Proposal for a Decision of the European Parliament and of the Council on a common framework for the marketing of products
Date: 2007-02-14
Institutions: European Commission
Subjects: EC conformity marking, administrative formalities, free movement of goods, marketing, product safety, quality control of industrial products, supervisory body

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 14.2.2007 
COM(2007) 53 final 

2007/0030 (COD) 

Proposal for a 

DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on a common framework for the marketing of products 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

•  Grounds for and objectives of the proposal 

Free  movement  of  goods,  a  central  pillar  of  the  Single  Market,  is  a  major  driver  for 
competitiveness and economic growth in the EU. Moreover, Community technical legislation 
ensuring the free circulation of products has contributed considerably to the completion and 
operation of the Single Market. It provides for high levels of protection to be respected and 
generally also provides economic operators with the means to demonstrate conformity, thus 
ensuring free circulation through trust in the products.  

Experience in the implementation of all this legislation has shown, however: 

–  a certain risk of distortion to competition because of differing practices in the designation 
of conformity assessment bodies by national authorities and unequal treatment in the case 
of  non  complying  or  dangerous  products  on  the  market,  through  very  different  national 
market surveillance infrastructures, rules and means. 

–  a certain lack of trust in conformity marking. 

–  a certain lack of coherence in its implementation and enforcement. 

The proposals, following the Council's Resolution of 10 November 2003, have the objective 
to  provide  a  common  framework  for  the  existing  infrastructures  for  accreditation  for  the 
control of conformity assessment bodies, and market surveillance for the control of products 
and economic operators, by reinforcing and extending what exists and not weakening existing 
instruments  such  as  the  General  Product  Safety  Directive  which  is  very  successful  and 
effective.  Secondly  they  set  out  agreed  references  for  the  organisation  of  the  revision  of 
existing  product  related  Community  harmonisation  legislation,  where  necessary  and  for  the 
development of future product related legislation. 

•  General context 

The present proposals are embedded within the framework of the overall Commission policy 
to promote simplification and better regulation as widely as possible. Originally the Council, 
in  its  Resolution  of  10  November  2003,  invited  the  Commission  to  review  the  “new 
approach”  directives.  However  faced  with  the  possibility  of  bringing  together  harmonised 
instruments  that  could  apply  regardless  of  the  legislative  technique  used  (old/new  approach 
legislation) the option followed has been to put forward proposals that can apply in as many 
sectors as possible within a coherent and transparent, harmonised manner, with standardised 
instruments. This covers in particular such issues as definitions such as placing on the market 
etc, the obligations for economic operators, the evaluation of the competence of conformity 
assessment  bodies,  conformity  assessment  procedures,  control  of  products  from  third 
countries or conformity marking issues.  

It  also  covers  the  issues  relating  to  market  surveillance  in  general.  It  is  possible  to  put  into 
place an overall policy and infrastructures throughout the Community without having to do so 
sector by sector and especially by building on the experience of the General Product Directive 

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for consumer products, whose principles and mechanisms can be extended to the surveillance 
of products for professional use. 

•  Existing provisions in the area of the proposal 

The Council Resolution of 7 May 1985 relating the new approach to technical harmonisation 
and standardisation is the founding document in this area, whilst Council Decision 93/465 of 
22 July 1993 sets out the basic rules for CE marking and for the application of the harmonised 
conformity  assessment  procedures.  These  texts  have  been  complemented  by  different 
resolutions  on  standardization  as  well  as  by  Directive  98/34  recognising  the  role  of  the 
European  standardization  organizations  and  the  priority  for  European  standards,  not  to 
mention the 25 “new approach directives relating to different product sectors. 

Directive  2001/95/EC  of  the  European  Parliament  and  of  the  Council  on  general  product 
safety provides a market surveillance infrastructure and information exchange system and sets 
obligations for economic operators and national authorities in relation to consumer products. 

•  Consistency with the other policies and objectives of the Union 

These  proposals  are  central  to  the  completion  of  the  Single  market  for  products,  and 
contribute to other policies such as in particular, protection of the consumer, of workers and 
of  the  environment.  They  are  integral  to  the  overall  policies  of  the  Commission  within  the 
Lisbon agenda on the chapters better regulation, simplification and market surveillance. 

2. 

CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

•  Consultation of interested parties 

Consultation methods, main sectors targeted and general profile of respondents 

The content of the proposals was put together following 20 working documents which were 
widely circulated to all the major stakeholders. This brought some 250 contributions. 

In  2006  an  internet  consultation  via  Your  Voice  in  Europe  (IPM)  provoked  280  answers 
which mainly confirmed the results of the first consultations. 

The  Commission  drew  up  4  fact  finding  questionnaires  dedicated  to  different  stakeholder 
groups. The questionnaire for companies was used by the Euro Info Centre network to carry 
out a business panel operation (i.e. face to face interviews with 800 SMEs). 

Summary of responses and how they have been taken into account 

The contributions received confirm that the proposals should build on what exists as opposed 
to  creating  a  new  system.  Thus  the  existing  accreditation  system  requires  a  legal  base  as 
opposed  to  being  replaced  by  another  system.  They  reaffirm  it  as  a  public  authority  activity 
and that, as such, should be free of commercial competition. The conformity assessment body 
system requires stricter selection criteria and harmonised national selection processes. Support 
was given to the harmonised definitions and the obligations set out for the economic operators. 
It was confirmed that a systematic requirement for authorised representatives did not solve the 
problem  of  traceability.  Practically  all  contributions  supported  a  Community  market 
surveillance system with information and cooperation system between national authorities in 

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extension  to  the  mechanisms  of  the  GPSD  and  without  creating  new  tools.  The  option  of 
abandoning the CE marking was contested and clarifying its meaning and protecting it legally 
were supported.  

An  open  consultation  was  conducted  over  the  internet  from  01/06/2006  to  26/07/2006.  The 
Commission 
on 
http://ec.europa.eu/enterprise/newapproach/review_en.htm. 

responses. 

available 

received 

results 

The 

280 

are 

•  Collection and use of expertise 

Scientific/expertise domains concerned 

Professionals  in  the  fields  of  Conformity  assessment,  accreditation,  market  surveillance, 
standardisation  and  technical  harmonisation  were  involved  as  well  as  experts  from  trade, 
consumer protection and other associations. 

Methodology used 

The experts were consulted on the working documents, participated in meetings and were the 
addressees of the questionnaires. 

Main organisations/experts consulted 

The national experts responsible for standardization and horizontal issues have been consulted 
as have been those responsible for the implementation of Community legislation. The experts 
in  the  field  of  accreditation  and  conformity  assessment  have  also  been  consulted  as  have 
professional trade and consumer associations. 

Summary of advice received and used 

The  vast  majority  of  experts  have  expressed  agreement  with  the  contents  of  the  proposals 
which were drawn up on the basis of their contributions. 

Means used to make the expert advice publicly available 

The option of placing their contributions on the new approach website with the results of the 
consultations is being examined. 

•  Impact assessment 

Basically there are three general options:  

(1) 

(2) 

The first option consists in keeping the current situation unchanged. Products covered 
by  Community  harmonisation  legislation  would  be  marketed  under  the  conditions 
created by the existing legal framework and the non-legislative measures currently in 
place. 

The second option comprises non-regulatory measures which could be taken without a 
need  to  change  the  existing  or  introducing  new  legislation.  There  are  however  two 
limitations to the potential scope of this option:  

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(a) 

(b) 

Problems  originating  in  the  existing  legal  provisions  can  only  be  eliminated 
through a change in the legislation. 

The Commission has made extensive use of non-regulatory instruments. In the 
area  of  market  surveillance  and  evaluation/monitoring  of  notified  bodies  they 
have so far been insufficient to address effectively the problems related to the 
uneven level of enforcement by national authorities.  

(3) 

The  third  option  comprises  measures  requiring  the  intervention  of  the  Community 
legislator accompanied by the reinforcement of non regulated instruments.  

The only option which answers the feedback from all the stakeholders and which provides the 
solutions to the problems exposed is option 3. 

The  Commission  carried  out  an  impact  assessment  listed  in  the  Work  Programme,  whose 
report is accessible on http://ec.europa.eu/enterprise/newapproach/review_en.htm. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

•  Summary of the proposed action 

The proposals complete the different existing legislative tools by putting forward reinforced 
Community policies on market surveillance and accreditation; to bring coherence to existing 
sectoral  instruments  and  to  examine  how  these  horizontal  instruments  can  be  applied  to  all 
sectors regardless of whether they are "old" or "new" approach. 

The proposals consist in: a regulation for the introduction of accreditation and reinforcement 
market surveillance, and a sui generis decision to set the framework for future legislation. 

The regulation: 

–  organises  accreditation  at  the  national  and  European  levels;  irrespective  of  the  different 
sectors  of  activity  in  which  accreditation  is  used.  The  proposal  insists  on  the  public 
authority  nature  of  accreditation  in  order  for  it  to  be  the  last  level  of  public  authority 
control, and sets the framework for the recognition of the existing organisation European 
co-operation  for  Accreditation  (EA)  so  as  to  ensure  the  proper  functioning  of  a  rigorous 
peer evaluation. 

–  ensures,  when  not  foreseen  in  other  applicable  Community  legislation,  that  national 
authorities  are  given  equivalent  means  of  intervention  and  the  necessary  authority  to 
intervene in the market to be able to restrict or withdraw non compliant or unsafe products. 
It  ensures  cooperation  as  between  the  internal  authorities  and  the  customs  authorities 
controlling  products  entering  the  market  from  third  countries  and  sets  the  framework  for 
the exchange of information between national authorities and cooperation between them in 
the case of products on the markets of more than one Member State. 

The decision: 

–  sets the general framework for future sectoral legislation and give guidance on how to use 
the common elements to ensure as much coherence in future sectoral legislation as can be 
politically and technically possible. 

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–  sets  out  harmonised  definitions,  common  obligations  for  the  economic  operators,  criteria 
for  the  selection  of  the  conformity  assessment  bodies,  criteria  for  the  national  notifying 
authorities  and  rules  for  the  notification  process.  These  elements  are  supported  by  the 
provisions  on  accreditation.  It  also  sets  out  the  rules  for  the  selection  of  conformity 
assessment procedures as well as the harmonised range of procedures. 

–  provides a single definition for the CE marking and rules of responsibility for those who 
affix it and provide for its protection as a Community collective mark, for those directives 
which already provide for it. 

–  puts into place a proper information and market surveillance procedure as a prolongation 
of  the  GPSD  system,  for  the  effective  enforcement  of  Community  harmonisation 
legislation and to make the link with the safeguard clauses of such legislation. 

–  provides harmonised provisions for the future safeguard mechanisms as a complement to 

those for market surveillance. 

•  Legal basis 

The proposals are based on Article 95 of the Treaty. The Regulation is also based on Article 
133 for the control of products from third countries. 

•  Subsidiarity principle 

For over 20 years, in spite of Community policy initiatives for cooperation and development 
of  common  tools,  the  national  instruments  continue  to  vary  and  create  problems  for  an 
equivalent level of protection throughout the Community. Experience in the implementation 
of Community legislation has shown that national non harmonised initiatives have the effect 
of creating discrepancies which counteract the advantages of harmonisation and the internal 
market. 

Most of the contents of the proposal are geared to completing and bringing coherence to the 
legislative  instruments  used  by  the  Community  institutions  to  harmonise  the  national 
legislations which have created barriers to trade in the past or could create them in the future. 
They  are  not  designed  to  create  a  new  European  superstructure  but  to  set  a  framework  for 
better coordination and operation of infrastructures at the national level. 

The  objective  of  Community  legislation  is  to  create  a  sufficient  level  of  trust  as  between 
national authorities and as between operators throughout the Union. This can only be done if 
the  criteria  for  the  operation  of  legislative  requirements  are  fixed  in  common  and  that  the 
national systems put in place for their implementation can show that that they follow similar 
rules, processes and give equivalent results. 

If  these  activities  are  not  harmonised  the  legislation  misses  its  major  objective  which  is  to 
contribute to the protection of the citizen and to the operation of the Internal Market.  

•  Proportionality principle 

The  present  proposals  are  in  most  cases  built  on  existing  practices,  procedures  and 
infrastructures and constitute more their consolidation and extension than the creation of new 
measures and infrastructures. In the field of accreditation the proposals confirm the existing 
system giving it a Community legal basis and framework. In the field of market surveillance, 

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the  objective  of  the  proposals  is  to  coordinate  the  effective  functioning  of  subsidiarity 
activities and responsibilities by the national authorities. The information tools will be geared 
to extending existing tools (such as RAPEX) as opposed to creating new ones. The contents 
of  the  sui  generis  decision,  by  definition,  do  not  create  in  themselves  any  measures  which 
impound  on  national  powers  and  responsibilities.  The  implementation  of  these  measures  in 
future sectoral EU legislation will also be based on the techniques used today in the field of 
the elimination of technical barriers to trade, i.e. based very much on national implementation 
and  intervention  as  opposed  to  Commission  action.  Community  intervention  is  reduced  to 
coordination, cooperation and information in most cases. Where the Community intervenes is 
in cases of safeguard clauses where only the Community can take decisions. The objective of 
these proposals is to reinforce the operation of Community legislation in the field and to avoid 
as much as possible the need for further Community intervention. 

•  Choice of instruments 

The Commission has taken the option of splitting its proposal into two separate legal texts in 
order to take on board the consequences in legal terms of the contents of the proposals: the 
regulation sets the overall framework that completes all the existing legislation in relation to 
accreditation  and  market  surveillance.  This  Regulation  does  not  modify  existing  EU 
legislation  but  complements  it  and  helps  make  the  notification  of  conformity  assessment 
bodies and the operation of safeguard clauses more operational The Decision sets guidelines 
for the future legislator. For this purpose a sui generis decision is proposed, as was done in 
1993 in this same area, in order to set out the common elements for the future, accompanied 
by  guidelines  for  their  implementation.  Future  sectoral  legislation,  new  or  revisions  of 
existing  legislation,  should  use  these  elements  wherever  possible  to  ensure  coherence, 
simplification and to follow rules of better regulation. 

4. 

BUDGETARY IMPLICATION 

The Community financial contribution is extremely reduced in overall terms. In the field of 
accreditation  a  financial  contribution  of  some  15%  of  the  operational  costs  of  EA  which 
correspond  to  75.000  €,  is  foreseen  for  the  purpose  of  ensuring  the  proper  operation  of  the 
European peer evaluation system and therefore remains very modest. Moreover, it is foreseen 
to  provide  a  budget  intervention  of  one  million  €  for  inter  comparison  testing  which 
represents 10% of possible costs if all safeguard clause cases were to lead to inter comparison 
testing. In the field of market surveillance a 1.2 million € contribution for the cooperation of 
all  national  market  surveillance as  well  as  the  exchange  of  information  procedures  between 
them  covering  the  full  range  of  industrial  products  and  covering  controls  of  products 
manufactured in the Community and imported from third countries is minute compared to the 
present non coordinated costs of national market surveillance 

5. 

ADDITIONAL INFORMATION 

•  Simplification 

The  proposal  provides  for  simplification  of  legislation,  simplification  of  administrative 
procedures for public authorities (EU or national), simplification of administrative procedures 
for private parties. 

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The simplification will concern the contents of legislation and the manner in which it is drawn 
up  with  consolidated  ranges  of  solutions  which  have  already  been  tested  and  have  proven 
their effectiveness, meaning that the legislator will be faced with a catalogue of best practices. 

The proposals set standard rules and processes to operate across all sectors, in the form of best 
practices. By consolidating the rules and procedures into a set range, life should be simpler for 
the  national  public  authorities,  for  economic  operators  and  the  consequence  should  be  a 
clearer legislative and administrative image of the Community and greater legal stability. 

Standardised rules across all legislative sectors which apply to the same economic operators 
will lead to greater clarity, greater legal stability more coherence in the measures applicable to 
them  and  eventually  a  reduction  of  some  of  the  burdens  in  conformity  assessment  when  a 
harmonised  market  surveillance  policy  can  take  some  of  the  weight  off  the  pre  marketing 
requirements. 

The  proposal  is  included  in  the  Commission's  Work  and  Legislative  Programme  under  the 
reference CWLP 2006/ENTR 001. 

•  Repeal of existing legislation 

The adoption of the proposal will lead to the repeal of Council regulation 93/339 EEC. 

•  European Economic Area 

The proposed act concerns an EEA matter and should therefore extend to the European 
Economic Area.

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2007/0030 (COD) 

Proposal for a 

DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on a common framework for the marketing of products 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, and in particular Article 
95 thereof, 

Having regard to the proposal from the Commission1, 

Having regard to the opinion of the European Economic and Social Committee2, 

Having regard to the opinion of the Committee of the Regions3, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty4, 

Whereas: 

(1) 

(2) 

On  7  May  2003  the  Commission  issued  a  Communication  to  the  Council  and  the 
European  Parliament  on  “Enhancing  the  Implementation  of  the  New  Approach 
Directives”.  The  Council  acknowledged  in  its  Resolution  of  10  November  2003  the 
importance  of  the  New  Approach  as  an  appropriate  and  efficient  regulatory  model, 
allowing  technological  innovation  and  enhancing  competitiveness  of  European 
industry and confirmed the necessity to extend the application of its principles to new 
areas,  at  the  same  time  recognising  the  need  for  a  clearer  framework  for  conformity 
assessment, accreditation and market surveillance. 

This Decision provides common principles and reference provisions intended to apply 
across sectoral legislation in order to provide a coherent basis for revision or recasts of 
that  legislation.  This  Decision  therefore  constitutes  a  general  framework  of  a 
horizontal nature for future legislation harmonising the conditions for the marketing of 
products and a reference text for existing such legislation. However, the specificities 
of  sectoral  needs  may  provide  grounds  for  having  recourse  to  other  regulatory 
solutions.  

(3) 

This  Decision  provides,  in  the  form  of  reference  provisions,  definitions  and  general 
obligations for economic operators and a range of conformity assessment procedures 

1 
2 
3 
4 

OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 

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(4) 

from which the legislator can select as appropriate. It also lays down rules for the CE 
marking. Furthermore,  reference  provisions are provided as regards the requirements 
for conformity assessment bodies to be notified to the Commission as being competent 
to  carry  out  the  relevant  conformity  assessment  procedures  and  the  notification 
procedures.  In  addition,  this  Decision  includes  reference  provisions  concerning 
procedures dealing with products presenting a risk in order to ensure the safety of the 
market place. 

Regulation  (EC)  No  178/2002  of  the  European  Parliament  and  the  Council  of  28 
January  2002  laying  down  the  general  principles  and  requirements  of  food  law, 
establishing  the  European  Food  Safety  Authority  and  laying  down  procedures  in 
matters of food safety5 and Regulation (EC) No 882/2004 of the European Parliament 
and  of  the  Council  of  29  April  2004  on  official  controls  performed  to  ensure  the 
verification of compliance with feed and food law, animal health and animal welfare 
rules6, Directive 2001/37/EC of the European Parliament and of the Council of 5 June 
2001  on  the  approximation  of  the  laws,  regulations  and  administrative  provisions  of 
the  Member  States  concerning  the  manufacture,  presentation  and  sale  of  tobacco 
products7, Directive 2001/82/EC of the European Parliament and of the Council of 6 
November  2001  on  the  Community  code  relating  to  veterinary  medicinal  products8, 
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 
2001 on the Community code relating to medicinal products for human use9, Directive 
2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting 
standards  of  quality  and  safety  for  the  collection,  testing,  processing,  storage  and 
distribution  of  human  blood  and  blood  components  and  amending  Directive 
2001/83/EC10,  and  Directive  2004/23/EC  of  the  European  Parliament  and  of  the 
Council of 31 March 2004 on setting standards of quality and safety for the donation, 
procurement,  testing,  processing,  preservation,  storage  and  distribution  of  human 
tissues  and  cells11,  Regulation  (EC)  No 726/2004  of  the  European  Parliament  and  of 
the  Council  of  31 March  2004  laying  down  Community  procedures  for  the 
authorisation and supervision of medicinal products for human and veterinary use and 
establishing a European Medicines Agency12 already lay down a common and uniform 
regime on matters covered by this Decision and should therefore not be subject to this 
Decision. 

(5) 

Specific  product  legislation  should,  wherever  possible,  avoid  going  into  technical 
detail  but  should  limit  itself  to  the  expression  of  the  essential  requirements.  Such 
legislation should, where appropriate, have recourse to harmonised standards adopted 
pursuant to Directive 98/34/EC of the European Parliament and of the Council of 22 
June  1998  laying  down  a  procedure  for  the  provision  of  information  in  the  field  of 
technical standards and regulations13 for the purpose of expressing detailed technical 

5 

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8 
9 
10 
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12 
13 

OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 575/2006 (OJ 
L 100, 8.4.2006, p. 3). 
OJ L 165, 30.4.2004; corrected version in OJ L 191, 28.5.2004, p. 1. 
OJ L 194, 18:07:2001; p. 26. 
OJ L 311, 28.11.2001, p. 1. 
OJ L 311, 28.11.2001, p. 67. 
OJ L 033, 8.2.2003, p. 30. 
OJ.L.102, 7.4.2004, p.48. 
OJ L 136, 30.4.2004, p. 1. 
OJ L 204, 21.7.1998, p. 37. Directive as last amended by the 2003 Act of Accession. 

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that  way, 

specifications.  In 
the 
standardisation system provided for by that Directive. However, where safety, clarity 
and  practicability  so  require,  detailed  technical  specifications  may  be  set  out  in  the 
legislation concerned. 

this  Decision  builds  on  and  complements 

(6) 

(7) 

(8) 

(9) 

The presumption of conformity to a legal provision, conferred by the conformity to a 
harmonised  standard,  should  enhance  recourse  to  compliance  with  those  harmonised 
standards.  

It should be possible for Member States or the Commission to object in cases in which 
a  harmonised  standard  does  not  entirely  satisfy  the  requirements  in  Community 
harmonisation legislation. The Commission should have the possibility of deciding not 
to publish such a standard. 

Essential  requirements  should  be  worded  precisely  enough  in  order  to  create  legally 
binding  obligations.  They  should  be  formulated  so  as  to  enable  the  assessment  of 
conformity with those requirements even in the absence of harmonised standards or in 
a case in which the manufacturer chooses not to apply the latter. The degree of detail 
of the wording will depend on the characteristics of each sector. 

The  successful  accomplishment  of  the  required  conformity  assessment  procedure 
enables  economic  operators  to  demonstrate  and  the  competent  authorities  to  ensure 
that products made available on the market conform to the applicable requirements. 

(10)  The  modules  for  the  conformity  assessment  procedures  to  be  used  in  the  technical 
harmonisation legislation were initially set out in Council Decision 93/465/EEC of 22 
July 1993 concerning the modules for the various phases of the conformity assessment 
procedures and the rules for the affixing and use of the CE conformity marking, which 
are  intended  to  be  used  in  the  technical  harmonization  directives14.  This  Decision 
replaces that Decision. 

(11) 

It  is  necessary  to  offer  a  choice  of  clear,  transparent  and  coherent  conformity 
assessment procedures, restricting the possible variants. This Decision provides for a 
menu of modules, enabling the legislator to choose from the least to the most stringent 
procedure, proportionate to the level of risk involved and the level of safety required. 

(12)  For the purposes of ensuring inter-sectoral coherence and to avoid ad-hoc variants, it is 
desirable  that  the  procedures  which  are  to  be  used  in  sectoral  legislation  are  chosen 
from among the modules listed in accordance with the general criteria set out.  

(13) 

In the past, legislation on the free movement of goods has used a set of terms, partly 
without  defining  them,  therefore,  necessitating  guidelines  for  explanation  and 
interpretation. Where legal definitions have been introduced they differ to some extent 
in  their  wording  and  sometimes  in  their  meaning,  which  gives  rise  to  difficulties  in 
their  interpretation  and  correct  implementation.  This  Decision  therefore  introduces 
clear definitions of certain fundamental concepts. 

(14)  All  economic  operators  intervening  in  the  supply  and  distribution  chain  should  take 
the  appropriate  measures  to  ensure  that  they  make  available  on  the  market  only 

14 

OJ L 220, 30.8.1993, p. 23. 

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products  which  are  in  conformity  with  the  applicable  legislation.  This  Decision 
provides a clear and proportionate distribution of obligations which correspond to the 
respective role of each operator in the supply and distribution process. 

(15)  As  certain  tasks  can  only  be  executed  by  the  manufacturer,  it  is  necessary  to  clearly 
distinguish between the manufacturer and the operators further down the distribution 
chain.  It  is  furthermore  necessary  to  clearly  distinguish  the  importer  and  the 
distributor, as the importer introduces products from third countries on the Community 
market.  He  has  thus  to  ensure  that  these  products  comply  with  the  applicable 
Community requirements. 

(16)  The manufacturer, having detailed knowledge of the design and production process, is 
best placed to carry out the complete conformity assessment procedure. Importers and 
distributors  perform  a  trading  function  and  do  not  have  any  influence  on  the 
production process. The conformity assessment should therefore remain the obligation 
of the manufacturer alone. 

(17)  Since importers and distributors are downstream operators they cannot in the normal 
course of events be obliged to ensure themselves that the design and production of the 
product  is  in  compliance  with  the  applicable  requirements.  Their  obligations  in 
relation to the compliance of the product should be limited to certain control measures 
to  ascertain  whether  the  manufacturer  has  fulfilled  his  obligations,  such  as  verifying 
whether the product bears the required conformity marking and whether the required 
documents  have  been  supplied.  However,  it  can  be  expected  of  both  importers  and 
distributors  to  act  with  due  care  in  relation  to  the  applicable  requirements  when 
placing or making available products on the market. 

(18)  Where an importer or a distributor either places a product on the market under his own 
name  or  trademark  or  modifies  a  product  in  such  a  way  that  compliance  with 
applicable  requirements  may  be  affected,  he  should  be  considered  to  be  the 
manufacturer. 

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

(20)  Ensuring  traceability  of  a  product  throughout  the  whole  supply  chain  contributes  to 
rendering  market  surveillance  simpler  and  more  efficient.  An  efficient  traceability 
system  facilitates  the  task  of  market  surveillance  authorities  to  trace  the  economic 
operator responsible for supplying non-compliant products. 

(21)  The CE marking, materialising conformity of a product, is the visible consequence of 
a  whole  process  comprising  conformity  assessment  in  a  broad  sense.  General 
principles  governing  the  use  of  the  CE  marking,  and  rules  as  to  its  affixing,  to  be 
applied in Community harmonisation legislation providing for the use of that marking 
should therefore be set out in this Decision. 

(22) 

It  is  crucial  to  make  clear  to  both  manufacturers  and  users  that  by  affixing  the  CE 
marking  to  the  product  the  manufacturer  declares  that  the  product  is  in  conformity 
with all applicable requirements and that he takes full responsibility therefor. 

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(23)  The  legal  protection  of  the  CE  marking  which  is  granted  by  its  registration  as  a 
Community  collective  mark  allows  public  authorities  to  ensure  proper  enforcement 
and to legally pursue violations.  

(24) 

In  certain  circumstances  the  conformity  assessment  procedures  prescribed  by  the 
applicable legislation require the intervention of conformity assessment bodies, which 
are notified by the Member States to the Commission.  

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

(26) 

In  order  to  ensure  a  coherent  level  of  quality  in  the  performance  of  conformity 
assessment  it  is  not  only  necessary  to  consolidate  the  requirements  that  conformity 
assessment  bodies  wishing  to  be  notified  have  to  fulfil,  but  also,  in  parallel,  to  set 
requirements  that  notifying  authorities  and  other  bodies  involved  in  the  assessment, 
notification and monitoring of notified bodies have to fulfil. 

(27)  The  system  set  out  in  this  Decision  is  complemented  by  the  accreditation  system  as 
foreseen in Regulation [….] of the European Parliament and the Council of … setting 
out  the  requirements  for  accreditation  and  market  surveillance  relating  to  the 
marketing  of  products.  Since  accreditation  is  an  essential  means  of  verifying  the 
competence of conformity assessment bodies its use should also be encouraged for the 
purposes of notification. 

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

(29) 

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

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

(31)  For the purposes of competitiveness it is crucial that notified bodies apply the modules 
without  unnecessary  burden  for  the  economic  operators.  For  the  same  reason  and  to 
ensure equal treatment of economic operators, consistency in the technical application 

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of  the  modules  has  to  be  ensured.  This  can  best  be  achieved  through  appropriate 
coordination and co-operation between notified bodies. 

(32)  To ensure the proper functioning of the certification process, certain procedures, such 
as  exchange  of  experience  and  exchange  of  information  as  between  notified  bodies 
and notifying authorities and as between notified bodies, should be consolidated. 

(33)  Community  harmonisation  legislation  already  provides  for  a  safeguard  procedure 
which  intervenes  only  in  a  case  of  disagreement  between  the  Member  States  as  to 
measures  taken  by  a  Member  State.  In  order  to  increase  transparency  and  to  reduce 
processing  time,  it  is  necessary  to  improve  the  existing  safeguard  clause  procedure, 
with  the  aim  of  making  it  more  efficient  and  of  drawing  on  expertise  available  in 
Member States. 

(34)  The  existing  system  should  be  complemented  by  a  procedure  allowing  interested 
parties to be informed of measures intended with regard to products presenting a risk 
for the health and safety of persons or for other issues of public interest protection. It 
also allows market surveillance authorities, in cooperation with the relevant economic 
operators, to act at an earlier stage in respect of such products. 

(35) 

In a case in which Member States and the Commission agree as to the justification of a 
measure taken by a Member State, no further involvement of the Commission should 
be required, 

HAVE DECIDED AS FOLLOWS:  

Title I 

General principles for the drawing up of Community legislation laying down the 
conditions for the marketing of products 

Subject matter and scope 

Article 1 

This  Decision  sets  out  the  common  principles  determining  the  content  of  Community 
legislation harmonising the conditions for the marketing of products, hereinafter “Community 
legislation”, with the exception of the following legislation: 

(a) 

food law as defined in Article 2 of Regulation (EC) No 178/2002; 

(b) 

feed law as defined in Article 2 of Regulation (EC) No 882/2004; 

(c) 

Directive 2001/37/EC; 

(d) 

Directive 2001/82/EC; 

(e) 

Directive 2001/83/EC; 

(f) 

Directive 2002/98/EC; 

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(g) 

Directive 2004/23/EC; 

(h) 

Regulation (EC) No 726/2004. 

For  the  purposes  of  this  Decision  “product”  shall  mean  any  substance,  preparation  or 
transformed product. 

Community  legislation  shall  have  recourse  to  the  general  principles  of  Title  I  and  to  the 
relevant  reference  provisions  of  Title  II  and  of  Annexes  I  and  II,  while,  where  necessary, 
taking into account the specificities of the legislation concerned. 

Level of protection of public interests 

Article 2 

1. 

2. 

As regards the protection of public interest, Community legislation shall restrict itself 
to setting out the essential requirements determining the level of such protection and 
shall express those requirements in terms of the results to be achieved. 

Where recourse to essential requirements is not possible or not appropriate, detailed 
specifications may be set out in the Community legislation concerned. 

Where  Community  legislation  sets  out  essential  requirements,  it  shall  provide  for 
recourse  to  be  had  to  harmonised  standards,  adopted  in  accordance  with  Directive 
98/34/EC, which shall express such requirements in technical terms and which shall, 
alone  or  in  conjunction  with  other  harmonised  standards,  provide  presumption  of 
conformity with such requirements.  

Conformity assessment procedures 

Article 3 

1. 

Where  Community  legislation  requires  conformity  assessment  to  be  performed  in 
respect of a particular product, the procedures which are to be used shall be chosen 
from  among  the  modules  set  out  and  specified  in  Annex  I,  in  accordance  with  the 
following criteria: 

(a) 

whether the module concerned is appropriate to the type of product; 

(b) 

(c) 

(d) 

the nature of the risks entailed by the product and the extent to which 
such risks can be managed by conformity assessment; 

the  need  for  the  manufacturer  to  have  a  choice  between  quality 
assurance and product certification modules as set out in the Annex; 

the need to avoid imposing modules which would be too burdensome 
in relation to the risks covered by the legislation concerned. 

2. 

Where  a  product  is  subject  to  several  Community  acts  within  the  scope  of  this 
Decision, coherence in the conformity assessment procedures shall be ensured. 

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3. 

The modules referred to in paragraph 1 shall be applied as appropriate in respect of 
the  product  concerned  and  in  accordance  with  the  instructions  set  out  in  those 
modules. 

EC Declaration of conformity 

Article 4 

Where  Community  legislation  requires  a  statement  by  the  manufacturer  that  fulfilment  of 
requirements  relating  to  a  product  has  been  demonstrated,  hereinafter  “EC  declaration  of 
conformity”,  the  legislation  shall  provide  that  the  declaration  is  to  contain  all  relevant 
information to identify the Community legislation to which it relates, and where a product is 
subject to requirements set out in several Community acts, it shall provide that a declaration is 
drawn  up  in  respect  of  all  those  acts,  mentioning  the  publication  references  of  the  acts 
concerned. 

Conformity assessment 

Article 5 

1. 

2. 

Where  Community  legislation  requires  there  to  be  conformity  assessment,  it  may 
provide for such assessment to be carried out by public authorities, by manufacturers 
or by conformity assessment bodies. 

Where Community legislation provides for conformity assessment to be carried out 
by  public  authorities,  the  legislation  shall  provide  that  the  conformity  assessment 
bodies on which these authorities rely for technical assessments are to comply with 
the same criteria as those set out in this Decision for notified bodies. 

Title II 

Reference provisions for Community legislation laying down the conditions for the 
marketing of products 

Chapter 1 
Definitions 

Article 6 

Definitions 

For the purposes of this … [type of instrument] the following definitions shall apply: 

(1) 

“making  available  on  the  market”  means  any  supply  of  a  product  for  distribution, 
consumption or use on the Community market in the course of a commercial activity, 
whether in return for payment or free of charge; 

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(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

“placing  on  the  market”  means  the  first  making  available  of  a  product  on  the 
Community market; 

“manufacturer”  means  any  natural  or  legal  person  who  designs  or  manufactures  a 
product  or  who  has  such  a  product  designed  or  manufactured,  under  his  name  or 
trademark; 

“distributor”  means  any  natural  or  legal  person  in  the  supply  chain,  who  makes  a 
product available on the market; 

“importer” means any natural or legal person established within the Community, who 
places a product from a third country on the Community market; 

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

“technical specification”, “national standard”, “international standard” and “European 
standard” shall have the meanings assigned to them by Directive 98/34/EC; 

“harmonised  standard”  means  a  standard  adopted  by  one  of  the  European 
standardisation  bodies  listed  in  Annex I  to  Directive  98/34/EC  in  accordance  with 
Article 6 of Directive 98/34/EC; 

(9) 

“accreditation” has the meaning assigned to it by Regulation (EC) No […]; 

(10) 

(11) 

“withdrawal”  means  any  measure  aimed  at  preventing  the  making  available  on  the 
market of a product in the supply chain; 

“recall” means any measure aimed at achieving the return of a product that has already 
been made available to the end user. 

Chapter 2 
Obligations of Economic Operators 

Obligations of manufacturers 

Article 7 

1. 

2. 

Manufacturers  shall  ensure  that  their  products  are  designed  and  manufactured  in 
accordance with the requirements set out in … [reference to the relevant part of the 
legislation].  

Manufacturers shall draw up  the required technical documentation and carry out or 
have carried out the applicable conformity assessment procedure.  

Where  the  compliance  of  the  product  with  the  applicable  requirements  has  been 
demonstrated by such procedure, manufacturers shall draw up an EC declaration of 
conformity and affix the conformity marking.  

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3. 

4. 

5. 

6. 

7. 

8. 

Manufacturers  shall  keep  the  technical  documentation  and  the  EC  declaration  of 
conformity for a period of ….[to be specified] after the product has been placed on 
the market. 

Manufacturers  shall  ensure  that  procedures  are  in  place  to  ensure  the  continued 
conformity of series production. Changes in the product design or characteristics and 
changes  in  the  harmonised  standards  or  in  technical  specifications  by  reference  to 
which conformity of a product is stated shall be adequately taken into account. 

Manufacturers  shall,  in  all  cases  where  appropriate,  carry  out  sample  testing  of 
marketed products, investigating, and, if necessary, keeping a register of complaints, 
and keeping distributors informed of such monitoring. 

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

Manufacturers  shall  indicate  their  name  and  the  address  at  which  they  can  be 
contacted on the product or, where the size or nature of the product does not allow it, 
on its packaging or in a document accompanying the product. 

Manufacturers who consider or have reason to believe that a product which they have 
placed on the market is not in conformity with the applicable Community legislation 
shall take the necessary corrective measures to bring that product into conformity or 
withdraw it from the market and recall it from end users, if appropriate. They shall 
immediately inform the national authorities of the Member States where they made 
the  product  available  to  this  effect,  giving  details,  in  particular,  of  the  non-
compliance and of the corrective measures taken. 

Manufacturers  shall,  on  request  from  the  competent  national  authorities,  provide 
them  with  all  the  information  and  documentation  necessary  to  demonstrate  the 
conformity of the product. They shall cooperate with those authorities, at the request 
of  the  latter,  on  any  action  to  avoid  the  risks  posed  by  products  which  they  have 
placed on the market.  

Authorised representatives 

Article 8 

1. 

Manufacturers  may  appoint,  by  a  written  mandate,  any  natural  or  legal  person 
established within the Community, ("the authorised representative"),  to act on  their 
behalf for specified tasks with regard to the obligations of manufacturers under this 
… [act].  

The obligations under Article [7(1)] and the drawing up of technical documentation 
may not form part of the authorised representative's mandate. 

2. 

Where a manufacturer has appointed an authorised representative, the latter shall at 
least do the following: 

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(a) 

(b) 

(c) 

the  EC  declaration  of  conformity  and 

keep 
technical 
documentation at the disposal of national surveillance authorities for a 
period of … [to be specified];  

the 

on request from the competent national authorities, provide them with 
all  the  information  and  documentation  necessary  to  demonstrate  the 
conformity of the product.  

cooperate  with  the  competent  authorities,  at  the  request  of  the  latter, 
on  any  action  to  avoid  the  risks  posed  by  products  covered  by  their 
mandate. 

Obligations of importers 

Article 9 

1. 

2. 

3. 

4. 

5. 

6. 

When placing a product on the market importers shall act with due care in relation to 
the applicable requirements.  

Before  placing  a  product  on  the  market  importers  shall  verify  that  the  appropriate 
conformity  assessment  procedure  has  been  carried  out  by  the  manufacturer.  They 
shall verify that the manufacturer has drawn up the technical documentation, that the 
product  bears  the  required  conformity  marking(s),  is  accompanied  by  the  required 
documents  and  that  the  manufacturer  has  respected  the  requirements  set  out  in 
Article [7(5) and (6)]. 

Where an importer discovers that the product is not in conformity with … [reference 
to the relevant part of the legislation], he may place the product on the market only 
after it has been brought into conformity with the applicable requirements set out in 
... [reference to the relevant part of the legislation] 

Importers shall indicate their name and the address at which they can be contacted on 
the  product  or,  where  the  size  or  nature  of  the  product  does  not  allow  it,  on  its 
packaging or in a document accompanying the product. 

Importers shall ensure  that,  while a  product is under their responsibility, storage or 
transport conditions do not jeopardise its compliance with the requirements set out in 
… [reference to the relevant part of the legislation]. 

Importers  who  consider  or  have  reason  to  believe  that  a  product  which  they  have 
placed on the market is not in conformity with the applicable Community legislation 
shall take the necessary corrective measures to bring that product into conformity or 
withdraw it from the market and recall it from end users, if appropriate. They shall 
immediately inform the national authorities of the Member States where they made 
the  product  available  to  this  effect,  giving  details,  in  particular,  of  the  non-
compliance and of the corrective measures taken. 

Importers  shall,  for  a  period  of  …  [to  be  specified],  keep  a  copy  of  the  EC 
declaration  of  conformity  at  the  disposal  of  the  market  surveillance  authorities  and 
ensure  that  the  technical  documentation  can be  made  available  to  those  authorities, 
upon request. 

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7. 

Importers  shall,  on  request  from  the  competent  national  authorities,  provide  them 
with all the information and documentation necessary to demonstrate the conformity 
of the product. They shall cooperate with those authorities, at the request of the latter, 
on  any  action  to  avoid  the  risks  posed  by  products  which  they  have  placed  on  the 
market. 

Obligations of distributors 

Article 10 

1. 

2. 

3. 

4. 

5. 

When making a product available on the market distributors shall act with due care 
in relation to the applicable requirements. 

Before  making  a  product  available  on  the  market  distributors  shall  verify  that  the 
product bears the required conformity marking(s) and is accompanied by the required 
documents  and  that  the  manufacturer  and  the  importer  have  respected  the 
requirements set out in Article [7 (5) and (6)] and [Article 9 (3)]. 

Where a distributor discovers that a product is not in conformity with …[reference to 
the relevant part of the legislation], he may make the product available on the market 
only  after  it  has  been  brought  into  conformity  with  the  applicable  requirements  set 
out  in  …[reference  to  the  relevant  part  of  the  legislation].  The  distributor  shall 
inform the manufacturer or the importer to this effect. 

A distributor shall ensure that, while a product is under his responsibility, storage or 
transport conditions do not jeopardise its compliance with the requirements set out in 
... [reference to the relevant part of the legislation]. 

Distributors who consider or have reason to believe that a product which they have 
made  available  on  the  market  is  not  in  conformity  with  the  applicable  Community 
legislation  shall  take  the  necessary  corrective  measures  to  bring  that  product  in 
conformity  or  withdraw  it  from  the  market  and  recall  it  from  end  users,  if 
appropriate.  They  shall  immediately  inform  the  national  authorities  of  the  Member 
States  where  they  made  the  product  available  to  this  effect,  giving  details,  in 
particular, of the non-compliance and of the corrective measures taken. 

Distributors shall, on request from the competent national authorities, provide them 
with all the information and documentation necessary to demonstrate the conformity 
of the product. They shall cooperate with those authorities, at the request of the latter, 
on any action to avoid the risks posed by products which they have made available 
on the market. 

Article 11 

Cases in which obligations of manufacturers apply to importers and distributors 

An importer or distributor who places a product on the market under his name or trademark 
shall be subject to the obligations of the manufacturer under Article [7]. 

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An importer or a distributor, who modifies a product in such a way that compliance with the 
applicable  requirements  may  be  affected,  shall  be  subject  to  the  obligations  of  the 
manufacturer under Article [7] in respect of these modifications. 

Article 12 

Identification of economic operators 

Economic operators shall be able to identify the following: 

(a) 

any economic operator who has supplied them with a product; 

(b) 

any economic operator to whom they have supplied a product. 

To this end they shall have in place appropriate systems and procedures which allow for this 
information  to  be  made  available  to  the  market  surveillance  authorities  on  request,  for  a 
period of … [to be specified]. 

Chapter 3 

Conformity of the product 

Presumption of conformity  

Article 13 

Products which are in conformity with harmonised standards or parts thereof, the references 
of  which  have  been  published  in  the  Official  Journal  of  the  European  Union,  shall  be 
presumed  to  be  in  conformity  with  the  requirements  covered  by  those  standards  or  parts 
thereof, set out in … [reference to the relevant part of the legislation]. 

Formal objection against harmonised standards  

Article 14 

1. 

2. 

When a Member State or the Commission considers that a harmonised standard does 
not  entirely  satisfy  the  requirements  which  it  covers  and  which  are  set  out  in  … 
[reference  to  the  relevant  part  of  the  legislation],  the  Commission  or  the  Member 
State  concerned shall bring the  matter before  the  Committee  set  up  by  Article  5  of 
Directive  98/34/EC,  hereinafter  the  "Committee",  giving  its  arguments.  The 
Committee shall deliver its opinion without delay. 

In the light of the Committee’s opinion, the Commission shall decide to publish, not 
to publish, to publish with restriction, to maintain, to maintain with restriction or to 
withdraw the references to the harmonised standard concerned in the Official Journal 
of the European Union. 

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3. 

The Commission  shall inform  the European standardisation  body  concerned and, if 
necessary, request the revision of the harmonised standards concerned. 

EC declaration of conformity 

Article 15 

1. 

2. 

3. 

The  EC  declaration  of  conformity  shall  state  that  the  fulfilment  of  requirements 
specified in … [reference to relevant part of the legislation] has been demonstrated. 

The EC declaration of conformity shall as a minimum contain the elements specified 
in [the relevant modules set out in Annex I] and in this … [reference to the relevant 
part  of  the  legislation]  and  shall  continuously  be  updated.  The  EC  declaration  of 
conformity shall have the model structure set out in [Annex II]. 

By drawing up the EC declaration of conformity, the manufacturer shall assume the 
responsibility for the compliance of the product. 

General principles of the CE marking 

Article 16 

1. 

The  CE  marking  may  only  be  affixed  by  the  manufacturer  or  his  authorised 
representative.  

2. 

3. 

By  affixing  or  having  affixed  the  CE  marking  the  manufacturer  shall  assume  the 
responsibility for the conformity of the product with the requirements laid down in 
this … [act].  

The CE marking shall be the only marking which attests conformity of the product 
with the applicable requirements. Member States shall refrain from introducing into 
their  national  regulations  or  shall  withdraw  any  reference  to  a  conformity  marking 
other than the CE marking in connection with conformity to the provisions contained 
in the legislation on CE marking.  

The  affixing  on  a  product  of  markings,  signs  and  inscriptions  which  are  likely  to 
mislead  third  parties  as  to  the  meaning  or  form  of  the  CE  marking,  or  both,  is 
prohibited.  Any  other  marking  may  be  affixed  to  the  product  provided  that  the 
visibility, legibility and meaning of the CE marking are not thereby impaired. 

Rules and conditions for the affixing of the CE marking 

Article 17 

1. 

The  CE  marking  shall  consist  of  the  initials  “CE”  taking  the  following  form: 

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2. 

3. 

4. 

5. 

6. 

7. 

If  the  CE  marking  is  reduced  or  enlarged  the  proportions  given  in  the  graduated 
drawing in paragraph 1 must be respected. 

Where  specific  legislation  does  not  impose  specific  dimensions,  the  CE  marking 
shall have a height of at least 5 mm. 

The CE marking shall be affixed visibly, legibly and indelibly to the product or to its 
data plate. Where this is not possible or not warranted on account of the nature of the 
product,  it  shall  be  affixed  to  the  packaging  and  to  the  accompanying  documents, 
where the legislation concerned provides for such documents. 

The CE marking shall be affixed before the product is placed on the market. It may 
be followed by a pictogram or any other mark indicating a special risk or use. 

The CE marking shall be followed by the identification number of the notified body 
where such body is involved in the production control phase. 

The identification number of the notified body shall be affixed by the body itself or 
under  its  instructions,  by  the  manufacturer  or  his  authorised  representative 
established within the Community. 

Member States shall ensure correct implementation of the regime governing the CE 
marking  and,  if  they  deem  adequate,  take  legal  action  in  case  of  improper  use. 
Member  States  shall  also  put  in  place  penalties,  which  may  include  criminal 
sanctions, for serious infringements, that must be proportionate to the seriousness of 
the offence and constitute an effective deterrent against improper use. 

Chapter 4 
Notification of conformity assessment bodies 

Notification  

EN 

Article 18 

23 

   EN 

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

Notifying authorities 

Article 19 

1. 

2. 

3. 

Member  States  shall  designate  a  notifying  authority  that  shall  be  responsible  for 
setting  up  and  carrying  out  the  necessary  procedures  for  the  assessment  and 
notification of conformity assessment bodies and the monitoring of notified bodies, 
including compliance with the provisions of Article [24].  

Member  States  may  decide  that  the  assessment  and  monitoring  referred  to  in 
paragraph  1  shall  be  carried  out  by  their  national  accreditation  bodies  within  the 
meaning of and in accordance with Regulation (EC) No […]. 

Where  the  notifying  authority  delegates,  subcontracts  or  otherwise  entrusts  the 
assessment, notification or monitoring referred to in paragraph 1 to a body which is 
not a governmental entity, the delegated, subcontracted or otherwise entrusted body 
shall be a legal entity and shall have arrangements to cover liabilities arising from its 
activities. 

Requirements relating to notifying authorities 

Article 20 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

The notifying authority shall meet the requirements set out in paragraphs 2 to 7. 

The notifying authority shall be established in such a way that no conflicts of interest 
with conformity assessment bodies occur. 

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

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

The  notifying  authority  shall  not  offer  or  provide  any  activities  that  conformity 
assessment bodies perform, or consultancy. 

The  notifying  authority  shall  have  adequate  arrangements  to  safeguard  the 
confidentiality of the information obtained. 

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

Information obligation for the notifying authorities 

Article 21 

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24 

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Member  States  shall  inform  the  Commission  and  the  other  Member  States  of  their  national 
procedures  for  the  assessment  and  notification  of  conformity  assessment  bodies  and  the 
monitoring of notified bodies, and of any changes to that information.  

The Commission shall make that information publicly available. 

Requirements for notified bodies 

Article 22 

1. 

2. 

3. 

4. 

5. 

6. 

For  the  purposes  of  notification,  a  conformity  assessment  body  shall  meet  the 
requirements set out in paragraphs 2 to 11 of this Article. 

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

The  conformity  assessment  body  shall  be  a  third-party  body  independent  from  the 
organisation or the product it assesses. 

The  conformity  assessment  body,  its  top  level  management  and  the  personnel 
responsible  for  carrying  out  the  conformity  assessment  tasks  shall  not  be  the 
designer,  manufacturer,  supplier,  installer,  purchaser,  owner,  user  or  maintainer  of 
the  products  which  they  assess,  nor  the  authorised  representative  of  any  of  those 
parties. 

Nor shall they become directly involved in the design, manufacture or construction, 
the  marketing,  installation,  use  or  maintenance  of  those  products,  nor  represent  the 
parties engaged in those activities. 

They shall not provide consultancy related to the conformity assessment activities for 
which  they  are  notified  and  relating  to  products  intended  to  be  placed  on  the 
Community market. This shall not preclude the possibility of exchanges of technical 
information between the manufacturer and the conformity assessment body and the 
use  of  assessed  products  that  are  necessary  for  the  operations  of  the  conformity 
assessment body. 

The  conformity  assessment  body  shall  ensure  that  activities  of  its  subsidiaries  or 
subcontractors  do  not  affect  the  confidentiality,  objectivity  and  impartiality  of  its 
conformity assessment activities. 

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

The conformity assessment body shall be capable of carrying out all the conformity 
assessment  tasks  assigned  to  such  a  body  by  the  provisions  of  …  [reference  to 
relevant  part  of  the  legislation]  and  for  which  it  has  been  notified,  whether  those 

EN 

25 

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tasks  are  carried  out  by  the  conformity  assessment  body  itself  or  on  its  behalf  and 
under its responsibility. 

At  all  times  and  for  each  conformity  assessment  procedure  and  for  each  kind  or 
category  of  products  for  which  it  is  notified,  the  conformity  assessment  body  shall 
have at its disposal the necessary personnel with technical knowledge and sufficient 
and appropriate experience to perform the conformity assessment tasks. 

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 the conformity assessment activities shall 
have the following: 

(a) 

(b) 

(c) 

sound  technical  and  vocational  training  covering  all  the  conformity 
assessment  activities  of  the  relevant  scope  for  which  the  conformity 
assessment body has been notified; 

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

appropriate  knowledge  and  understanding  of 
the  essential 
requirements,  of  the  applicable  harmonised  standards  and  of  the 
relevant provisions of the relevant Community legislation and relevant 
implementing regulations; 

(d) 

the ability required to draw up the certificates, records and reports to 
demonstrate that the assessments have been carried out. 

8. 

The  impartiality  of  the  conformity  assessment  body,  its  top  level  management  and 
assessment personnel shall be guaranteed. 

9. 

10. 

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

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

The  personnel  of  the  conformity  assessment  body  shall  be  bound  to  observe 
professional  secrecy  with  regard  to  all  information  gained  in  carrying  out  its  tasks 
under  …  [reference  to  the  relevant  part  of  the  legislation]  or  any  provision  of 
national  law  giving  effect  to  it,  except  in  relation  to  the  competent  administrative 
authorities  of  the  Member  State  in  which  its  activities  are  carried  out.  Proprietary 
rights shall be protected. 

11. 

The  conformity  assessment  body  shall  participate  in,  or  ensure  that  its  assessment 
personnel is informed of, the relevant standardisation activities and the activities of 
the  notified  body  co-ordination  group  established  under  the  relevant  Community 

EN 

26 

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legislation and apply as general guidance the administrative decisions and documents 
produced as a work result of that group. 

Presumption of conformity 

Article 23 

Where  a  conformity  assessment  body  can  demonstrate  its  conformity  with  the  criteria  laid 
down in the harmonised standards, the references of which have been published in the Official 
Journal of the European Union, it shall be presumed to comply with the requirements set out 
in Article [22]. 

Subsidiaries and subcontracting of notified bodies 

Article 24 

1. 

2. 

3. 

4. 

Where  the  conformity  assessment  body  subcontracts  specific  tasks  connected  with 
the assessment of conformity or has recourse to a subsidiary, it shall ensure that the 
subcontractor or the subsidiary meets the requirements set out in Article [22]. 

The conformity assessment body shall take full responsibility for the tasks performed 
by subcontractors or subsidiaries wherever these are established.  

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

The conformity assessment body shall keep at the disposal of the national authorities 
the  relevant  documents  concerning  the  assessment  of  the  subcontractor’s  or 
subsidiary’s  qualifications  and  the  work  carried  out  by  the  subcontractor  or  the 
subsidiary under … [reference to the relevant part of the legislation]. 

Accredited in-house bodies 

Article 25 

1. 

For the purpose of conformity assessment procedures set out in [Annex 1 – modules 
A1,  A2,  C1  or  C2],  an  accredited  in-house  body,  which  forms  a  separate  and 
identifiable  part  of  an  undertaking  involved  in  the  design,  manufacture,  supply, 
installation, use or maintenance of the products that it assesses and which has been 
established to supply conformity assessment services to the undertaking of which it 
forms a part, may be used.  

2. 

The in-house body shall meet the following criteria:  

(a) 

it shall be accredited in accordance with Regulation (EC) No […].; 

(b) 

the  body  and  its  personnel  shall  be  organisationally  identifiable  and 
have  reporting  methods  within  the  undertaking  of  which  it  forms  a 

EN 

27 

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part,  which  ensure  its  impartiality  and  demonstrate  it  to  the  relevant 
national accreditation body; 

(c) 

the  body  and  its  personnel  must  not  be  responsible  for  the  design, 
manufacture,  supply,  installation,  operation  or  maintenance  of  the 
products which they assess, and must not engage in any activities that 
might  conflict  with  their  independence  of  judgment  and  integrity  in 
relation to their assessment activities; 

(d) 

the  body  shall  supply  its  services  exclusively  to  the  undertaking  of 
which it forms a part. 

3. 

Accredited  in-house  bodies  shall  not  be  notified  to  the  Member  States  or  the 
Commission,  but  information  about  their  accreditation  shall  be  provided  to  the 
notifying authority, on request. 

Application for notification 

Article 26 

1. 

2. 

3. 

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

The application shall be accompanied by a description of the conformity assessment 
activities, the conformity assessment module or modules and the product or products 
for which the body claims to be competent, as well as by an accreditation certificate, 
where  it  exists,  delivered  by  a  national  accreditation  body  within  the  meaning  of 
Regulation  (EC)  No  […],attesting  that  the  conformity  assessment  body  meets  the 
requirements laid down in Article ...[22]. 

Where  the  conformity  assessment  body  concerned  cannot  provide  an  accreditation 
certificate,  it  shall  provide  the  notifying  authority  with  all  documentary  evidence 
necessary for the verification, recognition and regular monitoring of its compliance 
with the requirements laid down in Article ...[22]. 

Notification procedure 

Article 27 

1. 

2. 

3. 

Notifying  authorities  may  notify  only  conformity  assessment  bodies  which  have 
satisfied the requirements laid down in Article ...[22]. 

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

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

EN 

28 

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4. 

5. 

Where a notification is not based on an accreditation certificate referred to in Article 
...[26(2)],  the  notifying  authority  shall  provide  the  Commission  and  the  other 
Member  States  with  all  documentary  evidence  necessary  for  the  verification  of  the 
conformity assessment body's competence. 

The  body  concerned  may  perform  the  activities  of  a  notified  body  only  where  no 
objections have been raised by the Commission and the other Member States within 
two months following that notification. 

Only such a body shall be considered as  a notified body for  the purpose of this … 
[act]. 

6. 

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

Identification numbers and lists of notified bodies 

Article 28 

1. 

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

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

2. 

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

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

Changes to the notification 

Article 29 

1. 

2. 

Where a notifying authority has ascertained or has been informed that a notified body 
no longer meets the requirements referred to in Article ...[22], or that it is failing to 
fulfil  its  obligations,  the  notifying  authority  shall  restrict,  suspend  or  withdraw  the 
notification as appropriate. It shall immediately inform the Commission and the other 
Member States thereof.  

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

Challenge of the competence of notified bodies 

Article 30 

EN 

29 

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1. 

2. 

3. 

4. 

The Commission shall investigate all cases where it doubts or doubt is brought to its 
attention  as  to  the  competence  of  a  notified  body  or  the  continued  fulfilment  by  a 
notified body of the requirements and responsibilities placed on it.  

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

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

Where  the  Commission  ascertains  that  a  notified  body  does  not  meet,  or  no  longer 
meets,  the  requirements  for  its  notification,  it  shall  inform  the  notifying  Member 
State thereof and request it to take the necessary corrective measures, including de-
notification, if necessary. 

Operational obligations for notified bodies 

Article 31 

1. 

2. 

3. 

4. 

5. 

Notified  bodies  shall  carry  out  conformity  assessments  in  accordance  with  the 
conformity  assessment  procedures  provided  for  in  …[the  relevant  part  of  the 
legislation]. 

Conformity  assessments  shall  be  carried  out  in  a  proportionate  manner,  avoiding 
unnecessary  burden  for  economic  operators,  in  particular  taking  into  consideration 
the  size  of  companies  and  the  relative  complexity  of  the  technology  used  by  the 
products. 

Where a notified body finds that requirements laid down in … [the relevant part of 
the  legislation]  or  corresponding  harmonised  standards  or  technical  specifications 
have  not  been  met  by  the  manufacturer,  it  shall  require  the  manufacturer  to  take 
appropriate corrective measures and it shall not deliver any conformity certificate. 

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

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

Information obligation for notified bodies 

Article 32 

1. 

Notified bodies shall inform the notifying authority of the following:  

(a) 

any refusal, restriction, suspension or withdrawal of certificates; 

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30 

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(b) 

(c) 

(d) 

any  circumstances  affecting 
notification; 

the  scope  of  and  conditions  for 

any  request  for  information  which  they  have  received  from  market 
surveillance authorities; 

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

2. 

Notified  bodies  shall  provide  the  other  bodies  notified  under  this  …  [act]  carrying 
out  similar  conformity  assessment  activities  and  covering  the  same  products  with 
relevant  information  on  issues  relating  to  negative  and,  on  request,  positive 
conformity assessment results.  

Exchange of experience 

Article 33 

The  Commission  shall  provide  for  the  organisation  of  exchange  of  experience  between  the 
Member States’ national authorities responsible for policy on notification.  

Coordination of notified bodies 

Article 34 

The Commission shall ensure that appropriate coordination and cooperation between bodies 
notified  under  …  [the  relevant  act  or  other  Community  legislation]  is  put  into  place  and 
properly operated in the form of (a) … [sectoral or cross sectoral] group(s) of notified bodies. 

Member  States  shall  ensure  that  the  bodies  notified  by  them  participate  in  the  work  of  that 
(those) group(s). 

Chapter 5 

Safeguard procedures 

Article 35  

Procedure to deal with products presenting a risk at national level  

1. 

Where  the  market  surveillance  authorities  of  one  Member  State  have  taken  action 
pursuant  to  Article  18  of  Regulation  (EC)  No  …[]  or  where  they  have  sufficient 
reason to believe that a product covered by … this [act] presents a risk for the health 
or safety of persons or for other issues of public interest protection covered by … this 
[act],  they  shall,  together  with  the  relevant  economic  operators,  perform  an 
evaluation  in  relation  to  the  product  concerned  covering  all  the  requirements  laid 
down by this ..[act].  

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31 

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Where, in the course of that evaluation, the market surveillance authorities find that 
the product does not comply with the requirements laid down by this … [act], they 
shall require the relevant economic operator to take all appropriate corrective actions 
to  bring  the  product  into  compliance  with  those  requirements  or  to  withdraw  the 
product  from  the  market  or  recall  it  within  such  reasonable  period,  commensurate 
with the nature of the risk, as they may prescribe.  

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

The economic operator shall ensure that any corrective actions are taken in respect of 
all the products concerned which he has made available on the market throughout the 
Community. 

Where  the  relevant  economic  operator,  within  the  period  referred  to  in  the  second 
subparagraph  of  paragraph  1,  does  not  take  adequate  corrective  actions,  the  market 
surveillance authorities shall take all appropriate provisional measures to prohibit or 
restrict the making available of the product on the national market or to withdraw the 
product from that market or to recall it. 

They  shall  inform  the  Commission  and  the  other  Member  States,  without  delay,  of 
such measures. 

The  information  referred  to  in  paragraph  4  shall  provide  all  available  details,  in 
particular  as  regards  the  necessary  data  for  the  identification  of  the  non-compliant 
product,  the  origin  of  the  product  ,  the  nature  of  the  risk  involved,  the  nature  and 
duration of national measures taken. In particular, the market surveillance authorities 
shall indicate whether the non compliance is due to either of the following:  

(a) 

(b) 

failure of the product to meet the requirements related to the health or 
safety  of  persons  or  to  other  issues  of  public  interest  protection  laid 
down by this … [act]; 

shortcomings in the harmonised standards referred to in … [reference 
to  the  relevant  part  of  the  legislation]  as  conferring  presumption  of 
conformity. 

Member  States  other  than  the  Member  State  which  initiated  the  procedure  shall 
without delay inform the Commission and the other Member States of any measures 
adopted  and  of  any  additional  information  relating  to  the  non-compliance  of  the 
product  concerned  at  their  disposal,  and,  in  the  event  of  disagreement  with  the 
notified national measure, of their objections. 

Where, within …. [period to be specified] 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 in relation 
to the product concerned, the measure shall be deemed justified. 

2. 

3. 

4. 

5. 

6. 

7. 

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32 

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Community safeguard procedure 

Article 36 

1. 

2. 

3. 

Where, on completion of the procedure set out in Article [35 (3) and (4)], objections 
are  raised  against  a  national  measure  of a  Member  State  or  where  the  Commission 
considers  the  national  measure  to  be  contrary  to  Community  legislation  the 
Commission shall without delay enter into consultation with the Member States and 
the relevant economic operator(s) and shall proceed to the evaluation of the national 
measure. On the basis of the results of that evaluation, the Commission shall take a 
decision, indicating whether the measure is justified or not.  

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

If  the  national  measure  is  considered  justified,  all  Member  States  shall  take  the 
necessary measures to ensure that the non compliant product is withdrawn from their 
markets.  Member  States  shall  inform  the  Commission  thereof.  If  the  national 
measure  is  considered  unjustified,  the  Member  State  concerned  shall  withdraw  the 
measure. 

Where the national measure is considered to be justified and the non-compliance of 
the product is attributed to shortcomings in the harmonised standards as referred to in 
Article  [35(5)  (b)],  the  Commission  or  the  Member  State  shall  bring  the  matter 
before the Standing Committee set up under Article 5 of Directive 98/34/EC. 

Complying products which nevertheless present a risk to health and safety 

Article 37 

1. 

2. 

3. 

4. 

Where  a  Member  State  after  having  performed  an  evaluation  under  Article [35 (1)] 
finds that although a product is in compliance with this … [act]., it presents a risk for 
the health or safety of persons or for other issues of public interest protection, it shall 
require the relevant economic operator to take all appropriate measures to ensure that 
the product concerned, when placed on the market, no longer presents that risk or to 
withdraw  the  product  from  the  market  or  recall  it  within  such  reasonable  period, 
commensurate with the nature of the risk, as it may prescribe.  

The economic operator shall ensure that any corrective actions are taken in respect of 
all the products concerned which he has made available on the market throughout the 
Community. 

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

The Commission shall without delay enter into consultation with the Member States 
and  the  relevant  economic  operator(s)  and  shall  proceed  to  the  evaluation  of  the 
national measure. On the basis of the results of that evaluation, the Commission shall 

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33 

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take  a  decision,  indicating  whether  the  measure  is  justified  or  not,  and  where 
necessary, propose appropriate measures. 

5. 

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

Formal non-compliance 

Article 38  

1. 

Without prejudice to Article 35, 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 conformity marking has been affixed in violation of Article [16] or 
Article [17]; 

(b) 

the conformity marking has not been affixed; 

(c) 

the EC declaration of conformity has not been drawn up; 

(d) 

the EC declaration of conformity has not been drawn up correctly. 

2. 

Where  the  non-compliance  referred  to  in  paragraph  1  continues,  the  Member  State 
shall take all appropriate measures to restrict or prohibit the making available on the 
market of the product or ensure that it is recalled or withdrawn from the market.  

Title III 

FINAL PROVISIONS 

Article 39 

Repeal 

Decision 93/465/EEC is repealed. 

References to the repealed Decision shall be construed as references to this Decision. 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President

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ANNEX I 
CONFORMITY ASSESSMENT PROCEDURES 

Module A 
Internal production control 

1. 

Internal  production  control  is  the  conformity  assessment  procedure  whereby  the 
manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and 
declares  on  his  sole  responsibility  that  the  products  concerned  satisfy  the 
requirements of the legislative instrument that apply to them.  

2. 

Technical documentation 

The  manufacturer  shall  establish  the  technical  documentation  as  described  in  the 
legislative instrument. The documentation shall enable the assessment of the product 
for  its  conformity  with  the  relevant  requirements,  and  shall  include  an  adequate 
analysis and assessment of the risk(s). The technical documentation shall specify the 
applicable requirements and cover, as far as relevant for the assessment, the design, 
manufacture and operation of the product15. 

3. 

Manufacturing 

The manufacturer shall take all measures necessary in order that the manufacturing 
process and its monitoring ensure compliance of the manufactured products 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 declaration of conformity 

4.1. 

4.2. 

15 

16 

The  manufacturer  shall  affix  the  CE  marking  according  to  the  applicable 
requirements of the legislative instrument. 

The  manufacturer  shall  draw  up  a  written  declaration  of  conformity  for  a  product 
model  and  keep  it  with  the  technical  documentation  at  the  disposal  of  the  national 
authorities  for  a  period  of  10  years16  after  the  last  product  has  been  manufactured. 
The declaration of conformity shall identify the product for which it has been drawn 
up. 

a general description of the product, 
conceptual  design  and  manufacturing  drawings  and  schemes  of  components,  sub-assemblies,  circuits, 

The content of the technical documentation shall be laid down in the specific legislative instrument in accordance 
with the products concerned.   
For example, the documentation must contain so far as relevant for assessment:  
- 
- 
etc., 
- 
operation of the product, 
- 
a list of the harmonised standards the references of which have been published in the OJEU, applied in 
full or in part, and descriptions of the solutions adopted to meet the essential requirements of the directive where 
these harmonised standards have not been applied, 
- 
- 
The specific legislative instruments may alter this period. 

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

descriptions  and  explanations  necessary  for  the  understanding  of  said  drawings  and  schemes  and  the 

EN 

35 

   EN 

 
                                                 
 
 
 
 
 
A copy of the declaration of conformity shall be supplied with each product that is 
made  available  on  the  market.  However,  this  requirement  may  be  interpreted  as 
applying to a batch or consignment rather than to individual products in those cases 
where a large number of products is delivered to a single user. 

5. 

Authorised representative 

The manufacturer’s obligations contained in points 4 may be fulfilled, on his behalf 
and under his responsibility, by his authorised representative. 

Module A1 
Internal production control plus supervised product testing 

1. 

Internal  production  control  plus  supervised  product  testing  is  the  conformity 
assessment procedure whereby the manufacturer fulfils the obligations laid down in 
points  2,  3,  4,  and  5,  and  ensures  and  declares  on  his  sole  responsibility  that  the 
products concerned satisfy the requirements of the legislative instrument that apply 
to them. 

2. 

Technical documentation 

The  manufacturer  shall  establish  the  technical  documentation  as  described  in  the 
legislative instrument. The documentation shall enable the assessment of the product 
for  its  conformity  with  the  relevant  requirements,  and  shall  include  an  adequate 
analysis and assessment of the risk(s). The technical documentation shall specify the 
applicable requirements and cover, as far as relevant for the assessment, the design, 
manufacture and operation of the product17. 

3. 

Manufacturing 

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

4. 

Product checks 

For each individual product manufactured, one or more tests on one or more specific 
aspects  of  the  product  shall  be  carried  out  by  the  manufacturer  or  on  his  behalf,  in 

17 

a general description of the product, 
conceptual  design  and  manufacturing  drawings  and  schemes  of  components,  sub-assemblies,  circuits, 

The content of the technical documentation shall be laid down in the specific legislative instrument in accordance 
with the products concerned.   
For example, the documentation must contain so far as relevant for assessment:  
- 
- 
etc., 
- 
operation of the product, 
- 
a list of the harmonised standards the references of which have been published in the OJEU, applied in 
full or in part, and descriptions of the solutions adopted to meet the essential requirements of the directive where 
these harmonised standards have not been applied, 
- 
- 

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

descriptions  and  explanations  necessary  for  the  understanding  of  said  drawings  and  schemes  and  the 

EN 

36 

   EN 

 
                                                 
 
 
 
 
 
order  to  verify  conformity  with  the  corresponding  requirements  of  the  legislative 
instrument18. At the choice of the manufacturer19, the tests are carried out either by 
an accredited in-house body or under the responsibility of a notified body, chosen by 
the manufacturer. 

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

5. 

CE marking and declaration of conformity 

5.1. 

5.2. 

The  manufacturer  shall  affix  the  CE  marking  according  to  the  applicable 
requirements of the legislative instrument. 

The  manufacturer  shall  draw  up  a  written  declaration  of  conformity  for  a  product 
model  and  keep  it  with  the  technical  documentation  at  the  disposal  of  the  national 
authorities  for  a  period  of  10  years20  after  the  last  product  has  been  manufactured. 
The declaration of conformity shall identify the product for which it has been drawn 
up. 

A copy of the declaration of conformity shall be supplied with each product that is 
made  available  on  the  market.  However,  this  requirement  may  be  interpreted  as 
applying to a batch or consignment rather than to individual products in those cases 
where a large number of products is delivered to a single user. 

6. 

Authorised representative 

The manufacturer’s obligations contained in point 5 may be fulfilled, on  his behalf 
and under his responsibility, by his authorised representative. 

Module A2 
Internal production control plus supervised product checks at random intervals 

1. 

Internal production control plus supervised product checks at random intervals is the 
conformity  assessment  procedure  whereby  the  manufacturer  fulfils  the  obligations 
laid down in points 2, 3, 4, and 5, and ensures and declares on his sole responsibility 
that the products concerned satisfy the requirements of the legislative instrument that 
apply to them. 

2. 

Technical documentation 

The  manufacturer  shall  establish  the  technical  documentation  as  described  in  the 
legislative instrument. The documentation shall enable the assessment of the product 
for  its  conformity  with  the  relevant  requirements,  and  shall  include  an  adequate 
analysis and assessment of the risk(s). The technical documentation shall specify the 

18 
19 
20 

The legislative instrument must specify the products concerned and the tests to be carried out 
The choice may be limited by the specific legislative instrument 
The specific legislative instruments may alter this period. 

EN 

37 

   EN 

 
                                                 
applicable requirements and cover, as far as relevant for the assessment, the design, 
manufacture and operation of the product21. 

3. 

Manufacturing 

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

4. 

Product checks 

At the choice of the manufacturer22, either an accredited in-house body or a notified 
body,  chosen  by  the  manufacturer,  shall  carry  out  product  checks  or  have  them 
carried out at random intervals determined by the body, in order to verify the quality 
of the internal checks of the product, taking into account inter alia the technological 
complexity  of  the  products  and  the  quantity  of  production.  An  adequate  sample  of 
the final products, taken on site by the body before the placing on the market, shall 
be  examined  and  appropriate  tests  as  identified  by  the  relevant  parts  of  the 
harmonised  standard  and/or  technical  specifications,  or  equivalent  tests,  shall  be 
carried out to check the conformity of the product with the appropriate requirements 
of the legislative instrument. 

The  acceptance  sampling  procedure  to  be  applied  is  intended  to  determine  whether 
the manufacturing process of the product at hand performs within acceptable limits. 
The appropriate tests, the adequate sampling schemes and the corresponding action 
to  be  taken  by  the  body  and/or  the  manufacturer  shall  be  defined  by  the  specific 
legislative instrument. 

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

5. 

CE marking and declaration of conformity 

5.1. 

The  manufacturer  shall  affix  the  CE  marking  according  to  the  applicable 
requirements of the legislative instrument. 

21 

22 

a general description of the product, 
conceptual  design  and  manufacturing  drawings  and  schemes  of  components,  sub-assemblies,  circuits, 

The content of the technical documentation shall be laid down in the specific legislative instrument in accordance 
with the products concerned.   
For example, the documentation must contain so far as relevant for assessment:  
- 
- 
etc., 
- 
operation of the product, 
- 
a list of the harmonised standards the references of which have been published in the OJEU, applied in 
full or in part, and descriptions of the solutions adopted to meet the essential requirements of the directive where 
these harmonised standards have not been applied, 
- 
- 
The choice may be limited by the specific legislative instrument. 

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

descriptions  and  explanations  necessary  for  the  understanding  of  said  drawings  and  schemes  and  the 

EN 

38 

   EN 

 
                                                 
 
 
 
 
 
5.2. 

The  manufacturer  shall  draw  up  a  written  declaration  of  conformity  for  a  product 
model  and  keep  it  with  the  technical  documentation  at  the  disposal  of  the  national 
authorities for a period of 10 years23 after the last product has been manufactured. 
The declaration of conformity shall identify the product for which it has been drawn 
up. 

A copy of the declaration of conformity shall be supplied with each product that is 
made  available  on  the  market.  However,  this  requirement  may  be  interpreted  as 
applying to a batch or consignment rather than to individual products in those cases 
where a large number of products is delivered to a single user. 

6. 

Authorised representative 

The manufacturer’s obligations contained in point 5 may be fulfilled, on  his behalf 
and under his responsibility, by his authorised representative. 

Module B 
EC type examination 

1. 

2. 

EC Type examination  is that  part  of  a conformity assessment procedure whereby a 
notified body examines the technical design of a product and verifies and attests that 
the  technical  design  of  the  product  meets  the  requirements  of  the  legislative 
instrument that apply to it. 

EC  Type  examination  may  be  carried  out  in  either  of  the  following  manners.  The 
specific  legislative  instrument  shall  determine  the  appropriate  manner  and  the 
specimens required: 

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

complete product (production type); 

–  assessment  of  the  adequacy  of  the  technical  design  of  the  product  through 
examination of the technical documentation and supporting evidence referred to in 
point  3,  plus  examination  of  specimens,  representative  of  the  production 
envisaged, of one or more critical parts of the product (combination of production 
type and design type); 

–  assessment  of  the  adequacy  of  the  technical  design  of  the  product  through 
examination of the technical documentation and supporting evidence referred to in 
point 3, without examination of a specimen (design type). 

3. 

The application for EC type examination shall be lodged by the manufacturer with a 
single notified body of his choice. 

The application shall include: 

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

authorised representative, his name and address in addition; 

23 

The specific legislative instruments may alter this period. 

EN 

39 

   EN 

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

notified body; 

–  the  technical  documentation,  as  described  in  the  legislative  instrument.  The 
technical  documentation  shall  enable  the  assessment  of  the  product  for  its 
conformity with the applicable requirements of the legislative instrument 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 
product24; 

–  the  specimens,  representative  of  the  production  envisaged,  as  required  by  the 
specific legislative instrument. The notified body may request further specimens if 
needed for carrying out the test programme; 

–  the  supporting  evidence  for  the  adequacy  of  the  technical  design  solution.  This 
supporting evidence shall mention any relevant documents that have been applied, 
in  particular  where 
technical 
specifications  have  not  been  applied  in  full.  The  supporting  evidence  shall 
include,  where  necessary,  the  results  of  tests  carried  out  by  the  appropriate 
laboratory of the manufacturer, or by another testing laboratory on his behalf and 
under his responsibility. 

the  relevant  harmonised  standards  and/or 

4. 

The notified body shall: 

For the product: 

4.1. 

examine the technical documentation and supporting evidence to assess the adequacy 
of the technical design of the product;  

4.2. 

24 

For the specimen(s): 

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

The content of the technical documentation must be laid down in the specific legislative instrument in 
accordance with the products concerned. 
For example, the documentation must contain as far as is relevant for assessment:  
- a general type-description,  
- conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, 
etc.,  
- descriptions and explanations necessary for the understanding of said drawings and schemes and the 
operation of the product,  
- a list of the harmonized standards the references of which have been published in the OJEU, applied in 
full  or  in  part,  and  descriptions  of  the  solutions  adopted  to  meet  the  essential  requirements  of  the 
directive where these harmonized standards have not been applied,  
- results of design calculations made, examinations carried out, etc.,  
- test reports. 

EN 

40 

   EN 

 
                                                 
 
 
 
 
 
 
 
4.3. 

4.4. 

carry out the appropriate examinations and tests, or have them carried out, to check 
whether,  where  the  manufacturer  has  chosen  to  apply  the  solutions  in  the  relevant 
harmonised  standards  and/or  technical  specifications,  these  have  been  applied 
correctly; 

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

4.5. 

agree with the applicant manufacturer the location where the examinations and tests 
shall be carried out. 

5. 

6. 

7. 

8. 

25 

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

Where  the  type  meets  the  requirements  of  the  specific  legislative  instrument  that 
apply to the product concerned, the notified body shall issue an EC-type examination 
certificate to the manufacturer. The certificate shall contain the name and address of 
the manufacturer, conclusions of the examination, conditions (if any) for its validity 
and the necessary data for identification of the approved type25. The certificate may 
have one or more annexes attached. 

The  certificate  and  its  annexes  shall  contain  all  relevant  information  to  allow  the 
conformity of manufactured products to be evaluated with the examined type. 

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

The  notified  body  shall  keep  itself  appraised  of  any  changes  of  the  generally 
acknowledged state of the art which indicate that the approved type may no longer 
comply  with  the  applicable  requirements  of  the  legislative  instrument,  and  shall 
determine  whether  such  changes  require  further  investigations.  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 EC-type examination certificate of all modifications to 
the  approved  type  that  may  affect  the  conformity  of  the  product  with  the  essential 
requirements  of  the  legislative  instrument  or  the  conditions  for  validity  of  the 
certificate. Such modifications require additional approval in the form of an addition 
to the original EC-type examination certificate. 

Each  notified  body  shall  inform  its  notifying  authorities  about  the  EC-type 
examination  certificates  and/or  any  additions  thereto  which  it  has  issued  or 
withdrawn,  and  shall,  periodically  or  upon  request,  make  available  to  its  notifying 

The specific legislative instruments may provide for the certificate to have a period of validity. 

EN 

41 

   EN 

 
                                                 
authorities the list of certificates and/or any additions thereto refused, suspended or 
otherwise restricted26. 

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

The Commission, the Member States and the other notified bodies may, on reasoned 
request, obtain a copy of the EC-type examination certificates and/or their additions. 
On reasoned request, the Commission and the Member States may obtain a copy of 
the  technical  documentation  and  the  results  of  the  examinations  carried  out  by  the 
notified  body.  The  notified  body  shall  hold  a  copy  of  the  EC-type  examination 
certificate,  its  annexes  and  additions,  as  well  as  the  technical  file  including  the 
documentation  submitted  by  the  manufacturer  for  a  period  up  to  the  end  of  the 
validity of the certificate27. 

9. 

The  manufacturer  shall  keep  a  copy  of  the  EC-type  examination  certificate,  its 
annexes and additions together with the technical documentation for a period of 10 
years28  after  the  last  product  has  been  manufactured  at  the  disposal  of  the  national 
authorities. 

10. 

The manufacturer’s authorised representative may lodge the application referred to in 
point 3 and carry out the obligations mentioned in points 7 and 9. 

Module C 
Conformity to type based on internal production control 

1. 

Conformity to type based on internal production control is that 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  products  concerned  are  in 
conformity  with  the  type  as  described  in  the  EC-type  examination  certificate  and 
satisfy the requirements of the legislative instrument that apply to them. 

2. 

Manufacturing 

The manufacturer shall take all measures necessary in order that the manufacturing 
process and its monitoring ensure conformity of the manufactured products with the 
approved  type  as  described  in  the  EC-type  examination  certificate  and  with  the 
requirements of the legislative instrument that apply to them. 

3. 

CE marking and declaration of conformity 

3.1. 

The  manufacturer  shall  affix  the  CE  marking  to  each  individual  product  that  is  in 
conformity  with  the  type  as  described  in  the  EC-type  examination  certificate  and 
satisfies the applicable requirements of the legislative instrument. 

26 
27 
28 

The specific legislative instruments may provide for different arrangements. 
The specific legislative instruments may alter this period. 
The specific legislative instruments may alter this period. 

EN 

42 

   EN 

 
                                                 
3.2. 

The  manufacturer  shall  draw  up  a  written  declaration  of  conformity  for  a  product 
model and keep it at the disposal of the national authorities for a period of 10 years29 
after  the  last  product  has  been  manufactured.  The  declaration  of  conformity  shall 
identify the product model for which it has been drawn up. 

A copy of the declaration of conformity shall be supplied with each product that is 
made  available  on  the  market.  However,  this  requirement  may  be  interpreted  as 
applying to a batch or consignment rather than to individual products in those cases 
where a large number of products is delivered to a single user. 

4. 

Authorised representative 

The manufacturer’s obligations contained in point 3 may be fulfilled, on  his behalf 
and under his responsibility, by his authorised representative. 

Module C1 
Conformity to type based on internal production control plus supervised product testing  

1. 

Conformity  to  type  based  on  internal  production  control  plus  supervised  product 
testing is that part of a conformity assessment procedure whereby the manufacturer 
fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his 
sole  responsibility  that  the  products  concerned  are  in  conformity  with  the  type  as 
described in the EC-type examination certificate and satisfy the requirements of the 
legislative instrument that apply to them. 

2. 

Manufacturing 

The manufacturer shall take all measures necessary in order that the manufacturing 
process and its monitoring ensure conformity of the manufactured products with the 
type as described in the EC-type examination certificate and with the requirements of 
the specific legislative instrument that apply to them. 

3. 

Product checks 

For each individual product manufactured one or more tests on one or more specific 
aspects  of  the  product  shall  be  carried  out  by  the  manufacturer  or  on  his  behalf,  in 
order  to  verify  conformity  with  the  corresponding  requirements  of  the  legislative 
instrument30. At the choice of the manufacturer, the tests are carried out either by an 
accredited in-house body or on the responsibility of a notified body, chosen by the 
manufacturer. 

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

4. 

CE marking and declaration of conformity 

29 
30 

The specific legislative instruments may alter this period. 
The legislative instrument must specify the products concerned and the tests to be carried out. 

EN 

43 

   EN 

 
                                                 
4.1. 

4.2. 

The  manufacturer  shall  affix  the  CE  marking  to  each  individual  product  that  is  in 
conformity  with  the  type  as  described  in  the  EC-type  examination  certificate  and 
satisfies the applicable requirements of the legislative instrument. 

The  manufacturer  shall  draw  up  a  written  declaration  of  conformity  for  a  product 
model and keep it at the disposal of the national authorities for a period of 10 years31 
after  the  last  product  has  been  manufactured.  The  declaration  of  conformity  shall 
identify the product model for which it has been drawn up. 

A copy of the declaration of conformity shall be supplied with each product that is 
made  available  on  the  market.  However,  this  requirement  may  be  interpreted  as 
applying to a batch or consignment rather than to individual products in those cases 
where a large number of products is delivered to a single user. 

5. 

Authorised representative 

The manufacturer’s obligations contained in point 4 may be fulfilled, on  his behalf 
and under his responsibility, by his authorised representative. 

Module C2 
Conformity to type based on internal production control plus supervised product checks at 
random intervals  

1. 

Conformity  to  type  based  on  internal  production  control  plus  supervised  product 
checks  at  random  intervals  is  that  part  of  a  conformity  assessment  procedure 
whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and 
ensures  and  declares  on  his  sole  responsibility  that  the  products  concerned  are  in 
conformity  with  the  type  as  described  in  the  EC-type  examination  certificate  and 
satisfy the requirements of the legislative instrument that apply to them. 

2. 

Manufacturing 

The manufacturer shall take all measures necessary in order that the manufacturing 
process and its monitoring ensure conformity of the manufactured products with the 
type as described in the EC-type examination certificate and with the requirements of 
the specific legislative instrument that apply to them. 

3. 

Product checks 

At the choice of the manufacturer32, either an accredited in-house body or a notified 
body,  chosen  by  the  manufacturer,  shall  carry  out  product  checks  or  have  them 
carried out at random intervals determined by the body, in order to verify the quality 
of the internal checks of the product, taking into account inter alia the technological 
complexity  of  the  products  and  the  quantity  of  production.  An  adequate  sample  of 
the  final  products,  taken  on  site  by  the  notified  body  before  the  placing  on  the 
market, shall be examined and appropriate tests as identified by the relevant parts of 
the harmonised standards and/or technical specifications, or equivalent tests, shall be 

31 
32 

The specific legislative instruments may alter this period. 
The choice may be milited by the specific legislative insturment. 

EN 

44 

   EN 

 
                                                 
carried out to check the conformity of the product with the appropriate requirements 
of the legislative instrument.  

The acceptance sampling procedure to be applied is designed to determine whether 
the manufacturing process of the product at hand performs within acceptable limits. 
The appropriate tests, the adequate sampling schemes and the corresponding action 
to  be  taken  by  the  manufacturer  shall  be  defined  by  the  specific  legislative 
instrument. 

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

4. 

CE marking and declaration of conformity 

4.1. 

4.2. 

The  manufacturer  shall  affix  the  CE  marking  to  each  individual  product  that  is  in 
conformity  with  the  type  as  described  in  the  EC-type  examination  certificate  and 
satisfies the applicable requirements of the legislative instrument. 

The  manufacturer  shall  draw  up  a  written  declaration  of  conformity  for  a  product 
model and keep it at the disposal of the national authorities for a period of 10 years33 
after  the  last  product  has  been  manufactured.  The  declaration  of  conformity  shall 
identify the product model for which it has been drawn up. 

A copy of the declaration of conformity shall be supplied with each product that is 
made  available  on  the  market.  However,  this  requirement  may  be  interpreted  as 
applying to a batch or consignment rather than to individual products in those cases 
where a large number of products is delivered to a single user. 

5. 

Authorised representative 

The manufacturer’s obligations contained in point 4 may be fulfilled, on  his behalf 
and under his responsibility, by his authorised representative. 

Module D 
Conformity to type based on quality assurance of the production process 

1. 

Conformity to type based on quality assurance of the production process is the part 
of  a  conformity  assessment  procedure  whereby  the  manufacturer  fulfils  the 
obligations  laid  down  in  points  2  and  5,  and  ensures  and  declares  on  his  sole 
responsibility  that  the  products  concerned  are  in  conformity  with  the  type  as 
described in the EC-type examination certificate and satisfy the requirements of the 
legislative instrument that apply to them. 

2. 

Manufacturing 

33 

The specific legislative instruments may alter this period. 

EN 

45 

   EN 

 
                                                 
The  manufacturer  shall  operate  an  approved  quality  system  for  production,  final 
product inspection and testing of the products concerned as specified in point 3 and 
is subject to surveillance as specified in point 4. 

3. 

Quality system 

3.1. 

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

The application shall include: 

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

authorised representative, his name and address in addition; 

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

notified body; 

–  all relevant information for the product category envisaged; 

–  the documentation concerning the quality system; 

–  the  technical  documentation  of  the  approved  type  and  a  copy  of  the  EC-type 

examination certificate. 

3.2. 

The  quality  system  shall  ensure  compliance  of  the  products  with  the  type  as 
described  in  the  EC-type  examination  certificate  and  with  the  requirements  of  the 
legislative instrument that apply to them. 

All the elements, requirements and provisions adopted by the manufacturer shall be 
documented  in  a  systematic  and  orderly  manner  in  the  form  of  written  policies, 
procedures  and  instructions.  The  quality  system  documentation  must  permit  a 
consistent interpretation of the quality programmes, plan, manuals and records. 

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

–  the quality objectives and the organisational structure, responsibilities and powers 

of the management with regard to product quality; 

–  the  corresponding  manufacturing,  quality  control  and  quality  assurance 

techniques, processes and systematic actions that will be used; 

–  the  examinations  and  tests  that  will  be  carried  out  before,  during  and  after 

manufacture, and the frequency with which they will be carried out; 

–  the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data, 

qualification reports of the personnel concerned, etc.; 

–  the means of monitoring the achievement of the required product quality and the 

effective operation of the quality system. 

3.3. 

The notified body shall assess the quality system to determine whether it satisfies the 
requirements referred to in point 3.2.  

EN 

46 

   EN 

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

In  addition  to  experience  in  quality  management  systems,  the  auditing  team  shall 
have at least one member with experience of evaluation in the relevant product field 
and product technology concerned, and knowledge of the applicable requirements of 
the  legislative  instrument.  The  audit  shall  include  an  assessment  visit  to  the 
manufacturer’s  premises.  The  auditing 
technical 
documentation  referred  to  in  point  3.1.,  fifth  indent  to  verify  the  manufacturer’s 
ability to identify the relevant requirements of the legislative instrument and to carry 
out the necessary examinations in view of ensuring compliance of the product with 
these requirements. 

team  shall 

review 

the 

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

3.4. 

3.5. 

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

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

The  notified  body  shall  evaluate  the  proposed  changes  and  decide  whether  the 
modified quality system will continue to satisfy the requirements referred to in point 
3.2, or whether a re-assessment is necessary. 

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

4. 

Surveillance under the responsibility of the notified body 

4.1. 

4.2. 

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

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

–  the quality system documentation, 

–  the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data, 

qualification reports of the personnel concerned, etc. 

4.3. 

The notified body shall carry out periodic34 audits to make sure that the manufacturer 
maintains  and  applies  the  quality  system  and  shall  provide  an  audit  report  to  the 
manufacturer. 

34 

In the specific legislative instruments, the frequency may be specified. 

EN 

47 

   EN 

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

5. 

CE marking and declaration of conformity 

5.1. 

5.2. 

The  manufacturer  shall  affix  the  CE  marking,  and,  under  the  responsibility  of  the 
notified body referred  to  in  point  3.1.,  the  latter’s  identification  number  to  each 
individual  product  that  is  in  conformity  with  the  type  as  described  in  the  EC-type 
examination  certificate  and  satisfies  the  applicable  requirements  of  the  legislative 
instrument. 

The manufacturer shall draw up a written declaration of conformity for each product 
model and keep it at the disposal of the national authorities for a period of 10 years35 
after  the  last  product  has  been  manufactured.  The  declaration  of  conformity  shall 
identify the product model for which it has been drawn up. 

A copy of the declaration of conformity shall be supplied with each product that is 
made  available  on  the  market.  However,  this  requirement  may  be  interpreted  as 
applying to a batch or consignment rather than to individual products in those cases 
where a large number of products is delivered to a single user. 

6. 

The manufacturer shall, for a period ending at least 10 years36 after the last product 
has been manufactured, keep at the disposal of the national authorities:  

–  the documentation referred to in point 3.1.; 

–  the change referred to in point 3.5., as approved; 

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

4.4. 

7. 

Each  notified  body  shall  inform  its  notifying  authorities  of  the  quality  system 
approvals  issued  or  withdrawn,  and  shall,  periodically  or  upon  request,  make 
available  to  its  notifying  authorities  the  list  of  quality  system  approvals  refused, 
suspended or otherwise restricted37. 

Each  notified  body  shall  inform  the  other  notified  bodies  of  the  quality  system 
approvals  which  it  has  refused,  suspended  or  withdrawn,  and,  upon  request,  of  the 
quality system approvals which it has issued. 

8. 

Authorised representative 

The  manufacturer’s  obligations  contained  in  points  3.1.,  3.5.,  5  and  6  may  be 
fulfilled, on his behalf and under his responsibility, by his authorised representative. 

35 
36 
37 

The specific legislative instruments may alter this period. 
The specific legislative instruments may alter this period. 
The specific legislative instruments may provide for different arrangements. 

EN 

48 

   EN 

 
                                                 
Module D1 
Quality assurance of the production process 

1. 

Quality assurance of the production process is the conformity assessment procedure 
whereby the manufacturer fulfils the obligations laid down in points 2, 4 and 7, and 
ensures and declares on his sole responsibility that the products concerned satisfy the 
requirements of the legislative instrument that apply to them.  

2. 

Technical documentation 

The  manufacturer  shall  establish  the  technical  documentation  as  described  in  the 
legislative instrument. The documentation shall enable the assessment of the product 
for  its  conformity  with  the  relevant  requirements,  and  shall  include  an  adequate 
analysis and assessment of the risk(s). The technical documentation shall specify the 
applicable requirements and cover, as far as relevant for the assessment, the design, 
manufacture and operation of the product38. 

3. 

The  manufacturer  shall  keep  the  technical  documentation  at  the  disposal  of  the 
relevant national authorities for a period of 10 years39 after the last product has been 
manufactured. 

4. 

Manufacturing 

The  manufacturer  shall  operate  an  approved  quality  system  for  production,  final 
product inspection and testing of the products concerned as specified in point 5 and 
is subject to surveillance as specified in point 6. 

5. 

Quality system 

5.1. 

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

The application shall include: 

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

authorised representative, his name and address in addition; 

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

notified body; 

38 

39 

a general description of the product, 
conceptual  design  and  manufacturing  drawings  and  schemes  of  components,  sub-assemblies,  circuits, 

The content of the technical documentation shall be laid down in the specific legislative instrument in accordance 
with the products concerned.   
For example, the documentation must contain so far as relevant for assessment:  
- 
- 
etc., 
- 
operation of the product, 
- 
a list of the harmonised standards the references of which have been published in the OJEU, applied in 
full or in part, and descriptions of the solutions adopted to meet the essential requirements of the directive where 
these harmonised standards have not been applied, 
- 
- 
The specific legislative instruments may alter this period. 

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

descriptions  and  explanations  necessary  for  the  understanding  of  said  drawings  and  schemes  and  the 

EN 

49 

   EN 

 
                                                 
 
 
 
 
 
–  all relevant information for the product category envisaged, 

–  the documentation concerning the quality system, 

–  the technical documentation referred to in point 2. 

5.2. 

The quality system shall ensure compliance of the products with the requirements of 
the legislative instrument that apply to them. 

All the elements, requirements and provisions adopted by the manufacturer shall be 
documented  in  a  systematic  and  orderly  manner  in  the  form  of  written  policies, 
procedures  and  instructions.  The  quality  system  documentation  must  permit  a 
consistent interpretation of the quality programmes, plan, manuals and records. 

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

–  the quality objectives and the organisational structure, responsibilities and powers 

of the management with regard to product quality; 

–  the  corresponding  manufacturing,  quality  control  and  quality  assurance 

techniques, processes and systematic actions that will be used; 

–  the  examinations  and  tests  that  will  be  carried  out  before,  during  and  after 

manufacture, and the frequency with which they will be carried out; 

–  the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data, 

qualification reports of the personnel concerned, etc.; 

–  the means of monitoring the achievement of the required product quality and the 

effective operation of the quality system. 

5.3. 

The notified body shall assess the quality system to determine whether it satisfies the 
requirements referred to in point 5.2. 

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

In  addition  to  experience  in  quality  management  systems,  the  auditing  team  shall 
have at least one member with experience of evaluation in the relevant product field 
and product technology concerned, and knowledge of the applicable requirements of 
the  legislative  instrument.  The  audit  shall  include  an  assessment  visit  to  the 
manufacturer’s  premises.  The  auditing 
technical 
documentation referred to in point 2 to verify the manufacturer’s ability to identify 
the relevant requirements of the legislative instrument and to carry out the necessary 
examinations in view of ensuring compliance of the product with these requirements. 

team  shall 

review 

the 

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

EN 

50 

   EN 

 
5.4. 

5.5. 

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

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

The  notified  body  shall  evaluate  the  proposed  changes  and  decide  whether  the 
modified quality system will continue to satisfy the requirements referred to in point 
5.2, or whether a re-assessment is necessary. 

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

6. 

Surveillance under the responsibility of the notified body 

6.1. 

6.2. 

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

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

–  the quality system documentation, 

–  the technical documentation referred to in point 2, 

–  the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data, 

qualification reports of the personnel concerned, etc. 

6.3. 

The notified body shall carry out periodic40 audits to make sure that the manufacturer 
maintains  and  applies  the  quality  system  and  shall  provide  an  audit  report  to  the 
manufacturer. 

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

7. 

CE marking and declaration of conformity 

7.1. 

The  manufacturer  shall  affix  the  CE  marking,  and,  under  the  responsibility  of  the 
notified  body  referred  to  in  point  5.1.,  the  latter’s  identification  number  to  each 
individual  product  that  satisfies  the  applicable  requirements  of  the  legislative 
instrument. 

7.2. 

The manufacturer shall draw up a written declaration of conformity for each product 
model and keep it at the disposal of the national authorities for a period of 10 years41 

40 
41 

In the specific legislative instruments, the frequency may be specified. 
The specific legislative instruments may alter this period. 

EN 

51 

   EN 

 
                                                 
after  the  last  product  has  been  manufactured.  The  declaration  of  conformity  shall 
identify the product model for which it has been drawn up. 

A copy of the declaration of conformity shall be supplied with each product that is 
made  available  on  the  market.  However,  this  requirement  may  be  interpreted  as 
applying to a batch or consignment rather than to individual products in those cases 
where a large number of products is delivered to a single user. 

8. 

The manufacturer shall, for a period ending at least 10 years42 after the last product 
has been manufactured, keep at the disposal of the national authorities:  

–  the documentation referred to in point 5.1.; 

–  the change referred to in point 5.5., as approved; 

–  the decisions and reports from the notified body referred to in points 5.5., 6.3. and 

6.4.  

9. 

Each  notified  body  shall  inform  its  notifying  authorities  of  the  quality  system 
approvals  issued  or  withdrawn,  and  shall,  periodically  or  upon  request,  make 
available  to  its  notifying  authorities  the  list  of  quality  system  approvals  refused, 
suspended or otherwise restricted43. 

Each  notified  body  shall  inform  the  other  notified  bodies  of  the  quality  system 
approvals  which  it  has  refused,  suspended  or  withdrawn,  and,  upon  request,  of  the 
quality system approvals which it has issued. 

10. 

Authorised representative 

The  manufacturer’s  obligations  contained  in  points  3,  5.1.,  5.5.,  7  and  8  may  be 
fulfilled, on his behalf and under his responsibility, by his authorised representative. 

Module E 
Conformity to type based on product quality assurance 

1. 

Conformity  to  type  based  on  product  quality  assurance  is  that  part  of  a  conformity 
assessment procedure whereby the manufacturer fulfils the obligations laid down in 
points 2 and 5, and ensures and declares on his sole responsibility that the products 
concerned are in conformity with the type as described in the EC-type examination 
certificate  and  satisfy  the  requirements  of  the  legislative  instrument  that  apply  to 
them. 

2. 

Manufacturing 

The  manufacturer  shall  operate  an  approved  quality  system  for  final  product 
inspection and testing of the products concerned as specified in point 3 and shall be 
subject to surveillance as specified in point 4. 

42 
43 

The specific legislative instruments may alter this period. 
The specific legislative instruments may provide for different arrangements. 

EN 

52 

   EN 

 
                                                 
3. 

Quality system 

3.1. 

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

The application shall include: 

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

authorised representative, his name and address in addition; 

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

notified body; 

–  all relevant information for the product category envisaged;  

–  the documentation concerning the quality system;  

–  the  technical  documentation  of  the  approved  type  and  a  copy  of  the  EC-type 

examination certificate.  

3.2. 

The  quality  system  shall  ensure  compliance  of  the  products  with  the  type  as 
described 
the  applicable 
the  EC-type  examination  certificate  and  with 
requirements of the legislative instrument.  

in 

All the elements, requirements and provisions adopted by the manufacturer shall be 
documented  in  a  systematic  and  orderly  manner  in  the  form  of  written  policies, 
procedures  and  instructions.  The  quality  system  documentation  must  permit  a 
consistent interpretation of the quality programmes, plan, manuals and records.  

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

–  the quality objectives and the organisational structure, responsibilities and powers 

of the management with regard to product quality; 

–  the examinations and tests that will be carried out after manufacture; 

–  the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data, 

qualification reports of the personnel concerned, etc.; 

–  the means of monitoring the effective operation of the quality system. 

3.3. 

The notified body shall assess the quality system to determine whether it satisfies the 
requirements referred to in point 3.2.  

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

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

EN 

53 

   EN 

 
the  legislative  instrument.  The  audit  shall  include  an  assessment  visit  to  the 
technical 
manufacturer’s  premises.  The  auditing 
documentation  referred  to  in  point  3.1.,  fifth  indent  to  verify  the  manufacturer’s 
ability to identify the relevant requirements of the legislative instrument and to carry 
out the necessary examinations in view of ensuring compliance of the product with 
these requirements. 

team  shall 

review 

the 

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

3.4. 

3.5. 

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

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

The  notified  body  shall  evaluate  the  proposed  changes  and  decide  whether  the 
modified quality system will continue to satisfy the requirements referred to in point 
3.2, or whether a re-assessment is necessary.  

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

4. 

Surveillance under the responsibility of the notified body 

4.1. 

4.2. 

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

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

–  the quality system documentation, 

–  the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data, 

qualification reports of the personnel concerned, etc. 

4.3. 

The notified body shall carry out periodic44 audits to make sure that the manufacturer 
maintains  and  applies  the  quality  system  and  shall  provide  an  audit  report  to  the 
manufacturer. 

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

5. 

CE marking and declaration of conformity 

44 

In the specific legislative instruments, the frequency may be specified. 

EN 

54 

   EN 

 
                                                 
5.1. 

5.2. 

The  manufacturer  shall  affix  the  CE  marking,  and,  under  the  responsibility  of  the 
notified  body  referred  to  in  point  3.1.,  the  latter’s  identification  number  to  each 
individual  product  that  is  in  conformity  with  the  type  as  described  in  the  EC-type 
examination  certificate  and  satisfies  the  applicable  requirements  of  the  legislative 
instrument. 

The manufacturer shall draw up a written declaration of conformity for each product 
model and keep it at the disposal of the national authorities for a period of 10 years45 
after  the  last  product  has  been  manufactured.  The  declaration  of  conformity  shall 
identify the product model for which it has been drawn up. 

A copy of the declaration of conformity shall be supplied with each product that is 
made  available  on  the  market.  However,  this  requirement  may  be  interpreted  as 
applying to a batch or consignment rather than to individual products in those cases 
where a large number of products is delivered to a single user. 

6. 

The manufacturer shall, for a period ending at least 10 years46 after the last product 
has been manufactured, keep at the disposal of the national authorities:  

–  the documentation referred to in point 3.1.; 

–  the change referred to in point 3.5., as approved; 

–  the  decisions  and  reports  from  the  notified  body  referred  to  in  points  3.5.  final 

subparagraph, point 4.3. and point 4.4.  

7. 

Each  notified  body  shall  inform  its  notifying  authorities  of  the  quality  system 
approvals  issued  or  withdrawn,  and  shall,  periodically  or  upon  request,  make 
available  to  its  notifying  authorities  the  list  of  quality  system  approvals  refused, 
suspended or otherwise restricted47. 

Each  notified  body  shall  inform  the  other  notified  bodies  of  the  quality  system 
approvals  which  it  has  refused,  suspended  or  withdrawn,  and,  upon  request,  of  the 
quality system approvals which it has issued. 

8. 

Authorised representative 

The  manufacturer’s  obligations  contained  in  points  3.1.,  3.5.,  5  and  6  may  be 
fulfilled, on his behalf and under his responsibility, by his authorised representative. 

Module E1 
Quality assurance of final product inspection and testing 

Quality  assurance  of  final  product  inspection  and  testing  is  the  conformity 
assessment procedure whereby the manufacturer fulfils the obligations laid down in 

The specific legislative instruments may alter this period. 
The specific legislative instruments may alter this period. 
The specific legislative instruments may provide for different arrangements. 

1. 

45 
46 
47 

EN 

55 

   EN 

 
                                                 
points 2, 4 and 7, and ensures and declares on his sole responsibility that the products 
concerned satisfy the requirements of the legislative instrument that apply to them.  

2. 

Technical documentation 

The  manufacturer  shall  establish  the  technical  documentation  as  described  in  the 
legislative instrument. The documentation shall enable the assessment of the product 
for  its  conformity  with  the  relevant  requirements,  and  shall  include  an  adequate 
analysis and assessment of the risk(s). The technical documentation shall specify the 
applicable requirements and cover, as far as relevant for the assessment, the design, 
manufacture and operation of the product48. 

3. 

The  manufacturer  shall  keep  the  technical  documentation  at  the  disposal  of  the 
relevant national authorities for a period of 10 years49 after the last product has been 
manufactured. 

4. 

Manufacturing 

The  manufacturer  shall  operate  an  approved  quality  system  for  final  product 
inspection and testing of the products concerned as specified in point 5 and is subject 
to surveillance as specified in point 6. 

5. 

Quality system 

5.1. 

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

The application shall include: 

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

authorised representative, his name and address in addition; 

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

notified body; 

–  all relevant information for the product category envisaged,  

–  the documentation concerning the quality system,  

48 

49 

a general description of the product, 
conceptual  design  and  manufacturing  drawings  and  schemes  of  components,  sub-assemblies,  circuits, 

The content of the technical documentation shall be laid down in the specific legislative instrument in accordance 
with the products concerned.   
For example, the documentation must contain so far as relevant for assessment:  
- 
- 
etc., 
- 
operation of the product, 
- 
a list of the harmonised standards the references of which have been published in the OJEU, applied in 
full or in part, and descriptions of the solutions adopted to meet the essential requirements of the directive where 
these harmonised standards have not been applied, 
- 
- 
The specific legislative instruments may alter this period. 

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

descriptions  and  explanations  necessary  for  the  understanding  of  said  drawings  and  schemes  and  the 

EN 

56 

   EN 

 
                                                 
 
 
 
 
 
–  the technical documentation referred to in point 2.  

5.2. 

The quality system shall ensure compliance of the products with the requirements of 
the legislative instrument that apply to them.  

All the elements, requirements and provisions adopted by the manufacturer shall be 
documented  in  a  systematic  and  orderly  manner  in  the  form  of  written  policies, 
procedures  and  instructions.  The  quality  system  documentation  must  permit  a 
consistent interpretation of the quality programmes, plan, manuals and records.  

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

–  the quality objectives and the organisational structure, responsibilities and powers 

of the management with regard to product quality; 

–  the examinations and tests that will be carried out after manufacture; 

–  the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data, 

qualification reports of the personnel concerned, etc.; 

–  the means of monitoring the effective operation of the quality system. 

5.3. 

The notified body shall assess the quality system to determine whether it satisfies the 
requirements referred to in point 5.2.  

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

In  addition  to  experience  in  quality  management  systems,  the  auditing  team  shall 
have at least one member with experience of evaluation in the relevant product field 
and product technology concerned, and knowledge of the applicable requirements of 
the  legislative  instrument.  The  audit  shall  include  an  assessment  visit  to  the 
manufacturer’s  premises.  The  auditing 
technical 
documentation referred to in point 2 to verify the manufacturer’s ability to identify 
the relevant requirements of the legislative instrument and to carry out the necessary 
examinations in view of ensuring compliance of the product with these requirements. 

team  shall 

review 

the 

The decision shall be notified to the manufacturer. The notification shall contain the 
conclusions  of  the  examination  and  the  reasoned  assessment  decision.  An  appeal 
procedure must be available. 

5.4. 

5.5. 

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

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

The  notified  body  shall  evaluate  the  proposed  changes  and  decide  whether  the 
modified quality system will continue to satisfy the requirements referred to in point 
5.2, or whether a re-assessment is necessary.  

EN 

57 

   EN 

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

6. 

Surveillance under the responsibility of the notified body 

6.1. 

6.2. 

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

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

–  the quality system documentation, 

–  the technical documentation referred to in point 2, 

–  the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data, 

qualification reports of the personnel concerned, etc. 

6.3. 

The notified body shall carry out periodic50 audits to make sure that the manufacturer 
maintains  and  applies  the  quality  system  and  shall  provide  an  audit  report  to  the 
manufacturer. 

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

7. 

CE marking and declaration of conformity 

7.1. 

7.2. 

The  manufacturer  shall  affix  the  CE  marking,  and,  under  the  responsibility  of  the 
notified  body  referred  to  in  point  5.1,  the  latter’s  identification  number  to  each 
individual  product  that  satisfies  the  applicable  requirements  of  the  legislative 
instrument. 

The manufacturer shall draw up a written declaration of conformity for each product 
model and keep it at the disposal of the national authorities for a period of 10 years51 
after  the  last  product  has  been  manufactured.  The  declaration  of  conformity  shall 
identify the product model for which it has been drawn up. 

A copy of the declaration of conformity shall be supplied with each product that is 
made  available  on  the  market.  However,  this  requirement  may  be  interpreted  as 
applying to a batch or consignment rather than to individual products in those cases 
where a large number of products is delivered to a single user. 

50 
51 

In the specific legislative instruments, the frequency may be specified. 
The specific legislative instruments may alter this period. 

EN 

58 

   EN 

 
                                                 
8. 

The manufacturer shall, for a period ending at least 10 years52 after the last product 
has been manufactured, keep at the disposal of the national authorities:  

–  the documentation referred to in point 5.1.; 

–  the change referred to in point 5.5., as approved; 

–  the decisions and reports from the notified body referred to in points 5.5., 6.3. and 

6.4.  

9. 

Each  notified  body  shall  inform  its  notifying  authorities  of  the  quality  system 
approvals  issued  or  withdrawn,  and  shall,  periodically  or  upon  request,  make 
available  to  its  notifying  authorities  the  list  of  quality  system  approvals  refused, 
suspended or otherwise restricted53. 

Each  notified  body  shall  inform  the  other  notified  bodies  of  the  quality  system 
approvals  which  it  has  refused,  suspended  or  withdrawn,  and,  upon  request,  of  the 
quality system approvals which it has issued. 

10. 

Authorised representative 

The  manufacturer’s  obligations  contained  in  points  3,  5.1.,  5.5.,  7  and  8  may  be 
fulfilled, on his behalf and under his responsibility, by his authorised representative. 

Module F 
Conformity to type based on product verification 

1. 

Conformity  to  type  based  on  product  verification  is  the  part  of  a  conformity 
assessment procedure whereby the manufacturer fulfils the obligations laid down in 
points 2, 3 and 6, and ensures and declares on his sole responsibility that the products 
that have been subjected to the provisions of point 3 are in conformity with the type 
as  described  in  the  EC-type  examination  certificate  and  satisfy  the  requirements  of 
the legislative instrument that apply to them.  

2. 

Manufacturing 

The manufacturer shall take all measures necessary in order that the manufacturing 
process and its monitoring ensure conformity of the manufactured products with the 
approved  type  as  described  in  the  EC-type  examination  certificate  and  with  the 
requirements of the legislative instrument that apply to them.  

3. 

Verification 

A  notified  body  chosen  by  the  manufacturer  shall  carry  out  the  appropriate 
examinations  and  tests  in  order  to  check  the  conformity  of  the  products  with  the 
approved  type  as  described  in  the  EC-type  examination  certificate  and  the 
appropriate requirements of the legislative instrument. 

52 
53 

The specific legislative instruments may alter this period. 
The specific legislative instruments may provide for different arrangements. 

EN 

59 

   EN 

 
                                                 
The  examinations  and  tests  to  check  the  conformity  of  the  products  with  the 
appropriate  requirements  will  be  carried  out,  at  the  choice  of  the  manufacturer54, 
either  by  examination  and  testing  of  every  product  as  specified  in  point  4,  or  by 
examination and testing of the products on a statistical basis as specified in point 5. 

4. 

Verification of conformity by examination and testing of every product 

4.1. 

All  products  shall  be  individually  examined  and  appropriate  tests  as  set  out  in  the 
relevant  harmonised  standard(s)  and/or  technical  specifications,  or  equivalent  tests, 
shall  be  carried  out  in  order  to  verify  their  conformity  with  the  approved  type  as 
described in the EC-type examination certificate and the appropriate requirements of 
the legislative instrument. In the absence of such a harmonised standard, the notified 
body concerned shall decide on the appropriate tests to be carried out. 

4.2. 

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

The  manufacturer  shall  keep  the  certificates  of  conformity  available  for  inspection 
purposes by the national authorities for a period of 10 years55 after the certification of 
the product. 

5. 

Statistical verification of conformity 

5.1. 

5.2. 

The  manufacturer  shall  take  all  measures  necessary  in  order  for  the  manufacturing 
process and its monitoring to ensure the homogeneity of each lot produced, and shall 
present his products for verification in the form of homogeneous lots. 

A  random  sample  shall  be  drawn  from  each  lot  according  to  the  requirements  of 
point  5.3.  All  products  in  a  sample  shall  be  individually  examined  and  appropriate 
tests as set out in the relevant harmonised standard(s) and/or technical specifications, 
or equivalent tests, shall be carried out in order to ensure their conformity with the 
applicable requirements of the legislative instrument and to determine whether the lot 
is  accepted  or  rejected.  In  the  absence  of  such  a  harmonised  standard,  the  notified 
body concerned shall decide on the appropriate tests to be carried out. 

5.3. 

The statistical procedure shall use the following elements:  

(Relevant elements must be specified here by the legislative instrument, such as the 
statistical method to be applied, the sampling plan with its operational characteristics, 
etc.) 

5.4. 

If  a  lot  is  accepted,  all  products  of  the  lot  are  approved,  except  for  those  products 
from the sample that were found not to satisfy the tests. 

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

54 
55 

The manufacturer's discretion may be limited in the specific legislative instrument. 
The specific legislative instruments may alter this period. 

EN 

60 

   EN 

 
                                                 
The  manufacturer  shall,  on  the  responsibility  of  the  notified  body,  affix  the  latter's 
identification symbol during the manufacturing process.  

The manufacturer shall keep the certificates of conformity available for the national 
authorities for a period of 10 years56 after the certification of the product.  

5.5. 

If a lot is rejected, the notified body or the competent authority shall take appropriate 
measures  to  prevent  the  placing  on  the  market  of  that  lot.  In  the  event  of  frequent 
rejection  of  lots  the  notified  body  may  suspend  the  statistical  verification  and  take 
appropriate measures. 

6. 

CE marking and declaration of conformity 

6.1. 

6.2. 

The  manufacturer  shall  affix  the  CE  marking  to  each  individual  product  that  is  in 
conformity  with  the  approved  type  as  described  in  the  EC-type  examination 
certificate and satisfies the applicable requirements of the legislative instrument. 

The manufacturer shall draw up a written declaration of conformity for each product 
model and keep it at the disposal of the national authorities, for a period of 10 years57 
after  the  last  product  has  been  manufactured.  The  declaration  of  conformity  shall 
identify the product model for which it has been drawn up. 

A copy of the declaration of conformity shall be supplied with each product that is 
made  available  on  the  market.  However,  this  requirement  may  be  interpreted  as 
applying to a batch or consignment rather than to individual products in those cases 
where a large number of products is delivered to a single user. 

If agreed upon by the notified body referred to in point 3, the manufacturer shall also 
affix  the  notified  body’s  identification  number  to  the  products,  under  the 
responsibility of the notified body. 

7. 

The  manufacturer  may,  if  agreed  upon  by  the  notified  body  and  under  its 
responsibility, affix the notified body’s identification number to the products during 
the manufacturing process. 

8. 

Authorised representative 

The  manufacturer’s  obligations  may  be  fulfilled,  on  his  behalf  and  under  his 
responsibility, by his authorised representative, except for the obligations contained 
in points 2 and 5.1. 

Module F1 
Conformity based on product verification 

Conformity  based  on  product  verification  is  the  conformity  assessment  procedure 
whereby  the  manufacturer  fulfils  the  obligations  laid  down  in  points  2,  4,  5  and  8, 
and ensures and declares on his sole responsibility that the products that have been 

The specific legislative instruments may alter this period. 
The specific legislative instruments may alter this period. 

1. 

56 
57 

EN 

61 

   EN 

 
                                                 
subjected to the provisions of point 5 are in conformity with the requirements of the 
legislative instrument that apply to them. 

2. 

Technical documentation 

The  manufacturer  shall  establish  the  technical  documentation  as  described  in  the 
legislative instrument. The documentation shall enable the assessment of the product 
for  its  conformity  with  the  relevant  requirements,  and  shall  include  an  adequate 
analysis and assessment of the risk(s). The technical documentation shall specify the 
applicable requirements and cover, as far as relevant for the assessment, the design, 
manufacture and operation of the product58. 

The  manufacturer  shall  keep  the  technical  documentation  at  the  disposal  of  the 
relevant national authorities for a period of 10 years59 after the last product has been 
manufactured. 

3. 

Manufacturing 

The manufacturer shall take all measures necessary in order that the manufacturing 
process and its monitoring ensure conformity of the manufactured products with the 
applicable requirements of the legislative instrument.  

4. 

Verification 

A  notified  body  chosen  by  the  manufacturer  shall  carry  out  the  appropriate 
examinations  and  tests,  or  have  them  carried  out,  to  check  the  conformity  of  the 
products with the applicable requirements of the legislative instrument. 

The examinations and tests to check the conformity with these requirements will be 
carried  out,  at  the  choice  of  the  manufacturer,  either  by  examination  and  testing  of 
every product as specified in point 6, or by examination and testing of the products 
on a statistical basis as specified in point 7. 

5. 

Verification of conformity by examination and testing of every product. 

5.1. 

All  products  shall  be  individually  examined  and  appropriate  tests,  as  set  out  in  the 
relevant  harmonised  standards  and/or  technical  specifications,  or  equivalent  tests, 
shall  be  carried  out  to  verify  their  conformity  with  the  requirements  that  apply  to 

58 

59 

a general description of the product, 
conceptual  design  and  manufacturing  drawings  and  schemes  of  components,  sub-assemblies,  circuits, 

The content of the technical documentation shall be laid down in the specific legislative instrument in accordance 
with the products concerned.   
For example, the documentation must contain so far as relevant for assessment:  
- 
- 
etc., 
- 
operation of the product, 
- 
a list of the harmonised standards the references of which have been published in the OJEU, applied in 
full or in part, and descriptions of the solutions adopted to meet the essential requirements of the directive where 
these harmonised standards have not been applied, 
- 
- 
The specific legislative instruments may alter this period. 

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

descriptions  and  explanations  necessary  for  the  understanding  of  said  drawings  and  schemes  and  the 

EN 

62 

   EN 

 
                                                 
 
 
 
 
 
them. In the absence of such a harmonised standard and/or technical specification the 
notified body concerned shall decide on the appropriate tests to be carried out. 

5.2. 

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

The manufacturer shall keep the certificates of conformity available for the national 
authorities for a period of 10 years60 after the certification of the product. 

6. 

Statistical verification of conformity 

6.1. 

6.2. 

The  manufacturer  shall  take  all  measures  necessary  in  order  for  the  manufacturing 
process  to  ensure  the  homogeneity  of  each  lot  produced,  and  shall  present  his 
products for verification in the form of homogeneous lots. 

A  random  sample  shall  be  drawn  from  each  lot  according  to  the  requirements  of 
point 7.3. All products in the sample shall be individually examined and appropriate 
tests as set out in the relevant harmonised standards and/or technical specifications, 
or equivalent tests, to establish their conformity with the requirements that apply to 
them, shall be carried out to determine whether the lot is accepted or rejected. In the 
absence  of  such  a  harmonised  standard  and/or  technical  specification  the  notified 
body concerned shall decide on the appropriate tests to be carried out. 

6.3. 

The statistical procedure shall use the following elements:  

(Relevant elements must be specified here by the legislative instrument, such as the 
statistical method to be applied, the sampling plan with its operational characteristics, 
etc.) 

6.4. 

If  a  lot  is  accepted,  all  products  of  the  lot  are  approved,  except  for  those  products 
from the sample that were found not to satisfy the tests. 

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

The manufacturer shall keep the certificates of conformity available for the national 
authorities for a period of10 years61 after the certification of the product. 

6.5. 

If a lot is rejected, the notified body shall take appropriate measures to prevent the 
placing on the market of that lot. In the event of frequent rejection of lots the notified 
body may suspend the statistical verification and take appropriate measures. 

7. 

CE marking and declaration of conformity 

7.1. 

The manufacturer shall affix the CE marking to each individual product that satisfies 
the applicable requirements of the legislative instrument. 

60 
61 

The specific legislative instruments may alter this period. 
The specific legislative instrument may alter this period. 

EN 

63 

   EN 

 
                                                 
7.2. 

The manufacturer shall draw up a written declaration of conformity for each product 
model and keep it at the disposal of the national authorities for a period of 10 years62 
after  the  last  product  has  been  manufactured.  The  declaration  of  conformity  shall 
identify the product model for which it has been drawn up. 

A copy of the declaration of conformity shall be supplied with each product that is 
made  available  on  the  market.  However,  this  requirement  may  be  interpreted  as 
applying to a batch or consignment rather than to individual products in those cases 
where a large number of products is delivered to a single user. 

If agreed upon by the notified body referred to in point 5, the manufacturer shall also 
affix  the  notified  body’s  identification  number  to  the  products,  under  the 
responsibility of the notified body. 

8. 

The  manufacturer  may,  if  agreed  upon  by  the  notified  body  and  under  its 
responsibility, affix the notified body’s identification number to the products during 
the manufacturing process. 

9. 

Authorised representative 

.. 

The  manufacturer’s  obligations  may  be  fulfilled,  on  his  behalf  and  under  his 
responsibility, by his authorised representative, except for the obligations contained 
in points 4 and 7.1. 

Module G 
Conformity based on unit verification 

1. 

Conformity  based  on  unit  verification  is  the  conformity  assessment  procedure 
whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 5, and 
ensures and declares on his sole responsibility that the product concerned, which has 
been subjected to the provisions of point 4, is in conformity with the requirements of 
the legislative instrument that apply to it.  

2. 

Technical documentation 

The  manufacturer  shall  establish  the  technical  documentation  as  described  in  the 
legislative instrument and make it available to the notified body referred to in point 
4. The documentation shall enable the assessment of the product for its conformity 
with  the  relevant  requirements,  and  shall  include  an  adequate  analysis  and 
assessment  of  the  risk(s).  The  technical  documentation  shall  specify  the  applicable 
requirements  and  cover,  as  far  as  relevant  for  the  assessment,  the  design, 
manufacture and operation of the product63. 

62 
63 

The specific legislative instruments may alter this period. 
The content of the technical documentation shall be laid down in the specific legislative instrument in accordance 
with the products concerned.   
For example, the documentation must contain so far as relevant for assessment:  
- 
- 

a general description of the product, 
conceptual  design  and  manufacturing  drawings  and  schemes  of  components,  sub-assemblies,  circuits, 

EN 

64 

   EN 

 
                                                 
 
The  manufacturer  shall  keep  the  technical  documentation  at  the  disposal  of  the 
relevant national authorities for a period of 10 years64 after the last product has been 
manufactured. 

3. 

Manufacturing 

The manufacturer shall take all measures necessary in order that the manufacturing 
process and its monitoring ensure conformity of the manufactured product with the 
applicable requirements of the legislative instrument. 

4. 

Verification 

A  notified  body  chosen  by  the  manufacturer  shall  carry  out  the  appropriate 
examinations  and  tests  as  set  out  in  the  relevant  harmonised  standards  and/or 
technical  specifications,  or  equivalent  tests,  to  check  the  conformity  of  the  product 
with the applicable requirements of the legislative instrument, or have them carried 
out. In the absence of such a harmonised standard and/or technical specification the 
notified body concerned shall decide on the appropriate tests to be carried out. 

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

The manufacturer shall keep the certificates of conformity available for the national 
authorities for a period of 10 years65 after the certification of the product. 

5. 

CE marking and declaration of conformity 

5.1. 

5.2. 

The  manufacturer  shall  affix  the  CE  marking  and,  under  the  responsibility  of  the 
notified body referred to in point 4, the latter's identification number to each product 
that satisfies the applicable requirements of the legislative instrument. 

The manufacturer shall draw up a written declaration of conformity and keep it at the 
disposal of the national authorities for a period of 10 years66 after the last product has 
been  manufactured.  The  declaration  of  conformity  shall  identify  the  product  for 
which it has been drawn up. 

A copy of the declaration shall be supplied with the product. 

6. 

Authorised representative 

descriptions  and  explanations  necessary  for  the  understanding  of  said  drawings  and  schemes  and  the 

etc., 
- 
operation of the product, 
a list of the harmonised standards the references of which have been published in the OJEU, applied in 
- 
full or in part, and descriptions of the solutions adopted to meet the essential requirements of the directive where 
these harmonised standards have not been applied, 
- 
- 
The specific legislative instruments may alter this period. 
The specific legislative instruments may alter this period. 
The specific legislative instruments may alter this period. 

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

65 

   EN 

64 
65 
66 

EN 

 
                                                                                                                                                         
 
 
 
 
The manufacturer’s obligations contained in points 2 and 5 may be fulfilled, on his 
behalf and under his responsibility, by his authorised representative. 

Module H 
Conformity based on full quality assurance 

1. 

Conformity  based on full quality assurance is the conformity assessment procedure 
whereby  the  manufacturer  fulfils  the  obligations  laid  down  in  points  2  and  5,  and 
ensures and declares on his sole responsibility that the products concerned satisfy the 
requirements of the legislative instrument that apply to them. 

2. 

Manufacturing 

The manufacturer shall operate an approved quality system for design, manufacture 
and  final  product  inspection  and  testing  of  the  products  concerned  as  specified  in 
point 3 and shall be subject to surveillance as specified in point 4.  

3. 

Quality system 

3.1. 

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

The application shall include: 

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

authorised representative, his name and address in addition; 

–  the  technical  documentation  as  described  in  the  legislative  instrument,  for  one 

model of each category of products intended to be manufactured; 

–  the documentation concerning the quality system;  

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

notified body. 

3.2. 

The quality system shall ensure compliance of the products with the requirements of 
the legislative instrument that apply to them. 

All the elements, requirements and provisions adopted by the manufacturer shall be 
documented  in  a  systematic  and  orderly  manner  in  the  form  of  written  policies, 
procedures  and  instructions.  This  quality  system  documentation  shall  permit  a 
consistent interpretation of the quality programmes, plans, manuals and records. 

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

–  the quality objectives and the organisational structure, responsibilities and powers 

of the management with regard to design and product quality;  

–  the technical design specifications, including standards, that will be applied and, 
where  the  relevant  harmonised  standards  and/or  technical  specifications  will  not 

EN 

66 

   EN 

 
be  applied  in  full,  the  means  that  will  be  used  to  ensure  that  the  essential 
requirements of the legislative instrument that apply to the products will be met;  

–  the  design  control  and  design  verification  techniques,  processes  and  systematic 
actions  that  will  be  used  when  designing  the  products  pertaining  to  the  product 
category covered;  

–  the  corresponding  manufacturing,  quality  control  and  quality  assurance 

techniques, processes and systematic actions that will be used;  

–  the  examinations  and  tests  that  will  be  carried  out  before,  during  and  after 

manufacture, and the frequency with which they will be carried out;  

–  the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data, 

qualification reports of the personnel concerned, etc.;  

–  the  means  of  monitoring  the  achievement  of  the  required  design  and  product 

quality and the effective operation of the quality system.  

3.3. 

The notified body shall assess the quality system to determine whether it satisfies the 
requirements referred to in point 3.2.  

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

In  addition  to  experience  in  quality  management  systems,  the  auditing  team  shall 
have at least one member experienced as an assessor in the relevant product field and 
product technology concerned, and knowledge of the applicable requirements of the 
legislative 
the 
instrument.  The  audit  shall 
technical 
manufacturer’s  premises.  The  auditing 
documentation referred to in point 3.1., second indent, to verify the manufacturer’s 
ability  to  identify  the  applicable  requirements  of  the  legislative  instrument  and  to 
carry out the necessary examinations in view of ensuring compliance of the product 
with these requirements. 

include  an  assessment  visit 

team  shall 

review 

the 

to 

The  manufacturer  or  his  authorised  representative  shall  be  notified  of  the  decision. 
The  notification  shall  contain  the  conclusions  of  the  examination  and  the  reasoned 
assessment decision. An appeal procedure must be available. 

3.4. 

3.5. 

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

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

The  notified  body  shall  evaluate  the  proposed  changes  and  decide  whether  the 
modified quality system will continue to satisfy the requirements referred to in point 
3.2., or whether a re-assessment is necessary.  

EN 

67 

   EN 

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

4. 

Surveillance under the responsibility of the notified body 

4.1. 

4.2. 

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

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

–  the quality system documentation; 

–  the  quality  records  as  foreseen  by  the  design  part  of  the  quality  system,  such  as 

results of analyses, calculations, tests, etc.; 

–  the  quality  records  as  foreseen  by  the  manufacturing  part  of  the  quality  system, 
such  as  inspection  reports  and  test  data,  calibration  data,  qualification  reports  of 
the personnel concerned, etc. 

4.3. 

The notified body shall carry out periodic67 audits to make sure that the manufacturer 
maintains  and  applies  the  quality  system  and  shall  provide  an  audit  report  to  the 
manufacturer. 

4.4.  Moreover, the notified body may pay unexpected visits to the manufacturer. During 
such visits, the notified body may, if necessary, carry out product tests, or have them 
carried  out,  in  order  to  check  the  proper  functioning  of  the  quality  system.  It  shall 
provide the manufacturer with a visit report and, if tests have been carried out, with a 
test report.  

5. 

CE marking and declaration of conformity 

5.1. 

5.2. 

The  manufacturer  shall  affix  the  CE  marking,  and,  under  the  responsibility  of  the 
notified  body  referred  to  in  point  3.1.,  the  latter’s  identification  number  to  each 
individual  product  that  satisfies  the  applicable  requirements  of  the  legislative 
instrument. 

The manufacturer shall draw up a written declaration of conformity for each product 
model and keep it at the disposal of the national authorities for a period of 10 years68 
after  the  last  product  has  been  manufactured.  The  declaration  of  conformity  shall 
identify the product model for which it has been drawn up. 

A copy of the declaration of conformity shall be supplied with each product that is 
made  available  on  the  market.  However,  this  requirement  may  be  interpreted  as 
applying to a batch or consignment rather than to individual products in those cases 
where a large number of products is delivered to a single user. 

67 
68 

In the specific legislative instruments, the frequency may be specified. 
The specific legislative instruments may alter this period. 

EN 

68 

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6. 

The manufacturer shall, for a period ending at least 10 years69 after the last product 
has been manufactured, keep at the disposal of the national authorities:  

–  the technical documentation referred to in point 3.1.; 

–  the documentation concerning the quality system referred to in point 3.1.; 

–  the change referred to in point 3.5., as approved; 

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

4.4.  

7. 

Each  notified  body  shall  inform  its  notifying  authorities  of  the  quality  system 
approvals  issued  or  withdrawn,  and  shall,  periodically  or  upon  request,  make 
available  to  its  notifying  authorities  the  list  of  quality  system  approvals  refused, 
suspended or otherwise restricted70. 

Each  notified  body  shall  inform  the  other  notified  bodies  of  the  quality  system 
approvals  which  it  has  refused,  suspended  or  withdrawn,  and,  upon  request,  of  the 
quality system approvals which it has issued. 

8. 

Authorised representative 

The  manufacturer’s  obligations  contained  in  points  3.1.,  3.5.,  5  and  6  may  be 
fulfilled, on his behalf and under his responsibility, by his authorised representative. 

Module H1 
Conformity based on full quality assurance plus design examination 

1. 

Conformity  based  on  full  quality  assurance  plus  design  examination  is  the 
conformity  assessment  procedure  whereby  the  manufacturer  fulfils  the  obligations 
laid down in points 2 and 6, and ensures and declares on his sole responsibility that 
the  products  concerned  satisfy  the  requirements  of  the  legislative  instrument  that 
apply to them. 

2. 

Manufacturing 

The manufacturer shall operate an approved quality system for design, manufacture 
and  final  product  inspection  and  testing  of  the  products  concerned  as  specified  in 
point 3 and shall be subject to surveillance as specified in point 5. The adequacy of 
the  technical  design  of  the  products  shall  have  been  examined  according  to  the 
provisions of point 4. 

3. 

Quality system 

3.1. 

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

69 
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The specific legislative instruments may alter this period. 
The specific legislative instruments may provide for different arrangements. 

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69 

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The application shall include: 

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

authorised representative, his name and address in addition; 

–  all relevant information for the product category envisaged; 

–  the documentation concerning the quality system;  

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

notified body. 

3.2. 

The quality system shall ensure compliance of the products with the requirements of 
the legislative instrument that apply to them. 

All the elements, requirements and provisions adopted by the manufacturer shall be 
documented  in  a  systematic  and  orderly  manner  in  the  form  of  written  policies, 
procedures  and  instructions.  This  quality  system  documentation  shall  permit  a 
consistent interpretation of the quality programmes, plans, manuals and records. 

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

–  the quality objectives and the organisational structure, responsibilities and powers 

of the management with regard to design and product quality;  

–  the technical design specifications, including standards, that will be applied and, 
where  the  relevant  harmonised  standards  and/or  technical  specifications  will  not 
be  applied  in  full,  the  means  that  will  be  used  to  ensure  that  the  essential 
requirements of the legislative instrument that apply to the products will be met;  

–  the  design  control  and  design  verification  techniques,  processes  and  systematic 
actions  that  will  be  used  when  designing  the  products  pertaining  to  the  product 
category covered;  

–  the  corresponding  manufacturing,  quality  control  and  quality  assurance 

techniques, processes and systematic actions that will be used;  

–  the  examinations  and  tests  that  will  be  carried  out  before,  during  and  after 

manufacture, and the frequency with which they will be carried out;  

–  the  quality  records,  such  as  inspection  reports  and  test  data,  calibration  data, 

qualification reports of the personnel concerned, etc.;  

–  the  means  of  monitoring  the  achievement  of  the  required  design  and  product 

quality and the effective operation of the quality system.  

3.3. 

The notified body shall assess the quality system to determine whether it satisfies the 
requirements referred to in point 3.2.  

It shall presume conformity with these requirements in respect of the elements of the 
quality  system  that  comply  with  the  corresponding  specifications  of  the  national 

EN 

70 

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standard  that  implements  the  relevant  harmonised  standard  and/or  technical 
specifications. 

In  addition  to  experience  in  quality  management  systems,  the  auditing  team  shall 
have at least one member experienced as an assessor in the relevant product field and 
product technology concerned, and knowledge of the applicable requirements of the 
legislative 
the 
manufacturer’s premises. 

include  an  assessment  visit 

instrument.  The  audit  shall 

to 

The  manufacturer  or  his  authorised  representative  shall  be  notified  of  the  decision. 
The  notification  shall  contain  the  conclusions  of  the  examination  and  the  reasoned 
assessment decision. An appeal procedure must be available. 

3.4. 

3.5. 

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

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

The  notified  body  shall  evaluate  the  proposed  changes  and  decide  whether  the 
modified quality system will continue to satisfy the requirements referred to in point 
3.2., or whether a re-assessment is necessary.  

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

3.6. 

Each  notified  body  shall  inform  its  notifying  authorities  of  the  quality  system 
approvals  issued  or  withdrawn,  and  shall,  periodically  or  upon  request,  make 
available  to  its  notifying  authorities  the  list  of  quality  system  approvals  refused, 
suspended or otherwise restricted71. 

Each  notified  body  shall  inform  the  other  notified  bodies  of  the  quality  system 
approvals  which  it  has  refused,  suspended  or  withdrawn,  and,  upon  request,  of  the 
quality system approvals which it has issued. 

4. 

Design examination 

4.1. 

4.2. 

The manufacturer shall lodge an application for examination of the design with the 
notified body referred to in point 3.1. 

The application shall enable understanding of the design, manufacture and operation 
of the product, and shall enable  assessment of conformity  with the requirements of 
the legislative instrument that apply to it. It shall include: 

–  the name and address of the manufacturer; 

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

notified body; 

71 

The specific legislative instruments may provide for different arrangements. 

EN 

71 

   EN 

 
                                                 
–  the  technical  documentation  as  described  in  the  legislative  instrument.  The 
documentation shall enable the assessment of the product for its conformity with 
the relevant requirements, and shall include an adequate analysis and assessment 
of  the  risk(s).  The  technical  documentation  shall  specify  the  applicable 
requirements  and  cover,  as  far  as  relevant  for  the  assessment,  the  design  and 
operation of the product; 

–  the  supporting  evidence  for  the  adequacy  of  the  technical  design.  This  evidence 
shall  mention  any  documents  that  have  been  applied,  in  particular  where  the 
relevant  harmonised  standards  and/or  technical  specifications  have  not  been 
applied in full, and shall include, where necessary, the results of tests carried out 
by the appropriate laboratory of the manufacturer, or by another testing laboratory 
on his behalf and under his responsibility. 

4.3. 

The  notified  body  shall  examine  the  application,  and  where  the  design  meets  the 
requirements of the legislative instrument that apply to the product it shall issue an 
EC design examination certificate to the manufacturer. The certificate shall contain 
the  name  and  address  of  the  manufacturer,  the  conclusions  of  the  examination, 
conditions  (if  any)  for  its  validity  and  the  necessary  data  for  identification  of  the 
approved design72. The certificate may have one or more annexes attached. 

The  certificate  and  its  annexes  shall  contain  all  relevant  information  to  allow  the 
conformity of manufactured products to be evaluated with the examined design, and 
to allow for in-service control, where applicable. 

Where  the  design  does  not  satisfy  the  applicable  requirements  of  the  legislative 
instrument,  the  notified  body  shall  refuse  to  issue  a  design  examination  certificate 
and shall inform the applicant accordingly, giving detailed reasons for its refusal. An 
appeal procedure must be available.  

4.4. 

The  notified  body  shall  keep  itself  appraised  of  any  changes  of  the  generally 
acknowledged state of the art which indicate that the approved design may no longer 
comply  with  the  applicable  requirements  of  the  legislative  instrument,  and  shall 
determine  whether  such  changes  require  further  investigations.  If  so,  the  notified 
body shall inform the manufacturer accordingly. 

The  manufacturer  shall  keep  the  notified  body  that  has  issued  the  EC  design 
examination  certificate  informed  of  any  modification  to  the  approved  design  that 
may  affect  the  conformity  with  the  essential  requirements  of  the  legislative 
instrument  or  the  conditions  for  validity  of  the  certificate..  Such  modifications 
require  additional  approval  -  from  the  notified  body  that  issued  the  EC  design 
examination  certificate  -  in  the  form  of  an  addition  to  the  original  EC  design 
examination certificate. 

4.5. 

Each  notified  body  shall  inform  its  notifying  authorities  about  the  EC  design 
examination  certificates  and/or  any  additions  thereto  which  it  has  issued  or 
withdrawn,  and  shall,  periodically  or  upon  request,  make  available  to  its  notifying 

72 

The specific legislative instruments may provide for the certificate to have a period of validity. 

EN 

72 

   EN 

 
                                                 
authorities the list of certificates and/or any additions thereto refused, suspended or 
otherwise restricted73. 

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

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

The  notified  body  shall  hold  a  copy  of  the  EC  design  examination  certificate,  its 
annexes  and  additions,  as  well  as  the  technical  file  including  the  documentation 
submitted  by  the  manufacturer  for  a  period  up  to  the  end  of  the  validity  of  the 
certificate74. 

4.6. 

The  manufacturer  shall  keep  a  copy  of  the  EC  design  examination  certificate,  its 
annexes  and  additions  with  the  technical  documentation  for  a  period  of  10  years75 
after  the  last  product  has  been  manufactured  at  the  disposal  of  the  national 
authorities. 

4.7. 

The manufacturer’s authorised representative may lodge the application referred to in 
points 4.1 and 4.2 and carry out the obligations mentioned in points 4.4 and 4.6.  

5. 

Surveillance under the responsibility of the notified body 

5.1. 

5.2. 

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

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

–  the quality system documentation; 

–  the  quality  records  as  foreseen  by  the  design  part  of  the  quality  system,  such  as 

results of analyses, calculations, tests, etc.; 

–  the  quality  records  as  foreseen  by  the  manufacturing  part  of  the  quality  system, 
such  as  inspection  reports  and  test  data,  calibration  data,  qualification  reports  of 
the personnel concerned, etc. 

73 
74 
75 

The specific legislative instruments may provide for different arrangements. 
The specific legislative instruments may alter this period. 
The specific legislative instruments may alter this period. 

EN 

73 

   EN 

 
                                                 
5.3. 

The notified body shall carry out periodic76 audits to make sure that the manufacturer 
maintains  and  applies  the  quality  system  and  shall  provide  an  audit  report  to  the 
manufacturer. 

5.4.  Moreover, the notified body may pay unexpected visits to the manufacturer. During 
such visits, the notified body may, if necessary, carry out product tests, or have them 
carried  out,  in  order  to  check  the  proper  functioning  of  the  quality  system.  It  shall 
provide the manufacturer with a visit report and, if tests have been carried out, with a 
test report.  

6. 

CE marking and declaration of conformity 

6.1. 

6.2. 

The  manufacturer  shall  affix  the  CE  marking,  and,  under  the  responsibility  of  the 
notified  body  referred  to  in  point  3.1.,  the  latter’s  identification  number  to  each 
individual  product  that  satisfies  the  applicable  requirements  of  the  legislative 
instrument. 

The manufacturer shall draw up a written declaration of conformity for each product 
model and keep it at the disposal of the national authorities for a period of 10 years77 
after  the  last  product  has  been  manufactured.  The  declaration  of  conformity  shall 
identify  the  product  model  for  which  it  has  been  drawn  up  and  shall  mention  the 
number of the design examination certificate. 

A copy of the declaration of conformity shall be supplied with each product that is 
made  available  on  the  market.  However,  this  requirement  may  be  interpreted  as 
applying to a batch or consignment rather than to individual products in those cases 
where a large number of products is delivered to a single user. 

7. 

The manufacturer shall, for a period ending at least 10 years78 after the last product 
has been manufactured, keep at the disposal of the national authorities: 

–  the documentation concerning the quality system referred to in point 3.1.; 

–  the change referred to in point 3.5., as approved; 

–  the decisions and reports from the notified body referred to in points 3.5., 5.3. and 

5.4. 

8. 

Authorised representative 

The  manufacturer’s  obligations  contained  in  points  3.1.,  3.5.,  6  and  7  may  be 
fulfilled, on his behalf and under his responsibility, by his authorised representative. 

76 
77 
78 

In the specific legislative instruments, the frequency may be specified. 
The specific legislative instruments may alter this period. 
The specific legislative instruments may alter this period. 

EN 

74 

   EN 

 
                                                 
D
E
S
I
G
N

P
R
O
D
U
C
T
I
O
N

A . Internal pro ductio n 

co ntro l

M anufacturer
    > Keeps technical
        do cumentatio n at
        the dispo sal o f 
        natio nal autho rities

TABLE: CONFORMITY ASSESSMENT PROCEDURES IN COMMUNITY LEGISLATION

B . Type examinatio n

G.  Unit verificatio n

H.  Full quality assurance

M anufacturer submits to  no tified bo dy
     > technical do cumentatio n
     > suppo rting evidence fo r the adequacy o f the technical design so lutio n
     > specimen(s), representative o f the pro ductio n envisaged, as required

M anufacturer
   > submits technical
       do cumentatio n

No tified B o dy
       > A scertains co nfo rmity with essential requirements
       > Examines technical do cumentatio n and suppo rting evidence to  assess adequacy o f the technical design
       > Fo r specimen(s): carries o ut tests, if necessary
       > Issues EC-type examinatio n certificate

EN ISO 9001:2000 (3)

M anufacturer
    >o perates an appro ved
      quality system fo r design
    >submits technical do cumentatio n

No tified B o dy
     >carries o ut surveillance o f the QS

   H1
No tified bo dy
  >verifies co nfo rmity o f design 
  >issues EC-design examinatio n
certificate 

C.  Co nfo rmity to  type

C.
M anufacturer
  > Declares co nfo rmity
      with appro ved type
  > A ffixes CE marking

A .
M anufacturer
     > Declares co nfo rmity
         with essential
         requirements
     > A ffixes CE marking

A 1
A ccredited in-ho use bo dy

C1
A ccredited in-ho use bo dy

o r no tified bo dy
 >Tests o n specific
   aspects o f the
     pro duct

o r no tified bo dy
 > Tests o n specific
    aspects o f the
   pro duct 

A 2
   > P ro duct checks at 
      rando m intervals

C2
  > P ro duct checks at
      rando m intervals 

I
I
D.  P ro ductio n quality 

I
I
E. P ro duct quality 

assurance
EN ISO 9001:2000 (1)

assurance
EN ISO 9001:2000 (2)

I
I

F. P ro duct verificatio n

M anufacturer
  >Operates an appro ved
    quality system fo r pro du
     ctio n, final inspectio n
     and testing
   >Declares co nfo rmity
      with appro ved type
>A ffixes CE marking

M anufacturer
  >Operates an appro ved
    quality system fo r final
     inspectio n and testing
  >Declares co nfo rmity
     with appro ved type
>A ffixes CE marking

M anufacturer
  > Declares co nfo rmity
      with appro ved type
  > A ffixes CE marking

M anufacturer
    > Submits pro duct
    > Declares co nfo rmity
    > A ffixes CE marking

M anufacturer
    > Operates an appro ved QS fo r 
        pro ductio n, final inspectio n
        and testing
     > Declares co nfo rmity
     > A ffixes CE marking

      D1
    Declares co nfo rmity
with essential requirements
 > A ffixes CE marking

E1
Declares co nfo rmity with
essential requirements
>A ffixes CE marking

F1
Declares co nfo rmity with 
essential requirements
>A ffixes CE marking

No tified B o dy
 > A ppro ves the QS
 > Carries o ut 
 surveillance o f the QS

No tified B o dy
 > A ppro ves the QS
 > Carries o ut 
       surveillance o f the QS

No tified bo dy
> Verifies co nfo rmity with
  essential requirements
 > Issues certificate o f
co nfo rmity

No tified bo dy
>Verifies co nfo rmity with
essential requirements
> Issues certificate o f
  co nfo rmity

No tified bo dy
 > Carries o ut surveillance o f
   the QS

(1) except fo r sub-clause 7.3 and requirements relating to  custo mer satisfactio n and co ntinual impro vement
(2) except fo r sub-clauses 7.1, 7.2.3, 7.3, 7.4, 7.5.1, 7.5.2, 7.5.3 and requirements relating to  custo mer satisfactio n and co ntinual impro vement  
(3) except fo r requirements relating to  custo mer satisfactio n and co ntinual impro vement   

EN 

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1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

ANNEX II 
EC DECLARATION OF CONFORMITY 

No xxxxxx (unique identification of the product) 

Name and address of (authorised representative of the) manufacturer:  

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

Object of the declaration (identification of product allowing traceability): 

The  object  of  the  declaration  described  above  is  in  conformity  with  the  relevant 
Community harmonisation legislation………  

References  to  the  relevant  harmonised  standards  used,  or  references  to  the 
specifications in relation to which conformity is declared: 

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

Additional information: 

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

(place and date of issue) 

(name, function)(signature) 

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