector-specific prob lems had been envisaged within  this timeframe. To ensure 
that the problems in relation to non-complian ce and notified bodies are nevertheless addressed 
in these sectors, and for the sake of consiste ncy of the overall regulatory environment on 
products, it was decided to align these directiv es 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 Act
1, which has stressed the need to restore 
consumer confidence in the quality of pr oducts on the market and the importance of 
reinforcing market surveillance. 
                                                 
1 Communication from the Commission to the European Parliament, the Council, the Economic and 
Social Committee and the Committee of the Regions, COM(2011) 206 final.  
EN 4   EN Furthermore it supports the Commission’s polic y on Better Regulation and simplification of 
the regulatory environment. 
2. CONSULTATION OF 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 implementa tion of this Directive,  the notified body group, 
the administrative cooperati on group as well as in bilate ral meetings with industry 
associations. 
From June to October 2010 a public consultation was organised that comprised all the sectors 
involved in this initiative. It consisted of four targeted quest ionnaires for economic operators, 
authorities, notified bodies and users and the Co mmission services received 300 replies. The 
results are published at:  
http://ec.europa.eu/enterpri se/policies/single-market-goods /regulatory-policies-common-
rules-for-products/new-legislative-framework/index_en.htm  
In addition to the general consultation a specif ic 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/enterpri se/policies/single-market- goods/files/new-legislative-
framework/smes_statistics_en.pdf  
The consultation process revealed widespread su pport for the initiative. There is unanimity on 
the need to improve market surveillance and 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 pl aying 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 co ncerns were expressed 
on some obligations which are, however, indispen sable for increasing the efficiency of market 
surveillance. These measures will not entail si gnificant costs for indus try, and the benefits 
resulting from improved market surveill ance should by far outweigh the costs.  
Collection and use of expertise 
The impact assessment for this implementation package has largely built on the impact 
assessment carried out for the New Legislativ e Framework. In addition to the expertise 
collected and analysed in that context, furt her consultation of sect or-specific experts and 
interest groups, as well as horizontal expert s active in the area of technical harmonisation, 
conformity assessment, accreditation and market surveillance, has taken place. 
Impact assessment  
Based on the information collected, the Commis sion carried out an impact assessment which 
examined and compared three options. 
Option 1 - No changes to  the current situation   
EN 5   EN This option proposes no changes to the current directive and relies ex clusively on certain 
improvements that can be expected from the NLF Regulation. 
Option 2 – Alignment to the NLF Deci sion by non-legislative measures 
Option 2 considers the possibility of encourag ing 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 Deci sion by legislative measures 
This option consists in integrating the provi sions 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 responsib ly, no extra costs or only neg ligible costs are expected; 
– it is considered more effective than option 2: du e to the lack of enforc eability of option 2 it 
is questionable that the positive impact s would materialise under that option; 
– options 1 and 2 do not provide an swers to the problem of inconsistencies in the regulatory 
framework and therefore have no positive impact on the simplification of the regulatory environment. 
3. M
AIN ELEMENTS OF THE PROPOSAL  
3.1. Horizontal definitions 
The proposal introduces harmonised definiti ons of terms which are commonly used 
throughout Union harmonisation le gislation and should therefor e be given a consistent 
meaning throughout that legislation.  
3.2. Obligations of economic operators  and traceability requirements 
The proposal clarifies the obliga tions of manufactur ers and authorised representatives and 
introduces obligations for impor ters and distributors. Importe rs must verify that the 
manufacturer has carried out the applicable c onformity assessment procedure and has drawn 
up a technical documentation. They must also ma ke sure with the manufacturer that this 
technical documentation can be made availa ble to authorities upon request. Furthermore 
importers must verify that apparatus are correctly marked and accompanied by the required documentation. They must keep a copy of the D eclaration of conformity and indicate their 
name and address on the produc t, or where this is not po ssible on the packaging or the 
accompanying documentation. Distributors must veri fy that apparatus bear the CE marking,  
EN 6   EN the name of the manufacturer and of the importe r, 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 addr ess and a number allowing  to identify and link 
the apparatus to its technical documentation. Wh en an apparatus is imported the importer’s 
name and address must also be on the appara tus. 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 st andards provides a presumpti on 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 Regula tion contains inter alia provisions on 
standardisation requests from the Commission to the European Standardisation Organisations, 
on the procedure for objections to harmonised standards and on stakehol der participation in 
the standardisation process. Consequently the provisions of Directive 2004/108/EC which 
cover the same aspects have been deleted in th is proposal for reasons of legal certainty.  
The provision conferring presumption of conf ormity 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 demo nstrate that their apparatus comply with the 
essential requirements. The proposal aligns thes e procedures to their updated versions set out 
in the NLF Decision maintaining certain specific  elements, regarding to the electromagnetic 
compatibility conformity assessment. The Di rective also introduces a model for the EU 
Declaration of conformity. 
General principles of the CE marking are se t out in Article 30 of Regulation 765/2008, while 
the detailed provisions on the a ffixing of the CE marking to a pparatus have been  inserted in 
this proposal. 
3.5. Notified Bodies 
The proposal reinforces the notification crite ria for notified bodies. It clarifies that 
subsidiaries or subcontractors must also comp ly with the notification requirements. Specific 
requirements for notifying authorities are intro duced, 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 Dire ctives 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.  
EN 7   EN notified bodies is revised. The competence of a notified body mu st be demonstrated by an 
accreditation certificate. Where accred itation has not been used to evaluate the competence of 
a notified body, the notification must compri se the documentation demonstrating how the 
competence of that body has been ev aluated. Member States will have the possibility to object 
to a notification. 
3.6. Market surveillance and the safeguard clause procedure 
The proposal revises the existing safeguard cl ause procedure. It introduces a phase of 
information exchange between Member States, and specifies the steps to be taken by the authorities concerned, when a non-compliant apparatus is found. A real safeguard clause 
procedure – leading to a Decision at Commissi on level on whether a measure is justified or 
not - is only launched when another Member St ate 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 Tr eaty 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 particul ar with regard to th e newly added provisions 
aiming at the improvement of effective enfo rcement of Directive 2004/108/EC namely, the 
importer and distributor obligations, the tra ceability provisions, the provisions on the 
assessment and notification of notified bodies, and the enhanced  cooperation obligations in 
the context of the revised market su rveillance and safeguard procedures.  
Experience with the enforcement of the legislat ion has shown that meas ures 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 natio nal level is limited to the territorial competence of a 
Member State. In view of the increasing inte rnationalisation of trad e, the number of cross-
border cases is constantly rising. Coordinated ac tion at EU level can much better achieve the 
objectives set, and will in particular render ma rket surveillance more effective. Hence it is 
more appropriate to take  action at EU level. 
As regards the problem of inconsistencies thro ughout the directives, th is is a problem which 
can only be solved by the EU legislator. 
Proportionality  
In accordance with the principle of proportionality, the proposed modifications do not go 
beyond what is necessary to achieve the objectives set.  
The new or modified obligations do not impos e unnecessary burdens an d costs on industry - 
especially on small and medium sized enterpri ses - or administrations . Where modifications  
EN 8   EN 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 th at entail added cost.  
Legislative technique used 
The alignment to the NLF Deci sion requires a number of subs tantive 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 acts
3.  
The changes made to the provisions of Dir ective 2004/108/EC concern: the definitions, the 
obligations of economic operators, the presum ption of conformity provided by harmonised 
standards, the declaration of conformity, CE  marking, notified bodies, the safeguard clause 
procedure and the conformity assessment procedures. 
The proposal does not change the scope of  Directive 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.  
EN 9   EN  
Ð 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 compatibilit yand repealing Directive 89/336/EEC  
(Recast) 
(Text with EEA relevance) 
THE EUROPEAN PARLIAMENT AND THE CO UNCIL 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 Eu ropean Economic and Social Committee
4, 
Acting in accordance with the or dinary legislative procedure, 
Whereas: 
 
Ð 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 Le gislation for the Internal Mark et (SLIM). Both the 
SLIM process and a subsequent in -depth consultation have revealed the need to 
complete, reinforce and clarify the frame work established by Directive 89/336/EEC.  
                                                 
4 OJ C 220, 16.9.2003, p. 13. 
5 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).  
EN 10   EN  
Ø new  
(1) A number of substantive changes are to be made to Directive 2004/108/EC of the 
European Parliament and of the Counc il 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 clarit y, that Directive should be 
recast. 
(2) Regulation (EC) No 765/2008 of the European Parliament and of th e Council of 9 July 
2008 setting out the requirements for accredi tation and market surveillance relating to 
the marketing of products and re pealing Regulation (EEC) No 339/937 lays down rules 
on the accreditation of  conformity assessm ent bodies, provides a framework for the 
market surveillance of products and for cont rols on products from third countries, and 
lays down the general princi ples of the CE marking. 
(3) Decision No 768/2008/EC of the European Pa rliament and of the Council of 9 July 
2008 on a common framework for the marketi ng 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. 
 
Ð 2004/108 recital 2 
(4) Member States are responsible for ensuri ng that radiocommunicat ions, 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 elec tromagnetic disturbance. 
 
Ð 2004/108 recital 3 (adapted) 
(5) Provisions of national law ensuring protection against electromagnetic 
disturbanceshould  ⌦ need to ⌫ be harmonised in order to guarantee the free 
movement of electrical and el ectronic apparatus without lo wering justified levels of 
protection in the Member States. 
                                                 
6 OJ L 390, 31.12.2004, p. 24 
7 OJ L 218, 13.8.2008, p. 30. 
8 OJ L 218, 13.8.2008, p. 82.  
EN 11   EN  
Ð 2004/108 recital 4 
(6) Protection against electromagne tic 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. 
 
Ð 2004/108 recital 5 
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, pe rsons, services and capital is assured.  
 
Ð 2004/108 recital 6 (adapted) 
(7) The equipment covered by this Directive should include both apparatus and fixed 
installations. However, separate provision s hould 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 in stalled 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 need s of their operators. 
 
Ð 2004/108 recital 7 (adapted) 
(8) Radio equipment and telecommunications te rminal equipment should not be covered 
by this Directive since they are alrea dy regulated by Directive 1999/5/EC of the 
European Parliament and of the Council of 9 March 1999 on radio equipment and 
telecommunications terminal equipment and the mutual recognition of their 
conformity9. The electromagnetic compatibility requirements in both Directives 
achieve the same level of protection. 
 
Ð 2004/108 recital 8 (adapted) 
(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. 
                                                 
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).   
EN 12   EN  
Ð 2004/108 recital 9 
(10) This Directive need not regulate equipment which is inherently benign in terms of 
electromagnetic compatibility. 
 
Ð 2004/108 recital 10 (adapted) 
(11) This Directive should not deal with the safety of equipment, since th at is dealt with by 
separate Community  ⌦ Union ⌫ or national legislation. 
 
Ð 2004/108 recital 11 (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. 
 
Ð 2004/108 recital 12 (adapted) 
The principles on which this Directive is based are those set out in th e Council Resolution of 
7 May 1985 on a new approach to technical harmonization and standards10. In accordance 
with that approach, the desi gn and manufacture of equipmen t is subject to essential 
requirements in relation to electromagnetic compatibility. Those requirements are given 
technical  expression by harmonised European sta ndards, to be adopted by the various 
European standardisation bodies, European Co mmittee for Standardisation (CEN), European 
Committee for Electro -technical Standardisation (CENELEC) and European 
Telecommunications Sta ndards 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 themse lves and the Commission, and with the procedure laid down 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 o f rules on Information Society services11. 
 
Ð 2004/108 recital 13 (adapted) 
Harmonised standards reflect the generally acknowledged stat e of the art as regards 
electromagnetic compatibility matters in th e European Union. It is thus in the inte rest of the 
functioning of the internal market to have st andards for the electromagnetic compatibility of 
                                                 
10 OJ C 136, 4.6.1985, p. 1.  
11 OJ L 204, 21.7.1998, p. 37. Directive as last amended by the 2003 Act of Accession.   
EN 13   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 Europ ean Union , compliance with 
it should raise a presumption of conformity with  the relevant essential requirements, although 
other means of demonstrating such conformi ty should be permitted. Compliance with a 
harmonised standard means conformity with its prov isions and demonstration thereof by the 
methods the harmonised standard describes or refers to.  
 
Ð 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 unde r normal operating conditions. Network 
operators should construct their networks  in such a way that manufacturers of 
equipment liable to be connected to networ ks do not suffer a disproportionate burden 
in order to prevent networks from sufferi ng an unacceptable degradation of service. 
The European standardisation organisations should take due  account of that objective 
(including the cumulative effects of the rele vant types of electromagnetic phenomena) 
when developing harmonised standards. 
 
Ð 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 estab lished that such apparatus has b een designed and 
manufactured in conformity with the requirement s of this Directive. Apparatus placed on the 
market should bear the ‘CE’ marking attestin g to compliance with this Directive. Although 
conformity assessment should be  the responsibility of the  manufacturer, wit hout any need to 
involve an independent conformity assessmen t body, manufacturers should be free to use the 
services of such a body.  
 
Ø new 
(14) Economic operators should be responsible for the compliance of products, in relation 
to their respective role s 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 interv ening in the supply and di stribution 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 wh ich 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 c onformity assessment procedure. Conformity 
assessment should therefore remain the ob ligation of the manu facturer alone.  
EN 14   EN (17) It is necessary to ensure th at products from third countri es entering the Union market 
comply with the requirements of this Direct ive, and in particul ar 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 shou ld 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 manuf acturers are available for inspection by 
the supervisory authorities. 
(18) The distributor makes a product available on th e market after it has been placed on the 
market by the manufacturer or the importer a nd should act with due care to ensure that 
its handling of the product doe s not adversely a ffect 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 a ffected 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 t hose 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 effici ent. An efficient traceability system 
facilitates market surveillan ce authorities' task of tracing economic operators who 
made non-compliant products available on the market. 
 
Ð 2004/108 recital 18 (adapted) 
(23) Fixed installations, incl uding large machines and networks, may generate 
electromagnetic disturbance, or be affect ed 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 i rrelevant whether the electromagne tic disturbance is produced by 
apparatus or by a fixed installation. Acco rdingly, fixed installations and apparatus 
should be subject to a coherent and comprehensive regime  of essential re quirements. It 
should be possible to use harmonised standa rds for fixed insta llations in order t o 
demonstrate conformity with the essentia l requirements covered by such standards.   
EN 15   EN  
Ø 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 acco rdance 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 speci fications of those requirements. 
(25) Regulation (EU) No [../..] [ on European Standardisation] provides for a procedure for 
objections to harmonised standards where thos e standards do not entirely satisfy the 
requirements of this Directive.  
(26) In order to enable economic operators to de monstrate and the competent authorities to 
ensure that products made available on  the market confor m 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 le vel of safety required. In or der to ensure inter-sectoral 
coherence and to avoid ad-hoc variants, c onformity assessment procedures should be 
chosen from among those modules. 
 
Ð 2004/108 recital 16 
(27) The conformity assessment obligation should require the manufactur er 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. 
 
Ð 2004/108 recital 17 
(28) Where apparatus is capable of taking different configur ations, the electromagnetic 
compatibility assessment should confirm wh ether the apparatus meets the protection 
requirements in the configurations foreseeabl e 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 c onfiguration most likely to cause maximum 
disturbance and the configuration mo st susceptible to disturbance. 
                                                 
12 OJ L […], […], p. […]  
EN 16   EN  
Ð 2004/108 recital 20 
(29) It is not pertinent to carr y out the conformity assessmen t of apparatus placed on the 
market for incorporation into a give n fixed installation, and otherwise not 
commercially available, in isolation from the fixed installation into which it is to be 
incorporated. Such apparatus should theref ore be exempted from the conformity 
assessment procedures normally applicable to apparatus. However, such apparatus 
should not be permitted to compromise the c onformity of the fixed installation into 
which it is incorporated. Should apparatus be incorporated into more than one 
identical fixed installation, identifyi ng the electromagnetic compatibility 
characteristics of these installations should be sufficient to ensure exemption from the 
conformity assessment procedure. 
 
Ø new 
(30) Manufacturers should draw up an EU declara tion of conformity to provide detailed 
information on the conformity of an apparatu s with the requirements of this Directive 
and of the other relevant Un ion harmonisation legislation.  
(31) The CE marking, indicating the conformity of  a product, is the vi sible consequence of 
a whole process comprising conformity assessment in a broad sense. General 
principles governing the CE marking ar e set out in Regulation (EC) No 765/2008. 
Rules governing the affixing of the CE marki ng should be laid down in this Directive. 
 
Ð 2004/108 recital 19 (adapted) 
(32) Due to their specific characteristics, fi xed installations need not be subject to 
theaffixation  ⌦ affixing ⌫ of the ‘CE’ marking or to the ⌦ EU ⌫ declaration of 
conformity. 
 
Ø 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 Directiv e 2004/108/EC that 
conformity assessment bodies have to fulfil to be notified to the Commission are not 
sufficient to ensure a uniformly high le vel of performance of notified bodies 
throughout the Union. It is, however, essentia l that all notified bodies perform their 
functions to the same level and under conditi ons of fair competition. That requires the 
setting of obligatory requirements for conf ormity assessment bodies wishing to be 
notified in order to provide conformity assessment services.  
EN 17   EN (35) 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. 
(36) If a conformity assessment body demonstrates conformity with the criteria laid down 
in harmonised standards, it should be presumed to co mply with the corresponding 
requirements set out in this Directive. 
(37) The system set out in this Directive s hould be complemented by the accreditation 
system provided for in Regulation (EC)  No 765/2008. Since ac creditation is an 
essential means of verifying the compet ence of conformity assessment bodies, it 
should also be used for th e purposes of notification. 
(38) Transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring 
the necessary level of confidence in confor mity 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 author ities, they should 
provide the Commission and th e other Member States with the necessary documentary 
evidence demonstrating the compliance of th e conformity assessment bodies evaluated 
with the relevant regu latory requirements. 
(39) Conformity assessment bodies frequently subcon tract parts of their activities linked to 
the assessment of conformity or have recour se to a subsidiary. In  order to safeguard 
the level of protection 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 relati on to the performa nce of conformity 
assessment tasks. Therefore, it is important  that the assessment of the competence and 
the performance of bodies to be notified and the monitori ng of bodies already notified 
cover also activities carried out by subcontractors and subsidiaries. 
(40) It is necessary to increase the efficiency a nd transparency of the notification procedure 
and, in particular, to adapt it to new technol ogies so as to enable online notification. 
(41) Since notified bodies may offer their services  throughout the Union, it is appropriate to 
give the other Member States and the Co mmission the opportunity to raise objections 
concerning a notified body. It is therefore important to provide for a period during 
which any doubts or concerns as to the co mpetence of conformity assessment bodies 
can be clarified before they start operating as notified bodies. 
(42) In the interests of compe titiveness, it is crucial that  notified bodies apply the 
conformity assessment procedures without  creating unnecessary burdens for economic 
operators. For the same reason, and to ensu re equal treatment of  economic operators, 
consistency in the technical application of the conformity assessment procedures needs 
to be ensured. That can best be achie ved through appropriate  coordination and 
cooperation between notified bodies. 
(43) In order to ensure legal certainty, it is neces sary to clarify that rules on Union market 
surveillance and control of products ente ring the Union market provided for in  
EN 18   EN Regulation (EC) No 765/2008 apply to equi pment 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 proces sing time, it is necessary to improve the 
existing safeguard clause procedure, with a view to making it more efficient and 
drawing on the expertise avai lable in Member States. 
(45) The existing system should be supplement ed by a procedure under which interested 
parties are informed of measures intende d to be taken with regard to products 
presenting a risk to aspects of public intere st protection. It shoul d also allow market 
surveillance authorities, in cooperation with th e relevant economic operators, to act at 
an earlier stage in resp ect 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 furt her involvement of the Commission should 
be required, except where non-compliance ca n 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 th is 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 appa ratus that has already been placed on the 
market in accordance with Directive 2004/108/EC. 
 
Ð 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 w ith an adequate level of electromagnetic 
compatibility, cannot be sufficiently achieve d by Member States a nd 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 proportional ity, as set out in that Article, this 
Directive does not go beyond what is necessary  in order to achieve that objective. 
 
Ø new 
(50) The obligation to transpose this Directive in to national law should be  confined to those 
provisions which represent a substantive change as compared with Directive 
2004/108/EC. The obligation to transpose the provisions which are unchanged arises 
under Directive 2004/108/EC.  
EN 19   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. 
 
Ð 2004/108 recital 21 (adapted) 
A transitional period is nece ssary in order to ensure that manufacturers and other concerned 
parties are able to adapt to the new regulatory regime.  
 
Ð 2004/108 (adapted) 
HAVE ADOPTED THIS DIRECTIVE: 
CHAPTER 1I  
GENERAL PROVISIONS 
Article 1 
Subject matter and scope  
 
Ð 2004/108  
1.This Directive regulates the electromagnetic comp atibility of equipment. It aims to ensure 
the functioning of the internal market by requir ing equipment to comply with an adequate 
level of electromagnetic compatibility.  
 
Ð 2004/108 (adapted) 
Article 2  
⌦ Scope ⌫ 
1. This Directive applies  ⌦ shall apply ⌫ to equipment as defined in Article 2 3. 
2. This Directive shall not apply to ⌦ the following ⌫ :  
EN 20   EN  
Ð 2004/108  
(a) equipment covered by Directive 1999/5/EC; 
(b) 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 com mon rules in the field of civil av iation and establishing a European 
Aviation Safety Agency14; 
 
Ð 2004/108 (adapted) 
(c) radio equipment used by radio amateurs wi thin the meaning of the Radio Regulations 
adopted in the framework of the Constitution ⌦ of the International 
Telecommunication Union ⌫ and ⌦ the ⌫ Convention of the 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.  
(d) 3.  This Directive shall not apply to  equipment the inherent nature of the physical 
characteristics of which is such that: 
 
Ð 2004/108 
(ai) it is incapable of generating or contri buting to electromagnetic emissions which 
exceed a level allowing radio and te lecommunication equipment and other 
equipment to operate as intended; and 
 
Ð 2004/108 (adapted) 
(bii) it will operate  ⌦ operates ⌫ without unacceptable degradation in the 
presence of the electromagnetic dist urbance normally consequent upon its 
intended use. 
⌦ For the purposes of point (c) of the first subp aragraph, kits of components to be assembled 
by radio amateurs and commercial  equipment modified by and fo r the use of radio amateurs 
are not regarded as commercially available equipment. ⌫ 
                                                 
13 OJ L 79, 19.3.2008, p. 1 
14 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).  
15 Constitution and Convention of the International Telecommunication Union adopted by the Additional 
Plenipotentiary Conference (Genev a, 1992) as amended by the Plen ipotentiary Conference (Kyoto, 
1994).  
EN 21   EN 43. Where, for the equipment referred to in para graph 1, the essential requirements referred to  
⌦ set out ⌫ in Annex I are wholly or partly laid down more specifically by other 
⌦ Union ⌫ Communit y directives, this Directive shall not apply, or shall cease to apply, to 
that equipment in respect of such requirement s from the date of implementation of those 
directives. 
 
Ð 2004/108 (adapted) 
54. This Directive shall not affect the application of ⌦ Union ⌫ Community  or national 
legislation regulating the safety of equipment. 
Article32  [Article R1 of Decision No 768/2008/EC] 
Definitions  
 
Ð 2004/108 (adapted) 
For the purposes of this Directive, the following definitions shall  apply: 
 
Ð 2004/108  
(a1) ‘equipment’ means any apparatus or fixed installation; 
(b2) ‘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 performa nce of which is liable to be affected by 
such disturbance;  
(c3) ‘fixed installation’ means a particular co mbination of several types of apparatus and, 
where applicable, other devices, which are assembled, installed and intended to be 
used permanently at a predefined location;  
(d4) ‘electromagnetic compatibility’ means the ability of equipment to function 
satisfactorily in its electromagnetic e nvironment without in troducing intolerable 
electromagnetic disturbances to other equipment in that environment; 
 
Ð 2004/108 (adapted)  
(e5) ‘electromagnetic disturbance’ means a ny electromagnetic phenomenon which may 
degrade the performance of equipment ⌦ , including, ⌫ . An electromagnetic 
disturbance may be  electromagnetic noise, an unwant ed signal or a change in the 
propagation medium itself;  
EN 22   EN  
Ð 2004/108  
(f6) ‘immunity’ means the ability of equipm ent 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 el ectromagnetic phenomena observable in a 
given location. ; 
 
Ø new 
(9) '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; 
(10) 'placing on the market' means the first making available of apparatus on the Union 
market; 
(11) 'manufacturer' means any natural or legal person who manufactures apparatus or has 
apparatus designed or manuf actured, and markets that ap paratus under his name or 
trademark; 
(12) 'authorised representative' means any natu ral or legal person established within the 
Union who has received a written mandate fr om a manufacturer to act on his behalf 
in relation to specified tasks; 
(13) 'importer' means any natural or legal pe rson established within the Union who places 
apparatus from a third country on the Union market; 
(14) 'distributor' means any natural or lega l person in the supply chain, other than the 
manufacturer or the importer, who ma kes apparatus available on the market; 
(15) 'economic operators' means the manufact urer, the authorised representative, the 
importer and the distributor; 
(16) 'technical specification' means a document that prescribes technical requirements to 
be fulfilled by the equipment; 
(17) 'harmonised standard' means harmonised st andard as defined in  Article 2(1)(c) of 
Regulation (EU) No [../..] [on European Standardisation]; 
(18) 'accreditation' means accreditation as defined in  Article 2(10) of Regulation (EC) No 
765/2008; 
(19) 'national accreditation body' means nati onal accreditation body as  defined in Article 
2(11) of Regulation (EC) No 765/2008;  
EN 23   EN (20) 'conformity assessment' means the pro cess demonstrating whether the requirements 
relating to an apparatus have been fulfilled; 
(21) 'conformity assessment body' means a body that performs conformity assessment 
activities including calib ration, testing, certification and inspection; 
(22) 'recall' means any measure aimed at ach ieving the return of apparatus that has 
already been made available to the end user; 
(23) 'withdrawal' means any measure aimed at  preventing apparatus in the supply chain 
from being made available on the market; 
(24) 'CE marking' means a marking by wh ich the manufacturer indicates that the 
apparatus is in conformity with the applicable requirements set out in Union 
harmonisation legislation pr oviding for its affixing; 
(25) 'Union harmonisation legislation' m eans any Union legislation harmonising the 
conditions for the marketing of products. 
 
Ð 2004/108 (adapted) 
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)  : 
 
Ð 2004/108 (adapted) 
Ö new 
 (a)‘components’ or ‘sub-assemblies’ intende d for incorporation into an apparatus by 
the end user, which are liable to genera te 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 m oved and operated in a range of locations.  
Article 43  
Placing  Ö Making available  on the market and/or putting into service 
Member States shall take all appropriate measures to ensure that equipment is placed  Ö made 
available  on the market and/or put into service onl y if it complies with the requirements of 
this Directive when properly installed, main tained and used for its intended purpose.  
EN 24   EN Article 54  
Free movement of equipment 
1. Member States shall not impede, for reasons  relating to electromagnetic compatibility, the 
placing  Ö 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 pr event the application in any Member State of 
the following special measures concerning th e 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 teleco mmunications 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 ev ents of equipment which does not comply with this Directive, 
provided that a visible sign cl early indicates that such equipment may not be placed  Ö made 
available  on the market and/or put in to service until it has been  brought into conformity 
with this Directive. Demonstrat ion may only take place provided  that adequate measures are 
taken to avoid electrom agnetic disturbances. 
Article 65  
Essential requirements 
 
Ð 2004/108 (adapted) 
The equipment referred to in Article 1  shall meet the essential requirements set out in 
Annex I.  
EN 25   EN  
Ø 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 a nd/or putting them into service, manufacturers 
shall ensure that they have been designed a nd manufactured in accordan ce 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 confor mity assessment procedure refe rred to in Article 15 or have 
it carried out. 
Where compliance of apparatus with the applic able requirements has been demonstrated by 
that procedure, manufacturers shall draw up an EU  declaration of confor mity and affix the CE 
marking. 
3. Manufacturers shall keep the technical documentation and the EU declaration of 
conformity for 10 years after the appara tus has been placed on the market. 
4. Manufacturers shall ensure that procedures ar e in place for series production to remain in 
conformity. Changes in apparatus design or ch aracteristics and cha nges in the harmonised 
standards or in technical specifications by refe rence 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, register ed trade name or registered trade mark and 
the address at which they can be contacted on th e 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 ma nufacturer can be contacted. 
7. Manufacturers shall ensure that the appara tus 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 dete rmined 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  
EN 26   EN immediately take the necessary corrective measures  to bring that apparatu s into conformity, to 
withdraw it or recall it, if a ppropriate. Furthermore, where the apparatus presents a risk, 
manufacturers shall immediately inform the co mpetent national authorities of the Member 
States in which they made the apparatus availabl e and/or put it into service to that effect, 
giving details, in particular, of the non-comp liance and of any corre ctive measures taken. 
9. Manufacturers shall, further to a reasoned request from a competent national authority, 
provide it with all the information and do cumentation necessary to demonstrate the 
conformity of the apparatus, in a language wh ich can be easily understood by that authority. 
They shall cooperate with that authority, at its request, on any action taken to eliminate the 
risks posed by apparatus which they have plac ed 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 author ised representative's mandate. 
2. An authorised representative shall perform the tasks specified in the mandate received from 
the manufacturer. The mandate shall allow the au thorised representative to do at least the 
following: 
(a) keep the EU declaration of conformity and the technical doc umentation 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 compet ent national authority, provide that authority 
with all the information and documentation nece ssary to demonstrate the conformity of the 
apparatus; 
(c) cooperate with the competent national authorit ies, at their request, on any action taken to 
eliminate the risks posed by the apparatus cove red by the authorised re presentative's mandate. 
Article 9 [Article R4 of Decision No 768/2008/EC] 
Obligations of importers 
1. Importers shall place only compliant apparatus on the market.  
2. Before placing apparatus on the market im porters shall ensure that the appropriate 
conformity assessment procedure has been carried out by the ma nufacturer. They shall ensure 
that the manufacturer has draw n up the technical documentation, that the apparatus bears the 
CE marking and is accompanied by the require d documents, and that the manufacturer has 
complied with the requirements set out in Article 7(5) and (6).  
EN 27   EN Where an importer considers or has reason to belie ve that apparatus is not in conformity with 
essential requirements set out in Annex I, he shall not place the appara tus on the market until 
it has been brought into conformity. Furthermor e, where the apparatus presents a risk, the 
importer shall inform the manufact urer and the market surveillan ce 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 ap paratus or, where that is not possible, on its 
packaging or in a document accompanying the apparatus. 
4. Importers shall ensure that the apparatu s 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 dete rmined by the Member State concerned. 
5. Importers shall ensure that, while apparatu s 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 be lieve that apparatus which they have placed on 
the market is not in conformity with the requir ements 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 th e apparatus presents a risk, importers shall 
immediately inform the competent national author ities of the Member States in which they 
made the apparatus available to that effect, givi ng details, in particular, of the non-compliance 
and of any corrective measures taken. 
7. Importers shall, for 10 years after the appara tus has been placed on the market, keep a copy 
of the EU declaration of conformity at the dis posal of the market surveillance authorities and 
ensure that the technical doc umentation can be made availa ble to those authorities, upon 
request. 
8. Importers shall, further to a reasoned request  from a competent nati onal authority, provide 
it with all the information and documentation n ecessary to demonstrate the conformity of 
apparatus in a language which can be easil y understood by that authority. They shall 
cooperate with that authority, at its request, on any action taken to el iminate 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 Ar ticle 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 requirem ents set out in Article 7(5) and (6)  and Article 9(3).  
EN 28   EN Where a distributor considers or has reason to believe that appara tus 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 appara tus 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 take n. Furthermore, where the apparatus presents a 
risk, distributors shall immediat ely inform the competent nationa l authorities of the Member 
States in which they made the apparatus availabl e to that effect, giving details, in particular, 
of the non-compliance and of a ny corrective measures taken. 
5. Distributors shall, further to a reasoned request from a competent national authority, 
provide it with all the information and do cumentation necessary to demonstrate the 
conformity of the apparatus. They shall coopera te with that authority, at its request, on any 
action taken to eliminate the risks posed by appa ratus which they have made available on the 
market. 
Article 11 [Article R6 of Decision No 768/2008/EC] 
Cases in which obligations of manufac turers apply to impor ters and distributors 
An importer or distributor shall be consider ed a manufacturer for the purposes of this 
Directive and he shall be subjec t to the obligations of the ma nufacturer 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 complia nce 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 refe rred to in the first paragraph 
for a period of 10 years after they have been supplied with the appara tus and for a period of 
10 years after they have supplied the apparatus.  
EN 29   EN  
Ð 2004/108 (adapted) 
CHAPTER 3III  
⌦ CONFORMITY OF EQUIPMENT  ⌫ 
Article 6 13 [Article R8 of Decision No 768/2008/EC] 
Harmonised standards  ⌦ Presumption of conformity ⌫  
 
Ð 2004/108 
1. ‘Harmonised standard’ means a technical specifica tion 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 es tablishing a European 
requirement. Compliance with a ‘harmonised standard’  is not compulsory.  
 
Ð 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 Journa l 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 cons iders 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 (herei nafter ‘the Committee’), 
stating its reasons. The Committee sha ll deliver an opini on 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 Journ al of the European Union .  
EN 30   EN The Commission shall inform the Member States of its decision without delay.  
 
Ø new 
[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 refere nces of those standards in 
the Official Journal of  the European Union.] 
 
Ð 2004/108 (adapted) 
Article 147  
Conformity assessment procedure for apparatus 
Compliance of apparatus with the essential requirements referre d 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 c ontrol). However, at the discretion of t he 
manufacturer or of his author ised representative in the Co mmunity, the procedure described 
in Annex III may also be followed.  
⌦ (a) internal production cont rol set out in Annex II; ⌫ 
⌦ (b) EU type examination that is followe d by Conformity to type based on internal 
production control set out in Annex III. ⌫ 
 
Ð 2004/108  
Article 8  
‘CE’ marking  
1. Apparatus whose compliance with this Dire ctive has been established by means of the 
procedu re laid down in Article 7 shall bear the ‘C E’ marking which attests to that fact. The 
affixing of the ‘CE’ marking shall be the respon sibility of the manufactur er or his authorised 
representative in the Community. The ‘C E’ marking shall be affixed in accor dance with 
Annex V  
2. Member States shall take the necessary measur es 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 g raphic form of the ‘CE’ marking  
3. Any other mark may be affixed to the apparatu s, its packaging, or th e instructions for its 
use, provided that neither the vi sibility nor the legibility of  the ‘CE’ marking is thereby 
impaired   
EN 31   EN 4. Without prejudice to Artic le 10, if a competent authority es tablishes that th e ‘CE’ marking 
has been unduly affixed, the manufacturer or hi s authorised representative in the Community 
shall bring the apparatus into conformity with  the provisions concerning the ‘CE’ marking 
under co nditions imposed by the Member State concerned  
 
Ø 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 Anne x I has been demonstrated. 
2. The EU declaration of conformity shall have th e model structure set out in Annex IV to this 
Directive and it shall be conti nuously updated. It shall be tran slated into the language or 
languages required by the Member State in whic h 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 declarat ion of conformity shall be dr awn up in respec t of all such 
Union acts. That declaration shall contain th e identification of the acts concerned including 
the publication references. 
4. By drawing up the EU declaration of c onformity, the manufacturer shall assume 
responsibility for the complia nce 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, legibl y and indelibly to the apparatus or to its data 
plate. Where that is not possibl e or not warranted on account of th e 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.  
EN 32   EN  
Ð 2004/108 (adapted) 
Article 189  
Other marks and  information 
 
Ð 2004/108  
1. Each apparatus shall be ide ntified in terms of type, batc h, serial number or any other 
information allowing for the identification of the apparatus.  
2. Each apparatus shall be accompanied by the na me 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 pers on in the Community responsible for placing the apparatus on the 
Community market.  
 
Ð 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 A nnex 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 c ontained  ⌦ included ⌫ in the instructi ons accompanying 
the apparatus. 
 
Ð 2004/108  
Article 10  
Safeguards  
1. Where a Member State ascertains that appara tus bearing the ‘CE’ marking does not comply 
with the requireme nts 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.   
EN 33   EN 2. The Member State concerned shall immedi ately inform the Commission and the other 
Member States of any such measure, indica ting the reasons and speci fying, in particular, 
whether non -compliance is due to:  
 (a) failure to satisfy the essential requirements referred  to in Annex I, where the 
appara tus does not comply with the harmonise d standards referred to in Article 6;  
 (b) incorrect applica tion of the harmonised standa rds referred to in Article  6; 
 (c) shortcomings in the harmonised standards referred to in Article 6.  
3. The Commission shall con sult 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, t he Commission, after consulting the parties,  shall, if the Member State concerned 
intends to uphold the measure, bring the ma tter before the Committee and initiate the 
procedure laid down in Article 6(3) and (4).  
5. Where the non -compliant apparatus has be en 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 referr ed to in Annex III, point 3, and shall inform the 
Commission and the other Member States accordingly.  
Article 11  
Decisions to withdraw, prohibit or res trict the free movement of apparatus  
1. Any decision taken pursuant to  this Directive to withdraw apparatus from the market, 
prohibit or restrict its pl acing on the market or its p utting into service, or  restrict the free 
movement thereof, shall state the exact grounds on which it is ba sed. Such decisions shall be 
notified without delay to the party concerned, w ho shall at the same time be informed of the 
remedies available to him u nder 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 manufac turer, his authorised 
representative, or any other interested party shall have the opportuni ty 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 wh ich they have designated to 
carry out the tasks refe rred to in Annex III. When determining the bodies to be designated, 
Member States shall apply the cr iteria 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  
EN 34   EN referred to in Annex I or whethe r the scope of designation is lim ited to certain specific aspects 
and/or categories of apparatus.  
2. Bodies which comply with the assessment cr iteria established by th e relevant harmonised 
standards shall be presumed to comply with th e criteria set out in A nnex VI covered by such 
harmonis ed standards. The Commis sion 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 crite ria listed in Annex VI, 
it shall inform the Commission and the othe r Member States accordingly. The Commission 
shall withdraw the reference to that body from the list referred to in paragraph 3.  
 
Ð 2004/108 (adapted) 
Ö new 
FIXED INSTALLATIONS  
Article 1913  
Fixed installations 
1. Apparatus which has been placed  Ö 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 sh all 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 fixe d installation in order not to compromise the 
conformity of that insta llation. It shall furthermore  ⌦ also ⌫ include the information 
referred to in Articles 9(1) and (2)  7(5), 7(6) and 9(3).  
 
Ð 2004/108  
2. Where there are indications of non-compliance of  the fixed installation, in particular, where 
there are complaints about dist urbances being generated by the installation, the competent 
authorities of the Member State concerned ma y request evidence of compliance of the fixed 
installation, and, when appropria te, initiate an assessment.  
EN 35   EN  
Ð 2004/108 (adapted) 
Where non-compliance is established, the comp etent authorities ma y 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 pr ovisions for identifying the person or persons 
responsible for the establishmen t of compliance of a fixed inst allation with the relevant 
essential requirements. 
 
Ø new 
CHAPTER 4 
NOTIFICATION OF CONFORMI TY ASSESSMENT BODIES  
Article 20 [Article R13 of Decision No 768/2008/EC] 
Notification of Notified Bodies 
Member States shall notify the Commission and th e other Member States of bodies authorised 
to carry out third-party conformity assessment tasks under this Directive. 
Article 21 [Article R14 of Decision No 768/2008/EC] 
Notifying authorities 
1. Member States shall designate  a notifying authority that sha ll be responsible for setting up 
and carrying out the necessary procedures for the assessment and notific ation of conformity 
assessment bodies and the monitoring of notifie d bodies, including compliance with Article 
26. 
2. Member States may decide that the assessmen t and monitoring referred to in paragraph 1 
shall be carried out by a nationa l accreditation body within the m eaning of and in accordance 
with Regulation (EC) No 765/2008. 
3. Where the notifying authority delegates or ot herwise 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 arrangem ents to cover liabilities arising 
out of its activities.  
EN 36   EN 4. The notifying authority shall take full res ponsibility 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 or ganised 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 prov ide any activities that conformity assessment 
bodies perform or consultancy services on a commercial or competitive basis. 
5. A notifying authority shall safeguard the conf identiality of the information it obtains. 
6. A notifying authority shall have a sufficient nu mber 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 proce dures 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 conform ity assessment body shall meet the requirements 
laid down in paragraphs 2 to 11. 
2. A conformity assessment body shall be es tablished under national law and have legal 
personality. 
3. A conformity assessment body shall be a th ird-party body independent of the organisation 
or the apparatus it assesses.  
EN 37   EN A body belonging to a business association or professional federation representing 
undertakings involved in the design, manufactur ing, 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 assess ment tasks shall not be the de signer, manufacturer, supplier, 
installer, purchaser, owner, user  or maintainer of the apparatus which they assess, nor the 
authorised representative of any of those par ties. This shall not preclude the use of assessed 
apparatus that are necessary fo r the operations of the conform ity assessment body or the use 
of such apparatus for personal purposes. 
A conformity assessment body, its top level ma nagement and the personnel responsible for 
carrying out the conformity assessment tasks sh all not be directly involved in the design, 
manufacture or construction, th e marketing, installation, us e or maintenance of those 
apparatus, or represent the partie s engaged in those activities. They  shall not engage in any 
activity that may conflic t with their independence of judgeme nt or integrity in relation to 
conformity assessment activities for which they are notified. This shall in particular apply to 
consultancy services. 
Conformity assessment bodies sh all ensure that the activitie s 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 cap able 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 conf ormity assessment body itself or on its behalf 
and under its responsibility.  
At all times and for each conformity assessm ent procedure and each  kind or category of 
apparatus in relation to which it has been notified, a conform ity assessment body shall have at 
its disposal the necessary: 
(a) personnel with technical knowledge and suffic ient and appropriate experience to perform 
the conformity assessment tasks; 
(b) descriptions of procedures in accordance w ith which conformity assessment is carried out, 
ensuring the transparency and the ability of re production of those proce dures. It shall have 
appropriate policies and procedures  in place that distinguish between tasks it carries out as a 
notified body and ot her activities; 
(c) procedures for the performance of activi ties 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 seri al nature of the production process.  
EN 38   EN 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 co nformity assessment activ ities shall have the 
following: 
(a) sound technical and vocational training cove ring 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 th e 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 certifi cates, records and reports demonstrating that assessments have 
been carried out. 
8. The impartiality of the conformity assessm ent 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 sh all take out liability  insurance unless lia bility 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 profe ssional secrecy with 
regard to all information obtained in carryi ng 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 activ ities are carried out. Proprieta ry rights shall be protected. 
11. Conformity assessment bodies shall partic ipate in, or ensure that their assessment 
personnel are informed of, the relevant standa rdisation activities and the activities of the 
notified body coordination group establishe d under the relevant Union harmonisation 
legislation and apply as ge neral guidance the administra tive 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  
EN 39   EN the requirements set out in Article 24 in so fa r as the applicable harm onised 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 subcontract s specific tasks connected with  conformity assessment or 
has recourse to a subsidiary, it shall ensure that the subcontract or or the subsidiary meets the 
requirements set out in Article 24 and sha ll 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 ou t by a subsidiary only with the agreement of 
the client. 
4. Notified bodies shall keep at th e disposal of the notifying au thority 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 we ll as by an accreditation certificate, where one 
exists, issued by a national accr editation body attesting that the conformity assessment body 
fulfils the requirements laid down in Article 24. 
3. Where the conformity assessment body c oncerned cannot provide an accreditation 
certificate, it shall provide the notifying aut hority with all the documentary evidence 
necessary for the verification, recognition and re gular monitoring of its compliance with the 
requirements laid down in Article 24. 
Article 28 [Article R23 of Decision No 768/2008/EC] 
Notification procedure 
1. Notifying authorities may no tify only conformity assessment  bodies which have satisfied 
the requirements laid down in Article 24.  
EN 40   EN 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 modul es and apparatus or apparatuses  concerned and the 
relevant attestation of competence. 
4. Where a notification is not ba sed on an accreditation certificate as referred to in Article 
27(2), the notifying authority shal l provide the Commission and th e other Member States with 
documentary evidence which attests to the c onformity assessment body's competence and the 
arrangements in place to ensure  that that body will be monitore d 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 onl y where no objections 
are raised by the Commission or the other Memb er States within two weeks of a notification 
where an accreditation certificate is used or within two mont hs of a notification where 
accreditation is not used. 
Only such a body shall be considered a notifie d body for the purposes of this Directive.  
6. The Commission and the other Member States sh all 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 iden tification number to a notified body. 
It shall assign a single such number even wh ere the body is notified under several Union acts. 
2. The Commission shall make publicly availabl e 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 ha s ascertained or has been informed that a notified body no 
longer meets the requirements laid down in Artic le 24, or that it is  failing to fulfil its 
obligations, the notifying authority shall rest rict, suspend or with draw 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.  
EN 41   EN 2. In the event of restri ction, suspension or withdrawal of notification, or where the notified 
body has ceased its activity, the notifying Member State shall take appropr iate steps to ensure 
that the files of that body are ei ther processed by another notif ied body or kept available for 
the responsible notifying and market survei llance 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 requirem ents and responsibilities to which it is subject. 
2. The notifying Member State shall provide th e Commission, on request, with all information 
relating to the basis for the no tification 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 notif ied body does not meet or no longer meets the 
requirements for its notification, it shall info rm the notifying Member State accordingly and 
request it to take the necessary corrective meas ures, 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 acco rdance with the conformity 
assessment procedure provided for in Annex III. 
2. Conformity assessments sh all be carried out in a pr oportionate manner, avoiding 
unnecessary burdens for economic operators. 
Conformity assessment bodies shall perform their activities taking due acc ount of the size of 
an undertaking, the sector in whic h it operates, its structure, the degree of complexity of the 
apparatus  technology in question and the mass or seri al nature of the production process. 
In so doing they shall nevertheless respect th e 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 esse ntial 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 appr opriate 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 re quire the manufacturer to  
EN 42   EN take appropriate corrective measures and sha ll 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 withdr aw any certificates, as appropriate. 
Article 33 
Appeal against decision s of notified bodies 
Member States shall ensure that  an appeal procedur e 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, suspensi on or withdrawal of a certificate; 
(b) any circumstances affecting the scope  of and conditions for notification; 
(c) any request for information which they have received from market surveillance authorities 
regarding conformity assessment activities; 
(d) on request, conformity assessment activities performed within the scope of their 
notification and any other activity perfor med, including cross-border activities and 
subcontracting. 
2. Notified bodies shall provide the other bodies notified under this Directive carrying out 
similar conformity assessment activities co vering 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 organisa tion of exchange of experience between the 
Member States' national authorities responsible for notification policy.  
EN 43   EN Article 36 [Article R30 of Decision No 768/2008/EC] 
Coordination of notified bodies 
The Commission shall ensure that appropriate  coordination and coope ration between bodies 
notified under this Directive are put in place an d 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 
Article 37 
Union market surveillance and control of  apparatus entering the Union market 
Article 15(3) and Articles 16 to 29 of Regula tion (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 suffici ent reason to believe 
that an apparatus covered by this Directive pr esents a risk to aspects of public interest 
protection covered by this Direct ive, 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 requirement s laid down in this Directive, they shall 
without delay require th e relevant economic operator to take  all appropriate corrective action 
to bring the apparatus into compliance with th ose requirements, to w ithdraw the apparatus 
from the market, or to recall it within a reasonable period, comme nsurate with the nature of 
the risk, as they may prescribe. 
The market surveillance author ities shall inform the releva nt notified body accordingly.   
EN 44   EN Article 21 of Regulation (EC) No 765/2008 shall ap ply to the measures referred to in the 
second subparagraph. 
2. Where the market surveillance authorities consid er that non-compliance is not restricted to 
their national territory, they shall inform the Commission and the other Me mber States of the 
results of the evaluation and of the actions wh ich they have required the economic operator to 
take. 
3. The economic operator shall ensure that all ap propriate corrective acti on 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 op erator does not take adequate  corrective action within the 
period referred to in the second subparagrap h of paragraph 1, the market surveillance 
authorities shall take all appropria te provisional measures to prohi bit 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 iden tification of the non-compliant a pparatus, the origin of the 
apparatus, the nature of the non-compliance a lleged 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 surv eillance authorities sha ll 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 Stat e initiating the procedure shall without delay 
inform the Commission and the other Member St ates 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 notifie d 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 re strictive measures are taken in respect of the 
apparatus concerned without delay.  
EN 45   EN 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 le gislation, the Commission shall without delay 
enter into consultation with the Member St ates and the relevant  economic operator or 
operators and shall evaluate th e 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 it s decision to all Member States and shall immediately 
communicate it to them and the releva nt economic operator or operators. 
2. If the national measure is cons idered justified, all Member St ates shall take the measures 
necessary to ensure that the non-compliant apparatus is wit hdrawn 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 st andards referred to in Article 38(5)(b) of this 
Directive, the Commission shall apply the proce dure 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 viol ation 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 conf ormity has not been drawn up; 
(d) the EU declaration of conform ity has not been drawn up correctly; 
(e) technical documentation is either  not available or not complete. 
2. Where the non-compliance referred to in paragr aph 1 persists, the Member State concerned 
shall take all appropriate measures to restrict  or prohibit the apparatu s being made available 
on the market or ensure that it is re called or withdrawn from the market.  
EN 46   EN  
Ð 2004/108 (adapted) 
CHAPTER IV 6 
⌦ TRANSITIONAL AND ⌫ FINAL PROVISIONS 
 
Ø new 
Article 41 
Penalties 
Member States shall lay down rules on penaltie s applicable to infringements of the national 
provisions adopted pursuant to this  Directive and shall take all measures necessary to ensure 
that they are enforced.  
The penalties provided for shall be eff ective, proportionate and dissuasive.  
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. 
 
Ð 2004/108 (adapted) 
Ö new 
Article 4215  
Transitional provisions 
Member States shall not impede the placing  Ö 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  Ö 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)]  .  
EN 47   EN  
Ð 2004/108 (adapted) 
Article 4316  
Transposition 
1. Member States shall adopt and publish ⌦ by [insert date - 2 year s after adopti on] 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, Artic les 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 a nd a correlation tabl e 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 refere nce to this Directive 
or shall  be accompanied by such reference on the o ccasion of their official publication. The 
methods of making such reference shall be laid do wn by Member States.  ⌦They shall also 
include a statement that references in existin g 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 Di rective 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 .  
EN 48   EN 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 . 
 
Ð 
Article 1, Article 2, Article 3 first subparagraph, points (1) to  (8) and second subparagraph, 
Article 5(2) and (3), Article 6, Article 13 firs t subparagraph, Article 19 (3) and Annex I shall 
apply from [the date set out in the second subparagraph of Article 43(1)]. 
 
Ð 2004/108 
Article 4618  
Addressees 
This Directive is addressed to the Member States. 
Done at […], 
For the European Parliament For the Council 
The President The President 
EN 49   EN  
Ð 2004/108 (adapted) 
ANNEX I  
ESSENTIAL  REQUIREMENTS  REFERRED  TO IN ARTICLE  5 
1. PROTECTION  ⌦ ESSENTIAL  ⌫ REQUIREMENTS  
 
Ð 2004/108 
Equipment shall be so designed a nd manufactured, having regard to the state of the art, as to 
ensure that: 
 (a) the electromagnetic disturbance genera ted 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 distur bance 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 intend ed use of components 
 
Ð 2004/108 (adapted) 
A fixed installation shall be installed applyi ng good engineering practices and respecting the 
information on the intended use of its componen ts, with a view to meeting the protection  
⌦ essential ⌫ requirements set out in P point 1. Those good engineering practices shall be 
documented and the documentation shall be held by the person(s) responsi ble at the disposal 
of the relevant national authori ties for inspection purposes for as  long as the fixed installation 
is in operation.  
EN 50   EN  
Ð 2004/108 (adapted) 
ANNEX II  
CONFORMITY  ASSESSMENT  PROCEDURE  REFERRED  TO IN 
ARTICLE  7 
 
Ð 2004/108 
(INTERNAL PRODUCTION CONTROL)  
1. The manu facturer shall perform an electromagne tic compatibility assessment of the 
apparatus, on the basis of the relevant phenom ena, with a view to meeting the protection 
requirements set out in Annex  I, point 1. The correct applic ation of all the relevant 
harmoni sed 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 a ssessment shall take into accoun t all normal intended 
operating conditions. Where the apparatus is capa ble of taking different configurations, the 
electromagnetic compatibility assessment sh all confirm whether the apparatus meets the 
protection requirements set out  in Annex I, point 1, i n all the possible configurations 
identified by the manufacturer as representative of its intended use.  
3. In accordance with the provis ions set out in Annex IV, th e 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 au thorised representative in the Community shall hold the 
technical documentation at the disposal of the co mpetent authorities for at least ten years after 
the dat e 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 ma nufacturer or his authorised representative in 
the Community.  
6. T he manufacturer or his auth orised 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 decl aration of conformity and the technical 
documentation at the disposal of the compet ent authorities shall lie with the person  who 
places the apparatus on the Community market.   
EN 51   EN 8. The manufacturer must take all measures necessary to ensure that the products are 
manufactured in accordance with the technical do cumentation referred to in point 3 and with 
the provisions of this Direc tive that apply to them.  
9. The technical documentation and the EC declar ation of conformity shall be drawn up in 
accordance with the provisi ons set out in Annex IV.  
 
Ø new 
1. Internal production control is the confor mity assessment procedure whereby the 
manufacturer performs an electromagnetic comp atibility 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 capa ble of taking different configurations, the 
electromagnetic compatibility assessment sh all 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 re presentative of its intended use. 
The correct application of all the relevant ha rmonised 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 estab lish 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 a pplicable requirements a nd cover, as far as 
relevant for the assessment, the design, manuf acture and operation of the apparatus. The 
technical documentation shall, wherever appli cable, 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 harm onised standards have not been applied. In the 
event of partly applied harmoni sed 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  
EN 52   EN The manufacturer shall take all measures necessa ry so that the manufacturing process and its 
monitoring ensure compliance of the ma nufactured apparatus with the technical 
documentation referred to in point 2 and with the requirements of the legislative instruments 
that apply to them. 
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 w ith 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 appara tus 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 respons ibility, provided that th ey are specified in 
the mandate.  
EN 53   EN  
Ð 2004/108 
ANNEX III  
CONFORMITY  ASSESSMENT  PROCEDURE  REFERRED  TO IN 
ARTICLE  7 
1. This procedure consists of applyi ng 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 re presentative in the 
Community shall specify to the notif ied body which aspects of the essential requirements 
must be assessed by the notified body.  
3. The notified body shall review the techni cal documentation and assess whether the 
technical documentation properly demonstrates that th e 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 o f the apparatus. That statement sh all be limited to those aspects 
of the essential requirements which ha ve been assessed by the notified body.  
4. The manufacturer shall add the statemen t of the notified bo dy to the technical 
documentation.  
 
Ø new 
Part A 
EU-TYPE EXAMINATION 
1. EU-type examination is the pa rt of a conformity assessment  procedure in which a notified 
body examines the technical design of an apparatu s and verifies and atte sts 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 adequ acy of the technical 
design of the apparatus through examination of  the technical documentation and supporting 
evidence referred to in point 3, without examina tion of a specimen (design type). It may be 
restricted to some aspects of the essential requirements as speci fied by the manufacturer or his 
authorised representative in the Union.  
3. The manufacturer shall lodge an application for EU-type exam ination with a single notified 
body of his choice. 
The application shall include:  
EN 54   EN (a) the name and address of the manufactur er and, if the applic ation is lodged by the 
authorised representative, hi s name and address as well; 
(b) a written declaration that the same application has not been lodged with any other 
notified body; 
(c) the technical documentation. The technica l documentation shall make it possible to 
assess the apparatus conformity with the appli cable 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 te chnical documentation shall 
contain, wherever applicable, at  least the following elements: 
(i) a general descripti on of the apparatus; 
(ii) a list of the harmonised standards and/or other releva nt technical specifications 
the references of which have been publishe d in the Official Jour nal of the European 
Union, applied in full or in part, and descrip tions 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 a pplied harmonised standa rds, the technical 
documentation shall specify the parts which have been applied; 
(iii) results of design calculations ma de, 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 an d/or technical specifications ha ve not been applied in full. 
The supporting evidence shall include, where nece ssary, the results of te sts carried out by the 
appropriate laboratory of the ma nufacturer, or by another testi ng laboratory on his behalf and 
under his responsibility. 
4. The notified body shall examine the technica l documentation and sup porting evidence to 
assess the adequacy of the tech nical design of the apparatus. 
5. The notified body shall draw up an evaluation report that records the activities un dertaken 
in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à vis 
the notifying authorities, the notified body shall rel ease the content of that report, in full or in 
part, only with the agreem ent of the manufacturer. 
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 sh all contain the name and addr ess of the manufacturer, the 
conclusions of the examination, the conditions (i f 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 a nnexes shall contain all relevant information to allow the conformity 
of manufactured apparatus with th e examined type to be evaluated and to allow for in-service 
control.   
EN 55   EN Where the type does not satisfy the applicable requirements of this Directive, the notified 
body shall refuse to issue an EU-type examinati on certificate and shall inform the applicant 
accordingly, giving detailed reasons for its refusal. 
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. Su ch 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 no tifying authorities concerning the EU-type 
examination certificates and/or any additions thereto which it has issued or withdrawn, and 
shall, periodically or upon re quest, make available to its no tifying authorities the list of 
certificates and/or any additi ons thereto refused, suspende d or otherwise restricted. 
Each notified body shall inform the other notif ied bodies concerning the EU-type examination 
certificates and/or any additi ons thereto which it has refu sed, withdrawn, suspended or 
otherwise restricted, and, upon re quest, concerning the certificat es and/or additions thereto 
which it has issued.  
The Commission, the Member States and the ot her notified bodies may, on request, obtain a 
copy of the EU-type examinati on certificates and/or additions thereto. On request, the 
Commission and the Member St ates may obtain a copy of the technical documentation and 
the results of the examinations carried out by  the notified body. The not ified body shall keep a 
copy of the EU-type examination certificate, it s annexes and additions, as well as the 
technical file including the documentation subm itted by the manufacturer, until the expiry of 
the validity of the certificate. 
9. The manufacturer shall keep a copy of the EU -type examination certificate, its annexes and 
additions together with the tec hnical documentation at the dispos al of the national authorities 
for 10 years after the apparatus ha s been placed on the market. 
10. The manufacturer's authorised  representative may lodge th e application referred to in 
point 3 and fulfill the obligations set out in point s 7 and 9, provided that they are specified in 
the mandate. 
Part B 
CONFORMITY TO TYPE BASED ON  INTERNAL PRODUC TION 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 apparatu s 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  
EN 56   EN The manufacturer shall take all measures necessa ry so that the manufacturing process and its 
monitoring ensure conformity of the manuf actured 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 th e required CE marki ng set out in this Directive to each 
individual apparatus that is in  conformity with the type desc ribed 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 natio nal authorities for 10 years after the apparatus 
has been placed on the market. The EU declarat ion of conformity sha ll 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 respons ibility, provided that th ey are specified in 
the mandate.  
EN 57   EN  
Ð 2004/108 (adapted) 
ANNEX IV  
TECHNICAL  DOCUMENTATION  AND  EC ⌦ EU ⌫ DECLARATION  
OF CONFORMITY 
 
Ð 2004/108 
1. TECHNICAL DOCUMENTATI ON 
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 standa rds, or has applied them 
only in part, a description and explanation o f the steps taken to meet the essential 
requirements of the Directive, includi ng 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 th e procedure referred to in Annex III has 
been followed.  
2. EC DECLARATION OF CONF ORMITY  
The EC declaration of conformity mu st contain, at least, the following:  
– a reference to this Directive,  
– an identification of t he 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 repr esentative in the Community,  
– a dated reference to the speci fications under which conform ity is declared to ensure 
the conformity of the apparatus with  the provisions of  this Directive,  
– the date of that declaration,   
EN 58   EN – the identity and signature of the person em powered to bind the manufacturer or his 
authorised representative.  
 
Ø new 
1. No … (unique identification of the apparatus): 
2. Name and address of the manufacturer  or his authorised representative: 
3. This declaration of conformity is issued unde r the sole responsibility of the manufacturer 
(or installer): 
4. Object of the declaration (ide ntification of apparatus allowi ng 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 standa rds 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 notif ied 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):  
EN 59   EN  
Ð 2004/108 (adapted) 
ANNEX V  
‘CE’  MARKING  REFER RED  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 le ast 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 th e apparatus, it must  be affixed to the 
packaging, if any, and to the accompanying documents.  
Whe re the apparatus is the subject of other Dire ctives covering other aspects and which also 
provide for the ‘CE’ marking, the latter shall in dicate that the apparatus also conforms with 
those other Directives.  
However, where one or more of those Directives a llow the manufacturer, during a transitional 
period, to choose which arrangements to apply, the ‘CE’ marking shall indicate conformity 
only with the Directives appl ied by the manufacturer. In that  case, particulars of the 
Directives applied, as published i n the Official Journal of the European Union , must be given 
in the documents, notices or instructions re quired by the Directives and accompanying such 
apparatus. 
EN 60   EN  
Ð 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 prof essional integrity of personnel;  
 (c) independence in prepar ing the reports and performi ng the verification function 
provided for in this Directive;  
 (d) independence of staff and technical personn el in relation to all interested parties, 
groups or persons directly or indirectly  concerned with the equipment in ques tion; 
 (e) maintenance of profe ssional secrecy by personnel;  
 (f) possession of civil liability insuran ce 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 int ervals by the 
competent authorities of the Member State.   
EN 61   EN  
Ð 
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  
EN 62   EN  
Ð 2004/108 (adapted) 
ANNEX VI I 
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)  
Articl e 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 1(1)  
Article 2(2)  Article 1(4)  
Article 2(3)  Article 1(2)  
Article 3  Article 3  
Article 4  Article 5 and Annex I  
Article 5  Article 4(1)  
Article 6  Article 4(2)  
Article 7(1)(a)  Article 6(1) and (2)  
Article 7(1)(b)  -  
Article 7(2).  -  
Article 7(3)  -  
Article 8(1)  Article 6(3) and (4)  
Article 8(2)  -  
Article 9(1)  Article 10(1) and (2)  
Article 9(2)  Article 10(3) and (4)  
Article 9(3)  Article 10(5)   
EN 63   EN 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 7, Annexes II and III  
Article 10(3)  -  
Article 10(4)  -  
Article 10(5)  Article 7, Anne xes II and III  
Article 10(6)  Article 12  
Article 11  Article 14  
Article 12  Article 16  
Article 13  Article 18  
Annex I, point 1  Annex IV, point 2  
Annex I, point 2  Annex V  
Annex II  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) ⌫  
EN 64   EN ⌦ 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 3, last 
paragraph ⌫ 
⌦ 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 ⌫  
EN 65   EN ⌦ 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 ⌫