MT
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT REGULATIONS
Table of Provisions (20)
Statutory Text (20 Articles)
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
SUBSIDIARY LEGISLATION 427.60
CONFORMITY ASSESSMENT OF MARINE
EQUIPMENT REGULATIONS
18th September, 2016 *
LEGAL NOTICE 275 of 2016,as amended by Legal Notices 428 of 2018
and 53 of 2022.
(1) The title of these regulations is the Conformity
Assessment of Marine Equipment Regulations.
(2) These regulations transpose the conformity assessment
procedures of Directive 2014/90/EU of the European Parliament
and of the Council of 23 July 2014 on marine equipment and
repealing Council Directive 96/98/EC.
(3) The objective of these regulations is to enhance safety at
sea and to prevent marine pollution through the uniform application
of the relevant international instruments relating to marine
equipment to be placed on board EU ships, and to ensure the free
movement of such equipment within the Union.
These regulations shall apply as from 18th September 2016.
(1) These regulations shall apply to equipment placed or to
be placed on board an EU ship and for which the approval of the
flag State administration is required by the international
instruments, regardless of whether the ship is situated in the Union
at the time when it is fitted with the equipment.
(2) Notwithstanding the fact that the equipment referred to in
sub-regulation (1) may also fall within the scope of instruments of
Union law other than Directive 2014/90/EU, that equipment shall,
for the purpose set out in regulation 1(3), be subject only to the
national regulations transposing Directive 2014/90/EU.
For the purpose of these regulations, the following
definitions shall apply
"accreditation" means accreditation as defined in point 10 of
Article 2 of Regulation (EC) No 765/2008;
"authorised representative" means any natural or legal person
established within the Union who has received a written mandate
from a manufacturer to act on its behalf in relation to specified
tasks;
"conformity assessment" means the process carried out by the
notified bodies, in accordance with regulation 13, demonstrating
whether marine equipment complies with the requirements laid
down in these regulations;
"conformity assessment body" means a body that performs
conformity assessment activities including calibration, testing,
certification and inspection;
*
see regulation 2.
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
"distributor" means any natural or legal person in the supply
chain, other than the manufacturer or the importer, who makes
marine equipment available on the market;
"economic operators" means the manufacturer, the authorised
representative, the importer and the distributor;
"EU declaration of conformity" means a statement issued by the
manufacturer in accordance with regulation 14;
"EU ship" means a ship flying the flag of a Member State and
falling within the scope of the international conventions;
"importer" means any natural or legal person established within
the Union who places marine equipment from a third country on the
Union market;
"international conventions" means the following conventions,
together with their protocols and codes of mandatory application,
adopted under the auspices of the International Maritime
Organization (IMO), which have entered into force and which lay
down specific requirements for the approval by the flag State of
equipment to be placed on board ships
-
the 1972 Convention on the International Regulations
for Preventing Collisions at Sea (Colreg);
-
the 1973 International Convention for the Prevention
of Pollution from Ships (Marpol);
-
the 1974 International Convention for the Safety of
Life at Sea (Solas);
"international instruments" means the international conventions,
together with the resolutions and circulars of the IMO giving effect
to those conventions in their up-to-date version, and the testing
standards;
"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;
"manufacturer" means any natural or legal person who
manufactures marine equipment or has marine equipment designed
or manufactured, and markets that equipment under its name or
trademark;
"marine equipment" means equipment falling within the scope of
these regulations in accordance with regulation 3;
"national accreditation body" means national accreditation body
as defined in point 11 of Article 2 of Regulation (EC) No 765/2008;
"National Accreditation Board (Malta)" means the National
Accreditation Board (Malta) established in terms of regulation 3 of
the National Accreditation Board (Malta) (Establishment)
Regulations;
"notified body" means an organisation designated by the
Technical Regulations Division in accordance with regulation
15(1);
"placed on board" means installed or placed on board a ship;
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
"placing on the market" means the first making available of
marine equipment on the Union market;
"product" means an item of marine equipment;
"recall" means any measure aimed at achieving the return of
marine equipment that has already been placed on board EU ships
or purchased with the intention of being placed on board EU ships;
"testing standards" means the testing standards for marine
equipment set by
-
the International Maritime Organization (IMO);
-
the International Organization for Standardization
(ISO);
-
the International Electrotechnical Commission (IEC);
-
the European Committee for Standardization (CEN);
-
the European Committee for Electrotechnical
Standardization (Cenelec);
-
the International Telecommunication Union (ITU);
-
the European Telecommunications Standards Institute
(ETSI);
-
the Commission; in accordance with Article 8 and
Article 27(6) of Directive 2014/90/EU;
-
the regulatory authorities recognised in the mutual
recognition agreements to which the Union is a party;
"Registrar-General" has the same meaning as is assigned to it by
article 2 of the Merchant Shipping Act;
" Te c h n i c a l R e g u l a t i o n s D i v i s i o n " m e a n s t h e Te c h n i c a l
Regulations Division within the Malta Competition and Consumer
Affairs Authority as established by the Malta Competition and
Consumer Affairs Authority Act;
"Union" means the European Union;
"wheel mark" means the symbol referred to in regulation 7 and
set out in Schedule I or, as appropriate, the electronic tag referred
to in regulation 9;
"withdrawal" means any measure aimed at preventing marine
equipment in the supply chain from being made available on the
market.
(1) Marine equipment that is placed on board an EU ship
on or after 18th September 2016 shall meet the design, construction
and performance requirements of the international instruments as
applicable at the time when that equipment is placed on board.
(2) Compliance of marine equipment with the requirements
referred to in sub-regulation (1) shall be demonstrated solely in
accordance with the testing standards and by means of the
conformity assessment procedures referred to in regulation 13.
(3) The international instruments shall apply, without prejudice
to the conformity checking procedure set out in Article 5 of
Regulation (EC) No 2099/2002 of the European Parliament and of
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
the Council.
(4) The requirements and standards referred to in sub-
regulations (1) and (2) shall be implemented in a uniform manner,
in accordance with Article 35(2) of Directive 2014/90/EU.
(5) Without prejudice to sub-regulation (4), until the
implementing acts referred to in Article 35(2) of Directive 2014/90/
EU are published by the European Commission, the requirements
and testing standards stipulated in Annex A of Directive 96/98/EC
of 20 December 1996 on marine equipment shall remain
applicable.
The Technical Regulations Division and the Registrar-
General shall not prohibit the placing on the market or the placing
on board an EU ship of marine equipment which complies with
these regulations.
(1) Marine equipment the compliance of which with the
requirements laid down in these regulations has been demonstrated
in accordance 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 used shall be as set out in
Schedule 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.
(1) The wheel mark shall be affixed visibly, legibly and
indelibly to the product or to its data plate and, where relevant,
embedded in its software. 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 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
manufacturer or the manufacturer's authorised representative.
(1) In order to facilitate market surveillance and prevent
the counterfeiting of specific items of marine equipment, identified
by means of delegated acts issued in accordance with Article 37 of
Directive 2014/90/EU by the European Commission, manufacturers
may use an appropriate and reliable form of electronic tag instead
of, or in addition to, the wheel mark. In such a case, regulations 7
and 8 shall, mutatis mutandis, apply, as appropriate.
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
(2) For the specific items of marine equipment referred to in
sub-regulation (1), the wheel mark may, within three years after the
date of adoption of the appropriate technical criteria referred to in
Article 11(4) of Directive 2014/90/EU, be supplemented by an
appropriate and reliable form of electronic tag.
(3) For the specific items of marine equipment referred to in
sub-regulation (1), the wheel mark may, five years after the date of
adoption of the appropriate technical criteria referred to in Article
11(4) of Directive 2014/90/EU, be replaced by an appropriate and
reliable form of electronic tag.
(1) By affixing the wheel mark, manufacturers shall take
on responsibility for guaranteeing that the marine equipment to
which the mark is affixed has been designed and manufactured in
accordance with the technical specifications and standards referred
to in regulation 5 and shall assume the obligations laid down in
sub-regulations (2) to (9).
(2) Manufacturers shall draw up the required technical
documentation and have the applicable conformity assessment
procedures carried out.
(3) Where the compliance of marine equipment with the
applicable requirements has been demonstrated by the conformity
assessment procedure, manufacturers shall draw up an EU
declaration of conformity in accordance with regulation 14 and
affix the wheel mark in accordance with regulations 7 and 8.
(4) Manufacturers shall keep the technical documentation and
the EU declaration of conformity referred to in regulation 14 for at
least ten years after the wheel mark has been affixed and in no case
for a period shorter than the expected life of the marine equipment
concerned.
(5) Manufacturers shall ensure that procedures are in place for
series production to remain in conformity. Changes in marine
equipment design or characteristics and changes in the
requirements in the international instruments as referred to in
regulation 5, on the basis of which conformity of marine equipment
is declared, shall be taken into account. When necessary in
accordance with Schedule II, manufacturers 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 information is provided on the packaging
or in a document accompanying the product or both, as appropriate.
(7) Manufacturers shall indicate their name, registered trade
name or registered trade mark and the address at which they can be
contacted on the product or, where that is not possible, on its
packaging or in a document accompanying the product or both, as
appropriate. The address must indicate a single point at which the
manufacturer can be contacted.
(8) Manufacturers shall ensure that the product is accompanied
by instructions and all necessary information for safe installation
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
on board and safe use of the product, including limitations of use, if
any, that can be easily understood by the 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 to which they have affixed the wheel mark is not in
conformity with the applicable design, construction and
performance requirements and with the testing standards referred to
in regulation 5, shall immediately take the necessary corrective
measures to bring that product into conformity, to withdraw it or to
recall it, if appropriate. In addition, where the product presents a
risk, manufacturers shall immediately inform the competent
national authorities of the Member States, giving details, in
particular, of the non-compliance and of any corrective measures
taken.
(10) Manufacturers shall, further to a reasoned request from a
competent authority, promptly provide it with all the information
and documentation necessary to demonstrate the conformity of the
product, in a language which can be easily understood by or is
acceptable to that authority, grant that authority access to their
premises for market surveillance purposes in accordance with
Article 19 of Regulation (EC) No 765/2008 and provide samples or
access to samples in accordance with regulation 17(4). 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.
(1) A manufacturer who is not located in the territory of at
least one Member State shall, by a written mandate, appoint an
authorised representative for the Union and shall indicate in the
mandate the name of the authorised representative and the address
at which it can be contacted.
(2) Fulfilment of the obligations laid down in regulation 10(1)
and the drawing-up of technical documentation shall not form part
of the authorised representative’s mandate.
(3) An authorised representative shall perform the tasks
specified in the mandate received from the manufacturer. The
mandate shall allow the authorised representative to do at least the
following
(a) keep the EU declaration of conformity and the
technical documentation at the disposal of national
surveillance authorities for at least ten years after the
wheel mark has been affixed and in no case for a
period shorter than the expected life of the marine
equipment concerned;
(b) further to a reasoned request from a competent
authority, provide that authority with all the
information and documentation necessary to
demonstrate the conformity of a product;
(c) cooperate with the competent authorities, at their
request, on any action taken to eliminate the risks
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
posed by products covered by its mandate.
(1) Importers shall indicate their name, registered trade
name or registered trade mark and the address at which they can be
contacted on the product or, where that is not possible, on its
packaging or in a document accompanying the product or both, as
appropriate.
(2) Importers and distributors shall, further to a reasoned
request from a competent authority, provide it with all the
information and documentation necessary to demonstrate the
conformity of a product in a language which can be easily
understood by, or is acceptable to, that authority. They shall
cooperate with that authority, at its request, on any action taken to
eliminate the risks posed by products which they have placed on
the market. The competent authorities for products imported into
Malta shall be the Technical Regulations Division and the
Registrar-General and the necessary information documentation
shall be provided to such authorities in at least the Maltese or the
English language.
(3) An importer or distributor shall be considered a
manufacturer for the purposes of these regulations and shall be
subject to the obligations of the manufacturer under regulation 10,
where it places marine equipment on the market or on board an EU
ship under its 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.
(4) For a period of at least ten years after the wheel mark has
been affixed and in no case for a period shorter than the expected
life of the marine equipment concerned, economic operators shall,
on request, identify the following to the market surveillance
authorities, which in Malta are the Technical Regulations Division
and the Registrar-General
(a) any economic operator who has supplied them with a
product;
(b) any economic operator to whom they have supplied a
product.
(1) The conformity assessment procedures shall be as set
out in Schedule II.
(2) The Technical Regulations Division, in collaboration with
the Registrar-General, shall ensure that the manufacturer or the
manufacturer ’s authorised representative has the conformity
assessment carried out, through a notified body, for a specific item
of marine equipment, by using one of the options provided by
means of implementing acts adopted by the Commission in
accordance with the examination procedure referred to in Article
38(2) of Directive 2014/90/EU, from among one of the following
procedures
(a) where the EC type-examination (module B) is to be
used, before being placed on the market, all marine
equipment shall be subject to
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
(i) production-quality assurance (module D); or
(ii) product-quality assurance (module E); or
(iii) 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).
(1) The EU declaration of conformity shall state that the
fulfilment of the requirements laid down in accordance with
regulation 5 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
contain the elements specified in the relevant modules set out in
Schedule II and shall be kept up to date.
(3) By drawing up the EU declaration of conformity, the
manufacturer shall assume the responsibility and the obligations
referred to in regulation 10(1).
(4) A copy of the EU declaration of conformity shall be
provided to the notified body or to the bodies which carried out the
relevant conformity assessment procedures.
(1) The Technical Regulations Division shall, by means of
the information system made available by the European
Commission for that purpose, notify the European Commission and
t h e o t h e r M e m b e r St a t e s of b o d i e s a u t h o r i s e d t o c a r r y o u t
conformity assessment tasks under these regulations.
(2) The Technical Regulations Division shall be responsible for
setting up and carrying out the necessary procedures for the
assessment and notification of conformity assessment bodies for
the purposes of these regulations, and for the monitoring of notified
bodies, including compliance with regulations 16(2) to (5).
(3)
Notified bodies shall be monitored at least every two years.
(4) The assessment and monitoring referred to in sub-
regulation (2) shall be carried out by the National Accreditation
Board (Malta).
(5) The Technical Regulations Division shall take full
responsibility for the tasks performed by National Accreditation
Board (Malta) and referred to in sub-regulation (4).
(6) The Technical Regulations Division shall comply with the
requirements laid down in Schedule V.
(7) The Technical Regulations Division shall, by means of the
information system made available by the Commission for that
purpose, notify the Commission and the other Member States of
bodies authorised to carry out conformity assessment tasks under
these regulations.
(8) Where the Technical Regulations Division has ascertained,
or has been informed, that a notified body no longer meets the
requirements laid down in Schedule III, or that it is failing to fulfil
its obligations under these regulations, the Technical Regulations
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
Division shall restrict, suspend or withdraw notification as
appropriate, depending on the seriousness of the failure to meet
those requirements or fulfil those obligations. It shall, by means of
the information system made available by the European
Commission for that purpose, immediately inform the European
Commission and the other Member States accordingly.
(9) In the event of restriction, suspension or withdrawal of
notification, or where the notified body has ceased its activity, the
Technical Regulations Division shall take appropriate steps to
ensure that the files of that body are either processed by another
notified body or kept available to the responsible notifying and
market surveillance authorities, at their request.
(10) The Technical Regulations Division shall provide the
European Commission, on request, with all information relating to
the basis for the notification or the maintenance of the competence
of the body concerned.
(1) Notified Bodies shall comply with the requirements
laid down in Schedule III.
(2) Where a notified body subcontracts specific tasks
connected with conformity assessment or has recourse to a
subsidiary, it shall ensure that the subcontractor or the subsidiary
meets the requirements set out in Schedule III and shall inform the
Technical Regulations Division accordingly.
(3) Notified bodies shall take full responsibility for the tasks
performed by subcontractors or subsidiaries wherever these are
established.
(4) Activities may be subcontracted or carried out by a
subsidiary only with the agreement of the client.
(5) Notified bodies shall keep at the disposal of the Technical
Regulations Division the relevant documents concerning the
assessment of the qualifications of the subcontractor or the
subsidiary and the work carried out by such subcontractor or
subsidiary under these regulations.
(6) Notified bodies shall carry out conformity assessments or
have them carried out in accordance with the procedures provided
for in regulation 13.
(7) Where a notified body finds that the obligations laid down
in regulation 10 have not been met by a manufacturer, it shall
require that manufacturer to take appropriate corrective measures
without delay and shall not issue a conformity certificate.
(8) Where, in the course of monitoring conformity following
the issue of a conformity certificate, a notified body finds that a
product no longer complies, it shall require the manufacturer to
take appropriate corrective measures without delay and shall
suspend or withdraw the certificate if necessary. Where corrective
measures are not taken or do not have the required effect, the
notified body shall restrict, suspend or withdraw the certificate, as
appropriate.
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
(9) Notified bodies shall inform the Technical Regulations
Division of the following
(a) any refusal, restriction, suspension or withdrawal of a
conformity certificate;
(b) any circumstances affecting the scope of, and the
conditions for, notification;
(c) any request for information which they have received
from market surveillance authorities regarding
conformity assessment activities;
(d) on request, conformity assessment activities
performed within the scope of their notification and
any other activity performed, including cross-border
activities and subcontracting.
(10) Notified bodies shall provide the European Commission
and the Member States, on request, with relevant information
concerning issues relating to negative and positive conformity
assessment results. Notified bodies shall provide the other notified
bodies carrying out conformity assessment activities covering the
same products with information concerning negative and, on
request, positive conformity assessment results.
(11) Notified bodies shall participate, directly or by means of
designated representatives, in the appropriate coordination and
cooperation groups for notified bodies organised by the European
Commission.
(1) As regards marine equipment, the Technical
Regulations Division and the Registrar-General shall undertake
market surveillance in accordance with the EU market surveillance
framework laid down in Chapter III of Regulation (EC) No 765/
2008, subject to sub-regulations (2) and (3).
(2) Market surveillance infrastructures and programmes shall
take into account the specific features of the marine equipment
sector, including the various procedures carried out as part of the
conformity assessment, and in particular the responsibilities placed
on the flag State administration by the international conventions.
(3) Market surveillance may include documentary checks as
well as checks of marine equipment which bears the wheel mark,
whether or not it has been placed on board ships. Checks of marine
equipment already placed on board shall be limited to such
examination as can be carried out while the equipment concerned
remains fully functional on board.
(4) Where the Technical Regulations Division and the
Registrar-General intend to carry out sample checks, they may,
when it is reasonable and practicable to do so, request the
manufacturer to make the necessary samples available or to give
on-the-spot access to the samples at the manufacturer’s own cost.
(5) Where the Technical Regulations Division and, or the
Registrar-General has sufficient reasons to believe that marine
equipment covered by these regulations presents a risk to maritime
safety, to health or to the environment, they shall carry out an
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
evaluation in relation to the marine equipment concerned covering
all relevant requirements laid down in these regulations. The
relevant economic operators shall cooperate as necessary with the
Technical Regulations Division and, or the Registrar-General.
(6) Where, in the course of that evaluation, the Technical
Regulations Division and, or the Registrar-General find that the
marine equipment does not comply with the requirements laid
down in these regulations, they shall without delay require the
relevant economic operator to take all appropriate corrective
actions to bring the marine equipment into compliance with those
requirements, to withdraw the marine equipment from the market,
or to recall it within such reasonable period, commensurate with
the nature of the risk, as they may prescribe.
(7) The Technical Regulations Division and, or the Registrar-
General shall inform the relevant notified body accordingly.
(8) Article 21 of Regulation (EC) No 765/2008 shall apply to
the measure referred to in sub-regulation (6).
(9) Where the Technical Regulations Division and, or the
Registrar-General considers that non-compliance is not restricted to
the Maltese territory or to ships flying the Maltese flag, they shall
inform the European Commission and the other Member States, by
means of the information system made available by the European
Commission for market surveillance purposes, of the results of the
evaluation carried out under sub-regulations (5) to (8) and of the
actions which they have required the economic operator to take.
(10) The economic operator shall ensure that all appropriate
corrective action is taken in respect of all the products concerned
that it has made available on the market throughout the Union or, as
the case may be, placed or delivered to be placed on board EU
ships.
(11) Where the relevant economic operator does not take
adequate corrective action within the period prescribed by the
Technical Regulations Division and, or the Registrar-General in
accordance with sub-regulation (6), or otherwise fails to meet its
obligations under these regulations, the Technical Regulations
Division and, or the Registrar-General shall take all appropriate
provisional measures to prohibit or restrict the marine equipment
being made available on the Maltese market or placed on board
ships flying the Maltese flag, to withdraw the product from the
market or to recall it.
(12) The Technical Regulations Division and, or the Registrar-
General shall inform the European Commission and the other
Member States, without delay, of those measures.
(13) The information on the measures taken by the Technical
Regulations Division and, or the Registrar-General referred to in
sub-regulation (11) shall include all available details, in particular
the data necessary for the identification of the non-compliant
marine equipment, the origin of the product, the nature of the
alleged non-compliance and the risk involved, the nature and
duration of the national measures taken and the arguments put
forward by the economic operator concerned. In particular, the
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
Technical Regulations Division and, or the Registrar-General shall
indicate whether the non-compliance is due to either
(a) failure of the marine equipment to comply with the
applicable design, construction and performance
requirements as laid down pursuant to regulation 5;
(b) non-compliance with the testing standards referred to
in regulation 5 during the conformity assessment
procedure;
(c) shortcomings in those testing standards.
(14) When the procedure under this regulation is initiated by
another Member State, the Technical Regulations Division and, or
the Registrar-General shall without delay inform the European
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.
(15) Where, within four months of receipt of the information
concerning the measures taken by the market surveillance
authorities, as referred to in sub-regulation (11), no objection has
been raised by a Member State or by the European Commission in
respect of a provisional measure taken by a Member State, that
measure shall be deemed justified.
In such cases, the Technical Regulations Division and, or
the Registrar-General shall ensure that appropriate restrictive
measures in respect of the marine equipment concerned, such as
withdrawal of the product from the Maltese market, are taken
without delay.
(16) Where, on completion of the procedure set out in sub-
regulations (10) and (11), objections are raised against a measure
taken by the Technical Regulations Division and, or the Registrar-
General, or where the European Commission considers that a
national measure may be contrary to European Union legislation,
the European Commission shall without delay enter into
consultation with the Member States and the relevant economic
operator or operators and shall evaluate the national measure. On
the basis of the results of that evaluation, the European
Commission shall decide whether or not the relevant national
measure is justified.
If the relevant national measure is considered justified, the
Technical Regulations Division and, or the Registrar-General shall
take the measures necessary to ensure that the non-compliant
marine equipment is withdrawn from the Maltese market, and,
where necessary, recalled. They shall inform the European
Commission accordingly.
If the relevant national measure is considered unjustified,
the national measure shall be withdrawn.
(17) Where, having performed an evaluation under sub-
regulation (5), the Technical Regulations Division and, or the
R e g i s t r a r- G e n e r a l f i n d t h a t m a r i n e e q u i p m e n t w h i c h i s i n
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
compliance with these regulations nevertheless presents a risk to
maritime safety, to health or to the environment, it shall require the
economic operator concerned 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 such reasonable
period, commensurate with the nature of the risk, as it may
prescribe.
(18) The economic operator shall ensure that corrective action is
taken in respect of all the products concerned that it has made
available on the market throughout the Union or placed on board
EU ships.
(19) The Technical Regulations Division and, or the Registrar-
General shall immediately inform the European Commission and
the other Member States. The information provided shall include
all available details, in particular the data necessary for the
identification of the marine equipment concerned, the origin and
the supply chain of the marine equipment, the nature of the risk
involved and the nature and duration of the national measures
taken.
(20) Without prejudice to sub-regulations (5) to (15), where the
Technical Regulations Division and, or the Registrar-General make
one of the following findings, they shall require the relevant
economic operator to put an end to the non-compliance concerned
(a) the wheel mark has been affixed in violation of
regulations 7 or 8;
(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) the technical documentation is either not available or
not complete;
(f) the EU declaration of conformity has not been sent to
the ship.
(21) Where the non-compliance referred to in sub-regulation
(20) persists, the Technical Regulations Division and, or the
Registrar-General shall take all appropriate measures to restrict or
to prohibit the marine equipment being made available on the
Maltese market or to ensure that it is recalled or withdrawn from
the Maltese market.
The penalties applicable for the infringement of any of the
provisions of these regulations shall be those provided for in Part
IV of the Product Safety Act.
(1) Any references to the Conformity Assessment of
Marine Equipment Regulations, 2009, revoked by these
regulations, shall be construed as references to these regulations.
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
(2) Any references in existing laws, regulations and
administrative provisions to Directive 96/98/EC shall be construed
as references to Directive 2014/90/EU.
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
Schedule I
WHEEL MARK
The mark of conformity must take the following form
If the wheel mark is reduced or enlarged the proportions given in the graduated
drawing must be respected.
The various components of the wheel mark must have substantially the same
vertical dimension, which may not be less than 5 mm.
That minimum dimension may be waived for small devices.
Schedule II
CONFORMITY ASSESSMENT PROCEDURES
MODULE B: EC TYPE-EXAMINATION
1. EC type-examination is the part of a conformity assessment procedure in
which a notified body examines the technical design of marine equipment
and verifies and attests that the technical design of the marine equipment
meets the relevant requirements.
2. EC type-examination may be carried out in either of the following
manners
—
examination of a specimen, representative of the production
envisaged, of the complete product (production type);
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
assessment of the adequacy of the technical design of the marine
equipment through examination of the technical documentation and
supporting evidence referred to in point 3, plus examination of
specimens, representative of the production envisaged, of one or
more critical parts of the product (combination of production type
and design type).
3. The manufacturer shall lodge an application for EC type-examination with
a single notified body of its choice.
The application shall include
the name and address of the manufacturer and, if the application is
lodged by the authorised representative, its name and address as
well;
a written declaration that the same application has not been lodged
with any other notified body;
the technical documentation. The technical documentation shall
make it possible to assess the conformity of the marine equipment
with the applicable requirements of the international instruments as
referred to in regulation 5, and shall include an adequate analysis
and assessment of the risk(s). The technical documentation shall
specify the applicable requirements and shall 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)
a general description of the marine equipment;
(b)
conceptual design and manufacturing drawings and schemes
of components, sub-assemblies, circuits, etc.;
(c)
descriptions and explanations necessary for the
understanding of those drawings and schemes and of the
operation of the marine equipment;
(d)
a list of the requirements and testing standards which are
applicable to the marine equipment concerned in accordance
with these regulations, together with a description of the
solutions adopted to meet those requirements;
(e)
results of design calculations made, examinations carried
out, etc.; and
(f)
test reports;
the specimens representative of the production envisaged. The
notified body may request further specimens if needed for carrying
out the test programme;
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
—
the supporting evidence for the adequacy of the technical design
solution. This supporting evidence shall mention any documents
that have been used. The supporting evidence shall include, where
necessary, the results of tests carried out by the appropriate
laboratory of the manufacturer, or by another testing laboratory on
the manufacturer's behalf and under its responsibility.
4. The notified body shall
For the marine equipment
examine the technical documentation and supporting evidence to assess the
adequacy of the technical design of the marine equipment;
For the specimen(s)
verify that the specimen(s) have been manufactured in conformity with the
technical documentation, and identify the elements which have been
designed in accordance with the applicable provisions of the relevant
requirements and testing standards, as well as the elements which have
been designed without applying the relevant provisions of those standards;
carry out appropriate examinations and tests, or have them carried out, in
accordance with these regulations;
agree with the manufacturer on a location where the examinations and tests
will be carried out.
5. The notified body shall draw up an evaluation report that records the
activities undertaken in accordance with point 4 and their outcomes.
Without prejudice to its obligations vis-à-vis the notifying authorities, the
notified body shall release the content of that report, in full or in part, only
with the agreement of the manufacturer.
6. Where the type meets the requirements of the specific international
instruments that apply to the marine equipment concerned, the notified
body shall issue an EC type-examination certificate to the manufacturer.
The certificate shall contain the name and address of the manufacturer, the
conclusions of the examination, the conditions (if any) for its validity and
the necessary data for identification of the approved type. The certificate
may have one or more annexes attached.
The certificate and its annexes shall contain all relevant information to
allow the conformity of manufactured products with the examined type to
be evaluated and to allow for in-service control.
Where the type does not satisfy the applicable requirements of the
international instruments, the notified body shall refuse to issue an EC
type-examination certificate and shall inform the applicant accordingly,
giving detailed reasons for its refusal.
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
7. If the approved type no longer complies with the applicable requirements,
the notified body shall determine whether further testing or a new
conformity assessment procedure is necessary.
The manufacturer shall inform the notified body that holds the technical
documentation relating to the EC type-examination certificate of all
modifications to the approved type that may affect the conformity of the
marine equipment with the requirements of the relevant international
instruments or the conditions for validity of the certificate. Such
modifications shall require additional approval in the form of an addition to
the original EC type-examination certificate.
8. Each notified body shall inform its notifying authorities concerning the EC
type-examination certificates and/or any additions thereto which it has
issued or withdrawn, and shall, periodically or upon request, make
available to its notifying authorities the list of certificates and/or any
additions thereto refused, suspended or otherwise restricted.
Each notified body shall inform the other notified bodies concerning the
EC type-examination certificates and/or any additions thereto which it has
refused, withdrawn, suspended or otherwise restricted, and, upon request,
concerning the certificates and/or additions thereto which it has issued.
The Commission, the Member States and the other notified bodies may, on
request, obtain a copy of the EC type-examination certificates and/or
additions thereto. On request, the Commission and the Member States may
obtain a copy of the technical documentation and the results of the
examinations carried out by the notified body. The notified body shall keep
a copy of the EC type-examination certificate, its annexes and additions, as
well as the technical file including the documentation submitted by the
manufacturer, until the expiry of the validity of the certificate.
9. The manufacturer shall keep a copy of the EC type-examination certificate,
its annexes and additions together with the technical documentation at the
disposal of the national authorities for at least 10 years after the wheel mark
has been affixed on the last product manufactured and in no case for a
period shorter than the expected life of the marine equipment concerned.
10. The manufacturer’s authorised representative may lodge the application
referred to in point 3 and fulfil the obligations set out in points 7 and 9,
provided that they are specified in the mandate.
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
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 its sole responsibility that the marine equipment concerned is in
conformity with the type described in the EC type-examination certificate
and that it satisfies the requirements of the international instruments that
apply to it.
2. Manufacturing
The manufacturer shall operate an approved quality system for production,
final product inspection and testing of the products concerned as specified
in point 3, and shall be subject to surveillance as specified in point 4.
3. Quality system
The manufacturer shall lodge an application for assessment of its quality
system with the notified body of its choice, for the marine equipment
concerned.
The application shall include
—
the name and address of the manufacturer and, if the application is
lodged by the authorised representative, its name and address as
well;
—
a written declaration that the same application has not been lodged
with any other notified body;
—
all relevant information for the marine equipment category
envisaged;
—
the documentation concerning the quality system;
—
the technical documentation of the approved type and a copy of the
EC type-examination certificate.
The quality system shall ensure that the products are in conformity with the
type described in the EC type-examination certificate and that they comply
with the requirements of the international instruments that apply to them.
All the elements, requirements and provisions adopted by the manufacturer
shall be documented in a systematic and orderly manner in the form of
written policies, procedures and instructions. The quality system
documentation shall permit a consistent interpretation of the quality
programmes, plans, manuals and records.
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
It shall, in particular, contain an adequate description of
the quality objectives and the organisational structure, responsibilities and
powers of the management with regard to product quality;
the corresponding manufacturing, quality control and quality assurance
techniques, processes and systematic actions that will be used;
the examinations and tests that will be carried out before, during and after
manufacture, and the frequency with which they will be carried out;
the quality records, such as inspection reports and test data, calibration
data, qualification reports on the personnel concerned, etc.; and
the means of monitoring the achievement of the required product quality
and the effective operation of the quality system.
The notified body shall assess the quality system to determine whether it
satisfies the requirements referred to in point 3.2.
In addition to experience in quality management systems, the auditing team
shall have at least one member with experience of evaluation in the relevant
marine equipment field and marine equipment technology concerned, and
knowledge of the applicable requirements of the international instruments.
The audit shall include an assessment visit to the manufacturer’s premises.
The auditing team shall review the technical documentation referred to in
the fifth indent of point 3.1 in order to verify the manufacturer’s ability to
identify the relevant requirements of the international instruments and to
carry out the necessary examinations with a view to ensuring compliance of
the product with those requirements.
The decision shall be notified to the manufacturer. The notification shall
contain the conclusions of the audit and the reasoned assessment decision.
The manufacturer shall undertake to fulfil the obligations arising out of the
quality system as approved and to maintain it so that it remains adequate
and efficient.
The manufacturer shall keep the notified body that has approved the quality
system informed of any intended change to the quality system.
The notified body shall evaluate any proposed changes and decide whether
the modified quality system will continue to satisfy the requirements
referred to in point 3.2 or whether a re-assessment is necessary.
It shall notify the manufacturer of its decision. The notification shall
contain the conclusions of the examination and the reasoned assessment
decision.
4. Surveillance under the responsibility of the notified body
The purpose of surveillance is to make sure that the manufacturer duly
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
fulfils the obligations arising out of the approved quality system.
The manufacturer shall, for assessment purposes, allow the notified body
access to the manufacture, inspection, testing and storage sites, and shall
provide it with all necessary information, in particular
—
the quality system documentation;
—
the quality records, such as inspection reports and test data,
calibration data, qualification reports on the personnel concerned,
etc.
The notified body shall carry out periodic audits to make sure that the
manufacturer maintains and applies the quality system, and shall provide
the manufacturer with an audit report.
In addition, the notified body may pay unexpected visits to the
manufacturer, except where, under national law, and for defence or security
reasons, certain restrictions apply to such visits. During such visits the
notified body may, if necessary, carry out product tests, or have them
carried out, in order to verify that the quality system is functioning
correctly. The notified body shall provide the manufacturer with a visit
report and, if tests have been carried out, with a test report.
5. Conformity marking and declaration of conformity
The manufacturer shall affix the wheel mark referred to in regulation 7,
and, under the responsibility of the notified body referred to in point 3.1,
the latter’s identification number to each individual product that is in
conformity with the type described in the EC type-examination certificate
and that satisfies the applicable requirements of the international
instruments.
The manufacturer shall draw up a written declaration of conformity for
each product model and keep it at the disposal of the national authorities for
at least 10 years after the wheel mark has been affixed on the last product
manufactured and in no case for a period shorter than the expected life of
the marine equipment concerned. The declaration of conformity shall
identify the marine equipment model for which it has been drawn up.
A copy of the declaration of conformity shall be made available to the
relevant authorities upon request.
6. The manufacturer shall keep at the disposal of the competent authorities,
for at least 10 years after the wheel mark has been affixed on the last
product manufactured and in no case for a period shorter than the expected
life of the marine equipment concerned
—
the documentation referred to in point 3.1;
—
the change referred to in point 3.5, as approved;
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
—
the decisions and reports of the notified body referred to in points
3.5, 4.3 and 4.4.
7. Each notified body shall inform its notifying authorities of quality system
approvals issued or withdrawn, and shall, periodically or upon request,
make available to its notifying authorities the list of quality system
approvals refused, suspended or otherwise restricted.
Each notified body shall inform the other notified bodies of quality system
approvals which it has refused, suspended, withdrawn or otherwise
restricted, and, upon request, of quality system approvals which it has
issued.
8. Authorised representative
The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be
fulfilled by its authorised representative, on its behalf and under its
responsibility, provided that they are specified in the mandate.
MODULE E: CONFORMITY TO TYPE BASED ON PRODUCT
QUALITY ASSURANCE
1. Conformity to type based on product quality assurance is that part of a
conformity assessment procedure whereby the manufacturer fulfils the
obligations laid down in points 2 and 5, and ensures and declares on its sole
responsibility that the marine equipment concerned is in conformity with
the type described in the EC type-examination certificate and that it
satisfies the requirements of the international instruments that apply to it.
2. Manufacturing
The manufacturer shall operate an approved quality system for final
product inspection and testing of the products concerned as specified in
point 3, and shall be subject to surveillance as specified in point 4.
3. Quality system
The manufacturer shall lodge an application for assessment of its quality
system with the notified body of its choice, for the marine equipment
concerned.
The application shall include
—
the name and address of the manufacturer and, if the application is
lodged by the authorised representative, its name and address as
well;
—
a written declaration that the same application has not been lodged
with any other notified body;
—
all relevant information for the marine equipment category
envisaged;
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
—
the documentation concerning the quality system; and
—
the technical documentation of the approved type and a copy of the
EC type-examination certificate.
The quality system shall ensure compliance of the products with the type
described in the EC type-examination certificate and with the applicable
requirements of the international instruments.
All the elements, requirements and provisions adopted by the manufacturer
shall be documented in a systematic and orderly manner in the form of
written policies, procedures and instructions. The quality system
documentation shall permit a consistent interpretation of the quality
programmes, plans, manuals and records.
It shall, in particular, contain an adequate description of
—
the quality objectives and the organisational structure,
responsibilities and powers of the management with regard to
product quality;
—
the examinations and tests that will be carried out after manufacture;
—
the quality records, such as inspection reports and test data,
calibration data, qualification reports on the personnel concerned,
etc.;
—
the means of monitoring the effective operation of the quality
system.
The notified body shall assess the quality system to determine whether it
satisfies the requirements referred to in point 3.2.
In addition to experience in quality management systems, the auditing team
shall have at least one member with experience of evaluation in the relevant
marine equipment field and marine equipment technology concerned, and
knowledge of the applicable requirements of the international instruments.
The audit shall include an assessment visit to the manufacturer’s premises.
The auditing team shall review the technical documentation referred to in
the fifth indent of point 3.1, in order to verify the manufacturer’s ability to
identify the relevant requirements of the international instruments and to
carry out the necessary examinations with a view to ensuring compliance of
the product with those requirements.
The decision shall be notified to the manufacturer. The notification shall
contain the conclusions of the audit and the reasoned assessment decision.
The manufacturer shall undertake to fulfil the obligations arising out of the
quality system as approved and to maintain it so that it remains adequate
and efficient.
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
The manufacturer shall keep the notified body that has approved the quality
system informed of any intended change to the quality system.
The notified body shall evaluate any proposed changes and decide whether
the modified quality system will continue to satisfy the requirements
referred to in point 3.2 or whether a re-assessment is necessary.
It shall notify the manufacturer of its decision. The notification shall
contain the conclusions of the examination and the reasoned assessment
decision.
4. Surveillance under the responsibility of the notified body
The purpose of surveillance is to make sure that the manufacturer duly
fulfils the obligations arising out of the approved quality system.
The manufacturer shall, for assessment purposes, allow the notified body
access to the manufacture, inspection, testing and storage sites, and shall
provide it with all necessary information, in particular
—
the quality system documentation;
—
the quality records, such as inspection reports and test data,
calibration data, qualification reports on the personnel concerned,
etc.
The notified body shall carry out periodic audits to make sure that the
manufacturer maintains and applies the quality system, and shall provide
the manufacturer with an audit report.
In addition, the notified body may pay unexpected visits to the
manufacturer, except where, under national law, and for defence or security
reasons, certain restrictions apply to such visits. During such visits the
notified body may, if necessary, carry out product tests, or have them
carried out, in order to verify that the quality system is functioning
correctly. The notified body shall provide the manufacturer with a visit
report and, if tests have been carried out, with a test report.
5. Conformity marking and declaration of conformity
The manufacturer shall affix the wheel mark referred to in regulation 7,
and, under the responsibility of the notified body referred to in point 3.1,
the latter’s identification number to each individual product that is in
conformity with the type described in the EC type-examination certificate
and that satisfies the applicable requirements of the international
instruments.
The manufacturer shall draw up a written declaration of conformity for
each product model and keep it at the disposal of the national authorities for
at least 10 years after the wheel mark has been affixed on the last product
manufactured and in no case for a period shorter than the expected life of
the marine equipment concerned. The declaration of conformity shall
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
identify the marine equipment model for which it has been drawn up.
A copy of the declaration of conformity shall be made available to the
relevant authorities upon request.
6. The manufacturer shall keep at the disposal of the competent authorities,
for at least 10 years after the wheel mark has been affixed on the last
product manufactured and in no case for a period shorter than the expected
life of the marine equipment concerned
—
the documentation referred to in point 3.1;
—
the change referred to in point 3.5, as approved;
—
the decisions and reports of the notified body referred to in points
3.5, 4.3 and 4.4.
7. Each notified body shall inform its notifying authorities of quality system
approvals issued or withdrawn, and shall, periodically or upon request,
make available to its notifying authorities the list of quality system
approvals refused, suspended or otherwise restricted.
Each notified body shall inform the other notified bodies of quality system
approvals which it has refused, suspended or withdrawn, and, upon request,
of quality system approvals which it has issued.
8. Authorised representative
The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be
fulfilled by its authorised representative, on its behalf and under its
responsibility, provided that they are specified in the mandate.
MODULE F: CONFORMITY TO TYPE BASED ON PRODUCT
VERIFICATION
1. Conformity to type based on product verification is the part of a conformity
assessment procedure whereby the manufacturer fulfils the obligations laid
down in points 2, 5.1 and 6, and ensures and declares on its sole
responsibility that the products concerned, which have been subject to the
provisions of point 3, are in conformity with the type described in the EC
type-examination certificate and that they satisfy the requirements of the
international instruments that apply to them.
2. Manufacturing
The manufacturer shall take all measures necessary so that the
manufacturing process and its monitoring ensure conformity of the
manufactured products with the approved type described in the EC type-
examination certificate and with the requirements of the international
instruments that apply to them.
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
3. Verification
A notified body chosen by the manufacturer shall carry out appropriate
examinations and tests in order to check the conformity of the products
with the approved type described in the EC type-examination certificate
and with the appropriate requirements of the international instruments.
The examinations and tests to check the conformity of the products with
the appropriate requirements shall be carried out, at the choice of the
manufacturer, either by examination and testing of every product as
specified in point 4 or by examination and testing of the products on a
statistical basis as specified in point 5.
4. Verification of conformity by examination and testing of every product
All products shall be individually examined and tested in accordance with
these regulations, in order to verify conformity with the approved type
described in the EC type-examination certificate and with the appropriate
requirements of the international instruments.
The notified body shall issue a certificate of conformity in respect of the
examinations and tests carried out, and shall affix its identification number
to each approved product or have it affixed under its responsibility.
The manufacturer shall keep the certificates of conformity available for
inspection by the national authorities for at least 10 years after the wheel
mark has been affixed on the last product manufactured and in no case for a
period shorter than the expected life of the marine equipment concerned.
5. Statistical verification of conformity
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 its products for verification in the form of
homogeneous lots.
A random sample shall be taken from each lot. All products in a sample
shall be individually examined and tested in accordance with these
regulations, in order to ensure their conformity with the applicable
requirements of the international instruments and to determine whether the
lot is accepted or rejected.
If a lot is accepted, all products of the lot shall be considered approved,
except for those products from the sample that have been found not to
satisfy the tests.
The notified body shall issue a certificate of conformity in respect of the
examinations and tests carried out, and shall affix its identification number
to each approved product or have it affixed under its responsibility.
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
The manufacturer shall keep the certificates of conformity at the disposal
of the national authorities for at least 10 years after the wheel mark has
been affixed on the last product manufactured and in no case for a period
shorter than the expected life of the marine equipment concerned.
If a lot is rejected, the notified body or the competent authority shall take
appropriate measures to prevent that lot being placed on the market. In the
event of the frequent rejection of lots, the notified body may suspend the
statistical verification and take appropriate measures.
6. Conformity marking and declaration of conformity
The manufacturer shall affix the wheel mark referred to in regulation 7,
and, under the responsibility of the notified body referred to in point 3, the
latter’s identification number to each individual product that is in
conformity with the approved type described in the EC type-examination
certificate and that satisfies the applicable requirements of the international
instruments.
The manufacturer shall draw up a written declaration of conformity for
each product model and keep it at the disposal of the national authorities for
at least 10 years after the wheel mark has been affixed on the last product
manufactured and in no case for a period shorter than the expected life of
the marine equipment concerned. The declaration of conformity shall
identify the marine equipment model for which it has been drawn up.
A copy of the declaration of conformity shall be made available to the
relevant authorities upon request.
7. If the notified body agrees and under its responsibility, the manufacturer
may affix the notified body’s identification number to the products during
the manufacturing process.
8. Authorised representative
The manufacturer’s obligations may be fulfilled by its authorised
representative, on its behalf and under its responsibility, provided that they
are specified in the mandate. An authorised representative may not fulfil
the manufacturer’s obligations set out in points 2 and 5.1.
MODULE G: CONFORMITY BASED ON UNIT VERIFICATION
1. Conformity based on unit verification is the conformity assessment
procedure whereby the manufacturer fulfils the obligations laid down in
points 2, 3 and 5 and ensures and declares on its sole responsibility that the
product concerned, which has been subject to the provisions of point 4, is in
conformity with the requirements of the international instruments that
apply to it.
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
2. Technical documentation
The manufacturer shall draw up the technical documentation and make it
available to the notified body referred to in point 4. The documentation
shall make it possible to assess the product’s conformity with the relevant
requirements, and shall include an adequate analysis and assessment of the
risk(s). The technical documentation shall specify the applicable
requirements and shall cover, as far as relevant for the assessment, the
design, manufacture and operation of the product. The technical
documentation shall, wherever applicable, contain at least the following
elements
—
a general description of the product;
—
conceptual design and manufacturing drawings and schemes of
components, sub-assemblies, circuits, etc.;
—
descriptions and explanations necessary for the understanding of
those drawings and schemes and the operation of the product;
—
a list of the requirements and testing standards which are applicable
to the marine equipment concerned in accordance with these
regulations, together with a description of the solutions adopted to
meet those requirements;
—
results of design calculations made, examinations carried out; and
—
test reports.
The manufacturer shall keep the technical documentation at the disposal of
the relevant national authorities for at least 10 years after the wheel mark
has been affixed on the last product manufactured and in no case for a
period shorter than the expected life of the marine equipment concerned.
3. Manufacturing
The manufacturer shall take all measures necessary so that the
manufacturing process and its monitoring ensure conformity of the
manufactured product with the applicable requirements of the international
instruments.
4. Verification
A notified body chosen by the manufacturer shall carry out appropriate
examinations and tests in accordance with these regulations, in order to
check the conformity of the product with the applicable requirements of the
international instruments.
The notified body shall issue a certificate of conformity in respect of the
examinations and tests carried out and shall affix its identification number
to the approved product, or have it affixed under its responsibility.
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
The manufacturer shall keep the certificates of conformity at the disposal
of the national authorities for at least 10 years after the wheel mark has
been affixed on the last product manufactured and in no case for a period
shorter than the expected life of the marine equipment concerned
5. Conformity marking and declaration of conformity
The manufacturer shall affix the wheel mark referred to in regulation 7 and,
under the responsibility of the notified body referred to in point 4, the
latter’s identification number to each product that satisfies the applicable
requirements of the international instruments.
The manufacturer shall draw up a written declaration of conformity and
keep it at the disposal of the national authorities for at least 10 years after
the wheel mark has been affixed on the last product manufactured and in no
case for a period shorter than the expected life of the marine equipment
concerned. The declaration of conformity shall identify the product for
which it has been drawn up.
A copy of the declaration of conformity shall be made available to the
relevant authorities upon request.
6. Authorised representative
The manufacturer’s obligations set out in points 2 and 5 may be fulfilled by its
authorised representative, on its behalf and under its responsibility, provided that they
are specified in the mandate.
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
Schedule III
Amended by
L.N. 53 of 2022.
REQUIREMENTS TO BE MET BY
CONFORMITY ASSESSMENT BODIES
IN ORDER TO BECOME NOTIFIED
BODIES
1. For the purposes of notification, a conformity assessment body shall meet
the requirements laid down in points 2 to 11.
2. A conformity assessment body shall be established under national law and
have legal personality.
3. A conformity assessment body shall be a third-party body independent of
the organisation or the marine equipment which it assesses.
4. A body belonging to a business association or professional federation
representing undertakings involved in the design, manufacturing,
provision, assembly, use or maintenance of marine equipment which it
assesses, may, on condition that its independence and the absence of any
conflict of interest are demonstrated, be considered a conformity
assessment body.
5. A conformity assessment body, its top-level management and the personnel
responsible for carrying out the conformity assessment tasks shall not be
the designer, manufacturer, supplier, installer, purchaser, owner, user or
maintainer of the marine equipment which is assessed, nor the authorised
representative of any of those parties. This shall not preclude the use of
assessed products that are necessary for the operations of the conformity
assessment body or the use of such products for personal purposes
6. A conformity assessment body, its top-level management and the personnel
responsible for carrying out the conformity assessment tasks shall not be
directly involved in the design, manufacture or construction, the marketing,
installation, use or maintenance of that marine equipment, or represent the
parties engaged in those activities. They shall not engage in any activity
that may conflict with their independence of judgement or integrity in
relation to conformity assessment activities for which they are notified.
This shall apply, in particular, to consultancy services.
7. Conformity assessment bodies shall ensure that the activities of their
subsidiaries or subcontractors do not affect the confidentiality, objectivity
or impartiality of their conformity assessment activities.
8. Conformity assessment bodies and their personnel shall carry out the
conformity assessment activities with the highest degree of professional
integrity and the requisite technical competence in the specific field and
shall be free from all pressures and inducements, particularly of a financial
nature, which might influence their judgement or the results of their
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
conformity assessment activities, especially as regards persons or groups of
persons with an interest in the results of those activities.
9. A conformity assessment body shall be capable of carrying out all the
conformity assessment tasks assigned to it under these regulations 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.
10. At all times and for each conformity assessment procedure and each kind,
category or sub-category of marine equipment in relation to which it has
been notified, a conformity assessment body shall have at its disposal the
necessary
(a)
personnel with technical knowledge and sufficient and appropriate
experience to perform the conformity assessment tasks;
(b)
descriptions of procedures in accordance with which conformity
assessment is carried out, ensuring the transparency of those
procedures and the possibility of reproducing them. It shall have in
place appropriate policies and procedures that distinguish between
tasks that it carries out as a notified body and other activities;
(c)
procedures for the performance of activities which take due account
of the size of an undertaking, the sector in which it operates, its
structure, the degree of complexity of the marine equipment
technology in question and the mass or serial nature of the
production process.
11. A conformity assessment body shall have the means necessary to perform
the technical and administrative tasks connected with the conformity
assessment activities in an appropriate manner, and shall have access to all
necessary equipment and facilities.
12. The personnel responsible for carrying out conformity assessment
activities shall have the following
(a)
sound technical and vocational training covering all the conformity
assessment activities in relation to which the conformity assessment
body has been notified;
(b)
satisfactory knowledge of the requirements of the assessments they
carry out and adequate authority to carry out those assessments;
(c)
appropriate knowledge and understanding of the applicable
requirements and testing standards and of the relevant provisions of
Union legislation on harmonisation and of the regulations
implementing that legislation;
(d)
the ability to draw up certificates, records and reports demonstrating
that assessments have been carried out.
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
13. The impartiality of the conformity assessment bodies, of their top-level
management and of the assessment personnel shall be guaranteed.
14. The remuneration of the top-level management and of the 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 out liability insurance unless
liability is assumed by the State in accordance with national law, or the
Member State itself is directly responsible for the conformity assessment.
16. The personnel of a conformity assessment body shall observe professional
secrecy with regard to all information obtained in carrying out their tasks
under these regulations or pursuant to any provision of national law giving
effect to it, except in relation to the competent authorities of the Member
States in which its activities are carried out. Proprietary rights shall be
protected.
17. Conformity assessment bodies shall participate in, or ensure that their
assessment personnel are informed of, the relevant standardisation
activities and the activities of the notified body coordination group
established these regulations, and shall apply as general guidance the
administrative decisions and documents produced as a result of the work of
that group.
18. Conformity assessment bodies shall meet the requirements of standard EN
ISO/IEC 17065:2012.
19. Conformity assessment bodies shall ensure that testing laboratories used for
conformity assessment purposes meet the requirements of standard EN
ISO/IEC 17025:2017.
Schedule IV
NOTIFICATION PROCEDURE
1. Application for notification
A conformity assessment body shall submit an application for notification
to the notifying authority of the Member State in which it is established.
That application shall be accompanied by a description of the conformity
assessment activities, the conformity assessment module or modules and
the marine equipment for which that body claims to be competent, as well
as by an accreditation certificate, issued by the National Accreditation
Board (Malta) attesting that the conformity assessment body fulfils the
requirements laid down in Schedule III
Where the conformity assessment body concerned cannot provide an
accreditation certificate, it shall provide the notifying authority with all the
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
documentary evidence necessary for the verification, recognition and
regular monitoring of its compliance with the requirements laid down in
Schedule III.
2. Notification procedure
Notifying authorities may notify only conformity assessment bodies which
have satisfied the requirements laid down in Schedule III.
They shall notify the Commission and the other Member States using the
electronic notification tool developed and managed by the Commission.
The notification shall include full details of the conformity assessment
activities, the conformity assessment module or modules and marine
equipment concerned and the relevant attestation of competence.
Where a notification is not based on an accreditation certificate as referred
to in section 1, the notifying authority shall provide the Commission and
the other Member States with documentary evidence which attests to the
conformity assessment body’s competence and the arrangements in place to
ensure that that body will be monitored regularly and will continue to
satisfy the requirements laid down in Schedule III.
The body concerned may perform the activities of a notified body only
where no objections are raised by the Commission or the other Member
States within two weeks of a notification where an accreditation certificate
is used or within two months of a notification where accreditation is not
used.
Only a body referred to in point 2.5 shall be considered a notified body for
the purposes of these regulations.
The Commission and the other Member States shall be notified of any
subsequent relevant changes to the notification.
3. Identification numbers and lists of notified bodies
The Commission shall assign an identification number to a notified body.
It shall assign a single such number even where the notified body is
recognized as notified under several legislative acts of the Union.
The Commission shall make publicly available the list of the bodies
notified under these regulations, including the identification numbers that
have been allocated to them and the activities for which they have been
notified.
The Commission shall ensure that that list is kept up to date.
CONFORMITY ASSESSMENT OF MARINE EQUIPMENT
Schedule 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 organised and operated in such a way 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, on a commercial or
competitive basis, any activities that conformity assessment bodies perform
or any consultancy services.
5. A notifying authority shall safeguard the confidentiality of the information
it obtains.
6. A notifying authority shall have a sufficient number of competent
personnel at its disposal for the proper performance of its tasks.