The EU Directive on Marine Equipment (96/98 EC) entered into force 1 January 1999, latest amended in September 2002 by Commision Directive 2002/75/EC (mandatory from 23 March 2003).
What is the Marine Equipment Directive? The Marine Equipment Directive (MED) (96/98/EC as amended) covers certain equipment carried and used on ships registered under the flags of European Union member states.
What does the Directive cover?
If you manufacture, purchase or supply any of the equipment listed in the MED, it affects you. The list covers the following categories of equipment:
The MED is aimed at ensuring that equipment which has to meet the requirements of international conventions (e.g., SOLAS, MARPOL, etc.) agreed at IMO (the International Maritime Organisation), additionally meets a common standard of safety and performance.
It also ensures that certificates issued by European Union member states, or on their behalf by notified bodies, are acceptable to each member state through the harmonisation of their approval requirements.
MarED is the co-ordination
group for the Notified Bodies assigned by
the Member States to carry out the
conformity assessment procedures referred to
in the Marine Equipment Directive (COUNCIL
DIRECTIVE 96/98/EC of 20 December 1996 on
Marine Equipment). The MarED
Website contains information about the MarED
Group, Notified Bodies and the Marine
Equipment Directive.
Context:
Free movement of goods is a cornerstone of
the single European market. The European
Union has developed original and innovative
instruments to remove the barriers to free
circulation of goods. The mechanisms in
place to achieve this aim are based on
prevention of new barriers to trade, mutual
recognition and technical harmonisation.
Among these, the New Approach to product
regulation and the Global Approach to
conformity assessment take pride of place.
Notified bodies carry out the tasks
pertaining to the conformity assessment
procedures referred to in the applicable New
Approach directives when a third party is
required. Member States are responsible for
their notification. They may choose the
bodies they notify from the bodies under
their jurisdiction which comply with the
requirements of the directives and the
principles laid down in Decision 93/465/EEC.
A comprehensive "Guide to the
implementation of directives based on the
New Appporach and the Global Approach More
information" can be downloaded from the
Commission's
Website.
MarED provides a framework
for co-ordination and co-operation between
its members, the Commission and observers in
the application of the Marine Equipment
Directive. It is the intention of the MarED
to be a conduit for the exchange information
between members and to harmonise technical
aspects. Furthermore MarED aims at solving
unclear situations in reaching a consensus
on the procedures of the EC Type Examination
and surveillance modules in order to avoid
differences between Notified Bodies.
Further MarED OBJECTIVES are:
Setting up and maintenance of
co-operation between MarED Notified
Bodies to promote harmonisation in the
operation, scope and responsibilities
for attestation to Annex A1 of the
Marine Equipment Directive.
Providing a forum for identification
of any problems or interpretations in
the application of Attestation to Annex
A1 of the Directive and consultation
with appropriate bodies to enable
resolution.
Contribution towards the
interpretations of existing standards
which relate to its members' interests
and in preparation of similar standards.
Facilitating co-operation amongst the
members without inhibiting fair and open
competition between them.
Share experience and exchange views on
the application of the conformity
assessment procedures with the aim of
contributing to a uniformunderstanding
and application of the requirements and
procedures.
Elaborate opinions from a technical
point of view on matters of conformity
assessment procedures by seeking a
consensus.
Remain in coherence with
standardisation work at IMO and European
level.
Having regard to the Treaty establishing
the European Community, and in particular
Article 84 (2) thereof,
Having regard to the proposal from the
Commission (1),
Having regard to the opinion of the
Economic and Social Committee (2),
Acting in accordance with the procedure
laid down in Article 189c of the Treaty (3),
(1) Whereas within the framework of the
common transport policy further measures
must be adopted to ensure safety in maritime
transport;
(2) Whereas shipping accidents are a
matter of serious concern to the Community,
in particular those that cause loss of human
life and pollution of the Member States'
seas and coastlines;
(3) Whereas the risk of shipping
accidents can be effectively reduced by
means of common standards that ensure high
safety levels in the performance of the
equipment carried on board ships; whereas
testing standards and testing methods can
have great influence on the future
performance of equipment;
(4) Whereas international conventions
require flag States to ensure that the
equipment carried on board ships complies
with certain safety requirements and to
issue the relevant certificates; whereas to
that end testing standards for certain types
of marine equipment have been developed by
the international standardization bodies and
by the International Maritime Organization
(IMO); whereas the national testing
standards implementing the international
standards leave a margin of discretion
certification authorities, which themselves
have different levels of qualifications and
experience; whereas that leads to varying
levels of safety for products which the
competent national authorities have
certified as complying with the relevant
international safety standards and to great
reluctance on the part of Member States to
accept that without further verification
ships flying their flags carry equipment
approved by other Member States;
(5) Whereas common rules must be laid
down to eliminate differences in the
implementation of international standards;
whereas such common rules will result in the
elimination of unnecessary costs and
administrative procedures relating to the
approval of equipment, the improvement of
operating conditions and of the competitive
position of Community shipping and the
elimination of technical barriers to trade
by means of the mark of conformity affixed
to equipment;
(6) Whereas in its resolution of 8 June
1993 on a common policy on safe seas (4) the
Council urged the Commission to submit
proposals for harmonizing the implementation
of IMO standards and the procedures for the
approval of marine equipment;
(7) Whereas action at Community level is
the only possible way of achieving such
harmonization, since Member States acting
independently or through international
organizations cannot establish the same
level of safety performance in equipment;
(8) Whereas a Council Directive is the
appropriate legal instrument as it provides
a framework for uniform and compulsory
application of the international testing
standards by Member States;
(9) Whereas it is appropriate in the
first place to address equipment the
carriage of which on board ship and the
approval of which by national
administrations in accordance with safety
standards laid down in international
conventions or resolutions is mandatory
under the main international conventions;
(10) Whereas there are various Directives
that ensure the free movement of certain
products which could be used inter alia, as
equipment on board ships but which do not
concern the Member States' certification of
equipment in accordance with the relevant
international conventions; whereas equipment
to be placed on board ships must therefore
be regulated exclusively by new common
rules;
(11) Whereas new testing standards must
be laid down, preferably at international
level, for equipment for which such
standards do not already exist or are not
sufficiently detailed;
(12) Whereas Member States should ensure
that the notified bodies that assess the
compliance of equipment with testing
standards are independent, efficient and
professionally competent to carry out their
tasks;
(13) Whereas compliance with
international testing standards can best be
demonstrated by means of
conformity-assessment procedures such as
those laid down in Council Decision
93/465/EEC of 22 July 1993 concerning the
modules for the various phases of the
conformity-assessment procedures and the
rules for the affixing and use of the CE
conformity marking, which are intended to be
used in the technical harmonization
Directives (5);
(14) Whereas nothing in this Directive
restricts the right granted to a flag State
administration by international conventions
to carry out operational-performance tests
on board a ship for which it has issued a
safety certificate, provided such tests do
not duplicate the conformity-assessment
procedures;
(15) Whereas equipment covered by this
Directive should, as a general rule, bear a
mark to indicate its compliance with the
requirement of this Directive;
(16) Whereas Member States may in certain
cases take provisional measures to limit or
prohibit the use of equipment bearing the
mark of conformity;
(17) Whereas the use of equipment not
bearing the mark of conformity may be
allowed in exceptional circumstances;
(18) Whereas a simplified procedure
involving a regulatory committee must be
followed for the amendment of this
Directive,
HAS ADOPTED THIS DIRECTIVE:
Article 1
The purpose of this Directive shall be to
enhance safety at sea and the prevention of
marine pollution through the uniform
application of the relevant international
instruments relating to equipment listed in
Annex A to be placed on board ships for
which safety certificates are issued by or
on behalf of Member States pursuant to
international conventions and to ensure the
free movement of such equipment within the
Community.
Article 2
For the purposes of this Directive:
(a) 'conformity-assessment procedures`
shall mean the procedures set out in Article
10 and Annex B;
(b) 'equipment` shall mean items listed
in Annexes A.1 and A.2 which must be placed
on board a ship for use in order to comply
with international instruments or are
voluntarily placed on board for use, and for
which the approval of the flag State
administration is required according to
international instruments;
(c) 'radiocommunications equipment` shall
mean equipment required by Chapter IV of the
1984 Solas Convention, as amended with
regard to the Global Maritime Distress and
Safety System (GMDSS) in 1988, and two-way
VHF radiotelephone apparatus required by
Regulation III/6.2.1 of the same Convention;
(d) 'international conventions` shall
mean:
- the 1996 International Convention on
Load Lines (LL66),
- 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)
and
- the 1974 International Convention for
the Safety of Life at Sea (Solas),
together with their Protocols and the
amendments thereto in force on the date of
the adoption of this Directive;
(e) 'international instruments` shall
mean the relevant international conventions,
the relevant resolutions and circulars of
the International Maritime Organization
(IMO), and the relevant international
testing standards;
(f) 'mark` shall mean the symbol referred
to in Article 11 and set out in Annex D;
(g) 'notified body` shall mean an
organization designated by the competent
national administration of a Member State in
accordance with Article 9;
(h) 'placed on board` shall mean
installed or placed on board a ship;
(i) 'safety certificates` shall mean the
certificates issued by or on behalf of
Member States in accordance with
international conventions;
(j) 'ship` shall mean a ship falling
within the scope of international
conventions; warships shall not be covered;
(k) 'Community ship` shall mean a ship
for which safety certificates are issued by
or on behalf of Member States under
international conventions. This definition
shall not include a Member State
administration's issuing a certificate for a
ship at the request of a third country's
administration;
(l) 'new ship` shall mean a ship the keel
of which is laid or which is at a similar
stage of construction on or after the date
of the entry into force of this Directive.
For the purposes of this definition, 'a
similar stage of construction` shall mean
the stage at which:
(i) construction identifiable with a
specific ship begins
and
(ii) assembly of that ship has commenced,
comprising at least 50 tonnes or 1 % of the
estimated mass of all structural material,
whichever is less;
(m) 'existing ship` shall mean a ship
which is not a new ship;
(n) 'testing standards` shall mean the
standards 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)
and
- the European Telecommunication
Standards Institute (ETSI)
in force on the date of the adoption of
this Directive, and established in
accordance with the relevant international
conventions and with the relevant IMO
resolutions and circulars to define testing
methods and test results, but only in the
form referred to in Annex A;
(o) 'type-approval` shall mean the
procedures for evaluating equipment produced
in accordance with the appropriate testing
standards and the issue of the appropriate
certificate.
Article 3
1. This Directive shall apply to
equipment for use on board:
(a) a new Community ship whether or not
the ship is situated within the Community at
the time of construction;
(b) an existing Community ship
- where such equipment was not previously
carried on board
or
- where equipment which was previously
carried on board the ship is replaced,
except where international conventions
permit otherwise,
whether or not the ship is situated
within the Community when the equipment is
placed on board.
2. This Directive shall not apply to
equipment which on the date of the entry
into force of this Directive has already
been placed on board a ship.
3. Notwithstanding the fact that the
equipment referred to in paragraph 1 may
fall within the scope of Directives other
than this Directive for the purpose of free
movement, and in particular Council
Directives 89/336/EEC of 3 May 1989 on the
approximation of the laws of the Member
States relating to electromagnetic
compatibility (6) and 89/686/EEC of 21
December 1989 on the approximation of the
laws of the Member States relating to
personal protective equipment (7), that
equipment shall be subject only to this
Directive, to the exclusion of all others
for those purposes.
Article 4
Each Member State or the organizations
acting on its behalf shall ensure, when
issuing or renewing the relevant safety
certificates, that the equipment on board
Community ships for which it issues safety
certificates complies with the requirements
of this Directive.
Article 5
1. Equipment listed in Annex A.1 that is
placed on board a Community ship on or after
the date referred to in the second
subparagraph of Article 20 (1) shall meet
the applicable requirements of the
international instruments referred to in
that Annex.
2. The compliance of equipment with the
applicable requirements of the international
conventions and of the relevant resolutions
and circulars of the International Maritime
Organization shall be demonstrated solely in
accordance with the relevant testing
standards and the conformity-assessment
procedures referred to in Annex A.1. For
items listed in Annex A.1, where both IEC
and ETSI testing standards are given, those
standards shall be alternatives and a
manufacturer or his authorized
representative established within the
Community may determine which of them is to
be used.
3. Equipment listed in Annex A.1 and
manufactured before the date referred to in
paragraph 1 may also be placed on the market
and on board a Community ship the
certificates of which were issued by or on
behalf of a Member State in accordance with
international conventions during the two
years following that date if it was
manufactured in accordance with procedures
for type-approval already in force within
the territory of that Member State before
the date of the adoption of this Directive.
Article 6
1. No Member State shall prohibit the
placing on the market or the placing on
board a Community ship of equipment referred
to in Annex A.1 which bears the mark or for
other reasons complies with this Directive
or refuse to issue or renew the safety
certificates relating thereto.
2. A radio licence shall be issued in
accordance with the international radio
regulations by the competent authority
before the relevant safety certificate is
issued.
Article 7
1. After the date of the entry into force
of this Directive, the Community shall
submit a request to the IMO or to the
European standardization organizations, as
appropriate, for the establishment of
standards, including detailed testing
standards, for the equipment listed in Annex
A.2.
2. The request referred to in paragraph 1
shall be made:
- by the Presidency of the Council and by
the Commission, when it is submitted to the
IMO,
- by the Commission, in accordance with
Council Directive 83/189/EEC of 28 March
1983 laying down a procedure for the
provision of information in the field of
technical standards and regulations (8),
when it is submitted to the European
standardization organizations. The mandates
issued by the Commission shall aim for the
development of international standards
through procedures for cooperation between
the European bodies and their counterparts
at international level.
3. Member States shall do their utmost to
ensure that the international organizations,
including the IMO, develop those standards
expeditiously.
4. The Commission shall monitor the
development of the testing standards on a
regular basis.
5. Should the international
organizations, including the IMO, fail or
refuse to adopt appropriate testing
standards for a specific item of equipment
within a reasonable time, standards based on
the work of the European standardization
organizations may be adopted in accordance
with the procedure laid down in Article 18.
6. When the testing standards referred to
in paragraphs 1 or 5 are adopted or enter
into force, as appropriate, for a specific
item of equipment, that equipment may be
transferred from Annex A.2 to Annex A.1 in
accordance with the procedure laid down in
Article 18 and, Article 5 shall apply from
the date of that transfer.
Article 8
1. In the case of a new ship which,
irrespective of its flag, is not registered
in a Member State but is to be transferred
to the register of a Member State, such a
ship shall, on transfer, be subject to
inspection by the receiving Member State to
verify that the actual condition of its
equipment corresponds to its safety
certificates and either complies with this
Directive and bears the mark or is
equivalent, to the satisfaction of that
Member State's administration, to equipment
type-approval in accordance with this
Directive.
2. Unless the equipment either bears the
mark or that administration considers it to
be equivalent, it shall be replaced.
3. Equipment which is considered
equivalent pursuant to this Article shall be
given a certificate by the Member State
which shall at all times be carried with the
equipment and which gives the flag Member
State's permission for the equipment to be
placed on board the ship and imposes any
restrictions or lays down any provisions
relating to the use of the equipment.
4. In the case of radiocommunications
equipment, the flag State administration
shall require that such equipment does not
unduly affect the requirements of the
radio-frequency spectrum.
Article 9
1. Member States shall notify the
Commission and the other Member States of
the bodies which they have designated to
carry out the procedures for in Article 10
together with the specific tasks which those
notified bodies have been designated to
carry out and the identification numbers
assigned to them beforehand by the
Commission. Each organization shall submit
to the Member State which intends to
designate it complete information
concerning, and evidence of compliance with
the criteria laid down in Annex C.
2. At least once every two years each
Member State shall cause an audit of the
duties its notified bodies are undertaking
on its behalf to be carried out by the
administration or by an impartial external
organization appointed by the
administration. That audit shall ensure that
each notified body continues to comply with
the criteria laid down in Annex C.
3. A Member State which has designated a
body shall withdraw its designation if it
finds that that body no longer complies with
the criteria laid down in Annex C. It shall
immediately inform the Commission and the
other Member States accordingly.
Article 10
1. The conformity-assessment procedure,
details of which are listed in Annex B,
shall be:
(i) EC type-examination (module B) and,
before equipment is placed on the market and
according to the choice made by the
manufacturer or his authorized
representative established within the
Community from the possibilities indicated
in Annex A.1, all equipment shall be subject
to:
(a) the EC declaration of conformity to
type (module C);
(b) the EC declaration of conformity to
type (production-quality assurance) (module
D);
(c) the EC declaration of conformity to
type (product-quality assurance) (module E);
(d) the EC declaration of conformity to
type (product verification) (module F); or
(ii) EC full-quality assurance (module
H).
2. The declaration of conformity to type
shall be in written form and shall give the
information specified in Annex B.
3. Where sets of 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).
4. The Commission shall keep an
up-to-date list of approved equipment and
applications withdrawn or refused and shall
make it available to interested parties.
Article 11
1. Equipment referred to in Annex A.1
which complies with the relevant
international instruments and is
manufactured in accordance with the
conformity-assessment procedures shall have
the mark affixed to it by the manufacturer
or his authorized representative established
within the Community.
2. The mark shall be followed by the
identification number of the notified body
which has performed the
conformity-assessment procedure, if that
body is involved in the production-control
phase, and by the last two digits of the
number of the year in which the mark is
affixed. The identification number of the
notified body shall be affixed under its
responsibility either by the body itself or
by the manufacturer or his authorized
representative established within the
Community.
3. The form of the mark to be used shall
be as set out in Annex D.
4. The mark shall be affixed to the
equipment or to its data plate so as to be
visible, legible and indelible throughout
the anticipated useful life of the
equipment. However, where that is not
possible or not warranted on account of the
nature of the piece of equipment, it shall
be affixed to the packaging of the product,
to a label or to a leaflet.
5. No marks or inscriptions which are
likely to mislead third parties with regard
to the meaning or the graphics of the mark
referred to in this Directive shall be
affixed.
6. The mark shall be affixed at the end
of the production phase.
Article 12
1. Notwithstanding Article 6, each Member
State may take the measures necessary to
ensure that sample checks are carried out on
equipment bearing the mark which is on its
market and which has not yet been placed on
board, in order to ensure that it complies
with this Directive. Sample checks which are
not provided for in the modules for
conformity assessment in Annex B shall be
carried out at the expense of the Member
State.
2. Notwithstanding Article 6, after the
installation of equipment which complies
with this Directive on board a Community
ship, evaluation by that ship's flag State
administration of that equipment shall be
permitted when operational on-board
performance tests are required by
international instruments for safety and/or
pollution-prevention purposes, provided that
they do not duplicate the
conformity-assessment procedures already
carried out. The flag State administration
may require the manufacturer of the
equipment, his authorized representative
established within the Community or the
person responsible for marketing the
equipment within the Community to provide
the inspection/testing reports.
Article 13
1. Where a Member State ascertains by
inspection or otherwise that,
notwithstanding the fact that it bears the
mark, a piece of equipment referred to in
Annex A.1, when correctly installed,
maintained and used for its intended
purpose, may compromise the health and/or
safety of the crew, the passengers or, where
applicable, other persons, or adversely
affect the marine environment from the
market or prohibit or restrict its being
placed on the market or being used on board
a ship for which it issues the safety
certificates. The Member State shall
immediately inform the other Member States
and the Commission of that measure and
indicate the reasons for its decision and,
in particular, whether non-compliance with
this Directive is due to:
(a) failure to comply with Article 5 (1)
and (2);
(b) incorrect application of the testing
standards referred to in Article 5 (1) and
(2); or
(c) shortcomings in the testing standards
themselves.
2. The Commission shall enter into
consultation with the parties concerned as
soon as possible. Where, after such
consultation, the Commission finds that:
- the measures are justified, it shall
immediately so inform the Member State which
took the initiative and the other Member
States; where the decision referred to in
paragraph 1 is attributed to shortcomings in
the testing standards, the Commission shall,
after consulting the parties concerned,
bring the matter before the Committee
referred to in Article 18 within two months
if the Member State which has taken the
decision intends to maintain it and shall
initiate the procedure referred to in
Article 18,
- the measures are unjustified, it shall
immediately so inform the Member State which
took the initiative and the manufacturer or
his authorized representative established
within the Community.
3. Where a non-complying piece of
equipment bears the mark, the appropriate
measures shall be taken by the Member State
which has authority over whomsoever affixed
the mark; that Member State shall inform the
Commission and the other Member States of
the measures it has taken.
4. The Commission shall ensure that the
Member States are kept informed of the
progress and outcome of this procedure.
Article 14
1. Notwithstanding the provisions of
Article 5, in exceptional circumstances of
technical innovation, the flag State
administration may permit equipment which
does not comply with the
conformity-assessment procedures to be
placed on board a Community ship if it is
established by trial or otherwise to the
satisfaction of the flag State
administration that such equipment is at
least as effective as equipment which does
comply with the conformity-assessment
procedures.
In the case of radiocommunications
equipment, the flag State administration
shall require that such equipment does not
unduly affect the requirements of the
radio-frequency spectrum.
2. Such trial procedures shall in no way
discriminate between equipment produced in
the flag Member State and equipment produced
in other States.
3. Equipment covered by this Article
shall be given a certificate by the flag
Member State which shall at all times be
carried with the equipment and which gives
the flag Member State's permission for the
equipment to be placed on board the ship and
imposes any restrictions or lays down any
provisions relating to the use of the
equipment.
4. Where a Member State allows equipment
covered by this Article to be placed on
board a Community ship, that Member State
shall forthwith communicate the particulars
thereof together with the reports of all
relevant trials, assessments and
conformity-assessment procedures to the
Commission and the other Member States.
5. Equipment such as is referred to in
paragraph 1 shall be added to Annex A.2 in
accordance with the procedure laid down in
Article 18.
6. Where a ship with equipment on board
which is covered by paragraph 1 is
transferred to another Member State, the
receiving flag Member State may undertake
the measures necessary, which may include
tests and practical demonstrations, to
ensure that the equipment is at least as
effective as equipment which does comply
with the conformity-assessment procedures.
Article 15
1. Notwithstanding Article 5, a flag
State administration may permit equipment
which does not comply with the
conformity-assessment procedures or is not
covered by Article 14 to be placed on board
a Community ship for reasons of testing or
evaluation, but only when the following
conditions are complied with:
(a) the equipment must be given a
certificate by the flag Member State which
must at all times be carried with the
equipment and which gives the flag Member
State permission for the equipment to be
placed on board the Community ship and
imposes any restrictions or lays down any
provisions relating to the use of the
equipment;
(b) the permission must be limited to a
short period of time;
(c) the equipment must not be relied on
in place of equipment which meets the
requirements of this Directive and must not
replace such equipment, which must remain on
board the Community ship in working and
ready for immediate use.
2. In the case of radiocommunications
equipment, the flag State administration
shall require that such equipment does not
unduly affect the requirements of the
radio-frequency spectrum.
Article 16
1. Where equipment needs to be replaced
in a port outwith the Community and in
exceptional circumstances which shall be
duly justified to the flag State
administration where it is not practicable
in terms of reasonable time, delay and cost
to place on board equipment which is EC
type-approved, other equipment may be placed
on board in accordance with the following
procedure:
(a) the equipment shall be accompanied by
documentation issued by a recognized
organization equivalent to a notified body,
where an agreement has been concluded
between the Community and the third country
concerned on the mutual recognition of such
organizations;
(b) should it prove impossible to comply
with (a), equipment accompanied by
documentation issued by a Member State of
the IMO which is a party to the relevant
conventions, certifying compliance with the
relevant IMO requirements, may be placed on
board, subject to paragraphs 2 and 3.
2. The flag State administration shall be
informed at once of the nature and
characteristics of such other equipment.
3. The flag State administration shall,
at the earliest opportunity, ensure that the
equipment referred to in paragraph 1, along
with its testing documentation, complies
with the relevant requirements of the
international instruments and of this
Directive.
4. In the case of radiocommunications
equipment, the flag State administration
shall require that such equipment does not
unduly affect the requirements of the
radio-frequency spectrum.
Article 17
This Directive may be amended in
accordance with the procedure laid down in
Article 18, in order:
- to apply subsequent amendments of
international instruments for the purposes
of this Directive,
- to update Annex A, both by introducing
new equipment and by transferring equipment
from Annex A.2 to Annex A.1 and vice versa,
- to add the possibility of using modules
B + C and module H for equipment listed in
Annex A.1,
- to include other standardization
organizations in the definition of 'testing
standards` in Article 2.
Article 18
1. The Commission shall be assisted by
the committee set up by Article 12 of
Council Directive 93/75/EEC of 13 September
1993 concerning minimum requirements for
vessels bound for or leaving Community ports
and carrying dangerous or polluting goods
(9) in accordance with the procedure laid
down in this Article.
2. The Commission representative shall
submit to the committee a draft of the
measures to be taken. The committee shall
deliver its opinion on the draft within a
time limit which the chairman may lay down
according to the urgency of the matter. The
opinion shall be delivered by the majority
laid down in Article 148 (2) of the Treaty
in the case of decisions which the Council
is required to adopt on a proposal from the
Commission. The votes of the representatives
of the Member States within the committee
shall be weighted in the manner set out in
that Article. The chairman shall not vote.
3. (a) The Commission shall adopt the
measures envisaged if they are in accordance
with the opinion of the committee.
(b) If the measures envisaged are not in
accordance with the opinion of the
committee, or if no opinion is delivered,
the Commission shall, without delay, submit
to the Council a proposal relating to the
measures to be taken. The Council shall act
by a qualified majority.
If the Council has not acted within two
months of the date of the referral to it,
the Commission shall adopt the measures
proposed.
Article 19
The Member States shall offer each other
mutual assistance with a view to the
effective implementation and enforcement of
this Directive.
Article 20
1. Member States shall adopt and publish
the laws, regulations and administrative
provisions necessary to comply with this
Directive no later than 30 June 1998.
They shall apply those measures from 1
January 1999.
When Member States adopt the measures
referred to in the first subparagraph, these
shall contain references to this Directive
or shall be accompanied by such references
on their official publication. The methods
of making such references shall be laid down
by the Member States.
2. The Member States shall immediately
communicate to the Commission the texts of
the provisions of national law which they
adopt in the field governed by this
Directive. The Commission shall inform the
other Member States thereof.
Article 21
This Directive shall enter into force on
the day of its publication in the Official
Journal of the European Communities.
Article 22
This Directive is addressed to the Member
States.
Done at Brussels, 20 December 1996.
For the Council
The President
S. BARRETT
(1) OJ No C 218, 23. 8. 1995, p. 9.
(2) OJ No C 101, 3. 4. 1996, p. 3.
(3) European Parliament opinion of 29
November 1995 (OJ No C 339, 18. 12. 1995, p.
21), Council common position of 18 June 1996
(OJ No C 248, 26. 8. 1996, p. 10) and
European Parliament Decision of 24 October
1996 (OJ No C 347, 18. 11. 1996).
(4) OJ No C 271, 7. 10. 1993, p. 1.
(5) OJ No C 220, 30. 8. 1993, p. 23.
(6) OJ No L 139, 23. 5. 1989, p. 19.
Directive as last amended by Directive
93/68/EEC (OJ No L 220, 31. 8. 1993, p. 1).
(7) OJ No L 399, 30. 12. 1989, p. 18.
Directive as last amended by Directive
93/95/EEC (OJ No L 276, 9. 11. 1993, p. 11).
(8) OJ No L 109, 26. 4. 1983, p. 8.
Directive as last amended by the 1994 Act of
Accession.
(9) OJ No L 247, 5. 10. 1993, p. 19.
ANNEX A
Annex A.1: Equipment for which detailed
testing standards already exist in
international instruments (1)
IN ADDITION TO THE INTERNATIONAL TESTING
STANDARDS SPECIFICALLY MENTIONED A NUMBER OF
PROVISIONS, WHICH MUST BE CHECKED DURING
TYPE-EXAMINATION (TYPE-APPROVAL), ARE TO BE
FOUND IN THE RELEVANT CONVENTION REGULATIONS
>TABLE>
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Annex A.2: Equipment for which no
detailed testing standards exist in
international instruments
>TABLE>
>TABLE>
>TABLE>
(1) Where module H appears in column six,
module H plus design-examination certificate
is to be understood.
ANNEX B
Modules for conformity assessment
EC TYPE-EXAMINATION (MODULE B)
1. A notified body must ascertain and
attest that a specimen, representative of
the production envisaged, complies with the
provisions of the international instruments
that apply to it.
2. The application for the EC
type-examination must be lodged by the
manufacturer or his authorized
representative established within the
Community with a notified body of his
choice.
The application must include:
-the name and address of the manufacturer
and, if the application is lodged by the
authorized representative, his name and
address as well,
- a written declaration that the same
application has not been lodged
simultaneously with any other notified body,
- the technical documentation as
described in point 3.
The applicant must place at the disposal
of the notified body a specimen,
representative of the production envisaged
and hereinafter called 'type` (1). The
notified body may request further specimens
if needed for the test programme.
3. The technical documentation must make
it possible to assess the product's
compliance with the requirements of the
relevant international instruments. It must,
as far as is relevant for such assessment,
cover the design, the building standard,
manufacture, installation and functioning of
the product in accordance with the
description of technical documentation set
down in the Appendix to this Annex.
4. The notified body must:
4.1. examine the technical documentation
and verify that the type has been
manufactured in accordance with the
technical documentation;
4.2. perform the appropriate examinations
and necessary tests or have them performed
to check whether the requirements of the
relevant international instruments have
actually been met;
4.3. agree with the applicant the
location where the examinations and
necessary tests will be carried out.
5. Where the type meets the provisions of
the relevant international instruments, the
notified body must issue an EC
type-examination certificate to the
applicant. The certificate must give the
name and address of the manufacturer,
details of the equipment, the conclusions of
the examination, the conditions of its
validity and the necessary data for
identification of the approved type.
A list of the relevant parts of the
technical documentation must be annexed to
the certificate and a copy kept by the
notified body.
If a manufacturer is refused a
type-certification, the notified body must
give detailed reasons for that refusal.
Where a manufacturer reapplies for
type-approval for equipment for which a
type-certificate has been refused, his
submission to the notified body must include
all relevant documentation, including the
original test reports, the detailed reasons
for the previous refusal and details of all
modifications made to the equipment.
6. The applicant must inform the notified
body that holds the technical documentation
concerning the EC type-examination
certificate of all modifications to the
approved product, which must receive
additional approval where such changes may
affect compliance with the requirements or
the prescribed conditions for use of the
product. Such additional approval must be
given in the form of an addition to the
original EC type-examination certificate.
7. Each notified body must, on request,
provide flag Member State administrations
and the other notified bodies with the
relevant information concerning the EC
type-examination certificates and additions
issued and withdrawn.
8. The other notified bodies may receive
copies of the EC type-examination
certificates and/or their additions. The
Annexes to the certificates must be kept at
the disposal of the other notified bodies.
9. The manufacturer or his authorized
representative established within the
Community must keep with the technical
documentation copies of EC type-examination
certificates and their additions for at
least 10 years after the last product has
been manufactured.
CONFORMITY TO TYPE (MODULE C)
1. A manufacturer or his authorized
representative established within the
Community must ensure and declare that the
products concerned conform to type as
described in the EC type-examination
certificate and satisfy the requirements of
the international instruments that apply to
them. The manufacturer or his authorized
representative established within the
Community must affix the mark to each
product and draw up a written declaration of
conformity.
2. The manufacturer must take all
measures necessary to ensure that the
manufacturing process ensures that the
manufactured products conform to type as
described in the EC type-examination
certificate and comply with the requirements
of the international instruments that apply
to them.
3. The manufacturer or his authorized
representative established within the
Community must keep a copy of the
declaration of conformity for at least 10
years after the last product has been
manufactured.
PRODUCTION-QUALITY ASSURANCE (MODULE D)
1. A manufacturer who satisfies the
obligations of point 2 must ensure and
declare that the products concerned conform
to type as described in the EC
type-examination certificate. The
manufacturer or his authorized
representative established within the
Community must affix the mark to each
product and draw up a written declaration of
conformity. The mark must be accompanied by
the identification symbol of the notified
body responsible for surveillance as
specified in point 4.
2. The manufacturer must operate an
approved quality system for production,
final-product inspection and testing as
specified in point 3 and must be subject to
surveillance as specified in point 4.
3. Quality system
3.1. The manufacturer must lodge an
application for assessment of his quality
system with a notified body of his choice
for the products concerned.
The application must include:
- all relevant information for the
product 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 must ensure that
the products conform to type as described in
the EC type-examination certificate.
All the elements, requirements and
provisions adopted by the manufacturer must
be documented in a systematic and orderly
manner in the form of written policies,
procedures and instructions. The
quality-system documentation must permit a
consistent interpretation of the quality
programmes, plan, manuals and records.
It must, in particular, include an
adequate description of:
- the quality objectives and the
organizational structure, responsibilities
and powers of the management with regard to
product quality,
- the 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 of the personnel
concerned, etc.,
- the means of monitoring the achievement
of the required product quality and the
effective operation of the quality system.
3.3. The notified body must assess the
quality system to determine whether it
satisfies the requirements laid down in
point 3.2. It must presume compliance with
those requirements in respect of quality
systems that implement the relevant
harmonized standard.
The auditing team must have at least one
member with experience of assessment in the
product technology concerned. The assessment
procedure must include a visit to the
manufacturer's premises.
The manufacturer must be notified of the
decision. The notification must include the
conclusions of the examination and the
reasoned assessment decision.
3.4. The manufacturer must undertake to
fulfil the obligations arising out of the
quality system as approved and to uphold it
so that it remains adequate and efficient.
The manufacturer or his authorized
representative established within the
Community must keep the notified body that
has approved the quality system informed of
any intended updating of that quality
system.
The notified body must assess the
modifications proposed and decide whether
the modified quality system will still
satisfy the requirements laid down in point
3.2 or whether a reassessment is required.
The manufacturer must be notified of its
decision. The notification must include 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 must allow the
notified body access for inspection purposes
to the locations of manufacture, inspection
and testing and storage and must 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 of the personnel
concerned, etc.
4.3. The notified body must periodically
carry out audits to make sure that the
manufacturer maintains and applies the
quality system and must provide the
manufacturer with audit reports.
4.4. In addition, the notified body may
pay unannounced visits to the manufacturer.
During such visits the notified body may
carry out tests or cause tests to be carried
out to check that the quality system is
functioning correctly, if necessary. The
notified body must provide the manufacturer
with a visit report and, if a test has taken
place, with a test report.
5. The manufacturer must, for at least 10
years after the last product has been
manufactured, keep at the disposal of the
national authorities:
- the documentation referred to in the
second indent of the second paragraph of
point 3.1,
- the updating referred to in the second
paragraph of point 3.4,
- the decision and reports from the
notified body referred to in the final
paragraph of point 3.4, point 4.3 and point
4.4.
6. Each notified body must, on request,
provide flag Member State administrations
and the other notified bodies with the
relevant information concerning the
quality-system approvals issued and
withdrawn.
PRODUCT-QUALITY ASSURANCE (MODULE E)
1. A manufacturer who satisfies the
obligations of point 2 ensures and declares
that the products concerned conform to type
as described in the EC type-examination
certificate. The manufacturer or his
authorized representative established within
the Community must affix the mark to each
product and draw up a written declaration of
conformity. The mark must be accompanied by
the identification symbol of the notified
body responsible for surveillance as
specified in point 4.
2. The manufacturer must operate an
approved quality system for final inspection
and testing as specified in point 3 and must
be subject to surveillance as specified in
point 4.
3. Quality system
3.1. The manufacturer must lodge an
application for assessment of his quality
system for the products concerned with a
notified body of his choice.
The application must include:
- all relevant information for the
product category envisaged,
- documentation concerning the quality
system,
- the technical documentation of the
approved type and a copy of the EC
type-examination certificate.
3.2. Under the quality system, each
product must be examined and appropriate
tests must be carried out in order to ensure
its compliance with the relevant
requirements of the international
instruments. All the elements, requirements
and provisions adopted by the manufacturer
must be documented in a systematic and
orderly manner in the form of written
policies, procedures and instructions. That
quality-system documentation must ensure
common understanding of the quality
programmes, plans, manuals and records.
It must, in particular, include an
adequate description of:
- the quality objectives and the
organizational structure, responsibilities
and powers of the management with regard to
product quality,
- the examinations and tests that will be
carried out after manufacture,
- the means of monitoring the effective
operation of the quality system,
- the quality records, such as inspection
reports and test data, calibration data,
qualification reports of the personnel
concerned, etc.
3.3 The notified body must assess the
quality system to determine whether it
satisfies the requirements laid down in
point 3.2. It must presume compliance with
the requirements in respect of quality
systems that implement the relevant
harmonized standard.
The auditing team must have at least one
member with experience as an assessor in the
product technology concerned. The assessment
procedure must include an assessment visit
to the manufacturer's premises.
The manufacturer must be notified of the
decision. The notification must include the
conclusions of the examination and the
reasoned assessment decision.
3.4. The manufacturer must undertake to
fulfil the obligations arising out of the
quality system as approved and to maintain
it in an appropriate and efficient manner.
The manufacturer or his authorized
representative established within the
Community must keep the notified body that
has approved the quality system informed of
any intended updating of that quality
system.
The notified body must evaluate the
modifications proposed and decide whether
the modified quality system will still
satisfy the requirements laid down in point
3.2 or whether a reassessment is required.
The manufacturer must be notified of its
decisions. The notification must include 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 must allow the
notified body access for inspection purposes
to the locations of inspection, testing and
storage and must provide it with all
necessary information, in particular:
- the quality-system documentation,
- the technical documentation,
- the quality records, such as inspection
reports and test data, calibration data,
qualification reports of the personnel
concerned, etc.
4.3. The notified body must periodically
carry out audits to make sure that the
manufacturer maintains and applies the
quality system and must provide the
manufacturer with audit reports.
4.4. In addition, the notified body may
pay unannounced visits to the manufacturer.
During such visits the notified body may
carry out tests or cause tests to be carried
out to check that the quality system is
functioning correctly, if necessary. The
notified body must provide the manufacturer
with a visit report and, if a test has been
carried out, with a test report.
5. The manufacturer must, for at least 10
years after the last product has been
manufactured, keep at the disposal of the
national authorities:
- the documentation referred to in the
third indent of the second paragraph of
point 3.1,
- the updating referred to in the second
paragraph of point 3.4,
- the decision and reports from the
notified body referred to in the final
paragraph of point 3.4, point 4.3 and point
4.4.
6. Each notified body must on request
provide flag Member State administrations
and the other notified bodies with the
relevant information concerning the
quality-system approvals issued and
withdrawn.
PRODUCT VERIFICATION (MODULE F)
1. A manufacturer or his authorized
representative established within the
Community must check and attest that the
products subject to point 3 conform to the
type as described in the EC type-examination
certificate.
2. The manufacturer must take all
measures necessary to ensure that the
manufacturing process ensures that the
products conform to type as described in the
EC type-examination certificate. He must
affix the mark to each product and must draw
up a declaration of conformity.
3. The notified body must carry out the
appropriate examinations and tests in order
to check that the product complies with the
requirements of the international
instruments either by examination and
testing of every product as specified in
point 4 or by examination and testing of
products on a statistical basis, as
specified in point 5, at the choice of the
manufacturer.
3a. The manufacturer or his authorized
representative established within the
Community must keep a copy of the
declaration of conformity for at least 10
years after the last product has been
manufactured.
4. Verification by examination and
testing of every product
4.1. All products must be individually
examined and appropriate tests must be
carried out in order to verify their
conformity to type as described in the EC
type-examination certificate.
4.2. The notified body must affix its
identification symbol or cause it to be
affixed to each approved product and draw up
a written certificate of conformity relating
to the tests carried out.
4.3. The manufacturer or his authorized
representative established within the
Community must ensure that he is able to
supply the notified body's certificate of
conformity on request to the flag Member
State administration.
5. Statistical verification
5.1. The manufacturer must present his
products in the form of homogeneous lots and
must take all measures necessary to ensure
that the manufacturing process ensures the
homogeneity of each lot produced.
5.2. All products must be available for
verification in the form of homogeneous
lots. A random sample must be drawn from
each lot. Products in a sample must be
individually examined and appropriate tests
must be carried out to ensure that they
comply with the requirements of the
international instruments which apply to
them and to determine whether the lot is to
be accepted or rejected.
5.3. In the case of accepted lots, the
notified body must affix its identification
symbol or cause it to be affixed to each
product and must draw up a written
certificate of conformity relating to the
tests carried out. All products in the lot
may be put on the market except those
products from the sample which are found not
to comply.
If a lot is rejected, the notified body
or the competent authority must take
appropriate measures to prevent that lot's
being put on the market. In the event of
frequent rejection of lots the notified body
may suspend statistical verification.
The manufacturer may, under the
responsibility of the notified body, affix
the latter's identification symbol during
the manufacturing process.
5.4. The manufacturer or his authorized
representative established within the
Community must ensure that he is able to
supply the notified body's certificates of
conformity on request to the flag Member
State administration.
UNIT VERIFICATION (MODULE G)
1. The manufacturer must ensure and
declare that the product concerned, which
has been issued with the certificate
referred to in point 2, complies with the
requirements of the international
instruments that apply to it. The
manufacturer or his authorized
representative established within the
Community must affix the mark to the product
and draw up a declaration of conformity.
2. The notified body must examine the
individual product and carry out appropriate
tests to ensure that it complies with the
relevant requirements of the international
instruments.
The notified body must affix its
identification number or cause it to be
affixed to the approved product and must
draw up a certificate of conformity
concerning the tests carried out.
3. The aim of the technical documentation
is to enable compliance with the
requirements of the international
instruments to be assessed and the design,
manufacture and operation of the product to
be understood.
FULL-QUALITY ASSURANCE (MODULE H)
1. A manufacturer who satisfies the
obligations of paragraph 2 must ensure and
declare that the products concerned comply
with the requirements of the international
instruments that apply to them. The
manufacturer or his authorized
representative established within the
Community must affix the mark to each
product and draw up a written declaration of
conformity. The mark must be accompanied by
the identification symbol of the notified
body responsible for surveillance as
specified in point 4.
2. The manufacturer must operate an
approved quality system for design,
manufacture, final-product inspection and
testing as specified in point 3 and must be
subject to surveillance as specified in
point 4. 3. Quality system
3.1. The manufacturer must lodge an
application for assessment of his quality
system with a notified body.
The application must include:
- all relevant information for the
product category envisaged and
- documentation concerning the quality
system.
3.2. The quality system must ensure that
the products comply with the requirements of
the international instruments that apply to
them.
All the elements, requirements and
provisions adopted by the manufacturer must
be documented in a systematic and orderly
manner in the form of written policies,
procedures and instructions. The
quality-system documentation must ensure
common understanding of the quality policies
and procedures such as quality programmes,
plans, manuals and records.
It must, in particular, include an
adequate description of:
- the quality objectives and the
organizational structure, responsibilities
and powers of the management with regard to
product quality,
- the technical design specifications,
including standards, that will be applied
and the assurance that the essential
requirements of the international
instruments that apply to the products will
be met,
- the design-control and
design-verification techniques, processes
and systematic actions that will be used in
the design of the products pertaining to the
product category covered,
- 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 of the personnel
concerned, etc.,
- the means of monitoring the achievement
of the required design and product quality
and the effective operation of the quality
system.
3.3. The notified body must assess the
quality system to determine whether it
satisfies the requirements laid down in
point 3.2. It must presume compliance with
the requirements in respect of quality
systems that implement the relevant
harmonized standard.
The auditing team must have at least one
member with experience as an assessor in the
product technology concerned. The assessment
procedure must include an assessment visit
to the manufacturer's premises.
The manufacturer must be notified of the
decision. The notification must include the
conclusions of the examination and the
reasoned assessment decision.
3.4. The manufacturer must undertake to
fulfil the obligations arising from the
quality system as approved and to uphold it
so that it remains adequate and efficient.
The manufacturer or his authorized
representative established within the
Community must keep the notified body that
has approved the quality system informed of
any intended updating of that quality
system.
The notified body must evaluate the
modifications proposed and decide whether
the modified quality system will still
satisfy the requirements laid down in point
3.2 or whether a reassessment is required.
The manufacturer must be notified of its
decisions. The notification must include the
conclusions of the examination and the
reasoned assessment decision.
4. EC 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 must allow the
notified body access for inspection purposes
to the locations of design, manufacture,
inspection and testing and storage and must
provide it with all necessary information,
in particular:
- the quality-system documentation,
- the quality records as provided for in
the design part of the quality system, such
as the results of analyses, calculations,
tests, etc.,
- the quality records as provided for in
the manufacturing part of the quality
system, such as inspection reports and test
data, calibration data, qualification
reports of the personnel concerned, etc.
4.3. The notified body must periodically
carry out audits to make sure that the
manufacturer maintains and applies the
quality system and must provide the
manufacturer with audit reports.
4.4. In addition the notified body may
pay unannounced visits to the manufacturer.
During such visits, the notified body may
carry out tests or cause tests to be carried
out to check that the quality system is
functioning correctly, if necessary. The
notified body must provide the manufacturer
with a visit report and, if a test has been
carried out, with a test report.
5. The manufacturer must, for at least 10
years after the last product has been
manufactured, keep at the disposal of the
national authorities:
- the documentation referred to in the
second indent of the second paragraph of
point 3.1,
- the updating referred to in the second
paragraph of point 3.4,
- the decision and reports from the
notified body referred to in the final
paragraph of point 3.4, point 4.3 and point
4.4.
6. Each notified body must, on request,
provide flag Member State administrations
and the other notified bodies with the
relevant information concerning the
quality-system approvals issued and
withdrawn.
7. Design examination
7.1. The manufacturer must lodge an
application for examination of the design
with a single notified body.
7.2. The application must make it
possible to understand the design,
manufacture and operation of the product and
to assess compliance with the requirements
of international instruments.
It must include:
- the technical design specifications,
including standards, that have been applied
and
- the necessary supporting evidence for
their adequacy, in particular where the
standards specified in Article 5 have not
been applied in full. Such supporting
evidence must include the results of tests
carried out by an appropriate laboratory of
the manufacturer's or on his behalf.
7.3. The notified body must examine the
application and where the design complies
with those provisions of the international
instruments that apply it must issue an EC
design-examination certificate to the
applicant. The certificate must include the
conclusions of the examination, the
conditions of its validity, the data
necessary for identification of the approved
design and, if relevant, a description of
the product's functioning.
7.4. The applicant must keep the notified
body that has issued the EC
design-examination certificate informed of
any modification to the approved design.
Modifications to the approved design must
receive additional approval from the
notified body that issued the EC
design-examination certificate where such
changes may affect compliance with the
relevant requirements of the international
instruments or the prescribed conditions for
use of the product. Such additional approval
must be given in the form of an addition to
the original EC design-examination
certificate.
7.5. The notified bodies must, on
request, provide flag Member State
administrations and the other notified
bodies with the relevant information
concerning:
- the EC design-examination certificates
and additions issued and
- the EC design-approvals and additional
approvals withdrawn.
Appendix to Annex B
Technical documentation to be supplied by
the manufacturer to the notified body
The provisions set down in this Appendix
apply to all modules of Annex B.
The technical documentation referred to
in Annex B must comprise all relevant data
and means used by the manufacturer to ensure
that equipment complies with the essential
requirements relating to it.
The technical documentation must make it
possible to understand the design,
manufacture and operation of the product,
and must make it possible to assess
compliance with the requirements of the
relevant international instruments.
The documentation must, so far as they
are relevant to assessment, include:
- a general description of the type,
- conceptual-design, build standard and
manufacturing drawings and schemes of
components, sub-assemblies, circuits, etc.,
- descriptions and explanations necessary
for the understanding of those drawings and
schemes, including the operation of the
product,
- the results of design calculations
made, impartial examinations carried out,
etc.,
- impartial test reports,
- manuals for installation, use and
maintenance.
Where appropriate, the design
documentation must contain the following:
- attestations relating to the equipment
incorporated in the appliance,
- attestations and certificates relating
to the methods of manufacture and/or
inspection and/or monitoring of the
appliance,
- any other document that makes it
possible for the notified body to improve
its assessment.
(1) A type may cover several versions of
the product provided that the differences
between the versions do not affect the level
of safety or the other requirements
concerning the performance of the product.
ANNEX C
Minimum criteria to be taken into account
by Member States for the designation of
bodies
1. Notified bodies must fulfil the
requirements of the relevant EN 45000
series.
2. A notified body must be independent
and must not be controlled by manufacturers
or by suppliers.
3. A notified body must be established
within the territory of the Community.
4. Where type-approvals are issued by a
notified body on behalf of a Member State,
the Member State must ensure that the
qualifications, technical experience and
staffing of the notified body are such as
will enable it to issue type-approvals which
comply with the requirements of this
Directive and to guarantee a high level of
safety.
5. A notified body must be in a position
to provide maritime expertise.
A notified body is entitled to perform
conformity-assessment procedures for any
economic operator established within or
outwith the Community.
A notified body may perform
conformity-assessment procedures in any
Member State or State outwith the Community
using either its home-based means or the
personnel of its branch office abroad.
If a subsidiary of a notified body
performs conformity-assessment procedures,
all documents relating to the
conformity-assessment procedures must be
issued by and in the name of the notified
body and not in the name of the subsidiary.
A subsidiary of a notified body which is
established in another Member State may,
however, issue documents relating to
conformity-assessment procedures if it is
notified by that Member State.
ANNEX D
Mark of conformity
The mark of conformity must take the
following form:
>REFERENCE TO A FILM>
If the mark is reduced or enlarged the
proportions given in the above graduated
drawing must be respected.
The various components of the 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.
