Celex 31993L0068 en
Celex 31993L0068 en
Celex 31993L0068 en
II
COUNCIL
of 22 July 1993
THE COUNCIL OF THE EUROPEAN COMMUNITIES, marking; whereas, therefore, in the interests of
simplifying Community legislation and making it more
consistent, these various provisions need to be replaced
Having regard to the Treaty establishing the European by uniform prescriptions; whereas it is therefore
Economic Community, and in particular Article 100a necessary to harmonize these provisions, particularly with
thereof, regard to products which may fall within the scope of
several of these Directives;
Having regard to the proposal from the Commission ('),
Whereas, in its communication of 15 June 1989 on a
global approach to certification and testing (5), the
In cooperation with the European Parliament (2), Commission proposed that common rules be drawn up
concerning a 'CE' conformity marking with a single
design; whereas, in its Resolution of 21 December 1989
Having regard to the opinion of the Economic and Social
Committee (3 ), on a global approach to conformity assessment (6), the
Council approved as a guiding principle the adoption of a
consistent approach such as this with regard to the use of
Whereas the Council has already adopted a series of the 'CE' marking;
Directives designed to remove technical barriers to trade
in accordance with the principles established in its
Resolution of 7 May 1985 on a new approach to Whereas the two basic elements of the new approach
technical harmonization and standards (4 ); whereas each which must be applied are therefore the essential
of these Directives provides for the affixing of the 'CE' requirements and the conformity assessment procedures;
4. In Article 9 the first paragraph is replaced by the 3.3 . When a batch is examined, the inspection body
following text: shall ensure that the vessels have been
manufactured and checked in accordance with
' 1 . Member States shall notify the Commission the design and manufacturing schedule and
and the other Member States of the approved bodies perform a hydrostatic test or a pneumatic test
which they have appointed to carry out the of equivalent effect on each vessel in the batch
procedures referred to in Article 8 ( 1 ) and (2 ) at a pressure Ph equal to 1,5 times the vessel's
together with the specific tasks which these bodies design pressure in order to check its
have been appointed to carry out and the soundness. The pneumatic test shall be subject
identification numbers assigned to them beforehand to acceptance of the test safety procedures by
by the Commission. the Member State in which the test is
performed.
The Commission shall publish in . the Official
Journal of the European Communities a list of the Moreover, the inspection body shall carry out
notified bodies with their identification numbers and
tests on test-pieces taken from a representative
the tasks for which they have been notified. The production test-piece or from a vessel, as the
Commission shall ensure that this list is kept up to manufacturer chooses, in order to examine the
date.'; weld quality. The tests shall be carried out on
longitudinal welds . However, where differing
5 . Article 1 1 is replaced by the following text: weld techniques are used for longitudinal and
circular welds, the tests shall be repeated on
'EC verification the circular welds .
Article 11
For the vessels referred to in Annex I, section
1. EC verification is the procedure whereby a 2.1.2 these tests on test-pieces shall be replaced
manufacturer or his authorized representative by a hydrostatic test on five vessels taken at
random from each batch in order to check that
established within the Community ensures and
declares that the vessels which have been checked in they conform to the requirements of Annex I,
section 2.1.2 .
accordance with paragraph 3 are in conformity to
the type described in the EC type-examination
certificate or with the design and manufacturing 3.4. In the case of accepted batches, the approved
schedule referred to in Annex II section 3 having body shall affix, or cause to be affixed, its
received a certificate of adequacy. identification number to each recipient and
draw up a written certificate of conformity
2 . The manufacturer shall take all the necessary relating to the tests carried out. All recipients
measures for the manufacturing process to ensure in the batch may be placed on the market
that the vessels conform to the type described in the except for those which have not successfully
EC type-examination certificate or to the design and undergone a hydrostatic test or a pneumatic
test .
manufacturing schedule referred to in Annex II
section 3 - The manufacturer or his authorized
representative established within the Community If a batch is rejected, the notified body or the
shall affix the CE marking to each vessel and draw competent authority shall take appropriate
up a declaration of conformity. measures to prevent the putting on the market
of that batch. In the event of frequent rejection
3 . The approved body shall carry out the of batches, the notified body may suspend the
appropriate examinations and tests in order to check statistical verification .
the conformity of the vessels with the requirements
of this Directive by examination and testing of The manufacturer may, under the
vessels in accordance with the following responsibility of the notified body, affix the
paragraphs : latter's identification number during the
manufacturing process .
3.1 . The manufacturer shall present his vessels in
the form of uniform batches and shall take all 3.5 . The manufacturer or his authorized
necessary measures in order that the representative must be able to supply on
manufacturing process ensures the uniformity request the approved body's certificates of
of each batch produced . conformity referred to in subparagraph 3.4.';
3.2. These batches shall be accompanied by the EC
type-examination certificate referred to in
Article 10, or, where the vessels are not in Article 12 ( 1 ) the first sentence is replaced by the
manufactured in accordance with an approved following text:
prototype, by the design and manufacturing
schedule referred to in Annex II section 3 . In ' 1 . A manufacturer fulfilling the obligations
this case the approved body shall, prior to EC arising out of Article 13 shall affix the CE marking
verification, examine the schedule in order to provided for in Article 16 to vessels which he
certify its conformity. , declares to be in conformity:
No L 220/4 Official Journal of the European Communities 30 . 8 . 93
10. in Annex II, section 1 is replaced by the following 2. in Article 5 the first paragraph is replaced by the
text: following text:
'1. CE MARKING AND INSCRIPTIONS
'1. Member States shall presume that toys bearing
the CE marking laid down in Article 11 comply with
1 . (a ) CE conformity marking all the provisions of this Directive, including the
— The CE conformity marking shall
conformity assessment procedures referred to in
consist of the initials " CE " in the Articles 8 , 9 and 10.
following form:
Conformity of toys with the national standards which
transpose the harmonized standards the reference
numbers of which have been published in the Official
Journal of the European Communities shall result in
a presumption of conformity to the essential safety
requirements referred to in Article 3 . Member States
shall publish the reference numbers of such national
standards.';
30 . 8 . 93 Official Journal of the European Communities No L 220/5
'2 . The CE conformity marking shall consist of the Directive 89/106/EEC is hereby amended as follows:
initials " CE" taking the form of the specimen given in
Annex V. ';
1 . throughout the text, the term 'EC mark' is replaced
by 'CE marking';
6. in Article 11 the third paragraph is replaced by the
following text:
2 . in Article 2 the second paragraph is replaced by the
'3 . The affixing of markings on the toys which are following text:
likely to deceive third parties as to the meaning and
form of the CE marking shall be prohibited . Any '2. (a ) When products are subject to other Directives
other marking may be affixed to the toys, their with regard to other aspects and which also
packaging or a label provided that the visibility and provide for the affixing of the CE conformity
legibility of the EC marking is not thereby reduced .'; marking, referred to in Article 4 (2 ), the latter
shall indicate that the products are also
presumed to conform to the provisions of
7. the following paragraph is added to Article 12 : those other Directives .
' la. Without prejudice to Article 7: ( b ) However, where one or more of these
Directives allow the manufacturer, during a
(a ) where a Member State establishes that the CE transitional period, to choose which
marking has been affixed unduly, the arrangements to apply, the CE marking shall
No L 220/6 Official Journal of the European Communities 30 . 8 . 93
indicate conformity only to the Directives construction products on a label fixed to the product
applied by the manufacturer. In this case, packaging or on the accompanying commercial
particulars of the Directives applied, as documents provided that the visibility and legibility of
published in the Official Journal of the the CE marking is not thereby reduced.';
European Communities, must be given in the
documents, notices or instructions required 7. in Article 18 the first paragraph is replaced by the
by the Directives and accompany such following text:
products.';
'1 . Member States shall notify the Commission and
the other Member States of the certification and
3 . in Article 4 (2) the introduction is replaced by the
following text: inspection bodies and the testing laboratories which
they have designated for the tasks which must be
'2. Member States shall presume that products are carried out for the purposes of technical approval,
fit for use if they enable works in which they are certificates of conformity, inspections and tests, in
employed, provided the latter are properly designed accordance with this Directive, together with their
names and addresses and the identification numbers
and built, to satisfy the essential requirements referred
to in Article 3 where such products bear the CE assigned to them beforehand by the Commission.
marking indicating that they satisfy all the provisions
of this Directive, including the conformity assessment The Commission shall publish in the Official Journal
procedures laid down in Chapter V and the of the European Communities a list of the notified
bodies and laboratories with their identification
procedure laid down in Chapter III. The CE marking
shall indicate:'; numbers and the tasks and products for which they
have been notified . The Commission shall ensure that
this list is kept up to date.';
4. in Article 4 ( 6 ) the first subparagraph is replaced by
the following text: 8 . Annex III section 4 is replaced by the following
text :
'6. The CE marking signifies that products satisfy
the requirements of paragraphs 2 and 4 of this '4.1 . CE conformity marking
Article . It is for the manufacturer or his authorized
representative established within the Community to — The CE conformity marking shall consist of
take responsibility for affixing the CE marking on the the initials " CE" taking the following
product itself, on a label attached to it, on its form:
packaging, or on the accompanying commercial
documents.';
Member States shall take all appropriate measures to 6 . Annex I section 2 is replaced by the following text:
ensure that the apparatus referred to in Article 2 may
be placed on the market or taken into service only if '2 . CE conformity marking
it bears the CE marking provided for in Article 10
indicating its conformity to all the provisions of this — The CE conformity marking shall consist of
Directive, including the conformity assessment the initials " CE" taking the following form:
procedures laid down in Article 10, when it is
properly installed and maintained and when it is used
for the purposes for which it is intended .';
2 . in Article 8 the fifth paragraph is replaced by the regards the provisions concerning the CE
following text: marking and to end the infringement under
the conditions imposed by the Member
'5 . ( a) Where the machinery is subject to other State;
Directives concerning other aspects and
which also provide for the affixing of the EC ( b ) where non-conformity continues, the Member
marking, the latter shall indicate that the State must take all appropriate measures to
machinery is also presumed to conform to the restrict or prohibit the placing on the market
provisions of those other Directives. of the product in question or to ensure that it
is withdrawn from the market in accordance
( b) However, where one or more of these with the procedures laid down in Article 7.';
Directives allow the manufacturer, during a
transitional period, to choose which 7 . section 1.7.3 of Annex I is amended as follows :
arrangements to apply, the CE marking shall
indicate conformity only to the Directives (a ) the second indent is replaced by the following
applied by the manufacturer. In this case, text :
particulars of the Directives applied, as
published in the Official Journal of the '— the CE marking ( see Annex III)';
European Communities, must be given in the
documents, notices or instructions required ( b ) a fifth indent is added:
by the Directives and accompanying such
machinery.'; '— the year of construction';
3 . in Article 9 the first paragraph is replaced by the 8 . Annex III is replaced by the following text:
following text:
■'ANNEX III
' 1 . Member States shall notify the Commission and
the other Member States of the approved bodies CE CONFORMITY MARKING
which they have appointed to carry out the
procedures referred to in Article 8 together with the — The CE conformity marking shall consist of the
specific tasks which these bodies have been appointed initials " CE " taking the following form:
to carry out and the identification numbers assigned
to them beforehand by the Commission .
The Commission shall publish in the Official Journal
of the European Communities a list of the notified
bodies and their identification numbers and the tasks
for which they have been notified . The Commission
shall ensure that this list is kept up to date.';
4 . in Article 10 the first paragraph is replaced by the — If the CE marking is reduced or enlarged the
following text: proportions given in the above drawing must be
respected .
'1 . The CE conformity marking shall consist of the
initials " CE ". The form of the marking to be used is — The various components of the CE marking must
shown in Annex III.'; have substantially the same vertical dimension,
which may not be less than 5 mm. This minimum
5 . In Article 10 the third paragraph is replaced by the dimension may be waived for small-scale
following text: machinery.'
Directive and which bear the CE marking attesting notified body in the production control phase as
their conformity to all the provisions of this Directive, indicated in Article 11 , its identification number shall
including the certification procedures in Chapter II.'; be added .
'Article 13
1 . The CE conformity marking shall consist of the — If the CE marking is reduced or enlarged the
initials " CE" in the form shown in the specimen in proportions given in the above graduated drawing
Annex IV. In the event of the involvement of a must be respected.
No L 220/10 Official Journal of the European Communities 30 . 8 . 93
— The various components of the CE marking must carry out and the identification numbers assigned to
have substantially the same vertical dimension, them beforehand by the Commission.
which may not be less than 5 mm. This minimum
dimension may be waived for small-scale PPE. The Commission shall publish in the Official
Journal of the European Communities a list of the
Additional information notified bodies and their identification numbers and
the tasks for which they have been notified. The
— The last two digits of the year in which the CE Commission shall ensure that this list is kept up to
marking was affixed; this information is not date.';
required in the case of the PPE referred to in
Article 8 ( 3 ).' 5 . in Article 10 the third paragraph is replaced by the
following text:
' 3 . The affixing of markings on the instruments
Article 8
which are likely to deceive third parties as to the
meaning and form of the CE marking shall be
Directive 90/384/EEC is hereby amended as follows : prohibited . Any other marking may be affixed to the
instruments provided that the visibility and legibility
1 . throughout the text, the term ' EC mark' is replaced of the CE markings is not thereby reduced .';
by 'CE marking';
6. Article 11 is replaced by the following text:
2. in Article 2 the second paragraph is replaced by the 'Article 11
following text:
Without prejudice to Article 7:
'2 . Member States shall take all steps to ensure
that instruments may not be brought into service for (a ) where a Member State establishes that the CE
the uses set out in Article 1 (2 ) ( a ) unless they meet marking has been affixed unduly, the
the requirements of this Directive which apply to manufacturer or his authorized representative
them, including the conformity assessment established within the Community shall be
procedures referred to in Chapter II, and obliged to make the instrument conform as
accordingly bear the CE marking provided for in regards the provisions concerning the CE
Article 10 .'; marking and to end the infringement under the
conditions imposed by the Member State;
3 . in Article 8 the third paragraph is replaced by the ( b) where non-conformity continues, the Member
following text: State must take all appropriate measures to
restrict or prohibit the placing on the market of
'3 . (a ) Where the instruments are subject to other the instrument in question or to ensure that it is
Directives covering other aspects and which withdrawn from the market in accordance with
also provide for the affixing of the CE the procedures laid down in Article 7.';
marking, the latter shall indicate that the
instruments in question are also presumed 7. the following paragraphs of Annex II are amended
to conform to the provisions of those other as follows :
Directives .
( a ) in paragraph 2.1 the second and third
( b ) However, where one or more of the subparagraphs are replaced by the following
Directives which apply to the instruments text :
allow the manufacturer, during a
'The manufacturer or his authorized
transitional period, to choose which
arrangements to apply, the CE marking representative established within the
shall indicate conformity only to the Community shall affix the CE marking to each
Directives applied by the manufacturer. In instrument and the inscriptions provided for in
this case, particulars of the Directives Annex IV and shall draw up a written
applied, as published in the Official Journal declaration of conformity.
of the European Communities, must be The CE marking shall be accompanied by the
given in the documents, notices or identification number of the notified body
instructions required by the Directives and responsible for the EC surveillance referred to
accompanying such instruments.'; in paragraph 2.4 .';
4. in Article 9 the first paragraph is replaced by the ( b ) paragraphs 3 and 4 are replaced by the
following text: following text:
'3. EC verification
'1 . Member States shall notify the Commission
and the other Member States of the bodies which 3.1 . EC verification is the procedure whereby
they have appointed to carry out the procedures the manufacturer or his authorized
referred to in Article 8 together with the specific representative established within the
tasks which these bodies have been appointed to Community ensures and declares that the
30 . 8 . 93 Official Journal of the European Communities No L 220/11
instruments which have been checked in declares that the instrument, generally
accordance with paragraph 3.3 are, designed for a specific application, which
where applicable, in conformity to the has been issued with the certificate
type described in the EC referred to in paragraph 4.2 conforms to
type-examination certificate and satisfy the requirements of this Directive that
the requirements of the Directive which apply to it. The manufacturer or his
apply to them . authorized representative shall affix the
CE marking to the instrument and shall ,
3.2. The manufacturer shall take all necessary draw up a written declaration of
measures in order that the manufacturing conformity.
process ensures conformity of the
instruments, where applicable, with the 4.2. The notified body shall examine the
type as described in the EC instrument and carry out the appropriate
type-examination certificate and with the tests, as set out in the respective
requirements of this Directive which standard ( s ) referred to in Article 5 , or
apply to them. The manufacturer or his equivalent tests, in order to ensure its
authorized representative established conformity to the relevant requirements
within the Community shall affix the CE of this Directive.
marking to each instrument and draw up
a written declaration of conformity. The notified body shall affix, or cause to
be affixed, its identification number to
3.3 . The notified body shall carry out the the instrument the conformity of which
appropriate examinations and tests in to requirements has been established and
order to check the conformity of the shall draw up a written certificate of
product to the requirements of this conformity concerning the tests carried
Directive by examination and testing of out .
every instrument, as specified in
paragraph 3.5 . 4.3 . The aim of the technical documentation
3.4. For instruments not subject to EC relating to the design of the instrument,
type-approval, the documents relating to as referred to in Annex III, is to enable
the design of the instrument, as set out in conformity to the requirements of this
Annex III, must be accessible to the Directive to be assessed and the design,
notified body should the latter so manufacture and operation of the
instrument to be understood . It must be
request.
accessible to the notified body.
3.5 . Verification by checking and testing of
each instrument. 4.4 . The manufacturer or his authorized
representative shall ensure that he is able
3.5.1 . All instruments shall be individually to supply the notified body's certificates
examined and appropriate tests, as set of conformity on request.';
out in the relevant standard(s ) referred to
in Article 5 , or equivalent tests, shall be (c) paragraphs 5.3.1 and 5.3.2 are replaced by the
carried out in order to verify their following text:
conformity, where applicable, to the type
as described in the EC type-examination '5.3.1 . Where a manufacturer has opted for
certificate and the requirements of this execution in two stages of one of the
Directive that apply to them. procedures mentioned in 5.1 , and where
3.5.2 . The notified body shall affix, or cause to these two stages will be carried out by
be affixed, its identification number on different parties, an instrument which
each instrument the conformity of which has undergone the first stage of the
to requirements has been established and procedure shall bear the identification
draw up a written certificate of number of the notified body involved in
conformity relating to the tests carried that stage.
out.
5.3.2 . The party which has carried out the
3.5.3 . The manufacturer or his authorized first stage of the procedure shall issue
representative shall ensure that he is able for each of the instruments a certificate
to supply the notified body's certificates containing the necessary data for
of conformity on request. identification of the instrument and
specifying the examinations and tests
4. EC unit verification that have been carried out.
4.1 . EC unit verification is the procedure The party which carries out the second
whereby the manufacturer or his stage of the procedure shall carry out
authorized representative established those examinations and tests that have
within the Community ensures and not yet been carried out.
No L 220/12 Official Journal of the European Communities 30 . 8 . 93
The manufacturer or his authorized 2 . in Article 4 the first paragraph is replaced by the .
representative shall ensure that he is following text:
able to supply the notified body's
certificates of conformity on request.'; ' 1 . Member States shall not prevent the placing
on the market or the putting into service within
(d ) paragraph 5.3.4 is replaced by the following their territory of devices complying with the
text: provisions of this Directive and bearing the CE
'5.3.4. The CE marking shall be affixed to the marking provided for in Article 12 which indicate
instrument on completion of the second that they have been the subject of an evaluation of
stage, along with the identification their conformity in accordance with Article 9 .';
number of the notified body which
took part in the second stage .'; 3 . the following paragraph is added to Article 4:
'5 . (a ) Where the devices are subject to other
8 . in Annex IV paragraph 1.1 is amended as follows: Directives concerning other aspects and
(a) subparagraph (a ) is replaced by the following which also provide for the affixing of the
text: CE marking, the latter shall indicate that the
devices are also presumed to conform to the
'(a ) — the CE conformity marking comprising provisions of the other Directives .
the CE symbol as described in Annex VI,
followed by the last two digits of year in ( b ) However, where one or more of these
which it was affixed , Directives allow the manufacturer, during a
— the identification number(s) of the transitional period, to choose which
notified body/bodies that has/have arrangements to apply, the CE marking
carried out the EC surveillance or the shall indicate conformity to the provisions
EC verification . only of those Directives applied by the
manufacturer. In this case, particulars of the
The abovementioned marking and inscriptions Directives applied, as published in the
shall be affixed to the instrument distinctly Official Journal of the European
grouped together;'; Communities, must be given in the
documents, notices or instructions required
(b) in subparagraph (2 ), after the sixth indent, the by the Directives and accompanying such
following indent is added : devices; these documents, notices or
'— the last two digits of the year in which the instructions shall be accessible without it
CE marking was affixed,'; being necessary to destroy the packaging
which keeps the device sterile .';
9 . Annex VI is replaced by the following text:
'ANNEX VI
4. in Article 11 the first paragraph is replaced by the
following text:
CE CONFORMITY MARKING
'1. Member States shall notify the Commission
— The CE conformity marking shall consist of the and the other Member State of the bodies which
initials " CE " taking the following form : they have appointed to carry out the procedures
referred to in Article 9 together with the specific
tasks which these bodies have been appointed to
carry out and the identification numbers assigned to
them beforehand by the Commission.
The Commission shall publish in the Official
Journal of the European Communities a list of the
notified bodies and their identification numbers and
the tasks for which they have been notified. The
— If the CE marking is reduced or enlarged the Commission shall ensure that this list is kept up to
proportions given in the above graduated drawing date.';
must be respected.
5 . in Article 12 ( 2 ) the second subparagraph is replaced
— The various components of the CE marking must by the following text:
have substantially the same vertical dimension,
which may not be less than 5 mm .' 'It must be followed by the identification number of
the notified body responsible for implementation of
the procedures set out in Annexes 2, 4 and 5 .';
Article 9
6. in Article 12 the third paragraph is replaced by the
Directive 90/385/EEC is hereby amended as follows: following text:
1 . throughout the text, the term 'EC mark' is replaced '3 . The affixing of markings on the devices which
by 'CE marking'; are likely to deceive third parties as to the meaning
30 . 8 . 93 Official Journal of the European Communities No L 220/13
and form of the CE marking shall be prohibited. — the decisions and reports of the
Any other marking may be affixed to the packaging notified body referred to in
or to the instruction leaflet accompanying the device sections 3.4, 4.3, 5.3 and 5.4.
provided that the visibility and legibility of the CE
marking is not hereby reduced .'; 6.2. On request, the notified body shall make
available to the other notified bodies and
the competent authority all relevant
7. Article 13 is replaced by the following text: information on approvals of quality
systems issued, refused or withdrawn.
'Article 13
6.3 . Where neither the manufacturer nor his
Without prejudice to Article 7 authorized representative are established
in the Community, the task of keeping
(a ) where a Member State establishes that the CE available for the authorities the technical
marking has been affixed unduly, the documentation referred to in Article 4 (2)
manufacturer or his authorized representative shall fall to the person responsible for
established within the Community shall be placing the appliance on the Community
obliged to end the infringement under market.';
conditions imposed by the Member State;
( b) where non-compliance continues, the Member 9 . in Annex III sections 7 and 8 are replaced by the
State must take all appropriate measures to following text:
restrict or prohibit the placing on the market of
the device in question or to ensure that it is ' 7. Administrative provisions
withdrawn from the market in accordance with
the procedures laid down in Article 7.'; 7.1 . On request, each notified body shall make
available to the other notified bodies and the
8 . Annex II is amended as follows : competent authority, all relevant information
on EC type-examination certificates and
addenda issued, refused or withdrawn.
(a) in section 2 the second paragraph is replaced by
the following text: 7.2 . Other notified bodies may obtain a copy of the
'The manufacturer or his authorized
EC type-examination certificates and/or the
addenda to them . The annexes to the
representative established within the certificates shall be made available to the other
Community shall affix the CE marking in notified bodies when a reasoned application is
accordance with Article 12 and shall draw up a made and after the manufacturer has been
written declaration of conformity. informed .
This declaration shall cover one or more
7.3 . The manufacturer or his authorized
identified examples of the product and shall be
kept by the manufacturer or his authorized representative shall keep with the technical
representative established within the documentation a copy of the EC
type-examination certificates and the
Community.
supplements to them for a period of at least
The CE marking shall be accompanied by the five years from the manufacture of the last
identification number of the notified body appliance.
responsible.';
7.4 . Where neither the manufacturer nor his
authorized representative are established in the
( b) section 6 is replaced by the following text: Community, the task of keeping the technical
'6 . Administrative provisions documentation available for the authorities
shall fall to the person responsible for placing
6.1 . For at least five years from last date of the appliance concerned on the Community
manufacture of the product, the market.';
manufacturer shall keep available for the
national authorities :
10. Annex IV is replaced by the following text:
— the declaration of conformity,
'ANNEX IV
— the documentation referred to in the
second indent of section 3.1 , EC VERIFICATION
provisions of section 3 are in conformity with that the manufacturing process ensures the
the type as described in the EC uniformity of each batch produced.
type-examination certification and satisfy the
requirements of this Directive that apply to 6.2 . A random sample shall be taken from each
them. batch. Products in a sample shall be
individually examined and appropriate tests, as
2. The manufacturer or his authorized
set out in the standard(s) referred to in
representative established within the
Article 5 , or equivalent tests shall be carried
Community shall take all measures necessary out to verify their conformity to the type as
in order that the manufacturing process described in the EC type-examination
ensures conformity of the products to the type certificate and thereby determine whether a
as described in the EC type-examination
batch is to be accepted or rejected.
certification and to the requirements of this 6.3 . Statistical control of products shall be based
Directive that apply to them. The on attributes, entailing a sampling system with
manufacturer or his authorized representative the following characteristics:
established within the Community shall affix
the CE marking to each product and draw up — a level of quality corresponding to a
a written declaration of conformity. probability of acceptance of 95% , with a
non-conformity percentage of between 0,29
3. The manufacturer shall, before the start of and 1 % ,
manufacture, prepare documents defining the
manufacturing processes, in particular as — a limit quality corresponding to a
regards sterilization, together with all the probability of acceptance of 5% , with a
routine, pre-established provisions to be percentage of non-conformity of between 3
implemented to ensure uniformity of and 7% .
production and conformity of the products
with the type as described in the EC 6.4. Where batches are accepted, the notified body
type-examination certificate as well as with the shall affix, or cause to be affixed, its
relevant requirements of this Directive. identification number to each product and
draw up a written certificate of conformity
4. The manufacturer shall undertake to institute
relating to the tests carried out. All products in
the batch may be placed on the market except
and keep updated a post-marketing
for those products from the sample which were
surveillance system . This undertaking shall found not to be in conformity.
include the obligation on the part of the
manufacturer to notify the competent Where a batch is rejected, the notified body
authorities of the following events immediately shall take appropriate measures to prevent the
on learning of them: placing on the market of that batch. In the
event of frequent rejection of batches the
(i) any change in the characteristics or notified body may suspend the statistical
performances and any inaccuracies in the verification.
instruction leaflet for a device which
might lead to or have led to the death of a The manufacturer may, under the
patient or deterioration in his state of responsibility of the notified body, affix the
health; latter's identification number during the
manufacturing process.
(ii) any technical or medical reason resulting
in the withdrawal of a device from the 6.5 . The ' manufacturer or his authorized
market by a manufacturer. representative shall ensure that he is able to
supply the notified body's certificates of
5. The notified body shall carry out the conformity on request.';
appropriate examinations and tests in order to
check the conformity of the product to the
requirements of this Directive by examination 1 1 . the second subparagraph of section 2 of Annex V is
and testing of products on a statistical basis, as replaced by the following text:
specified in section 6 . The manufacturer must
authorize the notified body to evaluate the 'The manufacturer or his authorized representative
efficiency of the measures taken pursuant to established within the Community shall affix the CE
section 3 , by audit where appropriate. marking in accordance with Article 12 and draw up
a written declaration of conformity. This declaration
6. Statistical verification shall cover one or more identified specimens of the
product and shall be kept by the manufacturer. The
6.1 . Manufacturers shall present the products CE marking shall be accompanied by the
manufactured in the form of uniform batches identification number of the notified body
and shall take all necessary measures in order responsible.';
30 . 8 . 93 Official Journal of the European Communities No L 220/15
12. Annex IX is replaced by the following text: in the documents, notices or instructions
required by the Directives and accompanying
'ANNEX IX such devices.';
CE CONFORMITY MARKING
4. in Article 9 the first paragraph is replaced by the
— The CE conformity marking shall consist of the following text:
initials " CE" taking the following form: '1 . Member States shall notify the Commission and
the other Member States of the bodies, which they
have appointed to carry out the procedures referred
to in Article 8 together with the specific tasks which
these bodies have been appointed to carry out and the
identification numbers assigned to them beforehand
by the Commission.
The Commission shall, for information, publish in the
Official Journal of the European Communities, a list
— If the CE marking is reduced or enlarged the of these bodies, and the identification numbers it has
proportions given in the above graduated assigned to them and shall ensure that the list is kept
drawing must be respected . up to date .';
— The various components of the CE marking must
5 . in Article 10 the second paragraph is replaced by the
have substantially the same vertical dimension,
following text:
which may not be less than 5 mm.
'2 . The affixing of markings on the appliances
This minimum dimension may be waived for which are likely to deceive third parties as to the
small-scale devices .'
meaning and form of the CE marking shall be
prohibited . Any other marking may be affixed to the
appliance or to the data plate ' provided that the
Article 10 visibility and legibility of the CE marking is not
hereby reduced .';
Directive 90/396/EEC is hereby amended as follows:
6 . Article 11 is replaced by the following text:
1 . throughout the text, the term 'EC mark' is replaced
'Article 11
by 'CE marking';
Without prejudice to Article 7:
2. in Article 4 the first paragraph is replaced by the
following text: (a ) where a Member State establishes that the CE
marking has been affixed unduly, the
'1. Member States may not prohibit, restrict or manufacturer or his authorized representative
impede the placing on the market and the putting established within the Community shall be
into service of appliances which comply with all the obliged to make the product comply as regards
provisions of this Directive, including the conformity the provisions concerning the CE marking and to
assessment procedures laid down in Chapter II, and end the infringement under conditions imposed
which bear the CE marking provided for in by the Member State;
Article 10 .';
( b ) where non-compliance continues, the Member
State must take all appropriate measures to
3 . in Article 8 the fifth paragraph is replaced by the restrict or prohibit the placing on the market of
following text: the appliance in question or to ensure that it is
withdrawn from the market in accordance with
'5 . ( a) Where the appliances are covered by other the procedures laid down in Article 7.';
Directives dealing with other aspects and
specifying the affixing of the CE marking, the 7. Annex II is amended as follows :
latter shall indicate that the appliances are
also presumed to conform to the provisions (a ) in point 2.1 the second sentence is replaced by
of those other Directives . the following text:
( b ) However, where one or more of these 'The manufacturer or his authorized
Directives allow the manufacturer, during a representative established within the Community
transitional period, to choose which shall affix the CE marking on each appliance and
arrangements to apply, the CE marking shall draw up a written certificate of conformity.';
indicate conformity to the provisions only of
those Directives applied by the manufacturer. (b ) in point 2.1 the last sentence is replaced by the
In this case, particulars of the Directives following text:
applied, as published in the Official Journal 'The CE marking must be followed by the
of the European Communties, must be given identification number of the notified body
No L 220/ 16 Official Journal of the European Communities 30. 8 . 93
responsible for the random checks set out in to check the conformity of the appliance
point 2.3 .'; to the requirements of this Directive by
examination and testing of every
(c) in point 3.1 the second sentence is replaced by appliance, as specified in point 5.4, or by
the following text: examination and testing of appliances on a
'The manufacturer or his authorized statistical basis, as specified in point 5.5,
at the choice of the manufacturer.
representative established within the Community
must affix the CE marking to each appliance and
draw up a written declaration of conformity.'; 5.4 . Verification by checking and testing of
each appliance
(d ) in point 3.1 the last sentence is replaced by the
following text: 5.4.1 . All appliances must be individually
'The CE marking must be followed by the examined and appropriate tests, as set out
identification number of the notified body in the relevant standard(s ) referred to in
responsible for EC surveillance.'; Article 5, or equivalent tests, must be
carried out in order to verify their
(e ) in point 4.1 the second sentence is replaced by conformity with the type as described in
the following text: the EC type-examination certificate and
the requirements of this Directive that
'The manufacturer or his authorized apply to them.
representative established within the Community
must affix the CE marking to each appliance and 5.4.2 . The notified body must affix, or cause to
draw up a written declaration of conformity.'; be affixed , its identification number on
each appliance and draw up a written
( f) in point 4.1 the last sentence is replaced by the certificate of conformity relating to the
following text: tests carried out. The certificate of
'The CE marking must be followed by the conformity may cover one or more
identification number of the notified body appliances.
responsible for EC surveillance.'; 5.4.3 . The manufacturer or his authorized
(g) points 5 and 6 are replaced by the following representative must ensure that he is able
text : to supply the notified body's certificates of
conformity on request.
'5 . EC VERIFICATION
2. in Article 11 ( 4) the term 'the EC mark' is replaced numbers and a list of test laboratories together with
by 'the initials CE as shown in Annex VI'; the tasks for which they have been designated and
shall ensure that these lists are kept up to date.';
3 . in Article 3 the first paragraph is replaced by the
following text: 7. in Article 11 the first paragraph is replaced by the
following text:
' 1 . Member States shall take all appropriate 'The marking of terminal equipment complying with
measures to ensure that terminal equipment may be this Directive shall consist of the CE marking
placed on the market and put into service only if it consisting of the initials CE, followed by the
bears the CE marking provided for in Article 11 identification number of the notified body involved
attesting to its conformity to the requirements of in the production control stage and a symbol
this Directive, including the conformity assessment indicating that the equipment is intended and is
procedures laid down in Chapter II and where it is suitable to be connected to the public
properly installed and maintained and used for its telecommunications network . The form of CE
intended purpose .'; marking to be used, together with the other
information, is shown in Annex VI.';
4. the following paragraph is added to Article 3 :
8 . in Article 11 the second paragraph is replaced by the
'4. (a ) Where the terminal equipment is subject to following text:
other Directives concerning other aspects
and which also provide for the affixing of '2 . The affixing of markings on the equipment
the CE marking, the latter shall indicate that which are likely to deceive third parties as to the
the equipment is also presumed to conform meaning and form of the CE marking specified in
to the provisions of those other Directives. Annexes VI and VII shall be prohibited. Any other
marking may be affixed to the equipment provided
( b ) However, where one or more of these that the visibility and legibility of the CE marking is
Directives allow the manufacturer, during a not thereby reduced .';
transitional period , to choose which
arrangements to apply, the CE marking 9 . Article 12 is replaced by the following text:
shall indicate conformity to the provisions 'Article 12
only of those Directives applied by the
manufacturer . In this case, particulars of the Without prejudice to Article 8 :
Directives applied, as published in the
Official Journal of the European (a ) where a Member State establishes that the CE
Communities, must be given in the marking has been affixed unduly, the
documents, notices or instructions required manufacturer or his authorized representative
by the Directives and accompanying the established within the Community shall be
terminal equipment.'; obliged to make the equipment conform as
regards the provisions concerning the CE
marking and to end the infringement under the
5 . in Article 10 the first paragraph is replaced by the conditions imposed by the Member State.
following text:
( b ) where non-conformity continues, the Member
'1. Member States shall notify the Commission State must take all appropriate measures to
and the other Member States of the bodies restrict or prohibit the placing on the market of
established within the Community which they have the equipment in question or to ensure that it is
designated for carrying out the certification, product withdrawn from the market in accordance with
checks and associated surveillance tasks pertaining the procedures laid down in Article 8 .';
to the procedures referred to in Article 9 , together
with the identification numbers assigned to them 10 . in Annexes II and III the last sentence of point 1 is
beforehand by the Commission . replaced by the following text:
Member States shall apply the minimum criteria set 'The manufacturer or his authorized representative
out in Annex V for the designation of such bodies . established within the Community shall affix the
Bodies that satisfy the criteria fixed by the relevant markings provided for in Article 11 ( 1 ) to each
harmonized standards shall be presumed to satisfy product and draw up a written declaration of
the criteria set out in Annex V. '; conformity to type .';
— If the CE marking is reduced or enlarged the service within their territories of appliances and
proportions given in the above graduated boilers which comply with the provisions of this
drawing must be respected . Directive and which bear the CE marking provided
for in Article 7 attesting to the conformity to all the
— The various components of the CE marking must provisions of this Directive, including the conformity
have substantially the same vertical dimension, assessment procedures laid down in Articles 7 and 8 ,
which may not be less than 5 mm.'; save as otherwise laid down in the Treaty or other
Directives or Community provisions.';
13 . Annex VII is amended as follows :
•ANNEX VII
3 . the following paragraph 5 is added to Article 4:
MARKING FOR THE EQUIPMENT REFERRED TO IN
ARTICLE 11 (4 ) '5 . ( a ) Where the boilers are subject to other
Directives concerning other aspects which
also provide for the affixing of the CE
marking, the latter shall indicate that the
boilers in question are also presumed to
conform to the provisions of those other
Directives.
products of any markings likely to deceive third — If the CE marking is reduced or enlarged the
parties as to the meaning and form of the CE proportions given in the above graduated
marking shall be prohibited . Any other marking may drawing must be respected .
be affixed to the boilers and appliances provided that
the visibility and legibility of the CE marking is not — The various components of the CE marking
thereby reduced .'; must have substantially the same vertical
dimension, which may not be less than
5 mm .
5 . the following paragraph is added to Article 7:
2. Additional specific markings
'5. (a ) Where a Member State or a notified body — The last two digits of the year in which the EC
establishes that the CE marking has been marking was affixed .
affixed unduly, the manufacturer or his agent
established within the Community shall be — The energy performance label awarded under
Article 6 of this Directive consists of the
obliged to make the boiler comply as regards
the provisions concerning the CE marking following symbol:
and to end the infringement under conditions
imposed by the Member State;
1 . CE conformity marking
The CE conformity marking shall consist of the Article 13
initials " CE " taking the following form:
Directive 73/23/EEC is hereby amended as follows :
3 . the following paragraph 3 is added to Article 8 : 6. the following Annexes are added:
'3 . (a ) Where electrical equipment is subject to other 'ANNEX III
Directives concerning other aspects which
also provide for the affixing of the CE CE CONFORMITY MARKING AND EC
marking, the latter shall indicate that the DECLARATION OF CONFORMITY
equipment in question is also presumed to
conform to the provisions of those other A. CE conformity marking
Directives.
The CE conformity marking shall consist of the
( b ) However, where one or more of these initials " CE " taking the following form:
Directives allow the manufacturer, during a
transitional period, to choose which
arrangements to apply, the CE marking shall
indicate conformity to the provisions only of
those Directives applied by the manufacturer.
In this case, particulars of the Directives
applied, as published in the Official Journal
of the European Communities, must be given
in the documents, notices or instructions
required by the Directives and accompanying — If the CE marking is reduced or enlarged the
the electrical equipment.'; proportions given in the above graduated
drawing must be respected .
4. Article 10 is replaced by the following text: — The various components of the CE marking
must have substantially the same vertical
'Article 1 0
dimension, which may not be less than
5 mm .
1 . The CE conformity marking referred to in
Annex III shall be affixed by the manufacturer or his B. EC declaration of conformity
authorized representative established within the
Community to the electrical equipment or, failing The EC declaration of conformity must contain
that, to the packaging, the introduction sheet or the the following elements:
guarantee certificate so as to be visible , easily legible
and indelible . — name and address of the manufacturer or his
authorized respresentative established within
2. The affixing on electrical equipment of any the Community,
markings liable to deceive third parties as to the
meaning and form of the CE marking shall be — a description of the electrical equipment,
prohibited. However, any other marking may be — reference to the harmonized standards,
affixed to the electrical equipment, its packaging, the
instruction sheet or the guarantee certificate provided — where appropriate, references to the
that the visibility and legibility of the CE marking is specifications with which conformity is
not thereby reduced. declared,
No L 220/22 Official Journal of the European Communities 30 . 8 . 93
— identification of the signatory who has been — results of design calculations made,
empowered to enter into commitments on examinations carried out, etc.
behalf of the manufacturer or his authorized
representative established within the — test reports .
Community,
4. The manufacturer or his authorized representative
— the last two digits of the year in which the CE must keep a copy of the declaration of conformity
marking was affixed. with the technical documentation .
Where neither the manufacturer nor his 2. Until 1 January 1997 Member States shall allow the
authorized representative is established within the placing on the market and the bringing into service of
Community, this obligation is the responsibility of products which comply with the marking arrangements
the person who places the electrical equipment on in force before 1 January 1995 .
the Community market.
3 . Technical documentation must enable the 3. Member States shall communicate to the
conformity of the electrical equipment to the Commission the texts of the provisions of national law
requirements of this Directive to be assessed. It which they adopt in the field covered by this Directive.
The Commission shall inform the other Member States
must, as far as relevant for such assessment, cover
thereof.
the design, manufacture and operation of the
electrical equipment. It must include:
— a general description of the electrical
Article 15
equipment,
— conceptual design and manufacturing This Directive is addressed to the Member States .
drawings and schemes of components,
sub-assemblies, circuits, etc.,
— descriptions and explanations necessary for
the understanding of said drawings and Done at Brussels, 22 July 1993 .
schemes and the operation of the electrical
equipment,
— a list of the standards applied in full or in For the Council
part, and descriptions of the solutions adopted
to satisfy the safety aspects of this Directive The President
where standards have not been applied, M. OFFECIERS-VAN DE WIELE