EN    EN  
 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}  
Ref. Ares(2013)262740 - 28/02/2013EN 2   EN EXPLANATORY MEMORANDUM  
1. C ONTEXT OF THE PROPOSAL  
1.1. Background 
Marine equipment represents a significant fracti on 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 cert ain safety construction and pe rformance requirements and to 
issue the relevant certificates. To that end bot h the International Maritime Organization (IMO) 
and the international and European standard ization bodies produce te sting standards for 
marine equipment. The IMO develops the conven tion requirements and th e 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 sta ndards leave certain discretion to the flag 
administrations. Although in general IMO inst ruments containing requirements and testing 
standards become mandatory, the IMO tradition to work by consensus may from time to time 
lead to the adoption of impor tant safety standards for marine equipment by means of non-
binding instruments; for the same reason, some IMO instruments occasionally have 
exceedingly generous deadlines for thei r implementation or none at all.  
In its proposal for a directiv e on marine equipment, back in 1995, the Commission clearly 
identified the problems encountered  in the Internal Mark et as a result of th is state of affairs 
and in the absence of EU harmonisa tion in the marine equipment sector1. Member States were 
reluctant to mutually accept th eir respective conformity certifi cates even in the presence of 
comparable requirements – not at least withou t 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 equipment
2 (MED) thus laid 
down common rules to eliminate differences in the implementation of international standards 
by means of a clearly identified set of requi rements and uniform certification procedures. 
Today, these common rules continue to be ne cessary 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 implem entation of Directive 96/98/EC  
The experience gained in the implementation of  the MED has highlight ed four areas where 
the existing Directive does not fully  meet its objectives. These are:  
                                                 
1 Cf. COM (1995) 269 final 
2 OJ L 46, 17.2.1997, p. 25.  EN 3   EN 1.2.1. Identification of applicable requirements. The periodic am endment of Annex A of the 
directive 
The specific technical requirements and testin g 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 a nd, as appropriate, of the international and 
European standardization bodies, Annex A is in need of periodic updates.  
IMO instruments and internati onal 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 curren tly not the case. Until now, it has never been 
possible to fully meet the IMO deadlines, and the delay in the inco rporation of the IMO 
requirements into the national lega l 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 insufficien t, degree of control of  notified bodies by 
Member States administrations. The MED re quirements on notified bod ies currently do not 
provide detailed quality benchmarks for the notif ied 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 ra ised that these weaknesses may be confronting 
the industry with unfair competition from en tities 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 borde rs. Thus the marine equipment that actually 
enters the physical territory of the Member Stat es 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. Therefor e the system in the MED does not adapt to the 
reality of the market and in pr actice makes it very difficult for the Member States to carry out 
effective market surveillance.  
Market surveillance is therefore unlikely to pr ovide the national authorities with sufficient 
information to prevent the placing of non-complia nt products on board EU ships. This has a 
direct, negative impact on safety while comp liant manufacturers have to face the difficulties 
associated with unfair competition and counterfeit. 
1.2.4. Safeguard clause 
Experience has highlighted structural weakne sses in the safeguard clause mechanism as 
currently laid down in the MED. There is no incentive for a Member State to carry out an EN 4   EN 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 th e Member States to have a proper hearing of 
the manufacturer or put at its disposal any ap peal mechanisms, let alone to seek voluntary 
correction of any shortcomings in the first plac e. 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 assist ance of EMSA is taken into 
account.  
Moreover, the current safeguard clause mech anism is burdensome and lengthy, and thus 
exposes manufacturers to significant reputationa l damage for long periods until the case is 
finally decided.  
1.3. The new regulatory framework for the ma rketing of goods within the EU (NLF)  
Regulation 765/2008/EC of the European Parlia ment and of the Counc il setting out the 
requirements for accreditation and market survei llance relating to the marketing of products 
and repealing Regulation (EEC) No 339/93
3 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/EEC
4 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 ha rmonisation legislation). According to Article 
2, EU harmonisation legislation sha ll have recourse to the genera l principles set out in this 
Decision and to the relevant reference provisi ons of Annexes I, II and III. However, EU 
legislation may depart from those general prin ciples and reference provisions if that is 
appropriate on account of the specificities of  the sector concerned, especially if 
comprehensive legal systems are already in place. 
1.4. Objectives of the proposal 
1.4.1. General objectives 
Pursuant to Articles 90 and 91 TFEU, the Comm on Transport Policy (C TP) should contribute 
to the broader objectives of the Treaties, an d 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 mari ne equipment, the general obj ective of the pr oposed initiative 
is twofold: 
• to enhance the implementation and enfor cement 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 wh ile 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 purs uant to Article 173 TFEU. 
                                                
 
3 OJ L 218, 13.8.2008, p. 30 
4 OJ L218, 13.8.2008, p.82 EN 5   EN 1.4.2. Specific objectives 
This twofold general objective can be tr anslated into more specific objectives: 
• to find an optimal way to align MED on th e 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 fi eld of market surveillance, 
conformity assessment of products and obligati ons of actors in the distribution chain.  
• to shorten, simplify and clarify the trans position of amendments to IMO standards 
into the European and national legal frameworks. 
2. R ESULTS 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 th e revision exercise was launched, by means of 
questionnaires to the Member States, the indu stry and the MarED group of notified bodies. A 
formal stakeholder consultation meeting was he ld on 27 November 2008 in Brussels. In April 
2012, all stakeholders were cont acted again by the Commission in order to obtain fresher 
views on the possible amendments of the directiv e 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 optio ns were appropriate, 
conditional alignment was the most effective an d 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 th e initial version led to an in -depth reformulation of the 
impact assessment, i.a. refining the problem description, restructur ing policy options and 
shortening the document. In its second opinion, th e Board formulated a number of additional 
recommendations which have been in corporated 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. L EGAL ELEMENTS OF THE PROPOSAL  
3.1. Legal basis 
The legal basis for the propos al is Article 100 (2) TFEU. 
3.2. Subsidiarity and propor tionality principles 
The principles of subsidiarity and proportionality are fully respected.  EN 6   EN Harmonisation by the EU results in a clearly id entified set of requirements and uniform 
certification procedures capable of ensuring a high level of safety and of environmental 
protection whilst fostering the smooth f unctioning of the internal market.  
The objectives of the EU in the marine equipm ent sector cannot be sufficiently achieved by 
the action of the Member States alone; they ca n be better achieved tha nks to EU action.  
However, the proposed Directive does not cont ain the detailed technical specifications 
applicable to marine equipment falling unde r its scope, but limits itself to mandating 
compliance with the requirements and testing standards contained in the international 
instruments while providing a mechanism to impl ement those requirements and standards in a 
uniform way. While conformity-checking proce dures are harmonised, implementation is left 
entirely to the Member States, who remain re sponsible for ensuring that marine equipment 
due to be placed on board EU ships meets the requi rements 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 obj ections are raised against these measures 
within a reasonable time. Therefore EU action does not go beyond what is  strictly necessary 
to achieve the objectives sp elled 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 repr esent 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. B UDGETARY IMPLICATIONS  
This proposal has no budgetary implications . The tasks devolved to the Commission, 
including those for which the assistance of the Eu ropean 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. C ONTENT OF THE PROPOSAL  
Article 1 defines the objectives of the proposal in line with the re levant 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 s upplied. Although marine equipment is of course 
also traded within the borders of the EU, the sc ope of the Directive is defined by reference to 
equipment which is a) due to be installed on bo ard a ship flying the flag of a Member State, 
and b) for which the approval of the flag Stat e is required by the international conventions. 
Similarly, the application of conc urrent Directives is exclude d, as only the marine equipment 
directive can ensure that marine equipmen t 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 appl icable testing standards. Given the need to ensure continued EN 7   EN consistency with the international regulator y framework, these requirements and standards 
must apply in their up-to-date version; this au tomatic update is consistent with the general 
policy followed by the EU in the area of ma ritime safety. The automatic update does not 
apply to testing standards as experience has sh own 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 requireme nts of the international instruments is placed 
on board ships flying its flag. Equipment should remain in conformity with those 
requirements, unless requirements subsequen tly 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 recogn ition 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 regist er based on the principle of compliance with the 
Directive requirements, but allowing for the accep tance of equivalent equipment in order not 
to place a disproportionate and unjustified burde n 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. Howe ver, 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 disti nguish equipment complying with the requirements in the 
international maritime safety conventions, whic h may be different from those contained in 
other EU harmonisation instruments applying to e quipment which is similar in nature but is 
not for use or installation on boa rd ships. However, the genera l principles governing the CE 
marking, in particular as laid dow n in Regulation 765/2008/EC, are applied mutatis mutandis. 
In order to facilitate control by the flag and port State auth orities, and to co mbat counterfeit, 
Article 11 opens the possibility to use an electron ic 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 repairer s, 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 res ponsibilities and the effectivene ss of their obligations, which 
must include granting access to their premises  for national authoritie s carrying out market 
surveillance; b) the appointment of an author ised 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 su rveillance and, for importer s, 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 EN 8   EN products, only those modules which are consistent  with the requirement for specific approval 
by the flag State as laid down in the internat ional 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 le gitimate intellectual property ri ghts, all modules contain an 
obligation for the manufacturer  to provide the no tified body with a certified copy of the 
patent, license or document by which the applican t 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 drawi ng up of a declaration of 
conformity will trigger the manufacturer's respon sibilities 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 a nd 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, notif ying authorities, notified bodies and their 
respective regimes. This inclusion opens the possibility for the Member States to have recourse to accreditation – which could help re solve 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 proces s comprising design, testing, certification, 
production, delivery and placing on boa rd of marine equipment ma y entirely happen outside 
the EU borders, two additional safeguards have been added to the standard Member States' 
monitoring obligations: in the fi rst place, monitoring of notifie d bodies should occur at least 
every two years; secondly, the Commission
5 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 c hoice 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 co ntains two additional 
specific elements which appear to be necessary in the marine equipment sector.  
• 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 pro cedure 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.  
                                                
 
5 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. EN 9   EN Articles 32 to 34 contain the specific regime in exceptiona l circumstances, largely taken from 
the existing Directive. This concerns exempti ons in cases of technical innovation or for the 
purpose of testing and evaluation. More importa ntly, solutions are pr ovided for the cases 
where ships cannot obtain supplies of wheel mark ed equipment in ports outside the EU in 
reasonable terms or where wheelmarked equipmen t has become unavailabl e in the market. In 
all these cases, the Member States may aut horise 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 ne w Directive's architecture, with three 
distinctive elements: 
• The requirement for marine equipment to co mply with the specif ic 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 imp act assessment, the use of implementing 
Regulations is expected to resolve the probl ems 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 st andards, a necessary measure to ensure that 
divergent interpretations  by the Member States (e.g. in te rms 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 prepar atory 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 th e 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 e xpands existing practice an d will facilitate the 
implementation of the Directive by all acto rs, 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 empowerme nt 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 refe rences to international and European standards 
contained in the Directive. Aspecific crit erion allowing the Commission to identify the 
relevant conventions (namely the requirement of flag approval of ma rine equipment) is 
provided, so that the update of  the list by the Commission ca nnot constitute an indirect 
extension of the Directive's sc ope 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(co mmittee procedures), 39 (transposition), 41 
(entry into force) and 42 (addressees)  contain standard legislative provisions. EN 10   EN 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 CO UNCIL 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 Eu ropean Economic and Social Committee
1, 
Having regard to the opinion of  the Committee of the Regions2, 
Acting in accordance with the or dinary legislative procedure, 
Whereas: (1) The global dimension of shipping calls  for the Union to apply and support the 
international regulatory framework for ma ritime safety. The international maritime 
safety conventions require flag States to ensure that the equipment carried on board 
ships complies with certain safety require ments as regards design, construction and 
performance, and to issue the relevant certi ficates. To that end detailed performance 
and testing standards for certa in types of marine equipment have been developed by 
the International Maritime Organization (I MO) and by the international and European 
standardization bodies.  
(2) 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 auth orities have certified as complying with 
the said conventions and standards; as a re sult, 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 OJ C , , p. . 
2 OJ C , , p. . EN 11   EN (3) Harmonisation by the Union resolves thes e 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 inte rnational standards by means of a clearly 
identified set of requirements and uniform certification procedures.  
(4) There are other various instruments of  Union law which lay down requirements and 
conditions, inter alia  in order to ensure th e free movement of goods  within th e Internal 
Market or for environmental purposes, for ce rtain products which ar e similar in nature 
to equipment used on board ships, but whic h do not meet the international standards – 
which may substantially differ from the inte rnal legislation of the Union and are in 
constant evolution. These pr oducts cannot therefore be cer tified by the Member States 
in accordance with the relevant internationa l maritime safety conventions. Equipment 
to be placed onboard EU ships in accordan ce 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 equipmen t bearing that mark complies with the requirements laid 
down in the relevant internationa l conventions and instruments.  
(5) Experience in the implementation of Dir ective 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. 
(6) Requirements should therefore be establishe d 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.  
(7) Decision No 768/2008 of the European Pa rliament and of the Council on a common 
framework for the marketing of products
4 lays down common pr inciples and reference 
provisions intended to apply across sectoral le gislation in order to provide a coherent 
basis for revision or recasts of that legisl ation. This Decision constitutes a general 
framework of a horizontal natu re for future legislation harmonising the conditions for 
the marketing of products and a reference te xt for existing legislation. This general 
framework provides appropriate solutions  to the problems identified in 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.  
(8) Given that marine equipment is placed on board ships at the time of their construction 
or repair all over the world, market surv eillance becomes particularly difficult and 
cannot be effectively supported by border cont rols. 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 el ectronic tags to replace or 
supplement the wheelmark.  
                                                 
3 OJ L 46, 17.2.1997, p. 25.  
4 OJ L 218, 13.8.2008, p. 82. EN 12   EN (9) Similarly, the responsibilitie s of the economic operators should be laid down in a way 
which is proportionate and non-discriminatory  for those who are es tablished within the 
Union, taking into account that a significan t fraction of the marine equipment falling 
under the scope of this Directive may never be  imported and distribut ed in the territory 
of the Member States.  
(10) Compliance with international testing st andards could best be demonstrated by means 
of conformity-assessment procedur es such as those laid down in 
Decision No 768/2008. However, only those co nformity-assessment procedures which 
meet the requirements of the international instruments should be made available to 
manufacturers.  
(11) In order to ensure a fair and efficient procedure when examining suspected non-
compliance, the Member States should be en couraged to take al l 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 object ives of this Directive are not impaired by 
shortcomings in the applicable testing sta ndards or in case the IMO failed to produce 
appropriate standards for marine equipment fa lling under the scope of this Directive. It 
is also necessary to adopt appropriate techni cal criteria so that electronic tags can be 
affixed and used in a safe a nd 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 sa fety 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 accordan ce with Article 290 of the Treaty on the 
Functioning of the European Union should therefore be delegate d to the Commission 
in respect of the adoption, on an interim basi s, 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 car ry out appropriate c onsultations during 
its preparatory work, incl uding at expert level. 
(14) The Commission, when preparing and dr awing-up delegated ac ts, 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 Ma rket. It is therefor e necessary, for each 
item of marine equipment for which the approv al of the flag Stat e 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 implementa tion of those requirements and standards by 
notified bodies, Member State authorities and the economic operato rs. Moreover, it is EN 13   EN necessary to ensure that only in exceptio nal 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 conferre d on the Commission. Those powers should 
be exercised in accordance with Regula tion (EU) No 182/2011 of the European 
Parliament and of the Council of 16 Februa ry 2011 laying down the rules and general 
principles concerning mechanisms for cont rol by Member States of the Commission’s 
exercise of implementing powers.5 
(17) The Commission is assisted by the Eur opean Maritime Safety Agency, in accordance 
with Regulation (EC) […], in the effectiv e 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 theref ore, by reason of the scale of the action, 
be better achieved at Union level, the Un ion may adopt measures, in accordance with 
the principle of subsidiarity as set out in Ar ticle 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 represen t a major modification of the provisions of 
Directive 96/98/EC and therefor e, in the interest s 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 sa fety 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, a nd to ensure the free movement of such 
equipment within the Union. 
                                                 
5 OJ L 55, 28.2.2011, p. 13. EN 14   EN Article 2 
 
Definitions 
For the purposes of this Directive, the following definitions apply: 
(1) "Marine equipment" means equipment falli ng under the scope of this Directive 
in accordance with Article 3. 
(2) "EU ship" means a ship, for which safety certificates are issued by or on behalf 
of Member States under the internationa l conventions, with the exception of a 
ship for which the administration of a Me mber State issues a certificate at the 
request of a third count ry's administration; 
(3) "international conventions" means the conventions, togeth er with their 
Protocols and Codes of mandatory app lication, adopted under the auspices of 
the International Maritime Organiza tion (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 Re gulations 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 Maritim e Organization (IMO),  
– the International Organizati on for Standardization (ISO), 
– the International Electrot echnical Commission (IEC), 
– the European Committee for Standardization (CEN), 
– the European Committee for Electrot echnical Standardization (Cenelec) 
– the International Telecommunication Union (ITU) 
– the European Telecommunication Standards Institute (ETSI) 
– the Commission, in accordan ce with this Directive, 
– the Regulatory Authorities recognised in the mutual recognition agreements to 
which the Union is a party. EN 15   EN (5) "international instruments" means the in ternational conventions, together with 
the resolutions and circulars of the In ternational Maritime Organization giving 
effect to those conventions, and the testing standards; 
(6) "wheel mark" means the symbol referred to  in Article 9 and set out in Annex I 
or, as appropriate, the electroni c tag referred to in Article 11; 
(7) "notified body" means an organisati on designated by the competent national 
administration of a Member State in accordance with Article 17; 
(8) "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 de signed 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 wr itten mandate from a manufacturer to 
act on his behalf in rela tion 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 lega l 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 manufact urer, 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 natio nal accreditation body as defined in 
Article 2 (11) of Regulation (EC) No 765/2008; 
(17) "conformity assessment" means the pr ocess 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 includi ng calibration, testing, certi fication 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. EN 16   EN (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. This Directive shall apply to equipment to be placed on board an EU ship and for 
which the approval of the flag State admini stration is required by the international 
instruments. 
2. 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 
1. 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 de sign, construction and 
performance requirements of the internationa l instruments as applicable at the time 
the said equipment is placed on board. 
2. Compliance of marine equipment with the requirements referred to in paragraph 1 
shall be demonstrated solely  in accordance with the te sting standards and by means 
of the conformity-assessment procedures referred to in Article 15. 
3. The requirements and standards referred to in paragraphs 1 and 2 shall be 
implemented in a uniform manner, in acco rdance with Article 35(2) and (3). 
4. The international instruments, with the excep tion of testing standards, shall apply in 
their up-to-date version, wit hout 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 cert ificates 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. EN 17   EN the marine equipment on board those ships complies with the requirements of this 
Directive. 
2. Member States shall take the necessary meas ures 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 uni form 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 th e placing on board an EU ship 
of marine equipment which complies with this Di rective, nor refuse to issue the certificates 
relating thereto to the ships flying their fl ag, or to renew the said certificates. 
Article 7 
 
Transfer of a ship to the re gister of a Member State 
1. 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 re ceiving Member State to verify that the 
actual condition of its marine  equipment corresponds to it s safety certificates and 
either complies with this Directive and bears the wheel mark or is equivalent, to the satisfaction of that Member State's admini stration, to marine equipment certified in 
accordance with this Directive. 
2. Unless the equipment either bears the wheel  mark or the administration considers it 
to be equivalent, it shall be replaced. 
3. 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 
1. Without prejudice to Directive 98/34/EC  of the European Parliament and the 
Council
8, the Union shall pursue the develo pment by the IMO of appropriate 
international standards, including detail ed 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. EN 18   EN necessary to enhance maritime safety a nd the prevention of marine pollution. The 
Commission shall monitor this development on a regular basis. 
2. In the absence of appropriate interna tional standards developed by the IMO for a 
specific item of marine equipment, the Co mmission 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 ma rine equipment when 
it is necessary in order to remove an un acceptable threat to safety or to the 
environment. Those specifications and sta ndards 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 
1. Marine equipment whose compliance with the requirements laid down in this 
Directive has been demonstrated in acco rdance with the relevant conformity-
assessment procedures shall have the wheel mark affixed to it.  
2. The wheel mark shall not be affixed to any other product.  3. The form of the wheel mark to be us ed shall be as set out in Annex I. 
4. 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 
1. The wheel mark shall be affi xed visibly, legibly a nd 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. 
2. The wheel mark shall be affixed at  the end of the production phase.  
3. 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. 
4. The identification number of the notified  body shall be affixed by the body itself or, 
under its instructions, by the manufacture r or his authorised representative. EN 19   EN 5. Member States shall build upon existing mech anisms to ensure correct application of 
the regime governing the wheel mark and ta ke appropriate acti on 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 th e seriousness of the offence and constitute 
an effective deterrent against improper use. 
Article 11 
 
Electronic tag 
1. The wheel mark may be supplemented or replaced by an appropriate and reliable 
form of electronic tag. In such case, Ar ticles 9 and 10 shall apply, as appropriate, 
mutatis mutandi . 
2. The Commission shall adopt delegated acts, in accordance with Article 37, in order 
to identify the specific items of marine e quipment which can bene fit from electronic 
tagging, and to lay down appropriate tec hnical criteria as regards the design, 
performance, affixing and use of electronic tags.  
Chapter 3  
Obligations of economic operators 
Article 12 
 
Obligations of manufacturers 
1. By affixing the wheel mark, manufactur ers shall take on re sponsibility for 
guaranteeing that the marine equipment to  which the mark is affixed has been 
designed and manufactured in accordance with  the requirements se t out in Article 4 
and shall undertake the obliga tions laid down in paragraphs  2 to 9 of this Article. 
2. Manufacturers shall draw up the require d technical documentation and have the 
applicable conformity assessm ent procedures carried out. 
3. 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 c onformity in accordance with Article 16 and affix the 
conformity marking in accordance with Article 9. 
4. 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. 
5. Manufacturers shall ensure that procedur es are in place for series production to 
remain in conformity. Changes in marine equipment design or characteristics and EN 20   EN changes in the requirements in the internati onal instruments as referred to in Article 
4, on the basis of which conformity of ma rine equipment is declared shall be 
adequately taken into account. When neces sary in accordance with Annex II, they 
shall have a new conformity assessment carried out. 
6. 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 informa tion is provided on the packaging or in a 
document accompanying the product. 
7. Manufacturers shall indicate th eir name, registered trade  name or registered trade 
mark  and the address at which they can be c ontacted 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 wh ich the manufacturer can be contacted. 
8. Manufacturers shall ensure that the produc t is accompanied by instructions and all 
necessary information for safe installati on on board and safe use of the product, 
including limitations of use, if any, in a language which ca n be easily understood by 
the end-users, together with any other documentation required by the international 
instruments or testing standards. 
9. 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 correctiv e measures to bring that product into 
conformity, to withdraw it or  recall it, if appr opriate. In addition, where the product 
presents a risk, manufacturers shall imme diately inform the competent national 
authorities of the Member States, giving de tails, in particular, of the non-compliance 
and of any corrective measures taken. 
10. Manufacturers shall, further to a reas oned request from a competent national 
authority, promptly provide it with all the information and documentation necessary 
to demonstrate the conformity of the pr oduct, in a language wh ich 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 
1. A manufacturer who is not lo cated in the territory of a Member State shall, by a 
written mandate, appoint an authorised representative. 
2. The obligations laid down in Articl e 12(1) and the draw ing up of technical 
documentation shall not form part of th e authorised representative's mandate. 
3. An authorised representative shall pe rform the tasks specified in the mandate 
received from the manufacturer. The ma ndate shall allow the authorised 
representative to do at  least the following: EN 21   EN (a) keep the EU declaration of confor mity and the technical documentation 
at the disposal of national surveilla nce authorities for a period of time 
commensurate with the level of risk, and in no case less than the expected lifecycle of the marine eq uipment, after the wheel mark has 
been affixed on the last unit; 
(b) further to a reasoned request from a competent national authority, 
provide that authority with all the information and documentation 
necessary to demonstrate th e conformity of a product; 
(c) cooperate with the competent national authorities, at their request, on any 
action taken to eliminate the risk s posed by products covered by their 
mandate. 
Article 14 
 
Other economic operators 
1. Importers shall indicate their name, regist ered 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. 
2. Importers and distributors shall, furthe r to a reasoned request from a competent 
national authority, provide it with all the in formation and documentation necessary to 
demonstrate the conformity of a produc t in a language which can be easily 
understood by that authority. They shall coopera te with that authority, at its request, 
on any action taken to eliminate the risks posed by products which they have placed 
on the market. 
3. An importer or distributor shall be consider ed a manufacturer for the purposes of this 
Directive and he shall be subject to th e obligations of the manufacturer under 
Article 12, where he places marine equipmen t 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 notifica tion of conformity assessment 
bodies 
Article 15 
 
Conformity assessment procedures 
1. The conformity assessment procedures  shall be as set out in Annex II. EN 22   EN 2. Member States shall ensure that the manu facturer 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 examinat ion 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, be fore 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. The EU declaration of conformity shall st ate that the fulfilment of the requirements 
laid down in accordance with Arti cle 4 has been demonstrated. 
2. The EU declaration of conformity shall follow the model structure set out in Annex 
III to Decision No 768/2008/EC. It shall c ontain the elements specified in the 
relevant modules set out in Annex II to th is Directive  and shall be continuously 
updated. 
3. By drawing up the EU declaration of conf ormity, the manufacturer shall assume the 
responsibility and undertake the obligations referred to in Article 12(1). 
4. When marine equipment is placed on board an EU ship, a copy of the EU declaration 
of conformity covering the equipment conc erned shall be provide d to the ship, and 
shall be kept on board until the said equipm ent is removed from the ship. It shall be 
translated into the language or languages required by the flag State. 
5. A copy of the EU declaration of conform ity 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 Commissi on and the other Member States of bodies 
authorised to carry out thir d-party conformity assessment tasks under this Directive. EN 23   EN 2. Notified bodies shall comply with the requirements laid down in Annex III. 
Article 18 
 
Notifying authorities 
1. Member States shall designa te a notifying authority that  shall be responsible for 
setting up and carrying out the necessary procedures  for the assessment and 
notification of conformity assessment bodi es and the monitoring of notified bodies, 
including compliance with th e provisions of Article 20. 
2. Notified bodies shall be monitored at l east every two years. The Commission may 
choose to participate as an observer in the monitoring exercise. 
3. Member States may decide that the assessment and monitoring referred to in 
paragraph 1 shall be carried out  by a national acc reditation body. 
4. 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 sh all 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. 
5. The notifying authority shall take full re sponsibility for the tasks performed by the 
body referred to in paragraph 4.  
6. The notifying authority shall comply with  the requirements laid down in Annex V. 
Article 19 
 
Information obligation on notifying authorities 
1. Member States shall inform the Commission of their procedures for the assessment 
and notification of conform ity 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. Where a notified body subcontracts specif ic 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 a nd shall inform the 
notifying authority accordingly. 
2. Notified bodies shall take full res ponsibility for the tasks performed by 
subcontractors or subsidiaries wh erever these are established. EN 24   EN 3. Activities may be subcontracted or carr ied out by a subsid iary only with the 
agreement of the client. 
4. Notified bodies shall keep at the disposal  of the notifying authority the relevant 
documents concerning the assessment of the qua lifications of the subcontractor or the 
subsidiary and the work carried out by them under this Directive. 
Article 21  
 
Changes to notifications 
1. Where a notifying authority has ascertained or has been informed that a notified body 
no longer meets the requirements laid down in Annex III , or that it is failing to fulfil 
its obligations, the notifying au thority shall restrict, suspe nd or withdraw notification 
as appropriate, depending on the seriou sness of the failure to meet those 
requirements or fulfil those obligations. It shall immediately inform the Commission 
and the other Member States accordingly. 
2. In the event of restriction, suspension or  withdrawal of notif ication, 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 ar e either processed by another 
notified body or kept available for the re sponsible notifying and market surveillance 
authorities at their request. 
Article 22 
Challenge of the competence of notified bodies 
1. The Commission shall investigate all cases  where it doubts, based on the information 
available to it or brought to  its attention, th e competence of a notified body or the 
continued fulfilment by a notified body of th e requirements and responsibilities to 
which it is subject. 
2. The notifying Member State shall provi de the Commission, on request, with all 
information relating to the basis for the notification or the maintenance of the 
competence of the body concerned. 
3. The Commission shall ensure that all sensi tive information obtained in the course of 
its investigations is treated confidentially. 
4. Where the Commission ascertains that a notified body does not meet or no longer 
meets the requirements for its notification, it  shall inform the notifying Member State 
accordingly and request it to take the n ecessary corrective measures, including de-
notification if necessary. EN 25   EN Article 23 
 
Operational obligations of notified bodies 
1. Notified bodies shall carry out conformity assessments in accordance with the 
procedures provided for in Article 15. 
2. Where a notified body finds th at 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. 
3. Where, in the course of the monitori ng of conformity following the issue of a 
certificate, a notified body finds that a produc t no longer complies, it shall require the 
manufacturer to take appropriate correctiv e measures and shall suspend or withdraw 
the certificate if necessary. Wh ere corrective measures are not taken or do not have 
the required effect, the notified body sha ll restrict, suspend or withdraw any 
certificates, as appropriate. 
Article 24 
 
Information obligation on notified bodies 
1. Notified bodies shall inform the no tifying 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 ha ve received from market surveillance 
authorities regarding confor mity assessment activities; 
(d) on request, conformity assessment activit ies performed within the scope of 
their notification and a ny other activity performed, including cross-border 
activities and subcontracting. 
2. Notified bodies shall provi de the Commission and the Me mber States, on request, 
with relevant information on issues rela ting to negative and positive conformity 
assessment results. Notified bodies shall provide the other notified bodies carrying 
out conformity assessment ac tivities 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 26   EN Article 26 
 
Coordination of notified bodies 
1. The Commission shall ensure that appropr iate coordination a nd cooperation between 
notified bodies are put in place and properly ope rated in the form of a sectoral group 
of notified bodies. 
2. Member States shall ensure that the bodies  notified by them part icipate in the work 
of the sectoral group, directly or by means of designated representatives. 
Chapter 5 
Union market surveillance, co ntrol of products, safeguard 
provisions 
Article 27 
 
EU market surveillance framework  
1. As regards marine equipment, the Member States shall undertake market surveillance 
in accordance with the EU market surveillance framewor k laid down in Chapter III 
of Regulation (EC) No 765/2008, subject to the provisions of paragraphs 2 and 3 of 
this Article. 
2. National market surveillance infrastructur es and programmes shall take into account 
the specific features of the marine e quipment sector, and in particular the 
responsibilities pla ced with the flag State admi nistration by the international 
conventions. 
3. Market surveillance may include document ary checks as well as checks of marine 
equipment which bears the wheel mark wh ether 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 carry ing out the checks shal l be carried out in 
accordance with the relevant provisions of  Directive 2009/16/EC of the European 
Parliament and the Council
9. 
4. 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. 
                                                
 
9 OJ L 131, 28.5.2009, p. 57 EN 27   EN Article 28 
 
Procedure for dealing with marine equipm ent presenting a risk at national level 
1. Where the market surveillance authoritie s of one Member Stat e have taken action 
pursuant to Article 20 of Regulation (EC) No 765/2008, or where they have 
sufficient reason to believe th at marine equipment covered by this Directive presents 
a risk to maritime safety or to the protect ion 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 th at evaluation, the market surv eillance authorities find that 
the marine equipment does not comply with the requirements laid down in this Directive, they shall without delay require the relevant ec onomic 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 sh all inform the relevant notified body 
accordingly. 
Article 21 of Regulation (EC) No 765/2008 sha ll apply to the measures referred to in 
the second subparagraph of this paragraph. 
2. 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 require d the economic operator to take. 
3. The economic operator shall en sure that all appropriate co rrective 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. 
4. Where the relevant economic operator doe s 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 Dire ctive, the market surveillance authorities 
shall take all appropriate provisional measur es 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. 
5. The information referred to in paragraph 4 shall include all available details, in 
particular the data necessary for the id entification 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 econom ic operator. In particular, the market 
surveillance authorities sha ll indicate whether the non-co mpliance is due to either: EN 28   EN (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 test ing standards referred to in Article 4 during the 
conformity-assessment procedure; 
(c) shortcomings in the said testing standards. 
6. Member States other than the Member St ate initiating the pro cedure 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. 
7. 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 St ate, that measure shall be deemed 
justified. 
8. 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 
1. 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 operator s and shall evaluate the national measure. 
On the basis of the results of that eval uation, the Commission sh all decide whether 
the national measure is justified or not. 
2. 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. 
3. The Commission shall address its deci sion to all Member States and shall 
immediately communicate it to them and the relevant economic operator or operators. 
4. 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, r ecalled. They shall in form the Commission 
accordingly.  EN 29   EN 5. If the national measure is considered unj ustified, the Member State concerned shall 
withdraw the measure. 
6. 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 furthe rmore be empowered to adopt, by means 
of delegated acts in accordan ce with the procedure referre d to in Article 37, interim 
harmonised requirements and testing standa rds 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 c oncerned by the relevant international 
organisation. 
7. Where the testing standard concerned is a European Standard, the Commission shall 
inform the relevant European standardis ation 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 Eur opean standardisation body or bodies and 
deliver its opinion without delay. 
Article  30 
 
Compliant products which present a risk to ma ritime safety or to the protection of the 
environment 
1. Where, having performed an evaluation under Article 28(1), a Member State finds 
that although marine equipmen t is in compliance with this Directive, it presents a 
risk to marine safety or to the environm ent, 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. 
2. The economic operator shall ensu re that corrective action is taken in respect of all the 
products concerned that he has made ava ilable on the market throughout the Union 
or placed on board EU ships. 
3. The Member State shall immediately in form the Commission and the other Member 
States. That information shall include all available details, in particular the data necessary for the identification of the ma rine equipment concerned, the origin and 
the supply chain of the marine equipment, the nature of the ri sk involved and the 
nature and duration of th e national measures taken. 
4. The Commission shall without delay enter in to consultation with the Member States 
and the relevant economic operator or ope rators and shall evaluate the national 
measures taken. On the basis of the result s of that evaluation, the Commission shall 
decide whether the measure is justif ied or not, and where necessary, propose 
appropriate measures; for this pu rpose, Article 29(2) shall apply mutatis mutandis.  EN 30   EN 5. The Commission shall address its deci sion to all Member States and shall 
immediately communicate it to them and the relevant economic operator or operators. 
Article 31 
 
Formal non-compliance 
1. Without prejudice to Article 28, where a Me mber 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 viol ation 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. 
2. Where the non-compliance referred to in paragraph 1 persists, the Member State 
concerned shall take all appropriate measur es to restrict or prohibit the marine 
equipment being made available on the mark et or ensure that it is recalled or 
withdrawn from the market. 
Article 32 
 
Exemptions based on technical innovation 
1. In exceptional circumstances of technical  innovation, the flag State administration 
may permit marine equipment which doe s 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 Stat e administration that such equipment is at 
least as effective as marine equipment which does comply with the conformity-
assessment procedures. 
2. The trial procedures shall in no way discriminate between marine equipment 
produced in the flag Member State and ma rine equipment produced in other States. 
3. 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.  
4. Where a Member State allows marine equipm ent covered by this Article to be placed 
on board an EU ship, that Member State shall forthwith communicate the particulars EN 31   EN thereof together with the reports of all relevant trials, assessments and conformity-
assessment procedures to the Commi ssion and the other Member States. 
5. 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 sh all be adopted in accordance with the 
advisory procedure referred  to in Article 38(2). 
6. 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) the marine equipment shall be given a certificate by the flag Member State which 
shall at all times be carried with the e quipment, 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; 
(b) the permission shall be limited to a short period of time; 
(c) 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 work ing order and ready for immediate use. 
Article 34 
 
Exemptions in exceptional circumstances 
1. In exceptional circumstances, which shal l be duly justified to the flag State 
administration, when marine equipment need s 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. 
2. 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 32   EN 3. The flag State administration shall be  informed at once of the nature and 
characteristics of such other marine equipment.  
4. The flag State administration shall, at th e earliest opportunity, ensu re that the marine 
equipment referred to in paragraph 1, along with its testing documentation, complies with the relevant requirements of the intern ational instruments and of this Directive. 
5. Where it has been demonstrated that sp ecific marine equipm ent 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. 
6. The authorised marine equipment shall comply, as much as possible, with the 
requirements and testing standard s referred to in Article 4.  
7. The marine equipment placed on board  shall be accompanied by an interim 
certificate of approval issued by the flag Me mber State or by another Member State, 
stating the following: 
(a) the equipment bearing the wheel mark wh ich the certified equipment is due to 
replace; 
(b) the exact circumstances under which th e certificate of approval has been 
issued, and in particular the unavailabili ty in the market of equipment bearing 
the wheel mark; 
(c) the exact design, construction and perfor mance 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. 
8. The Member State issuing an interim certificate of approval shall inform the 
Commission forthwith. If the Commissi on 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 ta ke 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 Co mmission the name and contact details of 
the authorities in charge of the implemen tation of this Directive. The Commission 
shall draw up, periodically update and make public a list of these authorities. EN 33   EN 2. For each item of marine equipment fo r which the approval of the flag State 
administration is required by the intern ational conventions, the Commission shall 
identify by means of implementing acts the respective design, construction and 
performance requirements and the testing st andards provided for in the international 
instruments. 
3. 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).  
4. The Commission shall, by means of impl ementing acts, identify the respective 
design, construction and performance requ irements newly provided for in the 
international instruments and which apply to equipment placed on board before their 
adoption in order to ensure that equipm ent placed on board of EU ships complies 
with the international conventions. 
5. The Commission shall set up and maintain  a data base cont aining at least the 
following information: 
(a) the list and essential details of the conformity certificates issued under this 
Directive; 
(b) the list and essential details of the declar ations of conformity  issued under this 
Directive; 
(c) an up-to-date list of the applicable inte rnational instrument s, requirements and 
testing standards, including any upda tes becoming applicable by virtue of 
Article 4(3); 
(d) the list and full text of the criteria an d procedures referred to in paragraph 3; 
(e) the requirements and conditions for electro nic 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 th e public for information purposes only.  
6. The implementing acts referred to in this Ar ticle 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 Commissi on, by means of delegated acts, in order to:  EN 34   EN (a) amend the list of internationa l conventions set out in Articl e 2(3), in order to include 
those conventions which requir e the flag State's approval of equipment to be placed 
on board ships flying its flag; 
(b) 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 accord ance with the procedure laid down in Article 
37. 
Article 37 
 
Exercise of the delegation 
1. The power to adopt delegated acts is conferred on the Commission subject to the 
conditions laid down in  this Article.  
2. The delegation of power referred to in Ar ticles 8, 11, 29 and 36 sh all be conferred on 
the Commission for an indeterminate period of  time from the date of entry into force 
of this Directive. 
3. The delegation of power re ferred 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 th e 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.  
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council.  
5. A delegated act adopted pursuant to Artic les 8, 11, 29 and 36 shall enter into force 
only if no objection has been expressed eith er by the European Parliament or the 
Council within a period of 2 months of no tification of that ac t 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 m onths at the initiative of the European 
Parliament or the Council. 
Article 38 
 
Committee 
1. The Commission shall be assisted by the Committee on Safe Seas and the Prevention 
of Pollution from Ships (COSS) establis hed by Regulation (EC) No 2099/2002 of the 
European Parliament and of the Council
10. 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 35   EN 2. Where reference is made to this para graph, Article 4 of Regulation (EU) No 
182/2011 shall apply. 
3. Where reference is made to this para graph, Article 5 of Regulation (EU) No 
182/2011 shall apply. 
Article 39 
 
Transposition 
1. 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 comm unicate 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 determin e 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. Council Directive 96/98/EC is repealed with effect from [application date]. 
2. The requirements and testing standard s for marine equipment applicable on 
[application date] pursuant to the provisi ons 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 implementi ng acts referred to in Article 35(2). 
3. 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 tw entieth day following that of its publication in 
the Official Journal of  the European Union . EN 36   EN Article 42 
This Directive is addressed to the Member States. 
Done at Brussels,  
For the European Parliament For the Council 
The President The President EN 37   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 mu st have substantially  the same vertical 
dimension, which may not be less than 5 mm. 
That minimum dimension may be waived for small devices.EN 38   EN ANNEX II  
 
Conformity assessment procedures  
I. MODULE B: EC- TYPE EXAMINATION  
1. EC-type examination is the part of a c onformity assessment procedure in which a 
notified body examines the technical design of marine equipment and verifies and 
attests that the technical design of the ma rine 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, representati ve of the production envisaged, of the 
complete product (production type); 
– assessment of the adequacy of the tec hnical design of the marine equipment 
through examination of the technical documentation and supporting evidence referred to in point 3, plus examinati on of specimens, representative of the 
production envisaged, of one or more crit ical 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, hi s name and address as well; 
– a written declaration that the same applic ation 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 equipm ent 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 manu facturing drawings and schemes of components, sub-
assemblies, circuits, etc., EN 39   EN (a) descriptions and explanations necessa ry for the understanding of those 
drawings and schemes and the opera tion of the marine equipment, 
(b) 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 pr oduction 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 documen ts that have been used. The supporting 
evidence shall include, where necessary, th e results of tests carried out by the 
appropriate laboratory of the manufacturer, or by another testing labo ratory 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 ma nufactured in conformity  with the technical 
documentation, and identify the elements wh ich have been designed in accordance 
with the applicable provisions of the rele vant harmonised standa rds and/or technical 
specifications, as well as the elements wh ich have been designed without applying 
the relevant provisions of those standards; 
4.3. carry out appropriate  examinations and tests in acco rdance with this Directive; 
4.4. agree with the manufacturer on a location wh ere the examinations and tests will be 
carried out. 
5. The notified body shall draw up an evalua tion report that reco rds the activities 
undertaken in accordance with point 4 and their outcomes. Without prejudice to its 
obligations vis-à vis the notifying authorities, the no tified body shall release the 
content of that report, in fu ll or in part, only with the agreement of the manufacturer. 
6. Where the type meets the requirements of the specific international instruments that 
apply to the marine equipment concerned, the notified body shal l issue an EC-type 
examination certificate to the manufacturer . The certificate shall contain the name 
and address of the manufacturer, the conclu sions of the examin ation, 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 40   EN The certificate and its annexes shall contai n all relevant information to allow the 
conformity of manufactured products with the examined t ype to be evaluated and to 
allow for in-service control. 
Where the type does not satisfy the appli cable requirements of the international 
instruments, the notified body shall refu se to issue an EC -type examination 
certificate and shall inform the applicant accordingly, giving detailed reasons for its 
refusal. 
7. The notified body shall keep itself appr ised of any changes in the generally 
acknowledged state of the art which indica te that the approved type may no longer 
comply with the applicable requirements of  the international instruments, and shall 
determine whether such changes require furt her investigation. If  so, the notified body 
shall inform the manufacturer accordingly. 
The manufacturer shall inform the notified body th at holds the technical 
documentation relating to the EC-type examinat ion certificate of al l modifications to 
the approved type that may affect the conf ormity of the marine equipment with the 
requirements of the international instrume nts or the conditions for validity of the 
certificate. Such modifications shall require  additional approval in the form of an 
addition to the original EC-t ype examination certificate. 
8. Each notified body shall inform its notif ying authorities concerning the EC-type 
examination certificates and/or any addi tions thereto which it has issued or 
withdrawn, and shall, periodi cally or upon request, make available to its notifying 
authorities the list of certific ates and/or any additions th ereto refused, suspended or 
otherwise restricted. 
Each notified body shall inform the other notified bodies concer ning the EC-type 
examination certificates and/or any a dditions thereto which it has refused, 
withdrawn, suspended or otherwise rest ricted, and, upon reque st, concerning the 
certificates and/or additions thereto which it has issued. 
The Commission, the Member States and th e other notified bodies may, on request, 
obtain a copy of the EC-type examination cer tificates and/or a dditions thereto. On 
request, the Commission and th e Member States may obtai n a copy of th e 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. 
9. The manufacturer shall keep a copy of the EC-type examination certificate, its 
annexes and additions together with the t echnical documentation at the disposal of 
the national authorities for ten years after the last pr oduct has been manufactured. 
10. The manufacturer's authorised representativ e 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. EN 41   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 certific ate and satisfy the requirements of the 
international instruments that apply to them. 
2. Manufacturing 
The manufacturer shall operate an appr oved 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 whic h 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 th e manufacturer and, if the ap plication is lodged by the 
authorised representative, hi s name and address as well, 
– a written declaration that the same applic ation has not been lodged with any other 
notified body, 
– all relevant information for the ma rine equipment category envisaged, 
– the documentation concerning the quality system, 
– the technical documentation of the approv ed type and a copy of the EC-type 
examination certificate. 
3.2. The quality system shall en sure that the products are in  conformity with the type 
described in the EC-type examination certi ficate and comply with the requirements 
of the international instruments that apply to them. 
All the elements, requirements and provisi ons adopted by the ma nufacturer shall be 
documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quali ty system documentation shall permit a 
consistent interpretation of the quality programmes, plans, manuals and records. 
It shall, in particular, contai n an adequate description of: EN 42   EN – the quality objectives and the organisational st ructure, responsibiliti es and powers of the 
management with regard to product quality, 
– the corresponding manufacturing, quality c ontrol and quality assurance techniques, 
processes and systematic actions that will be used, 
– the examinations and tests that will be car ried 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 syst em to determine whet her it satisfies the 
requirements referred to in point 3.2. 
In addition to experience in quality mana gement systems, the auditing team shall 
have at least one member with experien ce of evaluation in the relevant marine 
equipment field and marine equipment t echnology concerned, and knowledge of the 
applicable requirements of the internationa l instruments. The audit shall include an 
assessment visit to the manufacturer's prem ises. 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 manuf acturer. The notification shall contain the 
conclusions of the audit and th e reasoned assessment decision. 
3.4. The manufacturer shall undertak e to fulfil the obligations arising out of the quality 
system as approved and to maintain it so  that it remains adequate and efficient. 
3.5. 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 evalua te any proposed changes and decide whether the 
modified quality system will continue to sa tisfy the requirements referred to in point 
3.2 or whether a re-assessment is necessary. 
It shall notify the manufactur er of its decision. The notification shall contain the 
conclusions of the examination a nd the reasoned assessment decision. 
4. Surveillance under the res ponsibility of the notified body 
4.1. The purpose of surveillance is to make sure  that the manufacturer duly fulfils the 
obligations arising out of th e approved quality system. 
4.2. 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 43   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. The notified body shall carry out periodic aud its to make sure that the manufacturer 
maintains and applies the quality system a nd shall provide the ma nufacturer with an 
audit report. 
4.4. In addition, the notified body may pay unexp ected visits to the manufacturer. During 
such visits the notified body may, if necessar y, 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 th e manufacturer with a visit report and, if tests have 
been carried out, w ith a test report. 
5. Conformity marking and declaration of conformity 5.1. The manufacturer shall affix the wheel ma rk 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 produ ct that is in conformity w ith the type described in the 
EC-type examination certificate and satisfies the applicable requirements of the international instruments. 
5.2. The manufacturer shall draw  up a written declaration of  conformity for each product 
model and keep it at the dis posal of the national authorities  for ten years after the last 
product has been manufactured. The declar ation of conformity  shall identify the 
marine equipment model for which it has been drawn up. 
A copy of the declaration of conformity sh all be made available to the relevant 
authorities upon request.  
6. The manufacturer shall, for a period endi ng at least ten years after the last product 
has been manufactured, keep at the di sposal of the natio nal 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 notifie d 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 no tified bodies of quality  system approvals 
which it has refused, suspended, withdraw n or otherwise restricted, and, upon 
request, of quality system approvals which it has issued. 
8. Authorised representative EN 44   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 manufactur er 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 w ith the type described in the EC-type 
examination certificate and satisfy the requ irements of the international instruments 
that apply to them. 
2. Manufacturing 
The manufacturer shall operate an a pproved quality system for final product 
inspection and testing of the products concer ned 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 whic h 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 th e manufacturer and, if the ap plication is lodged by the 
authorised representative, hi s name and address as well, 
– a written declaration that the same applic ation has not been lodged with any other 
notified body, 
– all relevant information for the ma rine equipment category envisaged, 
– the documentation concerning the quality system, and 
– the technical documentation of the approv ed type and a copy of the EC-type 
examination certificate. 
3.2. The quality system shall ensure complianc e of the products with  the type described 
in the EC-type examination certificate and with the appl icable requirements of the 
international instruments. 
All the elements, requirements and provisi ons adopted by the ma nufacturer shall be 
documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quali ty system documentation shall permit a 
consistent interpretation of the quality programmes, plans, manuals and records. EN 45   EN It shall, in particular, contai n an adequate description of: 
– the quality objectives and the organisational st ructure, responsibiliti es 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 effectiv e operation of the quality system. 
3.3. The notified body shall assess the quality syst em to determine whet her it satisfies the 
requirements referred to in point 3.2. 
In addition to experience in quality mana gement systems, the auditing team shall 
have at least one member with experien ce of evaluation in the relevant marine 
equipment field and marine equipment t echnology concerned, and knowledge of the 
applicable requirements of the internationa l instruments. The audit shall include an 
assessment visit to the manufacturer's prem ises. 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 manuf acturer. The notification shall contain the 
conclusions of the audit and th e reasoned assessment decision. 
3.4. The manufacturer shall undertak e to fulfil the obligations arising out of the quality 
system as approved and to maintain it so  that it remains adequate and efficient. 
3.5. 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 evalua te 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 manufactur er of its decision. The notification shall contain the 
conclusions of the examination a nd the reasoned assessment decision. 
4. Surveillance under the res ponsibility of the notified body 
4.1. The purpose of surveillance is to make sure  that the manufacturer duly fulfils the 
obligations arising out of th e approved quality system. 
4.2. 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; EN 46   EN – the quality records, such as inspection reports and test data, calibration data, 
qualification reports on the personnel concerned, etc. 
4.3. The notified body shall carry out periodic aud its to make sure that the manufacturer 
maintains and applies the quality system a nd shall provide the ma nufacturer with an 
audit report. 
4.4. In addition, the notified body may pay unexp ected visits to the manufacturer. During 
such visits the notified body may, if necessar y, 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 th e manufacturer with a visit report and, if tests have 
been carried out, w ith a test report. 
5. Conformity marking and declaration of conformity 5.1. 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 produc t that is in conformity with the type 
described in the EC-type examination ce rtificate and satisfies the applicable 
requirements of the international instruments. 
5.2. The manufacturer shall draw  up a written declaration of  conformity for each product 
model and keep it at the dis posal of the national authorities  for ten years after the last 
product has been manufactured. The declar ation of conformity  shall identify the 
marine equipment model for which it has been drawn up. 
A copy of the declaration of conformity sh all be made available to the relevant 
authorities upon request.  
6. The manufacturer shall, for a period endi ng at least ten years after the last product 
has been manufactured, keep at the di sposal of the natio nal 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 notifie d 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, periodical ly 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 no tified bodies of quality  system approvals 
which it has refused, suspe nded or withdrawn, and, upon re quest, 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.  EN 47   EN IV. MODULE F: CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION  
1. Conformity to type base d on product verification is the part of a conformity 
assessment procedure whereby the manufactur er 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 subjec t 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 n ecessary 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 sh all 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 cer tified 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 fo r sale or use its trademark, which, 
notwithstanding point 16 of Annex III, the not ified body shall keep at the disposal of 
the competent courts. 
The examinations and tests to check th e conformity of th e 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 statis tical basis as speci fied in point 5. 
4. Verification of conformity by exam ination and testing of every product 
4.1 All products shall be indi vidually 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.  
4.2. The notified body shall issu e a certificate of conform ity 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 pr oduct has been manufactured. 
5. Statistical verification of conformity EN 48   EN 5.1. 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 th e form of homogeneous lots. 
5.2. 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 appr oved, except for 
those products from the sample that have  been found not to satisfy the tests. 
The notified body shall issue a certificate of conform ity 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 pro duct has been manufactured. 
5.4. If a lot is rejected, the no tified body or the competent aut hority 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 susp end the statistical verification and take 
appropriate measures. 
6. Conformity marking and declaration of conformity 6.1. 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 prod uct that is in conformity with the 
approved type described in the EC-type examination certificate and satisfies the 
applicable requirements of the international instruments. 
6.2. The manufacturer shall draw  up a written declaration of  conformity for each product 
model and keep it at the disposal of the na tional authorities, for ten years after the 
last product has been manufactured. The decl aration of conformity shall identify the 
marine equipment model for which it has been drawn up. 
A copy of the declaration of conformity sh all be made available to the relevant 
authorities upon request. 
7. If the notified body agrees and under its re sponsibility, the manufacturer may affix 
the notified body's identificat ion number to the products during the manufacturing 
process. 
8. Authorised representative 
The manufacturer's obligations may be fulf illed by his authorised representative, on 
his behalf and under his responsibility, prov ided that they are specified in the 
mandate. An authorised representati ve may not fulfil the manufacturer's  obligations 
set out in points 2 and 5.1. 
V.
 MODULE G: CONFORMITY BASED ON UNIT VERIFICATION  EN 49   EN 1. Conformity based on unit verification is  the conformity assessment procedure 
whereby the manufacturer fulfils the obliga tions laid down in points 2, 3 and 5, and 
ensures and declares on his sole responsibil ity 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 tech nical 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 conform ity with the relevant requi rements, and shall include 
an adequate analysis and assessment of th e risk(s). The techni cal documentation shall 
specify the applicable requirements and cover,  as far as relevant for the assessment, 
the design, manufacture and operation of th e product. The technical documentation 
shall, wherever applicable, contain at least the following elements: 
– a certified copy of the patent, license or document by whic h 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 draw ings 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 standa rds 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 ma de, examinations carried out; and 
– test reports. 
The manufacturer shall keep  the technical documentati on at the disposal of the 
relevant national authorities for ten y ears after the last product has been 
manufactured. 
3. Manufacturing 
The manufacturer shall take all measures n ecessary 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 sh all 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 inte rnational instruments.  EN 50   EN The notified body shall issue a certificate of conform ity in respect of the 
examinations and tests carried out and sha ll affix its identification number to the 
approved product, or have it a ffixed under its responsibility. 
The manufacturer shall keep the certificates of conformity at the disposal of the 
national authorities for ten years after the last pro duct has been manufactured. 
5. Conformity marking and declaration of conformity 5.1. 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 satis fies the applicable requirements of the 
international instruments. 
5.2. The manufacturer shall draw up a written declaration of c onformity and keep it at the 
disposal of the national authorities for te n 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 sh all 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. EN 51   EN ANNEX III  
 
Requirements to be met by notified bodies  
1. For the purposes of notification, a c onformity assessment body shall meet the 
requirements laid down in points 2 to 11. 
2. A conformity assessment body shall be esta blished under national law and have legal 
personality. 
3. A conformity assessment body shall be a third-party body independent of the 
organisation or the marine  equipment it assesses. 
4. A body belonging to a business association or professional federation representing 
undertakings involved in the design, manu facturing, provision, assembly, use or 
maintenance of marine equipment whic h it assesses, may, on condition that its 
independence and the absence of any conf lict of interest are demonstrated, be 
considered such a body. 
5. A conformity assessment body, its top level management and the personnel 
responsible for carrying out the conform ity assessment tasks shall not be the 
designer, manufacturer, supplier, installer, pu rchaser, owner, user or maintainer of 
the marine equipment which they assess, nor the authorised repres entative of any of 
those parties. This shall not preclude the use of assessed products that are necessary 
for the operations of the conformity asse ssment body or the use of  such products for 
personal purposes. 
6. A conformity assessment body, its top level management and the personnel 
responsible for carrying out the conformity assessment ta sks shall not be directly 
involved in the design, manuf acture or construction, the ma rketing, installation, use 
or maintenance of that mari ne equipment, or represent the parties engaged in those 
activities. They shall not engage in a ny 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 . 
7. Conformity assessment bodies shall ensure th at the activities of th eir subsidiaries or 
subcontractors do not affect the confidentia lity, objectivity or impartiality of their 
conformity assessment activities. 
8. Conformity assessment bodies and their pe rsonnel shall carry out the conformity 
assessment activities with the highest de gree of professional integrity and the 
requisite technical competence in the spec ific field and shall be free from all 
pressures and inducements, particularly financial, which might influence their 
judgement or the results of their conform ity assessment activitie s, especially as 
regards persons or groups of persons with an interest in the results of those activities. 
9. A conformity assessment body shall be capab le 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. EN 52   EN 10. At all times and for each conformity asse ssment procedure and each kind or category 
of marine equipment in relation to wh ich it has been no tified, a conformity 
assessment body shall have at its disposal the necessary: 
(a) personnel with technical knowledge and su fficient and appropriate experience 
to perform the conformity assessment tasks; 
(b) descriptions of procedures in accordan ce 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 notifi ed body and other activities; 
(c) procedures for the performance of activi ties which take due a ccount of the size 
of an undertaking, the sector in which it operates, its structure, the degree of 
complexity of the marine equipment t echnology 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 administrativ e tasks connected with th e conformity assessment 
activities in an appropriate manner and sh all have access to all necessary equipment 
or facilities. 
12. The personnel responsible for carrying out  conformity assessm ent activities shall 
have the following: 
(a) sound technical and vocational training covering all the conformity assessment 
activities in relation to  which the conformity assessment body has been 
notified; 
(b) satisfactory knowledge of the requirements  of the assessments they carry out 
and adequate authority to carry out those assessments; 
(c) appropriate knowledge and understandi ng 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, r ecords and reports de monstrating that 
assessments have been carried out. 
13. The impartiality of the conformity assessment bodies, their top level management 
and of the assessment personnel shall be guaranteed. 
14. 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. 
15. Conformity assessment bodies shall take ou t liability insurance unless liability is 
assumed by the State in accordance with nati onal law, or the Member State itself is 
directly responsible for th e conformity assessment. 
16. The personnel of a conformity assessment body shall observe professional secrecy 
with regard to all in formation obtained in carrying out their tasks under this Directive EN 53   EN or any provision of national law giving e ffect to it, except in relation to the 
competent authorities of the Member Stat e in which its activities are carried out. 
Proprietary rights shall be protected. 
17. Conformity assessment bodies shall particip ate in, or ensure th at their assessment 
personnel are informed of, the relevant sta ndardisation activities and the activities of 
the notified body coordina tion group established under the relevant EU 
harmonisation legislation and apply as gene ral guidance the administrative decisions 
and documents produced as a resu lt of the work of that group. 
18. Conformity assessment bodies shall meet  the requirements of standard EN4011 (ISO 
guide 65), 
19. Conformity assessment bodies shall ensu re that testing la boratories used for 
conformity-assessment purposes meet the requirements of standard EN17025. EN 54   EN ANNEX IV  
 
Notification procedure  
1. Application for notification 
1.1. A conformity assessment body shall submit an application for notification to the 
notifying authority of the Member State in which it is established. 
1.2. That application shall be accompanied by a description of the conformity assessment 
activities, the conformity assessment modul e or modules and the marine equipment 
for which that body claims to be competent,  as well as by an accr editation certificate, 
where one exists, issued by a nationa l accreditation body attesting that the 
conformity assessment body fulfils the requi rements laid down in Annex III of this 
Directive. 
1.3. Where the conformity assessment body c oncerned cannot provide an accreditation 
certificate, it shall provide the notifying aut hority with all the documentary evidence 
necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Annex III . 
2. Notification procedure 2.1. Notifying authorities may notify only conf ormity assessment bodies which have 
satisfied the requirements laid down in Annex III . 
2.2. They shall notify the Commission and the ot her Member States us ing the electronic 
notification tool developed and managed by the Commission. 
2.3. The notification sha ll include full details of the conformity a ssessment 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 eviden ce 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. The body concerned may perform the activ ities of a notified body only where no 
objections are raised by the Commission or  the other Member States within two 
weeks of a notification wher e an accreditation certificate is used or within two 
months of a notification wher e accreditation is not used. 
2.6. Only such a body shall be considered a notified body for the purposes of this 
Directive. 
2.7. The Commission and the othe r Member States shall be notified of any subsequent 
relevant changes to the notification. 
3. Identification numbers and lists of notified bodies EN 55   EN 3.1. The Commission shall assign an iden tification number to a notified body. 
3.2. It shall assign a single such number even  where the notified body is recognised as 
notified under several EU acts. 
3.3. The Commission shall make publicly avai lable the list of th e 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. EN 56   EN ANNEX V  
 
Requirements to be met by notifying authorities  
1. A notifying authority shall be  established in such a way that no conflict of interest 
with conformity assessment bodies occurs. 
2. A notifying authority shall be organise d and operated so as to safeguard the 
objectivity and impartiality of its activities. 
3. A notifying authority shall be organised in such a way that each decision relating to 
notification of a conformity  assessment body is taken by competent persons different 
from those who carried out the assessment. 
4. A notifying authority shall not offer or provide any ac tivities that conformity 
assessment bodies perform or consultancy services on a commercial or competitive basis. 
5. A notifying authority shall safeguard the c onfidentiality of the information it obtains. 
6. A notifying authority shall have a suffici ent number of competent personnel at its 
disposal for the proper performance of its tasks.