Regulations (Amendment), 2018

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 20,103, 12 ta’ Diċembru, 2018

L.N. 428 of 2018

PRODUCT SAFETY ACT

(CAP. 427)

Conformity Assessment of Marine Equipment

Regulations (Amendment), 2018

IN EXERCISE of the powers conferred by articles 38 to 40 of the

Product Safety Act, the Ministry for Justice, Culture and Local

Government, on the advice of the Director General (Technical

Regulations), has made the following regulations:-

The title of these regulations is the Conformity Assessment Citation.

of Marine Equipment Regulations (Amendment), 2018 and these

regulations shall be read and construed as one with the Conformity S.L. 427.60

Assessment of Marine Equipment Regulations hereinafter referred to

as ''the principal regulations''.

Schedule I to the principal regulations shall be substituted Substitutes

Schedule I to

by the following:-

the principal

regulations.

''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 to the principal regulations shall be substituted

by the following:-

''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.

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.

The notified body shall draw up an evaluation report that

records the activities undertaken in accordance with point 4

and their outcomes. Without prejudice to its obligations vis-

à-vis the notifying authorities, the notified body shall

release the content of that report, in full or in part, only with

the agreement of the manufacturer.

Where the type meets the requirements of the specific

international instruments that apply to the marine

equipment concerned, the notified body shall issue an EC

type-examination certificate to the manufacturer. The

certificate shall contain the name and address of the

manufacturer, the conclusions of the examination, the

conditions (if any) for its validity and the necessary data for

identification of the approved type. The certificate may

have one or more annexes attached.

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.

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.

Each notified body shall inform its notifying authorities

concerning the EC type-examination certificates and/or any

additions thereto which it has issued or withdrawn, and

shall, periodically or upon request, make available to its

notifying authorities the list of certificates and/or any

additions thereto refused, suspended or otherwise

restricted.

Each notified body shall inform the other notified bodies

concerning the EC type-examination certificates and/or any

additions thereto which it has refused, withdrawn,

suspended or otherwise restricted, and, upon request,

concerning the certificates and/or additions thereto which it

has issued.

The Commission, the Member States and the other notified

bodies may, on request, obtain a copy of the EC type-

examination certificates and/or additions thereto. On

request, the Commission and the Member States may obtain

a copy of the technical documentation and the results of the

examinations carried out by the notified body. The notified

body shall keep a copy of the EC type-examination

certificate, its annexes and additions, as well as the

technical file including the documentation submitted by the

manufacturer, until the expiry of the validity of the

certificate.

The manufacturer shall keep a copy of the EC type-

examination certificate, its annexes and additions together

with the technical documentation at the disposal of the

national authorities for 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 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.

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.

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 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;

—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;

—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.

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 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.

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.

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.

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.

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.;''.

4. Schedule III to the principal regulations shall be substituted Substitutes

Schedule III to

by the following:-

the principal

regulations.

''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

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.

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.

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.

The impartiality of the conformity assessment bodies, of

their top-level management and of the assessment

personnel shall be guaranteed.

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.

Conformity assessment bodies shall take out liability

insurance unless liability is assumed by the State in

accordance with national law, or the Member State itself is

directly responsible for the conformity assessment.

The personnel of a conformity assessment body shall

observe professional secrecy with regard to all information

obtained in carrying out their tasks under 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.

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.

Conformity assessment bodies shall meet the requirements

of standard EN ISO/IEC 17065:2012.

Conformity assessment bodies shall ensure that testing

laboratories used for conformity assessment purposes meet

the requirements of standard EN ISO/IEC 17025:2005.''.

5. Schedule IV to the principal regulations shall be substituted

by the following:-

''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 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.''.

6. Schedule V to the principal regulations shall be substituted

by the following:-

''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.''.

€1.17