1993L0068 — EN — 02.08.1993 — 000.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B 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(machinery), 89/686/EEC (personal protective equipment), 90/384/EEC (non-automatic weighinginstruments), 90/385/EEC (active implantable medicinal devices), 90/396/EEC (appliances burninggaseous fuels), 91/263/EEC (telecommunications terminal equipment), 92/42/EEC (new hot-waterboilers fired with liquid or gaseous fuels) and 73/23/EEC (electrical equipment designed for use
within certain voltage limits)
(OJ L 220, 30.8.1993, p. 1)
Corrected by:
►C1 Corrigendum, OJ L 216, 8.8.1997, p. 99 (93/68)
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▼B
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 (machinery),89/686/EEC (personal protective equipment), 90/384/EEC (non-automatic weighing instruments), 90/385/EEC (active implantablemedicinal 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 EconomicCommunity, 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 theprinciples established in its Resolution of 7 May 1985 on a newapproach 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 andmaking it more consistent, these various provisions need to be replacedby uniform prescriptions; whereas it is therefore necessary to harmonizethese provisions, particularly with regard to products which may fallwithin 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 singledesign; whereas, in its Resolution of 21 December 1989 on a globalapproach to conformity assessment (
6), the Council approved as a
guiding principle the adoption of a consistent approach such as this withregard 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 conformityassessment procedures;
Whereas this harmonization of the provisions concerning the affixing
and use of the ‘CE' marking requires that existing Directives undergodetailed amendment to bring them into line with the new arrangements,
(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.
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HAS ADOPTED THIS DIRECTIVE:
Article 1
The following Directives are hereby amended:
1. Council Directive 87/404/EEC of 25 June 1987 on the harmon-
ization of the laws of the Member States relating to simple pressurevessels (
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 provi-sions 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 electromagneticcompatibility (
4);
5. Council Directive 89/392/EEC of 14 June 1989 on the approx-
imation 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 personalprotective equipment (
6);
7. Council Directive 90/384/EEC of 20 June 1990 on the harmon-
ization of the laws of the Member States relating to non-automaticweighing instruments (
7);
8. Council Directive 90/385/EEC of 20 June 1990 on the approx-
imation of the laws of the Member States relating to active implant-able medical devices (
8);
9. Council Directive 90/396/EEC of 29 June 1990 on the approx-
imation of the laws of the Member States relating to appliancesburning gaseous fuels (
9);
10. Council Directive 91/263/EEC of 29 April 1991 on the approx-
imation of the laws of the Member States concerning telecommuni-cations terminal equipment, including the mutual recognition oftheir conformity (
10);
11. Council Directive 92/42/EEC of 21 May 1992 on efficiency
requirements for new hot-water boilers fired with liquid or gaseousfuels (
11);
12. Council Directive 73/23/EEC of 19 February 1973 on the harmon-
ization of the laws of the Member States relating to electricalequipment 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';
(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.
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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 inChapter II.
Conformity of vessels with the national standards which trans-
pose the harmonized standards the reference numbers of whichhave 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. MemberStates shall publish the reference numbers of such national stan-dards.';
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 theaffixing of the CE marking, the latter shall indicate thatthe vessels in question are also presumed to conform tothe provisions of those other Directives.
(b) However, where one or more of those Directives allow
the manufacturer, during a transitional period, to choosewhich arrangements to apply, the CE marking shall indi-cate conformity only to the Directives applied by themanufacturer. In this case, particulars of the Directivesapplied, as published in the Official Journal of the Euro-
pean Communities , must be given in the documents,
notices or instructions required by the Directives andaccompanying 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 appointedto carry out the procedures referred to in Article 8 (1) and (2)together with the specific tasks which these bodies have beenappointed to carry out and the identification numbers assigned tothem beforehand 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 beennotified. The Commission shall ensure that this list is kept up todate.';
5. Article 11 is replaced by the following text:
‘EC verificationArticle 11
1. EC verification is the procedure whereby a manufacturer or
his authorized representative established within the Communityensures and declares that the vessels which have been checked inaccordance with paragraph 3 are in conformity to the typedescribed in the EC type-examination certificate or with thedesign and manufacturing schedule referred to in Annex IIsection 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 tothe type described in the EC type-examination certificate or to thedesign and manufacturing schedule referred to in Annex IIsection 3. The manufacturer or his authorized representativeestablished within the Community shall affix the CE marking toeach vessel and draw up a declaration of conformity.
3. The approved body shall carry out the appropriate examina-
tions and tests in order to check the conformity of the vesselswith the requirements of this Directive by examination andtesting of vessels in accordance with the following paragraphs:
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3.1. The manufacturer shall present his vessels in the form of
uniform batches and shall take all necessary measures inorder that the manufacturing process ensures the uniformityof each batch produced.
3.2. These batches shall be accompanied by the EC type-exam-
ination certificate referred to in Article 10, or, where thevessels are not manufactured in accordance with anapproved prototype, by the design and manufacturingschedule referred to in Annex II section 3. In this case theapproved body shall, prior to EC verification, examine theschedule 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 inaccordance with the design and manufacturing schedule andperform a hydrostatic test or a pneumatic test of equivalenteffect on each vessel in the batch at a pressure Ph equal to1,5 times the vessel’s design pressure in order to check itssoundness. The pneumatic test shall be subject to acceptanceof the test safety procedures by the Member State in whichthe test is performed.
Moreover, the inspection body shall carry out tests on test-
pieces taken from a representative production test-piece orfrom a vessel, as the manufacturer chooses, in order toexamine the weld quality. The tests shall be carried out onlongitudinal welds. However, where differing weld tech-niques are used for longitudinal and circular welds, the testsshall 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 onfive vessels taken at random from each batch in order tocheck 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 toeach recipient and draw up a written certificate ofconformity relating to the tests carried out. All recipients inthe batch may be placed on the market except for thosewhich have not successfully undergone a hydrostatic test ora pneumatic test.
If a batch is rejected, the notified body or the competent
authority shall take appropriate measures to prevent theputting on the market of that batch. In the event of frequentrejection of batches, the notified body may suspend thestatistical verification.
The manufacturer may, under the responsibility of the noti-
fied body, affix the latter’s identification number during themanufacturing process.
3.5. The manufacturer or his authorized representative must be
able to supply on request the approved body’s certificates ofconformity 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 16to 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 adequacyhas been drawn up, or
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— an approved prototype.' ;
7. Article 15 is replaced by the following text:
‘Article 15
Without prejudice to Article 7:
(a) where a Member State establishes that the CE marking has
been affixed unduly, the manufacturer or his authorizedrepresentative established within the Community shall beobliged to make the product conform as regards the provi-sions concerning the CE marking and to end the infringementunder 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 onthe market of the product in question or to ensure that it iswithdrawn from the market in accordance with the proced-ures 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 markingshall be followed by the distinguishing number referred to inArticle 9 (1) of the approved inspection body responsible for ECverifications 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 CEmarking shall be prohibited. Any other marking may be affixed tothe vessels or the data plate provided that the visibility andlegibility 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 propor-
tions given in the above graduated drawing must berespected.
— The various components of the CE marking must have
substantially the same vertical dimension, which maynot 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 (Tminin°C),
— the capacity of the vessel (V in l),— the name or mark of the manufacturer,— the type and serial or batch identification of the vessel,
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— 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 toenable 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 ofthis Directive, including the conformity assessment proceduresreferred 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 beenpublished in the Official Journal of the European Communities shall
result in a presumption of conformity to the essential safety require-ments referred to in Article 3. Member States shall publish thereference 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 CEmarking, the latter shall indicate that the toys in question arealso presumed to conform to the provisions of those otherDirectives.
(b) However, where one or more of these Directives allow the
manufacturer, during a transitional period, to choose whicharrangements to apply, the CE marking shall indicateconformity only to the Directives applied by the manufac-turer. In this case, particulars of the Directives applied, aspublished in the Official Journal of the European Communi-
ties, 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 outthe EC type-examination referred to in Article 8 (2) and Article 10together with the specific tasks which these bodies have beenappointed to carry out and the identification numbers assigned tothem beforehand by the Commission.
The Commission shall publish in the Official Journal of the Euro-
pean Communities a list of the notified bodies with their identication
number and the tasks for which they have been notified. TheCommission 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.';
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 markingshall be prohibited. Any other marking may be affixed to the toys,their packaging or a label provided that the visibility and legibility ofthe 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 representativeestablished within the Community shall be obliged to make the
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product conform as regards the provisions concerning the CEmarking and to end the infringement under the conditionsimposed by the Member State;
(b) where non-conformity continues, the Member State must take all
appropriate measures to restrict or prohibit the placing on themarket of the product in question or to ensure that it is with-drawn from the market in accordance with the procedures laiddown 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 substan-
tially the same vertical dimension, which may not be less that5 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 ofthe CE conformity marking, referred to in Article 4 (2),the latter shall indicate that the products are alsopresumed to conform to the provisions of those otherDirectives.
(b) However, where one or more of these Directives allow
the manufacturer, during a transitional period, to choosewhich arrangements to apply, the CE marking shall indi-cate conformity only to the Directives applied by themanufacturer. In this case, particulars of the Directivesapplied, as published in the Official Journal of the Euro-
pean Communities , must be given in the documents,
notices or instructions required by the Directives andaccompany 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 latterare properly designed and built, to satisfy the essential require-ments referred to in Article 3 where such products bear the CEmarking indicating that they satisfy all the provisions of thisDirective, including the conformity assessment procedures laiddown 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 require-
ments of paragraphs 2 and 4 of this Article. It is for the manufac-turer or his authorized representative established within the
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Community to take responsibility for affixing the CE marking onthe product itself, on a label attached to it, on its packaging, or onthe 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 establishedwithin the Community shall be obliged to make the productconform as regards the provisions concerning the CE markingand to end the infringement under conditions imposed by theMember State;
(b) where non-conformity continues, the Member State must take
all appropriate measures to restrict or prohibit the placing onthe market of the product in question or to ensure that it iswithdrawn from the market in accordance with the procedureslaid 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 arelikely to deceive third parties as to the meaning and form of theCE marking. Any other marking may be affixed to the construc-tion products on a label fixed to the product packaging or on theaccompanying commercial documents provided that the visibilityand 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 thetesting laboratories which they have designated for the taskswhich must be carried out for the purposes of technical approval,certificates of conformity, inspections and tests, in accordancewith this Directive, together with their names and addresses andthe identification numbers assigned to them beforehand by theCommission.
The Commission shall publish in the Official Journal of the Euro-
pean Communities a list of the notified bodies and laboratories
with their identification numbers and the tasks and products forwhich they have been notified. The Commission shall ensure thatthis list is kept up to date.';
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 notbe less than 5 mm.
— The CE marking shall be followed by the identification
number of the body involved in the production controlstage.
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Additional information
— The CE marking shall be accompanied by the name or
identifying mark of the producer, the last two digits ofthe year in which the marking was affixed, and whereappropriate, the number of the EC certificate ofconformity and, where appropriate, indications to iden-tify the characteristics of the product on the basis of thetechnical 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 ortaken into service only if it bears the CE marking provided for inArticle 10 indicating its conformity to all the provisions of thisDirective, including the conformity assessment procedures laiddown in Article 10, when it is properly installed and maintained andwhen 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 theguarantee certificate of markings which are likely to deceive thirdparties as to the meaning and form of the CE marking. Any othermarking may be affixed to the apparatus, its packaging, the instruc-tions for use or the guarantee certificate provided that the visibilityand legibility of the CE marking is not thereby reduced.';
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 thisArticle and the bodies responsible for issuing the EC type-exam-ination certificates referred to in paragraph 5, together with thespecific tasks which these bodies have been appointed to carry outand the identification numbers assigned to them beforehand by theCommission.
The Commission shall publish in the Official Journal of the Euro-
pean Communities a list of the notified authorities and bodies with
their identification numbers and the tasks for which they have beennotified. The Commission shall ensure that this list is kept up todate.';
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 orhis authorized representative established within the Communityshall be obliged to make the product comply as regards theprovisions concerning the CE marking and to end the infringe-ment 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 themarket of the product in question or to ensure that it is with-drawn from the market in accordance with the procedures laiddown in Article 9.' ;
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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 conformitymarking, the latter shall indicate that the appliances are alsopresumed to conform to those other Directives.
— However, where one or more of these Directives allow the
manufacturer, during a transitional period, to choose whicharrangements to apply, the CE marking shall indicateconformity only to the Directives applied by the manufac-turer. In this case, particulars of the Directives applied, aspublished in the Official Journal of the European Communi-
ties, must be given in the documents, notices or instructions
required by the Directives and accompanying such appa-ratus.
— The various components of the CE marking must have
substantially the same vertical dimension, which may not beless 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 theaffixing of the EC marking, the latter shall indicate that themachinery is also presumed to conform to the provisions ofthose other Directives.
(b) However, where one or more of these Directives allow the
manufacturer, during a transitional period, to choose whicharrangements to apply, the CE marking shall indicateconformity only to the Directives applied by the manufac-turer. In this case, particulars of the Directives applied, aspublished in the Official Journal of the European Communi-
ties, must be given in the documents, notices or instructions
required by the Directives and accompanying such machi-nery.' ;
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 tocarry out the procedures referred to in Article 8 together with thespecific tasks which these bodies have been appointed to carry outand the identification numbers assigned to them beforehand by theCommission.
The Commission shall publish in the Official Journal of the Euro-
pean Communities a list of the notified bodies and their identification
numbers and the tasks for which they have been notified. TheCommission shall ensure that this list is kept up to date.';
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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 markingshall be prohibited. Any other marking may be affixed to the machi-nery provided that the visibility and legibility of the CE marking isnot 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 representativeestablished within the Community shall be obliged to make theproduct conform as regards the provisions concerning the CEmarking and to end the infringement under the conditionsimposed by the Member State;
(b) where non-conformity continues, the Member State must take all
appropriate measures to restrict or prohibit the placing on themarket of the product in question or to ensure that it is with-drawn from the market in accordance with the procedures laiddown 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 substan-
tially the same vertical dimension, which may not be less than5 mm. This minimum dimension may be waived for small-scalemachinery.'
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 theprovisions of this Directive and which bear the CE marking attestingtheir conformity to all the provisions of this Directive, including thecertification procedures in Chapter II.';
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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 theCE marking, the latter shall indicate that the PPE is alsopresumed to conform to the provisions of the other Direct-ives.
(b) However, where one or more of these Directives allow the
manufacturer, during a transitional period, to choose whicharrangements to apply, the CE marking shall indicateconformity to the provisions only of those Directives appliedby the manufacturer. In this case, particulars of the Direct-ives 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 accom-panying such PPE.' ;
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 outthe procedures referred to in Article 8 together with the specific taskswhich these bodies have been appointed to carry out and the identifi-cation numbers assigned to them beforehand by the Commission.
The Commission shall publish in the Official Journal of the Euro-
pean Communities a list of the notified bodies and their identification
numbers and the tasks for which they have been notified. TheCommission 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 theCommunity:';
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 theinvolvement of a notified body in the production control phase asindicated 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 expectedlife of the PPE; however, if this is not possible in view of thecharacteristics of the product, the CE marking may be affixed to thepackaging.
3. The affixing of markings on the PPE which are likely to
deceive third parties as to the meaning and form of the CE markingshall be prohibited. Any other marking may be affixed to the PPE orits packaging provided that the visibility and legibility of the CEmarking 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 representativeestablished within the Community shall be obliged to make theproduct conform as regards the provisions concerning the CEmarking and to end the infringement under the conditionsimposed by the Member State;
(b) where non-conformity continues, the Member State must take all
appropriate measures to restrict or prohibit the placing on themarket of the product in question or to ensure that it is with-drawn from the market in accordance with the procedures laiddown 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);
1993L0068 — EN — 02.08.1993 — 000.001 — 14
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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:
— 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 substan-
tially the same vertical dimension, which may not be less than5 mm. This minimum dimension may be waived for small-scalePPE.
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 PPEreferred 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 applyto them, including the conformity assessment procedures referred toin Chapter II, and accordingly bear the CE marking provided for inArticle 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 theaffixing of the CE marking, the latter shall indicate that theinstruments in question are also presumed to conform to theprovisions of those other Directives.
(b) However, where one or more of the Directives which apply
to the instruments allow the manufacturer, during a trans-itional period, to choose which arrangements to apply, theCE marking shall indicate conformity only to the Directivesapplied by the manufacturer. In this case, particulars of theDirectives 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 accom-panying 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 outthe procedures referred to in Article 8 together with the specific taskswhich these bodies have been appointed to carry out and the identifi-cation numbers assigned to them beforehand by the Commission.
The Commission shall publish in the Official Journal of the Euro-
pean Communities a list of the notified bodies and their identification
1993L0068 — EN — 02.08.1993 — 000.001 — 15
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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 CEmarking shall be prohibited. Any other marking may be affixed tothe instruments provided that the visibility and legibility of the CEmarkings 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 representativeestablished within the Community shall be obliged to make theinstrument conform as regards the provisions concerning the CEmarking and to end the infringement under the conditionsimposed by the Member State;
(b) where non-conformity continues, the Member State must take all
appropriate measures to restrict or prohibit the placing on themarket of the instrument in question or to ensure that it iswithdrawn from the market in accordance with the procedureslaid 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 authorizedrepresentative established within the Community shall affix theCE marking to each instrument and the inscriptions provided forin Annex IV and shall draw up a written declaration ofconformity.
The CE marking shall be accompanied by the identification
number of the notified body responsible for the EC surveillancereferred 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 manufacturer or
his authorized representative established within theCommunity ensures and declares that the instruments whichhave been checked in accordance with paragraph 3.3 are,where applicable, in conformity to the type described in theEC type-examination certificate and satisfy the requirementsof the Directive which apply to them.
3.2. The manufacturer shall take all necessary measures in order
that the manufacturing process ensures conformity of theinstruments, where applicable, with the type as described inthe EC type-examination certificate and with the require-ments of this Directive which apply to them. The manufac-turer or his authorized representative established within theCommunity shall affix the CE marking to each instrumentand draw up a written declaration of conformity.
3.3. The notified body shall carry out the appropriate examina-
tions and tests in order to check the conformity of the productto the requirements of this Directive by examination andtesting of every instrument, as specified in paragraph 3.5.
3.4. For instruments not subject to EC type-approval, the docu-
ments relating to the design of the instrument, as set out inAnnex III, must be accessible to the notified body should thelatter so request.
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3.5. Verification by checking and testing of each instrument.3.5.1. All instruments shall be individually examined and appro-
priate tests, as set out in the relevant standard(s) referred to inArticle 5, or equivalent tests, shall be carried out in order toverify their conformity, where applicable, to the type asdescribed in the EC type-examination certificate and therequirements 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 ofwhich to requirements has been established and draw up awritten certificate of conformity relating to the tests carriedout.
3.5.3. The manufacturer or his authorized representative shall
ensure that he is able to supply the notified body’s certi-ficates of conformity on request
4.EC unit verification
4.1. EC unit verification is the procedure whereby the manufac-
turer or his authorized representative established within theCommunity ensures and declares that the instrument, gener-ally designed for a specific application, which has beenissued with the certificate referred to in paragraph 4.2conforms to the requirements of this Directive that apply toit. The manufacturer or his authorized representative shallaffix the CE marking to the instrument and shall draw up awritten 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 ensureits conformity to the relevant requirements of this Directive.
The notified body shall affix, or cause to be affixed, its
identification number to the instrument the conformity ofwhich to requirements has been established and shall draw upa written certificate of conformity concerning the tests carriedout.
4.3. The aim of the technical documentation relating to the design
of the instrument, as referred to in Annex III, is to enableconformity to the requirements of this Directive to beassessed and the design, manufacture and operation of theinstrument to be understood. It must be accessible to thenotified body.
4.4. The manufacturer or his authorized representative shall
ensure that he is able to supply the notified body’s certi-ficates 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 thesetwo stages will be carried out by different parties, an instru-ment which has undergone the first stage of the procedureshall bear the identification number of the notified bodyinvolved in that stage.
5.3.2. The party which has carried out the first stage of the proce-
dure shall issue for each of the instruments a certificatecontaining the necessary data for identification of the instru-ment and specifying the examinations and tests that havebeen carried out.
The party which carries out the second stage of the procedure
shall carry out those examinations and tests that have not yetbeen carried out.
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The manufacturer or his authorized representative shallensure that he is able to supply the notified body’s certi-ficates 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 identificationnumber of the notified body which took part in the secondstage.';
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 ◄
— the identification number(s) of the notified body/bodies
that has/have carried out the EC surveillance or the ECverification.
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 substan-
tially the same vertical dimension, which may not be less than5 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';
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 complyingwith the provisions of this Directive and bearing the CE markingprovided for in Article 12 which indicate that they have been thesubject of an evaluation of their conformity in accordance withArticle 9.';
3. the following paragraph is added to Article 4:
‘5. (a) Where the devices are subject to other Directives
concerning other aspects and which also provide for theaffixing of the CE marking, the latter shall indicate thatthe devices are also presumed to conform to the provisionsof the other Directives.
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(b) However, where one or more of these Directives allow the
manufacturer, during a transitional period, to choosewhich arrangements to apply, the CE marking shall indi-cate conformity to the provisions only of those Directivesapplied by the manufacturer. In this case, particulars of theDirectives applied, as published in the Official Journal of
the European Communities , must be given in the docu-
ments, notices or instructions required by the Directivesand accompanying such devices; these documents, noticesor instructions shall be accessible without it being neces-sary to destroy the packaging which keeps the devicesterile.' ;
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 outthe procedures referred to in Article 9 together with the specifictasks which these bodies have been appointed to carry out and theidentification numbers assigned to them beforehand by theCommission.
The Commission shall publish in the Official Journal of the Euro-
pean Communities a list of the notified bodies and their identifica-
tion numbers and the tasks for which they have been notified. TheCommission 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 inAnnexes 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 markingshall be prohibited. Any other marking may be affixed to thepackaging or to the instruction leaflet accompanying the deviceprovided that the visibility and legibility of the CE marking is nothereby 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 repres-entative established within the Community shall be obliged toend the infringement under conditions imposed by the MemberState;
(b) where non-compliance continues, the Member State must take
all appropriate measures to restrict or prohibit the placing onthe market of the device in question or to ensure that it iswithdrawn from the market in accordance with the procedureslaid 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 estab-lished within the Community shall affix the CE marking inaccordance with Article 12 and shall draw up a written declara-tion of conformity.
This declaration shall cover one or more identified examples of
the product and shall be kept by the manufacturer or hisauthorized representative established within the Community.
The CE marking shall be accompanied by the identification
number of the notified body responsible.';
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(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 nationalauthorities:
— 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 infor-mation on approvals of quality systems issued, refused orwithdrawn.
6.3. Where neither the manufacturer nor his authorized repres-
entative are established in the Community, the task of keepingavailable for the authorities the technical documentationreferred to in Article 4 (2) shall fall to the person responsiblefor 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 relevantinformation on EC type-examination certificates and addendaissued, refused or withdrawn.
7.2. Other notified bodies may obtain a copy of the EC type-exam-
ination certificates and/or the addenda to them. The annexesto the certificates shall be made available to the other notifiedbodies when a reasoned application is made and after themanufacturer 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 aperiod of at least five years from the manufacture of the lastappliance.
7.4. Where neither the manufacturer nor his authorized repres-
entative are established in the Community, the task of keepingthe technical documentation available for the authorities shallfall to the person responsible for placing the applianceconcerned on the Community market.';
10. Annex IV is replaced by the following text:
‘ANNEX IV
EC VERIFICATION
1. EC verification is the procedure whereby the manufacturer or
his authorized representative established within theCommunity ensures and declares that the products subject tothe provisions of section 3 are in conformity with the type asdescribed in the EC type-examination certification and satisfythe requirements of this Directive that apply to them.
2. The manufacturer or his authorized representative established
within the Community shall take all measures necessary inorder that the manufacturing process ensures conformity ofthe products to the type as described in the EC type-exam-ination certification and to the requirements of this Directivethat apply to them. The manufacturer or his authorized repres-entative established within the Community shall affix the CE
1993L0068 — EN — 02.08.1993 — 000.001 — 20
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marking to each product and draw up a written declaration ofconformity.
3. The manufacturer shall, before the start of manufacture,
prepare documents defining the manufacturing processes, inparticular as regards sterilization, together with all the routine,pre-established provisions to be implemented to ensureuniformity of production and conformity of the products withthe type as described in the EC type-examination certificate aswell 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 manufac-turer to notify the competent authorities of the followingevents immediately on learning of them:
(i) any change in the characteristics or performances and any
inaccuracies in the instruction leaflet for a device whichmight lead to or have led to the death of a patient ordeterioration 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 examinations
and tests in order to check the conformity of the product tothe requirements of this Directive by examination and testingof products on a statistical basis, as specified in section 6. Themanufacturer must authorize the notified body to evaluate theefficiency of the measures taken pursuant to section 3, byaudit where appropriate.
6.Statistical verification
6.1. Manufacturers shall present the products manufactured in the
form of uniform batches and shall take all necessary measuresin order that the manufacturing process ensures the uniformityof 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, orequivalent tests shall be carried out to verify their conformityto the type as described in the EC type-examination certificateand thereby determine whether a batch is to be accepted orrejected.
6.3. Statistical control of products shall be based on attributes,
entailing a sampling system with the following characteristics:
— a level of quality corresponding to a probability of accep-
tance of 95 %, with a non-conformity percentage ofbetween 0,29 and 1 %,
— a limit quality corresponding to a probability of accep-
tance of 5 %, with a percentage of non-conformity ofbetween 3 and 7 %.
6.4. Where batches are accepted, the notified body shall affix, or
cause to be affixed, its identification number to each productand draw up a written certificate of conformity relating to thetests carried out. All products in the batch may be placed onthe market except for those products from the sample whichwere found not to be in conformity.
Where a batch is rejected, the notified body shall take appro-
priate measures to prevent the placing on the market of thatbatch. In the event of frequent rejection of batches the notifiedbody may suspend the statistical verification.
The manufacturer may, under the responsibility of the notified
body, affix the latter’s ’identification number during themanufacturing process.
1993L0068 — EN — 02.08.1993 — 000.001 — 21
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6.5. The manufacturer or his authorized representative shall ensure
that he is able to supply the notified body’s certificates ofconformity 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 accordancewith Article 12 and draw up a written declaration of conformity.This declaration shall cover one or more identified specimens ofthe product and shall be kept by the manufacturer. The CE markingshall be accompanied by the identification number of the notifiedbody 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 substan-
tially the same vertical dimension, which may not be less than5 mm.
This minimum dimension may be waived for small-scale
devices.'
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 whichcomply with all the provisions of this Directive, including theconformity assessment procedures laid down in Chapter II, andwhich 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 theCE marking, the latter shall indicate that the appliances arealso presumed to conform to the provisions of those otherDirectives.
(b) However, where one or more of these Directives allow the
manufacturer, during a transitional period, to choose whicharrangements to apply, the CE marking shall indicateconformity to the provisions only of those Directives appliedby the manufacturer. In this case, particulars of the Direct-ives 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 accom-panying 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 outthe procedures referred to in Article 8 together with the specific tasks
1993L0068 — EN — 02.08.1993 — 000.001 — 22
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which these bodies have been appointed to carry out and the identifi-
cation 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 thatthe 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 markingshall be prohibited. Any other marking may be affixed to the appli-ance or to the data plate provided that the visibility and legibility ofthe 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 representativeestablished within the Community shall be obliged to make theproduct comply as regards the provisions concerning the CEmarking and to end the infringement under conditions imposedby the Member State;
(b) where non-compliance continues, the Member State must take
all appropriate measures to restrict or prohibit the placing on themarket of the appliance in question or to ensure that it is with-drawn from the market in accordance with the procedures laiddown in Article 7.' ;
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 estab-lished within the Community shall affix the CE marking oneach appliance and draw up a written certificate ofconformity.';
(b) in point 2.1 the last sentence is replaced by the following text:
‘The CE marking must be followed by the identificationnumber of the notified body responsible for the randomchecks 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 estab-lished within the Community must affix the CE marking toeach appliance and draw up a written declaration ofconformity.';
(d) in point 3.1 the last sentence is replaced by the following text:
‘The CE marking must be followed by the identificationnumber 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 estab-lished within the Community must affix the CE marking toeach appliance and draw up a written declaration ofconformity.';
(f) in point 4.1 the last sentence is replaced by the following text:
‘The CE marking must be followed by the identificationnumber 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 manufacturer or
his authorized representative established within theCommunity ensures and declares that the appliances subject tothe provisions of point 3 are in conformity to the type asdescribed in the EC type-examination certification and satisfythe requirements of this Directive that apply to them.
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5.2. The manufacturer or his authorized representative established
within the Community must take all measures necessary inorder that the manufacturing process ensures conformity ofthe appliances to the type as described in the EC type-exam-ination certification and to the requirements of this Directivethat apply to them. The manufacturer or his authorized repres-entative established within the Community must affix the CEmarking to each appliance and draw up a written declarationof conformity. The declaration of conformity may cover oneor more appliances and must be kept by the manufacturer orhis authorized representative established within theCommunity.
5.3. The notified body must carry out the appropriate examinations
and tests in order to check the conformity of the appliance tothe requirements of this Directive by examination and testingof every appliance, as specified in point 5.4, or by exam-ination and testing of appliances on a statistical basis, asspecified in point 5.5, at the choice of the manufacturer.
5.4.Verification 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 inArticle 5, or equivalent tests, must be carried out in order toverify their conformity with the type as described in the ECtype-examination certificate and the requirements of thisDirective 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 writtencertificate of conformity relating to the tests carried out. Thecertificate 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 ofconformity 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 necessarymeasures in order that the manufacturing process ensures theuniformity 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 consisting of unitsof a single model manufactured under the same conditions. Abatch is examined at random intervals. The appliances consti-tuting a sample are examined individually and appropriatetests, as laid down in the respective standard(s) referred to inArticle 5, or equivalent tests are carried out to determinewhether 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 accep-
tance of 95 %, with a non-conformity percentage ofbetween 0,5 and 1,5 %,
— a limit quality corresponding to a probability of accep-
tance of 5 %, with a percentage of non-conformity ofbetween 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 applianceand draw up a written certificate of conformity relating to thetests carried out. All appliances in the batch may be placed onthe market except for those products from the sample whichwere found not to be in confirmity.
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Where a batch is rejected, the notified body must take appro-priate measures to prevent the placing on the market of thatbatch. In the event of frequent rejection of batches the notifiedbody may suspend the statistical verification.
The manufacturer may, under the responsibility of the notified
body, affix the latter’s identification number during the manu-facturing process.
5.5.4. The manufacturer or his authorized representative must ensure
that he is able to supply the notified body’s certificates ofconformity on request.
6. EC UNIT VERIFICATION
6.1. EC unit verification is the procedure whereby the manufac-
turer or his authorized representative established within theCommunity ensures and declares that the appliance concerned,which has been issued with the certificate referred to in point2, conforms to the requirements of this Directive that apply toit. The manufacturer or his authorized representative mustaffix the CE marking to the appliance and draw up a writtendeclaration 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 documenta-tion in order to ensure its conformity with the essentialrequirements of this Directive.
The notified body must affix, or cause to be affixed, its
identification number to the approved appliance and mustdraw up a written certificate of conformity concerning thetests 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 enableconformity to the requirements of this Directive to be assessedand the design, manufacture and operation of the appliance tobe 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 examinations
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 ofconformity on request.';
8. Annex III is replaced by the following text:
‘ANNEX III
CE CONFORMITY MARKING AND INSCRIPTIONS1. The CE conformity marking consists of the initials “CE” as
shown below:
The CE marking must be followed by the identification numberof 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:
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— 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.
The various components of the CE marking must have substan-
tially the same vertical dimension, which may not be less than5 mm.'
Article 11
Directive 91/263/EEC is hereby amended as follows:
1. throughout the text, the term ‘EC mark' is replaced by ‘CE
marking';
2. in Article 11 (4) the term ‘the EC mark' is replaced by ‘the initials
CE as shown in Annex VI';
3. in Article 3 the first paragraph is replaced by the following text:
‘(1) Member States shall take all appropriate measures to ensure
that terminal equipment may be placed on the market and put intoservice only if it bears the CE marking provided for in Article 11attesting to its conformity to the requirements of this Directive,including the conformity assessment procedures laid down inChapter II and where it is properly installed and maintained andused for its intended purpose.';
4. the following paragraph is added to Article 3:
‘(4) (a) Where the terminal equipment is subject to other Directives
concerning other aspects and which also provide for theaffixing of the CE marking, the latter shall indicate that theequipment is also presumed to conform to the provisions ofthose other Directives.
(b) However, where one or more of these Directives allow the
manufacturer, during a transitional period, to choose whicharrangements to apply, the CE marking shall indicateconformity to the provisions only of those Directivesapplied by the manufacturer. In this case, particulars of theDirectives applied, as published in the Official Journal of
the European Communities , must be given in the docu-
ments, notices or instructions required by the Directivesand accompanying the terminal equipment.' ;
5. in Article 10 the first paragraph is replaced by the following text:
‘(1) Member States shall notify the Commission and the other
Member States of the bodies established within the Communitywhich they have designated for carrying out the certification,product checks and associated surveillance tasks pertaining to theprocedures referred to in Article 9, together with the identificationnumbers assigned to them beforehand by the Commission.
Member States shall apply the minimum criteria set out in Annex V
for the designation of such bodies. Bodies that satisfy the criteriafixed by the relevant harmonized standards shall be presumed tosatisfy the criteria set out in Annex V.';
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6. in Article 10 the third paragraph is replaced by the following text:
‘(3) The Commission shall publish in the Official Journal of the
European Communities a list of notified bodies together with their
identification numbers and a list of test laboratories together withthe tasks for which they have been designated and shall ensure thatthese lists are kept up to date.';
7. in Article 11 the first paragraph is replaced by the following text:
‘The marking of terminal equipment complying with this Directive
shall consist of the CE marking consisting of the initials CE,followed by the identification number of the notified body involvedin the production control stage and a symbol indicating that theequipment is intended and is suitable to be connected to the publictelecommunications network. The form of CE marking to be used,together with the other information, is shown in Annex VI.';
8. in Article 11 the second paragraph is replaced by the following text:
‘2. The affixing of markings on the equipment which are likely
to deceive third parties as to the meaning and form of the CEmarking specified in Annexes VI and VII shall be prohibited. Anyother marking may be affixed to the equipment provided that thevisibility and legibility of the CE marking is not thereby reduced.';
9. Article 12 is replaced by the following text:
‘Article 12
Without prejudice to Article 8:
(a) where a Member State establishes that the CE marking has
been affixed unduly, the manufacturer or his authorized repres-entative established within the Community shall be obliged tomake the equipment conform as regards the provisionsconcerning the CE marking and to end the infringement underthe 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 onthe market of the equipment in question or to ensure that it iswithdrawn from the market in accordance with the procedureslaid down in Article 8.' ;
10. in Annexes II and III the last sentence of point 1 is replaced by the
following text:
‘The manufacturer or his authorized representative established
within the Community shall affix the markings provided for inArticle 11 (1) to each product and draw up a written declaration ofconformity to type.';
11. in Annex IV the last sentence of point 1 is replaced by the
following text:
‘The manufacturer or his authorized representative shall affix the
markings provided for in Article 11 (1) to each product and drawup a written declaration of conformity.';
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12. Annex VI is replaced by the following text:
‘ANNEX VI
MARKING FOR THE TERMINAL EQUIPMENT
REFERRED TO IN ARTICLE 11 (1)
— The CE conformity marking shall consist of the initials “CE”
taking the following form, followed by the additional informa-tion referred to in Article 11 (1);
CE initials Identification number of
the notified bodySymbol of suitability for connection
to the public telecommunications
network
(SeeOfficial Journal of the European Communities for character font)
— 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 substan-
tially the same vertical dimension, which may not be less than5 mm.'
13. Annex VII is amended as follows:
‘ANNEX VII
MARKING FOR THE EQUIPMENT REFERRED TO IN
ARTICLE 11 (4)
— 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 substan-
tially the same vertical dimension, which may not be less than5 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 appli-ances and boilers which comply with the provisions of this Directiveand which bear the CE marking provided for in Article 7 attesting tothe conformity to all the provisions of this Directive, including theconformity assessment procedures laid down in Articles 7 and 8,save as otherwise laid down in the Treaty or other Directives orCommunity provisions.';
3. the following paragraph 5 is added to Article 4:
‘5. (a) Where the boilers are subject to other Directives concerning
other aspects which also provide for the affixing of the CEmarking, the latter shall indicate that the boilers in question
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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 whicharrangements to apply, the CE marking shall indicateconformity to the provisions only of those Directives appliedby the manufacturer. In this case, particulars of the Direct-ives 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 accom-panying 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 theCE marking, and also the inscriptions specified in Annex I, shall beaffixed on boilers in a visible, easily legible and indelible manner.The affixing on such products of any markings likely to deceive thirdparties as to the meaning and form of the CE marking shall beprohibited. Any other marking may be affixed to the boilers andappliances provided that the visibility and legibility of the CEmarking 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 manufactureror his agent established within the Community shall beobliged to make the boiler comply as regards the provisionsconcerning the CE marking and to end the infringementunder conditions imposed by the Member State;
(b) where non-compliance continues, the Member State must
take all appropriate measures to restrict or prohibit theplacing on the market of the product in question or to ensurethat it is withdrawn from the market, and shall inform theCommission and the other Member States accordingly.' ;
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 outthe procedures referred to in Article 7, together with specific taskswhich these bodies have been appointed to carry out and the identifi-cation numbers assigned to them beforehand by the Commission.
The Commission shall publish in the Official Journal of the Euro-
pean Communities a list of the notified bodies with their identication
numbers and the tasks for which they have been notified. TheCommission 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
SPECIFIC 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.
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— The various components of the CE marking must have
substantially the same vertical dimension, which may not beless 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 repres-entative established within the Community shall affix the CEmarking to each appliance and draw up a written declaration ofconformity.';
(b) the last two sentences of section 1 of module D are replaced by
the following text: ‘The manufacturer or his authorized repres-entative established within the Community shall affix the CEmarking to each appliance and draw up a written declaration ofconformity. The CE mark is accompanied by the identificationnumber of the notified body responsible for the checks referredto 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 repres-entative established within the Community shall affix the CEmarking to each boiler and appliance and draw up a writtendeclaration of conformity. The CE marking must be accompa-nied by the identification number of the notified body respon-sible 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 thevarious phases of the conformity assessment procedures which areintended to be used in the technical harmonization Direct-ives;Whereas the choice of procedures must not lead to a loweringof safety standards of electrical equipment, which have already beenestablished 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 equipmentreferred to in Article 1 must have affixed to it the CE markingprovided for in Article 10 attesting to its conformity to the provi-sions of this Directive, including the conformity assessmentprocedure 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 theaffixing of the CE marking, the latter shall indicate thatthe equipment in question is also presumed to conform tothe provisions of those other Directives.
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(b) However, where one or more of these Directives allow
the manufacturer, during a transitional period, to choosewhich arrangements to apply, the CE marking shall indi-cate conformity to the provisions only of those Directivesapplied by the manufacturer. In this case, particulars ofthe Directives applied, as published in the Official
Journal of the European Communities , must be given in
the documents, notices or instructions required by theDirectives 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 representativeestablished within the Community to the electrical equipment or,failing that, to the packaging, the introduction sheet or the guar-antee certificate so as to be visible, easily legible and indelible.
2. The affixing on electrical equipment of any markings liable
to deceive third parties as to the meaning and form of the CEmarking shall be prohibited. However, any other marking may beaffixed to the electrical equipment, its packaging, the instructionsheet or the guarantee certificate provided that the visibility andlegibility 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 establishedwithin the Community market shall be obliged to make theelectrical equipment comply as regards the provisionsconcerning the CE marking and to end the infringement underconditions imposed by the Member State;
(b) where non-compliance continues, the Member State must take
all appropriate measures to restrict or prohibit the placing onthe market of the electrical equipment in question or toensure that it is withdrawn from the market in accordancewith 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 beless than 5 mm.
B.EC declaration of conformity
The EC declaration of conformity must contain the following
elements:
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— 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 or hisauthorized representative established within the Community,
— the last two digits of the year in which the CE marking was
affixed.
ANNEX IVINTERNAL PRODUCTION CONTROL1. Internal production control is the procedure whereby the manufac-
turer or his authorized representative established within theCommunity, who carries out the obligations laid down in point 2,ensures and declares that the electrical equipment satisfies therequirements of this Directive that apply to it. The manufactureror his authorized representative established within the Communitymust affix the CE marking to each product and draw up a writtendeclaration of conformity.
2. The manufacturer must establish the technical documentation
described in point 3 and he or his authorized representative estab-lished within the Community must keep it on Community terri-tory at the disposal of the relevant national authorities for inspec-tion purposes for a period ending at least 10 years after the lastproduct has been manufactured.
Where neither the manufacturer nor his authorized representative
is established within the Community, this obligation is the respon-sibility of the person who places the electrical equipment on theCommunity market.
3. Technical documentation must enable the conformity of the elec-
trical equipment to the requirements of this Directive to beassessed. It must, as far as relevant for such assessment, coverthe 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 understanding
of said drawings and schemes and the operation of the elec-trical equipment,
— a list of the standards applied in full or in part, and descrip-
tions of the solutions adopted to satisfy the safety aspects ofthis 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 docu-mentation.
5. The manufacturer must take all measures necessary in order that
the manufacturing process shall ensure compliance of the manu-factured products with the technical documentation referred to inpoint 2 and with the requirements of this Directive that apply tothem.'
Article 14
1. Member States shall adopt and publish the laws, regulations and
administrative provisions necessary to comply with this Directive by1 July 1994. They shall forthwith inform the Commission thereof.
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They shall apply these provisions from 1 January 1995.
When Member States adopt these measures, they shall contain a
reference to this Directive or shall be accompanied by such a refer-ence on the occasion of their official publication. The methods ofmaking 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 complywith 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 fieldcovered by this Directive. The Commission shall inform the otherMember States thereof.
Article 15
This Directive is addressed to the Member States.