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"BCOUNCIL DIRECTIVE 93/68/EEC
of 22 July 1993
amending Directives 87/404/EEC (simple pressure vessels), 88/378/EEC (safety of toys), 89/106/EEC
(construction products), 89/336/EEC (electromagnetic compatibility), 89/392/EEC (machinery),89/686/EEC (personal protective equipment), 90/384/EEC (non-automatic weighing instruments),90/385/EEC (active implantable medicinal devices), 90/396/EEC (appliances burning gaseous fuels),91/263/EEC (telecommunications terminal equipment), 92/42/EEC (new hot-water boilers fired withliquid or gaseous fuels) and 73/23/EEC (electrical equipment designed for use within certain voltage
limits)
(OJ L 220, 30.8.1993, p. 1)
Amended by:
Official Journal
No page date
"M1 Directive 98/13/EC of the European Parliament and of the Council
of 12 February 1998L 74 1 12.3.1998
Corrected by:
"C1 Corrigendum, OJ L 216, 8.8.1997, p. 99 (93/68/EEC)1993L0068 — EN — 01.04.1998 — 001.001 — 1
COUNCIL DIRECTIVE 93/68/EEC
of 22 July 1993
amending Directives 87/404/EEC (simple pressure vessels),
88/378/EEC (safety of toys), 89/106/EEC (construction products),
89/336/EEC (electromagnetic compatibility), 89/392/EEC (ma-
chinery), 89/686/EEC (personal protective equipment), 90/384/EEC
(non-automatic weighing instruments), 90/385/EEC (active implant-
able medicinal devices), 90/396/EEC (appliances burning gaseous
fuels), 91/263/EEC (telecommunications terminal equipment),
92/42/EEC (new hot-water boilers fired with liquid or gaseous fuels)
and 73/23/EEC (electrical equipment designed for use within certain
voltage limits)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community, and in particular Article 100a thereof,
Having regard to the proposal from the Commission (1),
In cooperation with the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas the Council has already adopted a series of 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
technical harmonization and standards (4); whereas each of these
Directives provides for the affixing of the ‘CE’ marking; whereas,
therefore, in the interests of simplifying Community legislation and
making it more consistent, these various provisions need to be replaced
by uniform prescriptions; whereas it is therefore necessary to harmonize
these provisions, particularly with regard to products which may fall
within the scope of several of these Directives;
Whereas, in its communication of 15 June 1989 on a global approach to
certification and testing (5), the 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 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 the ‘CE’ marking;
Whereas the two basic elements of the new approach which must be
applied are therefore the essential requirements and the conformity
assessment procedures;
Whereas this harmonization of the provisions concerning the affixing
and use of the ‘CE’ marking requires that existing Directives undergo
detailed amendment to bring them into line with the new arrangements,!B
(1) OJ No C 160, 20. 6. 1991, p. 14;
and OJ No C 28, 2. 2. 1993, p. 16.
(2) OJ No C 125, 18. 5. 1992, p. 178;
OJ No C 115, 26. 4. 1993, p. 117; andDecision of 14 July 1993 (not yetpublished in the Official Journal).
(
3) OJ No C 14, 20. 1. 1992, p. 15; and
OJ No C 129, 10. 5. 1993, p. 3.
(4) OJ No C 136, 4. 6. 1985, p. 1.
(5) OJ No C 231, 8. 9. 1989, p. 3; and
OJ No C 267, 19. 10. 1989, p. 3.
(6) OJ No C 10, 16. 1. 1990, p. 1.1993L0068 — EN — 01.04.1998 — 001.001 — 2
HAS ADOPTED THIS DIRECTIVE:
Article 1
The following Directives are hereby amended:
1. Council Directive 87/404/EEC of 25 June 1987 on the harmonization
of the laws of the Member States relating to simple pressure
vessels (1);
2. Council Directive 88/378/EEC of 3 May 1988 on the approximation
of the laws of the Member States concerning the safety of toys (2);
3. Council Directive 89/106/EEC of 21 December 1988 on the
approximation of the laws, regulations and administrative provisions
of the Member States relating to construction products (3);
4. Council Directive 89/336/EEC of 3 May 1989 on the approximation
of the laws of the Member States relating to electromagnetic
compatibility (4);
5. Council Directive 89/392/EEC of 14 June 1989 on the approxi-
mation of the laws of the Member States relating to machinery (5);
6. Council Directive 89/686/EEC of 21 December 1989 on the
approximation of the laws of the Member States relating to personal
protective equipment (6);
7. Council Directive 90/384/EEC of 20 June 1990 on the harmonization
of the laws of the Member States relating to non-automatic weighing
instruments (7);
8. Council Directive 90/385/EEC of 20 June 1990 on the approxi-
mation of the laws of the Member States relating to active
implantable medical devices (8);
9. Council Directive 90/396/EEC of 29 June 1990 on the approxi-
mation of the laws of the Member States relating to appliances
burning gaseous fuels (9);
10. Council Directive 91/263/EEC of 29 April 1991 on the approxi-
mation of the laws of the Member States concerning telecommuni-
cations terminal equipment, including the mutual recognition of their
conformity (10);
11. Council Directive 92/42/EEC of 21 May 1992 on efficiency
requirements for new hot-water boilers fired with liquid or gaseous
fuels (11);
12. Council Directive 73/23/EEC of 19 February 1973 on the harmon-
ization of the laws of the Member States relating to electrical
equipment designed for use within certain voltage limits (12).
Article 2
Directive 87/404/EEC is hereby amended as follows:
1. throughout the text, the term ‘EC mark’ is replaced by ‘CE
marking’;!B
(1) OJ No L 220, 8. 8. 1987, p. 48; Directive amended by Directive 90/488/EEC
(OJ No L 270, 2. 10. 1990, p. 25).
(2) OJ No L 187, 16. 7. 1988, p. 1.
(3) OJ No L 40, 11. 2. 1989, p. 12.
(4) OJ No L 139, 23. 5. 1989, p. 19; Directive last amended by Directive
92/31/EEC (OJ No L 126, 12. 5. 1992, p. 11).
(5) OJ No L 183, 29. 6. 1989, p. 9; Directive amended by Directive 91/368/EEC
(OJ No L 198, 22. 7. 1991, p. 16).
(6) OJ No L 399, 30. 12. 1989, p. 18.
(7) OJ No L 189, 20. 7. 1990, p. 1.
(8) OJ No L 189, 20. 7. 1990, p. 17.
(9) OJ No L 196, 26. 7. 1990, p. 15.
(10) OJ No L 128, 23. 5. 1991, p. 1.
(11) OJ No L 167, 22. 6. 1992, p. 17.
(12) OJ No L 77, 26. 3. 1972, p. 29.1993L0068 — EN — 01.04.1998 — 001.001 — 3
2. in Article 5 the first paragraph is replaced by the following text:
‘1. Member States shall presume that vessels bearing the CE
marking comply with all the provisions of this Directive, including
the conformity assessment procedures referred to in Chapter II.
Conformity of vessels 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.’;
3. the following paragraph is added to Article 5:
‘3. (a) Where the vessels are subject to other Directives covering
other aspects and which also provide for the affixing of the
CE marking, the latter shall indicate that the vessels in
question are also presumed to conform to the provisions of
those other Directives.
(b) However, where one or more of those Directives allow the
manufacturer, during a transitional period, to choose which
arrangements to apply, the CE marking shall indicate
conformity only to the Directives applied by the manu-
facturer. 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
such vessels.’;
4. In Article 9 the first paragraph is replaced by the following text:
‘1. Member States shall notify the Commission and the other
Member States of the approved bodies which they have appointed to
carry out the procedures referred to in Article 8 (1) and (2) together
with the specific tasks which these bodies have been appointed to
carry out and the identification numbers assigned to them before-
hand by the Commission.
The Commission shall publish in the Official Journal of the
European Communities a list of the notified bodies with their
identification numbers and the tasks for which they have been
notified. The Commission shall ensure that this list is kept up to
date.’;
5. Article 11 is replaced by the following text:
‘EC verification
Article 11
1. EC verification is the procedure whereby a manufacturer or his
authorized representative established within the Community ensures
and declares that the vessels which have been checked in accordance
with paragraph 3 are in conformity to the type described in the EC
type-examination certificate or with the design and manufacturing
schedule referred to in Annex II section 3 having received a
certificate of adequacy.
2. The manufacturer shall take all the necessary measures for the
manufacturing process to ensure that the vessels conform to the type
described in the EC type-examination certificate or to the design and
manufacturing schedule referred to in Annex II section 3. The
manufacturer or his authorized representative established within the
Community shall affix the CE marking to each vessel and draw up a
declaration of conformity.
3. The approved body shall carry out the appropriate examinations
and tests in order to check the conformity of the vessels with the!B1993L0068 — EN — 01.04.1998 — 001.001 — 4
requirements of this Directive by examination and testing of vessels
in accordance with the following paragraphs:
3.1. The manufacturer shall present his vessels in the form of
uniform batches and shall take all necessary measures in order
that the manufacturing process ensures the uniformity of each
batch produced.
3.2. These batches shall be accompanied by the EC type-examination
certificate referred to in Article 10, or, where the vessels are not
manufactured in accordance with an approved prototype, by the
design and manufacturing schedule referred to in Annex II
section 3. In this case the approved body shall, prior to EC
verification, examine the schedule in order to certify its
conformity.
3.3. When a batch is examined, the inspection body shall ensure that
the vessels have been manufactured and checked in accordance
with the design and manufacturing schedule and perform a
hydrostatic test or a pneumatic test of equivalent effect on each
vessel in the batch at a pressure Ph equal to 1,5 times the vessel’ s
design pressure in order to check its soundness. The pneumatic
test shall be subject to acceptance of the test safety procedures
by the Member State in which the test is performed.
Moreover, the inspection body shall carry out tests on test-pieces
taken from a representative production test-piece or from a
vessel, as the manufacturer chooses, in order to examine the
weld quality. The tests shall be carried out on longitudinal welds.
However, where differing weld techniques are used for
longitudinal and circular welds, the tests shall be repeated on
the circular welds.
For the vessels referred to in Annex I, section 2.1.2 these tests on
test-pieces shall be replaced by a hydrostatic test on five vessels
taken at random from each batch in order to check that they
conform to the requirements of Annex I, section 2.1.2.
3.4. In the case of accepted batches, the approved body shall affix, or
cause to be affixed, its identification number to each recipient
and draw up a written certificate of conformity relating to the
tests carried out. All recipients in the batch may be placed on the
market except for those which have not successfully undergone a
hydrostatic test or a pneumatic test.
If a batch is rejected, the notified body or the competent
authority shall take appropriate measures to prevent the putting
on the market of that batch. In the event of frequent rejection of
batches, the notified body may suspend the statistical verifi-
cation.
The manufacturer may, under the responsibility of the notified
body, affix the latter’ s identification number during the manu-
facturing process.
3.5. The manufacturer or his authorized representative must be able
to supply on request the approved body’ s certificates of
conformity referred to in subparagraph 3.4.’;
6. in Article 12 (1) the first sentence is replaced by the following text:
‘1. A manufacturer fulfilling the obligations arising out of Article
13 shall affix the CE marking provided for in Article 16 to vessels
which he declares to be in conformity:
— to the design and manufacturing schedule referred to in Annex II
section 3, and on which a certificate of adequacy has been drawn
up, or
— an approved prototype.’;
7. Article 15 is replaced by the following text:
‘Article 15!B1993L0068 — EN — 01.04.1998 — 001.001 — 5
Without prejudice to Article 7:
(a) where a Member State establishes that the CE marking has been
affixed unduly, the manufacturer or his authorized representative
established within the Community shall be obliged to make the
product conform as regards the provisions concerning the CE
marking and to end the infringement under the conditions
imposed by the Member State;
(b) where non-conformity continues, the Member State must take all
appropriate measures to restrict or prohibit the placing on the
market of the product in question or to ensure that it is
withdrawn from the market in accordance with the procedures
laid down in Article 7.’;
8. in Article 16 (1) the second subparagraph is replaced by the
following text:
‘The CE conformity marking shall consist of the initials “CE’’ in the
form shown in the specimen in Annex II. The CE marking shall be
followed by the distinguishing number referred to in Article 9 (1) of
the approved inspection body responsible for EC verifications or EC
surveillance.’;
9. in Article 16 the second paragraph is replaced by the following text:
‘2. The affixing of markings on the vessels which are likely to
deceive third parties as to the meaning and form of the CE marking
shall be prohibited. Any other marking may be affixed to the vessels
or the data plate provided that the visibility and legibility of the CE
marking is not thereby reduced.’;
10. in Annex II, section 1 is replaced by the following text:
‘1. CE MARKING AND INSCRIPTIONS
1. (a) CE conformity marking
— The CE conformity marking shall consist of the
initials “CE’’ in the following form:
— If the CE marking is reduced or enlarged the
proportions given in the above graduated draw-
ing must be respected.
— The various components of the CE marking must
have substantially the same vertical dimension,
which may not be less than 5 mm.
1. (b) Inscriptions
The vessel or data plate must bear at least the
following information:
— the maximum working pressure (PS in bar),— the maximum working temperatur (T
maxin °C),
— the minimum working temperature (T minin °C),
— the capacity of the vessel (V in l),
— the name or mark of the manufacturer,!B1993L0068 — EN — 01.04.1998 — 001.001 — 6
— the type and serial or batch identification of the
vessel,
— the last two digits of the year in which the CE
marking was affixed.
Where the data plate is used, it must be so designed
that it cannot be re-used and must include a vacant
space to enable other information to be provided.’
Article 3
Directive 88/378/EEC is hereby amended as follows:
1. throughout the text, the term ‘EC mark’ is replaced by ‘CE
marking’;
2. in Article 5 the first paragraph is replaced by the following text:
‘1. Member States shall presume that toys bearing the CE marking
laid down in Article 11 comply with all the provisions of this
Directive, including the conformity assessment procedures referred
to in Articles 8, 9 and 10.
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.’;
3. the following paragraph is added to Article 5:
‘3. (a) Where the toys are subject to other Directives covering
other aspects and which also provide for the affixing of the
CE marking, the latter shall indicate that the toys in
question are also presumed to conform to the provisions of
those other Directives.
(b) However, where one or more of these Directives allow the
manufacturer, during a transitional period, to choose which
arrangements to apply, the CE marking shall indicate
conformity only to the Directives applied by the manu-
facturer. 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
such toys or, failing that, on their packaging.’;
4. in Article 9 the second paragraph is replaced by the following text:
‘2. Member States shall notify the Commission and the other
Member States of the bodies which they have appointed to carry out
the EC type-examination referred to in Article 8 (2) and Article 10
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 with their
identication number and the tasks for which they have been notified.
The Commission shall ensure that this list is kept up to date.’;
5. in Article 11 the second paragraph is replaced by the following text:
‘2. The CE conformity marking shall consist of the initials “CE’’
taking the form of the specimen given in Annex V .’;!B1993L0068 — EN — 01.04.1998 — 001.001 — 7
6. in Article 11 the third paragraph is replaced by the following text:
‘3. The affixing of markings on the toys which are likely to deceive
third parties as to the meaning and form of the CE marking shall be
prohibited. Any other marking may be affixed to the toys, their
packaging or a label provided that the visibility and legibility of the
EC marking is not thereby reduced.’;
7. the following paragraph is added to Article 12:
‘1a. Without prejudice to Article 7:
(a) where a Member State establishes that the CE marking has been
affixed unduly, the manufacturer or his authorized representative
established within the Community shall be obliged to make the
product conform as regards the provisions concerning the CE
marking and to end the infringement under the conditions
imposed by the Member State;
(b) where non-conformity continues, the Member State must take all
appropriate measures to restrict or prohibit the placing on the
market of the product in question or to ensure that it is
withdrawn from the market in accordance with the procedures
laid down in Article 7.’;
8. the following Annex is added:
‘ANNEX V
CE CONFORMITY MARKING— The CE conformity marking shall consist of the initials “CE’’
taking the following form:
— If the CE marking is reduced or enlarged the proportions given
in the above graduated drawing must be respected.
— The various components of the CE marking must have
substantially the same vertical dimension, which may not be
less that 5 mm.’
Article 4
Directive 89/106/EEC is hereby amended as follows:
1. throughout the text, the term ‘EC mark’ is replaced by ‘CE
marking’;
2. in Article 2 the second paragraph is replaced by the following text:
‘2. (a) When products are subject to other Directives with regard
to other aspects and which also provide for the affixing of
the CE conformity marking, referred to in Article 4 (2), the
latter shall indicate that the products are also presumed to
conform to the provisions of those other Directives.
(b) However, where one or more of these Directives allow the
manufacturer, during a transitional period, to choose which
arrangements to apply, the CE marking shall indicate
conformity only to the Directives applied by the manu-
facturer. In this case, particulars of the Directives applied,
as published in the Official Journal of the European!B1993L0068 — EN — 01.04.1998 — 001.001 — 8
Communities , must be given in the documents, notices or
instructions required by the Directives and accompany
such products.’;
3. in Article 4 (2) the introduction is replaced by the following text:
‘2. Member States shall presume that products are fit for use if they
enable works in which they are employed, provided the latter are
properly designed and built, to satisfy the essential requirements
referred to in Article 3 where such products bear the CE marking
indicating that they satisfy all the provisions of this Directive,
including the conformity assessment procedures laid down in
Chapter V and the procedure laid down in Chapter III. The CE
marking shall indicate:’;
4. in Article 4 (6) the first subparagraph is replaced by the following
text:
‘6. The CE marking signifies that products satisfy the requirements
of paragraphs 2 and 4 of this Article. It is for the manufacturer or his
authorized representative established within the Community to take
responsibility for affixing the CE marking on the product itself, on a
label attached to it, on its packaging, or on the accompanying
commercial documents.’;
5. in Article 15 the second paragraph is replaced by the following text:
‘2. Without prejudice to Article 21:
(a) where a Member State establishes that the CE marking has been
affixed unduly, the manufacturer or his agent established within
the Community shall be obliged to make the product conform as
regards the provisions concerning the CE marking and to end the
infringement under conditions imposed by the Member State;
(b) where non-conformity continues, the Member State must take all
appropriate measures to restrict or prohibit the placing on the
market of the product in question or to ensure that it is
withdrawn from the market in accordance with the procedures
laid down in Article 21.’;
6. in Article 15 the third paragraph is replaced by the following text:
‘3. Member States shall take the measures necessary to prohibit the
affixing to products or their packaging of markings which are likely
to deceive third parties as to the meaning and form of the CE
marking. Any other marking may be affixed to the construction
products on a label fixed to the product packaging or on the
accompanying commercial documents provided that the visibility
and legibility of the CE marking is not thereby reduced.’;
7. in Article 18 the first paragraph is replaced by the following text:
‘1. Member States shall notify the Commission and the other
Member States of the certification and inspection bodies and the
testing laboratories which they have designated for the tasks which
must be carried out for the purposes of technical approval,
certificates of conformity, inspections and tests, in accordance with
this Directive, together with their names and addresses 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 laboratories
with their identification numbers and the tasks and products for
which they have been notified. The Commission shall ensure that
this list is kept up to date.’;!B1993L0068 — EN — 01.04.1998 — 001.001 — 9
8. Annex III section 4 is replaced by the following text:
‘4.1. CE conformity marking
— The CE conformity marking shall consist of the initials
“CE’’ taking the following form:
— If the CE marking is reduced or enlarged the
proportions given in the above graduated drawing must
be respected.
— The various components of the CE marking must have
substantially the same vertical dimension, which may
not be less than 5 mm.
— The CE marking shall be followed by the identification
number of the body involved in the production control
stage.
Additional information— The CE marking shall be accompanied by the name or
identifying mark of the producer, the last two digits of
the year in which the marking was affixed, and where
appropriate, the number of the EC certificate of
conformity and, where appropriate, indications to
identify the characteristics of the product on the basis
of the technical specifications.’
Article 5
Directive 89/336/EEC is hereby amended as follows:
1. throughout the text, the term ‘EC mark’ is replaced by ‘CE
marking’;
2. Article 3 is replaced by the following text:
‘Article 3
Member States shall take all appropriate measures to ensure that the
apparatus referred to in Article 2 may be placed on the market or
taken into service only if it bears the CE marking provided for in
Article 10 indicating its conformity to all the provisions of this
Directive, including the conformity assessment 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.’;
3. the following fifth subparagraph is added to Article 10 (1):
‘Member States shall take the necessary measures to prohibit the
affixing to apparatus, its packaging, the instructions for use and the
guarantee certificate of markings which are likely to deceive third
parties as to the meaning and form of the CE marking. Any other
marking may be affixed to the apparatus, its packaging, the
instructions for use or the guarantee certificate provided that the
visibility and legibility of the CE marking is not thereby reduced.’;!B1993L0068 — EN — 01.04.1998 — 001.001 — 10
4. in Article 10 (6) the first subparagraph is replaced by the following
text:
‘6. Member States shall notify the Commission and the other
Member States of the competent authorities referred to in this Article
and the bodies responsible for issuing the EC type-examination
certificates referred to in paragraph 5, 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 authorities and bodies
with their identification numbers and the tasks for which they have
been notified. The Commission shall ensure that this list is kept up to
date.’;
5. the following paragraph is added to Article 10:
‘7. Without prejudice to Article 9:
(a) where a Member State or a competent authority establishes
that the CE marking has been affixed unduly, the
manufacturer or his authorized representative established
within the Community shall be obliged to make the
product comply as regards the provisions concerning the
CE marking and to end the infringement under conditions
imposed by the Member State;
(b) where non-compliance continues, the Member State must
take all appropriate measures to restrict or prohibit the
placing on the market of the product in question or to
ensure that it is withdrawn from the market in accordance
with the procedures laid down in Article 9.’;
6. Annex I section 2 is replaced by the following text:
‘2. CE conformity marking
— The CE conformity marking shall consist of the initials
“CE’’ taking the following form:
— If the CE marking is reduced or enlarged the
proportions given in the above graduated drawing must
be respected.
— Where apparatus is the subject of other Directives
covering other aspects and which also provide for the
CE conformity marking, the latter shall indicate that
the appliances are also presumed to conform to those
other Directives.
— However, where one or more of these Directives allow
the manufacturer, during a transitional period, to
choose which arrangements to apply, the CE marking
shall indicate conformity only to the 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 such apparatus.!B1993L0068 — EN — 01.04.1998 — 001.001 — 11
— The various components of the CE marking must have
substantially the same vertical dimension, which may
not be less than 5 mm.’
Article 6
Directive 89/392/EEC is hereby amended as follows:
1. throughout the text, the therm ‘EC mark’ is replaced by ‘CE
marking’;
2. in Article 8 the fifth paragraph is replaced by the following text:
‘5. (a) Where the machinery is subject to other Directives
concerning other aspects and which also provide for the
affixing of the EC marking, the latter shall indicate that the
machinery is also presumed to conform to the provisions of
those other Directives.
(b) However, where one or more of these Directives allow the
manufacturer, during a transitional period, to choose which
arrangements to apply, the CE marking shall indicate
conformity only to the Directives applied by the manu-
facturer. 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
such machinery.’;
3. in Article 9 the first paragraph is replaced by the following text:
‘1. Member States shall notify the Commission and the other
Member States of the approved 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 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 following text:
‘1. The CE conformity marking shall consist of the initials “CE’’.
The form of the marking to be used is shown in Annex III.’;
5. In Article 10 the third paragraph is replaced by the following text:
‘3. The affixing of markings on the machinery which are likely to
deceive third parties as to the meaning and form of the CE marking
shall be prohibited. Any other marking may be affixed to the
machinery provided that the visibility and legibility of the CE
marking is not thereby reduced.’;
6. the following paragraph is added to Article 10:
‘4. Without prejudice to Article 7:
(a) where a Member State establishes that the CE marking has
been affixed unduly, the manufacturer or his authorized
representative established within the Community shall be
obliged to make the product conform as regards the
provisions concerning the CE marking and to end the
infringement under the conditions imposed by the Member
State;
(b) where non-conformity continues, the Member State must
take all appropriate measures to restrict or prohibit the
placing on the market of the product in question or to!B1993L0068 — EN — 01.04.1998 — 001.001 — 12
ensure that it is withdrawn from the market in accordance
with the procedures laid down in Article 7.’;
7. section 1.7.3 of Annex I is amended as follows:
(a) the second indent is replaced by the following text:
‘ — the CE marking (see Annex III)’;
b) a fifth indent is added:
‘ — the year of construction’;
8. Annex III is replaced by the following text:
‘ANNEX III
CE CONFORMITY MARKING— The CE conformity marking shall consist of the initials “CE’’
taking the following form:
— If the CE marking is reduced or enlarged the proportions given
in the above drawing must be respected.
— The various components of the CE marking must have
substantially the same vertical dimension, which may not be
less than 5 mm. This minimum dimension may be waived for
small-scale machinery.’
Article 7
Directive 89/686/EEC is hereby amended as follows:
1. throughout the text, the term ‘EC mark’ is replaced by ‘CE
marking’;
2. in Article 4 the first paragraph is replaced by the following text:
‘1. Member States may not prohibit, restrict or hinder the placing on
the market of PPE or PPE components which comply with the
provisions of this Directive and which bear the CE marking attesting
their conformity to all the provisions of this Directive, including the
certification procedures in Chapter II.’;
3. the following paragraph is added to Article 5:
‘6. (a) Where the PPE is subject to other Directives concerning
other aspects and which also provide for the affixing of the
CE marking, the latter shall indicate that the PPE is also
presumed to conform to the provisions of the other
Directives.
(b) However, where one or more of these 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 docu-
ments, notices or instructions required by the Directives
and accompanying such PPE.’;!B1993L0068 — EN — 01.04.1998 — 001.001 — 13
4. in Article 9 the first paragraph is replaced by the following:
‘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 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.’;
5. the introductory sentence of Article 12 is replaced by the following
text:
‘The EC declaration of conformity is the procedure whereby the
manufacturer or his authorized representative established within the
Community:’;
6. Article 13 is replaced by the following text:
‘Article 13
1. The CE conformity marking shall consist of the initials “CE’’ in
the form shown in the specimen in Annex IV . In the event of the
involvement of a notified body in the production control phase as
indicated in Article 11, its identification number shall be added.
2. The CE marking must be affixed to each piece of manufactured
PPE so as to be visible, legible and indelible throughout the expected
life of the PPE; however, if this is not possible in view of the
characteristics of the product, the CE marking may be affixed to the
packaging.
3. The affixing of markings on the PPE which are likely to deceive
third parties as to the meaning and form of the CE marking shall be
prohibited. Any other marking may be affixed to the PPE or its
packaging provided that the visibility and legibility of the CE
marking is not thereby reduced.
4. Without prejudice to Article 7:(a) where a Member State establishes that the CE marking has been
affixed unduly, the manufacturer or his authorized representative
established within the Community shall be obliged to make the
product conform as regards the provisions concerning the CE
marking and to end the infringement under the conditions
imposed by the Member State;
(b) where non-conformity continues, the Member State must take all
appropriate measures to restrict or prohibit the placing on the
market of the product in question or to ensure that it is
withdrawn from the market in accordance with the procedures
laid down in Article 7.’;
7. the following text is added to section 1.4 of Annex II:
‘h) where appropriate, the references of the Directives applied in
accordance with Article 5 (6) (b);
i) the name, address and identification number of the notified body
involved in the design stage of the PPE.’;
8. Annex IV is replaced by the following text:
‘ANNEX IV
CE CONFORMITY MARKING AND INFORMATION
— The CE conformity marking shall consist of the initials “CE’’
taking the following form:!B1993L0068 — EN — 01.04.1998 — 001.001 — 14
— If the CE marking is reduced or enlarged the proportions given
in the above graduated drawing must be respected.
— The various components of the CE marking must have
substantially the same vertical dimension, which may not be
less than 5 mm. This minimum dimension may be waived for
small-scale PPE.
Additional information
— The last two digits of the year in which the CE marking was
affixed; this information is not required in the case of the PPE
referred to in Article 8 (3).’
Article 8
Directive 90/384/EEC is hereby amended as follows:
1. throughout the text, the term ‘EC mark’ is replaced by ‘CE
marking’;
2. in Article 2 the second paragraph is replaced by the following text:
‘2. Member States shall take all steps to ensure that instruments
may not be brought into service for the uses set out in Article 1 (2)
(a) unless they meet the requirements of this Directive which apply
to them, including the conformity assessment procedures referred to
in Chapter II, and accordingly bear the CE marking provided for in
Article 10.’;
3. in Article 8 the third paragraph is replaced by the following text:
‘3. (a) Where the instruments are subject to other Directives
covering other aspects and which also provide for the
affixing of the CE marking, the latter shall indicate that the
instruments in question are also presumed to conform to
the provisions of those other Directives.
(b) However, where one or more of the Directives which apply
to the instruments allow the manufacturer, during a
transitional period, to choose which arrangements to apply,
the CE marking shall indicate conformity only to the
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 such instruments.’;
4. in Article 9 the first paragraph is replaced by the following text:
‘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.!B1993L0068 — EN — 01.04.1998 — 001.001 — 15
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.’;
5. in Article 10 the third paragraph is replaced by the following text:
‘3. The affixing of markings on the instruments which are likely to
deceive third parties as to the meaning and form of the CE marking
shall be prohibited. Any other marking may be affixed to the
instruments provided that the visibility and legibility of the CE
markings is not thereby reduced.’;
6. Article 11 is replaced by the following text:
‘Article 11
Without prejudice to Article 7:
(a) where a Member State establishes that the CE marking has been
affixed unduly, the manufacturer or his authorized representative
established within the Community shall be obliged to make the
instrument conform as regards the provisions concerning the CE
marking and to end the infringement under the conditions
imposed by the Member State;
(b) where non-conformity continues, the Member State must take all
appropriate measures to restrict or prohibit the placing on the
market of the instrument in question or to ensure that it is
withdrawn from the market in accordance with the procedures
laid down in Article 7.’;
7. the following paragraphs of Annex II are amended as follows:
(a) in paragraph 2.1 the second and third subparagraphs are replaced
by the following text:
‘The manufacturer or his authorized representative established
within the Community shall affix the CE marking to each
instrument and the inscriptions provided for in Annex IV and
shall draw up a written declaration of conformity.
The CE marking shall be accompanied by the identification
number of the notified body responsible for the EC surveillance
referred to in paragraph 2.4.’;
(b) paragraphs 3 and 4 are replaced by the following text:
‘3. EC verification
3.1. EC verification is the procedure whereby the manu-
facturer or his authorized representative established
within the Community ensures and declares that the
instruments which have been checked in accordance with
paragraph 3.3 are, where applicable, in conformity to the
type described in the EC type-examination certificate and
satisfy the requirements of the Directive which apply to
them.
3.2. The manufacturer shall take all necessary measures in
order that the manufacturing process ensures conformity
of the instruments, where applicable, with the type as
described in the EC type-examination certificate and with
the requirements of this Directive which apply to them.
The manufacturer or his authorized representative
established within the Community shall affix the CE
marking to each instrument and draw up a written
declaration of conformity.
3.3. The notified body shall carry out the appropriate
examinations and tests in order to check the conformity
of the product to the requirements of this Directive by!B1993L0068 — EN — 01.04.1998 — 001.001 — 16
examination and testing of every instrument, as specified
in paragraph 3.5.
3.4. For instruments not subject to EC type-approval, the
documents relating to the design of the instrument, as set
out in Annex III, must be accessible to the notified body
should the latter so request.
3.5. Verification by checking and testing of each instrument.3.5.1. All instruments shall be individually examined and
appropriate tests, as set out in the relevant standard(s)
referred to in Article 5, or equivalent tests, shall be
carried out in order to verify their conformity, where
applicable, to the type as described in the EC type-
examination certificate and the requirements of this
Directive that apply to them.
3.5.2. The notified body shall affix, or cause to be affixed, its
identification number on each instrument the conformity
of which to requirements has been established and draw
up a written certificate of conformity relating to the tests
carried out.
3.5.3. The manufacturer or his authorized representative shall
ensure that he is able to supply the notified body’ s
certificates of conformity on request
4. EC unit verification
4.1. EC unit verification is the procedure whereby the
manufacturer or his authorized representative established
within the Community ensures and declares that the
instrument, generally designed for a specific application,
which has been issued with the certificate referred to in
paragraph 4.2 conforms to the requirements of this
Directive that apply to it. The manufacturer or his
authorized representative shall affix the CE marking to
the instrument and shall draw up a written declaration of
conformity.
4.2. The notified body shall examine the instrument and carry
out the appropriate tests, as set out in the respective
standard(s) referred to in Article 5, or equivalent tests, in
order to ensure its conformity to the relevant require-
ments of this Directive.
The notified body shall affix, or cause to be affixed, its
identification number to the instrument the conformity of
which to requirements has been established and shall
draw up a written certificate of conformity concerning the
tests carried out.
4.3. The aim of the technical documentation relating to the
design of the instrument, as referred to in Annex III, is to
enable conformity to the requirements of this Directive to
be assessed and the design, manufacture and operation of
the instrument to be understood. It must be accessible to
the notified body.
4.4. The manufacturer or his authorized representative shall
ensure that he is able to supply the notified body’ s
certificates of conformity on request.’;
(c) paragraphs 5.3.1 and 5.3.2 are replaced by the following text:
‘5.3.1. Where a manufacturer has opted for execution in two
stages of one of the procedures mentioned in 5.1, and
where these two stages will be carried out by different
parties, an instrument which has undergone the first stage
of the procedure shall bear the identification number of
the notified body involved in that stage.!B1993L0068 — EN — 01.04.1998 — 001.001 — 17
5.3.2. The party which has carried out the first stage of the
procedure shall issue for each of the instruments a
certificate containing the necessary data for identification
of the instrument and specifying the examinations and
tests that have been carried out.
The party which carries out the second stage of the
procedure shall carry out those examinations and tests
that have not yet been carried out.
The manufacturer or his authorized representative shall
ensure that he is able to supply the notified body’ s
certificates of conformity on request.’;
(d) paragraph 5.3.4 is replaced by the following text:
‘5.3.4.The CE marking shall be affixed to the instrument on
completion of the second stage, along with the identifi-
cation number of the notified body which took part in the
second stage.’;
8. in Annex IV paragraph 1.1 is amended as follows:
(a) subparagraph (a) is replaced by the following text:
‘ (a) — the CE conformity marking comprising the CE symbol
as described in Annex VI, "C1 3
— the identification number(s) of the notified body/
bodies that has/have carried out the EC surveillance or
the EC verification.
The abovementioned marking and inscriptions shall be affixed to
the instrument distinctly grouped together;’;
(b) in subparagraph (2), after the sixth indent, the following indent
is added:
‘ — the last two digits of the year in which the CE marking was
affixed,’;
9. Annex VI is replaced by the following text:
‘ANNEX VI
CE CONFORMITY MARKING
— The CE conformity marking shall consist of the initials “CE’’
taking the following form:
— If the CE marking is reduced or enlarged the proportions given
in the above graduated drawing must be respected.
— The various components of the CE marking must have
substantially the same vertical dimension, which may not be
less than 5 mm.’
Article 9
Directive 90/385/EEC is hereby amended as follows:
1. throughout the text, the term ‘EC mark’ is replaced by ‘CE
marking’;!B1993L0068 — EN — 01.04.1998 — 001.001 — 18
2. in Article 4 the first paragraph is replaced by the following text:
‘1. Member States shall not prevent the placing on the market or the
putting into service within their territory of devices complying with
the provisions of this Directive and bearing the CE marking provided
for in Article 12 which indicate that they have been the subject of an
evaluation of their conformity in accordance with Article 9.’;
3. the following paragraph is added to Article 4:
‘5. (a) Where the devices are subject to other Directives concern-
ing other aspects and which also provide for the affixing of
the CE marking, the latter shall indicate that the devices
are also presumed to conform to the provisions of the other
Directives.
(b) However, where one or more of these 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 docu-
ments, notices or instructions required by the Directives
and accompanying such devices; these documents, notices
or instructions shall be accessible without it being necess-
ary to destroy the packaging which keeps the device
sterile.’;
4. in Article 11 the first paragraph is replaced by the following text:
‘1. Member States shall notify the Commission and the other
Member State of the bodies which 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 Commission shall ensure that this list is kept up to
date.’;
5. in Article 12 (2) the second subparagraph is replaced by the
following text:
‘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.’;
6. in Article 12 the third paragraph is replaced by the following text:
‘3. The affixing of markings on the devices which are likely to
deceive third parties as to the meaning and form of the CE marking
shall be prohibited. Any other marking may be affixed to the
packaging or to the instruction leaflet accompanying the device
provided that the visibility and legibility of the CE marking is not
hereby reduced.’;
7. Article 13 is replaced by the following text:
‘Article 13
Without prejudice to Article 7
(a) where a Member State establishes that the CE marking has been
affixed unduly, the manufacturer or his authorized representative
established within the Community shall be obliged to end the
infringement under conditions imposed by the Member State;
(b) where non-compliance continues, the Member State must take
all appropriate measures to restrict or prohibit the placing on the!B1993L0068 — EN — 01.04.1998 — 001.001 — 19
market of the device in question or to ensure that it is withdrawn
from the market in accordance with the procedures laid down in
Article 7.’;
8. Annex II is amended as follows:
(a) in section 2 the second paragraph is replaced by the following
text:
‘The manufacturer or his authorized representative established
within the Community shall affix the CE marking in accordance
with Article 12 and shall draw up a written declaration of
conformity.
This declaration shall cover one or more identified examples of
the product and shall be kept by the manufacturer or his
authorized representative established within the Community.
The CE marking shall be accompanied by the identification
number of the notified body responsible.’;
(b) section 6 is replaced by the following text:
‘6. Administrative provisions
6.1. For at least five years from last date of manufacture of the
product, the manufacturer shall keep available for the
national authorities:
— the declaration of conformity,— the documentation referred to in the second indent of
section 3.1,
— the amendments referred to in section 3.4,— the documentation referred to in section 4.2,— the decisions and reports of the notified body referred
to in sections 3.4, 4.3, 5.3 and 5.4.
6.2. On request, the notified body shall make available to the
other notified bodies and the competent authority all
relevant information on approvals of quality systems
issued, refused or withdrawn.
6.3. Where neither the manufacturer nor his authorized
representative are established in the Community, the task
of keeping available for the authorities the technical
documentation referred to in Article 4 (2) shall fall to the
person responsible for placing the appliance on the
Community market.’;
9. in Annex III sections 7 and 8 are replaced by the following text:
‘7. Administrative provisions
7.1. On request, each notified body shall make available to the
other notified bodies and the competent authority, all relevant
information on EC type-examination certificates and addenda
issued, refused or withdrawn.
7.2. Other notified bodies may obtain a copy of the EC
type-examination certificates and/or the addenda to them.
The annexes to the certificates shall be made available to the
other notified bodies when a reasoned application is made and
after the manufacturer has been informed.
7.3. The manufacturer or his authorized representative shall keep
with the technical documentation a copy of the EC type-
examination certificates and the supplements to them for a
period of at least five years from the manufacture of the last
appliance.
7.4. Where neither the manufacturer nor his authorized represen-
tative are established in the Community, the task of keeping!B1993L0068 — EN — 01.04.1998 — 001.001 — 20
the technical documentation available for the authorities shall
fall to the person responsible for placing the appliance
concerned on the Community market.’;
10. Annex IV is replaced by the following text:
‘ANNEX IV
EC VERIFICATION1. EC verification is the procedure whereby the manufacturer or
his authorized representative established within the Commu-
nity ensures and declares that the products subject to the
provisions of section 3 are in conformity with the type as
described in the EC type-examination certification and satisfy
the requirements of this Directive that apply to them.
2. The manufacturer or his authorized representative established
within the Community shall take all measures necessary in
order that the manufacturing process ensures conformity of
the products to the type as described in the EC type-examin-
ation certification and to the requirements of this Directive
that apply to them. The manufacturer or his authorized
representative established within the Community shall affix
the CE marking to each product and draw up a written
declaration of conformity.
3. The manufacturer shall, before the start of manufacture,
prepare documents defining the manufacturing processes, in
particular as regards sterilization, together with all the
routine, pre-established provisions to be implemented to
ensure uniformity of production and conformity of the
products with the type as described in the EC type-examin-
ation certificate as well as with the relevant requirements of
this Directive.
4. The manufacturer shall undertake to institute and keep
updated a post-marketing surveillance system. This under-
taking shall include the obligation on the part of the
manufacturer to notify the competent authorities of the
following events immediately on learning of them:
(i) any change in the characteristics or performances and any
inaccuracies in the instruction leaflet for a device which
might lead to or have led to the death of a patient or
deterioration in his state of health;
(ii) any technical or medical reason resulting in the with-
drawal of a device from the market by a manufacturer.
5. The notified body shall carry out the appropriate examin-
ations and tests in order to check the conformity of the
product to the requirements of this Directive by examination
and testing of products on a statistical basis, as specified in
section 6. The manufacturer must authorize the notified body
to evaluate the efficiency of the measures taken pursuant to
section 3, by audit where appropriate.
6. Statistical verification
6.1. Manufacturers shall present the products manufactured in the
form of uniform batches and shall take all necessary measures
in order that the manufacturing process ensures the uniformity
of each batch produced.
6.2. A random sample shall be taken from each batch. Products in
a sample shall be individually examined and appropriate tests,
as set out in the standard(s) referred to in Article 5, or
equivalent tests shall be carried out to verify their conformity
to the type as described in the EC type-examination certificate
and thereby determine whether a batch is to be accepted or
rejected.!B1993L0068 — EN — 01.04.1998 — 001.001 — 21
6.3. Statistical control of products shall be based on attributes,
entailing a sampling system with the following character-
istics:
— a level of quality corresponding to a probability of
acceptance of 95 %, with a non-conformity percentage of
between 0,29 and 1 %,
— a limit quality corresponding to a probability of accept-
ance of 5 %, with a percentage of non-conformity of
between 3 and 7 %.
6.4. Where batches are accepted, the notified body shall affix, or
cause to be affixed, its identification number to each product
and draw up a written certificate of conformity relating to the
tests carried out. All products in the batch may be placed on
the market except for those products from the sample which
were found not to be in conformity.
Where a batch is rejected, the notified body shall take
appropriate measures to prevent the placing on the market of
that batch. In the event of frequent rejection of batches the
notified body may suspend the statistical verification.
The manufacturer may, under the responsibility of the notified
body, affix the latter’s ’identification number during the
manufacturing process.
6.5. The manufacturer or his authorized representative shall ensure
that he is able to supply the notified body’ s certificates of
conformity on request.’;
11. the second subparagraph of section 2 of Annex V is replaced by the
following text:
‘The manufacturer or his authorized representative established
within the Community shall affix the CE marking in accordance
with Article 12 and draw up a written declaration of conformity. This
declaration shall cover one or more identified specimens of the
product and shall be kept by the manufacturer. The CE marking shall
be accompanied by the identification number of the notified body
responsible.’;
12. Annex IX is replaced by the following text:
‘ANNEX IX
CE CONFORMITY MARKING— The CE conformity marking shall consist of the initials “CE’’
taking the following form:
— If the CE marking is reduced or enlarged the proportions given
in the above graduated drawing must be respected.
— The various components of the CE marking must have
substantially the same vertical dimension, which may not be
less than 5 mm.
This minimum dimension may be waived for small-scale
devices.’!B1993L0068 — EN — 01.04.1998 — 001.001 — 22
Article 10
Directive 90/396/EEC is hereby amended as follows:
1. throughout the text, the term ‘EC mark’ is replaced by ‘CE
marking’;
2. in Article 4 the first paragraph is replaced by the following text:
‘1. Member States may not prohibit, restrict or impede the placing
on the market and the putting into service of appliances which
comply with all the provisions of this Directive, including the
conformity assessment procedures laid down in Chapter II, and
which bear the CE marking provided for in Article 10.’;
3. in Article 8 the fifth paragraph is replaced by the following text:
‘5. (a) Where the appliances are covered by other Directives
dealing with other aspects and specifying the affixing of
the CE marking, the latter shall indicate that the appliances
are also presumed to conform to the provisions of those
other Directives.
(b) However, where one or more of these 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 docu-
ments, notices or instructions required by the Directives
and accompanying such devices.’;
4. in Article 9 the first paragraph is replaced by the following text:
‘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 of these bodies, and the
identification numbers it has assigned to them and shall ensure that
the list is kept up to date.’;
5. in Article 10 the second paragraph is replaced by the following text:
‘2. The affixing of markings on the appliances which are likely to
deceive third parties as to the 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 visibility and
legibility of the CE marking is not hereby reduced.’;
6. Article 11 is replaced by the following text:
‘Article 11
Without prejudice to Article 7:
(a) where a Member State establishes that the CE marking has been
affixed unduly, the manufacturer or his authorized representative
established within the Community shall be obliged to make the
product comply as regards the provisions concerning the CE
marking and to end the infringement under conditions imposed
by the Member State;
(b) where non-compliance continues, the Member State must take
all appropriate measures to restrict or prohibit the placing on the
market of the appliance in question or to ensure that it is
withdrawn from the market in accordance with the procedures
laid down in Article 7.’;!B1993L0068 — EN — 01.04.1998 — 001.001 — 23
7. Annex II is amended as follows:
(a) in point 2.1 the second sentence is replaced by the following
text:
‘The manufacturer or his authorized representative established
within the Community shall affix the CE marking on each
appliance and draw up a written certificate of conformity.’;
(b) in point 2.1 the last sentence is replaced by the following text:
‘The CE marking must be followed by the identification number
of the notified body responsible for the random checks set out in
point 2.3.’;
(c) in point 3.1 the second sentence is replaced by the following
text:
‘The manufacturer or his authorized representative established
within the Community must affix the CE marking to each
appliance and draw up a written declaration of conformity.’;
(d) in point 3.1 the last sentence is replaced by the following text:
‘The CE marking must be followed by the identification number
of the notified body responsible for EC surveillance.’;
(e) in point 4.1 the second sentence is replaced by the following
text:
‘The manufacturer or his authorized representative established
within the Community must affix the CE marking to each
appliance and draw up a written declaration of conformity.’;
(f) in point 4.1 the last sentence is replaced by the following text:
‘The CE marking must be followed by the identification number
of the notified body responsible for EC surveillance.’;
(g) points 5 and 6 are replaced by the following text:
‘5. EC VERIFICATION
5.1. EC verification is the procedure whereby the manu-
facturer or his authorized representative established
within the Community ensures and declares that the
appliances subject to the provisions of point 3 are in
conformity to the type as described in the EC type-
examination certification and satisfy the requirements of
this Directive that apply to them.
5.2. The manufacturer or his authorized representative
established within the Community must take all measures
necessary in order that the manufacturing process ensures
conformity of the appliances to the type as described in
the EC type-examination certification and to the
requirements of this Directive that apply to them. The
manufacturer or his authorized representative established
within the Community must affix the CE marking to each
appliance and draw up a written declaration of conform-
ity. The declaration of conformity may cover one or more
appliances and must be kept by the manufacturer or his
authorized representative established within the Commu-
nity.
5.3. The notified body must carry out the appropriate
examinations and tests in order to check the conformity
of the appliance to the requirements of this Directive by
examination and testing of every appliance, as specified
in point 5.4, or by examination and testing of appliances
on a statistical basis, as specified in point 5.5, at the
choice of the manufacturer.!B1993L0068 — EN — 01.04.1998 — 001.001 — 24
5.4. V erification by checking and testing of each appliance
5.4.1. All appliances must be individually examined and
appropriate tests, as set out in the relevant standard(s)
referred to in Article 5, or equivalent tests, must be
carried out in order to verify their conformity with the
type as described in the EC type-examination certificate
and the requirements of this Directive that apply to them.
5.4.2. The notified body must affix, or cause to be affixed, its
identification number on each appliance and draw up a
written certificate of conformity relating to the tests
carried out. The certificate of conformity may cover one
or more appliances.
5.4.3. The manufacturer or his authorized representative must
ensure that he is able to supply the notified body’ s
certificates of conformity on request.
5.5. Statistical verification
5.5.1. Manufacturers must present the appliances manufactured
in the form of uniform batches and must take all
necessary measures in order that the manufacturing
process ensures the uniformity of each batch produced.
5.5.2. Statistical control is as follows:
Appliances are subject to statistical control by attributes.
They should be grouped into identifiable batches consist-
ing of units of a single model manufactured under the
same conditions. A batch is examined at random inter-
vals. The appliances constituting a sample are examined
individually and appropriate tests, as laid down in the
respective standard(s) referred to in Article 5, or
equivalent tests are carried out to determine whether the
batch is to be accepted or rejected.
A sampling system with the following characteristics is
applied:
— a level of quality corresponding to a probability of
acceptance of 95 %, with a non-conformity percen-
tage of between 0,5 and 1,5 %,
— a limit quality corresponding to a probability of
acceptance of 5 %, with a percentage of non-con-
formity of between 5 and 10 %.
5.5.3. Where batches are accepted, the notified body must affix,
or cause to be affixed, its identification number to each
appliance and draw up a written certificate of conformity
relating to the tests carried out. All appliances in the batch
may be placed on the market except for those products
from the sample which were found not to be in confirmity.
Where a batch is rejected, the notified body must take
appropriate measures to prevent the placing on the market
of that batch. In the event of frequent rejection of batches
the notified body may suspend the statistical verification.
The manufacturer may, under the responsibility of the
notified body, affix the latter’s identification number
during the manufacturing process.
5.5.4. The manufacturer or his authorized representative must
ensure that he is able to supply the notified body’ s
certificates of conformity on request.
6. EC UNIT VERIFICATION
6.1. EC unit verification is the procedure whereby the
manufacturer or his authorized representative established
within the Community ensures and declares that the!B1993L0068 — EN — 01.04.1998 — 001.001 — 25
appliance concerned, which has been issued with the
certificate referred to in point 2, conforms to the
requirements of this Directive that apply to it. The
manufacturer or his authorized representative must affix
the CE marking to the appliance and draw up a written
declaration of conformity which he must keep.
6.2. The notified body must examine the appliance and carry
out the appropriate tests, taking account of the design
documentation in order to ensure its conformity with the
essential requirements of this Directive.
The notified body must affix, or cause to be affixed, its
identification number to the approved appliance and must
draw up a written certificate of conformity concerning the
tests carried out.
6.3. The aim of the technical documentation relating to the
design of the instrument, as referred to in Annex IV , is to
enable conformity to the requirements of this Directive to
be assessed and the design, manufacture and operation of
the appliance to be understood.
The design documentation referred to in Annex IV must
be made available to the notified body.
6.4. If deemed necessary by the notified body, the examin-
ations and tests may be carried out after installation of the
appliance.
6.5. The manufacturer or his authorized representative must
ensure that he is able to supply the notified body’ s
certificates of conformity on request.’;
8. Annex III is replaced by the following text:
‘ANNEX III
CE CONFORMITY MARKING AND INSCRIPTIONS
1. The CE conformity marking consists of the initials “CE’’ as
shown below:
The CE marking must be followed by the identification number
of the notified body involved in the production control phase.
2. The appliance or its data plate must bear the CE marking
together with the following inscriptions:
— the manufacturer’s name or identification symbol,
— the trade name of the appliance,— the type of electrical supply used, if applicable,
— the appliance category,
— the last two digits of the year in which the CE marking was
affixed.
Information needed for installation purposes may be added
according to the nature of the appliance.
3. If the CE marking is reduced or enlarged the proportions given
in the above graduated drawing must be respected.!B1993L0068 — EN — 01.04.1998 — 001.001 — 26
The various components of the CE marking must have
substantially the same vertical dimension, which may not be
less than 5 mm.’
Article 12
Directive 92/42/EEC is hereby amended as follows:
1. throughout the text, the term ‘EC mark’ is replaced by ‘CE
marking’;
2. in Article 4 the first paragraph is replaced by the following text:
‘1. Member States may not prohibit, restrict or impede the placing
on the market or entry into service within their territories of
appliances and boilers which comply with the provisions of this
Directive and which bear the CE marking provided for in Article 7
attesting to the conformity to all the provisions of this Directive,
including the conformity assessment procedures laid down in
Articles 7 and 8, save as otherwise laid down in the Treaty or other
Directives or Community provisions.’;
3. the following paragraph 5 is added to Article 4:
‘5. (a) Where the boilers are subject to other Directives concern-
ing 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.
(b) However, where one or more of these 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 docu-
ments, notices or instructions required by the Directives
and accompanying the boilers.’;
4. in Article 7 the fourth paragraph is replaced by the following text:
‘4. The CE mark of conformity to the requirements of this Directive
and to the other provisions concerning the granting of the CE
marking, and also the inscriptions specified in Annex I, shall be
affixed on boilers in a visible, easily legible and indelible manner.
The affixing on such products of any markings likely to deceive third
parties as to the meaning and form of the CE marking shall be
prohibited. Any other marking may be affixed to the boilers and
appliances provided that the visibility and legibility of the CE
marking is not thereby reduced.’;
5. the following paragraph is added to Article 7:
‘5. (a) Where a Member State or a notified body establishes that
the CE marking has been affixed unduly, the manufacturer
or his agent established within the Community shall be
obliged to make the boiler comply as regards the provisions
concerning the CE marking and to end the infringement
under conditions imposed by the Member State;
(b) where non-compliance continues, the Member State must
take all appropriate measures to restrict or prohibit the
placing on the market of the product in question or to
ensure that it is withdrawn from the market, and shall
inform the Commission and the other Member States
accordingly.’;!B
!M1
!B1993L0068 — EN — 01.04.1998 — 001.001 — 27
6. in Article 8 the first paragraph is replaced by the following text:
‘1. Member States shall inform the Commission and the other
Member States of the bodies which they have appointed to carry out
the procedures referred to in Article 7, together with 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 with their
identication numbers and the tasks for which they have been
notified. The Commission shall ensure that this list is kept up to
date.’;
7. Annex I is replaced by the following text:
‘ANNEX I
CE CONFORMITY MARKING AND ADDITIONAL SPE-
CIFIC MARKINGS
1. CE conformity marking
The CE conformity marking shall consist of the initials “CE’’
taking the following form:
— If the CE marking is reduced or enlarged the proportions
given in the above graduated drawing must be respected.
— The various components of the CE marking must have
substantially the same vertical dimension, which may not
be less than 5 mm.
2. Additional specific markings
— The last two digits of the year in which the EC marking
was affixed.
— The energy performance label awarded under Article 6 of
this Directive consists of the following symbol:
’
8. Annex IV is amended as follows:
(a) the last sentence of section 1 of module C is replaced by the
following text:
‘The manufacturer or his authorized representative established
within the Community shall affix the CE marking to each
appliance and draw up a written declaration of conformity.’;!B1993L0068 — EN — 01.04.1998 — 001.001 — 28
(b) the last two sentences of section 1 of module D are replaced by
the following text:
‘The manufacturer or his authorized representative established
within the Community shall affix the CE marking to each
appliance and draw up a written declaration of conformity. The
CE mark is accompanied by the identification number of the
notified body responsible for the checks referred to in section
4.’;
(c) the last two sentences of section 1 of module E are replaced by
the following text:
‘The manufacturer or his authorized representative established
within the Community shall affix the CE marking to each boiler
and appliance and draw up a written declaration of conformity.
The CE marking must be accompanied by the identification
number of the notified body responsible for the checks referred
to in section 4.’
Article 13
Directive 73/23/EEC is hereby amended as follows:
1. in the preamble the following two recitals are added to the end:
‘Whereas Decision 90/683/EEC (*) establishes the modules for the
various phases of the conformity assessment procedures which are
intended to be used in the technical harmonization Directives;
Whereas the choice of procedures must not lead to a lowering of
safety standards of electrical equipment, which have already been
established throughout the Community,
(*) OJ No L 380, 31. 12. 1990, p. 13.’;
2. in Article 8 the first paragraph is replaced by the following text:
‘1. Before being placed on the market, the electrical equipment
referred to in Article 1 must have affixed to it the CE marking
provided for in Article 10 attesting to its conformity to the provisions
of this Directive, including the conformity assessment procedure
described in Annex IV .’;
3. the following paragraph 3 is added to Article 8:
‘3. (a) Where electrical equipment is subject to other Directives
concerning other aspects which also provide for the
affixing of the CE marking, the latter shall indicate that
the equipment in question is also presumed to conform to
the provisions of those other Directives.
(b) However, where one or more of these 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 docu-
ments, notices or instructions required by the Directives
and accompanying the electrical equipment.’;
4. Article 10 is replaced by the following text:
‘Article 10
1. The CE conformity marking referred to in Annex III shall be
affixed by the manufacturer or his authorized representative
established within the Community to the electrical equipment or,
failing that, to the packaging, the introduction sheet or the guarantee
certificate so as to be visible, easily legible and indelible.!B1993L0068 — EN — 01.04.1998 — 001.001 — 29
2. The affixing on electrical equipment of any markings liable to
deceive third parties as to the meaning and form of the CE marking
shall be prohibited. However, any other marking may be affixed to
the electrical equipment, its packaging, the instruction sheet or the
guarantee certificate provided that the visibility and legibility of the
CE marking is not thereby reduced.
3. Without prejudice to Article 9:
(a) where a Member State establishes that the CE marking has been
affixed unduly, the manufacturer or his agent established within
the Community market shall be obliged to make the electrical
equipment comply as regards the provisions concerning the CE
marking and to end the infringement under conditions imposed
by the Member State;
(b) where non-compliance continues, the Member State must take
all appropriate measures to restrict or prohibit the placing on the
market of the electrical equipment in question or to ensure that it
is withdrawn from the market in accordance with the procedure
laid down in Article 9.’;
5. in Article 11 the second indent is deleted;6. the following Annexes are added:
‘ANNEX III
CE CONFORMITY MARKING AND EC DECLARATION OF
CONFORMITY
A. CE conformity marking
The CE conformity marking shall consist of the initials “CE’’
taking the following form:
— If the CE marking is reduced or enlarged the proportions
given in the above graduated drawing must be respected.
— The various components of the CE marking must have
substantially the same vertical dimension, which may not
be less than 5 mm.
B. EC declaration of conformity
The EC declaration of conformity must contain the following
elements:
— name and address of the manufacturer or his authorized
respresentative established within the Community,
— a description of the electrical equipment,— reference to the harmonized standards,
— where appropriate, references to the specifications with
which conformity is declared,
— identification of the signatory who has been empowered
to enter into commitments on behalf of the manufacturer!B1993L0068 — EN — 01.04.1998 — 001.001 — 30
or his authorized representative established within the
Community,
— the last two digits of the year in which the CE marking
was affixed.
ANNEX IV
INTERNAL PRODUCTION CONTROL
1. Internal production control is the procedure whereby the
manufacturer or his authorized representative established
within the Community, who carries out the obligations laid
down in point 2, ensures and declares that the electrical
equipment satisfies the requirements of this Directive that
apply to it. The manufacturer or his authorized representative
established within the Community must affix the CE marking
to each product and draw up a written declaration of
conformity.
2. The manufacturer must establish the technical documentation
described in point 3 and he or his authorized representative
established within the Community must keep it on Commu-
nity territory at the disposal of the relevant national authorities
for inspection purposes for a period ending at least 10 years
after the last product has been manufactured.
Where neither the manufacturer nor his authorized represen-
tative is established within the Community, this obligation is
the responsibility of the person who places the electrical
equipment on the Community market.
3. Technical documentation must enable the conformity of the
electrical equipment to the requirements of this Directive to
be assessed. It must, as far as relevant for such assessment,
cover the design, manufacture and operation of the electrical
equipment. It must include:
— a general description of the electrical equipment,— conceptual design and manufacturing drawings and
schemes of components, sub-assemblies, circuits, etc.,
— descriptions and explanations necessary for the under-
standing of said drawings and schemes and the operation
of the electrical equipment,
— a list of the standards applied in full or in part, and
descriptions of the solutions adopted to satisfy the safety
aspects of this Directive where standards have not been
applied,
— results of design calculations made, examinations carried
out, etc.
— test reports.
4. The manufacturer or his authorized representative must keep a
copy of the declaration of conformity with the technical
documentation.
5. The manufacturer must take all measures necessary in order
that the manufacturing process shall ensure compliance of the
manufactured products with the technical documentation
referred to in point 2 and with the requirements of this
Directive that apply to them.’
Article 14
1. Member States shall adopt and publish the laws, regulations and
administrative provisions necessary to comply with this Directive by 1
July 1994. They shall forthwith inform the Commission thereof.
They shall apply these provisions from 1 January 1995.!B1993L0068 — EN — 01.04.1998 — 001.001 — 31
When Member States adopt these measures, they shall contain a
reference to this Directive or shall be accompanied by such a reference
on the occasion of their official publication. The methods of making such
a reference shall be laid down by the Member States.
2. Until 1 January 1997 Member States shall allow the placing on the
market and the bringing into service of products which comply with the
marking arrangements in force before 1 January 1995.
3. Member States shall communicate to the Commission the texts of
the provisions of national law which they adopt in the field covered by
this Directive. The Commission shall inform the other Member States
thereof.
Article 15
This Directive is addressed to the Member States.!B1993L0068 — EN — 01.04.1998 — 001.001 — 32