s 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 conformity. The declaration of conformity may cover one or more appliances
and must be kept by the manufacturer or his authorized representative
established within the Community.

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.

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 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 consisting of units of a single model manufactured under the same
conditions. A batch is examined at random intervals. 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 percentage of
between 0,5 and 1,5 %,

- a limit quality corresponding to a
probability of acceptance of 5 %, with a percentage of non-conformity 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 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 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 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.

The various components of the CE
marking must have substantially the same vertical dimension, which may not be
less than 5 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 into service only if it bears the CE marking provided for in Article 11
attesting to its conformity to the requirements of this Directive, including
the conformity assessment procedures laid down in Chapter II and where it is
properly installed and maintained and used 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 the affixing of the CE marking, the latter shall indicate that the
equipment 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 documents, notices or
instructions required by the Directives and 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
Community which they have designated for carrying out the certification,
product checks and associated surveillance tasks pertaining to the procedures
referred to in Article 9, together with the identification numbers 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 criteria fixed by the relevant harmonized standards shall be
presumed to satisfy the criteria set out in Annex V.';

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 with the tasks for which they have been designated and shall ensure
that these 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
involved in the production control stage and a symbol indicating that the
equipment is intended and is suitable to be connected to the public
telecommunications 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 CE marking specified in Annexes VI and VII shall be prohibited. Any
other marking may be affixed to the equipment provided that the visibility 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
representative established within the Community shall be obliged to make the
equipment 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 equipment in question or to ensure that it is
withdrawn from the market in accordance with the procedures laid 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 in Article 11 (1) to each product and draw up a written
declaration of conformity 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 draw up a written declaration of conformity.';

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 information referred to in Article 11 (1);

Identification number of the
notified body

(See Official 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 substantially the same vertical dimension, which may not be
less than 5 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 drawin