Regulations, 2016

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 19,619, 9 ta’ Awwissu, 2016

L.N. 275 of 2016

PRODUCT SAFETY ACT

(CAP. 427)

Conformity Assessment of Marine Equipment

Regulations, 2016

IN exercise of the powers conferred by articles 38 and 39 of the

Product Safety Act, the Minister for Social Dialogue, Consumer

Affairs and Civil Liberties, on the advice of the Malta Competition

and Consumer Affairs Authority, has made the following regulations:-

(1) The title of these regulations is the Conformity Citation and

scope.

Assessment of Marine Equipment Regulations, 2016.

(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 18 th September Commencement.

2. 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.

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;

"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) S.L. 419.07

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;

"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;

"Technical Regulations Division" means the Technical

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 18 th 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 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- Functioning of

General shall not prohibit the placing on the market or the placing on the

market.

board an EU ship of marine equipment which complies with these

regulations.

(1) Marine equipment the compliance of which with the The wheel

requirements laid down in these regulations has been demonstrated in mark.

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 Rules and

indelibly to the product or to its data plate and, where relevant, conditions

affixing the

embedded in its software. Where that is not possible or not warranted wheel mark.

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.

(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 10 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 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 Authorised

at least one Member State shall, by a written mandate, appoint an representatives.

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 10 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 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 10 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 Conformity

assessment

set out in Schedule II.

procedures.

(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

(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 EU declaration

fulfilment of the requirements laid down in accordance with of conformity.

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

the other Member States of bodies authorised to carry out 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 16(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

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 Requirements

for notified

laid down in Schedule III.

bodies.

(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.

(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

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 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 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

Registrar-General find that marine equipment which is in 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 Penalties.

provisions of these regulations shall be those provided for in Part IV Cap. 427.

of the Product Safety Act.

The Conformity Assessment of Marine Equipment Revocation.

Regulations are hereby revoked.

(1) Any references to the revoked regulations shall be Saving.

construed as references to these regulations.

(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.

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);

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;

-

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

4.1. examine the technical documentation and supporting evidence to assess the

adequacy of the technical design of the marine equipment;

For the specimen(s)

4.2. verify that the specimen(s) have been manufactured in conformity with the

technical documentation, and identify the elements which have been

designed in accordance with the applicable provisions of the relevant

requirements and testing standards, as well as the elements which have been

designed without applying the relevant provisions of those standards;

4.3. carry out appropriate examinations and tests, or have them carried out, in

accordance with these regulations;

4.4. 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.

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.

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 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

3.1. 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.

3.2. 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.

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.

3.3. The notified body shall assess the quality system to determine whether it

satisfies the requirements referred to in point 3.2.

In addition to experience in quality management systems, the auditing team

shall have at least one member with experience of evaluation in the relevant

marine equipment field and marine equipment technology concerned, and

knowledge of the applicable requirements of the international instruments.

The audit shall include an assessment visit to the manufacturer’s premises.

The auditing team shall review the technical documentation referred to in

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.

3.4. 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.

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 evaluate any proposed changes and decide whether

the modified quality system will continue to satisfy the requirements

referred to in point 3.2 or whether a re-assessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain

the conclusions of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body

4.1. The purpose of surveillance is to make sure that the manufacturer duly

fulfils the obligations arising out of the 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;

-

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 audits to make sure that the

manufacturer maintains and applies the quality system, and shall provide the

manufacturer with an audit report.

4.4. 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

5.1. 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.

5.2. The manufacturer shall draw up a written declaration of conformity for each

product model and keep it at the disposal of the national authorities for 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;

-

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.

III. MODULE E: CONFORMITY TO TYPE BASED ON PRODUCT

QUALITY ASSURANCE

1. Conformity to type based on product quality assurance is that part of a

conformity assessment procedure whereby the manufacturer fulfils the

obligations laid down in points 2 and 5, and ensures and declares on 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

3.1. 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; and

-

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

type-examination certificate.

3.2. The quality system shall ensure compliance of the products with the type

described in the EC type-examination certificate and with the applicable

requirements of the international instruments.

All the elements, requirements and provisions adopted by the manufacturer

shall be documented in a systematic and orderly manner in the form of

written policies, procedures and instructions. The quality system

documentation shall permit a consistent interpretation of the quality

programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of

-

the quality objectives and the organisational structure, responsibilities

and powers of the management with regard to product quality;

-

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

-

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

data, qualification reports on the personnel concerned, etc.;

-

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

3.3. The notified body shall assess the quality system to determine whether it

satisfies the requirements referred to in point 3.2.

In addition to experience in quality management systems, the auditing team

shall have at least one member with experience of evaluation in the relevant

marine equipment field and marine equipment technology concerned, and

knowledge of the applicable requirements of the international instruments.

The audit shall include an assessment visit to the manufacturer’s premises.

The auditing team shall review the technical documentation referred to in

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.

3.4. 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.

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 evaluate any proposed changes and decide whether

the modified quality system will continue to satisfy the requirements

referred to in point 3.2 or whether a re-assessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain

the conclusions of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body

4.1. The purpose of surveillance is to make sure that the manufacturer duly

fulfils the obligations arising out of the 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;

-

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 audits to make sure that the

manufacturer maintains and applies the quality system, and shall provide the

manufacturer with an audit report.

4.4. 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

5.1. 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.

5.2. The manufacturer shall draw up a written declaration of conformity for each

product model and keep it at the disposal of the national authorities for 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;

-

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.

IV. MODULE F: CONFORMITY TO TYPE BASED ON PRODUCT

VERIFICATION

1. Conformity to type based on product verification is the part of a conformity

assessment procedure whereby the manufacturer fulfils the obligations laid

down in points 2, 5.1 and 6, and ensures and declares on 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.

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

4.1. 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.

4.2. The notified body shall issue a certificate of conformity in respect of the

examinations and tests carried out, and shall affix its identification number

to each approved product or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity available for

inspection 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

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 its products for verification in the 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 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.

5.3. If a lot is accepted, all products of the lot shall be considered approved,

except for those products from the sample that have been found not to satisfy

the tests.

The notified body shall issue a certificate of conformity in respect 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 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.

5.4. If a lot is rejected, the notified body or the competent authority shall take

appropriate measures to prevent that lot being placed on the market. In the

event of the frequent rejection of lots, the notified body may suspend the

statistical verification and take appropriate measures.

6. Conformity marking and declaration of conformity

6.1. 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.

6.2. The manufacturer shall draw up a written declaration of conformity for each

product model and keep it at the disposal of the national authorities for 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.

V. 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.

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.

Schedule III

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 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.

Schedule IV

NOTIFICATION PROCEDURE

1. Application for notification

1.1. A conformity assessment body shall submit an application for notification to

the Technical Regulations Division.

1.2. 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 National Accreditation Board (Malta)

attesting that the conformity assessment body fulfils the requirements laid

down in Schedule III.

2. Notification procedure

2.1. Notifying authorities may notify only conformity assessment bodies which

have satisfied the requirements laid down in Schedule III.

2.2. They shall notify the European Commission and the other Member States

using the electronic notification tool developed and managed by the

European Commission.

2.3. The notification shall include full details of the conformity assessment

activities, the conformity assessment module or modules and marine

equipment concerned and the relevant attestation of competence.

2.4. The body concerned may perform the activities of a notified body only

where no objections are raised by the European Commission or the other

Member States within two weeks of a notification.

2.5. Only a body referred to in point 2.4 shall be considered a notified body for

the purposes of Directive 2014/90/EU.

2.6. The Technical Regulations Division shall notify the Commission and the

other Member States of any subsequent relevant changes to the notification.

3. Identification numbers and lists of notified bodies

3.1. The Commission shall assign an identification 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 legislative acts of the Union.

3.3. The Commission shall make publicly available the list of the bodies notified

under Directive 2014/90/EU, 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.

Schedule V

REQUIREMENTS TO BE MET BY NOTIFYING AUTHORITIES

1. As a notifying authority, the Technical Regulations Division shall be

established in such a way that no conflict of interest with conformity

assessment bodies occurs.

2. As a notifying authority, the Technical Regulations Division shall be

organised and operated in such a way as to safeguard the objectivity and

impartiality of its activities.

3. As a notifying authority, the Technical Regulations Division 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. As a notifying authority, the Technical Regulations Division shall not offer

or provide, on a commercial or competitive basis, any activities that

conformity assessment bodies perform or any consultancy services.

5. As a notifying authority, the Technical Regulations Division shall safeguard

the confidentiality of the information it obtains.

6. As a notifying authority, the Technical Regulations Division shall have a

sufficient number of competent personnel at its disposal for the proper

performance of its tasks.

B

€1.62