Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the harmonisation  of the laws of the Member States relating to making available on the market of lifts and safety components for lifts
Date: 2011-11-21
Institutions: European Commission
Subjects: EC conformity marking, lift, market supervision, marketing standard, product safety, safety standard, technical standard

EUROPEAN COMMISSION 

Brussels, 21.11.2011 
COM(2011) 770 final 

2011/0354 (COD) 

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

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on the harmonisation  of the laws of the Member States relating to making available on 
the market of lifts and safety components for lifts 

(Recast) 

(Text with EEA relevance) 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

General context, reasons for and objectives of this proposal  

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

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

Directive 95/16/EC is an example of that Union harmonisation legislation, ensuring the free 
movement  of  lifts  and  safety  components  for  lifts.  It  sets  out  essential  health  and  safety 
requirements that lifts and safety components for lifts must comply with in order to be made 
available  on  the  EU  market.  Manufacturers  must  demonstrate  that  a  lift  and  a  safety 
component  for  lifts  have  been  designed  and  manufactured  in  compliance  with  the  essential 
health and safety requirements and affix the CE marking.  

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

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

certain lack of trust in CE marking 

–  competitive  disadvantages  for  economic  operators  complying  with  the  legislation  as 

opposed to those circumventing the rules 

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

amongst economic operators due to different enforcement practices 

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

authorities 

–  problems with the quality of certain notified bodies 

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

legislation  apply  simultaneously 

to  one  and 

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

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

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

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

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

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

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

For  a  number  of  other  Union  harmonisation  directives,  including  Directive  95/16/EC,  no 
revision  for  sector-specific  problems  had  been  envisaged  within  this  timeframe.  To  ensure 
that the problems in relation to non-compliance and notified bodies are nevertheless addressed 
in  these  sectors,  and  for  the  sake  of  consistency  of  the  overall  regulatory  environment  on 
products,  it  was  decided  to  align  these  directives  within  a  package  to  the  provisions  of  the 
NLF Decision. 

Consistency with other policies and objectives of the Union 

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

1 

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

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

2. 

CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

Consultation of interested parties 

The alignment of Directive 95/16/EC to the NLF Decision has been discussed with national 
experts  responsible  for  the  implementation  of  this  Directive,  the  notified  body  group,  the 
administrative cooperation group, standardisation bodies, representatives for the lifts sector as 
well  as  in  bilateral  meetings  with  associations  representing  lift  installers,  lifts  components 
manufacturers  and  small  and  medium  size  enterprises  in  the  lifts  industry,  trade  unions  and 
associations of property owners.  

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

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

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

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

Collection and use of expertise 

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

External  expertise  was  used  to  obtain  some  basic  data  on  certain  sectors,  including  studies 
concerning lifts: (2004)2 and (2007)3.  

2 

Evaluation  of  the  Application  of  the  Lift  Directive  (95/16/EC).  Final  Report  to  the  European 
Commission  (DG  ENTR)  of  21  June  2004.  [The  study  examined  the  functioning  of  the  Directive 

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Impact assessment  

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

Option 1 - No changes to the current situation 

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

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

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

Option 3 – Alignment to NLF Decision by legislative measures 

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

Option 3 was found to be the preferred option because 

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

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

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

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

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

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

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

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

3. 

MAIN ELEMENTS OF THE PROPOSAL 

3.1. 

Horizontal definitions 

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

3 

95/16/EC  in  7  Member  States:  Belgium,  Finland,  Germany,  Italy,  Portugal,  Spain  and  the  United 
Kingdom.] 
Study  on  the  Technical  Assessment  of  Means  of  Preventing  the  Crushing  Risk  on  Lifts  subject  to 
Directive 95/16/EC, Report Number ME/07/07 (2007). [The study aim was the examination whether the 
solutions  available,  other  than  free  space  or  refuges,  to  prevent  the  crushing  risk  can  provide  an 
equivalent level of safety.] 

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3.2. 

Obligations of economic operators and traceability requirements 

the  obligations  of 

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

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

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

3.3. 

Harmonised standards 

Compliance  with  harmonised  standards  provides  a  presumption  of  conformity  with  the 
essential health and safety requirements. On 1 June 2011 the Commission adopted a proposal 
for a Regulation on European Standardisation4 that sets out a horizontal legal framework for 
European  standardisation.  The  proposal  for  the  Regulation  contains  inter  alia  provisions  on 
standardisation requests from the Commission to the European Standardisation Organisations, 
on the procedure for objections to harmonised standards and on  stakeholder participation in 
the standardisation process. Consequently the provisions of Directive 95/16/EC which cover 
the same aspects have been deleted in this proposal for reasons of legal certainty.  

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

4 

Proposal for a Regulation of the European Parliament and of the Council on European Standardisation 
and  amending  Council  Directives  89/686/EEC  and  93/15/EEC  and  Directives  94/9/EC,  94/25/EC, 
95/16/EC,  97/23/EC,  98/34/EC,  2004/22/EC,  2007/23/EC,  2009/105/EC  and  2009/23/EC  of  the 
European Parliament and of the Council. COM(2011) 315 final 

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3.4. 

Conformity assessment and CE marking 

Directive  95/16/EC  has  selected  the  appropriate  conformity  assessment  procedures  which 
installers have to apply in order to demonstrate that lifts they install comply with the essential 
health and safety requirements.  

The proposal aligns these procedures to their updated versions set out in the NLF Decision. 
Sector specific elements of the procedures have been maintained. It also introduces a model 
for the EU Declaration of conformity. 

General principles of the CE marking are set out in Article 30 of Regulation 765/2008, while 
the detailed provisions on the affixing of the CE marking to lifts and safety components for 
lifts have been inserted in this proposal. 

3.5. 

Notified Bodies 

The  proposal  reinforces  the  notification  criteria  for  notified  bodies.  It  clarifies  that 
subsidiaries or subcontractors must also comply  with the notification requirements. Specific 
requirements  for  notifying  authorities  are  introduced,  and  the  procedure  for  notification  of 
notified  bodies  is  revised.  The  competence  of  a  notified  body  must  be  demonstrated  by  an 
accreditation certificate. Where accreditation has not been used to evaluate the competence of 
a  notified  body,  the  notification  must  comprise  the  documentation  demonstrating  how  the 
competence of that body has been evaluated. Member States will have the possibility to object 
to a notification. 

3.6.  Market surveillance and the safeguard clause procedure 

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

3.7. 

Comitology and Delegated acts 

The Treaty on the Functioning of the EU has introduced a clear distinction between delegated 
acts (Article 290) and implementing acts (Article 291) and clarified the role of committees. 

Directive 95/16/EC provided for a Standing Committee. As this committee is not involved in 
the  adoption  of  implementing  acts  provided  for  in  Article  291  of  the  Treaty  on  the 
Functioning  of  the  EU,  and  no  need  to  adopt  implementing  acts  appears  under  the  new 
Directive, this provision has been deleted in the proposal. 

The  Commission  will  set  up  an  expert  working  group  in  accordance  with  the  Commission 
Communication  -  Framework  for  Commission  expert  groups:  horizontal  rules  and  public 

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register5,  that  will  carry  out  the  tasks  of  the  Standing  Committee  provided  for  in  Directive 
95/16/EC, to examine any question relating to the application of the Directive. 

The  proposal  introduces  the  power  for  the  Commission  to  adopt  delegated  acts  in  order  to 
adapt the list of safety components for lifts set out in Annex III to technical progress and new 
scientific evidence. 

4. 

LEGAL ELEMENTS OF THE PROPOSAL 

Legal basis 

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

Subsidiarity principle 

The internal market is a competence that is shared between the Union and the Member States. 
The  subsidiarity  principle  arises  in  particular  with  regard  to  the  newly  added  provisions 
aiming  at  the  improvement  of  effective  enforcement  of  Directive  95/16/EC  namely,  the 
importer  and  distributor  obligations,  the  traceability  provisions,  the  provisions  on  the 
assessment  and  notification  of  notified  bodies,  and  the  enhanced  cooperation  obligations  in 
the context of the revised market surveillance and safeguard procedures.  

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

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

Proportionality 

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

The new or modified obligations do not impose unnecessary burdens and costs on industry - 
especially on small and medium sized enterprises - or administrations. Where modifications 
have been identified to have negative impacts, the analysis of the impacts of the option serves 
to  provide  the  most  proportionate  response  to  the  problems  identified.  A  number  of 
modifications  concern  the  improvement  of  clarity  of  the  existing  Directive  without 
introducing new requirements that entail added cost.  

Legislative technique used 

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C(2010) 7649 final 

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The  alignment  to  the  NLF  Decision  requires  a  number  of  substantive  amendments  to  the 
provisions of Directive 95/16/EC. To ensure the readability of the amended text the technique 
of  recasting  has  been  chosen  in  line  with  the  Interinstitutional  Agreement  of  28  November 
2001 on a more structured use of the recasting technique for legal acts6.  

The  changes  made  to  the  provisions  of  Directive  95/16/EC  concern:  the  definitions,  the 
obligations  of  economic  operators,  the  presumption  of  conformity  provided  by  harmonised 
standards,  the  declaration  of  conformity,  CE  marking,  notified  bodies,  the  safeguard  clause 
procedure and the conformity assessment procedures. 

The  proposal  does  not  change  the  scope  of  Directive  95/16/EC  and  the  essential  health  and 
safety requirements. 

5. 

BUDGETARY IMPLICATIONS 

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

6. 

ADDITIONAL INFORMATION 

Repeal of existing legislation 

The adoption of the proposal will lead to repeal of Directive 95/16/EC. 

European Economic Area 

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

6 

OJ C 77, 28.3.2002, p. 1–3 

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(cid:208) 95/16/EC (adapted) 

2011/0354 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on the ⌦ harmonisation ⌫ approximation of the laws of the Member States relating to 
⌦making available on the market of ⌫lifts ⌦ and safety components for lifts ⌫ 

(Recast) 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community ⌦ on the Functioning of 
the European Union ⌫ , and in particular Article 100a ⌦ 114 ⌫ thereof, 

Having regard to the proposal from the European Commission, 

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

Having regard to the opinion of the European Economic and Social Committee7, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

Whereas  Member  States  are  responsible  within  their  territory  for  the  health  and  safety  of 
people; 

(cid:208) 95/16/EC recital 1  

Whereas paragraphs 65 and 68 of the White Paper on the completion of the internal market, 
approved  by  the  European  Council  in  June  1985,  provide  for  a  new  approach  to  the 
approximation of laws; 

(cid:208) 95/16/EC recital 2 (adapted) 

7 

OJ C […]. 

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(cid:208) 95/16/EC recital 3 (adapted) 

Whereas  Council  Directive  84/529/EEC  of  17  September  1984  on  the  approximation  of  the 
laws  of  the  Member  States  relating  to  electrically,  hydraulically  or  oil-electrically  operated 
lifts8 does not ensure freedom of movement for all types of lift; whereas disparities between 
the  binding  provisions  of  the  various  national  systems  for  types  of  lift  not  covered  by 
Directive 84/529/EEC constitute barriers to trade within the Community; whereas the national 
rules on lifts should therefore be harmonized; 

(cid:208) 95/16/EC recital 4 (adapted) 

Whereas  Council  Directive  84/528/EEC  of  17  September  1984  on  the  approximation  of  the 
laws of the Member States relating to common provisions for lifting and mechanical handling 
appliances9  serves  as  a  framework  Directive  for  two  specific  Directives,  namely  Directive 
84/529/EEC and Council Directive 86/663/EEC of 22 December 1986 on the approximation 
of  the  laws  of  the  Member  States  relating  to  self-propelled  industrial  trucks10,  repealed  by 
Council  Directive  91/368/EEC  of  20  June  1991  amending  Directive  89/392/EEC  on  the 
approximation of the laws of the Member States relating to machinery11; 

(cid:216) new 

(1) 

(2) 

Directive 95/16/EC of the European Parliament  and the  Council of  29 June 1995 on 
the  approximation  of  the  laws  of  the  Member  States  relating  to  lifts12  has  been 
substantially  amended  several  times.  Since  further  amendments  are  to  be  made,  it 
should be recast in the interests of clarity. 

Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 
2008 setting out the requirements for accreditation and market surveillance relating to 
the  marketing  of  products  and  repealing  Regulation  (EEC)  No  339/9313  lays  down 
rules on the accreditation of conformity assessment bodies, provides a framework for 
the market surveillance of products and for controls on products from third countries, 
and  lays  down  the  general  principles  of  the  CE  marking.  In  order  to  ensure  legal 
certainty, it is necessary to clarify that rules on Union market surveillance and control 
of  lifts  and  safety  components  for  lifts  entering  the  Union  market  provided  for  in 
Regulation (EC) No 765/2008 apply to lifts and safety components for lifts covered by 
this  Directive.  This  Directive  should  not  prevent  Member  States  from  choosing  the 
competent authorities to carry out those tasks. 

(3) 

Decision  No  768/2008/EC  of  the  European  Parliament  and  of  the  Council  of  9  July 
2008  on  a  common  framework  for  the  marketing of products, and repealing Council 

8 

9 

10 
11 
12 
13 

OJ No L 300, 19. 11. 1984, p. 86. Directive as last amended by Directive 90/486/EEC (OJ No L 270, 2. 
10. 1990, p. 21). 
OJ No L 300, 19. 11. 1984, p. 72. Directive as last amended by Directive 88/665/EEC (OJ No L 382, 
31. 12. 1988, p. 42). 
OJ No L 384, 31. 12. 1986, p. 12. 
OJ No L 198, 22. 7. 1991, p. 16. 
OJ No L 213, 7. 9. 1995, p. 1. 
OJ L 218, 13.8.2008, p. 30. 

EN 

11 

   EN 

 
 
 
                                                 
Decision  93/465/EEC14  lays  down  a  common  framework  of  general  principles  and 
reference  provisions  intended  to  apply  across  the  legislation  harmonising  the 
conditions  for  the  marketing  of  products  in  order  to  provide  a  coherent  basis  for 
revision or recasts of that legislation. Directive 95/16/EC should therefore be adapted 
to that Decision. 

(4)  Whereas oOn 8 June 1995 the Commission adopted recommendation No 95/216/EC15 

to the Member States concerning improvement of safety of existing lifts;. 

(cid:208) 95/16/EC recital 5 (adapted) 

(cid:208) 95/16/EC recital 6 (adapted)  

Whereas  the  essential  requirements  of  this  Directive  will  guarantee  the  intended  level  of 
safety  only  if  appropriate  conformity  assessment  procedures,  chosen  from  among  the 
provisions of 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 
directives16 ensure compliance therewith. 

Whereas  the  CE  marking  must  be  visibly  affixed  to  lifts  or  to  certain  safety  components  of 
lifts which meet the essential health and safety requirements of this Directive to enable them 
to be placed on the market; 

(cid:208) 95/16/EC recital 7 (adapted) 

(cid:208) 95/16/EC recital 8 (adapted) 

Whereas this Directive defines only general essential health and safety requirements; whereas, 
in  order  to  help  manufacturers  prove  conformity  with  these  essential  requirements,  it  is 
desirable to have standards harmonized at European level concerning the prevention of risks 
arising from the design and installation of lifts, and also in order to enable conformity with 
the  essential  requirements  to  be  verified;  whereas  such  standards  are  drawn  up  at  European 
level  by  private-law  bodies  and  must  retain  their  non-binding  status;  whereas,  for  this 
purpose,  the  European  Committee  for  Standardization  (CEN)  and  the  European  Committee 
for  Electrotechnical  Standardization  (Cenelec)  are  recognized  as  the  competent  bodies  for 
adopting  harmonized  standards  in  accordance  with  the  general  guidelines  for  cooperation 
between  the  Commission  and  CEN  and  Cenelec  signed  on  13  November  1984;  whereas  a 
harmonized standard within the meaning of this Directive is a technical specification adopted 
by CEN and/or Cenelec on the basis of a mandate from the Commission in accordance with 
Council Directive 83/189/EEC of 28 March 1983 laying down a procedure for the provision 
of  information  in  the  field  of  technical  standards  and  regulations17  and  pursuant  to  the 
abovementioned general guidelines; 

14 
15 
16 
17 

OJ L 218, 13.8.2008, p. 82. 
OJ No L 134, 20. 6. 1995, p. 37. 
OJ No L 220, 30. 8. 1993, p. 23. 
OJ  No  L  109,  26.  4.  1983,  p.  8.  Directive  as  last  amended  by  European  Parliament  and  Council 
Directive 94/10/EC (OJ No L 100, 19. 4. 1994, p. 30). 

EN 

12 

   EN 

 
 
 
 
                                                 
(cid:208) 95/16/EC recital 10 (adapted) 

Whereas this Directive is designed to cover all risks caused by lifts and run by their users and 
by the occupants of the construction; whereas this Directive should therefore be regarded as a 
Directive  within  the  meaning  of  Article  2(3)  of  Council  Directive  89/106/EEC  of  21 
December  1988  on  the  approximation  of  laws,  regulations  and  administrative  provisions  of 
the Member States relating to construction products18; 

Whereas an agreement on a modus vivendi between the European Parliament, the Council and 
the Commission concerning the implementing measures for acts adopted in accordance with 
the procedure laid down in Article 189b of the EC Treaty was reached on 20 December 1994, 

(cid:208) 95/16/EC recital 11(adapted) 

(5) 

(6) 

(7) 

(8) 

(cid:216) new 

Economic  operators  should  be  responsible  for  the  compliance  of  lifts  and  safety 
components for lifts, in relation to their respective roles in the supply chain, so as to 
ensure a high level of protection of public interests, such as health and safety, and the 
protection of consumers and to guarantee fair competition on the Union market. 

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

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

It is necessary to ensure that safety components for lifts from third countries entering 
the Union market comply with the requirements of this Directive, and in particular that 
the appropriate assessment procedures have been carried out by the manufacturer with 
regard  to  those  safety  components  for  lifts.  Provision  should  therefore  be  made  for 
importers  to  make  sure that the  safety components for lifts they place on the market 
comply  with  the  requirements  of  this  Directive  and  that  they  do  not  place  on  the 
market  safety  components  for  lifts  which  do  not  comply  with  such  requirements  or 
present  a  risk.  Provision  should  also  be  made  for  importers  to  make  sure  that 
conformity assessment procedures have been carried out and that safety component for 
lifts  marking  and  documentation  drawn  up  by  manufacturers  are  available  for 
inspection by the supervisory authorities.  

(9) 

The distributor makes a safety component for lifts available on the market after it has 
been placed on the market by the manufacturer or the importer and should act with due 

18 

OJ No L 40, 11. 2. 1989, p. 12. 

EN 

13 

   EN 

 
 
 
                                                 
care  to  ensure  that  its  handling  of  the  safety  component  for  lifts  does  not  adversely 
affect the compliance of the safety component for lifts. 

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

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

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

(13)  Ensuring  traceability  of  lifts  or  safety  components  for  lifts  throughout  the  whole 
supply  chain  helps  to  make  market  surveillance  simpler  and  more  efficient.  An 
efficient traceability system facilitates market surveillance authorities' task of tracing 
economic  operators  who  made  non-compliant  lifts  or  safety  components  for  lifts 
available on the market.  

(14)  This  Directive  should  be  limited  to  the  expression  of  the  essential  health  and  safety 
requirements.  In  order  to  facilitate  conformity  assessment  for  lifts  and  safety 
components for lifts with those requirements it is necessary to provide for presumption 
of  conformity  for  lifts  and  safety  components  for  lifts  which  are  in  conformity  with 
harmonised standards that are adopted in accordance with Regulation (EU) No [../..] of 
the European Parliament and of the Council of [...] on European Standardisation and 
amending  Council  Directives  89/686/EEC  and  93/15/EEC  and  Directives  94/9/EC, 
94/25/EC,  95/16/EC,  97/23/EC,  98/34/EC,  2004/22/EC,  2007/23/EC,  2009/105/EC 
and  2009/23/EC  of  the  European  Parliament  and  of  the  Council19  for  the  purpose  of 
expressing detailed technical specifications of those requirements. The essential health 
and  safety  requirements  of  this  Directive  will  guarantee  the  intended  level  of  safety 
only if appropriate conformity assessment procedures ensure compliance therewith. 

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

(16) 

In order to enable economic operators to demonstrate and the competent authorities to 
ensure that lifts or safety components for lifts made available on the market conform 
to the essential health and safety requirements it is necessary to provide for conformity 
assessment procedures. Decision No 768/2008/EC establishes modules for conformity 
assessment procedures, which include procedures from the least to the most stringent, 

19 

OJ C […], [Date], p. […]. 

EN 

14 

   EN 

                                                 
in proportion to the level of risk involved and the level of safety required. In order to 
ensure  inter-sectoral  coherence  and  to  avoid  ad-hoc  variants,  conformity  assessment 
procedures should be chosen from among those modules. 

(17)  The installer or the manufacturer should draw up an EU declaration of conformity to 
provide detailed information on the conformity of a lift or safety components for lifts 
with the requirements of the relevant Union harmonisation legislation.  

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

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

(20)  Experience has shown that the criteria set out in Directive 95/16/EC that conformity 
assessment bodies have to fulfil to be notified to the Commission are not sufficient to 
ensure a uniformly high level of performance of notified bodies throughout the Union. 
It  is,  however,  essential  that  all  notified  bodies  perform  their  functions  to  the  same 
level and under conditions of fair competition. That requires the setting of obligatory 
requirements  for  conformity  assessment  bodies  wishing  to  be  notified  in  order  to 
provide conformity assessment services. 

(21) 

(22) 

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

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

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

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

(25)  Conformity assessment bodies frequently subcontract parts of their activities linked to 
the  assessment  of  conformity  or  have  recourse  to  a  subsidiary.  In  order  to  safeguard 

EN 

15 

   EN 

the level of protection required for the products to be placed on the Union market, it is 
essential  that  conformity  assessment  subcontractors  and  subsidiaries  fulfil  the  same 
requirements  as  notified  bodies  in  relation  to  the  performance  of  conformity 
assessment tasks. Therefore, it is important that the assessment of the competence and 
the performance of bodies to be notified and the monitoring of bodies already notified 
cover also activities carried out by subcontractors and subsidiaries. 

(26) 

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

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

(28) 

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

(29)  Directive 95/16/EC already provides for a safeguard procedure which applies only in 
the event of disagreement between Member States over 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  a  view  to  making  it  more 
efficient and drawing on the expertise available in Member States. 

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

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

(32) 

In order to keep the list of safety components for lifts up to date, the power to adopt 
acts in accordance with Article 290 of the Treaty on the Functioning of the European 
Union should be delegated to the Commission in respect of adaptations of Annex III to 
this  Directive  to  technical  progress  and  new  scientific  evidence.  It  is  of  particular 
importance  that  the  Commission  carry  out  appropriate  consultations  during  its 
preparatory work, including at expert level. 

(33)  The  Commission,  when  preparing  and  drawing-up  delegated  acts,  should  ensure  a 
simultaneous,  timely  and  appropriate  transmission  of  relevant  documents  to  the 
European Parliament and Council. 

EN 

16 

   EN 

(34) 

In  order  to  monitor  and  ensure  the  efficiency  in  the  application  of  this  Directive, 
Member States should be required to send a report on the application of the Directive 
to the Commission. The Commission should then draw up and publish a summary of 
the reports. 

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

(36)  Since the objective of this Directive, namely to ensure that lifts and safety components 
for lifts on the market fulfil the requirements  providing a high level  of  protection of 
health and safety and other public interests while guaranteeing the functioning of the 
internal  market,  cannot  be  sufficiently  achieved  by  the  Member  States  and  can 
therefore,  by  reason  of  its  scale  and  effects,  be  better  achieved  at  Union  level,  the 
Union may adopt measures, in accordance with the principle of subsidiarity as set out 
in  Article  5  of  the  Treaty  on  European  Union.  In  accordance  with  the  principle  of 
proportionality,  as  set  out  in  that  Article,  this  Directive  does  not  go  beyond  what  is 
necessary in order to achieve that objective. 

(cid:208) 95/16/EC recital 9 (adapted) 
(cid:214) new 

(37)  Whereas provisions should be made ⌦ It is necessary to provide ⌫ for transitional 
arrangements to enable installers to place on the market lifts manufactured before the 
date of implementation of this Directive; (cid:214) that allow making available on the market 
and  putting  into  service  of  lifts  that  have  already  been  placed  on  the  market  in 
accordance with Directive 95/16/EC.   

(38) 

It is necessary to provide for transitional arrangements that allow making available on 
the market of safety components for lifts that have already been placed on the market 
in accordance with Directive 95/16/EC. 

(cid:216) new 

EN 

17 

   EN 

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

(40)  This  Directive  should  be  without  prejudice  to  the  obligations  of  the  Member  States 
relating  to  the  time-limits  for  transposition  into  national  law  and  application  of  the 
Directives set out in Annex XIII, Part B. 

HAVE ADOPTED THIS DIRECTIVE: 

CHAPTER I 

(cid:208) 95/16/EC (adapted) 

SCOPE, PLACING ON THE MARKET AND FREE MOVEMENT 

⌦ GENERAL PROVISIONS ⌫ 

Article 1 

⌦ Scope ⌫ 

1. This Directive shall apply to lifts permanently serving buildings and constructions It shall 
also apply to the safety components for use in such lifts listed in Annex IV . 

2.  For  the  purposes  of  this  Directive,  ‘lift’  shall  mean  a  lifting  appliance  serving  specific 
levels, having a carrier moving along guides which are rigid and inclined at an angle of more 
than 15 degrees to the horizontal, and intended for the transport of: 

(cid:208) 2006/42/EC Art. 24.1 (adapted) 

(cid:208) 2006/42/EC Art. 24.1 

(a) 

- persons,; 

(b) 

- persons and goods,; 

- goods alone if the carrier is accessible, that is to say a person may enter it without 
(c) 
difficulty, and fitted with controls situated inside the carrier or within reach of a person inside 
the carrier. 

⌦ This Directive shall also apply to the safety components for lifts for use in such lifts listed 
in Annex III. ⌫ 

(cid:208) 95/16/EC (adapted) 

EN 

18 

   EN 

 
 
 
 
 
Lifting appliances moving along a fixed course even where they do not move along guides 
which are rigid shall be considered as lifts falling within the scope of this Directive. 

(cid:208) 2006/42/EC Art. 24.1 (adapted) 

(cid:208) 2006/42/EC Art. 24.1  

3.2. This Directive shall not apply to: 

(a) 

- lifting appliances whose speed is not greater than 0,15 m/s; 

(b) 

- construction site hoists; 

(c) 

- cableways, including funicular railways; 

(d) 

- lifts specially designed and constructed for military or police purposes; 

(e) 

- lifting appliances from which work can be carried out; 

(f) 

- mine winding gear; 

(g) 

- lifting appliances intended for lifting performers during artistic performances; 

(h) 

- lifting appliances fitted in means of transport; 

-  lifting  appliances  connected  to  machinery  and  intended  exclusively  for  access  to 

(i) 
workstations including maintenance and inspection points on the machinery; 

(j) 

- rack and pinion trains; 

(k) 

- escalators and mechanical walkways. 

(cid:208) 95/16/EC (adapted) 

5.3. Where,  for  lifts  ⌦ or  safety  components  for  lifts ⌫,  the  risks  referred  to  in  this 
Directive  are  wholly  or  partly  covered  by  specific  Directives  ⌦ Union  legislation,  and  in 
particular  Directive  2006/42/EC20  and  Directive  2004/108/EC21, ⌫  this  Directive  shall  not 
apply or shall cease to apply in the case of such lifts ⌦ or safety components for lifts ⌫ and 
these  ⌦ that ⌫  specific  Directives  ⌦ Union 
such  risks  as  from  application  of 
legislation. ⌫ 

Article 2 [Article R1 of Decision No 768/2008/EC] 

⌦ Definitions ⌫ 

4. For the purposes of this Directive ⌦ the following definitions apply ⌫ : 

20 
21 

OJ L 157, 9.06.2006, p. 24. 
OJ No L 390, 31.12.2004, p. 24. 

EN 

19 

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(cid:208) 2006/42/EC Art. 24.1 (adapted) 

⌦ (1) 'lift’ means a lifting appliance serving specific levels, having a carrier moving along 
guides which are rigid and inclined at an angle of more than 15 degrees to the horizontal, or a 
lifting appliance moving along a fixed course even where it does not move along rigid guides; 
⌫ 

(2) A 'carrier' means a part of the lift by which persons and/or goods are supported in order to 
be lifted or lowered,; 

(cid:208) 95/16/EC (adapted) 

(3)-  a  'model  lift'  shall  mean  ⌦ means ⌫  a  representative  lift  whose  technical  dossier 
⌦ file ⌫ shows the way in which the essential ⌦ health and ⌫ safety requirements ⌦ set 
out in Annex I ⌫ will be met for lifts which conform to the model lift defined by objective 
parameters and which uses identical safety components ⌦ for lifts ⌫,;  

(4)-  the  ‘installer  of  a  lift'  shall  mean  ⌦ means ⌫  the  natural  or  legal  person  who  takes 
responsibility  for  the  design,  manufacture,  installation  and  placing  on  the  market  of  the  lift 
and who affixes the CE marking and draws up the EC declaration of conformity,; 

– 

– 

– 

«placing on the market of the lift» shall occur when the installer first makes the lift 
available to the user, 

«safety component» shall mean a component as listed in Annex IV, 

the «manufacturer of the safety components» shall mean the natural or legal person 
who  takes  responsibility  for  the  design  and  manufacture  of  the  safety  components 
and who affixes the CE marking and draws up the EC declaration of conformity, 

(cid:216) new 

(5)  ‘making  available  on  the  market’  means  any  supply  of  a  safety  component  for  lifts  for 
distribution or use on the Union market or any supply of a lift for use on the Union market in 
the course of a commercial activity, whether in return for payment or free of charge; 

(6) 'placing on the market' means the first making available of a lift or a safety component for 
lifts on the Union market; 

(7)  'manufacturer'  means  any  natural  or  legal  person  who  manufactures  a  safety  component 
for lifts or has a safety component for lifts designed or manufactured and markets it under his 
name or trademark; 

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

(9) ‘importer’ means any natural or legal person established  within the  Union who places a 
safety component for lifts from a third country on the Union market; 

EN 

20 

   EN 

 
 
 
(10)  ‘distributor’  means  any  natural  or  legal  person  in  the  supply  chain,  other  than  the 
manufacturer or the importer, who makes a safety component for lifts available on the market; 

(11)  ‘economic  operators’  means  the  manufacturer  or  his  authorised  representative,  the 
importer or the distributor of a safety component for lifts or the installer; 

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

(13) ‘technical specification" means a document that prescribes technical requirements to be 
fulfilled by a lift or a safety component for lifts; 

(14)  ‘conformity  assessment’  means  the  process  demonstrating  whether  the  essential  health 
and  safety  requirements  set  out  in  Annex  I  relating  to  a  lift  or  a  safety  component  for  lifts, 
process and system have been fulfilled; 

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

(16) ‘recall’ means any measure aimed at achieving the return of a safety component for lifts 
that has already been made available to the installer; 

(17)  ‘withdrawal’  means  any  measure  aimed  at  preventing  a  lift  from  being  placed  on  the 
market or a safety component for lifts from being made available on the market; 

(18) ‘CE marking’ means a marking by which the installer or the manufacturer indicates that 
the lift or safety component for lifts are in conformity with the applicable requirements set out 
in Union harmonisation legislation providing for its affixing; 

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

(cid:208) 95/16/EC (adapted) 
(cid:214) new 

Article 43 

⌦ Freedom of movement ⌫ 

1. Member States may not prohibit, restrict or impede the placing (cid:214) making available  on 
the market or putting into service on their territory of lifts and/or (cid:214) the making available on 
the market of  safety components ⌦ for lifts on their territory ⌫ which comply with this 
Directive. 

2.  Member  States  may  not  prohibit,  restrict  or  impede  the  placing  on  the  market  of 
components  (cid:214) not  covered  by  Annex  III  which,  on  the  basis  of  a  declaration  by  the 
manufacturer  or  his  authorised  representative  established  in  the  Community ⌦ Union ⌫  , 
are intended to be incorporated into a lift covered by this Directive. 

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3.5.  At  trade  fairs,  exhibitions  or  demonstrations  in  particular,  Member  States  shall  not 
prevent the showing of lifts or safety components ⌦ for lifts ⌫ which do not conform to the 
Community provisions in force ⌦ are not in conformity with this Directive ⌫, provided that 
a  visible  sign  clearly  indicates  that  ⌦ they  ⌫  such  lifts  or  safety  components  are  not  in 
conformity  and  ⌦ will  not  be  made  available ⌫  are  not  for  sale  until  they  have  been 
brought into conformity by the installer of the lift, the manufacturer of the safety components 
or the latter's authorized representative established in the Community. During demonstrations, 
adequate safety measures shall be taken to ensure the protection of persons. 

4.  Without  prejudice  to  paragraphs  1,  2  and  3,  the  provisions  of  tThis  Directive  shall  not 
affect Member States' entitlement to lay down in conformity with the Treaty ⌦ legislation of 
the  Union ⌫  such  requirements  as  they  may  deem  necessary  to  ensure  that  persons  are 
protected when the lifts in question are put into service or used, provided that this does not 
mean that the lifts are modified in a way not specified in the ⌦ this ⌫ Directive.  

Article 42  

⌦ Making available on the market ⌫ 

1. Member States shall take all appropriate measures to ensure that ⌦ the ⌫ - lifts covered 
by this Directive may be placed on the market and put into service only if they are not liable 
to ⌦ do not ⌫ endanger the health or safety of persons or, where appropriate, the safety of 
property, when properly installed and maintained and used for their intended purpose. 

⌦ 2.  Member  States  shall  take  all  appropriate  measures  to  ensure  that ⌫  -  safety 
components ⌦ for lifts ⌫ covered by this Directive may be placed (cid:214) made available  on 
the market and put into service only if the lifts in which they are to be installed are not liable 
to ⌦ do not ⌫ endanger the health or safety of persons or, where appropriate, the safety of 
property when properly installed and maintained and used for their intended purpose. 

Article 53 

⌦ Essential health and safety requirements ⌫ 

(cid:208) 95/16/EC  

1. Lifts covered by this Directive must satisfy the essential health and safety requirements set 
out in Annex I. 

2. The Ssafety components ⌦ for lifts ⌫ covered by this Directive must satisfy the essential 
health and safety requirements set out in Annex I or enable the lifts in which they are installed 
to satisfy ⌦ those ⌫ the said essential requirements. 

(cid:208) 95/16/EC (adapted) 

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Article 6 

⌦ Buildings or constructions in which lifts are installed ⌫ 

1. 2. Member States shall take all appropriate measures to ensure that the person responsible 
for  work  on  the  building  or  construction  and  the  installer  of  the  lift,  on  the  one  hand,  keep 
⌦ both provide ⌫ each  other ⌦ with the necessary information ⌫  informed  of  the  facts 
necessary for, and, on the other hand, take the appropriate steps ⌦ in order ⌫ to ensure the 
proper operation and safe use of the lift. 

2. 3. Member States shall take all necessary measures to ensure that shafts intended for lifts 
do not contain any piping or wiring or fittings other than that necessary for the operation and 
safety of the lift. 

(cid:208) 95/16/EC  

(cid:216) new 

CHAPTER II 

OBLIGATIONS OF ECONOMIC OPERATORS  

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

Obligations of installers  

1. When placing a lift on the market or putting a lift into service, installers shall ensure that it 
has been designed, manufactured, installed and tested in accordance with the essential health 
and safety requirements set out in Annex I.  

2.  Installers  shall  draw  up  the  technical  file  and  carry  out  the  applicable  conformity 
assessment procedure referred to in Article 16 or have it carried out. 

Where the compliance of the lift with the applicable requirements has been demonstrated by 
that  procedure,  the  installer  shall  draw  up  an  EU  declaration  of  conformity,  ensure  that  it 
accompanies the lift, and affix the CE marking.  

3.  The  installer  shall  keep  the  required  technical  file  and  the  EU  declaration  of  conformity 
and, where applicable, the approval decision(s) for 10 years after the lift has been placed on 
the market. 

4.  When  deemed  appropriate  with  regard  to  the  risks  presented  by  a  lift,  installers  shall,  to 
protect  the  health  and  safety  of  consumers  investigate,  and,  if  necessary,  keep  a  register  of 
complaints,  of  non-conforming  lifts  and  shall  keep  distributors  informed  of  any  such 
monitoring. 

5. Installers shall ensure that lifts bear a type, batch, serial number or other element allowing 
their identification. 

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6. Installers shall indicate their name, registered trade name or registered trade mark and the 
address at which they can be contacted. The address must indicate a single point at which the 
installer of lifts can be contacted. 

7. Installers shall ensure that the lift is accompanied by the instruction for use referred to in 
point  6.2  of  Annex  I,  in  a  language  which  can  easily  be  understood  by  end-users,  as 
determined by the Member State in which the lift is installed. 

8. Installers who consider or have reason to believe that a lift which they have installed is not 
in conformity with this Directive shall immediately take the necessary corrective measures to 
bring  that  lift  into  conformity.  Furthermore,  where  the  lift  presents  a  risk,  installers  shall 
immediately  inform  the  competent  national  authorities  of  the  Member  States  in  which  they 
installed the lift to that effect, giving details, in particular, of the non-conformity and of any 
corrective measures taken. 

9. Installers shall, further to a reasoned request from a competent national authority, provide it 
with  all  the  information  and  documentation  necessary  to  demonstrate  the  conformity  of  the 
lift, in a language which can be easily understood by that authority.  

They shall cooperate with that authority, at its request, on any action taken to eliminate the 
risks posed by lifts which they have installed. 

Article 8 [Article R2 of Decision No 768/2008/EC]  

Obligations of manufacturers  

1.  When  placing  safety  components  for  lifts  on  the  market,  manufacturers  shall  ensure  that 
they have been designed and manufactured in accordance with the essential health and safety 
requirements set out in Annex I. 

2.  Manufacturers  shall  draw  up  the  required  technical  file  and  carry  out  the  conformity 
assessment procedure referred to in Article 15 or have it carried out  

Where compliance of the safety component for lifts with the applicable essential health and 
safety requirements has been demonstrated by that procedure, the manufacturer shall draw up 
an  EU  declaration  of  conformity,  ensure  that  it  accompanies  the  safety  component  for  lifts 
and affix the CE marking. 

3. The manufacturer shall keep the technical file and the EU declaration of conformity and, 
where applicable, the approval decision(s) for 10 years after the safety component for lifts has 
been placed on the market. 

4.  When  deemed  appropriate  with  regard  to  the  risks  presented  by  a  safety  component  for 
lifts,  manufacturers  shall,  to  protect  the  health  and  safety  of  consumers,  carry  out  sample 
testing  of  safety  component  for  lifts  made  available  on  the  market,  investigate,  and,  if 
necessary,  keep  a  register  of  complaints,  of  non-conforming  safety  component  for  lifts  and 
recalls of the safety component for lifts, and shall keep distributors and installers informed of 
any such monitoring. 

5. Manufacturers shall ensure that their safety components for lifts bear a type, batch or serial 
number  or  other  element  allowing  their  identification,  or,  where  the  size  or  nature  of  the 

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safety component for lifts does not allow it, that the required information is provided on the 
packaging or in a document accompanying the safety component for lifts. 

6. Manufacturers shall indicate their name, registered trade name or registered trade mark and 
the address at which they can be contacted on the safety component for lifts or, where that is 
not possible, a label inseparably attached to the safety component for lifts. The address must 
indicate a single point at which the manufacturers can be contacted. 

7.  Manufacturers  shall  ensure  that  the  safety  component  for  lifts  is  accompanied  by  the 
instruction  manual  referred  to  in  Point  6.1  of  Annex  I,  in  a  language  which  can  easily  be 
understood by end-users, as determined by the Member State concerned. 

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

9.  Manufacturers  shall,  further  to  a  reasoned  request  from  a  competent  national  authority, 
provide  it  with  all  the  information  and  documentation  necessary  to  demonstrate  the 
conformity of the safety components for lifts, in a language which can be easily understood 
by that authority.  

They shall cooperate with that authority, at its request, on any action taken to eliminate the 
risks posed by safety components for lifts which they have placed on the market. 

Article 9 [Article R3 of Decision No 768/2008/EC]  

Authorised representatives  

1. A manufacturer may, by a written mandate, appoint an authorised representative.  

2. The obligations laid down in Article 8(1) and the drawing up of the technical file referred 
to in Article 8(2) shall not form part of the authorised representative’s mandate. 

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

(a)  keep  the  EU  declaration  of  conformity  and,  where  applicable,  the  approval  decision(s) 
relating to the manufacturer's quality assurance system, and the technical file at the disposal 
of the national surveillance authorities for a period of 10 years after the safety component for 
lifts has been placed on the market;  

(b) further to a reasoned request from a competent national authority, provide that authority 
with  all  the  information  and  documentation  necessary  to  demonstrate  the  conformity  of  the 
safety components for lifts; 

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

Article 10 [Article R4 of Decision No 768/2008/EC]  

Obligations of importers of safety components for lifts 

1. Importers shall place only compliant safety components for lifts on the market. 

2. Before placing a safety component for lifts on the market, importers shall ensure that the 
appropriate conformity assessment procedure has been carried out by the manufacturer. They 
shall ensure that the manufacturer has drawn up the technical file, that the safety component 
for lifts bears the CE marking and is accompanied by the EU declaration of conformity and 
the instruction manual and that the manufacturer has complied with the requirements set out 
in Article 8(5) and 8(6).  

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

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

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

5. Importers shall ensure that, while a safety component for lifts is under their responsibility, 
storage or transport conditions do not jeopardise its compliance with the essential health and 
safety requirements set out in Annex I. 

6.  When  deemed  appropriate  with  regard  to  the  risks  presented  by  a  safety  component  for 
lifts, importers shall, to protect the health and safety of consumers, carry out sample testing of 
safety components for lifts made available on the market, investigate, and, if necessary, keep 
a register of complaints, of non-conforming safety components for lifts and safety component 
for lifts recalls, and shall keep distributors and installers informed of such monitoring. 

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

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8. Importers shall, for a period of 10 years after the safety component for lifts has been placed 
on  the  market,  keep  a  copy  of  the  EU  declaration  of  conformity  and,  where  applicable,  the 
approval decision(s) at the disposal of the market surveillance authorities and ensure that the 
technical file can be made available to those authorities, upon request. 

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

Article 11 [Article R5 of Decision No 768/2008/EC] 

Obligations of distributors  

1.  When  making  a  safety  component  for  lifts  available  on  the  market  distributors  shall  act 
with due care in relation to the requirements of this Directive. 

2. Before making a safety component for lifts available on the market, distributors shall verify 
that  the  safety  component  for  lifts  bears  the  CE  marking,  that  it  is  accompanied  by  the  EU 
declaration  of  conformity  and  by  the  instruction  manual  and  that  the  manufacturer  and  the 
importer  have  complied  with  the  requirements  set  out  in  Article  8(5)  and  8(6),  and  Article 
10(3).  

Where a distributor considers or has reason to believe that a safety component for lifts is not 
in conformity with the essential health and safety requirements  set out in Annex 1, he shall 
not make the safety component for lifts available on the market until it has been brought into 
conformity. Furthermore, where the safety component for lifts presents a risk, the distributor 
shall inform the manufacturer or the importer to that effect as well as the market surveillance 
authorities. 

3.  Distributors  shall  ensure  that,  while  a  safety  component  for  lifts  is  under  their 
responsibility,  storage  or  transport  conditions  do  not  jeopardise  its  compliance  with  the 
essential health and safety requirements set out in Annex I. 

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

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

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Article 12 [Article R6 of Decision No 768/2008/EC]  

Cases in which the obligations of manufacturers apply to importers or distributors  

An  importer  or  distributor  shall  be  considered  a  manufacturer  for  the  purposes  of  this 
Directive and he shall be subject to the obligations of the manufacturer under Article 8 where 
he places a safety component for lifts on the market under his name or trademark or modifies 
a safety component for lifts already placed on the market in such a way that compliance with 
the requirements of this Directive may be affected. 

Article 13 [Article R7 of Decision No 768/2008/EC] 

Identification of economic operators 

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

(a) 

(b) 

any economic operator who has supplied them with a safety component for lifts; 

any economic operator to whom they have supplied a safety component for lifts. 

Economic operators shall be able to present the information referred to in the first paragraph 
for a period of 10 years after they have been supplied with a safety component for lifts and for 
a period of 10 years after they have supplied a safety component for lifts. 

(cid:208) 95/16/EC (adapted) 

CHAPTER III  

⌦ CONFORMITY OF LIFTS AND SAFETY COMPONENTS FOR 
LIFTS ⌫ 

Article 14 [Article R8 of Decision No 768/2008/EC] 

⌦ Presumption of conformity ⌫ 

1.  Member  States  shall  regard  lifts  and  safety  components  bearing  the  CE  marking  and 
accompanied by the EC declaration of conformity referred to in Annex II as conforming to all 
the provisions of this Directive, including the conformity assessment procedures laid down in 
Chapter II. 

In  the  absence  of  harmonized  standards,  Member  States  shall  take  any  steps  they  deem 
necessary  to  bring  to  the  attention  of  the  parties  concerned  the  existing  national  technical 
standards  and  specifications  which  are  regarded  as  important  or  relevant  to  the  proper 
implementation of the essential health and safety requirements in Annex I.  

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(cid:208) 95/16/EC 

2. Where a national standard transposing a harmonized standard, the reference for which has 
been published in the Official Journal of the European Communities, covers one or more of 
the essential health and safety requirements:  

lifts  constructed  in  accordance  with  that  standard  shall  be  presumed  to  comply  with 

– 
the relevant essential requirements.  

or  

– 
safety  components  constructed  in  accordance  with  that  standard  shall  be  presumed 
suitable  to  enable  a  lift  on  which  they  are  correctly  installed  to  comply  with  the  relevant 
essential requirements .  

Member  States  shall  publish  the  references  of  national  standards  transposing  harmonized 
standards. 

3.  Member  States  shall  ensure  that  appropriate  measures  are  taken  to  enable  both  sides  of 
industry to have an influence at national level on the process of preparing and monitoring the 
harmonized standards. 

(cid:208) 95/16/EC (adapted) 

(cid:216) new 

1. Lifts and safety components for lifts which are in conformity with harmonised standards or 
parts  thereof  the  references  of  which  have  been  published  in  the  Official  Journal  of  the 
European  Union  shall  be  presumed  to  be  in  conformity  with  the  essential  health  and  safety 
requirements covered by those standards or parts thereof set out in Annex I. 

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

(cid:208) 95/16/EC (adapted) 

Article 8 15 

⌦ Conformity assessment procedure for safety components for lifts ⌫ 

1. Before placing safety components listed in Annex IV on the market, the manufacturer of a 
safety component or his authorized representative established in the Community must:  

⌦ Safety components for lifts shall be subject to any of the following conformity assessment 
procedures: ⌫ 

(a) 

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(i) either submit the model of the safety component for EC type-examination in 
accordance  with  Annex  V  and  for  production  checks  by  a  notified  body  in 
accordance with Annex XI; 

(ii)  or  submit  the  model  of  the  safety  component  for  EC  type-examination  in 
accordance  with  Annex  V  and  operate  a  quality  assurance  system  in 
accordance with Annex VIII for checking production; 

(iii) or operate a full quality assurance system in accordance with Annex IX; 

⌦ (a) the model of the safety component for lifts shall be submitted for EU type examination 
set out in Annex IV Part A and the conformity to type shall be ensured with random checking 
of the safety component for lifts set out in Annex IX; ⌫ 

⌦ (b) the model of the safety component for lifts shall be submitted for EU type examination 
set out in Annex IV Part A and be subject to a product quality assurance system in accordance 
with Annex VI; ⌫ 

⌦ (c) full quality assurance system set out in Annex VII. ⌫ 

(b)  affix  the  CE  marking  on  each  safety  component  and  draw  up  a  declaration  of 
conformity  containing  the  information  listed  in  Annex  II,  taking  account  of  the 
specifications given in the Annex used (Annex VIII, IX or XI as the case may be); 

(c) keep a copy of the declaration of conformity for 10 years from the date on which 
the safety component was last manufactured.  

(cid:208) 95/16/EC (adapted) 

Article 16  

⌦ Conformity assessment procedure for lifts ⌫ 

1.2.  Before  being  placed  ⌦ Lifts  shall  be  subject  to ⌫  on  the  market,  a  lift  must  have 
undergone one of the following ⌦ conformity assessment ⌫ procedures: 

(i) either, if it was designed in accordance with a lift having undergone an EC type-
examination as referred to in Annex V, it shall be constructed, installed and tested by 
implementing: 

– 

– 

– 

the final inspection referred to in Annex VI, or 

the quality assurance system referred to in Annex XII, or 

the quality assurance system referred to in Annex XIV. 

The  procedures  for  the  design  and  construction  stages,  on  the  one  hand,  and  the 
installation and testing stages, on the other, may be carried out on the same lift; 

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(ii)  or,  if  it  was  designed  in  accordance  with  a  model  lift  having  undergone  an  EC 
type-examination  as  referred  to  in  Annex  V,  it  shall  be  constructed,  installed  and 
tested by implementing: 

– 

– 

– 

the final inspection referred to in Annex VI, or 

the quality assurance system referred to in Annex XII, or 

the quality assurance system referred to in Annex XIV; 

(iii)  or,  if  it  was  designed  in  accordance  with  a  lift  for  which  a  quality  assurance 
system pursuant to Annex XIII was implemented, supplemented by an examination 
of the design if the latter is not wholly in accordance with the harmonized standards, 
it shall be installed and constructed and tested by implementing, in addition: 

– 

– 

– 

the final inspection referred to in Annex VI, or 

the quality assurance system in accordance with Annex XII, or 

the quality assurance system in accordance with Annex XIV; 

(iv) or, having undergone the unit verification procedure, referred to in Annex X, by 
a notified body; 

(v) or, having been subject to the quality assurance system in accordance with Annex 
XIII,  supplemented  by  an  examination  of  the  design  if  the  latter  is  not  wholly  in 
accordance with the harmonized standards. 

In the cases referred to in (i), (ii) and (iii) above, the person responsible for the design must 
supply  to  the  person  responsible  for  the  construction,  installation  and  testing  all  necessary 
documents and information for the latter to be able to operate in absolute security. 

(cid:208) 95/16/EC (adapted) 

⌦ (a)  if  they  are  designed  and  manufactured  in  accordance  with  a  model  lift  that  has 
undergone an EU type-examination referred to in Annex IV Part B, they shall be installed and 
tested by carrying out any of the following procedures: ⌫ 

⌦ (i) the final inspection referred to in Annex V; ⌫ 
⌦ (ii) the product quality assurance system referred to in Annex X; ⌫ 
⌦ (iii) the production quality assurance system referred to in Annex XII; ⌫ 

⌦ (b) if they are designed and manufactured in accordance with a model lift for which a full 
quality  assurance  system  pursuant  to  Annex  XI  has  been  carried  out,  supplemented  by  a 
design examination if the design is not wholly in accordance with the harmonized standards, 
they shall be installed and tested by carrying out any of the following procedures: ⌫ 

⌦ (i) the final inspection referred to in Annex V; ⌫ 
⌦ (ii) the product quality assurance system in accordance with Annex X; ⌫ 
⌦ (iii) the production quality assurance system in accordance with Annex XII; ⌫ 

⌦ (c) the unit verification procedure, referred to in Annex VIII; ⌫ 

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⌦ (d) the full quality assurance system referred to in Annex XI, supplemented by a design 
examination if the design is not wholly in accordance with the harmonized standards. ⌫ 

⌦ 2. In the cases referred to in point (a) and (b) of paragraph 1, the person responsible for 
the  design  and  manufacture  of  the  lift  must  supply  to  the  person  responsible  for  the 
installation and testing of the lift all the necessary documents and information to enable the 
latter to ensure correct and safe installation and testing of the lift. ⌫ 

3. In all the cases referred to in paragraph 2: 

(cid:208) 95/16/EC 

the  installer  shall  affix  the  CE  marking  on  the  lift  and  draw  up  a  declaration  of 
– 
conformity containing the information listed in Annex II, taking account of the specifications 
given in the Annex used (Annex VI, X, XII, XIII or XIV, as the case may be), 
– 
date on which the lift was placed on the market, 

the installer must keep a copy of the declaration of conformity for 10 years from the 

– 
the  Commission,  the  Member  States  and  the  other  notified  bodies  may,  on  request, 
obtain  from  the  installer  a  copy  of  the  declaration  of  conformity  and  reports  of  the  tests 
involved in the final inspection. 

4.  (a)  Where  the  lifts  or  safety  components  are  subject  to  other  Directives  concerning  other 
aspects and which also provide for the affixing of the CE marking, the latter shall indicate that 
the  lift  or  safety  component  is  also  presumed  to  conform  to  the  provisions  of  those  other 
Directives. 

(b) However, where one or more of these Directives allows the manufacturer, during a 
transitional  period,  to  choose  which  arrangements  to  apply,  the  CE  marking  shall  indicate 
conformity only to the Directives applied by the installer of the lift or the manufacturer of the 
safety  components.  In  this  case,  particulars  of  the  Directives  applied,  as  published  in  the 
Official  Journal  of  the  European  Communities,  must  be  given  in  the  documents,  notices  or 
instructions required by the Directives and accompanying the lift or safety component. 

5. Where neither the installer of the lift nor the manufacturer of the safety component nor his 
authorized representative established in the Community has complied with the obligations of 
the preceding paragraphs, those obligations shall devolve upon whomsoever places the lift or 
the safety component on the market in the Community. The same obligations shall apply to 
whomsoever manufactures the lift or safety component for his own use. 

(cid:208) 95/16/EC (adapted) 

3. All permitted variations between the model lift and the lifts forming part of the lifts derived 
from  the  model  lift  must  be  clearly  specified  (with  maximum  and  minimum  values)  in  the 
technical dossier ⌦ file ⌫. 

4.  By  calculation  and/or  on  the  basis  of  design  plans  it  is  permitted  to  demonstrate  the 
similarity  of  a  range  of  equipment  to  satisfy  the  essential  ⌦ health  and ⌫  safety 
requirements ⌦ set out in Annex I ⌫.  

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Article 17 [Article R10 of Decision No 768/2008/EC]  

⌦ EU declaration of conformity ⌫ 

(cid:216) new 

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

2. The EU declaration of conformity shall have the model structure set out in Annex II, shall 
contain the elements specified in the relevant modules set out in Annex V, VIII, X, XI or XII, 
and  shall  be  continuously  updated.  It  shall  be  translated  into  the  language  or  the  languages 
required  by  the  Member  State  on  which  market  the  lift  or  the  safety  component  for  lifts  is 
placed or made available. 

3.  Where  a  lift  or  the  safety  component  for  lifts  is  subject  to  more  than  one  Union  act 
requiring EU declaration of conformity, a single EU declaration of conformity shall be draw 
up  in  respect  of  all  such  Union  acts.  That  declaration  shall  contain  the  identification  of  the 
acts concerned including the publication references.  

4.  By  drawing  up  the  EU  declaration  of  conformity,  the  manufacturer  shall  assume 
responsibility  for  the  compliance  of  the  safety  component  for  lifts  and  the  installer  shall 
assume responsibility for the compliance of the lift. 

(cid:208) 95/16/EC (adapted) 

CHAPTER III 

CE MARKING 

Article 18 [Article R11 of Decision No 768/2008/EC] 

⌦ General principles of the CE marking ⌫ 

(cid:216) new 

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

(cid:208) 95/16/EC (adapted) 

Article 1910 [Article R12 of Decision No 768/2008/EC]  

 ⌦ Rules and conditions for affixing the CE marking and other markings ⌫ 

1. The CE marking shall consist of the initials CE. Annex III sets out the model to be used. 

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1.2.  The  CE  marking  shall  be  affixed ⌦ visibly, legibly and indelibly ⌫ to every ⌦ each 
⌫ lift car distinctly and visibly in accordance with Section 5 of Annex I and shall be affixed 
on each of the safety components ⌦ for lifts ⌫ listed in Annex III IV or, where that is not 
possible, on a label inseparably attached to the safety component.  

3. The affixing on the lifts or safety components of markings which are likely to mislead third 
parties as to the meaning and form of the CE marking shall be prohibited. Any other marking 
may be affixed to the lifts or safety components, provided that the visibility and legibility of 
the CE marking are not thereby reduced. 

4. Without prejudice to Article 7: 

(a) 

(b) 

where a Member State establishes that the CE marking has been affixed irregularly, 
the  installer  of  the  lift,  the  manufacturer  of  the  safety  component  or  the  authorized 
representative  of  the  latter  established  within  the  Community  shall  be  obliged  to 
make the product conform as regards the provisions concerning the CE marking and 
to end the infringement under the conditions imposed by the Member State; 

should non-conformity persist, the Member State must take all appropriate measures 
to restrict or prohibit the placing on the market of the safety component in question 
or to ensure that it is withdrawn from the market and prohibit the lift from being used 
and inform the other Member States in accordance with the procedures laid down in 
Article 7 (4). 

2.  The  CE  marking  shall  be  affixed  before  the  lifts  or  the  safety  components  for  lifts  are 
placed on the market. 

(cid:216) new 

(cid:208) 95/16/EC (adapted) 

⌦3. The CE marking on lifts shall be followed by the identification number of the notified 
body involved in the following conformity assessment procedures: ⌫ 

⌦ (a) the final inspection referred to in Annex V or approval of the quality assurance system 
(referred to in Annex X, XI or XII); ⌫ 

⌦ (b) the unit verification procedure, referred to in Annex VIII; ⌫ 

⌦ (c) the approval of the full quality assurance system referred to in Annex XI. ⌫ 

⌦ 4. The CE marking on safety components for lifts shall be followed by the identification 
number of the notified body involved in the following conformity assessment procedures: ⌫ 

⌦ (a) the approval of the product quality assurance system referred to in Annex VI; ⌫ 

⌦ (b) the approval of the full quality assurance system referred to in Annex VII. ⌫ 

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(cid:216) new 

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

The CE marking and, where applicable, the identification number referred to in paragraph 3 
and 4 may be followed by a pictogram or any other mark indicating a special risk or use. 

(cid:208) 95/16/EC (adapted) 

Article 9 

1.  Member  States  shall  notify  the  Commission  and  the  other  Member  States  of  the  bodies 
which they have appointed to carry out the procedures referred to in Article 8, together with 
the  specific  tasks  and  examination  procedures  which  these  bodies  have  been  appointed  to 
carry out and the identification numbers assigned to them beforehand by the Commission. 

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

2.  Member  States  shall  apply  the  criteria  laid  down  in  Annex  VII  in  assessing  the  notified 
bodies.  Bodies  meeting  the  assessment  criteria  laid  down  in  the  relevant  harmonized 
standards shall be presumed to fulfil the criteria laid down in Annex VII. 

3. A Member State which has notified a body must withdraw its notification if it finds that the 
body  no  longer  meets  the  criteria  laid  down  in  Annex  VII.  It  shall  immediately  inform  the 
Commission and the other Member States accordingly. 

(cid:216) new 

CHAPTER IV  

NOTIFICATION OF CONFORMITY ASSESSMENT BODIES  

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

Notification 

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

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

Notifying authorities 

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

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

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

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

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

Requirements relating to notifying authorities 

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

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

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

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

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

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

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

Information obligation on notifying authorities 

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

The Commission shall make that information publicly available. 

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

Requirements relating to notified bodies 

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

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

3. A conformity assessment body shall be a third-party body independent of the organisation 
or the lifts or safety components for lifts it assesses. 

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

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

A  conformity  assessment  body,  its  top  level  management  and  the  personnel  responsible  for 
carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, 
installer, purchaser, owner, user or maintainer of lifts which they assess.  

This  shall  not  preclude  the  use  of  assessed  lifts  or  safety  components  for  lifts  that  are 
necessary  for  the  operations  of  the  conformity  assessment  body  or  the  use  of  such  lifts  or 
safety components for lifts for personal purposes.  

This  does  not  preclude  the  possibility  of  exchange  of  technical  information  between  the 
manufacturer or the installer and the body.  

A  conformity  assessment  body,  its  top  level  management  and  the  personnel  responsible  for 
carrying  out  the  conformity  assessment  tasks  shall  not  be  directly  involved  in  the  design, 
manufacture or construction, the marketing, installation, use or maintenance of those lifts or 
safety components for lifts, or represent the parties engaged in those activities.  

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They shall not engage in any activity that may conflict with their independence of judgement 
or  integrity  in  relation  to  conformity  assessment  activities  for  which  they  are  notified.  This 
shall in particular apply to consultancy services. 

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

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

6.  A  conformity  assessment  body  shall  be  capable  of  carrying  out  all  the  conformity 
assessment  tasks  assigned  to  it  by  Article  15  and  16  and  in  relation  to  which  it  has  been 
notified, whether those tasks are carried out by the conformity assessment body itself or on its 
behalf and under its responsibility.  

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

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

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

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

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

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

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

(b) satisfactory knowledge of the requirements of the assessments they carry out and adequate 
authority to carry out those assessments; 

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(c) appropriate knowledge and understanding of the essential health and safety requirements 
set out in Annex I, of the applicable harmonised standards and of the relevant provisions of 
Union harmonisation legislation and of its relevant national legislation; 

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

8.  The  impartiality  of  the  conformity  assessment  body,  its  management  and  the  personnel 
responsible for carrying out the conformity assessment tasks shall be guaranteed.  

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

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

10.  The  personnel  of  a  conformity  assessment body  shall  observe  professional  secrecy  with 
regard to all information obtained in carrying out their tasks according to Article 15 and 16 or 
any provision of national law giving effect to it, except in relation to the competent authorities 
of  the  Member  State  in  which  its  activities  are  carried  out.  Proprietary  rights  shall  be 
protected. 

11.  Conformity  assessment  bodies  shall  participate  in,  or  ensure  that  their  assessment 
personnel are informed of, the relevant standardisation activities.  

The body shall participate in or be represented in the activities of the Coordination Group of 
Notified  Bodies  for  Lifts  established  under  Article  36  and  apply  as  general  guidance  the 
recommendations for use produced as a result of the work of that group. 

Article 25 [Article R18 of Decision No 768/2008/EC] 

Presumption of conformity of a notified body 

Where a conformity assessment body demonstrates its conformity with the criteria laid down 
in  the  relevant  harmonised  standards  or  parts  thereof  the  references  of  which  have  been 
published in the Official Journal of the European Union it shall be presumed to comply with 
the requirements set out in Article 24 in so far as the applicable harmonised standards cover 
those requirements. 

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

Subsidiaries of and subcontracting by notified bodies 

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

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2. Notified bodies shall take full responsibility for the tasks performed by subcontractors or 
subsidiaries wherever these are established. 

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

4. Notified bodies shall keep at the disposal of the notifying authority the relevant documents 
concerning the assessment of the qualifications of the subcontractor or the subsidiary and the 
work carried out by them under Article 15 and 16. 

Article 27 [Article R22 of Decision No 768/2008/EC] 

Application for notification 

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

2.  That  application  shall  be  accompanied  by  a  description  of  the  conformity  assessment 
procedures  for  lifts  or  for  safety  components  for  lifts  for  which  the  body  claims  to  be 
competent,  as  well  as  by  an  accreditation  certificate,  where  one  exists,  issued  by  a  national 
accreditation body attesting that the conformity assessment body fulfils the requirements laid 
down in Article 24. 

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

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

Notification procedure 

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

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

3. The notification shall include full details of the conformity assessment procedures for lifts 
or for safety components for lifts concerned and the relevant attestation of competence. 

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

5. The body concerned may perform the activities of a notified body only where no objections 
are raised by the Commission or the other Member States within two weeks of a notification 

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where  an  accreditation  certificate  is  used  or  within  two  months  of  a  notification  where 
accreditation is not used. 

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

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

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

Identification numbers and lists of notified bodies 

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

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

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

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

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

Changes to notifications 

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

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

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

Challenge to the competence of notified bodies 

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

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

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

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

Article 32 [Article R27 of Decision No 768/2008/EC] 

Operational obligations of notified bodies 

1. Notified bodies shall carry out conformity assessments in accordance with the conformity 
assessment procedures provided for in Article 15 and 16. 

2.  Conformity  assessments  shall  be  carried  out  in  a  proportionate  manner,  avoiding 
unnecessary  burdens  for  economic  operators.  Notified  bodies  shall  perform  their  activities 
taking due account of the size of an undertaking, the sector in which it operates, its structure, 
the degree of complexity of lift or safety component for lifts technology in question and the 
mass or serial nature of the production process.  

In  so  doing  they  shall  nevertheless  respect  the  degree  of  rigour  and  the  level  of  protection 
required for the conformity of the lifts or the safety components for lifts with the provisions of 
this Directive. 

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

4. Where, in the course of the monitoring of conformity following the issue of a certificate or 
an approval decision, as appropriate, a notified body finds that a lift or a safety component for 
lifts no longer complies, it shall require the installer or the manufacturer to take appropriate 
corrective measures and shall suspend or withdraw the certificate or the approval decision if 
necessary. 

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

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Article 33 [Article 4(7) of Decision No 768/2008/EC] 

Appeal against decisions of notified bodies  

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

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

Information obligation on notified bodies 

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

(a) 

(b) 

(c) 

(d) 

any  refusal,  restriction,  suspension  or  withdrawal  of  a  certificate  or  approval 
decision; 

any circumstances affecting the scope of and conditions for notification; 

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

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

2.  Notified  bodies  shall  provide  the  other  bodies  notified  under  this  Directive  carrying  out 
similar conformity assessment activities for lifts or safety components for lifts with relevant 
information  on  issues  relating  to  negative  and,  on  request,  positive  conformity  assessment 
results. 

Article 35 [Article R29 of Decision No 768/2008/EC] 

Exchange of experience 

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

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

Coordination of notified bodies 

The Commission shall ensure that appropriate coordination and cooperation between bodies 
notified  under  this  Directive  are  put  in  place  and  properly  operated  in  the  form  of  a 
Coordination Group of Notified Bodies for Lifts.  

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

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CHAPTER V  

UNION MARKET SURVEILLANCE AND CONTROL OF LIFTS OR 
SAFETY COMPONENTS FOR LIFTS ENTERING THE UNION 
MARKET AND SAFEGUARD PROCEDURES  

Article 37 

Union market surveillance and control of lifts or safety components for lifts entering the 
Union market 

Article  15(3)  and  Articles  16-29  of  Regulation  (EC)  No  765/2008  shall  apply  to  lifts  and 
safety components for lifts. 

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

Procedure for dealing with lifts or safety components for lifts presenting a risk at national 
level  

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

Where,  in  the  course  of  the  evaluation  referred  to  in  the  first  subparagraph,  the  market 
surveillance  authorities  find  that  a  lift  does  not  comply  with  the  requirements  laid  down  in 
this Directive, they shall, without delay, require the installer to take all appropriate corrective 
action  to  bring  the  lift  into  compliance  with  those  requirements  within  a  reasonable  period 
commensurate with the nature of the risk, as they may prescribe.  

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

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

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

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

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

4. Where the installer does not take adequate corrective action within the period referred to in 
the  second  subparagraph  of  paragraph  1,  the  market  surveillance  authorities  shall  take  all 
appropriate provisional measures to restrict the placing on their national market or the putting 
into service.  

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

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

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

(a) failure of the lift or the safety component for lifts to meet the essential health and
safety requirements set out in Annex I;  

(b)  shortcomings  in  the  harmonised  standards  referred  to  in  Article  14  conferring  a
presumption of conformity. 

6. Member States other than the Member State initiating the procedure shall, without delay, 
inform  the  Commission  and  the  other  Member  States  of  any  measures  adopted  and  of  any 
additional information at their disposal relating to the non-compliance of the lift or the safety 
component  for  lifts  concerned  and,  in  the  event  of  disagreement  with  the  notified  national 
measure, of their objections. 

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

8. Member States shall ensure that appropriate restrictive measures are taken, without delay, 
in respect of the lift or the safety component for lifts concerned. 

EN 

45 

   EN 

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

Union safeguard procedure 

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

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

2. If the national measure relating to a lift is considered justified, all Member States shall take 
the measures necessary to ensure that the non-compliant lift is restricted to be placed on their 
national market or put into service.  

If  the  national  measure  relating  to  a  safety  component  for  lifts  is  considered  justified,  all 
Member  States  shall  take  the  measures  necessary  to  ensure  that  the  non-compliant  safety 
component for lifts is withdrawn from their market. 

The Member States shall inform the Commission accordingly. 

If the national measure is considered unjustified, the Member State concerned shall withdraw 
the measure. 

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

Article 40 [Article R33 of Decision No 768/2008/EC] 

Compliant lift or safety component for lifts which present a risk to health and safety 

1.  Where,  having  performed  an  evaluation  under  Article  38(1),  a  Member  State  finds  that 
although a lift or safety components for lifts is in compliance with this Directive, it presents a 
risk to the health or safety of persons or to other aspects of public interest protection, it shall 
require the relevant economic operator to take all appropriate measures to ensure that the lifts 
or safety component for lifts concerned, when placed on the market, no longer presents that 
risk, to withdraw the safety component for lifts from the market or to recall it or to restrict the 
placing  the  lift  on  the  market  or  the  putting  it  into  service  within  a  reasonable  period, 
commensurate with the nature of the risk, as it may prescribe. 

2. The economic operator shall ensure that corrective action is taken in respect of all the lifts 
or safety components for lifts concerned that he has made available on the market throughout 
the Union.  

EN 

46 

   EN 

3. The Member State shall immediately inform the Commission and the other Member States. 
That  information  shall  include  all  available  details,  in  particular  the  data  necessary  for  the 
identification of the lifts or safety components for lifts concerned, the origin and the supply 
chain of the lifts or safety components for lifts, the nature of the risk involved and the nature 
and duration of the national measures taken. 

4.  The  Commission  shall  without  delay  enter  into  consultation  with  the  Member  States  and 
the  relevant  economic  operator  or  operators  and  shall  evaluate  the  national  measures  taken. 
On  the  basis  of  the  results  of  that  evaluation,  the  Commission  shall  decide  whether  the 
measure is justified or not, and where necessary, propose appropriate measures. 

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

Article 41 [Article R34 of Decision No 768/2008/EC] 

Formal non-compliance 

1.  Without  prejudice  to  Article  38,  where  a  Member  State  makes  one  of  the  following 
findings, it shall require the installer or the manufacturer, distributor or importer of a safety 
component for lifts to put an end to the non-compliance concerned:  

(a) the CE marking has been affixed in violation Article 30 of Regulation (EC) No 765/2008 
or of Article 18 and 19 of this Directive; 

(b) the CE marking has not been affixed; 

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

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

(e) the technical file referred to in Annexes IV Part A and Part B, VII, VIII and XI is either 
not available or not complete. 

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

(cid:208) 95/16/EC (adapted) 

Article 6 

1. Where a Member State or the Commission considers that the harmonized standards referred 
to in Article 5 (2) do not entirely satisfy the essential requirements referred to in Article 3, the 
Commission or the Member State concerned shall bring the matter before the Committee set 
up under Directive 83/189/EEC, giving the reasons therefore. The Committee shall deliver an 
opinion without delay.  

EN 

47 

   EN 

 
Upon  receipt  of  the  Committee's  opinion,  the  Commission  shall  inform  the  Member  States 
whether  or  not  it  is  necessary  to  withdraw  those  standards  from  the  published  information 
referred to in Article 5 (2).  

2. The Commission may adopt any appropriate measure with a view to ensuring the practical 
application in a uniform manner of this Directive in accordance with the procedure laid down 
in paragraph 3.  

(cid:208) 95/16/EC 

(cid:208) 1882/2003 Art. 1 and Annex 
I.10 (new) 

3. The Commission shall be assisted by a standing committee (hereinafter referred to as ‘the 
Committee’). 

Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC22 shall 
apply, having regard to the provisions of Article 8 thereof. 

The Committee shall adopt its rules of procedure. 

4.  The  Standing  Committee  may,  furthermore,  examine  any  question  concerning  the 
application of this Directive and raised by its chairman either at the latter's initiative or at the 
request of a Member State.  

(cid:208) 95/16/EC 

Article 7 

1. Where a Member State ascertains that a lift or a safety component bearing the CE marking 
and used in accordance with its intended purpose is liable to endanger the safety of persons 
and, where appropriate, of property, it shall take all appropriate measures to withdraw it from 
the market, to prohibit it from being placed on the market or put into service or to restrict its 
free movement 

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

(a) 

failure to satisfy the essential requirements referred to in Article 3; 

(b) 

incorrect application of the standards referred to in Article 5 (2);  

(c) 

shortcomings in the standards referred to in Article 5 (2) themselves.  

2.  The  Commission  shall  enter  into  consultation  with  the  parties  concerned  as  soon  as 
possible. Where, after such consultation, the Commission finds that:  

22 

Council  Decision  1999/468/EC  of  28 June  1999  laying  down  the  procedures  for  the  exercise  of 
implementing powers conferred on the Commission (OJ L 184, 17.7.1999, p. 23). 

EN 

48 

   EN 

 
 
 
                                                 
- the measures are justified, it shall immediately so inform the Member State which took the 
initiative and the other Member States; where the decision referred to in paragraph 1 is based 
on  shortcomings  in  the  standards,  the  Commission  shall,  after  consulting  the  parties 
concerned, bring the matter before the Committee referred to in Article 6 (1), if the Member 
State  which  has  taken  the  decision  intends  to  maintain  it,  and  shall  initiate  the  procedure 
referred to in Article 6 (1),  

- the measures are unjustified, it shall immediately so inform the Member State which took 
the  initiative  and  the  installer  of  the  lift,  the  manufacturer  of  the  safety  components  or  the 
latter's authorized representative established in the Community.  

3.  Where  a  lift  or  safety  component  which  does  not  comply  bears  the  CE  marking,  the 
competent  Member  State  shall  take  appropriate  action  against  whomsoever  affixed  the 
marking and shall so inform the Commission and the other Member States.  

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

(cid:216) new 

CHAPTER VI  

DELEGATING POWER  

Article 42  

Delegating power  

The Commission shall be empowered to adopt delegated acts in accordance with Article 43 
concerning adaptations of Annex III to technical progress and new scientific evidence.  

Article 43 

Exercise of the delegation  

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions 
laid down in this Article.  

2. The delegation of  power referred to in Article 42 shall be conferred for an indeterminate 
period of time from the date specified in Article 49 [entry into force of the directive].  

3.  The  delegation  of  powers  referred  to  in  Article  42  may  be  revoked  at  any  time  by  the 
European  Parliament  or  by  the  Council.  A  decision  of  revocation  shall  put  an  end  to  the 
delegation  of  the  power  specified  in  that  decision.  It  shall  take  effect  the  day  following  the 
publication  of  the  decision  in  the  Official  Journal  of  the  European  Union  or  at  a  later  date 
specified therein. It shall not affect the validity of any delegated acts already in force.  

EN 

49 

   EN 

 
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the 
European Parliament and to the Council.  

5. A delegated act adopted pursuant to Article 42 shall enter into force only if no objection 
has  been  expressed  either  by  the  European  Parliament  or  the  Council  within  a  period  of  2 
months of notification of that act to the European Parliament and the Council or if, before the 
expiry  of  that  period,  the  European  Parliament  and  the  Council  have  both  informed  the 
Commission  that  they  will  not  object.  That  period  shall  be  extended  by  2  months  at  the 
initiative of the European Parliament or the Council. 

(cid:208) 95/16/EC (adapted) 

CHAPTER IV VII 

⌦ TRANSITIONAL AND ⌫ FINAL PROVISIONS 

Article 11 

Any decision taken pursuant to this Directive which restricts: 

- the placing on the market and/or putting into service and/or use of a lift, 

- the placing on the market and/or putting into service of a safety component, 

shall state the exact grounds on which it is based. Such a decision shall be notified as soon as 
possible to the party concerned, who shall at the same time be informed of the legal remedies 
available to him under the laws in force in the Member State concerned and of the time limits 
to which such remedies are subject. 

(cid:216) new 

Article 44  

Penalties 

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

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

Member States shall notify those provisions to the Commission by […the date set out in the 
second  subparagraph  of  Article  46(1)]  and  shall  notify  it  without  delay  of  any  subsequent 
amendment affecting them.  

EN 

50 

   EN 

 
 
(cid:208) 95/16/EC (adapted) 

Article 12 

The  Commission  shall  take  the  necessary  steps  to  have  information  on  all  the  relevant 
decisions relating to the implementation of this Directive made available. 

Article 45 

⌦ Transitional and final provisions ⌫ 

(cid:216) new 

Member States shall not impede the making available on the market or putting into service of 
lifts  or  safety  components  for  lifts  covered  by  Directive  95/16/EC  which  are  in  conformity 
with that Directive and which were placed on the market before [the date set out in the second 
subparagraph of Article 46(1)]. 

Certificates of conformity issued under Directive 95/16/EC shall be valid under this Directive 
unless they expire before that date. 

(cid:208) 95/16/EC (adapted) 
(cid:214) new 

Article 46 

 ⌦ Transposition ⌫ 

1.  Member  States  shall  adopt  and  publish,  ⌦ by ⌫  (cid:214) [day  (generally  the  last  day  of  a 
month)/month/year = 2 years after this adoption]  ⌦ at the latest, ⌫ the laws, regulations 
and  administrative  provisions  necessary  to  comply  with  this  Directive ⌦ Articles:  [Article 
2(5)-2(19),  Articles:  7-14,  Articles:  17-18,  Article  19(5),  Articles:  20-45,  Article  46(1), 
Article 47-49] and Annexes: [Annex II Part A Points: (f), (k), (l), (m), Annex II Part B Points: 
(d),  (j),  (k),  (l),  Annex  IV  Part  A  Points:  2(e),  3(c),  3(e),  3(g),  Points:  4(b)-(e),  Points:  5-9, 
Annex IV Part B Points: 2(e), 3(c), 3(e), 3(h), Points: 4(c)-(e), Point 5 paragraphs: 2-4, Points: 
6-9, Annex V Point 3.3(b), Points: 6-7, Annex VI Points: 3.1(a)-(c), Point 3.3 paragraph 4 -5, 
Point 4.3, Points: 6-7, Annex VII Points: 3.1(a)-(b), 3.1(d), 3.1(f), Point 3.3, Point 4.2, Point 
6, Annex VII Points: 3(c)-(d), 3(g), Annex VII Point 4, Annex IX Points: 3(a)-(d), Annex X 
Points: 3.1(a), 3.1(e), Point: 3.4, Points: 6-7, Annex XI Points: 3.1(a)-(c), 3.1(e), Points: 3.3.3, 
3.3.4, Points: 3.4 -3.5, Point 5(b) Point 6, Annex XII Point 3.1(a), Point 3.3, Point  6]. [The 
articles  and  annexes  which  have  been  changed  as  to  the  substance  by  comparison  with  the 
earlier Directive]. ⌫ by 1 January 1997. They shall forthwith inform ⌦ communicate to⌫ 
the Commission thereof ⌦ the text of those provisions and a correlation table between those 
provisions and this Directive. ⌫ 

(cid:214) They  shall  apply 
month)/month/year = day after the date mentioned in first subparagraph].  

those  provisions  from  [day  (generally 

the 

first  day  of  a 

EN 

51 

   EN 

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

Member States shall apply these measures with effect from 1 July 1997. 

2. Until 30 June 1999 Member States shall allow: 

– 

– 

the placing on the market and putting into service of lifts, 

the placing on the market and putting into service of safety components, 

which  conform  to  the  provisions  in  force  in  their  territories  on  the  date  of  adoption  of  this 
Directive.  

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

(cid:208) 95/16/EC (adapted) 

Article 16 47  

⌦ Reporting ⌫ 

(cid:208) 95/16/EC 

No  later  than  30  June  2002,  the  Commission  shall,  in  consultation  with  the  Committee 
referred  to  in  Article  6  (3)  and  on  the  basis  of  reports  provided  by  the  Member  States,  re-
examine  the  functioning  of  the  procedures  laid  down  in  this  Directive  and,  if  necessary, 
submit any proposals for appropriate amendments. 

[By  …  and  every  5  years  after  that  date]  Member  States  shall  submit  to  the  Commission 
reports on the application of this Directive. 

(cid:216) new 

(cid:208) 95/16/EC (adapted) 

Article 13 48 

⌦ Repeal ⌫ 

Directive 84/528/EEC and Directive 84/529/EEC are hereby repealed with effect from 1 July 
1999. 

EN 

52 

   EN 

 
 
 
 
 
 
With regard to the aspects concerning the installation of the lift, this Directive is a Directive 
within the meaning of Article 2 (3) of Directive 89/106/EEC. 

Article 14 

(cid:208) 95/16/EC 
(cid:214) new 

(cid:214) Directive 95/16/EC, as amended by the acts listed in Annex XIII, Part A, is repealed with 
effect  from  the  date  set  out  in  the  second  subparagraph  of  Article  46(1)  of  this  Directive, 
without  prejudice  to  the  obligations  of  the  Member  States  relating  to  the  time  limits  for 
transposition into national law of the Directives set out in Annex XIII, Part B.   

(cid:214) References to the repealed Directive shall be construed as references to this Directive and 
shall be read in accordance with the correlation table in Annex XIV.  

(cid:208) 95/16/EC (adapted) 

Article 49  

 ⌦ Entry into force ⌫ 

(cid:208)95/16/EC (adapted) 
(cid:214) new 

(cid:214) This Directive shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union.  

⌦ Articles:  [Article  1,  Article  2(1)-2(5),  Articles:  3-6,  Articles:  15-16,  Article  19(1)-19(4), 
Article 45, Article 46(2), Article 50] and Annexes: [Annex I, Annex II Part A Points: (a), (b), 
(c), (d), (e), (g), (h), (i), (j), Annex II Part B Points: (a), (b), (c), (e), (f), (g), (h), (i), Annex III, 
Annex IV Part A Points: 1, 2(a)-(d), 3(a)-(b), 3(d), 3(f), 3(h)-(i), Annex IV Part A Point 4(a), 
Points 10-11, Annex IV Part B Points: 1, 2(a)-(d), 3(a)-(b), 3(d), 3(f)-(g) 3(i)-(j), Points: 4(a)-
(b),  Point  5  paragraph  1,  Points:  10-11,  Annex  V  Points:  1-3.2,  Point  3.3(a),  Points:  3.4-5, 
Annex VI Points: 1-2, Point 3.1(d)-(f), Point 3.2, Point 3.3 paragraphs: 1-3, Points: 3.4-4.2, 
Point 5, Annex VII Points 1-2, Points: 3.1(c), 3.1(e), Point 3.2, Point 3.4, Point 4.1, Points: 
4.3-5, Point 7, Annex VII Points: 1-2, Points: 3(a)-(b), 3(e)-(f), 3(h), Points: 5-6, Annex IX 
Points: 1-2, Points: 4-7, Annex X Points: 1-2, Points: 3.1(b)-(d), Points: 3.2-3.3, Points: 4-5, 
Annex  XI  Points:  1-2,  Point:  3.1(d),  Point  3.2,  Point  3.3.1,  Point  4,  Point  5(a),  5(c),  5(d), 
Point 7, Annex XII Points: 1-2, Points 3.1(b)-(d), Point 3.2, Point 3.4, Points: 4-5, Point 7]. 
[The  articles  and  annexes  which  are  unchanged  by  comparison  with  the  earlier  Directive] 
shall apply from [the date set out in the second subparagraph of Article 46(1)]. ⌫ 

EN 

53 

   EN 

 
 
 
 
(cid:208) 95/16/EC 

Article 5017 

This Directive is addressed to the Member States. 

Done at […], 

For the European Parliament 
The President 

For the Council  
The President  

EN 

54 

   EN 

 
(cid:208) 95/16/EC (adapted) 

ANNEX I 

ESSENTIAL HEALTH AND SAFETY REQUIREMENTS RELATING TO THE 
DESIGN AND CONSTRUCTION OF LIFTS AND SAFETY COMPONENTS 

PRELIMINARY REMARKS 

1.  Obligations  under  essential  health  and  safety  requirements  apply  only  where  ⌦  the 
corresponding risk exists for ⌫the lift or safety component ⌦ for lifts ⌫ is subject to the 
hazard in question when used as intended by the installer of the lift or the manufacturer of the 
safety components. 

2.  The  essential  health  and  safety  requirements  contained  in  the  Directive  are  imperatives. 
However, given the present state of the art, the objectives which they lay down may not be 
attainable.  In  such  cases,  and  to  the  greatest  extent  possible,  the  lift  or  safety  components 
⌦ for  lifts ⌫  must  be  designed  and  built  in  such  a  way  as  to  approximate  to  those 
objectives. 

3.  The  safety-component  manufacturer  and  the  installer  of  the  lift  are  under  an  obligation 
⌦ to carry out ⌫ assess the hazards ⌦a risk assessment ⌫ in order to identify all those 
⌦ the  risks ⌫  which  apply  to  their  products;  they  must  then  design  and  construct  them 
taking account of the assessment. 

4.  In  accordance  with  Article  14,  the  essential  requirements  laid  down  in  Directive 
89/106/EEC, not included in this Directive, apply to lifts. 

(cid:208) 95/16/EC 

(cid:208) 95/16/EC (adapted) 

1. GENERAL 

1.1.  Application  of  Directive  89/392/EEC,  as  amended  by  Directives  91/368/EEC, 

93/44/EEC and 93/68/EEC2006/42/EC. 

Where the relevant hazard ⌦ risk ⌫ exists and is not dealt with in this Annex, the essential 
health  and  safety  requirements  of  Annex  I  to  Directive  89/392/EEC  2006/42/EC23  of  the 
European  Parliament  and  of  the  Council apply.  The  essential  ⌦ health  and  safety ⌫ 
requirements  of  Section  Point 1.1.2  of  Annex  I  to  Directive  89/392/EEC  2006/42/EC  must 
apply in any event. 

23 

OJ L 157, 9.06.2006, p. 24. 

EN 

55 

   EN 

 
 
 
                                                 
(cid:208) 2006/42/EC Art. 24.2 

1.2. Carrier 

The carrier of each lift must be a car. This car must be designed and constructed to offer the 
space  and  strength  corresponding  to  the  maximum  number  of  persons  and  the  rated  load  of 
the lift set by the installer. 

Where  the lift is intended  for  the  transport  of  persons,  and  where  its  dimensions  permit,  the 
car must be designed and constructed in such a way that its structural features do not obstruct 
or impede access and use by disabled persons and so as to allow any appropriate adjustments 
intended to facilitate its use by them. 

(cid:208) 95/16/EC (adapted) 

1.3. Means of suspension and means of support 

The  means  of  suspension  and/or  support  of  the  car,  its  attachments  and  any  terminal  parts 
thereof must be selected and designed so as to ensure an adequate level of overall safety and 
to minimize the risk of the car falling, taking into account the conditions of use, the materials 
used and the conditions of manufacture. 

Where  ropes  or  chains  are  used  to  suspend  the  car,  there  must  be  at  least  two  independent 
cables or chains, each with its own anchorage system. Such ropes and chains  must  have no 
joins or splices except where necessary for fixing or forming a loop. 

1.4. Control of loading (including overspeed) 

1.4.1. Lifts must be so designed, constructed and installed as to prevent normal starting if the 
rated load is exceeded. 

1.4.2. Lifts must be equipped with an overspeed governor. 

These  requirements  do  not  apply  to  lifts  in  which  the  design  of  the  drive  system  prevents 
overspeed. 

1.4.3. Fast lifts must be equipped with a speed-monitoring and speed-limiting device. 

1.4.4. Lifts driven by friction pulleys must be designed so as to ensure stability of the traction 
cables on the pulley. 

1.5. Machinery 

1.5.1.  All  passenger  lifts  must  have  their  own  individual  lift  machinery.  This  requirement 
does not apply to lifts in which the counterweights are replaced by a second car. 

1.5.2. The installer of the lift must ensure that the lift machinery and the associated devices of 
a lift are not accessible except for maintenance and in emergencies. 

EN 

56 

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1.6. Controls 

1.6.1.  The  controls  of  lifts  intended  for  use  by  unaccompanied  disabled  persons  must  be 
designed and located accordingly. 

1.6.2. The function of the controls must be clearly indicated. 

1.6.3. The call circuits of a group of lifts may be shared or interconnected. 

1.6.4. Electrical equipment must be so installed and connected that: 

(a)- there can be no possible confusion with circuits which do not have any direct connection 
with the lift,; 

(b)- the power supply can be switched while on load,; 

(c)-  movements  of  the  lift  are  dependent  on  electrical  safety  devices  in  a  separate  electrical 
safety circuit,; 

(d)- a fault in the electrical installation does not give rise to a dangerous situation. 

2. HAZARD TO ⌦ RISKS FOR ⌫ PERSONS OUTSIDE THE CAR 

2.1. The lift must be designed and constructed to ensure that the space in which the car travels 
is inaccessible except for maintenance or in emergencies. Before a person enters that space, 
normal use of the lift must be made impossible. 

2.2. The lift must be designed and constructed to prevent the risk of crushing when the car is 
in one of its extreme positions. 

The  objective  will  be  achieved  by  means  of  free  space  or  refuge  beyond  the  extreme 
positions. 

However,  in  specific  cases,  in  affording  Member  States  the  possibility  of  giving  prior 
approval,  particularly  in  existing  buildings,  where  this  solution  is  impossible  to  fulfil,  other 
appropriate means may be provided to avoid this risk. 

2.3. The landings at the entrance and exit of the car must be equipped with landing doors of 
adequate mechanical resistance for the conditions of use envisaged. 

An interlocking device must prevent during normal operation: 

(a)-  starting  movement  of  the  car,  whether  or  not  deliberately  activated,  unless  all  landing 
doors are shut and locked,; 

(b)-  the  opening  of  a  landing  door  when  the  car  is  still  moving  and  outside  a  prescribed 
landing zone. 

However, all landing movements with the doors open shall be allowed in specified zones on 
condition that the levelling speed is controlled. 

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3. HAZARD TO ⌦ RISKS FOR ⌫ PERSONS IN THE CAR 

3.1.  Lift  cars  must  be  completely  enclosed  by  full-length  walls,  fitted  floors  and  ceilings 
included, with the exception of ventilation apertures, and with full-length doors. These doors 
must be so designed and installed that the car cannot move, except for the landing movements 
referred  to  in  the  third  subparagraph  of  Section  Point 2.3,  unless  the  doors  are  closed,  and 
comes to a halt if the doors are opened. 

The doors of the car must remain closed and interlocked if the lift stops between two levels 
where there is a risk of a fall between the car and the shaft or if there is no shaft. 

3.2. In the event of a power cut or failure of components the lift must have devices to prevent 
free fall or uncontrolled upward movements of the car. 

The device preventing the free fall of the car must be independent of the means of suspension 
of the car. 

This  device  must  be  able  to  stop  the  car  at  its  rated  load  and  at  the  maximum  speed 
anticipated  by  the  installer  of  the  lift.  Any  stop  occasioned  by  this  device  must  not  cause 
deceleration harmful to the occupants whatever the load conditions. 

3.3. Buffers must be installed between the bottom of the shaft and the floor of the car. 

In this case, the free space referred to in Section Point 2.2 must be measured with the buffers 
totally compressed. 

This requirement does not apply to lifts in which the car cannot enter the free space referred to 
in Section Point 2.2 by reason of the design of the drive system. 

3.4. Lifts must be so designed and constructed as to make it impossible for them to be set in 
motion if the device provided for in Section Point 3.2 is not in an operational position. 

4. OTHER HAZARDS ⌦ RISKS ⌫ 

4.1.  The  landing  doors  and  car  doors  or  the  two  doors  together,  where  motorized,  must  be 
fitted with a device to prevent the risk of crushing when they are moving. 

4.2.  Landing  doors,  where  they  have  to  contribute  to  the  protection  of  the  building  against 
fire,  including  those  with  glass  parts,  must  be  suitably  resistant  to  fire  in  terms  of  their 
integrity  and  their  properties  with  regard  to  insulation  (containment  of  flames)  and  the 
transmission of heat (thermal radiation). 

4.3. Counterweights must be so installed as to avoid any risk of colliding with or falling on to 
the car. 

4.4. Lifts must be equipped with means enabling people trapped in the car to be released and 
evacuated. 

4.5. Cars must be fitted with two-way means of communication allowing permanent contact 
with a rescue service. 

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4.6. Lifts must be so designed and constructed that, in the event of the temperature in the lift 
machine exceeding the maximum set by the installer of the lift, they can complete movements 
in progress but refuse new commands. 

4.7.  Cars  must  be  designed  and  constructed  to  ensure  sufficient  ventilation  for  passengers, 
even in the event of a prolonged stoppage. 

4.8.  The  car  should  be  adequately  lit  whenever  in  use  or  whenever  a  door  is  opened;  there 
must also be emergency lighting. 

4.9. The means of communication referred to in Section Point 4.5 and the emergency lighting 
referred  to  in  Section  Point  4.8  must  be  designed  and  constructed  so  as  to  function  even 
without the normal power supply. Their period of operation should be long enough to allow 
normal operation of the rescue procedure. 

4.10. The control circuits of lifts which may be used in the event of fire must be designed and 
manufactured  so  that  lifts  may  be  prevented  from  stopping  at  certain  levels  and  allow  for 
priority control of the lift by rescue teams. 

5. MARKING 

5.1.  In  addition  to  the  minimum  particulars  required  for  any  machine  pursuant  to  Section 
Point  1.7.3  of  Annex  I  to  Directive  89/392/EEC  2006/42/EC,  each  car  must  bear  an  easily 
visible  plate  clearly  showing  the  rated  load  in  kilograms  and  the  maximum  number  of 
passengers which may be carried. 

5.2. If the lift is designed to allow people trapped in the car to escape without outside help, the 
relevant instructions must be clear and visible in the car. 

(cid:208) 95/16/EC (adapted) 
(cid:214) new 

6. INSTRUCTIONS FOR USE 

6.1. The safety components ⌦ for lifts ⌫ referred to in Annex IV III must be accompanied 
by  an  instruction  manual  drawn  up  (cid:214) in  a  language  which  can  be  easily  understood  by 
consumers  and  other  end-users,  as  determined by   in  an  official  language  of  the  Member 
State of the lift installer or another Community language acceptable to him (cid:214) concerned  , 
so that: ⌦ the following can be carried out effectively and without danger: ⌫ 

(a)- assembly;, 

(b)- connection;, 

(c)- adjustment;, and 

(d)- maintenance., 

can be carried out effectively and without danger. 

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6.2.  Each  lift  must  be  accompanied  by  documentation  (cid:214) instructions  for  use   drawn  up 
in (cid:214) a  language  which  can  be  easily  understood  by  consumers  and  other  end-users,  as 
determined  by  the  Member  State  concerned.  the  official  language(s)  of  the  Community, 
which may be determined in accordance with the Treaty by the Member State in which the lift 
is installed. The documentation (cid:214) Those instructions for use  shall contain at least ⌦ the 
following documents: ⌫ 

(cid:208) 95/16/EC 

(a)-  an  instruction  manual  containing  the  plans  and  diagrams  necessary  for  normal  use  and 
relating to maintenance, inspection, repair, periodic checks and the rescue operations referred 
to in Section Point 4.4,; 

(b)- a logbook in which repairs and, where appropriate, periodic checks can be noted. 

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(cid:208) 95/16/EC (adapted) 

ANNEX II  

A.  CONTENT  OF  THE  ⌦ EU ⌫  EC  DECLARATION  OF  CONFORMITY  FOR  SAFETY 

COMPONENTS ⌦ FOR LIFTS ⌫ 

24 

The  ⌦ EU ⌫  EC  declaration  of  conformity  ⌦for  safety  components  for  lifts  shall  be 
drafted in the same language as the instruction manual referred to in Annex I, Point 6.1, and 
be either typewritten or printed and ⌫ must ⌦ shall ⌫ contain the following information: 

⌦ (a)  business ⌫  -  name  and  ⌦  full  ⌫  address  of  the  manufacturer  of  the  safety 
components25,; 

(b)-  where  appropriate,  ⌦ business ⌫  name  and  address  of  his  authorized  representative 
established in the Community26⌦Union ⌫,; 

(c)-  description  of  the  safety  component ⌦ for  lifts ⌫,  details  of  type  or  series  and  serial 
number (if any),; 

(d)-  safety  function  of  the  safety  component  ⌦ for  lifts ⌫,  if  not  obvious  from  the 
description,; 

(e)- year of manufacture of the safety component ⌦ for lifts ⌫,; 

(f)- all relevant provisions with which the safety component ⌦ for lifts ⌫ complies,; 

(g) a statement that the safety component for lifts is in conformity with all the relevant Union 
harmonisation legislation;  

(cid:216) new 

(cid:208) 95/16/EC (adapted) 

(h)-  where 
⌦ standard(s) ⌫ used,; 

appropriate, 

reference  ⌦ reference(s) ⌫ 

to  harmonized 

standard 

(i)-  where  appropriate,  ⌦ the ⌫  name,  address  and  identification  number  of  the  notified 
body which carried out the ⌦ EU ⌫ EC type-examination in accordance with Article 15(a) 
and  (b)  8  (1)(a)(i)  and  (ii),  ⌦ and ⌫  where  appropriate,  the  reference  to  ⌦  of  ⌫  the 
⌦ EU ⌫ EC type-examination certificate issued by that notified body,;  

24 

25 

26 

The declaration must be drafted in the same language as the instruction manual referred to in Annex I, 
Section 6.1, and be either typewritten or printed. 
Business name, full address; in the case of an authorized representative, also indicate the business name 
and address of the manufacturer of the safety components. 
Business name, full address; in the case of an authorized representative, also indicate the business name 
and address of the manufacturer of the safety components. 

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(j)-  where  appropriate,  name,  address  and  identification  number  of  the  notified  body  which 
carried  out  the  production  checks  in  accordance  with  Article  8(1)  (a)  (ii)  ⌦ conformity 
assessment procedure in accordance with Article 15(a) ⌫,;  

(k)- where appropriate, name, address and identification number of the  notified  body  which 
the  system  of  quality  assurance  ⌦ system  operated ⌫ 
checked  ⌦ approved ⌫ 
implemented by the manufacturer in accordance with Article 15(b) and (c); 8(1) (a) (iii), 

identification of the signatory empowered to act on behalf of the manufacturer of the safety 
components or his authorized representative established in the Community.  

⌦(l) the name and function of the person empowered to sign the declaration on behalf of the 
manufacturer or his authorized representative established in the Union; ⌫ 

(m) place and date of signature;  

(n) signature.  

(cid:216) new 

(cid:208) 95/16/EC (adapted) 

B. CONTENT OF THE EC ⌦ EU ⌫ DECLARATION OF CONFORMITY FOR INSTALLED LIFTS

27

The  EC  ⌦ EU ⌫  declaration  of  conformity  ⌦ for  lifts shall  be  drafted  in  the  same 
language as the instruction manual referred to in Annex I, Point 6.2, and be either typewritten 
or printed and ⌫ must ⌦ shall ⌫ contain the following information: 

⌦ (a) business ⌫ name and ⌦ full ⌫ address of the installer of the lift28,; 

(b)- description of the lift, details of the type or series, serial number and address where the 
lift is fitted ⌦ installed ⌫,; 

(c)- year of installation of the lift,; 

(d)- all relevant provisions to which the lift conforms,; 

(cid:208) 95/16/EC 

(cid:216) new 

(e)  a  statement  that  the  lift  is  in  conformity  with  all  the  relevant  Union  harmonisation 
legislation; 

27 

28 

This declaration must be drafted in the same language as the instruction manual referred to in Annex I, 
Section 6.2, and be either typewritten or printed. 
Business name and full address. 

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(cid:208) 95/16/EC (adapted) 
(cid:214) new 

(f)-  where  appropriate,  ⌦ the ⌫  reference  ⌦ reference(s) ⌫  to  harmonized  standards 
used,; 

(g)-  where  appropriate,  ⌦ the ⌫  name,  address  and  identification  number  of  the  notified 
body  which  carried  out  the  EC  ⌦ EU ⌫  type-examination  of  the  model  of  the  lift  in 
accordance  with  Article  16(1)  (a)  8  (2),  (i)  and  (ii),  ⌦ and  the ⌫  -  where  appropriate, 
reference  of  the  EC  ⌦ EU ⌫  type-examination  certificate,  ⌦ issued  by  that  notified 
body; ⌫ 

(h)-  where  appropriate,  ⌦ the ⌫  name,  address  and  identification  number  of  the  notified 
body which carried out the ⌦ unit ⌫ verification ⌦ procedure ⌫ of the lift in accordance 
with Article 8 (2) (iv), 16(1)(c),; 

(i)-  where  appropriate,  ⌦ the ⌫  name,  address  and  identification  number  of  the  notified 
body  which  carried  out  the  final  inspection  of  the lift  in  accordance  with  the  first  indent  of 
Article 8 (2), (i), (ii) and (iii), 16(1)(a)(i) and 16(1)(b)(i); 

(j)- where appropriate, name, address, and identification number of the notified body which 
inspected  (cid:214) approved   the  quality  assurance  system  implemented  ⌦ operated ⌫  by  the 
installer in accordance with the second and third indents of Article (8) (2) (i), (ii), (iii) and (v) 
16(1)(a)(ii); 16(1)(a)(iii); 16(1)(b)(ii); 16(1)(b)(iii) and 16(1)(d),; 

– 

identification  of  the  signatory  having  been  empowered  to  act  on  behalf  of  the  lift 
installer. 

⌦(k) the name and function of the person empowered to sign the declaration on behalf of the 
installer; ⌫ 

(l) place and date of signature;  

(m) signature. 

(cid:216) new  

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(cid:208) 95/16/EC 

ANNEX III 

CE CONFORMITY MARKING 

The CE conformity marking shall consist of the initials «CE» taking the following form: 

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

The  various  components  of  the  CE  marking  must  have  substantially  the  same  vertical 
dimension, which may not be less than 5 mm. This minimum dimension may be waived for 
small-scale safety components. 

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

– 

– 

the procedures referred to in Article 8 (1) (a) (ii) or (iii), 

the procedures referred to in Article 8 (2). 

(cid:208) 95/16/EC (adapted) 

ANNEX IIIIV 

LIST OF SAFETY COMPONENTS ⌦ FOR LIFTS ⌫ REFERRED TO IN ARTICLE 
1 (1) AND ARTICLE 8(1)15 

1. Devices for locking landing doors. 

(cid:208) 95/16/EC 

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2. Devices to prevent falls referred to in Section Point 3.2 of Annex I to prevent the car from 
falling or unchecked upward ⌦ uncontrolled ⌫ movements. 

(cid:208) 95/16/EC (adapted) 

3. Overspeed limitation devices.  

(cid:208) 95/16/EC  

(cid:208) 95/16/EC (adapted) 

4. (a) Energy-accumulating shock absorbers ⌦ buffers ⌫ : 

(i)- either non-linear, ⌦ or ⌫ 

(ii)- or with damping of the return movement. 

(b) Energy-dissipating shock absorbers ⌦ buffers ⌫ . 

5. Safety devices fitted to jacks of hydraulic power circuits where these are used as devices to 
prevent falls. 

(cid:208) 95/16/EC  

6. Electric safety devices in the form of safety switches ⌦ circuits ⌫ containing electronic 
components. 

(cid:208) 95/16/EC (adapted) 

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(cid:208) 95/16/EC (adapted) 
(cid:214) new 

ANNEX IVV  

EC ⌦ EU ⌫ TYPE-EXAMINATION ⌦ FOR LIFTS AND SAFETY COMPONENTS 
FOR LIFTS ⌫ 

(module B) 

A. EC ⌦ EU ⌫ TYPE-EXAMINATION OF SAFETY COMPONENTS ⌦ FOR LIFTS ⌫ 

1.  EC  ⌦ EU ⌫  type-examination  is  the  (cid:214) part  of  a  conformity  assessment   procedure 
whereby  a  notified  body  ascertains  and  certifies  that  a  representative  specimen  of  a  safety 
component  ⌦ for  lifts ⌫  will  permit  the  lift  to  which  it  is  correctly  fitted  to  satisfy  the 
applicable requirements of the Directive. 

2. The application for ⌦ EU ⌫ EC type-examination shall be lodged by the manufacturer, 
of  the  safety  component,  or  his  authorized  representative  established  in  the  Community 
⌦ Union, ⌫ with a (cid:214) single  notified body of his choice.  

The application must ⌦ shall ⌫ include: 

(a) - 

the  name  and  address  of  the  manufacturer  of  the  safety  component  and  of  his 
authorized  representative,  if  the  application  is  made  by  the  latter,,  ⌦ if  the 
application is lodged by the authorized representative, his name and address as well 
⌫ and the place of manufacture of the safety components ⌦ for lifts ⌫,; 

(b) - 

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

(cid:208) 95/16/EC 

(cid:208) 95/16/EC (adapted) 

(c) - 

a technical dossier, ⌦ file(s); ⌫  

(d) - 

a  representative  specimen  of  the  safety  component ⌦ for  lifts ⌫  or  details  of  the 
place  where  it  can  be  examined. The  notified  body  may  make  reasoned  request  for 
further specimens ⌦ if needed for carrying out the test program ⌫.;  

(cid:216) new 

(e) 

the  supporting  evidence  for  the  adequacy  of  the  technical  design  solution.  This 
supporting evidence shall mention any documents that have been used, in particular 
where  the  relevant  harmonised  standards  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.  

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(cid:208) 95/16/EC (adapted) 

3. The technical dossier ⌦ file ⌫ must ⌦ shall ⌫ allow an assessment of the conformity 
and adequacy of the safety component ⌦ for lifts ⌫ to enable a lift to which it is correctly 
fitted to conform with the provisions ⌦ to the applicable requirements ⌫ of the Directive. 

In  so  far  as  is  necessary  for  the  purpose  of  assessing  conformity,  Tthe  technical  dossier 
⌦ file ⌫ should include the following: 

(a)- a general description of the safety component ⌦ for lifts ⌫, including its area of use (in 
particular  possible  limits  on  speed,  load  and  power)  and  conditions  (in  particular  explosive 
environments and exposure to the elements) ,;  

(b)- design and manufacturing drawings or diagrams,; 

(cid:208) 95/16/EC 

(cid:216) new 

(c)  explanations  necessary  for  the  understanding  of  those  drawings  and  diagrams  and  the 
operation of the safety component for lifts;  

⌦ (d) a list of the essential health and safety requirements; ⌫essential requirement(s) taken 
into consideration and the means adopted to satisfy it (them) (e.g. a harmonized standard),  

(cid:208) 95/16/EC (adapted) 

(cid:216) new 

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

(f)-  results  of  any  tests  or  calculations  performed ⌦ by ⌫  or  subcontracted  by ⌦ for ⌫ 
the manufacturer,; 

(cid:208) 95/16/EC (adapted) 

(g) test reports;  

(cid:216) new 

(cid:208) 95/16/EC (adapted) 

(h)-  a  copy  of  the  assembly  instruction  ⌦ manual ⌫  for  the  safety  components  ⌦ for 
lifts ⌫,; 

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(i)- steps taken at the manufacturing stage to ensure that series-produced safety components 
⌦ for lifts ⌫ conform to the safety component ⌦ for lifts ⌫ examined. 

4. The notified body shall: 

examine the technical dossier to assess how far it can meet the desired aims,  

⌦ (a) examine the technical file to assess the adequacy of the technical design of the safety 
component for lifts; ⌫ 

(b) agree with the applicant on a location where the examinations and tests will be carried out;  

(cid:216) new 

(cid:208) 95/16/EC (adapted) 

– 

examine  the  safety  component  to  check  its  adequacy  in  terms  of  the  technical 
dossier, 

⌦ (c) verify that the representative specimen(s) has(have) been manufactured in conformity 
with  the  technical  file,  and  identify  the  elements  which  have  been  designed  in  accordance 
with  the  specifications  of  harmonised  standards,  as  well  as  the  elements  which  have  been 
designed without applying the specifications of those standards; ⌫ 

– 

perform  or  have  performed  the  appropriate  checks  and  tests  necessary  to  check 
whether the solutions adopted by the manufacturer of the safety component meet the 
requirements of the Directive allowing the safety component to carry out its function 
when correctly fitted on a lift. 

⌦ (d)  carry  out  appropriate  examinations  and  tests,  or  have  them  carried  out,  to  check 
whether,  where  the  manufacturer  has  chosen  to  apply  the  specifications  of  the  relevant 
harmonised standards, these have been applied correctly; ⌫ 

⌦ (e)  carry  out  appropriate  examinations  and  tests,  or  have  them  carried  out,  to  check 
whether, where the specifications of the relevant harmonised standards have not been applied, 
the solutions adopted by the manufacturer meet the corresponding essential health and safety 
requirements of the Directive. ⌫ 

The  notified  body  shall  draw  up  an  evaluation  report  that  records  the  examinations, 
verifications and tests carried out and their outcome. Without prejudice to its obligations vis-à 
vis the notifying authorities, the notified body shall release the content of that report, in full or 
in part, only with the agreement of the manufacturer. 

(cid:216) new 

5. If the representative specimen of the safety component complies with the provisions of the 
Directive applicable to it, the notified body must issue an EC type-examination certificate to 
the  applicant.  The  certificate  must  contain  the  name  and  address  of  the  manufacturer  of  the 

(cid:208) 95/16/EC (adapted) 

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safety component, the conclusions of the check,  any  conditions of validity  of  the certificate 
and the particulars necessary to identify the approved type.  

The Commission, the Member States and the other notified bodies may obtain a copy of the 
certificate  and,  on  a  reasoned  request,  a  copy  of  the  technical  dossier  and  reports  of 
examinations,  calculations  and  tests  carried  out.  If  the  notified  body  refuses  to  issue  an  EC 
type-examination certificate to the manufacturer, it must state the detailed grounds for refusal. 
Provision must be made for an appeal procedure. 

⌦ 5.  If  the  representative  specimen(s)  of  the  safety  component  for  lifts  complies(comply) 
with the essential health and safety requirements of the Directive, the notified body shall issue 
an EU type-examination certificate to the applicant manufacturer. The certificate shall contain 
the name and address of the manufacturer of the safety component and, where appropriate, of 
his  authorised  representative,  the  conclusions  of  the  type-examination,  any  conditions  of 
validity of the certificate and the particulars necessary to identify the approved type. ⌫ 

The certificate may have one or more annexes attached. 

(cid:216) new  

Where  the  representative  specimen(s)  does(do)  not  comply  with  the  applicable  essential 
health and safety requirements of the Directive, the notified body shall refuse to issue an EU 
type-examination  certificate  and  shall  inform  the  applicant  accordingly,  giving  detailed 
reasons for its refusal. 

The notified body shall keep a copy of the EU type-examination certificate, its annexes and 
additions, as well as the technical file and the evaluation report, for a period of 15 years from 
the date of issue of the certificate. 

(cid:208) 95/16/EC (adapted) 

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

6.  The  manufacturer  of  the  safety  component  or his authorized representative  established in 
the  Community  must  inform  the  notified  body  of  any  alterations,  even  of  a  minor  nature, 
which  he  has  made  or  plans  to  make  to  the  approved  safety  component,  including  new 
extensions  or  variants  not  specified  in  the  original  technical  dossier  (see  the  first  indent  of 
Section 3). The notified body must examine the alterations and inform the applicant whether 
the EC type-examination certificate remains valid29. 

⌦ 7. The manufacturer or his authorized representative shall inform the notified body of any 
modification to the approved type that may affect the conformity of the safety component for 

29 

If  the  notified  body  deems  it  necessary,  it  may  either  issue  an  addition  to  the  original  EC  type-
examination certificate or ask for a fresh application to be submitted. 

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lifts  with  the  essential  health  and  safety  requirements  of  the  Directive  or  the  conditions  of 
validity of the EU type-examination certificate. ⌫ 

7.  Each  notified  body  must  communicate  to  the  Member  States  the  relevant  information 
concerning: 

– 

– 

EC type-examination certificates issued, 

EC type-examination certificates withdrawn. 

Each  notified  body  must  also  communicate  to  the  other  notified  bodies  the  relevant 
information concerning the EC type-examination certificates it has withdrawn. 

⌦ The  notified  body  shall  examine  the  modification  and  inform  the  applicant  whether  the 
EU type-examination certificate remains valid or whether further examinations, verifications 
or tests are needed. As appropriate, the notified body shall issue an addition to the original EU 
type- examination certificate or ask for a new application for an EU type-examination to be 
submitted. ⌫ 

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

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

⌦ 9.  The  Commission,  the  Member  States  and  the  other  notified  bodies  may,  on  request, 
obtain a copy of the EU type-examination certificates and additions thereto. On request, the 
Commission and the Member States may obtain a copy of the technical file and of the report 
on the examinations, verifications and tests carried out by the notified body. ⌫ 

⌦ 10.  EU ⌫  8.  EC  type-examination  certificates  and  the  dossiers  ⌦ documents ⌫  and 
correspondence relating to ⌦ EU ⌫ EC type-examination procedures must ⌦ shall ⌫ be 
drawn up in an official language of the Member State where the notified body is established 
or in a language acceptable to it. 

(cid:208) 95/16/EC (adapted) 
(cid:214) new 

9.  11.  The  manufacturer  of  the  safety  component  or  his  authorized  representative  must 
⌦ shall ⌫ keep with the technical documentation ⌦ file ⌫ copies of ⌦ EU ⌫ EC type-
examination certificates (cid:214) , their annexes  and their additions for a period of 10 years after 
the last safety component ⌦ for lifts ⌫ has been ⌦ placed on the market ⌫ manufactured. 

Where  neither  the  manufacturer  of  a  safety  component  nor  his  authorized  representative  is 
established  in  the  Community  ⌦ Union, ⌫  the  obligation  to  keep  the  technical 
documentation  ⌦ file ⌫  available  falls  to  the  person  who  places  the  safety  component 
⌦ for lifts ⌫ on the Community ⌦ Union ⌫ market. 

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B. ⌦ EU ⌫ EC TYPE-EXAMINATION OF LIFTS 

(cid:208) 95/16/EC (adapted) 
(cid:214) new 

1.  ⌦ EU ⌫  EC  type-examination  is  the  (cid:214)  part  of  a  conformity  assessment  procedure 
whereby ⌦ in which ⌫ a notified body ascertains and certifies that a model lift or that a lift 
satisfies 
for 
for  which 
the ⌦ applicable ⌫ requirements of the Directive.  

extension  or  variant, 

is  no  provision 

there 

an 

2.  The  application  for ⌦ EU ⌫  EC  type-examination  must  ⌦ shall ⌫  be  lodged  by  the 
installer of the lift with a ⌦single ⌫ notified body of his choice. 

The application must ⌦ shall ⌫ include: 

(a)- the name and address of the installer of the lift,; 

(b)-  a  written  declaration  that  the  same  application  has  not  been  lodged  with  any 
other notified body,; 

(cid:208) 95/16/EC 

(c)- a technical dossier, ⌦ file(s); ⌫ 

(cid:208) 95/16/EC (adapted) 

(d)-  details  of  the  place  where  the  model  lift  can  be  examined.  The  model  lift 
submitted for examination shall include the terminal parts and be capable of serving 
at least three levels (top, middle and bottom),; 

(cid:216) new 

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

(cid:208) 95/16/EC (adapted) 

3. The technical dossier ⌦ file ⌫ must ⌦ shall ⌫ allow an assessment of the conformity 
of the lift with the provisions ⌦ essential health and safety requirements ⌫ of the Directive 
and an understanding of the design and operation of the lift. 

In  so  far  as  is  necessary  for  the  purpose  of  assessing  conformity,  Tthe  technical  dossier 
⌦ file ⌫ should include the following:  

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(a)- a general description of the representative model of the lift. The technical dossier should 
indicate  ⌦ indicating ⌫  clearly  all  ⌦ the  permitted  variations  of  the ⌫  possible 
extensions to the representative model lift under examination (see Article 1 (4)), ⌦ referred 
to in Article 2(3); ⌫ 

(b)- design and manufacturing drawings or diagrams,; 

(cid:208) 95/16/EC 

(cid:216) new 

(c) explanations necessary for the understanding of those drawings and diagrams and of the 
operation of the model lift;  

⌦ (d)  a  list  of  the ⌫  essential  ⌦ health  and  safety ⌫  requirements  taken  into 
consideration and the means adopted to satisfy them (e.g. a harmonised standard).; 

(cid:208) 95/16/EC (adapted) 

(cid:216) new 

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

(cid:208) 95/16/EC (adapted) 

(f)- a copy of the ⌦ EU ⌫ EC declarations of conformity of the safety components ⌦ for 
lifts ⌫ used in the manufacture of the ⌦ model ⌫ lift,; 

(g)- results of any tests or calculations performed or subcontracted by the manufacturer ⌦ by 
or for the installer ⌫,; 

(h) test reports;  

(i)- a copy of the lift instruction manual,; 

(cid:216) new 

(cid:208) 95/16/EC 

(j)- steps taken at the installation stage to ensure that the series-produced lift conforms to the 
provisions ⌦ essential health and safety requirements ⌫ of the Directive. 

(cid:208) 95/16/EC (adapted) 

4. The notified body must ⌦ shall: ⌫ 

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(a)- examine the technical dossier ⌦ file ⌫ to assess how far it can meet the desired aims, 
⌦ the adequacy of the technical design of the model lift; ⌫  

(b) agree with the installer on a location where the examinations and tests will be carried out;  

(cid:216) new 

– 

examine the representative model of the lift to check that it has been manufactured in 
accordance with the technical dossier, 

(cid:208) 95/16/EC (adapted) 

(c)  examine  the  model  lift  to  check  that  it  has  been  manufactured  in  accordance  with  the 
technical  file,  and  identify  the  elements  which  have  been  designed  in  accordance  with  the 
specifications of the relevant harmonised standards, as well as the elements which have been 
designed without applying the specifications of those standards; 

(cid:216) new 

– 

perform or have performed the appropriate checks and tests necessary to check that 
the  solutions  adopted  by  the  installer  of  the  lift  meet  the  requirements  of  the 
Directive and allow the lift to comply with them. 

(cid:208) 95/16/EC (adapted) 

(cid:216) new 

(d) carry out appropriate examinations and tests, or have them carried out, to check whether, 
where  the  installer  has  chosen  to  apply  the  specifications  of  the  relevant  harmonised 
standards, these have been applied correctly;  

(e) carry out appropriate examinations and tests, or have them carried out, to check whether, 
where  the  specifications  of  the  relevant  harmonised  standards  have  not  been  applied,  the 
solutions  adopted  by  the  installer  meet  the  corresponding  essential  health  and  safety 
requirements of the Directive.  

The  notified  body  shall  draw  up  an  evaluation  report  that  records  the  examinations, 
verifications  and  tests  carried  out  undertaken  and  their  outcome.  Without  prejudice  to  its 
obligations  vis-à  vis  the  notifying  authorities,  the  notified  body  shall  release  the  content  of 
that report, in full or in part, only with the agreement of the lifts manufacturer  

(cid:208) 95/16/EC (adapted) 
(cid:214) new 

5. If the model lift complies with the provisions of the Directive (cid:214) essential health and safety 
requirements set out in Annex I  applicable to it, the notified body must ⌦ shall ⌫ issue 
an EC ⌦ EU ⌫ type-examination certificate to the applicant ⌦ installer ⌫. The certificate 
must ⌦ shall ⌫ contain the name and address of the installer, the conclusions of the check, 
⌦ the  EU  type-examination ⌫,  any  conditions  of  validity  of  the  certificate  and  the 
particulars necessary to identify the approved type ⌦ model lift ⌫.  

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If the notified body refuses to issue an EC type-examination certificate to the manufacturer, it 
must state the detailed grounds for refusal. Provision must be made for an appeal procedure. 

6. The installer of the lift must inform the notified body of any alterations, even of a minor 
nature, which he has made or plans to make to the approved lift, including new extensions or 
variants not specified in the original technical dossier (see the first indent of Section 3). The 
notified  body  must  examine  the  alterations  and  inform  the  applicant  whether  the  EC  type-
examination certificate remains valid30. 

7.  Each  notified  body  must  communicate  to  the  Member  States  the  relevant  information 
concerning: 

– 

– 

EC type-examination certificates issued, 

EC type-examination certificates withdrawn. 

Each  notified  body  must  also  communicate  to  the  other  notified  bodies  the  relevant 
information concerning the EC type-examination certificates it has withdrawn. 

The certificate may have one or more annexes attached. 

(cid:216) new 

Where the model lift does not comply with the essential health and safety requirements set out 
in  Annex  I,  the  notified  body  shall  refuse  to  issue  an  EU  type-examination  certificate  and 
shall inform the installer accordingly, giving detailed reasons for its refusal. 

The notified body shall keep a copy of the EU type-examination certificate, its annexes and 
additions, as well as the technical file and the evaluation report for a period of 15 years from 
the date of issue of the certificate. 

6. The notified body shall keep itself apprised of any changes in the generally acknowledged 
state of the art which indicate that the approved type may no longer comply with the essential 
health and safety requirements set out in Annex I and shall determine whether such changes 
require further investigation. If so, the notified body shall inform the installer accordingly. 

7.  The  installer  shall  inform  the  notified  body  of  any  modifications  to  the  approved  type, 
including variations not specified in the original technical file, that may affect the conformity 
of  the  lift  with  the  essential  health  and  safety  requirements  set  out  in  Annex  I  or  the 
conditions of validity of the certificate. 

The  notified  body  shall  examine  the  modification  and  inform  the  installer  whether  the  EU 
type-examination  certificate  remains  valid  or  whether  further  examinations,  verifications  or 
tests are needed. As appropriate the notified body shall issue an addition to the original EU 
type-examination  certificate  or  ask  for  a  new  application  for  an  EU  type-examination  to  be 
submitted. 

30 

If  the  notified  body  deems  it  necessary,  it  may  either  issue  an  addition  to  the  original  EC  type-
examination certificate or ask for a fresh application to be submitted. 

EN 

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

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

(cid:208) 95/16/EC (adapted) 

9. The Commission, the Member States and the other notified bodies may ⌦, on request, ⌫ 
obtain  a  copy  of  the  EC  ⌦ EU type-examination  certificates  and  additions  thereto  ⌫ 
certificate  and,  on  a  reasoned  request,.  ⌦ On  request,  the  Commission  and  the  Member 
States may obtain ⌫ a copy of the technical ⌦ file ⌫ dossier and ⌦ of the report on the 
examinations,  verifications  and  tests  carried  out  by  the  notified  body. ⌫  and  reports  of 
examinations, calculations and tests carried out. 

8.10.  EC  ⌦ EU ⌫  type-examination  certificates  and  the  dossiers  ⌦ documents ⌫  and 
correspondence  relating  to  EC⌦ EU ⌫  type-examination  procedures  must ⌦ shall ⌫  be 
drawn  up  in  one  ⌦ an ⌫  of  the  official  languages  ⌦ language ⌫  of  the  Member  State 
where the notified body is established or in a language acceptable to it. 

(cid:208) 95/16/EC (adapted) 
(cid:214) new 

9.11.  The  installer  of  the  lift  must  ⌦ shall ⌫  keep  with  the  technical  documentation 
⌦ file ⌫  copies  of  EC  ⌦ EU ⌫  type-examination  certificates  (cid:214) ,  their  annexes   and 
their  additions  for  a  period  of  at  least  10  years  after  the  last  lift  has  been  manufactured 
⌦ placed on the market ⌫ in conformity with the representative model of the lift. 

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(cid:208) 95/16/EC (adapted) 

ANNEX VVI 

FINAL INSPECTION ⌦ FOR LIFTS ⌫ 

1. Final inspection is the procedure whereby the installer of the lift who fulfils the obligations 
of Section 2 ensures and declares that the lift which is being placed on the market satisfies the 
requirements of the Directive. The installer of the lift shall affix the CE marking in the car of 
each lift and draw up an EC declaration of conformity. 

⌦ 1.  Final  inspection  is  the  part  of  a  conformity  assessment  procedure  whereby  a  notified 
body ascertains and certifies that an installed lift subject to an EU type-examination certificate 
or designed and manufactured according to an approved full quality assurance system satisfies 
the essential health and safety requirements set out in Annex I. ⌫ 

2. The installer of the lift shall take all steps necessary to ensure that the lift being placed on 
the market conforms with the model lift described in the EC type-examination certificate and 
the essential health and safety requirements applicable to it. 

⌦ 2. OBLIGATIONS OF THE INSTALLER ⌫ 

⌦ 2.1.  The  installer  shall  take  all  measures  necessary  to  ensure  that  the  lift  being  installed 
complies with the essential health and safety requirements set out in Annex I and with any of 
the following: ⌫ 

⌦ (a)  an approved type described in an EU type-examination certificate; ⌫ 

⌦ (b) a  lift  designed  and  manufactured  in  accordance  with  a  full  quality  assurance  system 
pursuant to Annex XI and the EU design examination certificate if the design is not wholly in 
accordance with the harmonized standards. ⌫ 

⌦2.2. The installer shall draw up an EU declaration of conformity and affix the CE marking 
in  the  car  of  each  lift  which  satisfies  the  essential  health  and  safety  requirements  of  this 
Directive. ⌫ 

(cid:208) 95/16/EC (adapted) 

⌦ 3. FINAL INSPECTION. ⌫ 

5. The notified body must receive the following documents: 

⌦ 3.1 The installer shall provide to the notified body the following documents: ⌫ 

(a)- the plan of the complete lift,; 

(b)-  the  plans  and  diagrams  necessary  for  final  inspection,  in  particular  control  circuit 
diagrams,;  

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(c)- a copy of the instruction manual ⌦ for use ⌫ referred to in Annex I, Section Point 6.2. 

The  notified  body  may  not  require  detailed  plans  or  precise  information  not  necessary  for 
verifying the conformity of the ⌦ installed ⌫ lift about to be placed on the market with the 
model lift described in the EC type-examination declaration.  

⌦ 3.2  A  notified  body  chosen  by  the  installer  shall  carry  out  the  final  inspection  of  the 
installed lift about to be placed on the market in order to check the conformity of the lift with 
the applicable essential health and safety requirements of this Directive. ⌫ 

⌦ The  appropriate  examinations  and  tests  set  out  in  the  relevant  harmonised  standard(s) 
referred to in Article 14 shall be carried out in order to ensure the conformity of the lift with 
the  applicable  essential  health  and  safety  requirements  of  this  Directive.  In  the  absence  of 
such  harmonised  standards,  the  notified  body  concerned  shall  determine  the  appropriate 
equivalent tests to be carried out. ⌫ 

4.  A  notified  body  chosen  by  the  installer  of  the  lift  shall  carry  out  or  have  carried  out  the 
final inspection of the lift about to be placed on the market. The appropriate tests and checks 
defined  by  the  applicable  standard(s)  referred  to  in  Article  5,  or  equivalent  tests,  must  be 
carried  out  in  order  to  ensure  conformity  of  the  lift  with  the  relevant  requirements  of  the 
Directive. 

These checks and tests shall cover in particular: 

(a) 

examination  of  the  documentation  to  check  that  the  lift  conforms  with  the 
representative model of the lift approved in accordance with Annex V.B; 

⌦ 3.3. The examinations shall include at least any of the following: ⌫ 

⌦ (a)  examination  of  the  documents  referred  to  in  point  3.1  to  check  that  the  installed  lift 
conforms with the model lift subject to an EU type-examination certificate pursuant to Annex 
IV B; ⌫ 

(b) examination of the documents referred in point 3.1 to check that the installed lift conforms 
with the lift designed and manufactured in accordance with an approved full quality assurance 
system  pursuant  to  Annex  XI  and  if  the  design  is  not  wholly  in  accordance  with  the 
harmonized standards, with the EU design examination certificate.  

(cid:216) new 

⌦ 3.4. The tests shall include at least any of the following: ⌫ 

(cid:208) 95/16/EC (adapted) 

(cid:208) 95/16/EC 

(a)- operation of the lift both empty and at maximum load to ensure correct installation and 
operation of the safety devices (end stops, locking devices, etc.),; 

(b)- operation of the lift at both maximum load and empty to ensure the correct functioning of 
the safety devices in the event of loss of power,; 

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(c)- static test with a load equal to 1,25 times the nominal ⌦ rated ⌫ load.  

The nominal ⌦ rated ⌫ load shall be that referred to in Annex I, Section Point 5. 

(cid:208) 95/16/EC (adapted) 

After these tests, the notified body shall check that no distortion or deterioration which could 
impair the use of the lift has occurred. 

(cid:208) 95/16/EC 

(cid:208) 95/16/EC (adapted) 

⌦ 4. If the installed lift satisfies the essential health and safety requirements set out in Annex 
I,  the  notified  body  shall  affix  or  have  affixed  its  identification  number  adjacent  to  the  CE 
marking in accordance with Articles 18 and 19 and shall draw up a final inspection certificate 
which mentions the examinations and tests carried out. ⌫ 

6.  If  the  lift  satisfies  the  provisions  of  the  Directive,  the  notified  body  shall  affix  or  have 
affixed its identification number adjacent to the CE marking in accordance with Annex III and 
shall draw up a final inspection certificate which mentions the checks and tests carried out. 

The notified body shall fill in the corresponding pages in the logbook referred to in Annex I, 
Section Point 6.2. 

(cid:208) 95/16/EC 

(cid:208) 95/16/EC (adapted) 

If the notified body refuses to issue the final inspection certificate, it must ⌦ shall ⌫ state 
the  detailed  reasons  for  refusal  recommend  means  whereby  acceptance  may  be  obtained. 
⌦ and indicate the necessary corrective measures to be taken. ⌫ Where the installer again 
applies for final inspection, he must ⌦ shall ⌫ apply to the same notified body. 

7.  The  final  inspection  certificate,  dossiers  and  correspondence  relating  to  the  acceptance 
procedures shall be drawn up in one of the official languages of the Member State where the 
notified body is established or in a language acceptable to it. 

⌦ 5. The final inspection certificate, documentation and correspondence relating to the final 
inspection  acceptance  procedures  shall  be  drawn  up  in  one  of  the  official  languages  of  the 
Member State where the notified body is established or in a language acceptable to it. ⌫ 

6. 3. The installer of the lift shall keep a copy of the EC ⌦ EU ⌫ declaration of conformity 
and  the  final  inspection  certificate  referred  to  in  Section  6  for  10  years  after  ⌦ the 
placing ⌫ from the date when the lift was placed on the market ⌦ of the lift ⌫ .  

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7.  The  Commission  and  the  Member  states  may  obtain  a  copy  of  the  final  inspection 
certificate on request. 

(cid:216) new 

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(cid:208) 95/16/EC (adapted) 

ANNEX VII 

MINIMUM CRITERIA TO BE TAKEN INTO ACCOUNT BY MEMBER STATES 
FOR THE NOTIFICATION OF BODIES 

1. The body, its director and the staff responsible for carrying out verification operations may 
not be the designer, builder, supplier or manufacturer of safety components or installer of the 
lifts which they inspect, nor the authorized representative  of  any of these parties.  Similarly, 
the body, its director and the staff responsible for supervising the quality assurance systems 
referred  to  in  Article  8  of  the  Directive  may  not  be  the  designer,  builder,  supplier  or 
manufacturer  of  safety  components  or  installer  of  the  lifts  which  they  inspect,  nor  the 
authorized  representative  of  any  of  these  parties.  They  may  not  become  involved  either 
directly or as authorized representatives in the design, construction, marketing or maintenance 
of the safety components or in the installation of lifts. This does not preclude the possibility of 
exchanges of technical information between the manufacturer of the safety components or the 
installer of the lift and the body. 

2.  The  body  and  its  staff  must  carry  out  the  inspection  or  supervision  operations  with  the 
highest degree of professional integrity and technical competence and must be free from all 
pressures and inducements, particularly financial, which might influence their judgment or the 
results of the inspection, especially from persons or groups of persons with an interest in the 
result of inspection or supervision. 

3. The body must have at its disposal the necessary staff and possess the necessary facilities to 
enable it to perform properly the technical and administrative tasks connected with inspection 
or supervision; it must also have access to the equipment required for special verification. 

4. The staff responsible for inspection must have: 

sound technical and professional training, satisfactory knowledge of the requirements for the 
tests  they  carry  out  and  adequate  experience  of  such  tests,  the  ability  to  draw  up  the 
certificates, records and reports required to authenticate the performance of the tests. 

5.  The  impartiality  of  the  inspection  staff  must  be  guaranteed.  Their  remuneration  must  not 
depend on the number of tests carried out or on the results of such tests. 

6.  The  body  must  take  out  liability  insurance  unless  its  liability  is  assumed  by  the  State  in 
accordance with national law, or the Member State itself is directly responsible for the tests. 

7.  The  staff  of  the  body  must  observe  professional  secrecy  with  regard  to  all  information 
gained  in  carrying  out  its  tasks  (except  vis-à-vis  the  competent  administrative  authorities  of 
the  State  in  which  its  activities  are  carried  out)  under  this  Directive  or  any  provision  of 
national law giving effect to it. 

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(cid:208) 95/16/EC (adapted) 
(cid:214) new 

ANNEX VI VIII  

PRODUCT QUALITY ASSURANCE ⌦ FOR SAFETY COMPONENTS FOR 
LIFTS ⌫ 

(module E) 

Product quality assurance is the procedure whereby the manufacturer of the safety component 
who  satisfies  Section  2  ensures  and  declares  that  the  safety  components  are  in  conformity 
with the type as described in the EC type-examination certificate and satisfy the requirements 
of the Directive that apply to them and ensures and declares that the safety component will 
enable a lift to which it is correctly fitted to satisfy the provisions of the Directive. 

The manufacturer of the safety component or his authorized representative established in the 
Community  must  affix  the  CE  marking  to  each  safety  component  and  draw  up  an  EC 
declaration  of  conformity.  The  CE  marking  must  be  accompanied  by  the  identification 
number of the notified body responsible for surveillance as specified in Section 4. 

2. The manufacturer must apply an approved quality assurance system for final inspection of 
the safety component and testing as specified in Section 3, and must be subject to surveillance 
as specified in Section 4.  

⌦ 1. Product quality assurance for safety components for lifts is the part of the conformity 
assessment procedure whereby a notified body assesses the product quality assurance system 
of a manufacturer in order to ensure that the safety components for lifts are manufactured and 
monitored in conformity with the type described in the EU type-examination certificate and 
satisfy the essential health and safety requirements set out in Annex I and will enable a lift to 
which they are correctly fitted to satisfy those requirements. ⌫ 

⌦ 2. OBLIGATIONS OF THE MANUFACTURER ⌫ 

⌦ 2.1. The manufacturer shall apply an approved product quality assurance system for final 
inspection  and  testing  of  the  safety  component  for lifts as specified in Point 3, and shall be 
subject to surveillance as specified in Point 4. ⌫ 

⌦ 2.2. The manufacturer or his authorized representative established in the Union shall affix 
the  CE  marking  to  each  safety  component  for  lifts  and  draw  up  an  EU  declaration  of 
conformity. ⌫ 

3. ⌦ PRODUCT ⌫ QQUALITY ASSURANCE SYSTEM 

3.1. The manufacturer of the safety components ⌦ or his authorised representative ⌫ must 
⌦ shall ⌫ lodge an application for assessment of his ⌦ the product ⌫ quality assurance 
system for the safety components concerned ⌦ for lifts ⌫ with a (cid:214) single  notified body 
of his choice. 

The application must include: 

EN 

81 

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(cid:216) new 

(a)  the  name  and  address  of  the  manufacturer  and,  if  the  application  is  lodged  by  his 
authorised representative, his name and address as well; 

(b) a written declaration that the same application has not been lodged with any other notified 
body; 

(c)  the  premises  where  final  inspection  and  testing  of  the  safety  components  for  lifts  are 
carried out;  

(cid:208) 95/16/EC (adapted) 

(d)- all relevant information for ⌦ on ⌫ the safety components envisaged ⌦ for lifts to be 
manufactured ⌫,; 

(e)- the documentation on the ⌦ product ⌫ quality assurance system,; 

(f)- the technical documentation ⌦ file(s) ⌫ of the approved safety components ⌦ for lifts 
to  be  manufactured ⌫  and  a  copy  of  the  EC  ⌦ EU ⌫  type-examination  certificates. 
⌦ certificate(s). ⌫ 

3.2.  Under  the  ⌦ product ⌫  quality  assurance  system,  each  safety  component  ⌦ for 
lifts shall  ⌫  must  be  examined  ⌦ inspected ⌫  and  appropriate  tests  as  set  out  in  the 
relevant  standards  referred  to  in  Article  514  or  equivalent  tests ⌦shall ⌫  must  be  carried 
out  in  order  to  ensure  its  conformity  to  the  relevant  requirements  of  the  Directive. 
⌦ essential health and safety requirements set out in Annex I. ⌫ 

All  the  elements,  requirements  and  provisions  adopted  by  the  manufacturer  of  the  safety 
components must ⌦ shall ⌫ be documented in a systematic and orderly manner in the form 
instructions.  This  quality  assurance  system 
of  written  measures,  procedures  and 
documentation must ⌦ shall ⌫ ensure a common understanding of the quality programmes, 
plans, manuals and records. 

It must contain in particular an adequate description of: 

(a) 

the quality objectives; 

(cid:208) 95/16/EC 

(cid:208) 95/16/EC (adapted) 

(b) 

(c) 

(d) 

the  organizational  structure,  responsibilities  and  powers  of  the  management  with 
regard to quality of the safety component ⌦ for lifts ⌫; 

the  examinations  ⌦ inspections ⌫  and  tests  that  will  be  carried  out  after 
manufacture; 

the  means  to  verify  the  effective  operation  of  the ⌦ product ⌫  quality  assurance 
system; 

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(e) 

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

(cid:208) 95/16/EC 

(cid:208) 95/16/EC (adapted) 

3.3. The notified body must assess the ⌦ product ⌫ quality assurance system to determine 
whether  it  satisfies  the  requirements  referred  to  in  Section  Point  3.2.  It  ⌦ shall ⌫  must 
presume  conformity  with  these  requirements  in  respect  of ⌦ product ⌫  quality  assurance 
systems that implement the relevant harmonized standard31. 

The  auditing  team  must  have  at  least  one  member  with  experience  of  assessment  in  the  lift 
technology concerned ⌦ and  knowledge  of  the  essential  health  and  safety  requirements  set 
out in Annex I. ⌫ 

The  assessment  procedure  must  ⌦ shall ⌫  include  a  visit  to  the  premises  of  the  safety 
component manufacturer ⌦ where final inspection and testing of safety components for lifts 
are carried out ⌫. 

(cid:208) 95/16/EC (adapted) 

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

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

Under  the  responsibility  of  the  notified  body,  the  manufacturer  shall  affix  the  identification 
number of the notified body adjacent to the CE marking in accordance with Articles 18 and 
19 to the safety components for lifts during the manufacturing process.  

(cid:216) new 

(cid:208) 95/16/EC (adapted) 

3.4. The manufacturer of the safety components must ⌦ shall ⌫ undertake to discharge the 
obligations  arising  from  the  ⌦ product ⌫  quality  assurance  system  as  approved  and  to 
ensure that it is maintained in an appropriate and efficient manner. 

The manufacturer of the safety components or his authorized representative established in the 
Community ⌦ Union ⌫ must ⌦ shall ⌫ keep the notified body which has approved the 
⌦ product ⌫  quality  assurance  system  informed  of  any  intended  updating  of  the  quality 
assurance system. 

31 

This  harmonized  standard  will  be  EN  29003,  supplemented  where  necessary  to  take  account  of  the 
specific features of safety components. 

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The  notified  body  must  ⌦ shall ⌫  assess  the  modifications  proposed  and  decide  whether 
the modified ⌦ product ⌫ quality assurance system still satisfies the requirements referred 
to in Section Point 3.2 or whether a reassessment is required. 

It must ⌦ shall ⌫ notify its decision to the manufacturer. The notification must ⌦ shall ⌫ 
contain  the  conclusions  of  the  examination  and  the  reasoned  assessment  ⌦ report ⌫ 
decision. 

4. SURVEILLANCE UNDER THE RESPONSIBILITY OF THE NOTIFIED BODY 

4.1.  The  purpose  of  surveillance  is  to  make  sure  that  the  manufacturer  of  the  safety 
component  duly  fulfils  the  obligations  arising  out  of  the  approved  ⌦ product ⌫  quality 
assurance system. 

4.2.  The  manufacturer  must  ⌦ shall ⌫  allow  the  notified  body  access  for  inspection 
purposes to the ⌦ premises where final ⌫ inspection, testing and storage locations ⌦ are 
carried out ⌫ and provide it with all necessary information, in particular: 

(a)- the ⌦ product ⌫ quality assurance system documentation,; 

(b)- the technical ⌦ file(s); ⌫ documentation, 

(c)- the quality records, such as inspection reports and test data, calibration data, reports on 
the qualifications of the personnel concerned, etc. 

(cid:208) 95/16/EC 

(cid:208) 95/16/EC (adapted) 
(cid:214) new 

4.3.  The  notified  body  must  ⌦ shall ⌫  periodically  carry  out  audits  to  ensure  that  the 
manufacturer  of  the  safety  components  maintains  and  applies  the  ⌦ product ⌫  quality 
assurance  system  and  must  ⌦ shall ⌫  provide  an  audit  report  to  the  manufacturer  of  the 
safety components, (cid:214)and, where appropriate, to his authorised representative.   

4.4.  Additionally,  the  notified  body  may  pay  unexpected  visits  to  the  manufacturer  of  the 
safety  component  ⌦ premises  where  final  inspection  and  testing  of  safety  components  for 
lifts are carried out ⌫.  

At  the  time  of  such  visits,  the  notified  body  may, where  necessary, carry  out  tests  or  have 
them  carried  out  in  order  to  check  the  proper  functioning  of  the  ⌦ product  ⌫  quality 
assurance  system  where  necessary;. it  must  ⌦ It  shall ⌫  provide  the  manufacturer  of  the 
safety components (cid:214)and, where appropriate, to his authorised representative,  with a visit 
report and, if a test has been carried out, with a test report. 

5.  The  manufacturer  must  ⌦ shall ⌫  for  a  period  ending  10  years  after  the  last  safety 
component  ⌦ for  lifts ⌫  has  been  manufactured  (cid:214) placed  on  the  market ,  keep  at  the 
disposal of the national authorities: 

EN 

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(a)-  the  documentation  ⌦ technical  file(s) ⌫  referred  to  in  the  third  indent  of  the  second 
paragraph of Section Point 3.1(f),; 

(cid:208) 95/16/EC (adapted) 

(b) the documentation referred to in Point 3.1(e); 

(cid:216) new 

(cid:208) 95/16/EC (adapted) 

(c)- the updating referred to in the second paragraph of Section Point 3.4,; 

(d)-  the  decisions  and  reports  from  the  notified  body  which  are  referred  to  in  the  final 
paragraph of Section Point 3.4 and in Sections Points 4.3 and 4.4. 

6.  Each  notified  body  must  forward  to  the  other  notified  bodies  the  relevant  information 
concerning the quality assurance system approvals issued and withdrawn.  

(cid:216) new 

6.  Each  notified  body  shall  inform  its  notifying  authorities  of  product  quality  assurance 
system  approval  decision(s)  issued  or  withdrawn,  and  shall,  periodically  or  upon  request, 
make  available  to  its  notifying  authorities  the  list  of  approval  decisions,  issued,  refused, 
suspended or otherwise restricted.  

Each notified body shall inform the other notified bodies of product quality assurance system 
approval  decision(s)  which  it  has  refused,  suspended  or  withdrawn  and,  upon  request,  of 
approval decision(s) which it has issued.  

On  request,  the  notified  body  shall  provide  the  Commission  and  the  Member  States  with  a 
copy of product quality assurance system approval decision(s) issued.  

7. The documents and correspondence relating to the product quality assurance system shall 
be drawn up in one of the official languages of the Member State where the notified body is 
established or in a language acceptable to it.  

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(cid:208) 95/16/EC (adapted) 

ANNEX VII IX  

FULL QUALITY ASSURANCE ⌦ FOR SAFETY COMPONENTS FOR LIFTS ⌫ 

(module H) 

1. Full quality assurance is the procedure whereby the manufacturer of the safety component 
who  satisfies  the  obligations  of  Section  2  ensures  and  declares  that  the  safety  components 
satisfy the requirements of the Directive that apply to them and that the safety component will 
enable a lift to which it is correctly fitted to satisfy the requirements of the Directive. 

The  manufacturer  or  his  authorized  representative  established  in  the  Community  must  affix 
the CE marking to each safety component and draw up an EC declaration of conformity. The 
CE  marking  must  be  accompanied  by  the  identification  number  of  the  notified  body 
responsible for the surveillance as specified in Section 4. 

2.  The  manufacturer  must  operate  an  approved  quality  assurance  system  for  design, 
manufacture and final inspection of the safety components and testing as specified in Section 
3 and must be subject to surveillance as specified in Section 4. 

⌦ 1.  Full  quality  assurance  for  safety  components  for  lifts  is  the  conformity  assessment 
procedure  whereby  a  notified  body  assesses  the  full  quality  assurance  system  of  a 
manufacturer  to  ensure  that  the  safety  components  for  lifts  are  designed,  manufactured, 
inspected and tested in order to satisfy the essential health and safety requirements set out in 
Annex I and to enable a lift to which they are correctly fitted to satisfy those requirements. ⌫ 

⌦ 2.1.  The  manufacturer  shall  operate  an  approved  full  quality  assurance  system  for  the 
design, manufacture, final inspection and testing of safety components for lifts as specified in 
Point 3 and shall be subject to surveillance as specified in Point 4. ⌫ 

⌦ 2.2. The manufacturer or his authorized representative established in the Union shall affix 
the  CE  marking  to  each  safety  component  for  lifts  and  draw  up  an  EU  declaration  of 
conformity.  The  CE  marking  shall  be  accompanied  by  the  identification  number  of  the 
notified body responsible for the surveillance as specified in Point 4. ⌫ 

3. ⌦ FULL ⌫ QQUALITY ASSURANCE SYSTEM 

(cid:208) 95/16/EC (adapted) 
(cid:214) new 

3.1. The manufacturer must ⌦ or his authorised representative shall ⌫ lodge an application 
for  assessment  of  his ⌦ full ⌫  quality  assurance  system  with  a  (cid:214) single  notified  body 
⌦ of his choice ⌫. The application must ⌦ shall ⌫ include: 

(a)  the  name  and  address  of  the  manufacturer  and,  if  the  application  is  lodged  by  his 
authorised representative, his name and address as well;  

(cid:216) new 

EN 

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(b) the premises where the safety components for lifts are designed, manufactured, inspected 
and tested;  

(c)- all relevant information on safety components ⌦ for lifts to be manufactured ⌫,; 

(cid:208) 95/16/EC (adapted) 

(d) a technical file according to Annex IVA Point 3 for one model of each category of safety 
component for lifts according to Annex III to be manufactured;  

(cid:216) new 

(e) the documentation on the ⌦ full ⌫ quality assurance system,; 

(cid:208) 95/16/EC (adapted) 

(f) a written declaration that the same application has not been lodged with any other notified 
body.  

(cid:216) new 

(cid:208) 95/16/EC (adapted) 

3.2. The quality assurance system must ensure compliance of the safety components with the 
requirements  of  the  Directive  that  apply  to  them  and  enable  lifts  to  which  they  have  been 
correctly fitted to satisfy those requirements. 

3.2.  All  the  elements,  requirements  and  provisions  adopted  by  the  manufacturer  must 
⌦ shall ⌫  be  documented  in  a  systematic  and  orderly  manner  in  the  form  of  written 
instructions.  This  ⌦ full ⌫  quality  assurance  system 
measures,  procedures  and 
documentation must ⌦ shall ⌫ ensure a common understanding of the quality policies and 
procedures such as quality programmes, plans, manuals and records. 

It must ⌦ shall ⌫ contain in particular an adequate description of: 

(a)- the quality objectives and the organizational structure, responsibilities and powers of the 
management with regard to the design and quality of the safety components ⌦ for lifts ⌫,; 

(b)- the technical design specifications, including  standards, that  will be applied  and, where 
the standards referred to in Article 514 ⌦ are not ⌫will not be applied ⌦ or not applied ⌫ 
in  full,  the  means  that  will  be  used  to  ensure  that  the  essential  ⌦ health  and  safety ⌫ 
requirements of the Directive that apply to the safety components ⌦ set out in Annex I ⌫ 
will be met,;  

(c)-  the  design  control  and  design  verification  techniques,  processes  and  systematic  actions 
that will be used when designing the safety components ⌦ for lifts ⌫,; 

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(cid:208) 95/16/EC 

(d)-  the  corresponding  manufacturing,  quality  control  and  quality  assurance  techniques, 
processes and systematic actions that will be used,; 

(e)- the examinations and tests that will be carried out before, during and after manufacture, 
and the frequency with which they will be carried out,; 

(f)- the quality records, such as inspection reports and test data, calibration data, reports on the 
qualifications of the personnel concerned, etc.,; 

(g)- the means of monitoring the achievement of the required design and product quality and 
the effective operation of the quality assurance system. 

(cid:208) 95/16/EC (adapted) 
(cid:214) new 

3.3.  The  notified  body  must ⌦ shall ⌫  assess  the ⌦ full ⌫  quality  assurance  system  to 
determine  whether  it  satisfies  the  requirements  referred  to  in  Section  Point  3.2.  It  must 
⌦ shall ⌫  presume  compliance  with  these  requirements  in  respect  of  quality  assurance 
systems that implement the relevant harmonized standard32. 

The auditing team must ⌦ shall ⌫ have at least one member with experience of assessment 
in  the  lift  technology  concerned (cid:214) and  knowledge  of  the  essential  health  and  safety 
requirements  set  out  in  Annex  I.  The  assessment  procedure  must  include  a  visit  to  the 
manufacturer's premises. 

The  auditing  team  shall  review  the  technical  file(s)  referred  to  in  Point  3.1  to  verify  the 
manufacturer's ability to identify the essential health and safety requirements set out in Annex 
I and to carry out the necessary examinations with a view to ensuring compliance of the safety 
components for lifts with those requirements.  

(cid:216) new 

(cid:208) 95/16/EC (adapted) 
(cid:214) new 

The  decision  must  ⌦ shall ⌫  be  notified  to  the  manufacturer of  the  safety  components 
(cid:214) and,  where  appropriate,  to  his  authorised  representative.  The  notification  must 
⌦ shall ⌫ contain the conclusions of the ⌦ assessment ⌫ examination and the reasoned 
assessment ⌦ approval ⌫ decision. 

32 

This  harmonized  standard  will  be  EN  29001,  supplemented  where  necessary  to  take  account  of  the 
specific features of safety components. 

EN 

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Under  the  responsibility  of  the  notified  body,  the  manufacturer  shall  affix  the  identification 
number of the notified body adjacent to the CE marking in accordance with Articles 18 and 
19 to the safety components for lifts during the manufacturing process.  

(cid:216) new 

(cid:208) 95/16/EC (adapted) 

3.4.  The  manufacturer  of  the  safety  components  must  undertake  ⌦ shall  undertake ⌫  to 
discharge  the  obligations  arising  from  the ⌦ full ⌫  quality  assurance  system  as  approved 
and to ensure that it is maintained in an appropriate and efficient manner. 

The  manufacturer  or  his  authorized  representative  established  in  the  Community  must 
⌦ shall ⌫  keep  the  notified  body  which  has  approved  the  ⌦ full ⌫  quality  assurance 
system informed of any intended updating of the quality assurance system. 

The  notified  body  must  ⌦ shall ⌫  assess  the  modifications  proposed  and  decide  whether 
the modified ⌦ full ⌫ quality assurance system will still satisfy the requirements referred to 
in Section Point 3.2 or whether a reassessment is required. 

It must ⌦ shall ⌫ notify its decision to the manufacturer. The notification must ⌦ shall ⌫ 
contain  the  conclusions  of  the  ⌦ assessment ⌫  examination  and  the  reasoned  assessment 
⌦ approval ⌫ decision. 

4. SURVEILLANCE UNDER THE RESPONSIBILITY OF THE NOTIFIED BODY 

4.1.  The  purpose  of  surveillance  is  to  make  sure  that  the  manufacturer  of  the  safety 
components  duly  fulfils  the  obligations  arising  out  of  the  approved  ⌦ full ⌫  quality 
assurance system. 

4.2.  The  manufacturer  of  the  safety  components  must  ⌦ shall ⌫  allow  the  notified  body 
access for inspection purposes to the design, manufacture, inspection and testing, and storage 
locations, and must ⌦ shall ⌫ provide it with all necessary information, in particular: 

(a)- the ⌦ full ⌫ quality assurance system documentation,; 

(b)-  the  quality  records  provided  for  in  the  design  part  of  the  ⌦ full ⌫  quality 
⌦ assurance ⌫ system, such as results of analyses, calculations, tests, etc.,; 

(c) the technical files for the safety components for lifts manufactured;  

(cid:216) new 

(d)-  the  quality  records  provided  for  in  the  manufacturing  part  of  the  ⌦ full ⌫  quality 
assurance  system,  such  as  inspection  reports  and  test  data,  calibration  data,  reports  on  the 
qualifications of the personnel concerned, etc. 

(cid:208) 95/16/EC (adapted) 
(cid:214) new 

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4.3.  The  notified  body  must ⌦ shall ⌫  periodically  carry  out  audits  to  make  sure  that  the 
manufacturer  of  the  safety  components  maintains  and  applies  the  ⌦ the  approved  full ⌫ 
quality assurance system and must ⌦ shall ⌫ provide an audit report to the manufacturer of 
the safety components. 

4.4.  Additionally,  the  notified  body  may  pay  unexpected  visits  to  the  manufacturer  of  the 
safety components. At the time of such visits, the notified body may, where necessary, carry 
out tests or have them carried out in order to check the proper functioning of the ⌦ full ⌫ 
quality assurance system where necessary; . it must ⌦ It shall ⌫ provide the manufacturer 
of  the  safety  components  with  a  visit  report  and,  if  a  test  has  been  carried  out,  with  a  test 
report. 

5.  The  manufacturer  of  the  safety  components  or  his  authorized  representative  must 
⌦ shall ⌫ for a period of 10 years after the last safety component ⌦ for lifts ⌫ has been 
manufactured (cid:214) placed on the market,  keep at the disposal of the national authorities: 

(a)-  the  documentation  referred  to  in  the  second  indent  of  the  second  paragraph  of  Section 
Point 3.1(e),; 

(cid:208) 95/16/EC (adapted) 

(b) the technical file referred to in Point 3.1(d); 

(cid:216) new 

(cid:208) 95/16/EC 

(c)- the updating referred to in the second paragraph of Section Point 3.4,; 

(cid:208) 95/16/EC (adapted) 

(d)-  the  decisions  and  reports  from  the  notified  body  which  are  referred  to  in  the  final 
paragraph of Section Point 3.4 and in Sections Points 4.3 and 4.4. 

Where, neither the manufacturer of the safety components ⌦ for lifts ⌫ nor his authorized 
representative  is  established  in  the  ⌦ Union ⌫  Community,  the  obligation  to  keep  the 
technical documentation available falls to the person who places the safety component ⌦ for 
lifts ⌫ on the ⌦ Union ⌫ Community market. 

6.  Each  notified  body  must  forward  to  the  other  notified  bodies  the  relevant  information 
concerning the quality assurance system approvals issued and withdrawn. 

6.  Each  notified  body  shall  inform  its  notifying  authorities  of  full  quality  assurance  system 
approval  decision(s)  issued  or  withdrawn,  and  shall,  periodically  or  upon  request,  make 
available to its notifying authorities the list of approval decisions issued, refused, suspended 
or otherwise restricted.  

(cid:216) new 

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

On  request,  the  notified  body  shall  provide  the  Commission  and  the  Member  States  with  a 
copy of full quality system approval decision(s) issued.  

The  notified  body  shall  keep  a  copy  of  the  approval  decision(s)  issued,  its  annexes  and 
additions, as well as the technical file for a period of 15 years from the date of their issue. 

7.  The  dossiers ⌦ documents ⌫  and  correspondence  relating  to  the  full  quality  assurance 
procedures  must  ⌦ shall ⌫  be  drawn  up  in  one  of  the  official  languages  of  the  Member 
State where the notified body is established or in a language acceptable to it. 

(cid:208) 95/16/EC (adapted) 

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(cid:208) 95/16/EC (adapted) 
(cid:214) new 

ANNEX VIII X 

UNIT VERIFICATION ⌦ FOR LIFTS ⌫ 

(module G) 

1. Unit verification is the procedure whereby the installer of a lift ensures and declares that a 
lift which is being placed on the market and which has obtained the certificate of conformity 
referred to in Section 4 complies with the requirements of the Directive. The installer of the 
lift  must  affix  the  CE  marking  in  the  car  of  the  lift  and  draw  up  an  EC  declaration  of 
conformity.  

⌦1.  Unit  verification  is  the  conformity  assessment  procedure  whereby  a  notified  body 
assesses  whether  an  installed  lift  complies  with the  essential  health  and  safety  requirements 
set out in Annex I. ⌫ 

⌦ 2. OBLIGATIONS OF THE INSTALLER ⌫ 

⌦ 2.1.The  installer  shall  affix  the  CE  marking  in  the  car  of  the  lift  and  draw  up 
an EU declaration of conformity. ⌫ 

2.2.2.  The  lift  installer  shall  apply  to  a (cid:214) single   notified  body  of  his  choice  for  unit 
verification. 

The application shall contain: 

(a)- the name and address of the installer, of the lift,;  

(b)- and the location where the lift is installed,;  

(cid:208) 95/16/EC 

(cid:208) 95/16/EC (adapted) 

(cid:208) 95/16/EC 

(c)-  a  written  declaration  to  the  effect  that  a  similar  application  has  not  been  lodged  with 
another notified body,; 

(d)- a technical ⌦ file ⌫ dossier . 

(cid:208) 95/16/EC (adapted) 

3.  The  purpose  of  the  technical  dossier  is  to  enable  the  conformity  of  the  lift  with  the 
requirements of the Directive to be assessed and the design, installation and operation of the 

EN 

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lift to be understood. ⌦ The technical file shall allow an assessment of the conformity of the 
lift with the essential health and safety requirements set out in Annex I ⌫. 

So far as relevant for conformity assessment, tThe technical ⌦ file ⌫ dossier shall contain 
⌦ at least ⌫ the following ⌦ elements ⌫ : 

(cid:208) 95/16/EC (adapted) 

(a)- a general description of the lift,; 

(b)- design and manufacturing drawings and diagrams,; 

– 

the  essential  requirements  in  question  and  the  solution  adopted  to  meet  them  (e.g. 
harmonized standard), 

(cid:216) new 

(c) explanations necessary for the understanding of those drawings and diagrams and of the 
operation of the lift;  

(d)  a  list  of  the  harmonised  standards  the  references  of  which  have  been  published  in  the 
Official  Journal  of  the  European  Union,  applied  in  full  or  in  part,  and  descriptions  of  the 
solutions  adopted  to  meet  the  essential  health  and  safety  requirements  set  out  in  Annex  I 
where  those  harmonised  standards  have  not  been  applied.  In  the  event  of  partly  applied 
harmonised standards, the technical file shall specify the parts which have been applied;  

(cid:208) 95/16/EC (adapted) 

(e)-  a  copy  of  the  ⌦ EU ⌫  EC  type-examination  certificates  of  the  safety  components 
⌦ for lifts ⌫ used ⌦ in the lift ⌫,; 

(f)- results of any tests or calculations ⌦ performed by or for the installer; ⌫ carried out or 
subcontracted by the installer of the lift,; 

(g) test reports;  

(cid:216) new 

(cid:208) 95/16/EC (adapted) 

(h)- a copy of the instructions for use of the lift ⌦referred to in point 6.2 of Annex I ⌫ . 

4. The notified body must ⌦ shall ⌫ examine the technical dossier ⌦ file ⌫ and the lift 
and carry out the appropriate tests as set out in the relevant standard(s) referred to in Article 
514  of  the  Directive,  or  equivalent  tests,  to  ensure  its  conformity  with  the  relevant 
⌦ essential health and safety ⌫ requirements of this Directive ⌦ set out in Annex I. The 
tests shall include at least the tests referred to in Point 3.4 (e) of Annex V. ⌫ 

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If the lift meets the requirements of this Directive, the notified body shall affix, or cause to be 
affixed,  its  identification  number  adjacent  to  the  CE  marking  in  accordance  with  Annex  III 
and shall draw up a certificate of conformity relating to the tests carried out.  

⌦ If the lift meets the essential health and safety requirements set out in Annex I the notified 
body  shall  draw  up  a  certificate  of  conformity  relating  to  the  tests  carried  out.  The  notified 
body shall affix, or cause to be affixed, its identification number adjacent to the CE marking 
in accordance with Articles 18 and 21. ⌫ 

The notified body shall fill in the corresponding pages of the logbook referred to in Section 
Point 6.2 of Annex I. 

If the notified body refuses to issue the certificate of conformity, it must ⌦ shall ⌫ state in 
detail  its  reasons  for  refusing  ⌦ refusal ⌫  and  indicate  ⌦ the  necessary  corrective 
measures  to  be  taken ⌫  how  conformity  can  be  achieved.  When  the  installer  of  the  lift 
reapplies for ⌦ unit ⌫ verification he must ⌦ shall ⌫ apply to the same notified body.  

On  request,  the  notified  body  shall  provide  the  Commission  and  the  Member  states  with  a 
copy of the certificate of conformity. 

(cid:216) new 

(cid:208) 95/16/EC (adapted) 

5.  The  certificate  of  conformity  and  the  dossiers  ⌦ documents ⌫  and  correspondence 
relating to unit verification procedures must ⌦ shall ⌫ be drawn up in an official language 
of the Member State where the notified body is established or in a language acceptable to it. 

6.  The  installer  of  the  lift  shall  keep  with  the  technical  ⌦ file ⌫  dossier  a  copy  of  the 
certificate of conformity for a period of 10 years from the date on which the lift is placed on 
the market. 

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(cid:208) 95/16/EC (adapted) 

ANNEX IX XI 

CONFORMITY TO TYPE WITH RANDOM CHECKING  

⌦ FOR SAFETY COMPONENTS FOR LIFTS ⌫ 

(module ⌦ F ⌫ C) 

1. Conformity to type is the procedure whereby the manufacturer of the safety components or 
his  authorized  representative  established  in  the  Community  ensures  and  declares  that  the 
safety components are in conformity with the type as described in the EC type certificate and 
satisfy the requirements of the Directive that apply to them and enable any lift to which they 
are correctly fitted to satisfy the essential health and safety requirements of the Directive. 

⌦ 1.  Conformity  to  type  with  random  checking  is  the  part  of  the  conformity  assessment 
procedure whereby a notified body carries out checks on safety components for lifts to ensure 
that they are in conformity with the type as described in the EU type certificate and satisfy the 
applicable essential health and safety requirements of the Directive and enable a lift to which 
they are correctly fitted to satisfy those requirements. ⌫ 

The manufacturer of the safety components, or his authorized representative established in the 
Community,  must  affix  the  CE  marking  to  each  safety  component  and  draw  up  an  EC 
declaration of conformity. 

2. The manufacturer of the safety components must take all measures necessary to ensure that 
the  manufacturing  process  assures  conformity  of  the  manufactured  safety  components  with 
the type as described in the EC type-examination certificate and with the requirements of the 
Directive that apply to them. 

⌦ 2. OBLIGATIONS OF THE MANUFACTURER ⌫ 

⌦ 2.1. The manufacturer shall take all measures necessary to ensure that the manufacturing 
process ensures conformity of the manufactured safety components for lifts with the type as 
described  in  the  EU  type  examination  certificate  and  with  the  essential  health  and  safety 
requirements set out in Annex I. ⌫ 

⌦ 2.2. The manufacturer or his authorized representative established in the Union must affix 
the  CE  marking  to  each  safety  component  for  lifts  and  draw  up  an  EU  declaration  of 
conformity. ⌫ 

⌦ 3.The manufacturer or his authorised representative shall lodge an application for random 
checking with a single notified body of his choice.  

The application shall include: ⌫ 

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(cid:216) new 

(a)  the  name  and  address  of  the  manufacturer  and,  if  the  application  is  lodged  by  his 
authorised representative, his name and address as well; 

(b) a written declaration that the same application has not been lodged with any other notified 
body; 

(c) all relevant information on the safety components for lifts manufactured; 

(d) the premises where the sample of the safety components for lifts can be taken. 

(cid:208) 95/16/EC (adapted) 

4.  A  ⌦ The ⌫  notified  body  chosen  by  the  manufacturer  must  ⌦ shall ⌫  carry  out  or 
have  carried  out  checks  on  safety  components  ⌦ for  lifts ⌫  at  random  intervals.  An 
adequate sample of the finished safety components, taken on site by the notified body, must 
be examined and appropriate tests as set out in the relevant standard(s) referred to in Article 
514,  or  equivalent  tests,  must  ⌦ shall ⌫  be  carried  out  to  check  the  conformity  of 
production  to  the  relevant  requirements  of  the  Directive  ⌦ essential  health  and  safety 
requirements  set  out  in  Annex  I ⌫  .  In  those  cases  where  one  or  more  of  the  safety 
components ⌦ for lifts ⌫ checked do not conform, the notified body must ⌦ shall ⌫ take 
appropriate measures. 

The points to be taken into account when checking the safety components ⌦ for lifts ⌫ will 
be defined by joint agreement between all the notified bodies responsible for this procedure, 
taking into consideration the essential characteristics of the safety components ⌦ for lifts ⌫ 
referred to in Annex III IV. 

⌦ On request, the notified body shall provide the Commission and the Member states with a 
copy of the certificate of conformity. ⌫ 

On  the  responsibility  of  the  notified  body,  the  manufacturer  must  affix  that  body's 
identification number during the manufacturing process. 

⌦ 6.  Under  the  responsibility  of  the  notified  body,  the  manufacturer  shall  affix  the 
identification  number  of  the  notified  body  adjacent  to  the  CE  marking  in  accordance  with 
Articles 18 and 19 to the safety components for lifts during the manufacturing process. ⌫ 

3.  The  manufacturer  of  the  safety  components  or  his  authorized  representative  must  keep  a 
copy  of  the  EC  declaration  of  conformity  for  a  period  of  10  years  after  the  last  safety 
component has been manufactured. 

⌦ The manufacturer or his authorized representative must keep a copy of the EU declaration 
of conformity for a period of 10 years after the last safety component has been manufactured. 
⌫ 

Where  neither  the  manufacturer  of  the  safety  components  nor  his  authorized  representative 
are  established  in  the  Community  ⌦ Union  ⌫,  the  obligation  to  keep  the  technical 
documentation available falls to the person who places the safety components ⌦ for lifts ⌫ 
on the ⌦ Union ⌫ market.  

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5.7.  The  ⌦ documents ⌫  dossiers  and  correspondence  relating  to  the  random  checking 
procedures referred to in Section Point 4 ⌦ shall ⌫ must be drawn up in one of the official 
languages  of  the  Member  State  where  the  notified  body  is  established  or  in  a  language 
acceptable to it. 

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(cid:208) 95/16/EC (adapted) 
(cid:214) new 

ANNEX X XII 

PRODUCT QUALITY ASSURANCE FOR LIFTS 

(module E) 

1.  Product  quality  assurance  is  the  procedure  whereby  the  installer  of  a  lift  who  satisfies 
Section  2  ensures  and  declares  that  the  lifts  installed  are  in  conformity  with  the  type  as 
described in the EC type-examination certificate and satisfy the requirements of the Directive 
that apply to them. 

The installer of a lift must affix the CE marking to each lift and draw up an EC declaration of 
conformity.  The  CE  marking  must  be  accompanied  by  the  identification  number  of  the 
notified body responsible for surveillance as specified in Section 4. 

2. The installer of a lift must apply an approved quality assurance system for final inspection 
of the lift and testing as specified in Section 3, and must be subject to surveillance as specified 
in Section 4. 

⌦ 1. Product quality assurance is the part of the conformity assessment procedure whereby a 
notified body assesses the product quality assurance system of an installer to ensure that the 
lifts  installed  are  in  conformity  with  the  type  as  described  in  the  EU  type-examination 
certificate or with a lift designed and manufactured by an installer who operates a full quality 
assurance  system  in  accordance  with  Annex  XI, and  satisfy  the  essential  health  and  safety 
requirements set out in Annex I. ⌫ 

⌦ 2. OBLIGATIONS OF THE INSTALLER ⌫ 

⌦ 2.1.  The  installer  shall  apply  an  approved  product  quality  assurance  system  for  final 
inspection and testing of the lift as specified in Point 3, and shall be subject to surveillance as 
specified in Point 4. ⌫ 

⌦ 2.2. The installer shall affix the CE marking to each lift and draw up an EU declaration of 
conformity. ⌫ 

3. ⌦ PRODUCT ⌫ QUALITY ASSURANCE SYSTEM 

3.1.  The  installer  of  a  lift  ⌦ shall ⌫  must  lodge  an  application  for  assessment  of  his 
⌦ product ⌫  quality  assurance  system  for  the  lifts  concerned  with  a (cid:214) single  notified 
body of his choice. 

The application ⌦ shall ⌫ must include: 

(a) 

the name and address of the installer;  

(cid:216) new 

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(b)- all relevant information ⌦ on the lifts to be installed ⌫ for the lifts envisaged,; 

(c)- the documentation on the ⌦ product ⌫ quality assurance system,; 

(cid:208) 95/16/EC (adapted) 

(d)- the technical documentation ⌦ file ⌫ on the approved lifts and a copy of the EC type-
examination certificates, ⌦ of the lifts to be installed; ⌫ 

(e) a written declaration that the same application has not been lodged with any other notified 
body.  

(cid:216) new 

(cid:208) 95/16/EC (adapted) 

3.2.  Under  the  ⌦ product ⌫  quality  assurance  system,  each  lift  ⌦ shall ⌫  must  be 
examined and appropriate tests as set out in the relevant standards referred to in Article 514 or 
equivalent  tests  ⌦ shall ⌫  must  be  carried  out  in  order  to  ensure  its  conformity  to  the 
relevant requirements of the Directive ⌦ to the essential health and safety requirements set 
out in Annex I ⌫ . 

All  the  elements,  requirements  and  provisions  adopted  by  the  installer  of  a  lift ⌦ shall ⌫ 
must  be  documented  in  a  systematic  and  orderly  manner  in  the  form  of  written  measures, 
procedures  and  instructions.  This  ⌦ product ⌫  quality  assurance  system  documentation 
⌦ shall ⌫ must ensure a common understanding of the quality programmes, plans, manuals 
and quality records. 

It ⌦ shall ⌫ must contain in particular an adequate description of: 

(a)- the quality objectives,; 

(b)- the organizational structure, responsibilities and powers of the management with regard 
to lift quality,; 

(c)- the examinations and tests that will be carried out before placing on the market, including 
at the very least the tests laid down in Point 3.3.(b) of Annex VI, 4 (b),; 

(d)-  the  means  to  verify  the  effective  operation  of  the  ⌦ product ⌫  quality  assurance 
system,; 

(e)- quality records, such as inspection reports and test data, calibration data, reports on the 
qualifications of the personnel concerned, etc. 

(cid:208) 95/16/EC 

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(cid:208) 95/16/EC (adapted) 
(cid:214) new 

3.3. The notified body ⌦ shall ⌫ must assess the ⌦ product ⌫ quality assurance system 
to  determine  whether  it  satisfies  the  requirements  referred  to  in  Section  Point  3.2.  It  must 
⌦ shall ⌫  presume  conformity  with  these  requirements  in  respect  of  quality  assurance 
systems that implement the relevant harmonized standard33. 

The auditing team must ⌦ shall ⌫ have at least one member with experience of assessment 
in  the  lift  technology  concerned (cid:214) and  knowledge  of  the  essential  health  and  safety 
requirements  set  out  in  Annex  I.  The  assessment  procedure  must  ⌦ shall ⌫  include  a 
visit to the premises of the lift installer and a visit to the installation site. 

The decision must ⌦ shall ⌫ be notified to the lift installer. The notification must contain 
the conclusions of the examination and the reasoned assessment ⌦ approval ⌫ decision. 

3.4.  The  installer  of  a  lift  must  ⌦ shall ⌫  undertake  to  discharge  the  obligations  arising 
from  the  ⌦ product ⌫  quality  assurance  system  as  approved  and  to  ensure  that  it  is 
maintained in an appropriate and efficient manner. 

The  installer  of  a  lift  must  keep  the  notified  body  which  has  approved  the  quality 
⌦ product ⌫ assurance system informed of any intended updating of the quality assurance 
system. 

The  notified  body  must  ⌦ shall ⌫  assess  the  modifications  proposed  and  decide  whether 
the modified ⌦ product ⌫ quality assurance system still satisfies the requirements referred 
to in Section Point 3.2 or whether a reassessment is required. 

It must ⌦ shall ⌫ notify its decision to the lift installer. The notification must contain the 
conclusions of the examination ⌦ assessment ⌫ and the reasoned assessment decision. 

The notified body shall affix, or cause to be affixed, its identification number adjacent to the 
CE marking in accordance with Articles 18 and 21. 

(cid:216) new 

(cid:208) 95/16/EC (adapted) 

4. SURVEILLANCE UNDER THE RESPONSIBILITY OF THE NOTIFIED BODY 

4.1.  The  purpose  of  surveillance  is  to  make  sure  that  the  installer  of  a  lift  duly  fulfils  the 
obligations arising out of the approved ⌦ product ⌫ quality assurance system. 

4.2.  The  installer  of  a  lift  must  ⌦ shall ⌫  allow  the  notified  body  access  for  inspection 
purposes to the inspection and testing locations and provide it with all necessary information, 
in particular: 

33 

This  harmonized  standard  will  be  EN  29003,  supplemented  where  necessary  to  take  account  of  the 
specific features of the lifts. 

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(a)- the ⌦ product ⌫ quality assurance system documentation,; 

(b)- the technical ⌦ file(s) ⌫ documentation,; 

(c)- the quality records, such as inspection reports and test data, calibration data, reports on 
the qualifications of the personnel concerned, etc. 

(cid:208) 95/16/EC 

4.3.  The  notified  body  must  ⌦ shall ⌫  periodically  carry  out  audits  to  ensure  that  the 
installer  of  a  lift  maintains  and  applies  the  quality  assurance  system  and  must  ⌦ shall ⌫ 
provide an audit report to the lift installer. 

(cid:208) 95/16/EC (adapted) 

4.4. Additionally, the notified body may pay unexpected visits to the lift installation sites. 

(cid:208) 95/16/EC 

(cid:208) 95/16/EC (adapted) 

At  the  time  of  such  visits,  the  notified  body  may,  where  necessary, carry  out  tests  or  have 
them  carried  out  in  order  to  check  the  proper  functioning  of  the  ⌦ product ⌫  quality 
assurance  system  where  necessary  and  of  the  lift;.  it  must  ⌦ It  shall ⌫  provide  the  lift 
installer with a visit report and, if a test has been carried out, with a test report. 

5. The installer of a lift, must ⌦ shall ⌫ for a period of 10 years after the last lift has been 
⌦ installed ⌫ manufactured , keep at the disposal of the national authorities: 

(a)-  the  documentation  referred  to  in  the  third  indent  of  the  second  paragraph  of  Section 
Point 3.1(c),; 

(cid:208) 95/16/EC (adapted) 

(b) the technical file referred to in Point 3.1(d); 

(cid:216) new 

(cid:208) 95/16/EC (adapted) 

(c)- the updating referred to in the second paragraph of Section Point 3.4,; 

(d)-  the  decisions  and  reports  from  the  notified  body  which  are  referred  to  in  the  final 
paragraph of Section Point 3.4 and in Sections Points 4.3 and 4.4. 

6.  Each  notified  body  must  forward  to  the  other  notified  bodies  the  relevant  information 
concerning the quality assurance system approvals issued and withdrawn. 

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(cid:216) new 

6.  Each  notified  body  shall  inform  its  notifying  authorities  of  product  quality  assurance 
system  approval  decision(s)  issued  or  withdrawn,  and  shall,  periodically  or  upon  request, 
make  available  to  its  notifying  authorities  the  list  of  approval  decisions,  issued,  refused, 
suspended or otherwise restricted.  

Each notified body shall inform the other notified bodies of product quality assurance system 
approval  decision(s)  which  it  has  refused,  suspended  or  withdrawn  and,  upon  request,  of 
approval decision(s) which it has issued.  

On  request,  the  notified  body  shall  provide  the  Commission  and  the  Member  States  with  a 
copy of product quality assurance system approval decision(s) issued.  

7.  The  documents  and  correspondence  relating  to  the  product  quality  assurance  procedures 
shall  be  drawn  up  in  one  of  the  official  languages  of  the  Member  State  where  the  notified 
body is established or in a language acceptable to it.  

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(cid:208) 95/16/EC (adapted) 
(cid:214) new 

ANNEX XI XIII 

FULL QUALITY ASSURANCE ⌦ PLUS DESIGN EXAMINATION ⌫ FOR LIFTS 

(module H) 

1.  Full  quality  assurance  is  the  procedure  whereby  the  installer  of  a  lift  who  satisfies  the 
obligations  of  Section  2  ensures  and  declares  that  lifts  satisfy  the  requirements  of  the 
Directive that apply to them. 

The installer of a lift must affix the CE marking on each lift and draw up an EC declaration of 
conformity.  The  CE  marking  must  be  accompanied  by  the  identification  number  of  the 
notified body responsible for the surveillance as specified in Section 4. 

2.  The  installer  of  a  lift  must  operate  an  approved  quality  assurance  system  for  design, 
manufacture, assembly, installation and final inspection of the lifts and testing as specified in 
Section 3 and must be subject to surveillance as specified in Section 4. 

⌦ 1.  Full  quality  assurance  plus  design  examination  for  lifts  is  the  conformity  assessment 
procedure whereby a notified body assesses the full quality assurance system of an installer 
and,  where  appropriate,  the  design  of  the  lifts,  to  ensure  that  the  lifts  installed  satisfy  the 
essential health and safety requirements set out in Annex I. ⌫ 

⌦ 2. OBLIGATIONS OF THE INSTALLER ⌫ 

⌦ 2.1. The installer shall operate an approved full quality assurance system for the design, 
manufacture, assembly, installation, final inspection and testing of lifts as specified in Point 3 
and shall be subject to surveillance as specified in Point 4. ⌫ 

⌦ 2.2. The installer must affix the CE marking on each lift and draw up an EU declaration of 
conformity.  The  CE  marking  must  be  accompanied  by  the  identification  number  of  the 
notified body responsible for the surveillance as specified in Point 4. ⌫ 

3. ⌦ FULL ⌫ QUALITY ASSURANCE SYSTEM 

3.1.  The  installer  of  a  lift  must  ⌦ shall ⌫  lodge  an  application  for  assessment  of  his 
⌦ full ⌫ quality assurance system with a (cid:214) single  notified body (cid:214) of his choice  . 

The application must ⌦ shall ⌫ include: 

(a) 

the name and address of the installer; 

(cid:216) new 

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(b)-  all  relevant  information  on  the  lifts  ⌦ to  be  installed ⌫  ,  in  particular  information 
which makes for an understanding of the relationship between the design and operation of the 
lift and enables conformity with the requirements of the Directive to be assessed,; 

(cid:208) 95/16/EC (adapted) 

(c)- the documentation on the quality assurance system,; 

(cid:208) 95/16/EC  

(cid:216) new 

(d) a technical file according to Annex IV B for one model of lift;  

(e) a written declaration that the same application has not been lodged with any other notified 
body. 

(cid:208) 95/16/EC (adapted) 

3.2. The quality assurance system must ensure conformity of the lifts with the requirements of 
the Directive that apply to them. 

All the elements, requirements and provisions adopted by the lift installer must ⌦ shall ⌫ 
be  documented  in  a  systematic  and  orderly  manner  in  the  form  of  written  measures, 
procedures and instructions. This quality assurance system documentation must ⌦ shall ⌫ 
ensure a common understanding of the procedures such as programmes, plans, manuals and 
quality records.  

It ⌦ shall ⌫ must contain in particular an adequate description of: 

(a)- the quality objectives and the organizational structure, responsibilities and powers of the 
management with regard to the design and quality of the lifts,; 

(cid:208) 95/16/EC 

(b)-  the  technical  design  specifications,  including  standards  that  will  be  applied  and,  where 
the standards referred to in Article 514 of the Directive will ⌦ are ⌫ not be applied ⌦ or 
not applied ⌫ in full, the means that will be used to ensure that the ⌦ applicable essential 
health and safety ⌫ requirements of the Directive that apply to the lifts will be met,; 

(cid:208) 95/16/EC (adapted) 

(cid:208) 95/16/EC (adapted) 

(c)-  the  design  control  and  design  verification  techniques,  processes  and  systematic  actions 
that will be used when designing the lifts,; 

(d)-  the  examinations  and  tests  that  will  be  carried  out  on  acceptance  of  the  supplies  of 
materials, components and sub-assemblies,; 

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(e)-  the  corresponding  assembly,  installation  and  quality  control  techniques,  processes  and 
systematic actions that will be used,; 

(f)-  the  examinations  and  tests  that  will  be  carried  out  before  (inspection  of  installation 
conditions:  shaft,  housing  of  machinery,  etc.),  during  and  after  installation  (including  at  the 
very least the tests laid down in Point 3.4 (e) of Annex V Annex VI, Section 4 (b)),; 

(g)- the quality records, such as inspection reports and test data, calibration data, reports on 
the qualifications of the personnel concerned, etc. ,; 

(h)- the means of monitoring the achievement of the required design and installation quality 
and the effective operation of the quality assurance system. 

(cid:208) 95/16/EC (adapted) 

3.3. Design inspection 

3.3.1. When the design is not entirely in accordance with harmonized standards, the notified 
body  must  ascertain  whether  the  design  conforms  to  the  provisions ⌦ essential  health  and 
safety  requirements set  out  in  Annex  I  ⌫  of  the  Directive  and,  if  it  does,  issue  an  'EC 
⌦ EU ⌫ design examination certificate' to the installer, stating the limits of the certificate's 
validity and giving the details required for identification of the approved design. 

(cid:216) new 

3.3.2.  Where  the  design  does  not  satisfy  the  applicable  requirements  of  this  Directive,  the 
notified  body  shall  refuse  to  issue  a  design  examination  certificate  and  shall  inform  the 
installer accordingly, giving detailed reasons for its refusal. 

The  notified  body  shall  keep  itself  apprised  of  any  changes  in  the  generally  acknowledged 
state  of  the  art  which  indicate  that  the  approved  design  may  no  longer  comply  with  the 
essential health and safety requirements set out in Annex I, and shall determine whether such 
changes  require  further  investigation.  If  so,  the  notified  body  shall  inform  the  installer 
accordingly.  

The  installer  shall  keep  the  notified  body  that  has  issued  the  EU  design  examination 
certificate informed of any modification to the approved design that may affect the conformity 
with  the  essential  health  and  safety  requirements  set  out  in  Annex  I  or  the  conditions  for 
validity  of  the  certificate.  Such  modifications  shall  require  additional  approval  —  from  the 
notified body that issued the EU design examination certificate — in the form of an addition 
to the original EU design examination certificate. 

3.3.3. Each notified body shall inform its notifying authorities of the EU 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 authorities the list of EU design 
examination  certificates  and/or  any  additions  thereto  refused,  suspended  or  otherwise 
restricted. 

Each  notified  body  shall  inform  the  other  notified  bodies  of  the  EU  design  examination 
certificates  and/or  any  additions  thereto  which  it  has  refused,  withdrawn,  suspended  or 

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otherwise restricted, and, upon request, of the certificates and/or additions thereto which it has 
issued. 

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

3.3.4. The installer shall keep a copy of the EU design examination certificate, its annexes and 
additions together with the technical file at the disposal of the national authorities for 10 years 
after the lift has been placed on the market. 

(cid:208) 95/16/EC (adapted) 
(cid:214) new 

3.4. Assessment of the ⌦ full ⌫ quality assurance system 

The notified body must assess the ⌦ full ⌫ quality assurance system to determine whether 
it  satisfies  the  requirements  referred  to  in  Section  Point  3.2.  It  ⌦ shall ⌫  must  presume 
compliance  with  these  requirements  in  respect  of ⌦ full ⌫  quality  assurance  systems  that 
implement the relevant harmonized standard34. 

The auditing team ⌦ shall ⌫ must have at least one member with experience of assessment 
in  the  lift  technology  concerned (cid:214) and  knowledge  of  the  essential  health  and  safety 
requirements set  out  in  Annex  I.  The  assessment  procedure  ⌦ shall ⌫  must  include  a 
visit to the lift installer's premises and a visit to an installation site. 

The  auditing  team  shall  review  the  technical  file  referred  to  in  point  3.1,  to  verify  the 
installer’s ability to identify the essential health and safety requirements of set out in Annex I 
and  to  carry  out  the  necessary  examinations  with  a  view  to  ensuring  compliance  of  the  lift 
with those requirements.  

(cid:216) new 

(cid:208) 95/16/EC (adapted) 

The decision ⌦ shall ⌫ must be notified to the lift installer. The notification must contain 
the  conclusions  of  the  examination  ⌦ assessment ⌫  and  the  reasoned  assessment 
⌦ report ⌫ decision. 

3.5. The lift installer ⌦ shall ⌫ must undertake to discharge the obligations arising from the 
⌦ full ⌫  quality  assurance  system  as  approved  and  to  ensure  that  it  is  maintained  in  an 
appropriate and efficient manner. 

The  lift  installer ⌦ shall ⌫  must  keep  the  notified  body  that  has  approved  the ⌦ full ⌫ 
quality assurance system informed of any intended updating of the quality assurance system. 

34 

This  harmonized  standard  will  be  EN  29001,  supplemented  where  necessary  to  take  account  of  the 
specific features of the lifts. 

EN 

106 

   EN 

 
 
 
                                                 
The  notified  body  ⌦ shall ⌫  must  assess  the  modifications  proposed  and  decide  whether 
the modified ⌦ full ⌫ quality assurance system will still satisfy the requirements referred to 
in Section Point 3.2 or whether a reassessment is required. 

It ⌦ shall ⌫ must notify its decision to the lift installer. The notification must contain the 
conclusions  of 
reasoned  assessment 
⌦ approval ⌫ decision. 

the  examination  ⌦ assessment ⌫  and 

the 

The notified body shall affix, or cause to be affixed, its identification number adjacent to the 
CE marking in accordance with Articles 18 and 21. 

(cid:216) new 

(cid:208) 95/16/EC (adapted) 

4. SURVEILLANCE UNDER THE RESPONSIBILITY OF THE NOTIFIED BODY 

4.1.  The  purpose  of  surveillance  is  to  make  sure  that  the  installer  of  a  lift  duly  fulfils  the 
obligations arising out of the approved ⌦ full ⌫ quality assurance system. 

4.2. The lift installer ⌦ shall ⌫ must allow the notified body access for inspection purposes 
to  the  design,  manufacture,  assembly,  installation,  inspection  and  testing  and  storage 
locations, and ⌦ shall ⌫ must provide it with all necessary information, in particular: 

(a)- the ⌦ full ⌫ quality assurance system documentation,; 

(cid:208) 95/16/EC 

(b)- the quality records provided for in the design part of the quality assurance system, such as 
results of analyses, calculations, tests, etc.,; 

(c)-  the  quality  records  provided  for  in  the  part  of  the  quality  assurance  system  concerning 
acceptance  of  supplies  and  installation,  such  as  inspection  reports  and  test  data,  calibration 
data, reports on the qualifications of the personnel concerned, etc. 

4.3. The notified body must periodically carry out audits to make sure that the installer of a 
lift maintains and applies the quality assurance system and must provide the installer with an 
audit report. 

(cid:208) 95/16/EC (adapted) 

4.4.  Additionally,  the  notified  body  may  pay  unexpected  visits  to  the  premises  of  a  lift 
installer  or  to  the  assembly  site  of  a  lift.  At  the  time  of  such  visits,  the  notified  body  may, 
⌦ where necessary, ⌫ carry out tests or have them carried out in order to check the proper 
functioning  of  the  ⌦ full ⌫  quality  assurance  system,  where  necessary;  it  must  ⌦  It 
shall ⌫ provide the lift installer with a visit report and, if a test has been carried out, with a 
test report. 

5.  The  installer  ⌦ shall ⌫  of  a  lift  must,  for  a  period  of  10  years  after  the  lift  has  been 
placed on the market, keep at the disposal of the national authorities: 

EN 

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(a)-  the  documentation  referred  to  in  the  second  indent  of  the  second  paragraph  of  Section 
Point 3.1(c),;  

(b) a technical file referred to in Point 3.1(d);  

(cid:216) new 

(cid:208) 95/16/EC (adapted) 

(c)- the ⌦ updates ⌫ updating referred to in the second paragraph of Section Point 3.5,; 

(d)-  the  decisions  and  reports  from  the  notified  body  which  are  referred  to  in  the  final 
paragraph of Section Point 3.5 and in Sections Points 4.3 and 4.4. 

(cid:208) 95/16/EC 

(cid:208) 95/16/EC (adapted) 

Where the installer is not established in the ⌦ Union ⌫ Community, this obligation falls to 
the notified body. 

6.  Each  notified  body  shall  forward  to  the  other  notified  bodies  the  relevant  information 
concerning the quality assurance systems issued and withdrawn. 

(cid:216) new 

6.  Each  notified  body  shall  inform  its  notifying  authorities  of  full  quality  assurance  system 
approvals issued or withdrawn, and shall, periodically or upon request, make available to its 
notifying  authorities  the  list  of  full  quality  assurance  system  approval  decision(s)  issued, 
refused, suspended or otherwise restricted.  

Each  notified  body  shall  inform  the  other  notified  bodies  of  full  quality  assurance  system 
approval decision(s) which it has refused, suspended or withdrawn, and, upon request, of full 
quality assurance system approval decision(s) which it has issued.  

The  notified  body  shall  keep  a  copy  of  the  approval  decision(s)  issued,  its  annexes  and 
additions, as well as the technical file for a period of 15 years from the date of their issue. 

On  request,  the  notified  body  shall  provide  the  Commission  and  the  Member  States  with  a 
copy of full quality assurance system approval decision(s) issued. 

7.  The  dossiers ⌦ documents ⌫  and  correspondence  relating  to  the  full  quality  assurance 
procedures must be drawn up in one of the official languages of the Member State where the 
notified body is established or in a language acceptable to it. 

(cid:208) 95/16/EC (adapted) 

EN 

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(cid:208) 95/16/EC (adapted) 

ANNEX XII XIV 

PRODUCTION QUALITY ASSURANCE ⌦ FOR LIFTS ⌫ 

(module D) 

1. Production quality assurance is the procedure whereby the installer of a lift who satisfies 
the obligations of Section 2 ensures and declares that the lifts satisfy the requirements of the 
Directive that apply to them. The installer of the lift must affix the CE marking to each lift 
and draw up a written declaration of conformity. The CE marking must be accompanied by 
the  identification  symbol  of  the  notified  body  responsible  for  surveillance  as  specified  in 
Section 4. 

2. The installer of the lift must operate an approved quality assurance system for production, 
installation,  final  lift  inspection  and  testing  as  specified  in  Section  3  and  is  subject  to 
surveillance as specified in Section 4. 

⌦ 1. Production quality assurance for lifts is the part of the conformity assessment procedure 
whereby  a  notified  body  assesses  the  production  quality  assurance  system  of  a  installer  to 
ensure  that  the  lifts  installed  are  in  conformity  with  the  type  as  described  in  the  EU  type-
examination certificate or with a lift designed and manufactured by an installer who operates 
a full quality assurance system in accordance with Annex XI, and satisfy the essential health 
and safety requirements set out in Annex I. ⌫ 

⌦ 2. OBLIGATIONS OF THE INSTALLER ⌫ 

⌦ 2.1.  The  installer  shall  operate  an  approved  production  quality  assurance  system  for 
manufacture, assembly, installation, final inspection and testing of lifts as specified in Point 3 
and is subject to surveillance as specified in Point 4. ⌫ 

⌦ 2.2. The installer shall affix the CE marking to each lift and draw up a written declaration 
of conformity. ⌫ 

3. ⌦ PRODUCTION ⌫ QQUALITY ASSURANCE SYSTEM 

3.1.  The 
⌦ production ⌫ quality assurance system with a notified body of his choice. 

installer  must  ⌦ shall ⌫ 

lodge  an  application  for  assessment  of  his 

The application must ⌦ shall ⌫ include: 

(a) the name and address of the installer; 

(cid:216) new 

(cid:208) 95/16/EC (adapted) 

(b)- all relevant information for the lifts ⌦ to be installed ⌫,; 

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(c)- the documentation concerning ⌦ on the production ⌫ the quality assurance system,; 

(d)-  the  technical  documentation ⌦ file ⌫  of ⌦ the  lifts  to  be  installed ⌫  the  approved 
type and a copy of the EC type-examination certificate,; 

(e) a written declaration that the same application has not been lodged with any other notified 
body. 

(cid:216) new 

3.2. The quality assurance system must ensure compliance of the lifts with the requirements 
of the Directive that apply to them. 

(cid:208) 95/16/EC 

(cid:208) 95/16/EC (adapted) 

All  the  elements,  requirements  and  provisions  adopted  by  the  installer  of  a  lift  shall  be 
documented  in  a  systematic  and  orderly  manner  in  the  form  of  written  policies,  procedures 
and instructions. The ⌦ production ⌫ quality assurance system documentation must permit 
a consistent interpretation of the quality programmes, plans, manuals and records. 

It ⌦ shall ⌫ must contain in particular an adequate description of: 

(a)- the quality objectives and the organizational structure, responsibilities and powers of the 
management with regard to the quality of the lifts,; 

(b)-  the  manufacturing,  quality  control  and  quality  assurance  techniques,  processes  and 
systematic actions that will be used,; 

(c)- the examinations and tests that will be carried out before, during and after installation35,; 

(d)- the quality records, such as inspection reports and test data, calibration data, qualification 
reports of the personnel concerned, etc.,; 

(e)-  the  means  to  monitor  the  achievement  of  the  required  lift  quality  and  the  effective 
operation of the ⌦ production ⌫ quality assurance system. 

3.3.  The  notified  body  ⌦ shall ⌫  must  assess  the  ⌦ production ⌫  quality  assurance 
system to determine whether it satisfies the requirements referred to in Section Point 3.2. It 
presumes  conformity  with  these  requirements  in  respect  of  quality  assurance  systems  that 
implement the relevant harmonized standard36. 

The auditing team must ⌦ shall ⌫ have at least one member with experience of assessment 
in  the  lift  technology  concerned ⌦ and  knowledge  of  the  requirements  set  out  in 
Annex I. ⌫  

35 
36 

These tests include at least the tests provided for in Annex V Point 3.4VI, Section 4 (b). 
This  harmonized  standard  will  be  EN  29002,  supplemented  where  necessary  to  take  account  of  the 
specific nature of the lifts. 

EN 

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The  assessment  procedure  must  ⌦ shall ⌫  include  an  inspection  visit  to  the  installer's 
premises ⌦ and a visit to an installation site ⌫.  

The decision ⌦ shall ⌫ must be notified to the installer. The notification must contain the 
conclusions of the examination ⌦ assessment ⌫ and the reasoned assessment ⌦ report ⌫ 
decision. 

3.4.  The  installer  ⌦ shall ⌫  must  undertake  to  discharge  the  obligations  arising  from  the 
⌦ production ⌫ quality assurance system as approved and to ensure that it is maintained in 
an appropriate and efficient manner. 

The  installer  shall  keep  the  notified  body  that  has  approved  the  ⌦ production ⌫  quality 
assurance system informed of any intended updating of the quality assurance system. 

The  notified  body  ⌦ shall ⌫  must  assess  the  modifications  proposed  and  decide  whether 
the  modified  ⌦ production ⌫  quality  assurance  system  will  still  satisfy  the  requirements 
referred to in Section Point 3.2 or whether a re-assessment is required. 

It  ⌦ shall ⌫  must  notify  its  decision  to  the  installer.  The  notification  must  contain  the 
conclusions of the examination ⌦ assessment ⌫ and the reasoned assessment ⌦ report ⌫ 
decision. 

4. SURVEILLANCE UNDER THE RESPONSIBILITY OF THE NOTIFIED BODY 

4.1. The purpose of surveillance is to make sure that the installer duly fulfils the obligations 
arising out of the approved ⌦ production ⌫ quality assurance system. 

4.2. The installer ⌦ shall ⌫ must allow the notified body access for inspection purposes to 
the  manufacture,  inspection,  assembly,  installation,  testing  and  storage  locations  and  must 
provide it with all necessary information, in particular: 

(a)- the ⌦ production ⌫ quality assurance system documentation,; 

⌦ (b) the technical file(s); ⌫  

(c)- the quality records, such as inspection reports and test data, calibration data, reports on 
the qualifications of the personnel concerned, etc. 

(cid:208) 95/16/EC 

(cid:208) 95/16/EC (adapted) 

4.3.  The  notified  body ⌦ shall ⌫  must  periodically  carry  out  audits  to  make  sure  that  the 
installer  maintains  and  applies  the  quality  ⌦ production ⌫  assurance  system  and 
⌦ shall ⌫ must provide an audit report to the installer. 

4.4.  Additionally  the  notified  body  may  pay  unexpected  visits  to  the  installer.  During  such 
visits  the  notified  body  may, where  necessary carry  out,  or  cause  to  be  carried  out,  tests  to 
verify  that  the  ⌦ production ⌫  quality  assurance  system  is  functioning  correctly,  if 
necessary. The notified body ⌦ shall ⌫ must provide the installer with a visit report and, if 
a test has taken place, with a test report. 

EN 

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5.  The  installer  ⌦ shall ⌫  must,  for  a  period  of  10  years  after  the  last  lift  has  been 
manufactured, keep at the disposal of the national authorities: 

(a)- the documentation referred to in the second indent of Section Point 3.1(c),; 

(cid:208) 95/16/EC (adapted) 

(b) the technical file referred to in Point 3.1(d);  

(cid:216) new 

(cid:208) 95/16/EC 

(c)- the updating referred to in the second paragraph of Section Point 3.4,; 

(d)-  the  decisions  and  reports  from  the  notified  body  which  are  referred  to  in  the  final 
paragraph of Section Points 3.4, Section 4.3 and 4.4.  

(cid:216) new 

6.  Each  notified  body  shall  inform  its  notifying  authorities  of  production  quality  assurance 
system approvals issued or withdrawn, and shall, periodically or upon request, make available 
to its notifying authorities the list of production quality assurance system approval decision(s) 
issued, refused, suspended or otherwise restricted.  

Each  notified  body  shall  inform  the  other  notified  bodies  of  production  quality  assurance 
system approval decision(s) which it has refused, suspended or withdrawn, and, upon request, 
of production quality assurance system approval decision(s) which it has issued.  

On  request,  the  notified  body  shall  provide  the  Commission  and  the  Member  States  with  a 
copy of production quality assurance system approval decision(s) issued. 

(cid:208) 95/16/EC (adapted) 

6. Each notified body must give the other notified bodies the relevant information concerning 
the quality assurance system approvals issued and withdrawn. 

7.  ⌦ The documentation ⌫  Documents  and  correspondence  relating  to  the  production 
quality assurance procedures shall be drawn up in an official language of the Member State in 
which the notified body is established or in a language acceptable to it. 

EN 

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(cid:207) 

ANNEX XIII 

Part A 

Repealed Directive with list of its successive amendments  

European Parliament and Council Directive 
95/16/EC 

(OJ L 213, 7.9.1995, p. 1) 

Regulation (EC) No 1882/2003 of the 
European Parliament and of the Council 

Only Pt. 10) of Annex I 

(OJ L 284, 31.10.2003, p.1) 

Directive 2006/42/EC of the European 
Parliament and the Council 

Only Article 24 

(OJ L 157, 9.6.2006, p.24) 

List of time-limits for transposition into national law [and application] 

Part B 

Directive 

Time-limit for transposition 

Date of application 

95/16/EC 

1 January 1997 

1 July 199737 

2006/42/EC Art.24 

29 June 2008 

29 December 2009 

ANNEX XIV 

CORRELATION TABLE 

Directive 95/16/EC 

This Directive 

37 

Until 30 June 1999 Member States shall allow: — the placing on the market and putting into service of 
lifts, — the placing on the market and putting into service of safety components, which conform to the 
provisions  in  force  in  their  territories  on  the  date  of  adoption  of  this  Directive.  See  Article  15(2)  of 
Directive 95/16/EC. 

EN 

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Article 1(1) 

__ 

Article 1(1) first subparagraph 

Article 1(1), second subparagraph 

Article 1(2) first subparagraph 

Article 1(2), second subparagraph 

Article 1(2), third subparagraph 

Article 1(3) 

__ 

__ 

Article 2(2) 

Article 1(2) 

Article 1(4) first indent of first subparagraph  Article 2(4) 

Article  1(4)  second,  third  and  fourth  indents 
of first subparagraph 

__ 

Article 1(4) fifth indent of first subparagraph  Article 2(3) 

Article 1(4) second subparagraph 

Article 16(3) 

Article 1(4) third subparagraph 

Article 16(4) 

Article 1(5) 

_ 

Article 2(1) first indent  

Article 2(1) second indent  

Article 2(2) 

Article 2(3) 

Article 2(4) 

Article 2(5) 

Article 3, first paragraph  

Article 3, second paragraph  

Article 4(1) 

Article 4(2) 

__ 

Article 5 

Article 6(1) and (2) 

EN 

Article 1(3) 

Article 2(1) 

Article 4(1)  

Article 4(2)  

Article 6(1) 

Article 6(2) 

Article 3(4) 

Article 3(3) 

Article 5(1) 

Article 5(2) 

Article 3(1) 

Article 3(2) 

Articles 7 to 14 

__  

__  

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   EN 

Article 6(3) and (4) 

Article 7 

__ 

_ 

Article 8(1) (a) 

Article 8(1) (b) and (c) 

Article 8(2) 

__ 

Article 8(3), (4) and (5)  

__ 

Article 9 

Article 10(1) 

Article 10(2) 

Article 42  

__  

Articles 37 to 41 

Article 43 

Article 15 

__ 

Article 16 

Article 17 

__ 

Article 18 

__  

__ 

Article 19(1) 

Article 10(3) and (4)  

__ 

__ 

__ 

Article 11 

__ 

Article 12 

Article 13 

Article 14 

Article 15(1) and (2) 

Article 15(3) 

__ 

Article 19(2) to (5) 

Articles 20 to 45 

__ 

Article 44 

__ 

__ 

__ 

__ 

Article 46(2) 

Article 46(1) 

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Article 16  

__ 

Article 17 

Annex I  

Annex II Part A 

Annex II Part B 

Annex III 

Annex IV 

Annex V Part A 

Annex V Part B 

Annex VI 

Annex VII 

Annex VIII 

Annex IX  

Annex X 

Annex XI 

Annex XII 

Annex XIII 

Annex XIV 

__ 

__ 

_ 

Articles 47 to 49 

Article 50 

Annex I  

Annex II Part A 

Annex II Part B 

__ 

Annex III 

Annex IV Part A 

Annex IV Part B 

Annex V  

__ 

Annex VI 

Annex VII 

Annex VIII 

Annex IX 

Annex X 

Annex XI 

Annex XII 

Annex XIII 

Annex XIV 

EN 

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