Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on marine equipment and repealing Directive 96/98/EC
Date: 2012-12-17
Institutions: European Commission
Subjects: EC conformity marking, international standard, maritime safety, market supervision, marketing standard, quality standard, technical standard, vehicle parts, vessel

EUROPEAN 
COMMISSION 

Brussels, 17.12.2012  
COM(2012) 772 final 

2012/0358 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on marine equipment and repealing Directive 96/98/EC 

(Text with EEA relevance) 

{SWD(2012) 437 final} 
{SWD(2012) 438 final} 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

1.1. 

Background 

Marine equipment represents a significant fraction of the value of a newly built ship, and its 
quality and good operation are critical for the safety of the ship and its crew, as well as for the 
prevention of maritime accidents and pollution of the marine environment.  

The  international  maritime  safety  conventions  contain  specific  requirements  for  ships  to  be 
properly equipped; furthermore they require flag States to ensure that the equipment carried 
on board ships complies with certain safety construction and performance requirements and to 
issue the relevant certificates. To that end both the International Maritime Organization (IMO) 
and  the  international  and  European  standardization  bodies  produce  testing  standards  for 
marine equipment. The IMO develops the convention requirements and the testing standards, 
and keeps them up to date, by means of a number of instruments such as Codes, Resolutions 
and Circulars. 

The  international  conventions  and  testing  standards  leave  certain  discretion  to  the  flag 
administrations.  Although  in  general  IMO  instruments  containing  requirements  and  testing 
standards become mandatory, the IMO tradition to work by consensus may from time to time 
lead  to  the  adoption  of  important  safety  standards  for  marine  equipment  by  means  of  non-
binding  instruments;  for  the  same  reason,  some  IMO  instruments  occasionally  have 
exceedingly generous deadlines for their implementation or none at all.  

In  its  proposal  for  a  directive  on  marine  equipment,  back  in  1995,  the  Commission  clearly 
identified the problems encountered in the Internal Market as a result of this state of affairs 
and in the absence of EU harmonisation in the marine equipment sector1. Member States were 
reluctant  to  mutually  accept  their  respective  conformity  certificates  even  in  the  presence  of 
comparable  requirements  –  not  at  least  without  additional  national  controls;  the  result  was 
multiple  approval  procedures  for  the  same  marine  equipment.  The  Commission  noted  how 
harmonisation would lead to the elimination of important administrative barriers and open the 
internal  market  to  marine  equipment  certified  in  the  Member  States,  with  significant 
economies of scale. 

Council  Directive  96/98/EC  of  20  December  1996  on  marine  equipment2  (MED)  thus  laid 
down common rules to eliminate differences in the implementation of international standards 
by  means  of  a  clearly  identified  set  of  requirements  and  uniform  certification  procedures. 
Today,  these  common  rules  continue  to  be  necessary  to  achieve  a  smooth  operation  of  the 
internal market in the marine  equipment sector while ensuring  a high level of safety  and of 
environmental protection.  

1.2. 

Experience gained in the implementation of Directive 96/98/EC  

The  experience  gained  in  the  implementation  of  the  MED  has  highlighted  four  areas  where 
the existing Directive does not fully meet its objectives. These are:  

1 
2 

Cf. COM (1995) 269 final 
OJ L 46, 17.2.1997, p. 25.  

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1.2.1. 

Identification of applicable requirements. The periodic amendment of Annex A of the 
directive 

The  specific  technical  requirements  and  testing  standards  applicable  to  equipment  falling 
under the scope of the MED are listed in Annex A to the directive. Given the need to keep up 
with  the  legislative  production  of  the  IMO  and,  as  appropriate,  of  the  international  and 
European standardization bodies, Annex A is in need of periodic updates.  

IMO instruments and international standards normally leave a reasonable time between their 
adoption  and  their  entry  into  force,  ranging  in  most  cases  between  twelve  and  twenty-four 
months.  The  system  must  be  capable  of  bringing  the  new  requirements  into  national 
legislation within that window, which is currently not the case. Until now, it has never been 
possible  to  fully  meet  the  IMO  deadlines,  and  the  delay  in  the  incorporation  of  the  IMO 
requirements into the national legal orders of the Member States has reached peaks of several 
years. 

This  generates  significant  disturbance  for  the  industry,  which  must  produce  to  different 
standards  for  the  European  and  international  markets  and  has  difficulties  in  identifying  the 
applicable requirements. The risk of detention of European ships in foreign ports increases.  

1.2.2.  Quality of the work of the notified bodies 

There  is  a  clearly  uneven,  where  not  insufficient,  degree  of  control  of  notified  bodies  by 
Member  States  administrations.  The  MED  requirements  on  notified  bodies  currently  do  not 
provide  detailed  quality  benchmarks  for  the  notified  bodies  themselves  or  efficient  ways  of 
control  for  the  Member  States.  Given  that  correctly  functioning  conformity  checking 
procedures  are  the  first  and  main  line  of  defence  to  avoid  the  entry  of  non-compliant 
equipment in the market, concerns have been raised that these weaknesses may be confronting 
the industry with unfair competition from entities taking advantage of this situation. 

1.2.3.  Market surveillance 

Marine equipment is mostly placed on board when the ship is built or repaired – anywhere in 
the world and mostly away from the EU's borders. Thus the marine equipment that actually 
enters the physical territory of the Member States is only a fraction of the equipment covered 
by the Directive.  

However, the MED only allows market surveillance to take place on equipment not yet placed 
on board and contains no detailed framework – to the point that market surveillance appears 
as an option rather than an obligation. Therefore the system in the MED does not adapt to the 
reality of the market and in practice makes it very difficult for the Member States to carry out 
effective market surveillance.  

Market  surveillance  is  therefore  unlikely  to  provide  the  national  authorities  with  sufficient 
information to prevent the placing of non-compliant products on board EU ships. This has a 
direct, negative impact on safety while compliant manufacturers have to face the difficulties 
associated with unfair competition and counterfeit. 

1.2.4. 

Safeguard clause 

Experience  has  highlighted  structural  weaknesses  in  the  safeguard  clause  mechanism  as 
currently  laid  down  in  the  MED.  There  is  no  incentive  for  a  Member  State  to  carry  out  an 

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exhaustive procedure during market surveillance and all the way to the adoption of restrictive 
measures, where sample testing is carried out independently and with sufficient guarantees of 
reliability. Nothing in the current text obliges the Member States to have a proper hearing of 
the  manufacturer  or  put  at  its  disposal  any  appeal  mechanisms,  let  alone  to  seek  voluntary 
correction of any  shortcomings  in  the  first place. This may lead, as in the above mentioned 
case,  to  premature  notification  to  the  Commission  thus  transferring  to  it  the  detailed 
examination  of  the  substance.  This  also  places  on  the  Commission  a  burden  which  is  well 
beyond  its  resources  and  technical  capacities,  even  if  the  assistance  of  EMSA  is  taken  into 
account.  

Moreover,  the  current  safeguard  clause  mechanism  is  burdensome  and  lengthy,  and  thus 
exposes  manufacturers  to  significant  reputational  damage  for  long  periods  until  the  case  is 
finally decided.  

1.3. 

The new regulatory framework for the marketing of goods within the EU (NLF)  

Regulation  765/2008/EC  of  the  European  Parliament  and  of  the  Council  setting  out  the 
requirements for accreditation and market surveillance relating to the marketing of products 
and  repealing  Regulation  (EEC)  No  339/933  lays  down  a  common  EU  framework  for 
accreditation and market surveillance. Decision No 768/2008/EC of the European Parliament 
and of the Council of 9 July 2008 on a common framework for the marketing of products and 
repealing  Council  Decision  93/465/EEC4  sets  out  the  common  framework  of  general 
principles  and  reference  provisions  for  the  drawing  up  of  EU  legislation  harmonising  the 
conditions for the marketing of products (EU harmonisation legislation). According to Article 
2,  EU  harmonisation  legislation  shall  have  recourse  to  the  general  principles  set  out  in  this 
Decision  and  to  the  relevant  reference  provisions  of  Annexes  I,  II  and  III.  However,  EU 
legislation  may  depart  from  those  general  principles  and  reference  provisions  if  that  is 
if 
appropriate  on  account  of 
comprehensive legal systems are already in place. 

the  sector  concerned,  especially 

the  specificities  of 

1.4. 

Objectives of the proposal 

1.4.1.  General objectives 

Pursuant to Articles 90 and 91 TFEU, the Common Transport Policy (CTP) should contribute 
to the broader objectives of the Treaties, and hence the free movement of goods, and include 
measures  to  ensure  the  safety  of  transport.  Within  the  framework  of  CTP  and  taking  into 
account the specificities of marine equipment, the general objective of the proposed initiative 
is twofold: 

• 

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to  enhance  the  implementation  and  enforcement  mechanisms  of  the  MED,  thereby 
guaranteeing  the  proper  functioning  of  the  internal  market  for  marine  equipment 
while ensuring a high level of safety at sea and prevention of marine pollution;  

to  simplify  the  regulatory  environment  while  guaranteeing  that  IMO  requirements 
are  applied  and  implemented  in  a  harmonised  way  across  the  EU,  thereby 
contributing to ensuring that the conditions necessary for the competitiveness of the 
Union's industry exist pursuant to Article 173 TFEU. 

OJ L 218, 13.8.2008, p. 30 
OJ L218, 13.8.2008, p.82 

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1.4.2. 

Specific objectives 

This twofold general objective can be translated into more specific objectives: 

• 

• 

2. 

to find an optimal way to align MED on the New Legislative Framework (as required 
under  Article  2  of  Decision  768/2008/EC  (the  NLF  Decision)  while  taking  due 
account of the specificities of marine equipment in the field of market surveillance, 
conformity assessment of products and obligations of actors in the distribution chain.  

to  shorten,  simplify  and  clarify  the  transposition  of  amendments  to  IMO  standards 
into the European and national legal frameworks. 

RESULTS  OF  CONSULTATION  WITH  THE  INTERESTED  PARTIES  AND  IMPACT 
ASSESSMENT 

Further to regular contacts with stakeholders since the coming into force of the MED in 1997, 
stakeholders  were  consulted  in 2008 when the  revision  exercise was launched, by means of 
questionnaires to the Member States, the industry and the MarED group of notified bodies. A 
formal stakeholder consultation meeting was held on 27 November 2008 in Brussels. In April 
2012,  all  stakeholders  were  contacted  again  by  the  Commission  in  order  to  obtain  fresher 
views on the possible amendments of the directive or new data. The answers received largely 
confirmed the problems already examined. 

The  impact  assessment  focused  on  two  alternatives  to  the  baseline  (statu  quo)  scenario, 
namely  maximum  alignment  with  the  NLF  and  conditional  alignment;  in  this  latter  case 
allowing for a number of MED-specific measures in order to cater for the sector's particular 
features.  The  analysis  showed  that  while  on  the  whole  both  options  were  appropriate, 
conditional  alignment  was  the  most  effective  and  less  burdensome  solution  and  at  the  same 
time it had the most positive overall economic, social and environmental impacts. 

The Commission's Impact assessment board was consulted twice, namely in September 2009 
and in August 2012. The remarks on the initial version led to an in-depth reformulation of the 
impact  assessment,  i.a.  refining  the  problem  description,  restructuring  policy  options  and 
shortening the document. In its second opinion, the Board formulated a number of additional 
recommendations which have been incorporated in the final document. 

The  complete  assessment  can  be  found  in  the  impact  assessment  report  accompanying  this 
proposal and is also published online at: http://ec.europa.eu/governance/impact/index_en.htm 
. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

3.1. 

Legal basis 

The legal basis for the proposal is Article 100 (2) TFEU. 

3.2. 

Subsidiarity and proportionality principles 

The principles of subsidiarity and proportionality are fully respected.  

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Harmonisation  by  the  EU  results  in  a  clearly  identified  set  of  requirements  and  uniform 
certification  procedures  capable  of  ensuring  a  high  level  of  safety  and  of  environmental 
protection whilst fostering the smooth functioning of the internal market.  

The objectives of the EU in the marine equipment sector cannot be sufficiently achieved by 
the action of the Member States alone; they can be better achieved thanks to EU action.  

However,  the  proposed  Directive  does  not  contain  the  detailed  technical  specifications 
applicable  to  marine  equipment  falling  under  its  scope,  but  limits  itself  to  mandating 
compliance  with  the  requirements  and  testing  standards  contained  in  the  international 
instruments while providing a mechanism to implement those requirements and standards in a 
uniform way. While conformity-checking procedures are harmonised, implementation is left 
entirely  to  the  Member  States,  who  remain  responsible  for  ensuring  that  marine  equipment 
due to be placed on board EU ships meets the requirements of the Directive. In case restrictive 
measures  are  adopted  by  a  Member  State  as  regards  non-compliant  equipment,  the 
Commission  is  required  to  intervene  only  if  objections  are  raised  against  these  measures 
within a reasonable time. Therefore EU action does not go beyond what is strictly necessary 
to achieve the objectives spelled out in section 2.3. 

3.3. 

Choice of instrument 

A Directive continues to be the most appropriate instrument in order to achieve the objectives 
of  the  proposal.  The  measures  envisaged  represent  a  major  modification  of  the  provisions 
contained in Directive 96/98/EC and therefore, in the interests of clarity, this Directive should 
be repealed and replaced by a new Directive. 

4. 

BUDGETARY IMPLICATIONS 

This  proposal  has  no  budgetary  implications.  The  tasks  devolved  to  the  Commission, 
including those for which the assistance of the European Maritime Safety Agency is foreseen, 
are  not  expected  to  represent  on  the  whole  an  increase  in  workload  and  will  be  carried  out 
with existing resources. 

5. 

CONTENT OF THE PROPOSAL 

Article 1 defines the objectives of the proposal in line with the relevant objectives laid down 
in the Treaties, as referred to in section 1.4 of this memorandum. 

The  scope  of  the  Directive  is  defined  in  Article  3.  Marine  equipment  is  installed  on  board 
ships wherever they are built, repaired or supplied. Although marine equipment is of course 
also traded within the borders of the EU, the scope of the Directive is defined by reference to 
equipment which is a) due to be installed on board a ship flying the flag of a Member State, 
and b) for which the approval of the flag State is required by the international conventions. 
Similarly, the application of concurrent Directives is excluded, as only the marine equipment 
directive  can  ensure  that  marine  equipment  installed  on  EU  ships  complies  with  the 
requirements in the international conventions and instruments. 

The  requirements  for  marine  equipment  are  defined  in  Article  4  by  reference  to  the 
international conventions and instruments. As required by these, demonstration of compliance 
is  confined  to  the  specific  applicable  testing  standards.  Given  the  need  to  ensure  continued 

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consistency  with  the  international  regulatory  framework,  these  requirements  and  standards 
must  apply  in  their  up-to-date  version;  this  automatic  update  is  consistent  with  the  general 
policy  followed  by  the  EU  in  the  area  of  maritime  safety.  The  automatic  update  does  not 
apply to testing standards as experience has shown it may lead to disproportionate effects. 

Article 5 reflects another distinctive element of the marine equipment sector, namely, that the 
flag State has the responsibility to ensure that only equipment which has been duly approved 
in accordance with the then applicable requirements of the international instruments is placed 
on  board  ships  flying  its  flag.  Equipment  should  remain  in  conformity  with  those 
requirements,  unless  requirements  subsequently  adopted  by  the  IMO  apply  to  equipment 
already placed on board ships.  

Article 6 provides the basis for the free movement of marine equipment within the EU, based 
on the concept of mutual recognition between Member States of equipment complying with 
the  requirements  laid  down  in  the  Directive.  Article  7  governs  the  particular  case  of  the 
transfer of a ship to a Member State's register based on the principle of compliance with the 
Directive requirements, but allowing for the acceptance of equivalent equipment in order not 
to place a disproportionate and unjustified burden on the ship owners or penalise EU flags. 

Article  8  reflects  the  priority  given  to  the  international  regulation  of  maritime  safety, 
consistent with the global nature of shipping. However, it is necessary to ensure that failure by 
the IMO to produce appropriate standards does not impair the objectives of the Directive, and 
thus  the  Commission  must  be  empowered  to  lay  down  appropriate  specifications  while 
awaiting the production of the international standards, by means of delegated acts. 

Articles  9  to  11  deal  with  the  wheel  mark.  As  in  the  current  Directive,  a  specific  mark  is 
necessary  in  order  to  distinguish  equipment  complying  with  the  requirements  in  the 
international  maritime  safety  conventions,  which  may  be  different  from  those  contained  in 
other EU harmonisation instruments applying to equipment which is similar in nature but is 
not for use or installation on board ships. However, the general principles governing the CE 
marking, in particular as laid down in Regulation 765/2008/EC, are applied mutatis mutandis. 
In order to facilitate control by the flag and port State authorities, and to combat counterfeit, 
Article 11 opens the possibility to use an electronic tag in addition to or in place of the wheel 
mark. 

Articles  12  to  14  incorporate  the  reference  provisions  of  Decision  768/2008  as  regards  the 
specific  obligations  of  the  economic  operators.  It  must  be  taken  into  account  that  a)  only  a 
fraction of the marine equipment falling under the scope of the Directive is traded within EU 
borders, normally by ship yards and ship repairers, and b) as stated above, a specific mandate 
is placed on the Member States to ensure that only compliant equipment is installed on board 
ships  flying  their  flags.  As  a  result  of  this,  a)  for  importers,  the  act  of  affixing  the  mark 
triggers  the  assumption  of  responsibilities  and  the  effectiveness  of  their  obligations,  which 
must  include  granting  access  to  their  premises  for  national  authorities  carrying  out  market 
surveillance;  b)  the  appointment  of  an  authorised  representative  has  been  made  compulsory 
for manufacturers located outside the EU; and c) in the case of importers and distributors, the 
respective  obligations  have  been  limited  to  those  which  are  relevant  for  the  sector,  namely 
cooperation with market surveillance and, for importers, clear identification. 

The conformity-checking procedures made available to manufacturers are listed in Article 15 
and further developed in Annex II. Among the modules foreseen in Decision 768/2008 of the 
European  Parliament  and  of  the  Council  on  a  common  framework  for  the  marketing  of 

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products, only those modules which are consistent with the requirement for specific approval 
by  the  flag  State  as  laid  down  in  the  international  conventions  and  instruments  have  been 
retained.  Slight  adaptations  in  the  text  have  been  made  for  the  same  purpose.  In  order  to 
facilitate  the  protection  of  legitimate  intellectual  property  rights,  all  modules  contain  an 
obligation  for  the  manufacturer  to  provide  the  notified  body  with  a  certified  copy  of  the 
patent,  license  or  document  by  which  the  applicant  purports  to  have  the  right  to  make,  use, 
sell or offer the marine equipment for sale or use its trademark; this document shall be made 
available to the competent courts upon request. 

As  regards  the  EU  declaration  of  conformity, Article  16  aligns  the  Directive  with  Decision 
768/2008.  Like  the  affixing  of  the  wheel  mark,  the  act  of  drawing  up  of  a  declaration  of 
conformity will trigger the manufacturer's responsibilities and obligations under the Directive. 
Additional provisions ensure that copies of the declaration will be deposited with the relevant 
notified  body  and  can  always  be  found  on  board,  which  will  greatly  facilitate  control  by 
market surveillance authorities, the flag State and the Port State authorities – at the price of a 
negligible additional administrative burden.  

Articles  17  to  26  as  well  as  Annexes  III  to  V  incorporate  the  reference  provisions  of 
Decision  768/2008  as  regards  notification,  notifying  authorities,  notified  bodies  and  their 
respective  regimes.  This  inclusion  opens  the  possibility  for  the  Member  States  to  have 
recourse  to  accreditation  –  which  could  help  resolve  the  chronic  paucity  of  resources  in 
national  maritime  administrations.  Furthermore,  in  order  to  reinforce  the  control  of  notified 
bodies  in  a  context  where  the  entire  process  comprising  design,  testing,  certification, 
production, delivery and placing on board of marine equipment may entirely happen outside 
the  EU  borders,  two  additional  safeguards  have  been  added  to  the  standard  Member  States' 
monitoring obligations: in the first place, monitoring of notified bodies should occur at least 
every two years; secondly, the Commission5 may participate in the audits as an observer. As 
regards  notified  bodies,  the  possibility  of  a  manufacturer's  in-house  notified  body  has  been 
discarded, given  that it is not appropriate for the restricted choice of  conformity-assessment 
procedures referred to above. 

By  virtue  of  Articles  27  to  31,  the  Directive  is  fully  aligned  with  the  general  EU  market 
surveillance framework, including as regards the safeguard procedure. Checks on board may 
be  necessary  and  are  therefore  regulated  in  Article  27.  Article  29  contains  two  additional 
specific elements which appear to be necessary in the marine equipment sector.  

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If  the  Commission  is  satisfied  that  the  technical  assessment  carried  out  by  the  Member 
State  concerned  has  been  fair  and  objective,  it  should  not  be  obliged  to  repeat  this 
evaluation  when  reviewing  the  restrictive  measures  adopted  by  that  Member  State  as 
regards non-compliant equipment. The objective is to ensure that the burden placed on the 
Commission is commensurate with the means at its disposal and to encourage the Member 
States  to  ensure  a  fair  procedure  and  take  all  measures  conducive  to  an  exhaustive  and 
objective evaluation of the risks.  
It  is  necessary  to  cater  for  the  possibility  that  shortcomings  are  identified  in  the  IMO 
standards. In this case, a mechanism similar to that described under Article 8 is provided 
for.  

It  must  be  recalled  that,  as  stated  in  recital  17,  the  European  Maritime  Safety  Agency  assists  the 
Commission  in  the  implementation  of  the  Directive  and  in  carrying  out  the  tasks  entrusted  to  the 
former. 

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Articles 32 to 34 contain the specific regime in exceptional circumstances, largely taken from 
the  existing  Directive.  This  concerns  exemptions  in  cases  of  technical  innovation  or  for  the 
purpose  of  testing  and  evaluation.  More  importantly,  solutions  are  provided  for  the  cases 
where  ships  cannot  obtain  supplies  of  wheel  marked  equipment  in  ports  outside  the  EU  in 
reasonable terms or where wheelmarked equipment has become unavailable in the market. In 
all these cases, the Member States may authorise the placing on board of non-wheelmarked 
equipment – subject to the necessary procedural constraints to ensure that these exemptions 
do not impair the objectives of the Directive. 

Article  35  constitutes  an  essential  part  of  the  new  Directive's  architecture,  with  three 
distinctive elements: 

•  The  requirement  for  marine  equipment  to  comply  with  the  specific  design,  construction 
and  performance  requirements  laid  down  in  the  international  instruments,  including  the 
relevant testing standards, as defined by the Legislator, will be uniformly implemented by 
empowering  the  Commission  to  identify  from  these  instruments  the  requirements  and 
standards  corresponding  to  each  item  of  equipment.  This  will  be  done  by  means  of 
implementing  acts.  As  shown  in  the  impact  assessment,  the  use  of  implementing 
Regulations is expected to resolve the problems of delay and legal uncertainty described 
above,  inter  alia  given  that  transposition  into  the  Member  States'  legal  order  will  no 
longer be needed.  

•  Secondly,  the  Commission  is  also  empowered  to  adopt  common  criteria  and  procedures 
for the application of these requirements and standards, a necessary measure to ensure that 
divergent interpretations by the Member States (e.g. in terms of time, scope or technical 
implementation)  cannot  have  an  impact  on  safety  or  on  the  smooth  functioning  of  the 
internal market. In this respect, the preparatory work carried out by the group of notified 
bodies  established  by  the  Directive  will  be  taken  into  account.  In  this  case,  the  use  of 
implementing acts has been considered the most appropriate course of action.  

•  Finally, the Commission is charged with the task of gathering and publishing a significant 
package of information. This codifies and expands existing practice and will facilitate the 
implementation  of  the  Directive  by  all  actors,  as  has  been  suggested  during  the 
stakeholder consultation.  

Continued  consistency  of  the  new  Directive  with  the  international  regulatory  framework  is 
ensured by means of the empowerment given to the Commission in Article 36, so that it can 
adopt  delegated  acts  in  order  to  update  the  list  of  relevant  international  conventions  and  of 
standardisation organisations as well as the references to international and European standards 
contained  in  the  Directive.  Aspecific  criterion  allowing  the  Commission  to  identify  the 
relevant  conventions  (namely  the  requirement  of  flag  approval  of  marine  equipment)  is 
provided,  so  that  the  update  of  the  list  by  the  Commission  cannot  constitute  an  indirect 
extension of the Directive's scope as defined in Article 3.  

Article  40  provides  for  the  repeal  of  Directive  96/98/EC  and  lays  down  the  necessary 
transitional arrangements.  

Articles  37(exercise  of  delegation),  38(committee  procedures),  39  (transposition),  41 
(entry into force) and 42 (addressees) contain standard legislative provisions. 

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2012/0358 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on marine equipment and repealing Directive 96/98/EC 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 100(2) 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 Committee1, 

Having regard to the opinion of the Committee of the Regions2, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

The  global  dimension  of  shipping  calls  for  the  Union  to  apply  and  support  the 
international  regulatory  framework  for  maritime  safety.  The  international  maritime 
safety  conventions  require  flag  States  to  ensure  that  the  equipment  carried  on  board 
ships  complies  with  certain  safety  requirements  as  regards  design,  construction  and 
performance,  and  to  issue  the  relevant  certificates.  To  that  end  detailed  performance 
and  testing  standards  for  certain  types  of  marine  equipment  have  been  developed  by 
the International Maritime Organization (IMO) and by the international and European 
standardization bodies.  

The  international  instruments  leave  a  significant  margin  of  discretion  to  the  flag 
administrations. In the absence of harmonisation, this leads to varying levels of safety 
for products which the competent national authorities have certified as complying with 
the said conventions and standards; as a result, the smooth functioning of the Internal 
Market is affected as it becomes difficult for the Member States to accept equipment 
certified  in  another  Member  State  to  be  placed  on  board  ships  flying  their  flags 
without further verification.  

1 
2 

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

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(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

Harmonisation by the Union resolves these problems. Council Directive 96/98/EC of 
20 December 1996 on marine equipment3 thus laid down common rules to eliminate 
differences  in  the  implementation  of  international  standards  by  means  of  a  clearly 
identified set of requirements and uniform certification procedures.  

There  are  other  various  instruments  of  Union  law  which  lay  down  requirements  and 
conditions, inter alia in order to ensure the free movement of goods within the Internal 
Market or for environmental purposes, for certain products which are similar in nature 
to equipment used on board ships, but which do not meet the international standards – 
which  may  substantially  differ  from  the  internal  legislation  of  the  Union  and  are  in 
constant evolution. These products cannot therefore be certified by the Member States 
in accordance with the relevant international maritime safety conventions. Equipment 
to  be  placed  onboard  EU  ships  in  accordance  with  international  safety  standards 
should therefore be regulated exclusively by this Directive, which should in any event 
be considered the lex specialis; furthermore, a specific marking should be established 
to indicate that the equipment bearing that mark complies with the requirements laid 
down in the relevant international conventions and instruments.  

Experience in the implementation of Directive 96/98/EC has shown that it is necessary 
to take additional measures in order to enhance the implementation and enforcement 
mechanisms  of  the  said  Directive  and  simplify  the  regulatory  environment  while 
guaranteeing  that  IMO  requirements  are  applied  and  implemented  in  a  harmonised 
way across the Union. 

Requirements should therefore be established for marine equipment to meet the safety 
standards laid down in the applicable international instruments, including the relevant 
testing  standards,  in  order  to  ensure  that  equipment  which  complies  with  these 
requirements  can  circulate  unimpeded  within  the  Internal  Market  and  be  placed  on 
board ships flying the flag of any Member State.  

Decision No 768/2008  of  the  European  Parliament  and  of  the  Council  on  a  common 
framework for the marketing of products4 lays down common principles and reference 
provisions intended to apply across sectoral legislation in order to provide a coherent 
basis  for  revision  or  recasts  of  that  legislation.  This  Decision  constitutes  a  general 
framework of a horizontal nature for future legislation harmonising the conditions for 
the  marketing  of  products  and  a  reference  text  for  existing  legislation.  This  general 
framework  provides  appropriate  solutions 
the 
implementation  of  Directive  96/98/EC.  It  is  therefore  necessary  to  incorporate  the 
definitions  and  reference  provisions  of  Decision No 768/2008  into  this  Directive  by 
making  the  adaptations  which  are  required  by  the  specific  features  of  the  marine 
equipment sector.  

the  problems 

identified 

to 

in 

Given that marine equipment is placed on board ships at the time of their construction 
or  repair  all  over  the  world,  market  surveillance  becomes  particularly  difficult  and 
cannot be effectively supported by border controls. Therefore it is necessary to provide 
market surveillance authorities and port State control officers with additional, specific 
means to facilitate their task, such as enabling the use of electronic tags to replace or 
supplement the wheelmark.  

3 
4 

OJ L 46, 17.2.1997, p. 25.  
OJ L 218, 13.8.2008, p. 82. 

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(9) 

Similarly, the responsibilities of the economic operators should be laid down in a way 
which is proportionate and non-discriminatory for those who are established within the 
Union, taking into account that a significant fraction of the marine equipment falling 
under the scope of this Directive may never be imported and distributed in the territory 
of the Member States.  

conformity-assessment 

(10)  Compliance with international testing standards could best be demonstrated by means 
of 
in 
Decision No 768/2008. However, only those conformity-assessment procedures which 
meet  the  requirements  of  the  international  instruments  should  be  made  available  to 
manufacturers.  

procedures 

down 

those 

such 

laid 

as 

(11) 

In  order  to  ensure  a  fair  and  efficient  procedure  when  examining  suspected  non-
compliance, the Member States should be encouraged to take all measures conducive 
to an exhaustive and objective evaluation of the risks; if the Commission is satisfied 
that  this  condition  has  been  met,  it  should  not  be  obliged  to  repeat  this  evaluation 
when  reviewing  the  restrictive  measures  adopted  by  the  Member  States  as  regards 
non-compliant equipment. 

(12)  The use of marine equipment not bearing the mark of conformity may be allowed in 
exceptional  circumstances,  especially  when  it  is  not  possible  for  a  ship  to  obtain 
equipment bearing the wheel mark in a port or installation outside the Union or when 
equipment bearing the wheel mark has become unavailable in the market. 

(13) 

It  is  necessary  to  ensure  that  the  objectives  of  this  Directive  are  not  impaired  by 
shortcomings in the applicable testing standards or in case the IMO failed to produce 
appropriate standards for marine equipment falling under the scope of this Directive. It 
is also necessary to adopt appropriate technical criteria so that electronic tags can be 
affixed and used in a safe and reliable way. Moreover, it is necessary to keep up-to-
date  a  number  of  non-essential  elements  of  this  Directive,  namely  the  list  of 
international  conventions  laying  down  safety  requirements  for  marine  equipment 
contained in Article 2(3) and the references to specific standards contained in Annex 
III.  The  power  to  adopt  acts  in  accordance  with  Article  290  of  the  Treaty  on  the 
Functioning of the European Union should therefore be delegated to the Commission 
in respect of the adoption, on an interim basis, of harmonised technical specifications 
and  testing  standards  and  in  order  to  amend  the  said  lists  and  references.  It  is  of 
particular importance that the Commission carry out appropriate consultations during 
its preparatory work, including at expert level. 

(14)  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. 

(15) 

In order to meet the objectives of this Directive, the international instruments should 
be  uniformly  implemented  in  the  Internal  Market.  It  is  therefore  necessary,  for  each 
item of marine equipment for which the approval of the flag State is required by the 
international  conventions,  to  identify  in  a  clear  and  timely  way  the  design, 
construction and performance requirements as well as the associated testing standards 
laid  down  in  the  international  instruments  for  that  equipment,  and  to  adopt  common 
criteria and procedures for the implementation of those requirements and standards by 
notified bodies, Member State authorities and the economic operators. Moreover, it is 

EN 

12 

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necessary  to  ensure  that  only  in  exceptional  and  duly  justified  cases  equipment  not 
bearing the wheel mark is allowed to be placed on board.  

(16) 

In  order  to  ensure  uniform  conditions  for  the  implementation  of  this  Directive, 
implementing powers should be conferred on the Commission. Those powers should 
be  exercised  in  accordance  with  Regulation  (EU)  No  182/2011  of  the  European 
Parliament and of the Council of 16 February 2011 laying down the rules and general 
principles concerning mechanisms for control by Member States of the Commission’s 
exercise of implementing powers.5 

(17)  The Commission is assisted by the European Maritime Safety Agency, in accordance 
with  Regulation  (EC)  […],  in  the  effective  implementation  of  relevant  binding  legal 
acts  of  the  Union  and  in  the  performance  of  the  tasks  therein  entrusted  to  the 
Commission; 

(18)  Since  the  objectives  of  this  Directive,  namely  to  enhance  safety  at  sea  and  the 
prevention  of  marine  pollution  through  the  uniform  application  of  the  relevant 
international  instruments  relating  to  equipment  to  be  placed  on  board  ships,  and  to 
ensure the free movement of such equipment within the Union, cannot be sufficiently 
achieved by the Member States and can therefore, by reason of the scale of the action, 
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. 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, 

(19)  The  measures  to  be  adopted  represent  a  major  modification  of  the  provisions  of 
Directive 96/98/EC and therefore, in the interests of clarity, that Directive should be 
repealed and replaced by a new Directive.  

HAVE ADOPTED THIS DIRECTIVE: 

Chapter 1  

General provisions 

Article 1 

Objective 

The  purpose  of  this  Directive  is  to  enhance  safety  at  sea  and  to  prevent  marine  pollution 
through  the  uniform  application  of  the  relevant  international  instruments  relating  to  marine 
equipment  to  be  placed  on  board  EU  ships,  and  to  ensure  the  free  movement  of  such 
equipment within the Union. 

5 

OJ L 55, 28.2.2011, p. 13. 

EN 

13 

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Article 2 

Definitions 

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

(1) 

(2) 

(3) 

– 

– 

– 

– 

– 

"Marine equipment" means equipment falling under the scope of this Directive 
in accordance with Article 3. 

"EU ship" means a ship, for which safety certificates are issued by or on behalf 
of Member States under the international conventions, with the exception of a 
ship for which the administration of a Member State issues a certificate at the 
request of a third country's administration; 

"international  conventions"  means  the  conventions,  together  with  their 
Protocols and  Codes of mandatory application, adopted under the auspices of 
the  International  Maritime  Organization  (IMO)  which  lay  down  specific 
requirements  for  the  approval  by  the  flag State  of  equipment  to  be  placed  on 
board ships. This includes: 

the 1966 International Convention on Load Lines (LL66), 

the 1972 Convention on the International Regulations for Preventing Collisions 
at Sea (Colreg), 

the  1973  International  Convention  for  the  Prevention  of  Pollution  from  Ships 
(Marpol), 

the 1974 International Convention for the Safety of Life at Sea (Solas), 

the 2004 International Convention for the Control and Management of Ships’ 
Ballast Water and Sediments (BWMC); 

(4) 

"testing standards" means the testing standards for marine equipment set by 

– 

– 

– 

– 

– 

– 

– 

– 

– 

the International Maritime Organization (IMO),  

the International Organization for Standardization (ISO), 

the International Electrotechnical Commission (IEC), 

the European Committee for Standardization (CEN), 

the European Committee for Electrotechnical Standardization (Cenelec) 

the International Telecommunication Union (ITU) 

the European Telecommunication Standards Institute (ETSI) 

the Commission, in accordance with this Directive, 

the Regulatory Authorities recognised in the mutual recognition agreements to 
which the Union is a party. 

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(5) 

(6) 

(7) 

(8) 

"international instruments" means the international conventions, together with 
the resolutions and circulars of the International Maritime Organization giving 
effect to those conventions, and the testing standards; 

"wheel mark" means the symbol referred to in Article 9 and set out in Annex I 
or, as appropriate, the electronic tag referred to in Article 11; 

"notified  body"  means  an  organisation  designated  by  the  competent  national 
administration of a Member State in accordance with Article 17; 

"making  available  on  the  market"  means  any  supply  of  marine  equipment  on 
the Union market in the course of a commercial activity, whether in return for 
payment or free of charge; 

(9) 

"placing on the market" means the first making available of marine equipment 
on the Union market; 

(10)  "manufacturer"  means  any  natural  or  legal  person  who  manufactures  marine 
equipment  or  has  marine  equipment  designed  or  manufactured,  and  markets 
that equipment under his name or trademark; 

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

(12)  "importer" means any natural or legal person established within the Union who 

places marine equipment from a third country on the EU market; 

(13)  "distributor" means any natural or legal person in the supply chain, other than 
the  manufacturer  or  the  importer,  who  makes  marine  equipment  available  on 
the market; 

(14)  "economic  operators"  means  the  manufacturer,  the  authorised  representative, 

the importer and the distributor; 

(15)  "accreditation"  means  accreditation  as  defined  in  Article  2(10)  of  Regulation 

(EC) No 765/2008 of the European Parliament and of the Council 6; 

(16)  "national accreditation body" means national accreditation body as defined in 

Article 2 (11) of Regulation (EC) No 765/2008; 

(17)  "conformity  assessment"  means  the  process  demonstrating  whether  marine 
equipment  complies  with  the  requirements  laid  down  in  this  Directive,  in 
accordance with Article 15; 

(18)  "conformity  assessment  body"  means  a  body  that  performs  conformity 
assessment activities including calibration, testing, certification and inspection; 

(19)  "recall" means any measure aimed at achieving the return of marine equipment 

that has already been placed on board EU ships; 

6 

OJ L 218, 13.8.2008, p. 30. 

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(20)  "withdrawal" means any measure aimed at preventing marine equipment in the 

supply chain from being made available on the market; 

(21)  "EU declaration of conformity" means a statement issued by the manufacturer 

in accordance with article 16; 

(22)  "product" means an item of marine equipment. 

Article 3 

Scope 

1. 

2. 

1. 

2. 

3. 

4. 

This  Directive  shall  apply  to  equipment  to  be  placed  on  board  an  EU  ship  and  for 
which  the  approval  of  the  flag  State  administration  is  required  by  the  international 
instruments. 

Notwithstanding the  fact that the  marine equipment  referred  to  in  paragraph  1  may 
also fall within the scope of instruments of Union law other than this Directive, that 
marine equipment shall, for the purpose set out in Article 1, be subject only to this 
Directive . 

Article 4 

Requirements for marine equipment 

Marine equipment that is placed on board an EU ship on or after the date referred to 
in the second subparagraph of Article 39(1) shall meet the design, construction and 
performance  requirements  of  the  international  instruments  as  applicable  at  the  time 
the said equipment is placed on board. 

Compliance  of  marine  equipment  with  the  requirements  referred  to  in  paragraph  1 
shall be demonstrated solely in accordance with the testing standards and by means 
of the conformity-assessment procedures referred to in Article 15. 

The  requirements  and  standards  referred  to  in  paragraphs  1  and  2  shall  be 
implemented in a uniform manner, in accordance with Article 35(2) and (3). 

The international instruments, with the exception of testing standards, shall apply in 
their  up-to-date  version,  without  prejudice  to  Article  5  of  Regulation  (EC)  No 
2099/2002 of the European Parliament and of the Council 7. 

Article 5 

Application 

1. 

When issuing, endorsing or renewing the certificates of the ships flying their flag in 
accordance  with  the  international  conventions,  the  Member  States  shall  ensure  that 

7 

OJ L 324, 29.11.2002, p.1. 

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the  marine  equipment  on  board  those  ships  complies  with  the  requirements  of  this 
Directive. 

2. 

Member States shall take the necessary measures to ensure that marine equipment on 
board  ships  flying  their  flag  complies  with  the  requirements  in  the  international 
instruments  which  are  applicable  to  equipment  already  placed  on  board.  These 
requirements shall be implemented in a uniform manner, in accordance with Article 
35(4). 

Article 6 

Functioning of the internal market 

Member States shall not prohibit the placing on the market or the placing on board an EU ship 
of marine equipment which complies with  this Directive, nor refuse to issue the certificates 
relating thereto to the ships flying their flag, or to renew the said certificates. 

1. 

2. 

3. 

1. 

Article 7 

Transfer of a ship to the register of a Member State 

In  the  case  of  a  ship  which,  irrespective  of  its  flag,  is  not  registered  in  a  Member 
State  but  is  to  be  transferred  to  the  register  of  a  Member  State,  that  ship  shall,  on 
transfer,  be  subject  to  inspection  by  the  receiving  Member  State  to  verify  that  the 
actual  condition  of  its  marine  equipment  corresponds  to  its  safety  certificates  and 
either complies with this Directive and bears the wheel mark or is equivalent, to the 
satisfaction of that Member State's administration, to marine equipment certified in 
accordance with this Directive. 

Unless the equipment either bears the wheel mark or the administration considers it 
to be equivalent, it shall be replaced. 

Marine  equipment  which  is  considered  equivalent  pursuant  to  this  Article  shall  be 
given a certificate by the Member State which shall at all times be carried with the 
equipment. It shall give the flag Member State's permission for the equipment to be 
placed  on  board  the  ship  and  imposes  any  restrictions  or  lays  down  any  provisions 
relating to the use of the equipment. 

Article 8 

Standards for marine equipment 

Without  prejudice  to  Directive  98/34/EC  of  the  European  Parliament  and  the 
Council8,  the  Union  shall  pursue  the  development  by  the  IMO  of  appropriate 
international  standards,  including  detailed  technical  specifications  and  testing 
standards, for marine equipment whose use or installation on board ships is deemed 

8 

OJ L 204, 21.7.1998, p. 37. 

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necessary  to  enhance  maritime  safety  and  the  prevention  of  marine  pollution.  The 
Commission shall monitor this development on a regular basis. 

In  the  absence  of  appropriate  international  standards  developed  by  the  IMO  for  a 
specific item of marine equipment, the Commission shall be empowered to adopt, by 
means  of  delegated  acts  in  accordance  with  Article  37,  harmonised  technical 
specifications and testing standards for that specific item of marine equipment when 
it  is  necessary  in  order  to  remove  an  unacceptable  threat  to  safety  or  to  the 
environment. Those specifications and standards shall apply on an interim basis and 
until such time as the IMO has adopted appropriate standards.  

Chapter 2  

The wheel mark 

Article 9 

The wheel mark 

Marine  equipment  whose  compliance  with  the  requirements  laid  down  in  this 
Directive  has  been  demonstrated  in  accordance  with  the  relevant  conformity-
assessment procedures shall have the wheel mark affixed to it.  

The wheel mark shall not be affixed to any other product.  

The form of the wheel mark to be used shall be as set out in Annex I. 

Use of the wheel mark shall be subject to the general principles set out in paragraphs 
1 and 3 to 6 of Article 30 of Regulation (EC) No 765/2008, where any reference to 
the CE marking shall be construed as a reference to the wheel mark. 

Article 10 

Rules and conditions for affixing the wheel mark 

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

The wheel mark shall be affixed at the end of the production phase.  

The wheel mark shall be followed by the identification number of the notified body, 
where  that  body  is  involved  in  the  production  control  phase,  and  by  the  last  two 
digits of the number of the year in which the mark is affixed. 

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

2. 

1. 

2. 

3. 

4. 

1. 

2. 

3. 

4. 

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5. 

1. 

2. 

1. 

2. 

3. 

4. 

5. 

Member States shall build upon existing mechanisms to ensure correct application of 
the  regime  governing  the  wheel  mark  and  take  appropriate  action  in  the  event  of 
improper  use  of  the  mark.  Member  States  shall  also  provide  for  penalties  for 
infringements,  which  may  include  criminal  sanctions  for  serious  infringements. 
Those penalties shall be proportionate to the seriousness of the offence and constitute 
an effective deterrent against improper use. 

Article 11 

Electronic tag 

The  wheel  mark  may  be  supplemented  or  replaced  by  an  appropriate  and  reliable 
form  of  electronic  tag.  In  such  case,  Articles  9  and  10  shall  apply,  as  appropriate, 
mutatis mutandi. 

The Commission shall adopt delegated acts, in accordance with Article 37, in order 
to identify the specific items of marine equipment which can benefit from electronic 
tagging,  and  to  lay  down  appropriate  technical  criteria  as  regards  the  design, 
performance, affixing and use of electronic tags.  

Chapter 3  

Obligations of economic operators 

Article 12 

Obligations of manufacturers 

By  affixing  the  wheel  mark,  manufacturers  shall  take  on  responsibility  for 
guaranteeing  that  the  marine  equipment  to  which  the  mark  is  affixed  has  been 
designed and manufactured in accordance with the requirements set out in Article 4 
and shall undertake the obligations laid down in paragraphs 2 to 9 of this Article. 

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

Where  compliance  of  marine  equipment  with  the  applicable  requirements  has  been 
demonstrated by the conformity assessment procedure, manufacturers shall draw up 
an  EU  declaration  of  conformity  in  accordance  with  Article  16  and  affix  the 
conformity marking in accordance with Article 9. 

Manufacturers  shall  keep  the  technical  documentation  and  the  EU  declaration  of 
conformity referred to in Article 16 for a period of time commensurate with the level 
of risk, and in no case less than the expected lifecycle of the marine equipment, after 
the wheel mark has been affixed on the last unit. 

Manufacturers  shall  ensure  that  procedures  are  in  place  for  series  production  to 
remain  in  conformity.  Changes  in  marine  equipment  design  or  characteristics  and 

EN 

19 

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changes in the requirements in the international instruments as referred to in Article 
4,  on  the  basis  of  which  conformity  of  marine  equipment  is  declared  shall  be 
adequately  taken  into  account.  When  necessary  in  accordance  with  Annex  II,  they 
shall have a new conformity assessment carried out. 

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

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

Manufacturers  shall  ensure  that  the  product  is  accompanied  by  instructions  and  all 
necessary  information  for  safe  installation  on  board  and  safe  use  of  the  product, 
including limitations of use, if any, in a language which can be easily understood by 
the  end-users,  together  with  any  other  documentation  required  by  the  international 
instruments or testing standards. 

Manufacturers who consider or have reason to believe that a product which they have 
placed on the market or on board EU ships is not in conformity with the applicable 
requirements  in  the  international  instruments  as  referred  to  in  Article  4,  shall 
immediately  take  the  necessary  corrective  measures  to  bring  that  product  into 
conformity, to withdraw it or recall it, if appropriate. In addition, where the product 
presents  a  risk,  manufacturers  shall  immediately  inform  the  competent  national 
authorities of the Member States, giving details, in particular, of the non-compliance 
and of any corrective measures taken. 

Manufacturers  shall,  further  to  a  reasoned  request  from  a  competent  national 
authority, promptly provide it with all the information and documentation necessary 
to  demonstrate  the  conformity  of  the  product,  in  a  language  which  can  be  easily 
understood by that authority, and grant to that authority access to their premises for 
market  surveillance  purposes  in  accordance with  Article  19  of  Regulation  (EC)  No 
765/2008. They shall cooperate with that authority, at its request, on any action taken 
to eliminate the risks posed by products which they have placed on the market. 

Article 13 

Authorised representatives 

A  manufacturer  who  is  not  located  in  the  territory  of  a  Member  State  shall,  by  a 
written mandate, appoint an authorised representative. 

The  obligations  laid  down  in  Article  12(1)  and  the  drawing  up  of  technical 
documentation shall not form part of the authorised representative's mandate. 

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

6. 

7. 

8. 

9. 

10. 

1. 

2. 

3. 

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20 

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(a)  keep the EU  declaration of  conformity and the technical documentation 
at  the  disposal  of  national  surveillance  authorities  for  a  period  of  time 
commensurate  with  the  level  of  risk,  and  in  no  case  less  than  the 
expected  lifecycle  of  the  marine  equipment,  after  the  wheel  mark  has 
been affixed on the last unit; 

(b) 

(c) 

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 a product; 

cooperate with the competent national authorities, at their request, on any 
action  taken  to  eliminate  the  risks  posed  by  products  covered  by  their 
mandate. 

Article 14 

Other economic operators 

1. 

2. 

3. 

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

Importers  and  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  a  product  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 products which they have placed 
on the market. 

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 12, where he places marine equipment on the market or on board an EU ship 
under  his  name  or  trademark  or  modifies  marine  equipment  already  placed  on  the 
market  in  such  a  way  that  compliance  with  the  applicable  requirements  may  be 
affected. 

Chapter 4 

Conformity assessment and notification of conformity assessment 
bodies 

Article 15 

Conformity assessment procedures 

1. 

The conformity assessment procedures shall be as set out in Annex II. 

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21 

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2. 

Member  States  shall  ensure  that  the  manufacturer  or  his  authorized  representative 
carry  out  the  conformity  assessment,  for  a  specific  item  of  marine  equipment,  by 
using  one  of  the  options  provided  by  means  of  implementing  acts  adopted  by  the 
Commission  in  accordance  with  the  examination  procedure  referred  to  in  Article 
38(3), from among one of the following procedures: 

(a)  where the EC type-examination (module B) is to be used, before being placed 

on the market, all marine equipment shall be subject to: 

– 

– 

– 

production-quality assurance (module D); 

product-quality assurance (module E); or 

product verification (module F);  

(b)  where  sets  of  marine  equipment  are  produced  individually  or  in  small 
quantities  and  not  in  series  or  in  mass,  the  conformity-  assessment  procedure 
may be the EC unit verification (module G). 

3. 

The  Commission  shall  keep  an  up-to-date  list  of  approved  marine  equipment  and 
applications withdrawn or refused and shall make it available to interested parties. 

Article 16 

EU declaration of conformity 

1. 

2. 

3. 

4. 

5. 

The EU declaration of conformity shall state that the fulfilment of the requirements 
laid down in accordance with Article 4 has been demonstrated. 

The EU declaration of conformity shall follow the model structure set out in Annex 
III  to  Decision No 768/2008/EC.  It  shall  contain  the  elements  specified  in  the 
relevant  modules  set  out  in  Annex  II  to  this  Directive  and  shall  be  continuously 
updated. 

By drawing up the EU declaration of conformity, the manufacturer shall assume the 
responsibility and undertake the obligations referred to in Article 12(1). 

When marine equipment is placed on board an EU ship, a copy of the EU declaration 
of conformity covering the equipment concerned shall be provided to the ship, and 
shall be kept on board until the said equipment is removed from the ship. It shall be 
translated into the language or languages required by the flag State. 

A copy of the EU declaration of conformity shall be provided to the notified body or 
to the bodies having carried out the relevant conformity-assessment procedures. 

Article 17 

Notification 

1. 

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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22 

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2. 

Notified bodies shall comply with the requirements laid down in Annex III. 

Article 18 

Notifying authorities 

1. 

2. 

3. 

4. 

5. 

6. 

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 the provisions of Article 20. 

Notified  bodies  shall  be  monitored  at  least  every  two  years.  The  Commission  may 
choose to participate as an observer in the monitoring exercise. 

Member  States  may  decide  that  the  assessment  and  monitoring  referred  to  in 
paragraph 1 shall be carried out by a national accreditation body. 

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  Annex  V.  In  addition  it  shall  have 
arrangements to cover liabilities arising out of its activities. 

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

The notifying authority shall comply with the requirements laid down in Annex V. 

Article 19 

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 such bodies, 
and of any changes thereto. 

2. 

The Commission shall make that information publicly available. 

Article 20 

Subsidiaries of and subcontracting by notified bodies 

1. 

2. 

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  Annex  III  and  shall  inform  the 
notifying authority accordingly. 

the 
Notified  bodies  shall 
subcontractors or subsidiaries wherever these are established. 

take  full  responsibility  for 

tasks  performed  by 

EN 

23 

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3. 

4. 

1. 

2. 

1. 

2. 

3. 

4. 

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

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 this Directive. 

Article 21  

Changes to notifications 

Where a notifying authority has ascertained or has been informed that a notified body 
no longer meets the requirements laid down in Annex III , 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. 

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 22 
Challenge of the competence of notified bodies 

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

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. 

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

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

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24 

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Article 23 

Operational obligations of notified bodies 

1. 

2. 

3. 

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

Where  a  notified  body  finds  that  the  requirements  laid  down  in  accordance  with 
Article 4 have not been met by a manufacturer, it shall require that manufacturer to 
take appropriate corrective measures and shall not issue a conformity certificate. 

Where,  in  the  course  of  the  monitoring  of  conformity  following  the  issue  of  a 
certificate, a notified body finds that a product no longer complies, it shall require the 
manufacturer to take appropriate corrective measures and shall suspend or withdraw 
the certificate if necessary. Where corrective measures are not taken or do not have 
the  required  effect,  the  notified  body  shall  restrict,  suspend  or  withdraw  any 
certificates, as appropriate. 

Article 24 

Information obligation on notified bodies 

1. 

Notified bodies shall inform the notifying authority of the following: 

(a) 

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

(b) 

any circumstances affecting the scope of and conditions for notification; 

(c) 

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

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

2. 

Notified  bodies  shall  provide  the  Commission  and  the  Member  States,  on  request, 
with  relevant  information  on  issues  relating  to  negative  and  positive  conformity 
assessment  results.  Notified  bodies  shall  provide  the  other  notified  bodies  carrying 
out  conformity  assessment  activities  covering  the  same  products  with  information 
concerning negative and, on request, positive conformity assessment results. 

Article 25 

Exchange of experience 

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

EN 

25 

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Article 26 

Coordination of notified bodies 

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

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

Chapter 5 

Union market surveillance, control of products, safeguard 
provisions 

Article 27 

EU market surveillance framework  

As regards marine equipment, the Member States shall undertake market surveillance 
in accordance with the EU market surveillance framework laid down in Chapter III 
of Regulation (EC) No 765/2008, subject to the provisions of paragraphs 2 and 3 of 
this Article. 

National market surveillance infrastructures and programmes shall take into account 
the  specific  features  of  the  marine  equipment  sector,  and  in  particular  the 
responsibilities  placed  with  the  flag  State  administration  by  the  international 
conventions. 

Market  surveillance  may  include  documentary  checks  as  well  as  checks  of  marine 
equipment which bears the wheel mark whether or not it has been placed on board 
ships. Checks of marine equipment already placed on board shall be limited to such 
examination  as  can  be  carried  out  while  the  equipment  concerned  remains  fully 
functional  on  board.  Checks  of  marine  equipment  placed  on  board  ships  flying  the 
flag of a Member State other than that carrying out the checks shall be carried out in 
accordance  with  the  relevant  provisions  of  Directive  2009/16/EC  of  the  European 
Parliament and the Council9. 

Where  the  market  surveillance  authorities  of  a  Member  State  intend  to  carry  out 
sample  checks,  they  may  request  the  manufacturer  to  make  the  necessary  samples 
available at its own cost in the territory of that Member State. 

1. 

2. 

1. 

2. 

3. 

4. 

9 

OJ L 131, 28.5.2009, p. 57 

EN 

26 

   EN 

 
 
                                                 
1. 

2. 

3. 

4. 

5. 

Procedure for dealing with marine equipment presenting a risk at national level 

Article 28 

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 marine equipment covered by this Directive presents 
a risk to maritime safety or to the protection of the environment, they shall carry out 
an  evaluation  in  relation  to  the  marine  equipment  concerned  covering  all  the 
requirements  laid  down  in  this  Directive.  The  relevant  economic  operators  shall 
cooperate as necessary with the market surveillance authorities. 

Where, in the course of that evaluation, the market surveillance authorities find that 
the  marine  equipment  does  not  comply  with  the  requirements  laid  down  in  this 
Directive, they shall without delay require the relevant economic operator to take all 
appropriate  corrective  actions  to  bring  the  marine  equipment  into  compliance  with 
those requirements, to withdraw the marine equipment 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 subparagraph of this paragraph. 

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

The economic operator shall ensure that all appropriate corrective action is taken in 
respect  of  all  the  products  concerned  that  it  has  made  available  on  the  market 
throughout the Union or, as necessary, placed or delivered to be placed on board EU 
ships. 

Where  the  relevant  economic  operator  does  not  take  adequate  corrective  action 
within the period referred to in the second subparagraph of paragraph 1, or otherwise 
fails to meet its obligations under this Directive, the market surveillance authorities 
shall  take  all  appropriate  provisional  measures  to  prohibit  or  restrict  the  marine 
equipment  being  made  available  on  their  national  market  or  placed  on  board  the 
ships flying their flag, to withdraw the product from that market or to recall it. 

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

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

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27 

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(a) 

failure  of  the  marine  equipment  to  comply  with  the  applicable  design, 
construction and performance requirements as laid down pursuant to Article 4; 

(b)  non-compliance  with  the  testing  standards  referred  to  in  Article  4  during  the 

conformity-assessment procedure; 

(c) 

shortcomings in the said testing standards. 

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 marine equipment concerned, and, in the event of disagreement with the notified 
national measure, of their objections. 

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

Member States shall ensure that appropriate restrictive measures are taken in respect 
of  the  marine  equipment  concerned,  such  as  withdrawal  of  the  product  from  their 
market, without delay. 

Article 29 

EU safeguard procedure 

Where,  on  completion  of  the  procedure  set  out  in  Article 28(3)  and (4),  objections 
are  raised  against  a  measure  taken  by  a  Member  State,  or  where  the  Commission 
considers  that  a  national  measure  may  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. 

For the purpose of paragraph 1, where the Commission is satisfied that the procedure 
followed in the adoption of the national measure is appropriate for an exhaustive and 
objective evaluation of the risk and complies with the provisions laid down in Article 
21  of  Regulation  (EC)  No  765/2008,  it  may  limit  itself  to  examining  the 
appropriateness  and  proportionality  of  the  national  measure  in  relation  to  the  said 
risk. 

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

If  the  national  measure  is  considered  justified,  all  Member  States  shall  take  the 
measures necessary to ensure that the non-compliant marine equipment is withdrawn 
from their market, and, where necessary, recalled. They shall inform the Commission 
accordingly.  

6. 

7. 

8. 

1. 

2. 

3. 

4. 

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28 

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5. 

6. 

7. 

1. 

2. 

3. 

4. 

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

Where  the  national  measure  is  considered  justified  and  the  non-compliance  of  the 
marine equipment is attributed to shortcomings in the testing standards referred to in 
Article  4,  the  Commission  may  confirm,  modify  or  revoke  the  said  measure  by 
means of implementing acts in accordance with the advisory procedure referred to in 
Article 38(2). The Commission shall furthermore be empowered to adopt, by means 
of delegated acts in accordance with the procedure referred to in Article 37, interim 
harmonised  requirements  and  testing  standards  for  that  specific  item  of  marine 
equipment in order to remove the threat to safety or to the environment pending the 
modification  of  the  testing  standard  concerned  by  the  relevant  international 
organisation. 

Where the testing standard concerned is a European Standard, the Commission shall 
inform  the  relevant  European  standardisation  body  or  bodies  and  shall  bring  the 
matter  before  the  Committee  set  up  by  Article 5  of  Directive 98/34/EC.  That 
Committee  shall  consult  the  relevant  European  standardisation  body  or  bodies  and 
deliver its opinion without delay. 

Article 30 

Compliant products which present a risk to maritime safety or to the protection of the 
environment 

Where,  having  performed  an  evaluation  under  Article  28(1),  a  Member  State  finds 
that  although  marine  equipment  is  in  compliance  with  this  Directive,  it  presents  a 
risk  to  marine  safety  or  to  the  environment,  it  shall  require  the  relevant  economic 
operator  to  take  all  appropriate  measures  to  ensure  that  the  marine  equipment 
concerned, when placed on the market, no longer presents that risk, to withdraw the 
marine  equipment  from  the  market  or  to  recall  it  within  a  reasonable  period, 
commensurate with the nature of the risk, as it may prescribe. 

The economic operator shall ensure that corrective action is taken in respect of all the 
products concerned that he has made available on the market throughout the Union 
or placed on board EU ships. 

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  marine  equipment  concerned,  the  origin  and 
the  supply  chain  of  the  marine  equipment,  the  nature  of  the  risk  involved  and  the 
nature and duration of the national measures taken. 

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; for this purpose, Article 29(2) shall apply mutatis mutandis. 

EN 

29 

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5. 

1. 

2. 

1. 

2. 

3. 

4. 

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 31 

Formal non-compliance 

Without prejudice to Article 28, where a Member State makes one of the following 
findings,  it  shall  require  the  relevant  economic  operator  to  put  an  end  to  the 
non-compliance concerned: 

(a) 

the wheel mark has been affixed in violation of Article 9 or of Article 10; 

(b) 

the wheel mark has not been affixed; 

(c) 

the EU declaration of conformity has not been drawn up; 

(d) 

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

(e) 

technical documentation is either not available or not complete. 

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

Article 32 

Exemptions based on technical innovation 

In  exceptional  circumstances  of  technical  innovation,  the  flag  State  administration 
may  permit  marine  equipment  which  does  not  comply  with  the  conformity 
assessment procedures to be placed on board an EU ship if it is established by trial or 
otherwise to the satisfaction of the flag State administration that such equipment is at 
least  as  effective  as  marine  equipment  which  does  comply  with  the  conformity-
assessment procedures. 

The  trial  procedures  shall  in  no  way  discriminate  between  marine  equipment 
produced in the flag Member State and marine equipment produced in other States. 

Marine  equipment  covered  by  this  Article  shall  be  given  a  certificate  by  the  flag 
Member State which shall at all times be carried with the equipment and which gives 
the flag Member State's permission for the equipment to be placed on board the ship 
and  imposes  any  restrictions  or  lays  down  any provisions relating to  the  use  of  the 
equipment.  

Where a Member State allows marine equipment covered by this Article to be placed 
on board an EU ship, that Member State shall forthwith communicate the particulars 

EN 

30 

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thereof  together  with  the  reports  of  all  relevant  trials,  assessments  and  conformity-
assessment procedures to the Commission and the other Member States. 

5. 

6. 

Within twelve months of receipt of the communication referred to in paragraph 4, the 
Commission, if it considers that the conditions laid down in paragraph 1 are not met, 
may require the Member State concerned to withdraw the permission granted within 
a  specified  deadline.  For  this  purpose,  the  Commission  shall  act  by  means  of 
implementing acts. Those implementing acts shall be adopted in accordance with the 
advisory procedure referred to in Article 38(2). 

Where  a  ship  with  marine  equipment  on  board  which  is  covered  by  paragraph  1  is 
transferred to another Member State, the receiving flag Member State may undertake 
the  necessary  measures,  which  may  include  tests  and  practical  demonstrations,  to 
ensure  that  the  equipment  is  at  least  as  effective  as  equipment  which  does  comply 
with the conformity-assessment procedures. 

Article 33 

Exemptions for testing or evaluation 

A  flag  State  administration  may  permit  marine  equipment  which  does  not  comply  with  the 
conformity-assessment  procedures or is not covered by Article 32 to be placed  on board an 
EU  ship  for  reasons  of  testing  or  evaluation,  if  the  following  cumulative  conditions  are 
complied with: 

(a) 

(b) 

(c) 

1. 

2. 

the  marine  equipment  shall  be  given  a  certificate  by  the  flag  Member  State  which 
shall  at  all  times  be  carried  with  the  equipment,  state  the  said  Member  State's 
permission  for  the  equipment  to  be  placed  on  board  the  EU  ship,  impose  all 
necessary restrictions and lay down any other appropriate provisions as regards the 
use of the equipment concerned; 

the permission shall be limited to a short period of time; 

the marine equipment shall not be relied on in place of equipment which meets the 
requirements  of  this  Directive  and  shall  not  replace  such  equipment,  which  shall 
remain on board the EU ship in working order and ready for immediate use. 

Article 34 

Exemptions in exceptional circumstances 

In  exceptional  circumstances,  which  shall  be  duly  justified  to  the  flag  State 
administration,  when  marine  equipment  needs  to  be  replaced  in  a  port  outside  the 
Union where it is not practicable in terms of reasonable time, delay and cost to place 
on  board  equipment  which  bears  the  wheel  mark,  other  marine  equipment  may  be 
placed on board subject to paragraphs 2 to 4 of this Article. 

The  marine  equipment  placed  on  board  shall  be  accompanied  by  documentation 
issued by a Member State of the IMO which is a party to the relevant conventions, 
certifying compliance with the relevant IMO requirements. 

EN 

31 

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3. 

4. 

5. 

6. 

7. 

8. 

The  flag  State  administration  shall  be  informed  at  once  of  the  nature  and 
characteristics of such other marine equipment.  

The flag State administration shall, at the earliest opportunity, ensure that the marine 
equipment referred to in paragraph 1, along with its testing documentation, complies 
with the relevant requirements of the international instruments and of this Directive. 

Where  it  has  been  demonstrated  that  specific  marine  equipment  bearing  the  wheel 
mark  has  become  unavailable  on  the  market,  the  flag  Member  State  may  authorise 
other marine equipment to be placed on board subject to the provisions of paragraphs 
6 to 8 of this Article. 

The  authorised  marine  equipment  shall  comply,  as  much  as  possible,  with  the 
requirements and testing standards referred to in Article 4.  

The  marine  equipment  placed  on  board  shall  be  accompanied  by  an  interim 
certificate of approval issued by the flag Member State or by another Member State, 
stating the following: 

(a) 

(b) 

the equipment bearing the wheel mark which the certified equipment is due to 
replace; 

the  exact  circumstances  under  which  the  certificate  of  approval  has  been 
issued, and in particular the unavailability in the market of equipment bearing 
the wheel mark; 

(c) 

the exact design, construction and performance requirements against which the 
equipment has been approved by the certifying Member State; 

(d) 

the testing standards applied, if any, in the relevant approval procedures. 

The  Member  State  issuing  an  interim  certificate  of  approval  shall  inform  the 
Commission  forthwith.  If  the  Commission  considers  that  the  conditions  of 
paragraphs 6 and 7 have not been met, it may require that Member State to revoke 
the  said  certificate  or  take  other  appropriate  measures  by  means  of  implementing 
acts.  Those  implementing  acts  shall  be  adopted  in  accordance  with  the  advisory 
procedure referred to in Article 38(2). 

Chapter 6 

Final provisions 

Article 35 

Implementing measures 

1. 

The Member States shall notify to the Commission the name and contact details of 
the  authorities  in  charge  of  the  implementation  of  this  Directive.  The  Commission 
shall draw up, periodically update and make public a list of these authorities. 

EN 

32 

   EN 

 
2. 

3. 

4. 

5. 

For  each  item  of  marine  equipment  for  which  the  approval  of  the  flag  State 
administration  is  required  by  the  international  conventions,  the  Commission  shall 
identify  by  means  of  implementing  acts  the  respective  design,  construction  and 
performance requirements and the testing standards provided for in the international 
instruments. 

The  Commission  may  adopt  by  means  of  implementing  acts  common  criteria  and 
detailed  procedures  for  the  application  of  the  requirements  and  testing  standards 
referred to in paragraph (2).  

The  Commission  shall,  by  means  of  implementing  acts,  identify  the  respective 
design,  construction  and  performance  requirements  newly  provided  for  in  the 
international instruments and which apply to equipment placed on board before their 
adoption  in  order  to  ensure  that  equipment  placed  on  board  of  EU  ships  complies 
with the international conventions. 

The  Commission  shall  set  up  and  maintain  a  data  base  containing  at  least  the 
following information: 

(a) 

(b) 

(c) 

the  list  and  essential  details  of  the  conformity  certificates  issued  under  this 
Directive; 

the list and essential details of the declarations of conformity issued under this 
Directive; 

an up-to-date list of the applicable international instruments, requirements and 
testing  standards,  including  any  updates  becoming  applicable  by  virtue  of 
Article 4(3); 

(d) 

the list and full text of the criteria and procedures referred to in paragraph 3; 

(e) 

the requirements and conditions for electronic tagging referred to in Article 11; 

(f) 

any other useful information with a view to facilitating correct implementation 
of this Directive by the Member States, the notified bodies and the economic 
operators. 

This database shall be made accessible to the Member States. It shall also be made 
available, in whole or in part, to the public for information purposes only.  

6. 

The implementing acts referred to in this Article shall be adopted in accordance with 
the examination procedure referred to in Article 38(3).  

Article 36 

Amendments  

This Directive may be amended by the Commission, by means of delegated acts, in order to:  

EN 

33 

   EN 

 
(a) 

(b) 

amend the list of international conventions set out in Article 2(3), in order to include 
those conventions which require the flag State's approval of equipment to be placed 
on board ships flying its flag; 

update  the  references  to  international  and  European  standards,  as  referred  to  in 
Annex III when new standards become available. 

Those delegated acts shall be adopted in accordance with the procedure laid down in Article 
37. 

1. 

2. 

3. 

4. 

5. 

1. 

Article 37 

Exercise of the delegation 

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

The delegation of power referred to in Articles 8, 11, 29 and 36 shall be conferred on 
the Commission for an indeterminate period of time from the date of entry into force 
of this Directive. 

The delegation of power referred to in Articles 8, 11, 29 and 36 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.  

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

A delegated act adopted pursuant to Articles 8, 11, 29 and 36 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. 

Article 38 

Committee 

The Commission shall be assisted by the Committee on Safe Seas and the Prevention 
of Pollution from Ships (COSS) established by Regulation (EC) No 2099/2002 of the 
European  Parliament  and  of  the  Council10.  That  committee  shall  be  a  committee 
within the meaning of Regulation (EU) No 182/2011. 

10 

OJ L 324, 29.11.2002, p. 1.  

EN 

34 

   EN 

 
 
                                                 
2. 

3. 

1. 

Where  reference  is  made  to  this  paragraph,  Article  4  of  Regulation  (EU)  No 
182/2011 shall apply. 

Where  reference  is  made  to  this  paragraph,  Article  5  of  Regulation  (EU)  No 
182/2011 shall apply. 

Article 39 

Transposition 

Member  States  shall  adopt  and  publish,  by  [one  year  after  entry  into  force]  at  the 
latest, the laws, regulations and administrative provisions necessary to comply with 
this Directive. They shall forthwith communicate to the Commission the text of those 
provisions. 

They shall apply those provisions from [one year after the date of entry into force]. 

When  Member  States  adopt  those  provisions,  they  shall  contain  a  reference  to  this 
Directive  or  be  accompanied  by  such  a  reference  on  the  occasion  of  their  official 
publication. Member States shall determine how such reference is to be made. 

2. 

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

Article 40 

Repeal 

1. 

2. 

3. 

Council Directive 96/98/EC is repealed with effect from [application date]. 

The  requirements  and  testing  standards  for  marine  equipment  applicable  on 
[application date] pursuant to the provisions of national law adopted by the Member 
States in order to comply with Directive 96/98/EC shall continue to apply until the 
entry into force of the implementing acts referred to in Article 35(2). 

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

Article 41 

Entry into force 

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

EN 

35 

   EN 

 
 
 
Article 42 

This Directive is addressed to the Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

EN 

36 

   EN 

ANNEX I  

Wheel mark  

The mark of conformity must take the following form: 

If the wheel mark is reduced or enlarged the proportions given in the graduated drawing must 
be respected. 

The  various  components  of  the  wheel  mark  must  have  substantially  the  same  vertical 
dimension, which may not be less than 5 mm. 

That 

minimum 

dimension 

may 

be 

waived 

for 

small 

devices.

EN 

37 

   EN 

 
 
ANNEX II 

Conformity assessment procedures  

I. MODULE B: EC-TYPE EXAMINATION 

1. 

EC-type  examination  is  the  part  of  a  conformity  assessment  procedure  in  which  a 
notified  body  examines  the  technical  design  of  marine  equipment  and  verifies  and 
attests  that  the  technical  design  of  the  marine equipment meets  the requirements in 
the international instruments. 

2. 

EC-type examination may be carried out in either of the following manners: 

– 

– 

examination of a specimen, representative of the production envisaged, of the 
complete product (production type); 

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

3. 

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

– 

– 

– 

– 

The application shall include: 

a certified copy of the patent, license or document by which the applicant purports to 
have  the  right  to  make,  use,  sell  or  offer  the  marine  equipment  for  sale  or  use  its 
trademark,  which,  notwithstanding  point  16  of  Annex  III,  the  notified  body  shall 
keep at the disposal of the competent courts; 

the  name  and  address  of  the  manufacturer  and,  if  the  application  is  lodged  by  the 
authorised representative, his name and address as well; 

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

the technical documentation. The technical documentation shall make it possible to 
assess  the  conformity  of  the  marine  equipment  with  the  applicable  requirements  of 
the international instruments as referred to in Article 4, and shall include an adequate 
analysis and assessment of the risk(s). The technical documentation shall specify the 
applicable requirements and cover, as far as relevant for the assessment, the design, 
manufacture  and  operation  of  the  marine  equipment.  The  technical  documentation 
shall contain, wherever applicable, at least the following elements: 

–  a general description of the marine equipment, 

–  conceptual design and manufacturing drawings and schemes of components, sub-

assemblies, circuits, etc., 

EN 

38 

   EN 

 
(a) 

(b) 

descriptions and explanations necessary for the understanding of those 
drawings and schemes and the operation of the marine equipment, 

a list of the requirements and testing standards which are applicable to 
the  marine  equipment  concerned  in  accordance  with  this  Directive, 
together  with  a  description  of  the  solutions  adopted  to  meet  the  said 
requirements, 

(c) 

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

(d) 

test reports; 

–  the  specimens  representative  of  the  production  envisaged.  The  notified  body  may 

request further specimens if needed for carrying out the test programme; 

–  the  supporting  evidence  for  the  adequacy  of  the  technical  design  solution.  This 
supporting evidence shall mention any documents that have been used. The supporting 
evidence  shall  include,  where  necessary,  the  results  of  tests  carried  out  by  the 
appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf 
and under his responsibility. 

4. 

The notified body shall: 

For the marine equipment: 

4.1. 

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

For the specimen(s): 

4.2. 

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

4.3. 

carry out appropriate examinations and tests in accordance with this Directive; 

4.4. 

agree with the manufacturer on a location where the examinations and tests will be 
carried out. 

5. 

6. 

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

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

EN 

39 

   EN 

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

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

The  notified  body  shall  keep  itself  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  international  instruments,  and  shall 
determine whether such changes require further investigation. If so, the notified body 
shall inform the manufacturer accordingly. 

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

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

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

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

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

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

7. 

8. 

9. 

10. 

EN 

40 

   EN 

II. MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION 
PROCESS 

1. 

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

2. 

Manufacturing 

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

3. 

Quality system 

3.1. 

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

The application shall include: 

–  a  certified  copy  of  the  patent,  license  or  document  by  which  the  applicant  purports  to 
have  the  right  to  make,  use,  sell  or  offer  the  marine  equipment  for  sale  or  use  its 
trademark, which, notwithstanding point 16 of Annex III, the notified body shall keep at 
the disposal of the competent courts, 

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

authorised representative, his name and address as well, 

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

notified body, 

–  all relevant information for the marine equipment category envisaged, 

–  the documentation concerning the quality system, 

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

examination certificate. 

3.2. 

The  quality  system  shall  ensure  that  the  products  are  in  conformity  with  the  type 
described in the EC-type examination certificate and comply with the requirements 
of the international instruments that apply to them. 

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

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

EN 

41 

   EN 

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

management with regard to product quality, 

–  the  corresponding  manufacturing,  quality  control  and  quality  assurance  techniques, 

processes and systematic actions that will be used, 

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

and the frequency with which they will be carried out, 

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

qualification reports on the personnel concerned, etc. and 

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

effective operation of the quality system. 

3.3. 

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

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

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

3.4. 

3.5. 

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

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

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

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

4. 

Surveillance under the responsibility of the notified body 

4.1. 

4.2. 

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

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

EN 

42 

   EN 

–  the quality system documentation; 

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

qualification reports on the personnel concerned, etc. 

4.3. 

4.4. 

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

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

5. 

Conformity marking and declaration of conformity 

5.1. 

5.2. 

The  manufacturer  shall  affix  the  wheel  mark  set  out  in  Article  9,  and,  under  the 
responsibility  of  the  notified  body  referred  to  in  point 3.1,  the  latter's  identification 
number to each individual product that is in conformity with the type described in the 
EC-type  examination  certificate  and  satisfies  the  applicable  requirements  of  the 
international instruments. 

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

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

6. 

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

–  the documentation referred to in point 3.1, 

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

–  the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4. 

7. 

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

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

8. 

Authorised representative 

EN 

43 

   EN 

The manufacturer's obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by 
his authorised representative, on his behalf and under his responsibility, provided that 
they are specified in the mandate. 

III. MODULE E: CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE 

1. 

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

2. 

Manufacturing 

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

3. 

Quality system 

3.1. 

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

The application shall include: 

–  a  certified  copy  of  the  patent,  license  or  document  by  which  the  applicant  purports  to 
have  the  right  to  make,  use,  sell  or  offer  the  marine  equipment  for  sale  or  use  its 
trademark, which, notwithstanding point 16 of Annex III, the notified body shall keep at 
the disposal of the competent courts, 

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

authorised representative, his name and address as well, 

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

notified body, 

–  all relevant information for the marine equipment category envisaged, 

–  the documentation concerning the quality system, and 

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

examination certificate. 

3.2. 

The quality system shall ensure compliance of the products with the type described 
in  the  EC-type  examination  certificate  and  with  the  applicable  requirements  of  the 
international instruments. 

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

EN 

44 

   EN 

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

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

management with regard to product quality; 

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

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

qualification reports on the personnel concerned, etc.; 

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

3.3. 

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

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

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

3.4. 

3.5. 

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

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

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

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

4. 

Surveillance under the responsibility of the notified body 

4.1. 

4.2. 

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

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

–  the quality system documentation; 

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

qualification reports on the personnel concerned, etc. 

4.3. 

4.4. 

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

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

5. 

Conformity marking and declaration of conformity 

5.1. 

5.2. 

The  manufacturer  shall  affix  the  required  conformity  marking  set  out  in  Article  9, 
and, under the responsibility of the notified body referred to in point 3.1, the latter's 
identification number to each individual product that is in conformity with the type 
described  in  the  EC-type  examination  certificate  and  satisfies  the  applicable 
requirements of the international instruments. 

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

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

6. 

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

–  the documentation referred to in point 3.1; 

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

–  the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4. 

7. 

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

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

8. 

Authorised representative 

The manufacturer's obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by 
his authorised representative, on his behalf and under his responsibility, provided that 
they are specified in the mandate. 

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IV. MODULE F: CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION 

1. 

Conformity  to  type  based  on  product  verification  is  the  part  of  a  conformity 
assessment procedure whereby the manufacturer fulfils the obligations laid down in 
points 2,  5.1  and 6,  and  ensures  and  declares  on  his  sole  responsibility  that  the 
products  concerned,  which  have  been  subject  to  the  provisions  of  point 3,  are  in 
conformity with the type described in the EC-type examination certificate and satisfy 
the requirements of the international instruments that apply to them. 

2. 

Manufacturing 

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

3. 

Verification 

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

The manufacturer shall provide the notified body with a certified copy of the patent, 
license or document by which the applicant purports to have the right to make, use, 
sell  or  offer  the  marine  equipment  for  sale  or  use  its  trademark,  which, 
notwithstanding point 16 of Annex III, the notified body shall keep at the disposal of 
the competent courts. 

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

Verification of conformity by examination and testing of every product 

All  products  shall  be  individually  examined  and  tested  in  accordance  with  this 
Directive,  in  order  to  verify  conformity  with  the  approved  type  described  in  the 
EC-type  examination  certificate  and  with  the  appropriate  requirements  of  the 
international instruments.  

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

The manufacturer shall keep the certificates of conformity available for inspection by 
the national authorities for ten years after the last product has been manufactured. 

4. 

4.1 

4.2. 

5. 

Statistical verification of conformity 

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5.1. 

5.2. 

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

A  random  sample  shall  be  taken  from  each  lot.  All  products  in  a  sample  shall  be 
individually examined and tested in accordance with this Directive, in order to ensure 
their  conformity  with  the  applicable  requirements  of  the  international  instruments 
and to determine whether the lot is accepted or rejected.  

5.3. 

If a lot is accepted, all products of the lot shall be considered approved, except for 
those products from the sample that have been found not to satisfy the tests. 

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

The  manufacturer  shall  keep  the  certificates  of  conformity  at  the  disposal  of  the 
national authorities for ten years after the last product has been manufactured. 

5.4. 

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

6. 

Conformity marking and declaration of conformity 

6.1. 

6.2. 

The  manufacturer  shall  affix  the  required  conformity  marking  set  out  in  Article  9, 
and,  under  the  responsibility  of  the  notified  body  referred  to  in  point 3,  the  latter's 
identification  number  to  each  individual  product  that  is  in  conformity  with  the 
approved  type  described  in  the  EC-type  examination  certificate  and  satisfies  the 
applicable requirements of the international instruments. 

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

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

7. 

If the notified body agrees  and  under its  responsibility, the manufacturer may affix 
the  notified  body's  identification  number  to  the  products  during  the  manufacturing 
process. 

8. 

Authorised representative 

The manufacturer's obligations may be fulfilled by his authorised representative, on 
his  behalf  and  under  his  responsibility,  provided  that  they  are  specified  in  the 
mandate. An authorised representative may not fulfil the manufacturer's obligations 
set out in points 2 and 5.1. 

V. MODULE G: CONFORMITY BASED ON UNIT VERIFICATION 

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1. 

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

2. 

Technical documentation 

The manufacturer shall establish the technical documentation and make it available 
to the notified body referred to in point 4. The documentation shall make it possible 
to assess the product's conformity with the relevant requirements, and shall include 
an adequate analysis and assessment of the risk(s). The technical documentation shall 
specify the applicable requirements and cover, as far as relevant for the assessment, 
the design, manufacture and operation of the product.  The technical documentation 
shall, wherever applicable, contain at least the following elements: 

–  a  certified  copy  of  the  patent,  license  or  document  by  which  the  applicant  purports  to 
have  the  right  to  make,  use,  sell  or  offer  the  marine  equipment  for  sale  or  use  its 
trademark, which, notwithstanding point 16 of Annex III, the notified body shall keep at 
the disposal of the competent courts, 

–  a general description of the product, 

–  conceptual  design  and  manufacturing  drawings  and  schemes  of  components,  sub-

assemblies, circuits, etc., 

–  descriptions  and  explanations  necessary  for  the  understanding  of  those  drawings  and 

schemes and the operation of the product, 

–  a  list  of  the  requirements  and  testing  standards  which  are  applicable  to  the  marine 
equipment  concerned  in  accordance  with  this  Directive,  together  with  a  description  of 
the solutions adopted to meet the said requirements, 

–  results of design calculations made, examinations carried out; and 

–  test reports. 

The  manufacturer  shall  keep  the  technical  documentation  at  the  disposal  of  the 
relevant  national  authorities  for  ten  years  after  the  last  product  has  been 
manufactured. 

3. 

Manufacturing 

The manufacturer shall take all measures necessary so that the manufacturing process 
and  its  monitoring  ensure  conformity  of  the  manufactured  product  with  the 
applicable requirements of the international instruments. 

4. 

Verification 

A notified body chosen by the manufacturer shall carry out appropriate examinations 
and tests in accordance with this Directive, in order to check the conformity of the 
product with the applicable requirements of the international instruments.  

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

The  manufacturer  shall  keep  the  certificates  of  conformity  at  the  disposal  of  the 
national authorities for ten years after the last product has been manufactured. 

5. 

Conformity marking and declaration of conformity 

5.1. 

5.2. 

The  manufacturer  shall  affix  the  required  conformity  marking  set  out  in  Article  9 
and,  under  the  responsibility  of  the  notified  body  referred  to  in  point  4,  the  latter's 
identification number to each product that satisfies the applicable requirements of the 
international instruments. 

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

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

6. 

Authorised representative 

The  manufacturer's  obligations  set  out  in  points 2  and 5  may  be  fulfilled  by  his 
authorised  representative,  on  his  behalf  and  under  his  responsibility,  provided  that 
they are specified in the mandate. 

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1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

ANNEX III 

Requirements to be met by notified bodies 

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

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

A  conformity  assessment  body  shall  be  a  third-party  body  independent  of  the 
organisation or the marine equipment 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  marine  equipment  which  it  assesses,  may,  on  condition  that  its 
independence  and  the  absence  of  any  conflict  of  interest  are  demonstrated,  be 
considered such a body. 

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

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

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

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

A  conformity  assessment  body  shall  be  capable  of  carrying  out  all  the  conformity 
assessment  tasks  assigned  to  it  under  this  Directive  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. 

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10. 

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

(a)  personnel with technical knowledge and sufficient and appropriate experience 

to perform the conformity assessment tasks; 

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

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

11. 

A  conformity  assessment  body  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. 

12. 

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

(a) 

(b) 

(c) 

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

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

appropriate  knowledge  and  understanding  of  the  requirements,  of  the 
applicable  harmonised  standards  and  of  the  relevant  provisions  of  EU 
harmonisation legislation and of its implementing regulations; 

(d) 

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

13. 

14. 

15. 

16. 

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

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

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. 

The  personnel  of  a  conformity  assessment  body  shall  observe  professional  secrecy 
with regard to all information obtained in carrying out their tasks under this Directive 

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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. 

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

Conformity assessment bodies shall meet the requirements of standard EN4011 (ISO 
guide 65), 

Conformity  assessment  bodies  shall  ensure  that  testing  laboratories  used  for 
conformity-assessment purposes meet the requirements of standard EN17025. 

17. 

18. 

19. 

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ANNEX IV  

Notification procedure 

1. 

Application for notification 

1.1. 

1.2. 

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

That application shall be accompanied by a description of the conformity assessment 
activities, the conformity assessment module or modules and the marine equipment 
for which that body claims to be competent, as well as by an accreditation certificate, 
where  one  exists,  issued  by  a  national  accreditation  body  attesting  that  the 
conformity assessment body fulfils the requirements laid down in Annex III of this 
Directive. 

1.3.  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 Annex III . 

2. 

Notification procedure 

2.1. 

2.2. 

2.3. 

Notifying  authorities  may  notify  only  conformity  assessment  bodies  which  have 
satisfied the requirements laid down in Annex III . 

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

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

2.4.  Where  a  notification  is  not  based  on  an  accreditation  certificate  as  referred  to  in 
section  1,  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 
Annex III to this Directive. 

2.5. 

2.6. 

2.7. 

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

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

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

3. 

Identification numbers and lists of notified bodies 

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3.1. 

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

3.2. 

3.3. 

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

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. 

3.4. 

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

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ANNEX V 

Requirements to be met by notifying authorities 

1. 

2. 

3. 

4. 

5. 

6. 

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

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

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. 

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

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

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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