ether with the specific
tasks which these bodies have been appointed to carry out and the identification
numbers assigned to them beforehand by the Commission.

The Commission shall publish in the
Official Journal of the European Communities a list of the notified bodies and
their identification numbers and the tasks for which they have been notified.
The Commission shall ensure that this list is kept up to date.';

5. in Article 10 the third paragraph
is replaced by the following text:

'3. The affixing of markings on the
instruments which are likely to deceive third parties as to the meaning and
form of the CE marking shall be prohibited. Any other marking may be affixed to
the instruments provided that the visibility and legibility of the CE markings
is not thereby reduced.';

6. Article 11 is replaced by the
following text:

'Article 11

Without prejudice to Article 7:

(a) where a Member State establishes
that the CE marking has been affixed unduly, the manufacturer or his authorized
representative established within the Community shall be obliged to make the
instrument conform as regards the provisions concerning the CE marking and to
end the infringement under the conditions imposed by the Member State;

(b) where non-conformity continues,
the Member State must take all appropriate measures to restrict or prohibit the
placing on the market of the instrument in question or to ensure that it is
withdrawn from the market in accordance with the procedures laid down in
Article 7.';

7. the following paragraphs of Annex
II are amended as follows:

(a) in paragraph 2.1 the second and
third subparagraphs are replaced by the following text:

'The manufacturer or his authorized
representative established within the Community shall affix the CE marking to
each instrument and the inscriptions provided for in Annex IV and shall draw up
a written declaration of conformity.

The CE marking shall be accompanied
by the identification number of the notified body responsible for the EC
surveillance referred to in paragraph 2.4.';

(b) paragraphs 3 and 4 are replaced
by the following text:

'3. EC verification

3.1. EC verification is the
procedure whereby the manufacturer or his authorized representative established
within the Community ensures and declares that the instruments which have been
checked in accordance with paragraph 3.3 are, where applicable, in conformity
to the type described in the EC type-examination certificate and satisfy the
requirements of the Directive which apply to them. 3.2. The manufacturer shall
take all necessary measures in order that the manufacturing process ensures
conformity of the instruments, where applicable, with the type as described in
the EC type-examination certificate and with the requirements of this Directive
which apply to them. The manufacturer or his authorized representative
established within the Community shall affix the CE marking to each instrument
and draw up a written declaration of conformity.

3.3. The notified body shall carry
out the appropriate examinations and tests in order to check the conformity of
the product to the requirements of this Directive by examination and testing of
every instrument, as specified in paragraph 3.5.

TEXT CONTINUED UNDER DOC.NUM:
393L0068.1

3.4. For instruments not subject to
EC type-approval, the documents relating to the design of the instrument, as
set out in Annex III, must be accessible to the notified body should the latter
so request.

3.5. Verification by checking and
testing of each instrument.

3.5.1. All instruments shall be
individually examined and appropriate tests, as set out in the relevant
standard(s) referred to in Article 5, or equivalent tests, shall be carried out
in order to verify their conformity, where applicable, to the type as described
in the EC type-examination certificate and the requirements of this Directive
that apply to them.

3.5.2. The notified body shall
affix, or cause to be affixed, its identification number on each instrument the
conformity of which to requirements has been established and draw up a written
certificate of conformity relating to the tests carried out.

3.5.3. The manufacturer or his
authorized representative shall ensure that he is able to supply the notified
body's certificates of conformity on request.

4. EC unit verification

4.1. EC unit verification is the
procedure whereby the manufacturer or his authorized representative established
within the Community ensures and declares that the instrument, generally
designed for a specific application, which has been issued with the certificate
referred to in paragraph 4.2 conforms to the requirements of this Directive
that apply to it. The manufacturer or his authorized representative shall affix
the CE marking to the instrument and shall draw up a written declaration of
conformity.

4.2. The notified body shall examine
the instrument and carry out the appropriate tests, as set out in the
respective standard(s) referred to in Article 5, or equivalent tests, in order
to ensure its conformity to the relevant requirements of this Directive.

The notified body shall affix, or
cause to be affixed, its identification number to the instrument the conformity
of which to requirements has been established and shall draw up a written
certificate of conformity concerning the tests carried out.

4.3. The aim of the technical
documentation relating to the design of the instrument, as referred to in Annex
III, is to enable conformity to the requirements of this Directive to be
assessed and the design, manufacture and operation of the instrument to be
understood. It must be accessible to the notified body.

4.4. The manufacturer or his
authorized representative shall ensure that he is able to supply the notified
body's certificates of conformity on request.';

(c) paragraphs 5.3.1 and 5.3.2 are
replaced by the following text:

'5.3.1. Where a manufacturer has
opted for execution in two stages of one of the procedures mentioned in 5.1,
and where these two stages will be carried out by different parties, an
instrument which has undergone the first stage of the procedure shall bear the
identification number of the notified body involved in that stage.

5.3.2. The party which has carried
out the first stage of the procedure shall issue for each of the instruments a
certificate containing the necessary data for identification of the instrument
and specifying the examinations and tests that have been carried out.

The party which carries out the
second stage of the procedure shall carry out those examinations and tests that
have not yet been carried out.

The manufacturer or his authorized
representative shall ensure that he is able to supply the notified body's certificates
of conformity on request.';

(d) paragraph 5.3.4 is replaced by
the following text:

'5.3.4. The CE marking shall be
affixed to the instrument on completion of the second stage, along with the
identification number of the notified body which took part in the second
stage.';

8. in Annex IV paragraph 1.1 is
amended as follows:

(a) subparagraph (a) is replaced by
the following text:

'(a) - the CE conformity marking
comprising the CE symbol as described in Annex VI, followed by the last two
digits of year in which it was affixed,

- the identification number(s) of
the notified body/bodies that has/have carried out the EC surveillance or the
EC verification.

The abovementioned marking and
inscriptions shall be affixed to the instrument distinctly grouped together; ';


(b) in subparagraph (2), after the
sixth indent, the following indent is added:

'- the last two digits of the year
in which the CE marking was affixed,';

9. Annex VI is replaced by the
following text:

'ANNEX VI

CE CONFORMITY MARKING

- The CE conformity marking shall
consist of the initials "CE " taking the following form:

- If the CE marking is reduced or
enlarged the proportions given in the above graduated drawing must be
respected.

- The various components of the CE
marking must have substantially the same vertical dimension, which may not be
less than 5 mm.'

 

Article 9

Directive 90/385/EEC is hereby
amended as follows:

1. throughout the text, the term 'EC
mark' is replaced by 'CE marking';

2. in Article 4 the first paragraph
is replaced by the following text:

'1. Member States shall not prevent
the placing on the market or the putting into service within their territory of
devices complying with the provisions of this Directive and bearing the CE
marking provided for in Article 12 which indicate that they have been the
subject of an evaluation of their conformity in accordance with Article 9.';

3. the following paragraph is added
to Article 4:

'5. (a) Where the devices are
subject to other Directives concerning other aspects and which also provide for
the affixing of the CE marking, the latter shall indicate that the devices are
also presumed to conform to the provisions of the other Directives.

(b) However, where one or more of
these Directives allow the manufacturer, during a transitional period, to
choose which arrangements to apply, the CE marking shall indicate conformity to
the provisions only of those Directives applied by the manufacturer. In this
case, particulars of the Directives applied, as published in the Official
Journal of the European Communities, must be given in the documents, notices or
instructions required by the Directives and accompanying such devices; these
documents, notices or instructions shall be accessible without it being
necessary to destroy the packaging which keeps the device sterile.';

4. in Article 11 the first paragraph
is replaced by the following text:

'1. Member States shall notify the
Commission and the other Member State of the bodies which they have appointed
to carry out the procedures referred to in Article 9 together with the specific
tasks which these bodies have been appointed to carry out and the
identification numbers assigned to them beforehand by the Commission.

The Commission shall publish in the
Official Journal of the European Communities a list of the notified bodies and
their identification numbers and the tasks for which they have been notified.
The Commission shall ensure that this list is kept up to date.';

5. in Article 12 (2) the second
subparagraph is replaced by the following text:

'It must be followed by the
identification number of the notified body responsible for implementation of
the procedures set out in Annexes 2, 4 and 5.';

6. in Article 12 the third paragraph
is replaced by the following text:

'3. The affixing of markings on the
devices which are likely to deceive third parties as to the meaning and form of
the CE marking shall be prohibited. Any other marking may be affixed to the
packaging or to the instruction leaflet accompanying the device provided that
the visibility and legibility of the CE marking is not hereby reduced.';

7. Article 13 is replaced by the
following text:

'Article 13

Without prejudice to Article 7

(a) where a Member State establishes
that the CE marking has been affixed unduly, the manufacturer or his authorized
representative established within the Community shall be obliged to end the
infringement under conditions imposed by the Member State;

(b) where non-compliance continues,
the Member State must take all appropriate measures to restrict or prohibit the
placing on the market of the device in question or to ensure that it is
withdrawn from the market in accordance with the procedures laid down in
Article 7.';

8. Annex II is amended as follows:

(a) in section 2 the second paragraph
is replaced by the following text:

'The manufacturer or his authorized
representative established within the Community shall affix the CE marking in
accordance with Article 12 and shall draw up a written declaration of
conformity.

This declaration shall cover one or
more identified examples of the product and shall be kept by the manufacturer
or his authorized representative established within the Community.

The CE marking shall be accompanied
by the identification number of the notified body responsible.';

(b) section 6 is replaced by the
following text:

'6. Administrative provisions