EN-AU>6.1. For at least five years from
last date of manufacture of the product, the manufacturer shall keep available
for the national authorities:

- the declaration of conformity,

- the documentation referred to in
the second indent of section 3.1,

- the amendments referred to in
section 3.4,

- the documentation referred to in
section 4.2,

- the decisions and reports of the
notified body referred to in sections 3.4, 4.3, 5.3 and 5.4.

6.2. On request, the notified body
shall make available to the other notified bodies and the competent authority
all relevant information on approvals of quality systems issued, refused or
withdrawn.

6.3. Where neither the manufacturer
nor his authorized representative are established in the Community, the task of
keeping available for the authorities the technical documentation referred to
in Article 4 (2) shall fall to the person responsible for placing the appliance
on the Community market.';

9. in Annex III sections 7 and 8 are
replaced by the following text:

'7. Administrative provisions

7.1. On request, each notified body
shall make available to the other notified bodies and the competent authority,
all relevant information on EC type-examination certificates and addenda
issued, refused or withdrawn.

7.2. Other notified bodies may
obtain a copy of the EC type-examination certificates and/or the addenda to
them. The annexes to the certificates shall be made available to the other
notified bodies when a reasoned application is made and after the manufacturer
has been informed.

7.3. The manufacturer or his
authorized representative shall keep with the technical documentation a copy of
the EC type-examination certificates and the supplements to them for a period
of at least five years from the manufacture of the last appliance.

7.4. Where neither the manufacturer
nor his authorized representative are established in the Community, the task of
keeping the technical documentation available for the authorities shall fall to
the person responsible for placing the appliance concerned on the Community
market.';

10. Annex IV is replaced by the
following text:

'ANNEX IV

EC VERIFICATION

1. EC verification is the procedure
whereby the manufacturer or his authorized representative established within
the Community ensures and declares that the products subject to the provisions
of section 3 are in conformity with the type as described in the EC
type-examination certification and satisfy the requirements of this Directive
that apply to them.

2. The manufacturer or his
authorized representative established within the Community shall take all
measures necessary in order that the manufacturing process ensures conformity
of the products to the type as described in the EC type-examination
certification and to the requirements of this Directive that apply to them. The
manufacturer or his authorized representative established within the Community
shall affix the CE marking to each product and draw up a written declaration of
conformity.

3. The manufacturer shall, before
the start of manufacture, prepare documents defining the manufacturing
processes, in particular as regards sterilization, together with all the
routine, pre-established provisions to be implemented to ensure uniformity of
production and conformity of the products with the type as described in the EC
type-examination certificate as well as with the relevant requirements of this
Directive.

4. The manufacturer shall undertake
to institute and keep updated a post-marketing surveillance system. This
undertaking shall include the obligation on the part of the manufacturer to
notify the competent authorities of the following events immediately on
learning of them:

(i) any change in the
characteristics or performances and any inaccuracies in the instruction leaflet
for a device which might lead to or have led to the death of a patient or
deterioration in his state of health;

(ii) any technical or medical reason
resulting in the withdrawal 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 to the requirements of this Directive by examination and testing of
products on a statistical basis, as specified in section 6. The manufacturer
must authorize the notified body to evaluate the efficiency of the measures
taken pursuant to section 3, by audit where appropriate.

6. Statistical verification

6.1. Manufacturers shall present the
products manufactured in the form of uniform batches and shall take all
necessary measures in order that the manufacturing process ensures the
uniformity of each batch produced.

6.2. A random sample shall be taken
from each batch. Products in a sample shall be individually examined and
appropriate tests, as set out in the standard(s) referred to in Article 5, or
equivalent tests shall be carried out to verify their conformity to the type as
described in the EC type-examination certificate and thereby determine whether
a batch is to be accepted or rejected.

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 acceptance of 95 %, with a non-conformity percentage of
between 0,29 and 1 %,

- a limit quality corresponding to a
probability of acceptance of 5 %, with a percentage of non-conformity of
between 3 and 7 %.

6.4. Where batches are accepted, the
notified body shall affix, or cause to be affixed, its identification number to
each product and draw up a written certificate of conformity relating to the
tests carried out. All products in the batch may be placed on the market except
for those products from the sample which were found not to be in conformity.

Where a batch is rejected, the
notified body shall take appropriate measures to prevent the placing on the
market of that batch. In the event of frequent rejection of batches the
notified body may suspend the statistical verification.

The manufacturer may, under the
responsibility of the notified body, affix the latter's identification number
during the manufacturing process.

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

11. the second subparagraph of
section 2 of Annex V is replaced by the following text:

'The manufacturer or his authorized
representative established within the Community shall affix the CE marking in
accordance with Article 12 and draw up a written declaration of conformity.
This declaration shall cover one or more identified specimens of the product
and shall be kept by the manufacturer. The CE marking shall be accompanied by
the identification number of the notified body responsible.';

12. Annex IX is replaced by the
following text:

'ANNEX IX

CE CONFORMITY MARKING

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

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

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

This minimum dimension may be waived
for small-scale devices.'

 

Article 10

Directive 90/396/EEC is hereby
amended as follows:

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

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

'1. Member States may not prohibit,
restrict or impede the placing on the market and the putting into service of
appliances which comply with all the provisions of this Directive, including
the conformity assessment procedures laid down in Chapter II, and which bear
the CE marking provided for in Article 10.';

3. in Article 8 the fifth paragraph
is replaced by the following text:

'5. (a) Where the appliances are
covered by other Directives dealing with other aspects and specifying the
affixing of the CE marking, the latter shall indicate that the appliances are
also presumed to conform to the provisions of those other Directives.

(b) However, where one or more of
these Directives allow the manufacturer, during a transitional period, to
choose which arrangements to apply, the CE marking shall indicate conformity to
the provisions only of those Directives applied by the manufacturer. In this
case, particulars of the Directives applied, as published in the Official
Journal of the European Communties, must be given in the documents, notices or
instructions required by the Directives and accompanying such devices.';

4. in Article 9 the first paragraph
is replaced by the following text:

'1. Member States shall notify the
Commission and the other Member States of the bodies, which they have appointed
to carry out the procedures referred to in Article 8 together with the specific
tasks which these bodies have been appointed to carry out and the
identification numbers assigned to them beforehand by the Commission.

The Commission shall, for
information, publish in the Official Journal of the European Communities, a
list of these bodies, and the identification numbers it has assigned to them and
shall ensure that the list is kept up to date.';

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

'2. The affixing of markings on the
appliances which are likely to deceive third parties as to the meaning and form
of the CE marking shall be prohibited. Any other marking may be affixed to the
appliance or to the data plate provided that the visibility and legibility of
the CE marking is not hereby reduced.';

6. Article 11 is replaced by the
following text:

'Article 11

Without prejudice to Article 7:

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

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

7. Annex II is amended as follows:

(a) in point 2.1 the second sentence
is replaced by the following text:

'The manufacturer or his authorized
representative established within the Community shall affix the CE marking on
each appliance and draw up a written certificate of conformity.';

(b) in point 2.1 the last sentence
is replaced by the following text:

'The CE marking must be followed by
the identification number of the notified body responsible for the random
checks set out in point 2.3.';

(c) in point 3.1 the second sentence
is replaced by the following text:

'The manufacturer or his authorized
representative established within the Community must affix the CE marking to
each appliance and draw up a written declaration of conformity.';

(d) in point 3.1 the last sentence
is replaced by the following text:

'The CE marking must be followed by
the identification number of the notified body responsible for EC
surveillance.';

(e) in point 4.1 the second sentence
is replaced by the following text:

'The manufacturer or his authorized
representative established within the Community must affix the CE marking to each
appliance and draw up a written declaration of conformity.';

(f) in point 4.1 the last sentence
is replaced by the following text:

'The CE marking must be followed by
the identification number of the notified body responsible for EC
surveillance.';

(g) points 5 and 6 are replaced by
the following text:

'5. EC VERIFICATION

5.1. EC verification is the
procedure whereby the manufacturer or his authorized representative established
within the Community ensures and declares that the appliances subject to the
provisions of point 3 are in conformity to the type as described in the EC
type-examination certification and satisfy the requirement