SCHEDULE 2Conformity Assessment Procedures
PART 1F14EU-Type Examination (Module B)
E31
E41
EU-type examination (Module B) is a conformity assessment procedure in which a notified body examines the technical design of a vessel and verifies and attests that the technical design of the vessel meets the applicable requirements of these Regulations that apply to it.
E52
1
2
The application must include—
a
the name and address of the manufacturer and, if the application is lodged by an authorised representative, the name and address of the authorised representative;
b
a written declaration that the same application has not been lodged with any other F15approved body;
c
the technical documentation;
d
where applicable, the prototype vessels (and any further prototype vessels requested by the F15approved body if needed for carrying out the test programme) representative of the production envisaged;
e
the supporting evidence for the adequacy of the technical design solution; this supporting evidence must—
i
mention any documents that have been used, in particular where the relevant F7designated standards have not been applied in full;
ii
include, where necessary, the results of tests carried out in accordance with other technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on the manufacturer's behalf and under his responsibility.
E62
1
A manufacturer must lodge an application for EU-type examination (Module B) with a single notified body of the manufacturer's choice.
2
The application must include—
a
the name and address of the manufacturer and, if the application is lodged by an authorised representative, the name and address of the authorised representative;
b
a written declaration that the same application has not been lodged with any other notified body;
c
the technical documentation;
d
where applicable, the prototype vessels (and any further prototype vessels requested by the notified body if needed for carrying out the test programme) representative of the production envisaged;
e
the supporting evidence for the adequacy of the technical design solution; this supporting evidence must—
i
mention any documents that have been used, in particular where the relevant harmonised standards have not been applied in full;
ii
include, where necessary, the results of tests carried out in accordance with other technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on the manufacturer's behalf and under his responsibility.
E73
1
The technical documentation referred to in paragraph 2(2)(c) must—
a
make it possible to assess the vessel's conformity with the applicable requirements of these Regulations and must include an adequate analysis and assessment of any risks;
b
specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the vessel;
c
contain, wherever applicable, at least the following elements—
i
a general description of the vessel;
ii
conceptual design and manufacturing drawings and schemes of components;
iii
descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the vessel;
iv
v
where F5designated standards have not been applied, descriptions of the solutions adopted to meet the essential safety requirements, including a list of other relevant technical specifications applied;
vi
results of design calculations made and examinations carried out;
vii
test reports;
viii
the instructions and safety information;
ix
A document describing—
aa
the materials selected;
bb
the welding processes selected;
cc
the checks selected; and
dd
any pertinent details as to the vessel design.
2
Where a prototype vessel is examined, the technical documentation must also include—
a
the certificates relating to the suitable qualification of the welding operations and of the welders or welding operators;
b
the inspection slip for the materials used in the manufacture of parts and components contributing to the strength of the vessel;
c
a report on the examination and tests performed or a description of the proposed checks.
E83
1
The technical documentation referred to in paragraph 2(2)(c) must—
a
make it possible to assess the vessel's conformity with the applicable requirements of these Regulations and must include an adequate analysis and assessment of any risks;
b
specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the vessel;
c
contain, wherever applicable, at least the following elements—
i
a general description of the vessel;
ii
conceptual design and manufacturing drawings and schemes of components;
iii
descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the vessel;
iv
a list of the harmonised standards applied in full or in part (where applicable specifying the parts which have been applied), the references to which have been published in the Official Journal;
v
where harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential safety requirements, including a list of other relevant technical specifications applied;
vi
results of design calculations made and examinations carried out;
vii
test reports;
viii
the instructions and safety information;
ix
A document describing—
aa
the materials selected;
bb
the welding processes selected;
cc
the checks selected; and
dd
any pertinent details as to the vessel design.
2
Where a prototype vessel is examined, the technical documentation must also include—
a
the certificates relating to the suitable qualification of the welding operations and of the welders or welding operators;
b
the inspection slip for the materials used in the manufacture of parts and components contributing to the strength of the vessel;
c
a report on the examination and tests performed or a description of the proposed checks.
E134
1
The F15approved body must examine the technical documentation and supporting evidence in respect of a vessel and, if provided, the prototype representative of the production of the vessel, to assess the adequacy of the technical design of the vessel.
2
Where a prototype vessel is examined, the F15approved body must—
a
verify that a prototype vessel—
i
has been manufactured in conformity with the technical documentation;
ii
may safely be used under its intended working conditions;
iii
identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards, as well as the elements which have been designed in accordance with other relevant technical specifications;
b
carry out, or arrange the carrying out, of appropriate examinations and tests to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards, these have been applied correctly;
c
carry out, or arrange the carrying out, of appropriate examinations and tests to check whether, where the solutions in the relevant harmonised standards have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential safety requirements of these Regulations; and
d
agree with the manufacturer on a location where the examinations and tests will be carried out.
E144
1
The notified body must examine the technical documentation and supporting evidence in respect of a vessel and, if provided, the prototype representative of the production of the vessel, to assess the adequacy of the technical design of the vessel.
2
Where a prototype vessel is examined, the notified body must—
a
verify that a prototype vessel—
i
has been manufactured in conformity with the technical documentation;
ii
may safely be used under its intended working conditions;
iii
identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards, as well as the elements which have been designed in accordance with other relevant technical specifications;
b
carry out, or arrange the carrying out, of appropriate examinations and tests to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards, these have been applied correctly;
c
carry out, or arrange the carrying out, of appropriate examinations and tests to check whether, where the solutions in the relevant harmonised standards have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential safety requirements of these Regulations; and
d
agree with the manufacturer on a location where the examinations and tests will be carried out.
E155
The F15approved body must draw up an evaluation report that records the activities undertaken in accordance with paragraph 4 and their outcomes and, without prejudice to the notifying body's obligations vis-à-vis the Secretary of State, the F15approved body may disclose the content of that report, in full or in part, only with the agreement of the manufacturer.
E165
The notified body must draw up an evaluation report that records the activities undertaken in accordance with paragraph 4 and their outcomes and, without prejudice to the notifying body's obligations vis-à-vis the Secretary of State, the notified body may disclose the content of that report, in full or in part, only with the agreement of the manufacturer.
E96
1
Where the type meets the requirements of these Regulations, the F15approved body must issue F2a Type examination certificate to the manufacturer, which must contain—
a
the name and address of the manufacturer;
b
the conclusions of the examination;
c
the conditions (if any) for its validity;
d
all relevant information to allow the conformity of manufactured vessels with the examined type to be evaluated and to allow for in-service control; and
e
the necessary data for the identification of the approved type.
2
The F16Type examination certificate referred to in sub-paragraph (1)—
a
may have one or more annexes attached;
b
must be accompanied by the descriptions and drawings necessary for identification of the approved type.
3
E106
1
Where the type meets the requirements of these Regulations, the notified body must issue an EU-type examination certificate to the manufacturer, which must contain—
a
the name and address of the manufacturer;
b
the conclusions of the examination;
c
the conditions (if any) for its validity;
d
all relevant information to allow the conformity of manufactured vessels with the examined type to be evaluated and to allow for in-service control; and
e
the necessary data for the identification of the approved type.
2
The EU-type examination certificate referred to in sub-paragraph (1)—
a
may have one or more annexes attached;
b
must be accompanied by the descriptions and drawings necessary for identification of the approved type.
3
Where the type does not satisfy the applicable requirements of these Regulations, the notified body must refuse to issue an EU-type certificate and must inform the applicant accordingly, giving detailed reasons for its refusal.
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F1An approved body must keep itself appraised of any changes to the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of these Regulations, and must determine whether such changes require further investigation and, if so, the F15approved body must inform the manufacturer accordingly.
2
A manufacturer must inform the F15approved body that holds the technical documentation relating to the F16Type examination certificate of all modifications to the approved type that may affect the conformity of the vessel with the essential safety requirements or the conditions for validity of the certificate; such modifications require additional approval in the form of an addition to the original F16Type examination certificate.
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1
A notified body must keep itself appraised of any changes to the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of these Regulations, and must determine whether such changes require further investigation and, if so, the notified body must inform the manufacturer accordingly.
2
A manufacturer must inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the conformity of the vessel with the essential safety requirements or the conditions for validity of the certificate; such modifications require additional approval in the form of an addition to the original EU-type examination certificate.
E18
1
Each F15approved body must inform the Secretary of State of all the F16Type examination certificates and any additions thereto which it has issued or withdrawn and must, periodically or upon request, make available to the Secretary of State the list of such certificates and any additions thereto refused, suspended, or otherwise restricted.
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4
5
E28
1
Each notified body must inform the Secretary of State of all the EU-type examination certificates and any additions thereto which it has issued or withdrawn and must, periodically or upon request, make available to the Secretary of State the list of such certificates and any additions thereto refused, suspended, or otherwise restricted.
2
Each notified body must inform the other notified bodies concerning the EU-type examination certificates and any additions thereto which it has refused, withdrawn, suspended or otherwise restricted and, upon request, concerning such certificates and additions thereto which it has issued.
3
A notified body must, on request, provide the Commission, the F12relevant states and the other notified bodies, with a copy of the EU-type examination certificates and additions thereto which it has issued.
4
A notified body must, on request, provide the Commission and the F13relevant states with a copy of the technical documentation and the results of the examinations carried out by the notified body.
5
A notified body must keep a copy of the EU-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 that certificate.
E189
A manufacturer must keep a copy of the F16Type examination certificate, its annexes and additions together with the technical documentation at the disposal of the enforcing authorities for a period of 10 years beginning on the day on which the vessel is placed on the market.
E179
A manufacturer must keep a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the enforcing authorities for a period of 10 years beginning on the day on which the vessel is placed on the market.
Word in Sch. 2 heading omitted (E.W.S.) (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 21 para. 40(a) (with Sch. 21 para. 37) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)