# EUR-Lex - 52011PC0766 - EN

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# 52011PC0766

**Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the harmonisation of the laws of the Member States relating to making available on the market of non-automatic weighing instruments /* COM/2011/0766 final - 2011/0352 (COD) */**

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EXPLANATORY MEMORANDUM

1.
CONTEXT
OF THE PROPOSAL

General context, reasons for and
objectives of this proposal

This proposal is presented in the framework
of the implementation of the “goods package” adopted in 2008. It is part
of a package of proposals aligning ten product directives to Decision No
768/2008/EC establishing
a common framework for the marketing of products.

Union (EU) harmonisation legislation
ensuring the free movement of products has contributed considerably to the
completion and operation of the Single Market. It is based on a high level of
protection and provides economic operators with the means to demonstrate
conformity, thus ensuring free movement through trust in the products.

Directive 2009/23/EC is an example of that
Union harmonisation legislation, ensuring the free movement of non-automatic
weighing instruments. It sets out essential requirements that non-automatic
weighing instruments must comply with in order to be made available on the EU
market. Manufacturers must demonstrate that a non-automatic weighing instrument
has been designed and manufactured in compliance with the essential
requirements and affix the CE marking.

Experience with the implementation of Union
harmonisation legislation has shown – on a cross-sector scale - certain
weaknesses and inconsistencies in the implementation and enforcement of this
legislation, leading to

–
the presence of non-compliant or dangerous
products on the market and consequently a certain lack of trust in CE marking

–
competitive disadvantages for economic operators
complying with the legislation as opposed to those circumventing the rules

–
unequal treatment in the case of non-compliant
products and distortion of competition amongst economic operators due to
different enforcement practices

–
differing practices in the designation of
conformity assessment bodies by national authorities

–
problems with the quality of certain notified
bodies

Furthermore the regulatory environment has
become more and more complex, as frequently several pieces of legislation apply
simultaneously to one and the same product. Inconsistencies in these pieces of
legislation make it increasingly difficult for economic operators and
authorities to correctly interpret and apply that legislation.

To remedy these horizontal shortcomings in
Union harmonisation legislation observed across several industrial sectors, the
“New Legislative Framework” was adopted in 2008 as part of the goods
package. Its objective is to strengthen and
complete the existing rules and to improve practical aspects of their
application and enforcement. The New Legislative Framework (NLF) consists of
two complementary instruments, Regulation (EC) No 765/2008 on
accreditation and market surveillance and Decision No 768/2008/EC
establishing a common framework for the marketing of products.

The NLF Regulation has introduced rules on
accreditation (a tool for the evaluation of competence of conformity assessment
bodies) and requirements for the organisation and performance of market
surveillance and controls of products from third countries. Since 1 January
2010 these rules apply directly in all Member States.

The NLF Decision sets out a common
framework for EU product harmonisation legislation. This framework consists of
the provisions which are commonly used in EU product legislation (e.g.
definitions, obligations of economic operators, notified bodies, safeguard
mechanisms, etc). These common provisions have been reinforced to ensure that
the directives can be applied and enforced more effectively in practice. New
elements, such as obligations on importers, have been introduced, which are
crucial for improving the safety of products on the market.

The provisions of the NLF Decision and
those of the NLF Regulation are complementary and closely interlinked. The NLF
Decision contains the corresponding obligations for economic operators and
notified bodies allowing market surveillance authorities and authorities
responsible for notified bodies to properly perform the tasks imposed on them
by the NLF Regulation and to ensure an effective and consistent enforcement of
EU product legislation.

However, unlike the NLF Regulation, the
provisions of the NLF Decision are not directly applicable. To ensure that all
economic sectors subject to Union harmonisation legislation benefit from the
improvements of the NLF, the provisions of the NLF Decision need to be
integrated into the existing product legislation.

A survey after the adoption of the goods
package in 2008 showed that a majority of Union harmonisation legislation on products
was due to be revised within the following 3 years, not only to address the
problems observed throughout all sectors but also for sector-specific reasons.
Any such revision would automatically include an alignment of the legislation
concerned to the NLF Decision since Parliament, Council and Commission have
committed themselves to use its provisions as much as possible in future
legislation on products in order to further the utmost coherence of the
regulatory framework..

For a number of other Union harmonisation
directives, including Directive 2009/23/EC no revision for sector-specific
problems had been envisaged within this timeframe. To ensure that the problems
in relation to non-compliance and notified bodies are nevertheless addressed in
these sectors, and for the sake of consistency of the overall regulatory
environment on products, it was decided to align these directives within a
package to the provisions of the NLF Decision.

Consistency with other policies and
objectives of the Union

This initiative is in
line with the Single Market Act[1], which has
stressed the need to restore consumer confidence in the quality of products on
the market and the importance of reinforcing market surveillance.

Furthermore it supports
the Commission’s policy on Better Regulation and simplification of the
regulatory environment.

2.
consultation of interested parties and impact
assessment

Consultation of interested parties

The alignment of Directive 2009/23/EC to
the NLF Decision has been discussed with national experts responsible for the
implementation of this Directive and with other interested stakeholders as well
as in bilateral meetings with the European weighing instruments industry
associations.

From June to October 2010 a public
consultation was organised that comprised all the sectors involved in this
initiative. It consisted of four targeted questionnaires for economic
operators, authorities, notified bodies and users and the Commission services
received 300 replies. The results are published at:

http://ec.europa.eu/enterprise/policies/single-market-goods/regulatory-policies-common-rules-for-products/new-legislative-framework/index_en.htm

In addition to the general consultation a
specific SME consultation was carried out. 603 SMEs were consulted through the
Enterprise Europe Network in May/June 2010. The results are available at http://ec.europa.eu/enterprise/policies/single-market-goods/files/new-legislative-framework/smes_statistics_en.pdf

The consultation process revealed
widespread support for the initiative. There is unanimity on the need to
improve market surveillance and the system for assessing and monitoring
Notified Bodies. Authorities fully support the exercise because it will
strengthen the existing system and improve cooperation at EU level. Industry
expects a more level playing field resulting from more effective actions
against products that do not comply with the legislation, as well as a
simplification effect from the alignment of legislation. Certain concerns were
expressed on some obligations which are, however, indispensable for increasing
the efficiency of market surveillance. These measures will not entail significant
costs for industry, and the benefits resulting from improved market
surveillance should by far outweigh the costs.

Collection and use of expertise

The impact assessment for this
implementation package has largely built on the impact assessment carried out
for the New Legislative Framework. In addition to the expertise collected and
analysed in that context, further consultation of sector-specific experts and
interest groups, as well as horizontal experts active in the area of technical
harmonisation, conformity assessment, accreditation and market surveillance,
has taken place.

Impact assessment

Based on the information collected, the
Commission carried out an impact assessment which examined and compared three
options.

Option 1 - No changes to the current
situation

This option proposes no changes to the
current directive and relies exclusively on certain improvements that can be
expected from the NLF Regulation.

Option 2 – Alignment to the NLF Decision
by non-legislative measures

Option 2 considers the possibility of
encouraging a voluntary alignment to the provisions set out in the NLF Decision
by, e.g., presenting them as best practices in guidance documents.

Option 3 – Alignment to NLF Decision by
legislative measures

This option consists in integrating the
provisions of the NLF Decision into the existing directives.

Option 3 was
found to be the preferred option because

–
it will improve the competitiveness of companies
and notified bodies taking their obligations seriously, as opposed to those
cheating on the system;

–
it will improve the functioning of the internal
market by ensuring equal treatment of all economic operators, notably importers
and distributors, as well as notified bodies;

–
it does not entail significant costs for
economic operators and notified bodies; for those who are already acting
responsibly, no extra costs or only negligible costs are expected;

–
it is considered more effective than option 2:
due to the lack of enforceability of option 2 it is questionable that the
positive impacts would materialise under that option;

–
options 1 and 2 do not provide answers to the
problem of inconsistencies in the regulatory framework and therefore have no
positive impact on the simplification of the regulatory environment.

3.
Main elements of the proposal
3.1.
Horizontal definitions

The proposal
introduces harmonised definitions of terms which are commonly used throughout
Union harmonisation legislation and should therefore be given a consistent
meaning throughout that legislation.

3.2.
Obligations of economic operators and
traceability requirements

The proposal clarifies the obligations of
manufacturers and authorised representatives and introduces obligations for
importers and distributors. Importers must verify that the manufacturer has
carried out the applicable conformity assessment procedure and has drawn up a
technical documentation. They must also make sure with the manufacturer that
this technical documentation can be made available to authorities upon request.
Furthermore importers must verify that the non-automatic weighing instruments
are correctly marked and accompanied by instructions and information. They must
keep a copy of the Declaration of conformity and indicate their name and
address on the product, or where this is not possible on the packaging or the
accompanying documentation. Distributors must verify that the non-automatic
weighing instrument bears the CE marking, the name of the manufacturer and of
the importer, if relevant, and that it is accompanied by the required
documentation and instructions.

Importers and distributors must cooperate
with market surveillance authorities and take appropriate actions when they
have supplied non-compliant non-automatic weighing instruments.

Enhanced traceability obligations are introduced for all economic operators. Non-automatic weighing instruments
have to bear the manufacturer’s name and address and a number allowing to
identify and link the non-automatic weighing instrument to its technical
documentation. When a non-automatic weighing instrument is imported the
importer’s name and address must also be on the non-automatic weighing instruments.
Furthermore every economic operator must be able to identify towards
authorities the economic operator who has supplied him with a non-automatic
weighing instrument or to whom he has supplied a non-automatic weighing instrument.

3.3.
Harmonised standards

Compliance with harmonised standards
provides for a presumption of conformity with the essential requirements. On 1
June 2011 the Commission adopted a proposal for a Regulation on European
Standardisation[2] that sets out a horizontal
legal framework for European standardisation. The proposal for the Regulation
contains inter alia provisions on standardisation requests from the Commission
to the European Standardisation Organisations, on the procedure for objections
to harmonised standards and on stakeholder participation in the standardisation
process. Consequently the provisions of Directive 2009/23/EC which cover the
same aspects have been deleted in this proposal for reasons of legal certainty.
The provision conferring presumption of conformity to harmonised standards has
been modified to clarify the extent of the presumption of conformity when
standards only partially cover the essential requirements.

3.4.
Conformity assessment and CE marking

Directive 2009/23/EC has selected the
appropriate conformity assessment procedures which manufacturers have to apply
in order to demonstrate that their non-automatic weighing instruments comply
with the essential requirements. The proposal aligns these procedures to their
updated versions set out in the NLF Decision. It keeps some sector specific
elements already provided for in Directive 2009/23/EC as the intervention in
certain cases of two notified bodies in the production control phase.
Furthermore, the statistical verification provided for in Modules F and F1 of
the NLF Decision has not been kept, as it is not relevant for the non-automatic
weighing instruments sector.

General principles of the CE marking are
set out in Article 30 of Regulation 765/2008, while the detailed provisions on
the affixing of the CE marking and the M marking to non-automatic
weighing instruments have been inserted in this
proposal.

3.5.
Notified Bodies

The proposal reinforces the notification
criteria for notified bodies. It clarifies that subsidiaries or subcontractors
must also comply with the notification requirements. Specific requirements for
notifying authorities are introduced, and the procedure for notification of
notified bodies is revised. The competence of a notified body must be
demonstrated by an accreditation certificate. Where accreditation has not been
used to evaluate the competence of a notified body, the notification must
comprise the documentation demonstrating how the competence of that body has
been evaluated. Member States will have the possibility to object to a
notification.

3.6.
Market surveillance and the safeguard clause
procedure

The proposal revises the existing safeguard
clause procedure. It introduces a phase of information exchange between Member
States, and specifies the steps to be taken by the authorities concerned, when
a non-compliant non-automatic weighing instrument is found. A real safeguard
clause procedure – leading to a Decision at Commission level on whether a
measure is justified or not - is only launched when another Member State
objects to a measure taken against a non-automatic weighing instrument. Where
there is no disagreement on the restrictive measure taken, all Member States
must take the appropriate action on their territory.

4.
legal elements of the proposal

Legal basis

The proposal is based on Article 114 of the
Treaty on the Functioning of the European Union.

Subsidiarity principle

The internal market is a competence that is
shared between the Union and the Member States. The subsidiarity principle
arises in particular with regard to the newly added provisions aiming at the
improvement of effective enforcement of Directive 2009/23/EC, namely, the
importer and distributor obligations, the traceability provisions, the
provisions on the assessment and notification of notified bodies, and the
enhanced cooperation obligations in the context of the revised market
surveillance and safeguard procedures.

Experience with the enforcement of the
legislation has shown that measures taken at national level have led to
divergent approaches and to a different treatment of economic operators inside
the EU, which undermines the objective of this directive. If actions are taken
at national level to address the problems, this risks creating obstacles to the
free movement of goods. Furthermore action at national level is limited to the
territorial competence of a Member State. In view of the increasing
internationalisation of trade, the number of cross-border cases is constantly
rising. Coordinated action at EU level can much better achieve the objectives
set, and will in particular render market surveillance more effective. Hence it
is more appropriate to take action at EU level.

As regards the problem of inconsistencies
throughout the directives, this is a problem which can only be solved by the EU
legislator.

Proportionality

In accordance with the principle of
proportionality, the proposed modifications do not go beyond what is necessary
to achieve the objectives set.

The new or modified obligations do not
impose unnecessary burdens and costs on industry - especially on small and medium
sized enterprises - or administrations. Where modifications have been identified
to have negative impacts, the analysis of the impacts of the option serves to
provide the most proportionate response to the problems identified. A number of
modifications concern the improvement of clarity of the existing Directive
without introducing new requirements that entail added cost.

Legislative technique used

The alignment to the NLF Decision requires
a number of substantive amendments to the provisions of Directive 2009/23/EC.
To ensure the readability of the amended text the technique of recasting has
been chosen in line with the Interinstitutional Agreement of 28 November 2001
on a more structured use of the recasting technique for legal acts[3].

The changes made to the provisions of
Directive 2009/23/EC concern: the definitions, the obligations of economic
operators, the presumption of conformity provided by harmonised standards, the
declaration of conformity, CE marking, notified bodies, the safeguard clause procedure
and the conformity assessment procedures.

The proposal does not change the scope of
Directive 2009/23/EC and the essential requirements.

5.
budgetary implications

This proposal does not have any
implications for the EU budget.

6.
additional information

Repeal of existing legislation

The adoption of the proposal will lead to
repeal of Directive 2009/23/EC.

European Economic Area

The proposal concerns the EEA and should
therefore be extended to the European Economic Area.

ê 2009/23/EC
(adapted)

2011/0352 (COD)

Proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

on the harmonisation of the laws of the
Member States relating to making available on the market of non-automatic
weighing instruments

(Recast)
(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community Ö on the
Functioning of the European Union Õ, and in
particular Article 95
Ö 114 Õ thereof,

Having regard to the proposal from the European
Commission,

After transmission of the draft legislative
act to the national Parliaments,

Having regard to the opinion of the
European Economic and Social Committee[4],

Acting in accordance with the ordinary
legislative procedure,

Whereas:

ê 2009/23/EC
recital 1 (adapted)

Council Directive 90/384/EEC of 20 June 1990 on
the harmonisation of the laws of the Member States relating to non-automatic
weighing instruments[5] has been
substantially amended[6]. In the
interests of clarity and rationality the said Directive should be codified.

ò new

(1)
A number of substantive
changes are to be made to Directive 2009/23/EC of the European Parliament and
of the Council of 23 April 2009 on non-automatic weighing instruments[7].
In the interests of clarity, that Directive should be recast.

(2)
Regulation (EC) No
765/2008/EC of the European Parliament and of the Council of 9 July 2008
setting out the requirements for accreditation and market surveillance relating
to the marketing of products and repealing Regulation (EEC) No 339/93[8]
lays down rules on the accreditation of conformity assessment bodies, provides
a framework for the market surveillance of products and for controls on products
from third countries, and lays down the general principles of the CE marking.

(3)
Decision No
768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a
common framework for the marketing of products and repealing Council Decision
93/465/EEC[9] lays down a common
framework of general principles and reference provisions intended to apply
across the legislation harmonising the conditions for the marketing of products
in order to provide a coherent basis for revision or recasts of that legislation.
Directive 2009/23/EC should therefore be adapted to that Decision.

ê 2009/23/EC
recital 2

(4)
            Member States have the
responsibility of protecting the public against incorrect results of weighing
operations by means of non-automatic weighing instruments when used for certain
categories of applications.

ê 2009/23/EC
recital 3 (adapted)

In each Member State, mandatory provisions fix in
particular the necessary performance requirements of non-automatic weighing
instruments by specifying metrological and technical requirements, together
with inspection procedures before and after going into service. These mandatory
provisions do not necessarily lead to different levels of protection from one
Member State to another but do, by their
disparity, impede trade within the Community.

ò new

(5)
Economic operators
should be responsible for the compliance of non-automatic weighing instruments,
in relation to their respective roles in the supply chain, so as to ensure a
high level of protection of public interests, as health and safety and the
protection of users, and to guarantee fair competition on the Union market.

(6)
All economic operators
intervening in the supply and distribution chain should take appropriate
measures to ensure that they only make available on the market non-automatic
weighing instruments which are in conformity with this Directive. It is
necessary to provide for a clear and proportionate distribution of obligations
which correspond to the role of each operator in the supply and distribution
process.

(7)
The manufacturer,
having detailed knowledge of the design and production process, is best placed
to carry out the complete conformity assessment procedure. Conformity
assessment should therefore remain the obligation of the manufacturer alone.

(8)
It is necessary to
ensure that non-automatic
weighing instruments from
third countries entering the Union market comply with the requirements of this
Directive, and in particular that appropriate assessment procedures have been carried
out by manufacturers with regard to those non-automatic weighing instruments. Provision should therefore be made for
importers to make sure that the non-automatic
weighing instruments they
place on the market comply with the requirements of this Directive and that
they do not place on the market non-automatic
weighing instruments which do
not comply with such requirements or present a risk. Provision should also be
made for importers to make sure that the conformity assessment procedures have
been carried out and that product marking and documentation drawn up by
manufacturers are available for inspection by the supervisory authorities.

(9)
The distributor makes
a non-automatic weighing
instrument available on the
market after it has been placed on the market by the manufacturer or the
importer and should act with due care to ensure that its handling of the non-automatic weighing instrument does not adversely affect the compliance
of the instrument.

(10)
When placing a
non-automatic weighing instrument on the market, every importer should indicate
on the non-automatic weighing instrument his name and the address at which he
can be contacted. Exceptions should be provided for in cases where the size or
nature of the non-automatic weighing instrument does not allow it. This
includes cases where the importer should have to open the packaging to put his
name and address on the instrument.

(11)
            Any
economic operator that either places a non-automatic weighing instrument on the
market under his own name or trademark or modifies a non-automatic weighing
instrument in such a way that compliance with the requirements of this
Directive may be affected should be considered to be the manufacturer and should assume the obligations of the
manufacturer.

(12)
Distributors and
importers, being close to the market place, should be involved in market
surveillance tasks carried out by the competent national authorities, and
should be prepared to participate actively, providing those authorities with
all necessary information relating to the non-automatic weighing instrument concerned.

(13)
Ensuring traceability
of a non-automatic weighing
instrument throughout the
whole supply chain helps to make market surveillance simpler and more
efficient. An efficient traceability system facilitates market surveillance
authorities' task of tracing economic operators who made non-compliant non-automatic weighing instruments available on the market.

ê 2009/23/EC
recital 4 (adapted)

ð new

(14)
This Directive should set out ð be limited to the expression of ï mandatory and the
essential requirements as regards metrology and performance in relation to
non-automatic weighing instruments. Ö In order Õ Tto facilitate proof of conformity Ö assessment Õ with the essential
Ö those Õ requirements,
it is necessary to have
Ö provide
for presumption of conformity for non-automatic weighing instruments which are
in conformity with Õ harmonised
standards at
European level, ð that are adopted in accordance with
Regulation (EU) No [../..] of
the European Parliament and of the Council of [.....] on European Standardisation
and amending Council Directives 89/686/EEC and 93/15/EEC and Directives
94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC,
2009/105/EC and 2009/23/EC of the European Parliament and of the Council[10] for the purpose of expressing detailed
technical specifications of those requirements, ï in particular as to the metrological, design and construction
characteristics, so that instruments complying with those
harmonised standards may be assumed to conform to the essential requirements.
These standards, harmonised at European level,
are drawn up by private bodies and must remain non-mandatory texts. For that
purpose the European Committee for Standardisation (CEN), the European
Committee for Electrotechnical Standardisation (Cenelec) and the European
Telecommunications Standards Institute
(ETSI) are recognised as the competent bodies for the adoption of harmonised
standards in accordance with the general guidelines[11] for cooperation between the Commission, the
European Free Trade Association (EFTA) and those three bodies, signed on 28
March 2003.

ò new

(15)
Regulation (EU) No
[../..] [European Standardisation] provides for a procedure for objections to
harmonised standards where those standards do not entirely satisfy requirements
of this Directive.

ê 2009/23/EC
recital 5 (adapted)

A series of Directives designed to remove
technical barriers to trade in accordance with the principles established in
the Council Resolution of 7 May 1985 on a new approach to technical
harmonisation and standards[12] has
been adopted; each of those Directives provides for the affixing of the ‘CE’
conformity marking. In its communication of 15 June 1989[13] on a
global approach to certification and testing, the Commission proposed that
common rules be drawn up concerning a ‘CE’ conformity marking with a single
design. In its Resolution of 21 December 1989 on a global approach to
conformity assessment[14], the
Council approved as a guiding principle the adoption of a consistent approach
such as this with regard to the use of the ‘CE’ conformity marking. The two
basic elements of the new approach which should be applied are the essential
requirements and the conformity assessment procedures.

ê 2009/23/EC
recital 6

(16)
Assessment of conformity with the
relevant metrological and technical provisions is necessary to provide
effective protection for users and third parties. The existing
conformity assessment procedures differ from one Member State to another. To
avoid multiple assessments of conformity, which are in effect barriers to
the free movement of the instruments, arrangements should be made for the
mutual recognition of conformity assessment procedures by the Member States. To
facilitate the mutual recognition of conformity assessment procedures,
Community procedures should be set up,
together with criteria for the designation of the bodies responsible for
carrying out tasks pertaining to the conformity assessment procedures.

ò new

(17)
In order to enable
economic operators to demonstrate and the competent authorities to ensure that
non-automatic weighing instruments made available on
the market conform to the essential requirements, it is necessary to provide
for conformity assessment procedures. Decision No 768/2008/EC establishes
modules for conformity assessment procedures, which include procedures from the
least to the most stringent, in proportion to the level of risk involved and
the level of safety required. In order to ensure inter-sectoral coherence and
to avoid ad-hoc variants, conformity assessment procedures should be chosen
from among those modules.

(18)
Manufacturers should
draw up an EU declaration of conformity to provide detailed information on the
conformity of the non-automatic weighing instrument with
the requirements of this Directive and of other relevant Union
harmonisation legislation.

(19)
The CE marking, indicating the conformity of a
non-automatic weighing
instrument, is the visible
consequence of a whole process comprising conformity assessment in a broad
sense. General principles governing the CE marking and its relationship to
other markings are set out in Regulation (EC) No 765/2008. Together
with the CE marking, the manufacturer should affix the sticker bearing the letter ‘M’. Rules governing the affixing of the CE marking and the “M” sticker should be laid down in this Directive.

ò new

(20)
The conformity
assessment procedures set out in this Directive require the intervention of
conformity assessment bodies, which are notified by the Member States to the
Commission.

ê 2009/23/EC
recital 7

It is therefore
essential to ensure that such designated bodies ensure a high level of quality throughout
the Community.

ò new

(21)
Experience has shown
that the criteria set out in Directive 2009/23/EC that conformity assessment
bodies have to fulfil to be notified to the Commission are not sufficient to
ensure a uniformly high level of performance of notified bodies throughout the
Union. It is, however, essential that all notified bodies perform their
functions to the same level and under conditions of fair competition. That
requires the setting of obligatory requirements for conformity assessment
bodies wishing to be notified in order to provide conformity assessment
services.

(22)
In order to ensure a
consistent level of conformity assessment quality, it is also necessary to set
requirements for notifying authorities and other bodies involved in the
assessment, notification and monitoring of notified bodies.

(23)
If a conformity
assessment body demonstrates conformity with the criteria laid down in
harmonised standards, it should be presumed to comply with the corresponding
requirements set out in this Directive.

(24)
The system set out in
this Directive should be complemented by the accreditation system provided for
in Regulation (EC) No 765/2008. Since accreditation is an essential means of
verifying the competence of conformity assessment bodies, it should also be
used for the purposes of notification.

(25)
            Transparent
accreditation as provided for in Regulation (EC) No 765/2008, ensuring the
necessary level of confidence in conformity certificates, should be considered
by the national public authorities throughout the Union as the preferred means
of demonstrating the technical competence of conformity assessment bodies.
However, national authorities may consider that they possess the appropriate
means of carrying out this evaluation themselves. In such cases, in order to
ensure the appropriate level of credibility of evaluations carried out by other
national authorities, they should provide the Commission and the other Member
States with the necessary documentary evidence demonstrating the compliance of
the conformity assessment bodies evaluated with the relevant regulatory
requirements.

(26)
Conformity assessment
bodies frequently subcontract parts of their activities linked to the
assessment of conformity or have recourse to a subsidiary. In order to
safeguard the level of protection required for the non-automatic weighing instruments to be placed on the Union market, it is
essential that conformity assessment subcontractors and subsidiaries fulfil the
same requirements as notified bodies in relation to the performance of
conformity assessment tasks. Therefore, it is important that the assessment of
the competence and the performance of bodies to be notified and the monitoring
of bodies already notified cover also activities carried out by subcontractors
and subsidiaries.

(27)
It is necessary to
increase the efficiency and transparency of the notification procedure and, in
particular, to adapt it to new technologies so as to enable online
notification.

(28)
Since notified bodies
may offer their services throughout the Union, it is appropriate to give the
other Member States and the Commission the opportunity to raise objections
concerning a notified body. It is therefore important to provide for a period
during which any doubts or concerns as to the competence of conformity
assessment bodies can be clarified before they start operating as notified
bodies.

(29)
In the interests of
competitiveness, it is crucial that notified bodies apply the conformity
assessment procedures without creating unnecessary burdens for economic
operators. For the same reason, and to ensure equal treatment of economic
operators, consistency in the technical application of the conformity
assessment procedures needs to be ensured. That can best be achieved through
appropriate coordination and cooperation between notified bodies.

(30)
In order to ensure
legal certainty, it is necessary to clarify that rules on Union market
surveillance and control of products entering the Union market provided for in
Regulation (EC) No 765/2008 apply to non-automatic weighing instruments covered
by this Directive. This Directive should not prevent Member States from
choosing the competent authorities to carry out those tasks.

(31)
Directive 2009/23/EC
already provides for a safeguard procedure allowing the Commission to examine
the justification for a measure taken by a Member State against non-automatic
weighing instruments it considers being non-compliant. In order to increase
transparency and to reduce processing time, it is necessary to improve the
existing safeguard clause procedure, with a view to making it more efficient
and drawing on expertise available in Member States.

(32)
The existing system
should be supplemented by a procedure under which interested parties are
informed of measures intended to be taken with regard to non-automatic weighing
instruments presenting a risk to the health and safety of persons or to other
aspects of public interest protection. It should also allow market surveillance
authorities, in cooperation with the relevant economic operators, to act at an
earlier stage in respect of such non-automatic weighing instruments.

(33)
Where the Member
States and the Commission agree as to the justification of a measure taken by a
Member State, no further involvement of the Commission should be required,
except where non-compliance can be attributed to shortcomings of a harmonised
standard.

(34)
Member
States should lay down rules on penalties applicable to infringements of the
national provisions adopted pursuant to this Directive and ensure that they are
implemented. Those penalties should be effective, proportionate and dissuasive.

(35)
It is necessary to
provide for transitional arrangements that allow making available on the market
and putting into service non-automatic weighing instruments that have already
been placed on the market in accordance with Directive 2009/23/EC.

(36)
Since
the objective of this Directive, namely to ensure that non-automatic weighing instruments on the market fulfil the requirements providing
a high level of protection of health and safety and other public interests
while guaranteeing the functioning of the internal market, cannot be
sufficiently achieved by the Member States and can therefore, by reason of its
scale and effects, be better achieved at Union level, the Union may adopt
measures, in accordance with the principle of subsidiarity as set out in
Article 5 of the Treaty on European Union. In accordance with the principle of
proportionality, as set out in that Article, this Directive does not go beyond
what is necessary in order to achieve that objective.

ê 2009/23/EC
recital 8

The presence on a
non-automatic weighing instrument of the ‘CE’ conformity marking or of the sticker
bearing the letter ‘M’ should indicate that there is a presumption that it
satisfies the provisions of this Directive and therefore make it unnecessary to
repeat the assessments of conformity already carried out.

ò new

(37)
The
obligation to transpose this Directive into national law should be confined to
those provisions which represent a substantive change as compared with
Directive 2009/23/EC. The obligation to transpose the provisions which are
unchanged arises under the earlier Directive.

ê 2009/23/EC
recital 9

(38)
This Directive should be without prejudice to
the obligations of the Member States relating to the time limits for
transposition into national law and application of the Directives set out in Annex
VII, Part B of Annex VII to Directive 2009/23/EC.,

ê 2009/23/EC
(adapted)

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER 1

SCOPE, PLACING ON THE MARKET AND FREE MOVEMENT

Ö GENERAL
PROVISIONS Õ

Article 1

Ö Scope Õ

ê 2009/23/EC
(adapted)

1. This Directive shall apply to all
non-automatic weighing instruments.

2. For the purposes of this Directive, the
following categories of use of non-automatic weighing instruments shall be
distinguished:

(a)

(ai)
determination of mass for commercial transactions;

(bii)
determination of mass for the calculation of a toll, tariff, tax, bonus,
penalty, remuneration, indemnity or similar type of payment;

(ciii)
determination of mass for the application of laws or regulations or for an
expert opinion given in court proceedings;

(div)
determination of mass in the practice of medicine for weighing patients for the
purposes of monitoring, diagnosis and medical treatment;

(ev)
determination of mass for making up medicines on prescription in a pharmacy and
determination of mass in analyses carried out in medical and pharmaceutical
laboratories;

(fvi)
determination of price on the basis of mass for the purposes of direct sales to
the public and the making-up of prepackages;

(gb)
all applications other than those listed in points (a) Ö to
(f) Õ .

ê 2009/23/EC
(adapted)

Article 2

Ö Definitions Õ

For the purposes of this Directive, the
following definitions shall apply:

(1.)         ‘weighing
instrument’: Ö means Õ a measuring
instrument serving to determine the mass of a body by using the action of
gravity on that body.
A weighing instrument may also Ö or
serving Õ serve
to determine other mass-related magnitudes, quantities, parameters or
characteristics;

(2.)         ‘non-automatic
weighing instrument’ or ‘instrument’: Ö means Õ a weighing
instrument requiring the intervention of an operator during weighing;

ê 2009/23/EC

3.           ‘harmonised standard’: a technical specification
(European standard or harmonised document) adopted by the European Committee
for Standardisation (CEN), the European Committee for Electrotechnical Standardisation
(Cenelec), or the European Telecommunications Standards Institute (ETSI), or by
two or three of those bodies, upon a remit from the Commission in accordance
with Directive 98/34/EC of the European Parliament and of the Council of 22
June 1998 laying down a procedure for the
provision of information in the field of technical standards and regulations[15] and the general guidelines for cooperation
between the Commission, the European Free Trade Association (EFTA) and those
three bodies, signed on 28 March 2003.

ò new

(3)          ‘making
available on the market’ means any supply of an instrument for distribution, or
use on the Union market in the course of a commercial activity, whether in
return for payment or free of charge;

(4)          ‘placing
on the market’ means the first making available of an instrument on the Union
market;

(5)          ‘manufacturer’
means any natural or legal person who manufactures an instrument or has an
instrument designed or manufactured, and markets that instrument under his name
or trademark;

(6)          ‘authorised
representative’ means any natural or legal person established within the Union
who has received a written mandate from a manufacturer to act on his behalf in
relation to specified tasks;

(7)          ‘importer’
means any natural or legal person established within the Union who places an
instrument from a third country on the Union market;

(8)          ‘distributor’
means any natural or legal person in the supply chain, other than the
manufacturer or the importer, who makes an instrument available on the market;

(9)          ‘economic
operators’ means the manufacturer, the authorised representative, the importer
and the distributor;

(10)        ‘technical
specification’ means a document that prescribes technical requirements to be
fulfilled by an instrument, process or service;

(11)        ‘harmonised
standard’ means harmonised standard as defined in Article 2(1)(c) of Regulation
(EU) No [...] [European Standardisation];

(12)        ‘accreditation’
means accreditation as defined in Article 2(10) of Regulation (EC) No 765/2008;

(13)        ‘national
accreditation body’ means national accreditation body as defined in Article
2(11) of Regulation (EC) No 765/2008;

(14)        ‘conformity
assessment’ means the process demonstrating whether the requirements of this
Directive relating to an instrument have been fulfilled;

(15)        ‘conformity
assessment body’ means a body that performs conformity assessment activities
including calibration, testing, certification and inspection;

(16)        ‘recall’
means any measure aimed at achieving the return of an instrument that has
already been made available to the end user;

(17)        ‘withdrawal’
means any measure aimed at preventing an instrument in the supply chain from
being made available on the market;

(18)        ‘CE
marking’ means a marking by which the manufacturer indicates that the
instrument is in conformity with the applicable requirements set out in Union
harmonisation legislation providing for its affixing;

(19)        ‘Union
harmonisation legislation’ means any Union legislation harmonising the
conditions for the marketing of products.

ê 2009/23/EC
(adapted)

Article 3

Ö Making available on the market and
putting into service Õ

ê 2009/23/EC

ð new

1.         Member States shall take all
steps to ensure that only instruments that meet the requirements of this
Directive may be placed ð made available ï on the market.

ê 2009/23/EC
(adapted)

2.         Member States shall take all
steps to ensure that instruments may not be brought into service for the uses
referred to in points (a) to (f) of Article 1(2) unless they meet
the requirements of this Directive and accordingly bear the ‘CE’ conformity marking
provided for in Article 11.

Article 14

3.         Member States shall take all steps to ensure that
instruments bearing
the ‘CE’ conformity marking attesting conformity with the requirements of this
Directive continue to conform to those Ö the Õ requirements Ö of this
Directive Õ .

Article 4

Ö Essential requirements Õ

ê 2009/23/EC

ð new

Instruments used for the applications
listed in points (a) to (f) of Article 1(2) must satisfy the
essential requirements set out in Annex I ð and bear the CE marking and the
inscriptions provided for in point 1 of Annex III ï .

ê 2009/23/EC

In cases where the instrument includes, or
is connected to, devices which are not used for the applications listed in points (a) to
(f) of Article 1(2), such devices shall not be subject to those
essential requirements.

ê 2009/23/EC
(adapted)

Article 5

Ö Free movement Õ

ê 2009/23/EC

ð new

1.         Member States shall not impede
the placing ð making available ï on the market of instruments which meet the requirements of this
Directive.

2.         Member States shall not impede
the putting into service, for the uses referred to in points (a) to
(f) of Article 1(2), of instruments which meet the requirements of
this Directive.

ò new

CHAPTER 2

OBLIGATIONS OF
ECONOMIC OPERATORS

Article 6 [Article
R2 of Decision No 768/2008/EC]

Obligations of manufacturers

1.         When
placing on the market their instruments used for the applications listed in
points (a) to (f) of Article 1(2), manufacturers shall ensure that they have
been designed and manufactured in accordance with the essential requirements
set out in Annex I.

When placing on
the market their instruments not used for the applications listed in points (a)
to (f) of Article 1(2), manufacturers shall ensure that they bear the
inscriptions provided for in point 2 of Annex III.

2.         For
the instruments used for the applications listed in points (a) to (f) of
Article 1(2), manufacturers shall draw up the required technical documentation
and carry out the relevant conformity assessment procedure referred to in
Article 14 or have it carried out.

Where compliance
of the instrument with the applicable requirements has been demonstrated by
that procedure, manufacturers shall draw up an EU declaration of conformity and
affix the CE marking and the inscriptions provided for in point 1 of Annex III.

For the
instruments not used for the applications listed in points (a) to (f) of
Article 1(2), manufacturers shall affix the inscriptions provided for in point
2 of Annex III.

ê 2009/23/EC
(adapted)

Where an instrument which is used for any
of the applications referred to in points
(a) to (f) of Article 1(2)
includes, or is connected to, devices that have not been subject to conformity
assessment as
referred to in Article 913, each of those devices shall bear the
symbol restricting its use as defined Ö provided
for Õ in point 3 of by Annex IV
III,
point
3.

ò new

3.         For
the instruments used for the applications listed in points (a) to (f) of
Article 1(2), manufacturers shall keep the technical documentation and the EU
declaration of conformity for 10 years after the instrument has been placed on
the market.

4.         Manufacturers
shall ensure that procedures are in place for series production to remain in
conformity. Changes in instrument design or characteristics and changes in the
harmonised standards or in technical specifications by reference to which
conformity of an instrument is declared shall be adequately taken into account.

When deemed
appropriate with regard to the performance presented by an instrument,
manufacturers shall carry out sample testing of instruments made available on
the market, investigate, and, if necessary, keep a register of complaints, of
non-conforming instruments and instrument recalls, and shall keep distributors
informed of any such monitoring.

5.         Manufacturers
shall ensure that their instruments bear a type, batch or serial number or
other element allowing their identification, as set out in Annex III.

6.         Manufacturers
shall indicate their name, registered trade name or registered trade mark and
the address at which they can be contacted on the instrument or, where that is
not possible, on its packaging or in a document accompanying the instrument.
The address must indicate a single point at which the manufacturer can be
contacted.

7.         Manufacturers
shall ensure that the instrument is accompanied by instructions and information
in a language which can be easily understood by consumers and other end-users,
as determined by the Member State concerned.

8.         Manufacturers
who consider or have reason to believe that an instrument which they have
placed on the market is not in conformity with this Directive shall immediately
take the necessary corrective measures to bring that instrument into
conformity, to withdraw it or recall it, if appropriate. Furthermore, where the
instrument presents a risk, manufacturers shall immediately inform the
competent national authorities of the Member States in which they made the
instrument available to that effect, giving details, in particular, of the
non-compliance and of any corrective measures taken.

9.         Manufacturers
shall, further to a reasoned request from a competent national authority,
provide it with all the information and documentation necessary to demonstrate
the conformity of the instrument, in a language which can be easily understood
by that authority. They shall cooperate with that authority, at its request, on
any action taken to eliminate the risks posed by instruments which they have
placed on the market.

Article 7 [Article
R3 of Decision No 768/2008/EC]

Authorised representatives

1.         A
manufacturer may, by a written mandate, appoint an authorised representative.

The obligations
laid down in Article 6(1) and the drawing up of technical documentation shall
not form part of the authorised representative's mandate.

2.         An
authorised representative shall perform the tasks specified in the mandate
received from the manufacturer. The mandate shall allow the authorised
representative to do at least the following:

(a)     keep the EU
declaration of conformity and the technical documentation at the disposal of national
surveillance authorities for 10 years after the instrument has been placed on
the market;

(b)     further to a
reasoned request from a competent national authority, provide that authority
with all the information and documentation necessary to demonstrate the
conformity of an instrument;

(c)     cooperate
with the competent national authorities, at their request, on any action taken
to eliminate the risks posed by instruments covered by the authorised
representative’s mandate.

Article 8 [Article
R4 of Decision No 768/2008/EC]

Obligations of importers

1.         Importers
shall place only compliant instruments on the Union market.

2.         Before
placing on the market an instrument used for the applications listed in points
(a) to (f) of Article 1(2), importers shall ensure that the appropriate
conformity assessment procedure has been carried out by the manufacturer. They
shall ensure that the manufacturer has drawn up the technical documentation,
that the instrument bears the CE marking, the inscriptions provided for in point
1 of Annex III and is accompanied by the required documents, and that the
manufacturer has complied with the requirements set out in Article 6(5) and (6).

Where an importer
considers or has reason to believe that an instrument used for the applications
listed in points (a) to (f) of Article 1(2) is not in conformity with the essential
requirements set out in Annex I, he shall not place the instrument on the
market until it has been brought into conformity. Furthermore, where the
instrument presents a risk, the importer shall inform the manufacturer and the
market surveillance authorities to that effect.

Before placing on
the market an instrument not used for the applications listed in points (a) to
(f) of Article 1(2), importers shall ensure that the instrument bears
the inscriptions provided for in point 2 of Annex III and that the manufacturer
has complied with the requirements set out in Article 6(5) and (6).

3.         Importers
shall indicate their name, registered trade name or registered trade mark and
the address at which they can be contacted on the instrument or, where that is
not possible, on its packaging or in a document accompanying the instrument.

4.         Importers
shall ensure that the instrument is accompanied by instructions and information
in a language which can be easily understood by consumers and other end-users,
as determined by the Member State concerned.

5.         Importers
shall ensure that, while an instrument used for the applications listed in
points (a) to (f) of Article 1(2) is under their responsibility, storage or
transport conditions do not jeopardise its compliance with the essential requirements
set out in Annex I.

6.         When
deemed appropriate with regard to the performance of an instrument, importers
shall carry out sample testing of instruments made available on the market,
investigate, and, if necessary, keep a register of complaints, of
non-conforming instruments and instrument recalls, and shall keep distributors
informed of such monitoring.

7.         Importers
who consider or have reason to believe that an instrument which they have
placed on the market is not in conformity with this Directive shall immediately
take the corrective measures necessary to bring that instrument into
conformity, to withdraw it or recall it, if appropriate. Furthermore, where the
instrument presents a risk, importers shall immediately inform the competent
national authorities of the Member States in which they made the instrument
available to that effect, giving details, in particular, of the non-compliance
and of any corrective measures taken.

8.         For
the instruments used for the applications listed in points (a) to (f) of
Article 1(2), importers shall, for 10 years after the instrument has been
placed on the market keep a copy of the EU declaration of conformity at the disposal
of the market surveillance authorities and ensure that the technical
documentation can be made available to those authorities, upon request.

9.         Importers
shall, further to a reasoned request from a competent national authority,
provide it with all the information and documentation necessary to demonstrate
the conformity of an instrument in a language which can be easily understood by
that authority. They shall cooperate with that authority, at its request, on
any action taken to eliminate the risks posed by instruments which they have
placed on the market.

Article 9 [Article
R5 of Decision No 768/2008/EC]

Obligations of distributors

1.         When
making an instrument available on the market distributors shall act with due
care in relation to the requirements of this Directive.

2.         Before
making an instrument used for the applications listed in points (a) to (f) of
Article 1(2) available on the market, distributors shall verify that the
instrument bears the CE marking, the inscriptions provided for in point 1 of
Annex III, that it is accompanied by the required documents and by instructions
and information in a language which can be easily understood by consumers and
other end-users in the Member State in which the instrument is to be made
available on the market, and that the manufacturer and the importer have
complied with the requirements set out in Article 6(5) and (6) and
Article 8(3).

Where a
distributor considers or has reason to believe that an instrument is not in
conformity with the essential requirements set out in Annex I, he shall not
make the instrument available on the market until it has been brought into
conformity. Furthermore, where the instrument presents a risk, the distributor
shall inform the manufacturer or the importer to that effect as well as the
market surveillance authorities.

Before making an
instrument not used for the applications listed in points (a) to (f) of Article
1(2) available on the market, distributors shall verify that the instrument
bears the inscriptions provided for in point 2 of Annex III and that the
manufacturer and the importer have complied with the requirements set out in
Article 6(5) and (6) and Article 8(3).

3.         Distributors
shall ensure that, while an instrument used for the applications listed in
points (a) to (f) of Article 1(2) is under their responsibility, storage or
transport conditions do not jeopardise its compliance with the essential requirements
set out in Annex I.

4.         Distributors
who consider or have reason to believe that an instrument which they have made
available on the market is not in conformity with this Directive shall make
sure that the corrective measures necessary to bring that instrument into
conformity, to withdraw it or recall it, if appropriate, are taken.
Furthermore, where the instrument presents a risk, distributors shall
immediately inform the competent national authorities of the Member States in
which they made the instrument available to that effect, giving details, in
particular, of the non-compliance and of any corrective measures taken.

5.         Distributors
shall, further to a reasoned request from a competent national authority,
provide it with all the information and documentation necessary to demonstrate
the conformity of an instrument. They shall cooperate with that authority, at
its request, on any action taken to eliminate the risks posed by instruments
which they have made available on the market.

Article 10 [Article
R6 of Decision No 768/2008/EC]

Cases in which obligations of manufacturers apply to importers and
distributors

An importer or
distributor shall be considered a manufacturer for the purposes of this
Directive and he shall be subject to the obligations of the manufacturer under
Article 6, where he places an instrument on the market under his name or
trademark or modifies an instrument already placed on the market in such a way
that compliance with the requirements of this Directive may be affected.

Article 11 [Article
R7 of Decision No 768/2008/EC]

Identification of economic operators

Economic
operators shall, on request, identify the following to the market surveillance
authorities:

(a) any economic
operator who has supplied them with an instrument;

(b) any economic
operator to whom they have supplied an instrument.

Economic
operators shall be able to present the information referred to in the first
paragraph for a period of 10 years after they have been supplied with the
instrument and for a period of 10 years after they have supplied the
instrument.

ê 2009/23/EC
(adapted)

CHAPTER 23

CONFORMITY ASSESSMENT Ö OF
INSTRUMENTS Õ

ê 2009/23/EC

Article 6

1. Member States
shall presume conformity with the essential requirements set out in Annex I in
respect of instruments which comply with the relevant national standards
implementing the harmonised standards that meet those requirements.

2. The Commission
shall publish the references of the harmonised standards referred to in
paragraph 1 in the Official
Journal of the European Union.

Member States
shall publish the references of the national standards referred to in
paragraph 1.

ò new

Article 12 [Article
R8 of Decision No 768/2008/EC]

Presumption of conformity

Instruments which
are in conformity with harmonised standards or parts thereof the references of
which have been published in the Official Journal of the European Union
shall be presumed to be in conformity with the essential requirements covered
by those standards or parts thereof, set out in Annex I.

[Where a
harmonised standard satisfies the requirements which it covers and which are
set out in Annex I or Article 23, the Commission shall publish the references
of that standard in the Official Journal of the European Union.]

ê 2009/23/EC
(adapted)

Article 913

Ö Conformity assessment
procedures Õ

ê 2009/23/EC

1. The conformity of instruments to the
essential requirements set out in Annex I may be certified by either of the
following procedures as selected by the applicant:

ê 2009/23/EC
(adapted)

(a) EC type examination Ö Module B Õ as referred to
Ö set out Õ in point 1 of Annex II, point
1, followed either by the EC declaration of type conformity (guarantee
of production quality) Ö Module D Õ as referred to
Ö set out Õ in point 2 of Annex II, point
2, or by the EC verification Ö Module F Õ as referred to
Ö set out Õ in point 4 of Annex II,
point
3.

However, EC type examination Ö Module
B Õ shall not be
compulsory for instruments which do not use electronic devices and the
load-measuring device of which does not use a spring to balance the load Ö . For
those instruments not submitted to Module B, Module D1 as set out in point 3 of
Annex II or Module F1 as set out in point 5 of Annex II shall apply Õ;

(b) EC unit verification Ö Module G Õ as referred to
Ö set out Õ in point 6 of Annex II,
point
4.

2. The documents and correspondence
relating to the procedures referred to in paragraph 1 shall be drafted in an Ö one of the Õ official languages
of the Member State where the said Ö those Õ procedures are
carried out, or in a language accepted by the body notified in accordance with
Article 10(1)18.

ê 2009/23/EC

3.         Where
the instruments are subject to other
Directives covering other aspects and which also provide for the affixing of
the ‘CE’ conformity marking, that marking shall indicate that the instruments
in question are also presumed to conform to the provisions of those other
Directives.

However,
where one or more of the Directives which apply to the instruments allow the
manufacturer, during a transitional period, to choose which arrangements to
apply, the ‘CE’ conformity marking shall indicate conformity only to the
Directives applied by the manufacturer. In
this case, particulars of publication in the Official Journal of the European Union of the Directives applied must be given in the
documents, notices or instructions required by the Directives and accompanying
such instruments.

Article 7

Where a Member
State or the Commission considers that the harmonised standards referred to in
Article 6(1) do not fully meet the essential requirements set out in Annex I,
the Commission or the Member State concerned shall bring the matter before the
Standing Committee set up under Article 5 of
Directive 98/34/EC, hereinafter referred to as ‘the Committee’, giving its
reasons for doing so.

The Committee
shall deliver an opinion without delay.

In the light of
the Committee’s opinion, the Commission shall inform the Member States
whether or not it is necessary to withdraw those standards from the
publications referred to in Article 6(2).

ò new

Article 14 [Article
R10 of Decision No 768/2008/EC]

EU declaration of conformity

1.         The EU
declaration of conformity shall state that the fulfilment of the essential requirements
set out in Annex I has been demonstrated.

2.         The EU
declaration of conformity shall have the model structure set out in Annex III
of Decision No 768/2008/EC, shall contain the elements specified in the
relevant modules set out in Annex II to this Directive and shall be
continuously updated. It shall be translated into the language or languages
required by the Member State in which market the instrument is placed or made
available.

3.         Where
an instrument is subject to more than one Union act requiring an EU declaration
of conformity, a single EU declaration of conformity shall be drawn up in
respect of all such Union acts. That declaration shall contain the
identification of the acts concerned including the publication references.

4.         By
drawing up the EU declaration of conformity, the manufacturer shall assume
responsibility for the compliance of the instrument.

ê 2009/23/EC

Article 8

1. Where a Member
State considers that instruments bearing the ‘CE’ conformity marking
referred to in Annex II, points 2, 3 and 4, do not meet the requirements of
this Directive when properly installed and used for the purposes for which they
are intended, it shall take all appropriate measures to withdraw those instruments from the market or to prohibit or
restrict their being put into service and/or placed on the market.

The Member State
concerned shall immediately inform the Commission of any such measure,
indicating the reasons for its decision, and in particular whether
non-compliance is due to:

(a)
failure to meet the essential requirements set out in Annex I, where
instruments do not meet the harmonised standards referred to in Article 6(1);

(b)
incorrect application of the harmonised standards referred to in Article
6(1);

(c)
shortcomings in the harmonised standards referred to in Article 6(1)
themselves.

2. The Commission
shall enter into consultation with the parties concerned as soon as possible.

After such
consultation the Commission shall immediately inform the Member State which
took the action of the result. Should it find that the measure is justified it
shall immediately inform the other Member States.

If the decision is
attributed to shortcomings in the standards, the Commission, after
consulting the parties concerned, shall bring the matter before the Committee
within two months if the Member State which has taken the measures intends to
maintain them, and shall subsequently initiate the procedures referred to in
Article 7.

3. Where an
instrument which does not comply bears the ‘CE’ conformity marking, the
competent Member State shall take appropriate action against whomsoever has
affixed the marking and shall inform the Commission and the other Member States
thereof.

4. The Commission
shall ensure that the Member States are kept informed of the progress and
outcome of this procedure.

Article 10

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 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 Union 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.

2. Member States
shall apply the minimum criteria set out in Annex V for the designation of
bodies. Bodies which satisfy the criteria fixed by the relevant harmonised
standards shall be presumed to satisfy the criteria set out in that Annex.

3. A Member State
which has designated a body shall cancel the designation if the body no
longer meets the criteria for designation referred to in paragraph 2. It shall
immediately inform the other Member States and the Commission thereof and
withdraw the notification.

CHAPTER 3

‘CE’ CONFORMITY
MARKING AND INSCRIPTIONS

ò new

Article 15 [Article
R11 of Decision No 768/2008/EC]

General principles of the CE marking

The CE marking
shall be subject to the general principles set out in Article 30 of Regulation
(EC) No 765/2008.

Article 16 [Article
R12 of Decision No 768/2008/EC]

Rules and conditions for affixing the CE marking and of the inscriptions

1.         The CE
marking and the inscriptions
provided for in point 1 of Annex III or the inscriptions provided for in point
2 of Annex III shall be
affixed visibly, legibly and indelibly to the instrument or to its data plate.

2.         The CE
marking and/or the inscriptions shall be affixed before the instrument is
placed on the market.

3.         The CE
marking shall be followed by the identification number of the notified body involved
in the production control phase.

The
identification number of the notified body shall be affixed by the body itself
or, under its instructions, by the manufacturer or his authorised
representative.

4.         The CE
marking and the identification number referred to in paragraph 3 may be
followed by a pictogram or any other mark indicating a special risk or use.

5.         The CE
marking and the identification number referred to in paragraph 3 shall be
followed by the sticker bearing the letter “M”, provided for in point 1.1(b) of
Annex III.

ê 2009/23/EC

Article 11

1. The ‘CE’
conformity marking and the required supplementary data as described in Annex
IV, point 1, shall be affixed in a clearly visible, easily legible and
indelible form to instruments for which EC conformity has been established.

2. The inscriptions referred to in Annex IV, point 2 shall be affixed in a clearly visible, easily
legible and indelible form to all other instruments.

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

Article 12

Without
prejudice to Article 8:

(a)
where a Member State establishes that the ‘CE’ conformity marking has been
affixed unduly, the manufacturer or his authorised representative established
within the Community shall be obliged to make the instrument conform as
regards the provisions concerning the ‘CE’ conformity 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 8.

ê 2009/23/EC
(adapted)

Article
17

Ö Restrictive use symbol Õ

That Ö The Õ symbol Ö referred
to in the fourth subparagraph of Article 6(2) Õ shall be
affixed to the devices in a clearly visible and indelible form.

ò new

CHAPTER 4

NOTIFICATION
OF CONFORMITY ASSESSMENT BODIES

Article 18 [Article
R13 of Decision No 768/2008/EC]

Notification

Member States
shall notify the Commission and the other Member States of bodies authorised to
carry out third-party conformity assessment tasks under this Directive.

Article 19 [Article
R14 of Decision No 768/2008/EC]

Notifying authorities

1.         Member
States shall designate a notifying authority that shall be responsible for
setting up and carrying out the necessary procedures for the assessment and
notification of conformity assessment bodies and the monitoring of notified
bodies, including compliance with Article 24.

2.         Member
States may decide that the assessment and monitoring referred to in paragraph 1
shall be carried out by a national accreditation body within the meaning of and
in accordance with Regulation (EC) No 765/2008.

3.         Where
the notifying authority delegates or otherwise entrusts the assessment,
notification or monitoring referred to in paragraph 1 to a body which is not a
governmental entity, that body shall be a legal entity and shall comply mutatis
mutandis with the requirements laid down in Article 20(1) to (6). In addition
it shall have arrangements to cover liabilities arising out of its activities.

4.         The
notifying authority shall take full responsibility for the tasks performed by
the body referred to in paragraph 3.

Article 20 [Article
R15 of Decision No 768/2008/EC]

Requirements relating to notifying authorities

1.         A
notifying authority shall be established in such a way that no conflict of
interest with conformity assessment bodies occurs.

2.         A
notifying authority shall be organised and operated so as to safeguard the
objectivity and impartiality of its activities.

3.         A
notifying authority shall be organised in such a way that each decision
relating to notification of a conformity assessment body is taken by competent
persons different from those who carried out the assessment.

4.         A
notifying authority shall not offer or provide any activities that conformity
assessment bodies perform or consultancy services on a commercial or
competitive basis.

5.         A
notifying authority shall safeguard the confidentiality of the information it
obtains.

6.         A
notifying authority shall have a sufficient number of competent personnel at
its disposal for the proper performance of its tasks.

Article 21 [Article
R16 of Decision No 768/2008/EC]

Information obligation on notifying authorities

Member States
shall inform the Commission of their procedures for the assessment and
notification of conformity assessment bodies and the monitoring of notified
bodies, and of any changes thereto.

The Commission
shall make that information publicly available.

Article 22 [Article
R17 of Decision No 768/2008/EC]

Requirements relating to notified bodies

1.         For
the purposes of notification, a conformity assessment body shall meet the
requirements laid down in paragraphs 2 to 11.

2.         A
conformity assessment body shall be established under national law and have
legal personality.

3.         A
conformity assessment body shall be a third-party body independent of the
organisation or the instrument it assesses.

A body belonging
to a business association or professional federation representing undertakings
involved in the design, manufacturing, provision, assembly, use or maintenance
of instruments which it assesses, may, on condition that its independence and
the absence of any conflict of interest are demonstrated, be considered such a
body.

4.         A
conformity assessment body, its top level management and the personnel
responsible for carrying out the conformity assessment tasks shall not be the
designer, manufacturer, supplier, installer, purchaser, owner, user or
maintainer of the instruments which they assess, nor the authorised
representative of any of those parties. This shall not preclude the use of
assessed instruments that are necessary for the operations of the conformity
assessment body or the use of such instruments for personal purposes.

A conformity
assessment body, its top level management and the personnel responsible for
carrying out the conformity assessment tasks shall not be directly involved in
the design, manufacture or construction, the marketing, installation, use or
maintenance of those instruments, or represent the parties engaged in those
activities. They shall not engage in any activity that may conflict with their
independence of judgement or integrity in relation to conformity assessment
activities for which they are notified. This shall in particular apply to
consultancy services.

Conformity
assessment bodies shall ensure that the activities of their subsidiaries or
subcontractors do not affect the confidentiality, objectivity or impartiality
of their conformity assessment activities.

5.         Conformity
assessment bodies and their personnel shall carry out the conformity assessment
activities with the highest degree of professional integrity and the requisite
technical competence in the specific field and shall be free from all pressures
and inducements, particularly financial, which might influence their judgement
or the results of their conformity assessment activities, especially as regards
persons or groups of persons with an interest in the results of those
activities.

6.         A
conformity assessment body shall be capable of carrying out all the conformity
assessment tasks assigned to it by Article 13 and in relation to which it has
been notified, whether those tasks are carried out by the conformity assessment
body itself or on its behalf and under its responsibility.

At all times and
for each conformity assessment procedure and each kind or category of
instruments in relation to which it has been notified, a conformity assessment
body shall have at its disposal the necessary:

(a)     personnel
with technical knowledge and sufficient and appropriate experience to perform
the conformity assessment tasks;

(b)     descriptions
of procedures in accordance with which conformity assessment is carried out,
ensuring the transparency and the ability of reproduction of those procedures.
It shall have appropriate policies and procedures in place that distinguish
between tasks it carries out as a notified body and other activities;

(c)     procedures
for the performance of activities which take due account of the size of an
undertaking, the sector in which it operates, its structure, the degree of
complexity of the instrument technology in question and the mass or serial
nature of the production process.

It shall have the
means necessary to perform the technical and administrative tasks connected
with the conformity assessment activities in an appropriate manner and shall
have access to all necessary equipment or facilities.

7.         The
personnel responsible for carrying out conformity assessment activities shall
have the following:

(a)     sound
technical and vocational training covering all the conformity assessment
activities in relation to which the conformity assessment body has been
notified;

(b)     satisfactory
knowledge of the requirements of the assessments they carry out and adequate
authority to carry out those assessments;

(c)     appropriate
knowledge and understanding of the essential requirements set out in Annex I,
of the applicable harmonised standards and of the relevant provisions of Union
harmonisation legislation and of national legislation;

(d)     the ability
to draw up certificates, records and reports demonstrating that assessments
have been carried out.

8.         The
impartiality of the conformity assessment bodies, their top level management
and of the assessment personnel shall be guaranteed.

The remuneration
of the top level management and assessment personnel of a conformity assessment
body shall not depend on the number of assessments carried out or on the
results of those assessments.

9.         Conformity
assessment bodies shall take out liability insurance unless liability is
assumed by the State in accordance with national law, or the Member State
itself is directly responsible for the conformity assessment.

10.       The
personnel of a conformity assessment body shall observe professional secrecy
with regard to all information obtained in carrying out their tasks under
Article 13 or any provision of national law giving effect to it, except in
relation to the competent authorities of the Member State in which its
activities are carried out. Proprietary rights shall be protected.

11.       Conformity
assessment bodies shall participate in, or ensure that their assessment
personnel are informed of, the relevant standardisation activities and the
activities of the notified body coordination group established under the
relevant Union harmonisation legislation and apply as general guidance the
administrative decisions and documents produced as a result of the work of that
group.

Article 23 [Article
R18 of Decision No 768/2008/EC]

Presumption of conformity

Where a
conformity assessment body demonstrates its conformity with the criteria laid
down in the relevant harmonised standards or parts thereof the references of
which have been published in the Official Journal of the European Union
it shall be presumed to comply with the requirements set out in Article 22
in so far as the applicable harmonised standards
cover those requirements.

Article 24 [Article
R20 of Decision No 768/2008/EC]

Subsidiaries of and subcontracting by notified bodies

1.         Where
a notified body subcontracts specific tasks connected with conformity
assessment or has recourse to a subsidiary, it shall ensure that the
subcontractor or the subsidiary meets the requirements set out in Article 22 and
shall inform the notifying authority accordingly.

2.         Notified
bodies shall take full responsibility for the tasks performed by subcontractors
or subsidiaries wherever these are established.

3.         Activities
may be subcontracted or carried out by a subsidiary only with the agreement of
the client.

4.         Notified
bodies shall keep at the disposal of the notifying authority the relevant documents
concerning the assessment of the qualifications of the subcontractor or the
subsidiary and the work carried out by them under Article 13.

Article 25 [Article
R22 of Decision No 768/2008/EC]

Application for notification

1.         A
conformity assessment body shall submit an application for notification to the
notifying authority of the Member State in which it is established.

2.         That
application shall be accompanied by a description of the conformity assessment
activities, the conformity assessment module or modules and the instrument or
instruments for which that body claims to be competent, as well as by an
accreditation certificate, where one exists, issued by a national accreditation
body attesting that the conformity assessment body fulfils the requirements
laid down in Article 22.

3.         Where
the conformity assessment body concerned cannot provide an accreditation
certificate, it shall provide the notifying authority with all the documentary
evidence necessary for the verification, recognition and regular monitoring of
its compliance with the requirements laid down in Article 22.

Article 26 [Article
R23 of Decision No 768/2008/EC]

Notification procedure

1.         Notifying
authorities may notify only conformity assessment bodies which have satisfied
the requirements laid down in Article 22.

2.         They
shall notify the Commission and the other Member States using the electronic
notification tool developed and managed by the Commission.

3.         The
notification shall include full details of the conformity assessment activities,
the conformity assessment module or modules and instrument or instruments
concerned and the relevant attestation of competence.

4.         Where
a notification is not based on an accreditation certificate as referred to in
Article 25(2), the notifying authority shall provide the Commission and the
other Member States with documentary evidence which attests to the conformity
assessment body's competence and the arrangements in place to ensure that that
body will be monitored regularly and will continue to satisfy the requirements
laid down in Article 22.

5.         The
body concerned may perform the activities of a notified body only where no
objections are raised by the Commission or the other Member States within two
weeks of a notification where an accreditation certificate is used or within
two months of a notification where accreditation is not used.

Only such a body
shall be considered a notified body for the purposes of this Directive.

6.         The
Commission and the other Member States shall be notified of any subsequent
relevant changes to the notification.

Article 27 [Article
R24 of Decision No 768/2008/EC]

Identification numbers and lists of notified bodies

1.         The
Commission shall assign an identification number to a notified body.

It shall assign a
single such number even where the body is notified under several Union acts.

.2.        The
Commission shall make publicly available the list of the bodies notified under
this Directive, including the identification numbers that have been allocated
to them and the activities for which they have been notified.

The Commission
shall ensure that that list is kept up to date.

Article 28 [Article
R25 of Decision No 768/2008/EC]

Changes to notifications

1.         Where
a notifying authority has ascertained or has been informed that a notified body
no longer meets the requirements laid down in Article 22, or that it is failing
to fulfil its obligations, the notifying authority shall restrict, suspend or
withdraw notification as appropriate, depending on the seriousness of the
failure to meet those requirements or fulfil those obligations. It shall
immediately inform the Commission and the other Member States accordingly.

2.         In the
event of restriction, suspension or withdrawal of notification, or where the
notified body has ceased its activity, the notifying Member State shall take
appropriate steps to ensure that the files of that body are either processed by
another notified body or kept available for the responsible notifying and
market surveillance authorities at their request.

Article 29 [Article
R26 of Decision No 768/2008/EC]

Challenge of the competence of notified bodies

1.         The
Commission shall investigate all cases where it doubts, or doubt is brought to
its attention regarding, the competence of a notified body or the continued
fulfilment by a notified body of the requirements and responsibilities to which
it is subject.

2.         The
notifying Member State shall provide the Commission, on request, with all
information relating to the basis for the notification or the maintenance of
the competence of the body concerned.

3.         The
Commission shall ensure that all sensitive information obtained in the course
of its investigations is treated confidentially.

4.         Where
the Commission ascertains that a notified body does not meet or no longer meets
the requirements for its notification, it shall inform the notifying Member
State accordingly and request it to take the necessary corrective measures,
including de-notification if necessary.

Article 30 [Article
R27 of Decision No 768/2008/EC]

Operational obligations of notified bodies

1.         Notified
bodies shall carry out conformity assessments in accordance with the conformity
assessment procedures provided for in Annex II.

2.         Conformity
assessments shall be carried out in a proportionate manner, avoiding unnecessary
burdens for economic operators. Conformity assessment bodies shall perform
their activities taking due account of the size of an undertaking, the sector
in which it operates, its structure, the degree of complexity of the instrument
technology in question and the mass or serial nature of the production process.

In so doing they
shall nevertheless respect the degree of rigour and the level of protection
required for the compliance of the instrument with the provisions of this
Directive.

3.         Where
a notified body finds that the essential requirements set out in Annex I or
corresponding harmonised standards or technical specifications have not been
met by a manufacturer, it shall require that manufacturer to take appropriate
corrective measures and shall not issue a conformity certificate.

4.         Where,
in the course of the monitoring of conformity following the issue of a
certificate, a notified body finds that an instrument no longer complies, it
shall require the manufacturer to take appropriate corrective measures and
shall suspend or withdraw the certificate if necessary.

5.         Where
corrective measures are not taken or do not have the required effect, the
notified body shall restrict, suspend or withdraw any certificates, as
appropriate.

Article 31

Appeal against decisions of notified
bodies

Member States
shall ensure that an appeal procedure against decisions of the notified bodies
is available.

Article 32 [Article
R28 of Decision No 768/2008/EC]

Information obligation on notified bodies

1.         Notified
bodies shall inform the notifying authority of the following:

(a) any refusal,
restriction, suspension or withdrawal of a certificate;

(b) any
circumstances affecting the scope of and conditions for notification;

(c) any request for
information which they have received from market surveillance authorities
regarding conformity assessment activities;

(d) on request,
conformity assessment activities performed within the scope of their
notification and any other activity performed, including cross-border
activities and subcontracting.

2.         Notified
bodies shall provide the other bodies notified under this Directive carrying
out similar conformity assessment activities covering the same instruments with
relevant information on issues relating to negative and, on request, positive
conformity assessment results.

Article 33 [Article
R29 of Decision No 768/2008/EC]

Exchange of experience

The Commission
shall provide for the organisation of exchange of experience between the Member
States' national authorities responsible for notification policy.

Article 34 [Article
R30 of Decision No 768/2008/EC]

Coordination of notified bodies

The Commission
shall ensure that appropriate coordination and cooperation between bodies
notified under this Directive are put in place and properly operated in the
form of a sectoral or cross sectoral group or groups of notified bodies.

Member States
shall ensure that the bodies notified by them participate in the work of that
or those group or groups, directly or by means of designated representatives.

CHAPTER 5

UNION MARKET
SURVEILLANCE, CONTROL OF INSTRUMENTS ENTERING THE UNION MARKET AND SAFEGUARD PROCEDURES

Article 35

Union market surveillance, control of
instruments entering the Union market

Article 15(3) and
Articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to instruments.

Article 36 [Article
R31 of Decision No 768/2008/EC]

Procedure for dealing with instruments presenting a risk at national
level

1.         Where
the market surveillance authorities of one Member State have taken action
pursuant to Article 20 of Regulation (EC) No 765/2008, or where they have
sufficient reason to believe that an instrument covered by this Directive
presents a risk to the aspects of public interest protection covered by this
Directive, they shall carry out an evaluation in relation to the instrument
concerned covering all the requirements laid down in this Directive. The
relevant economic operators shall cooperate as necessary with the market
surveillance authorities.

Where, in the
course of that evaluation, the market surveillance authorities find that the
instrument does not comply with the requirements laid down in this Directive,
they shall without delay require the relevant economic operator to take all
appropriate corrective action to bring the instrument into compliance with
those requirements, to withdraw the instrument from the market, or to recall it
within a reasonable period, commensurate with the nature of the risk, as they
may prescribe.

The market
surveillance authorities shall inform the relevant notified body accordingly.

Article 21 of
Regulation (EC) No 765/2008 shall apply to the measures referred to in the
second subparagraph.

2.         Where
the market surveillance authorities consider that non-compliance is not
restricted to their national territory, they shall inform the Commission and
the other Member States of the results of the evaluation and of the actions
which they have required the economic operator to take.

3.         The
economic operator shall ensure that all appropriate corrective action is taken
in respect of all the instruments concerned that it has made available on the
market throughout the Union.

4.         Where
the relevant economic operator does not take adequate corrective action within
the period referred to in the second subparagraph of paragraph 1, the market
surveillance authorities shall take all appropriate provisional measures to
prohibit or restrict the instrument's being made available on their national
market, to withdraw the instrument from that market or to recall it.

The market
surveillance authorities shall inform the Commission and the other Member
States, without delay, of those measures.

5.         The
information referred to in paragraph 4 shall include all available details, in
particular the data necessary for the identification of the non-compliant
instrument, the origin of the instrument, the nature of the non-compliance
alleged and the risk involved, the nature and duration of the national measures
taken and the arguments put forward by the relevant economic operator. In
particular, the market surveillance authorities shall indicate whether the
non-compliance is due to either of the following:

(a)     failure of
the instrument to meet requirements relating to the aspects of public interest
protection laid down in this Directive;

(b)     shortcomings
in the harmonised standards referred to in Article 12 conferring a presumption
of conformity.

6.         Member
States other than the Member State initiating the procedure shall without delay
inform the Commission and the other Member States of any measures adopted and
of any additional information at their disposal relating to the non-compliance
of the instrument concerned, and, in the event of disagreement with the
notified national measure, of their objections.

7.         Where,
within two months of receipt of the information referred to in paragraph 4, no
objection has been raised by either a Member State or the Commission in respect
of a provisional measure taken by a Member State, that measure shall be deemed
justified.

8.         Member
States shall ensure that appropriate restrictive measures are taken in respect
of the instrument concerned without delay.

Article 37 [Article
R32 of Decision No 768/2008/EC]

Union safeguard procedure

1.         Where,
on completion of the procedure set out in Article 36(3) and (4), objections are
raised against a measure taken by a Member State, or where the Commission
considers a national measure to be contrary to Union legislation, the
Commission shall without delay enter into consultation with the Member States
and the relevant economic operator or operators and shall evaluate the national
measure. On the basis of the results of that evaluation, the Commission shall
decide whether the national measure is justified or not.

The Commission
shall address its decision to all Member States and shall immediately
communicate it to them and the relevant economic operator or operators.

2.         If the
national measure is considered justified, all Member States shall take the
measures necessary to ensure that the non-compliant instrument is withdrawn
from their market, and shall inform the Commission accordingly. If the national
measure is considered unjustified, the Member State concerned shall withdraw
the measure.

3.         Where
the national measure is considered justified and the non-compliance of the
instrument is attributed to shortcomings in the harmonised standards referred
to in Article 36(5)(b) of this Directive, the Commission shall apply the
procedure provided for in Article 8 of Regulation (EU) No [...] [on European
Standardisation].

Article 38 [Article
R33 of Decision No 768/2008/EC]

Compliant instruments which present a risk

1.         Where,
having performed an evaluation under Article 36(1), a Member State finds that
although an instrument is in compliance with this Directive, it presents a risk
to aspects of public interest protection, it shall require the relevant
economic operator to take all appropriate measures to ensure that the
instrument concerned, when placed on the market, no longer presents that risk,
to withdraw the instrument from the market or to recall it within a reasonable
period, commensurate with the nature of the risk, as it may prescribe.

2.         The
economic operator shall ensure that corrective action is taken in respect of
all the instruments concerned that he has made available on the market
throughout the Union.

3.         The
Member State shall immediately inform the Commission and the other Member
States. That information shall include all available details, in particular the
data necessary for the identification of the instrument concerned, the origin
and the supply chain of the instrument, the nature of the risk involved and the
nature and duration of the national measures taken.

4.         The
Commission shall without delay enter into consultation with the Member States
and the relevant economic operator or operators and shall evaluate the national
measures taken. On the basis of the results of that evaluation, the Commission
shall decide whether the measure is justified or not, and where necessary,
propose appropriate measures.

5.         The
Commission shall address its decision to all Member States and shall
immediately communicate it to them and the relevant economic operator or
operators.

Article 39 [Article
R34 of Decision No 768/2008/EC]

Formal non-compliance

1.         Without
prejudice to Article 36, where a Member State makes one of the following
findings, it shall require the relevant economic operator to put an end to the
non-compliance concerned:

(a)     the CE
marking and/or the inscriptions provided for in Annex III have been affixed in
violation of Article 30 of Regulation (EC) No 765/2008 or of Article 16 of this
Directive;

(b) the CE marking
and/or the inscriptions provided for in Annex III have not been affixed;

(c) the EU
declaration of conformity has not been drawn up;

(d) the EU
declaration of conformity has not been drawn up correctly;

(e) technical
documentation is either not available or not complete.

2.         Where
the non-compliance referred to in paragraph 1 persists, the Member State
concerned shall take all appropriate measures to restrict or prohibit the
instrument being made available on the market or ensure that it is recalled or
withdrawn from the market.

ê 2009/23/EC
(adapted)

CHAPTER 46

Ö TRANSITIONAL AND Õ FINAL PROVISIONS

ê 2009/23/EC

Article 15

Any decision
taken pursuant to this Directive and resulting in restrictions on the putting
into service of an instrument shall state the exact grounds on which it is
based.

Such a decision
shall be notified without delay to the party concerned, who shall at the same
time be informed of the judicial remedies available to him under the laws in
force in the Member State in question and of the time limits to which such
remedies are subject.

ò new

Article 40

Penalties

Member States
shall lay down rules on penalties applicable to infringements of the national
provisions adopted pursuant to this Directive and shall take all measures
necessary to ensure that they are enforced.

The penalties
provided for shall be effective, proportionate and dissuasive.

Member States
shall notify those provisions to the Commission by [the date set out in the
second subparagraph of Article 42(1)] at the latest and shall notify to it
without delay any subsequent amendment affecting them.

Article 41

Transitional provisions

Member States
shall not impede the making available on the market and/or the putting into
service of instruments covered by Directive 2009/23/EC which are in conformity
with that Directive and which were placed on the market before [the date set
out in the second subparagraph of Article 42(1)].

Certificates of
conformity issued under Directive 2009/23/EC shall be valid under this
Directive until [the date set out in the second subparagraph of Article 42(1)]
unless they expire before that date.

ê

Article 42

Transposition

1.         Member States shall adopt and
publish by [insert date - 2 years after adoption] at the latest, the laws,
regulations and administrative provisions necessary to comply with Articles 2(3)
to (19), 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 19, 20, 21, 22, 23, 24,
25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41 and Annex
II. They shall forthwith communicate to the Commission the text of those
provisions and a correlation table between those provisions and this Directive.

They shall apply those provisions from [day
after the date set out in the first subparagraph].

When Member States adopt those provisions,
they shall contain a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. They shall also
include a statement that references in existing laws, regulations and administrative
provisions to the Directive repealed by this Directive shall be construed as
references to this directive. Member States shall determine how such reference
is to be made and how that statement is to be formulated.

ê 2009/23/EC

Article 16

2.         Member States shall communicate to the Commission the text
of the main provisions of national law which they adopt in the field covered by
this Directive.

ê 2009/23/EC
(adapted)

Article 1743

Ö Repeal Õ

Directive 90/384/EEC 2009/23/EC as
amended by the Directive listed in Annex VII, Part A, is
repealed Ö from the
date set out in the second subparagraph of Article 42(1) Õ, without
prejudice to the obligations of the Member States relating to the time limits
for transposition into national law and application of the Directives set out
in Annex
VII, Part B of Annex
VII to Directive 2009/23/EC.

ê 2009/23/EC

References to the repealed Directive shall
be construed as references to this Directive and shall be read in accordance
with the correlation table in Annex VIIIIV.

ê 2009/23/EC
(adapted)

Article 1844

Ö Entry into force Õ

This Directive shall enter into force on
the twentieth day following Ö that
of Õ its
publication in the Official Journal of the European Union.

Articles 1, 2(1) and (2), 3, 4, 5, 17 and
Annexes I and III shall apply from [the date set out in the second subparagraph
of Article 42(1)].

ê 2009/23/EC

Article 1945

This
Directive is addressed to the Member States.

Done at [...],

For the European Parliament                       For
the Council

The
President                                                 The President

ê 2009/23/EC
(adapted)

ANNEX I

ESSENTIAL
REQUIREMENTS

The terminology used is that of the
International Organisation of Legal Metrology.

Preliminary observation

Where an instrument includes, or is connected
to, more than one indicating or printing device used for the applications
listed in points (a) to (f) of Article 1(2), those devices
which repeat the results of the weighing operation and which cannot influence
the correct functioning of the instrument shall not be subject to the essential
requirements if the weighing results are printed or recorded correctly and
indelibly by a part of the instrument which meets the essential requirements
and the results are accessible to both parties concerned by the measurement.
However, in the case of instruments used for direct sales to the public,
display and printing devices for the vendor and the customer must fulfil the
essential requirements.

METROLOGICAL
REQUIREMENTS

1. Units of mass

The units of mass used shall be the legal
units within the meaning of Council Directive 80/181/EEC of
20 December 1979 on the approximation of the laws of the Member States relating
to units of measurement[16].

Subject to compliance with this condition,
the following units are permitted:

(a) - SI units: kilogram, microgram,
milligram, gram, tonne,;

(b) - imperial unit: troy ounce, if weighing
precious metals,;

(c) - other non-SI unit: metric carat, if
weighing precious stones.

For instruments that make use of the
imperial unit of mass referred to above, the relevant essential requirements
specified below shall be converted to that unit, using simple interpolation.

2. Accuracy classes

2.1. The following accuracy classes have
been defined:

(a)     I special

(b)     II high

(c)     III medium

(d)     IIII ordinary

The specifications of these classes are
given in Table 1.

Table 1

Accuracy classes

Class || Verification scale interval (e) || Minimum capacity (Min) || Number of verification scale intervals n = ((Max)/(e))

|| || || minimum value || minimum value || maximum value

I || 0,001 || g ≤ e || 100 e || 50 000 || —

II || 0,001 || g ≤ e ≤ 0,05 g || 20 e || 100 || 100000

0,1 || g ≤ e || 50 e || 5000 || 100000

III || 0,1 || g ≤ e ≤ 2 g || 20 e || 100 || 10000

5 || g ≤ e || 20 e || 500 || 10000

IIII || 5 || g ≤ e || 10 e || 100 || 1000

The minimum capacity is reduced to 5 e for
instruments in classes II and III for determining a conveying tariff.

2.2. Scale intervals

2.2.1. The actual scale interval (d) and
the verification scale interval (e) shall be in the form:

1 × 10k, 2 × 10k, or
5 × 10k mass units,

k being any integer or zero.

2.2.2. For all instruments other than those
with auxiliary indicating devices:

d = e.

2.2.3. For instruments with auxiliary
indicating devices the following conditions apply:

e = 1 × 10k g,;

d < e ≤ 10 d,.

except Ö Those
conditions do not apply Õ for
instruments of class I with d < 10–4 g, for which e = 10–3
g.

3. Classification

3.1. Instruments with one weighing
range

Instruments equipped with an auxiliary
indicating device shall belong to class I or class II. For these instruments
the minimum capacity lower limits for these two classes are obtained from Table
1 by replacement in column 3 of the verification scale interval (e) by the
actual scale interval (d).

If d < 10–4 g, the maximum
capacity of class I may be less than 50000 e.

3.2. Instruments with multiple
weighing ranges

Multiple weighing ranges are permitted,
provided they are clearly indicated on the instrument. Each individual weighing
range is classified according to point 3.1. If the weighing ranges fall into
different accuracy classes the instrument shall comply with the severest of the
requirements that apply for the accuracy classes in which the weighing ranges
fall.

3.3. Multi-interval instruments

3.3.1. Instruments with one weighing range
may have several partial weighing ranges (multi-interval instruments).

Multi-interval instruments shall not be
equipped with an auxiliary indicating device.

3.3.2. Each partial weighing range i of
multi-interval instruments is defined by:

— its verification scale interval ei || with e(i + 1) > ei

— its maximum capacity Maxi || with Maxr = Max

— its minimum capacity Mini || with Mini = Max (i – 1) and Min1 = Min

where:

i || = || 1, 2, ... r,

i || = || partial weighing range number,

r || = || the total number of partial weighing ranges.

All capacities are capacities of net load,
irrespective of the value of any tare used.

3.3.3. The partial weighing ranges are
classified according to Table 2. All partial weighing ranges shall fall into
the same accuracy class, that class being the instrument’s accuracy class.

Table 2

Multi-interval instruments

i         =          1, 2, ... r               i         =          partial weighing range number               r         =          total number of partial weighing ranges

Class || Verification scale interval (e) || Minimum capacity (Min) || Number of verification scale intervals

|| || || Minimum value || Minimum value[17] n = ((Maxi)/(e(i+1))) || Maximum value n = ((Maxi)/(ei))

I || 0,001 || g ≤ ei || 100 e1 || 50000 || —

II || 0,001 || g ≤ ei ≤ 0,05 g || 20 e1 || 5000 || 100000

0,1 || g ≤ ei || 50 e1 || 5000 || 100000

III || 0,1 || g ≤ ei || 20 e1 || 500 || 10000

IIII || 5 || g ≤ ei || 10 e1 || 50 || 1000

4. Accuracy

4.1. On implementation of the procedures
laid down in Article 913, the error of indication shall not
exceed the maximum permissible error of indication as shown in Table 3. In case
of digital indication the error of indication shall be corrected for the
rounding error.

The maximum permissible errors apply to the
net value and tare value for all possible loads, excluding preset tare values.

Table 3

Maximum permissible errors

Load || Maximum permissible error

Class I || Class II || Class III || Class IIII

0 ≤ m ≤ 50000 e || 0 ≤ m ≤ 5000 e || 0 ≤ m ≤ 500 e || 0 ≤ m ≤ 50 e || ±0,5 e

50000 e < m ≤ 200000 e || 5000 e < m ≤ 20000 e || 500 e < m ≤ 2000 e || 50 e < m ≤ 200 e || ±1,0 e

200000 e < m || 20000 e < m ≤ 100000 e || 2000 e < m ≤ 10000 e || 200 e < m ≤ 1000 e || ±1,5 e

4.2. The maximum permissible errors in
service are twice the maximum permissible errors fixed in Section 4.1.

5. Weighing results of an instrument shall
be repeatable, and shall be reproducible by the other indicating devices used
and in accordance with other methods of balancing used.

The weighing results shall be sufficiently
insensitive to changes in the position of the load on the load receptor.

6. The instrument shall react to small
variations in the load.

7. Influence quantities and time

7.1. Instruments of classes II, III and
IIII, liable to be used in a tilted position, shall be sufficiently insensitive
to the degree of tilting that can occur in normal use.

7.2. The instruments shall meet the
metrological requirements within the temperature range specified by the manufacturer.
The value of this range shall be at least equal to:

(a)     - 5 °C for an instrument in class I,;

(b)     - 15 °C for an instrument in class
II,;

(c)     - 30 °C for an instrument in class
III or IIII.

In the absence of a manufacturer’s
specification, the temperature range of – 10 °C to + 40 °C applies.

7.3. Instruments operated from a mains
power supply shall meet the metrological requirements under conditions of power
supply within the limits of normal fluctuation.

Instruments operated from battery power shall
indicate whenever the voltage drops below the minimum required value and shall
under those circumstances either continue to function correctly or be
automatically put out of service.

7.4. Electronic instruments, except those
in class I and in class II if e is less than 1 g, shall meet the metrological
requirements under conditions of high relative humidity at the upper limit of
their temperature range.

7.5. Loading an instrument in class II, III
or IIII for a prolonged period of time shall have a negligible influence on the
indication at load or on the zero indication immediately after removal of the
load.

7.6. Under other conditions the instruments
shall either continue to function correctly or be automatically put out of
service.

Design and construction

8. General requirements

8.1. Design and construction of the
instruments shall be such that the instruments will preserve their metrological
qualities when properly used and installed and when used in an environment for
which they are intended. The value of the mass must be indicated.

8.2. When exposed to disturbances,
electronic instruments shall not display the effects of significant faults, or
shall automatically detect and indicate them.

Upon automatic detection of a significant
fault, electronic instruments shall provide a visual or audible alarm that
shall continue until the user takes corrective action or the fault disappears.

8.3. The requirements of points 8.1 and 8.2
shall be met on a lasting basis during a period of time that is normal in view
of the intended use of such instruments.

Digital electronic devices shall always
exercise adequate control of the correct operation of the measuring process, of
the indicating device, and of all data storage and data transfer.

Upon automatic detection of a significant
durability error, electronic instruments shall provide a visual or audible
alarm that shall continue until the user takes corrective action or the error
disappears.

8.4. When external equipment is connected
to an electronic instrument through an appropriate interface the metrological
qualities of the instrument shall not be adversely influenced.

8.5. The instruments shall have no
characteristics likely to facilitate fraudulent use, whereas possibilities for
unintentional misuse shall be minimal. Components that may not be dismantled or
adjusted by the user shall be secured against such actions.

8.6. Instruments shall be designed to
permit ready execution of the statutory controls laid down by this Directive.

9. Indication of weighing results and
other weight values

The indication of the weighing results and
other weight values shall be accurate, unambiguous and non-misleading and the
indicating device shall permit easy reading of the indication under normal
conditions of use.

The names and symbols of the units referred
to in point 1 of this Annex shall comply with the provisions of Directive
80/181/EEC with the addition of the symbol for the metric carat which shall be
the symbol ‘ct’.

Indication shall be impossible above the
maximum capacity (Max), increased by 9 e.

An auxiliary indicating device is permitted
only to the right of the decimal mark. An extended indicating device may be
used only temporarily, and printing shall be inhibited during its functioning.

Secondary indications may be shown, provided
that they cannot be mistaken for primary indications.

10. Printing of weighing results and
other weight values

Printed results shall be correct, suitably
identified and unambiguous. The printing shall be clear, legible, non-erasable
and durable.

11. Levelling

When appropriate, instruments shall be
fitted with a levelling device and a level indicator, sufficiently sensitive to
allow proper installation.

12. Zeroing

Instruments may be equipped with zeroing
devices. The operation of these devices shall result in accurate zeroing and
shall not cause incorrect measuring results.

13. Tare devices and preset tare
devices

The instruments may have one or more tare
devices and a preset tare device. The operation of the tare devices shall
result in accurate zeroing and shall ensure correct net weighing. The operation
of the preset tare device shall ensure correct determination of the calculated
net value.

14. Instruments for direct sales to the
public, with a maximum capacity not greater than 100 kg: additional requirements

Instruments for direct sale to the public
shall show all essential information about the weighing operation and, in the
case of price-indicating instruments, shall clearly show the customer the price
calculation of the product to be purchased.

The price to pay, if indicated, shall be
accurate.

Price-computing instruments shall display
the essential indications long enough for the customer to read them properly.

Price-computing instruments may perform
functions other than per-article weighing and price computation only if all
indications related to all transactions are printed clearly and unambiguously
and are conveniently arranged on a ticket or label for the customer.

Instruments shall bear no characteristics
that can cause, directly or indirectly, indications the interpretation of which
is not easy or straightforward.

Instruments shall safeguard customers
against incorrect sales transactions due to their malfunctioning.

Auxiliary indicating devices and extended
indicating devices are not permitted.

Supplementary devices are permitted only if
they cannot lead to fraudulent use.

Instruments similar to those normally used
for direct sales to the public which do not satisfy the requirements of this
Section must carry near to the display the indelible marking ‘Not to be used
for direct sale to the public’.

15. Price labelling instruments

Price labelling instruments shall meet the
requirements of price indicating instruments for direct sale to the public, as
far as applicable to the instrument in question. The printing of a price label
shall be impossible below a minimum capacity.

ê 2009/23/EC

ANNEX II

CONFORMITY
ASSESSMENT PROCEDURES

ê 2009/23/EC
(adapted)

1. Ö MODULE
B : EU Õ EC-type
examination

ê 2009/23/EC

1.1. EC
type-examination is the procedure whereby a notified body verifies and
certifies that an instrument, representative of the production envisaged, meets
the requirements of this Directive.

1.2. The
application for EC type-examination shall be lodged with a single notified
body by the manufacturer or his authorised representative established within
the Community.

The application
shall include:

–
the name and
address of the manufacturer and, if the application is lodged by the
authorised representative, his name and address in addition,

–
a written
declaration that the application has not been lodged with any other notified
body,

–
the design
documentation, as described in Annex III.

The applicant
shall place at the disposal of the notified body an instrument,
representative of the production envisaged, hereinafter the ‘type’.

1.3. The notified
body shall:

1.3.1. examine the
design documentation and verify that the type has been manufactured in
accordance with that documentation;

1.3.2. agree
with the applicant on the location where the examinations and/or tests shall be
carried out;

1.3.3. perform or
have performed the appropriate examinations and/or tests to check whether the
solutions adopted by the manufacturer meet the essential requirements where
the harmonised standards referred to in Article 6(1) have not been applied;

1.3.4. perform or
have performed the appropriate examinations and/or tests to check whether,
where the manufacturer has chosen to apply the relevant standards, these
standards have been applied effectively, thereby assuring conformity with the
essential requirements.

1.4. Where the
type complies with the provisions of this Directive, the notified body shall
issue an EC type-approval certificate to the applicant. The certificate
shall contain the conclusions of the examination, conditions (if any) for its
validity, the necessary data for identification of the approved instrument and,
if relevant, a description of its functioning. All the relevant technical
elements such as drawings and layouts shall
be annexed to the EC type-approval certificate.

The certificate
shall have a validity period of 10 years from the date of its issue, and may be
renewed for subsequent periods of 10 years each.

In the event of
fundamental changes to the design of the instrument, e.g. as a result of the
application of new techniques, the validity of the certificate may be limited
to two years and extended by three years.

1.5. Each notified
body shall periodically make available to all Member States the list of:

–
applications
received for EC type-examination,

–
EC type-approval
certificates issued,

–
applications for
type-certificates refused,

–
additions and
amendments relating to documents already issued.

Each notified body
shall moreover inform all the Member States forthwith of withdrawals of EC
type-approval certificates.

Each Member State
shall make this information available to the bodies which it has notified.

1.6. The other
notified bodies may receive a copy of the certificates together with the
annexes to them.

1.7. The applicant
shall keep the notified body that has issued the EC type-approval certificate
informed of any modification to the approved type.

Modifications to
the approved type must receive additional approval from the notified body
that issued the EC type-approval certificate where such changes influence
conformity with the essential requirements of this Directive or the prescribed
conditions for use of the instrument. This additional approval is given in the
form of an addition to the original EC
type-approval certificate.

ò new

1.1. EU-type
examination is the part of a conformity assessment procedure in which a
notified body examines the technical design of an instrument and verifies and
attests that the technical design of the instrument meets the requirements of
this Directive that apply to it.

1.2. EU-type
examination may be carried out in any of the following manners:

– examination of a specimen, representative
of the production envisaged, of the complete instrument (production type);

– assessment of the adequacy of the
technical design of the instrument through examination of the technical
documentation and supporting evidence referred to in point 1.3, plus
examination of specimens, representative of the production envisaged, of one or
more critical parts of the instrument (combination of production type and
design type);

– assessment of the adequacy of the
technical design of the instrument through examination of the technical
documentation and supporting evidence referred to in point 1.3, without
examination of a specimen (design type).

1.3. The
manufacturer shall lodge an application for EU-type examination with a single
notified body of his choice.

The application
shall include:

(a)
 the name and address
of the manufacturer and, if the application is lodged by the authorised
representative, his name and address as well;

(b)
a written declaration
that the same application has not been lodged with any other notified body;

(c)
the technical documentation.
The technical documentation shall make it possible to assess the instrument's
conformity with the applicable requirements of this Directive and shall include
an adequate analysis and assessment of the risk(s). The technical documentation
shall specify the applicable requirements and cover, as far as relevant for the
assessment, the design, manufacture and operation of the instrument. The
technical documentation shall contain, wherever applicable, at least the
following elements:

(i)      a general
description of the instrument;

(ii)      conceptual
design and manufacturing drawings and schemes of components, sub-assemblies,
circuits, etc.;

(iii)     descriptions
and explanations necessary for the understanding of those drawings and schemes
and the operation of the instrument;

(iv)     a list of
the harmonised standards and/or other relevant technical specifications the
references of which have been published in the Official Journal of the
European Union, applied in full or in part, and descriptions of the
solutions adopted to meet the essential requirements of this Directive where
those harmonised standards have not been applied. In the event of partly
applied harmonised standards, the technical documentation shall specify the
parts which have been applied;

(v)     results of
design calculations made, examinations carried out, etc.;

(vi)     test
reports;

(d)
the specimens
representative of the production envisaged. The notified body may request
further specimens if needed for carrying out the test programme;

(e)
the supporting
evidence for the adequacy of the technical design solution. This supporting
evidence shall mention any documents that have been used, in particular where
the relevant harmonised standards and/or technical specifications have not been
applied in full. The supporting evidence shall include, where necessary, the
results of tests carried out by the appropriate laboratory of the manufacturer,
or by another testing laboratory on his behalf and under his responsibility.

1.4. The notified
body shall:

For the
instrument:

1.4.1. examine
the technical documentation and supporting evidence to assess the adequacy of
the technical design of the instrument;

For the
specimen(s):

1.4.2. verify
that the specimen(s) have been manufactured in conformity with the technical
documentation, and identify the elements which have been designed in accordance
with the applicable provisions of the relevant harmonised standards and/or
technical specifications, as well as the elements which have been designed
without applying the relevant provisions of those standards;

1.4.3. carry out
appropriate examinations and tests, or have them carried out, to check whether,
where the manufacturer has chosen to apply the solutions in the relevant
harmonised standards and/or technical specifications, these have been applied
correctly;

1.4.4. carry out
appropriate examinations and tests, or have them carried out, to check whether,
where the solutions in the relevant harmonised standards and/or technical
specifications have not been applied, the solutions adopted by the manufacturer
meet the corresponding essential requirements of this Directive;

1.4.5. agree with
the manufacturer on a location where the examinations and tests will be carried
out.

1.5. The notified
body shall draw up an evaluation report that records the activities undertaken
in accordance with point 1.4 and their outcomes. Without prejudice to its
obligations vis-à-vis the notifying authorities, the notified body shall
release the content of that report, in full or in part, only with the agreement
of the manufacturer.

1.6. Where the
type meets the requirements of this Directive, the notified body shall issue an
EU-type examination certificate to the manufacturer. The certificate shall
contain the name and address of the manufacturer, the conclusions of the
examination, the conditions (if any) for its validity and the necessary data
for identification of the approved type. The certificate may have one or more
annexes attached.

The certificate
and its annexes shall contain all relevant information to allow the conformity
of manufactured instruments with the examined type to be evaluated and to allow
for in-service control.

The certificate
shall have a validity period of ten years from the date of its issue, and may
be renewed for subsequent periods of ten years each. In the event of fundamental
changes to the design of the instrument, e.g. as a result of the application of
new techniques, the validity of the certificate may be limited to two years and
extended by three years.

Where the type
does not satisfy the applicable requirements of this Directive, the notified
body shall refuse to issue an EU-type examination certificate and shall inform
the applicant accordingly, giving detailed reasons for its refusal.

1.7. The notified
body shall keep itself apprised of any changes in the generally acknowledged
state of the art which indicate that the approved type may no longer comply
with the applicable requirements of this Directive, and shall determine whether
such changes require further investigation. If so, the notified body shall inform
the manufacturer accordingly. The manufacturer shall inform the notified body
that holds the technical documentation relating to the EU-type examination
certificate of all modifications to the approved type that may affect the
conformity of the instrument with the essential requirements of this Directive
or the conditions for validity of the certificate. Such modifications shall
require additional approval in the form of an addition to the original EU-type
examination certificate.

1.8. Each
notified body shall inform its notifying authorities concerning the EU-type
examination certificates and/or any additions thereto which it has issued or
withdrawn, and shall, periodically or upon request, make available to its
notifying authorities the list of certificates and/or any additions thereto
refused, suspended or otherwise restricted.

The Commission,
the Member States and the other notified bodies may, on request, obtain a copy
of the EU-type examination certificates and/or additions thereto. On request,
the Commission and the Member States may obtain a copy of the technical
documentation and the results of the examinations carried out by the notified
body. The notified body shall keep a copy of the EU-type examination
certificate, its annexes and additions, as well as the technical file including
the documentation submitted by the manufacturer, until the expiry of the
validity of the certificate.

1.9. The
manufacturer shall keep a copy of the EU-type examination certificate, its
annexes and additions together with the technical documentation at the disposal
of the national authorities for 10 years after the instrument has been placed
on the market.

1.10. The
manufacturer's authorised representative may lodge the application referred to
in point 1.3 and fulfil the obligations set out in points 1.7 and 1.9, provided
that they are specified in the mandate.

ê 2009/23/EC
(adapted)

2. EC
declaration of type conformity (guarantee of production quality)
Ö MODULE D:
Conformity to type based on quality assurance of the production process Õ

ê 2009/23/EC

2.1. The EC
declaration of type conformity (guarantee of production quality) is the
procedure whereby the manufacturer who satisfies the obligations of point 2.2
declares that the instruments concerned are, where applicable, in conformity
with the type as described in the EC type-approval certificate and that they
satisfy the requirements of this Directive.

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

The ‘CE’
conformity marking shall be accompanied by the identification number of the
notified body responsible for the EC surveillance referred to in point 2.4.

2.2. The
manufacturer shall have adequately implemented a quality system as specified in
point 2.3 and shall be subject to EC surveillance as specified in point 2.4.

2.3. Quality
system

2.3.1. The
manufacturer shall lodge an application for approval of his quality system with
a notified body.

The application
shall include:

–
an undertaking to
carry out the obligations arising from the approved quality system,

–
an undertaking to maintain
the approved quality system to ensure its continuing suitability and
effectiveness.

The manufacturer
shall make available to the notified body all relevant information, in
particular the quality system’s documentation and the design documentation of
the instrument.

2.3.2. The quality
system shall ensure conformity of the instruments with the type as described in
the EC type-approval certificate and with the requirement(s) of this Directive.

All the elements,
requirements and provisions adopted by the manufacturer shall be documented
in a systematic and orderly manner in the form of written rules, procedures and
instructions. This quality system documentation shall ensure a proper
understanding of the quality programmes, plans, manuals and records.

It shall
contain in particular an adequate description of:

–
the quality
objectives and the organisational structure, responsibilities and powers of the
management with regard to product quality,

–
the manufacturing
process, the quality control and assurance techniques and the systematic
measures that will be used,

–
the examinations
and tests that will be carried out before, during and after manufacture, and
the frequency with which they will be carried out,

–
the means to
monitor the achievement of the required product quality and the effective
operation of the quality system.

2.3.3. The
notified body shall examine and evaluate the quality system to determine
whether it satisfies the requirements referred to in point 2.3.2. It shall
presume conformity with these requirements in respect of quality systems
that implement the corresponding harmonised standard.

It shall notify
its decision to the manufacturer and inform the other notified bodies thereof.
The notification to the manufacturer shall contain the conclusions of the
examination and, in the event of refusal, the justification for the decision.

2.3.4. The
manufacturer or his authorised representative shall keep the notified body that
has approved the quality system informed of any updating of the quality assurance
system in relation to changes brought about by, e.g. new technologies and new
quality concepts.

2.3.5. Any
notified body that withdraws approval of a quality system shall so inform the
other notified bodies.

2.4. EC
surveillance

2.4.1. The purpose
of EC surveillance is to make sure that the manufacturer duly fulfils the
obligations arising out of the approved quality system.

2.4.2. The
manufacturer shall grant the notified body access for inspection purposes to
the manufacture, inspection, testing and storage premises and shall provide
it with all necessary information, in particular:

–
the quality system
documentation,

–
the design
documentation,

–
the quality
records, e.g. the inspection reports and tests and calibration data, reports on
the qualifications of the personnel concerned, etc.

The notified body
shall periodically carry out audits in order to ensure that the manufacturer is
maintaining and applying the quality system; it shall provide the manufacturer
with an audit report.

In addition, the
notified body may carry out unscheduled visits to the manufacturer. During
such visits, the notified body may carry out full or partial audits. It shall
provide the manufacturer with a report on the visit, and, where appropriate, an
audit report.

2.4.3. The notified
body shall ensure that the manufacturer maintains and applies the approved
quality system.

ò new

2.1. Conformity
to type based on quality assurance of the production process is the part of a
conformity assessment procedure whereby the manufacturer fulfils the
obligations laid down in points 2.2 and 2.5, and ensures and declares on his
sole responsibility that the instruments concerned are in conformity with the
type described in the EU-type examination certificate and satisfy the
requirements of this Directive that apply to them.

2.2.
Manufacturing

The manufacturer
shall operate an approved quality system for production, final instrument
inspection and testing of the instruments concerned as specified in point 2.3,
and shall be subject to surveillance as specified in point 2.4.

2.3. Quality
system

2.3.1. The
manufacturer shall lodge an application for assessment of his quality system
with the notified body of his choice, for the instruments concerned.

The application
shall include:

(a)     the name and
address of the manufacturer and, if the application is lodged by the authorised
representative, his name and address as well;

(b)     a written
declaration that the same application has not been lodged with any other
notified body;

(c)     all relevant
information for the instrument category envisaged;

(d)     the
documentation concerning the quality system;

(e)     the
technical documentation of the approved type and a copy of the EU-type
examination certificate.

2.3.2. The
quality system shall ensure that the instruments are in conformity with the
type described in the EU-type examination certificate and comply with the
requirements of this Directive that apply to them.

All the elements,
requirements and provisions adopted by the manufacturer shall be documented in
a systematic and orderly manner in the form of written policies, procedures and
instructions. The quality system documentation shall permit a consistent
interpretation of the quality programmes, plans, manuals and records.

It shall, in
particular, contain an adequate description of:

(a)     the quality
objectives and the organisational structure, responsibilities and powers of the
management with regard to instrument quality;

(b)     the
corresponding manufacturing, quality control and quality assurance techniques,
processes and systematic actions that will be used;

(c)     the
examinations and tests that will be carried out before, during and after
manufacture, and the frequency with which they will be carried out;

(d)     the quality
records, such as inspection reports and test data, calibration data,
qualification reports on the personnel concerned, etc.;

(e)     the means of
monitoring the achievement of the required instrument quality and the effective
operation of the quality system.

2.3.3. The
notified body shall assess the quality system to determine whether it satisfies
the requirements referred to in point 2.3.2.

It shall presume
conformity with those requirements in respect of the elements of the quality
system that comply with the corresponding specifications of the national
standard that implements the relevant harmonised standard and/or technical
specifications.

In addition to
experience in quality management systems, the auditing team shall have at least
one member with experience of evaluation in the relevant instrument field and
instrument technology concerned, and knowledge of the applicable requirements
of this Directive. The audit shall include an assessment visit to the
manufacturer's premises. The auditing team shall review the technical
documentation referred to in point 2.3.1(e) to verify the manufacturer's
ability to identify the relevant requirements of this Directive and to carry
out the necessary examinations with a view to ensuring compliance of the
instrument with those requirements.

The decision shall
be notified to the manufacturer. The notification shall contain the conclusions
of the audit and the reasoned assessment decision.

2.3.4. The
manufacturer shall undertake to fulfil the obligations arising out of the
quality system as approved and to maintain it so that it remains adequate and
efficient.

2.3.5. The
manufacturer shall keep the notified body that has approved the quality system
informed of any intended change to the quality system.

The notified body
shall evaluate any proposed changes and decide whether the modified quality
system will continue to satisfy the requirements referred to in point 2.3.2 or
whether a reassessment is necessary.

It shall notify
the manufacturer of its decision. The notification shall contain the
conclusions of the examination and the reasoned assessment decision.

2.4. Surveillance
under the responsibility of the notified body

2.4.1. The
purpose of surveillance is to make sure that the manufacturer duly fulfils the
obligations arising out of the approved quality system.

2.4.2. The
manufacturer shall, for assessment purposes, allow the notified body access to
the manufacture, inspection, testing and storage sites and shall provide it
with all necessary information, in particular:

(a)     the quality
system documentation;

(b)     the quality
records, such as inspection reports and test data, calibration data,
qualification reports on the personnel concerned, etc.

2.4.3. The
notified body shall carry out periodic audits to make sure that the
manufacturer maintains and applies the quality system and shall provide the
manufacturer with an audit report.

2.4.4. In
addition, the notified body may pay unexpected visits to the manufacturer.
During such visits the notified body may, if necessary, carry out instrument
tests, or have them carried out, in order to verify that the quality system is
functioning correctly. The notified body shall provide the manufacturer with a
visit report and, if tests have been carried out, with a test report.

2.5. Conformity
marking and declaration of conformity

2.5.1. The
manufacturer shall affix the CE marking and the inscriptions provided for in point 1 of Annex
III, and, under the
responsibility of the notified body referred to in point 2.3.1, the latter's
identification number to each individual instrument that is in conformity with
the type described in the EU-type examination certificate and satisfies the
applicable requirements of this Directive.

2.5.2. The
manufacturer shall draw up a written declaration of conformity for each
instrument model and keep it at the disposal of the national authorities for 10
years after the instrument has been placed on the market. The declaration of
conformity shall identify the instrument model for which it has been drawn up.

A copy of the
declaration of conformity shall be made available to the relevant authorities
upon request.

2.6. The
manufacturer shall, for a period ending at least 10 years after the instrument
has been placed on the market, keep at the disposal of the national
authorities:

(a)     the
documentation referred to in point 2.3.1;

(b)     the change
referred to in point 2.3.5, as approved;

(c)     the
decisions and reports of the notified body referred to in points 2.3.5, 2.4.3
and 2.4.4.

2.7. Each
notified body shall inform its notifying authorities of quality system
approvals issued or withdrawn, and shall, periodically or upon request, make
available to its notifying authorities the list of quality system approvals
refused, suspended or otherwise restricted.

2.8. Authorised
representative

The
manufacturer's obligations set out in points 2.3.1, 2.3.5, 2.5 and 2.6 may be
fulfilled by his authorised representative, on his behalf and under his
responsibility, provided that they are specified in the mandate.

3. MODULE D1: Quality assurance of the
production process

3.1. Quality
assurance of the production process is the conformity assessment procedure
whereby the manufacturer fulfils the obligations laid down in points 3.2, 3.4
and 3.7, and ensures and declares on his sole responsibility that the
instruments concerned satisfy the requirements of this Directive that apply to
them.

3.2. Technical
documentation

The manufacturer
shall establish the technical documentation. The documentation shall make it
possible to assess the instrument’s conformity with the relevant requirements,
and shall include an adequate analysis and assessment of the risk(s). The
technical documentation shall specify the applicable requirements and cover, as
far as relevant for the assessment, the design, manufacture and operation of
the instrument. The technical documentation shall, wherever applicable, contain
at least the following elements:

(a)     a general
description of the instrument;

(b)     conceptual
design and manufacturing drawings and schemes of components, sub-assemblies,
circuits, etc.;

(c)     descriptions
and explanations necessary for the understanding of those drawings and schemes
and the operation of the instrument;

(d)     a list of
the harmonised standards and/or other relevant technical specifications the
references of which have been published in the Official Journal of the
European Union, applied in full or in part, and descriptions of the
solutions adopted to meet the essential requirements of this Directive where
those harmonised standards have not been applied. In the event of partly
applied harmonised standards, the technical documentation shall specify the
parts which have been applied;

(e)     results of
design calculations made, examinations carried out, etc.;

(f)      test
reports.

3.3. The
manufacturer shall keep the technical documentation at the disposal of the
relevant national authorities for 10 years after the instrument has been placed
on the market.

3.4.
Manufacturing

The manufacturer
shall operate an approved quality system for production, final product
inspection and testing of the instruments concerned as specified in point 3.5,
and shall be subject to surveillance as specified in point 3.6.

3.5. Quality
system

3.5.1. The
manufacturer shall lodge an application for assessment of his quality system
with the notified body of his choice, for the instruments concerned.

The application
shall include:

(a)     the name and
address of the manufacturer and, if the application is lodged by the authorised
representative, his name and address as well;

(b)     a written
declaration that the same application has not been lodged with any other
notified body;

(c)     all relevant
information for the instrument category envisaged;

(d)     the
documentation concerning the quality system;

(e)     the
technical documentation referred to in point 3.2.

3.5.2. The
quality system shall ensure compliance of the instruments with the requirements
of this Directive that apply to them.

All the elements,
requirements and provisions adopted by the manufacturer shall be documented in
a systematic and orderly manner in the form of written policies, procedures and
instructions. The quality system documentation shall permit a consistent
interpretation of the quality programmes, plans, manuals and records.

It shall, in
particular, contain an adequate description of:

(a)     the quality
objectives and the organisational structure, responsibilities and powers of the
management with regard to instrument quality;

(b)     the
corresponding manufacturing, quality control and quality assurance techniques,
processes and systematic actions that will be used;

(c)     the
examinations and tests that will be carried out before, during and after
manufacture, and the frequency with which they will be carried out;

(d)     the quality
records, such as inspection reports and test data, calibration data,
qualification reports on the personnel concerned, etc.;

(e)     the means of
monitoring the achievement of the required instrument quality and the effective
operation of the quality system.

3.5.3. The
notified body shall assess the quality system to determine whether it satisfies
the requirements referred to in point 3.5.2.

It shall presume
conformity with those requirements in respect of the elements of the quality
system that comply with the corresponding specifications of the national
standard that implements the relevant harmonised standard and/or technical
specification.

In addition to
experience in quality management systems, the auditing team shall have at least
one member with experience of evaluation in the relevant instrument field and instrument
technology concerned, and knowledge of the applicable requirements of this
Directive. The audit shall include an assessment visit to the manufacturer's
premises. The auditing team shall review the technical documentation referred
to in point 3.2 in order to verify the manufacturer's ability to identify the
relevant requirements of this Directive and to carry out the necessary
examinations with a view to ensuring compliance of the instrument with those
requirements.

The decision
shall be notified to the manufacturer. The notification shall contain the
conclusions of the audit and the reasoned assessment decision.

3.5.4. The
manufacturer shall undertake to fulfil the obligations arising out of the
quality system as approved and to maintain it so that it remains adequate and
efficient.

3.5.5. The
manufacturer shall keep the notified body that has approved the quality system
informed of any intended change to the quality system.

The notified body
shall evaluate any proposed changes and decide whether the modified quality
system will continue to satisfy the requirements referred to in point 3.5.2 or
whether reassessment is necessary.

It shall notify
the manufacturer of its decision. The notification shall contain the
conclusions of the examination and the reasoned assessment decision.

3.6. Surveillance
under the responsibility of the notified body

3.6.1. The
purpose of surveillance is to make sure that the manufacturer duly fulfils the
obligations arising out of the approved quality system.

3.6.2. The
manufacturer shall, for assessment purposes, allow the notified body access to
the manufacture, inspection, testing and storage sites and shall provide it
with all necessary information, in particular:

(a)     the quality
system documentation;

(b)     the
technical documentation referred to in point 3.2;

(c)     the quality
records, such as inspection reports and test data, calibration data,
qualification reports on the personnel concerned, etc.

3.6.3. The
notified body shall carry out periodic audits to make sure that the
manufacturer maintains and applies the quality system and shall provide the
manufacturer with an audit report.

3.6.4. In
addition, the notified body may pay unexpected visits to the manufacturer.
During such visits the notified body may, if necessary, carry out product
tests, or have them carried out, in order to verify that the quality system is
functioning correctly. The notified body shall provide the manufacturer with a
visit report and, if tests have been carried out, with a test report.

3.7. Conformity
marking and declaration of conformity

3.7.1. The
manufacturer shall affix the CE marking and the inscriptions provided for in point 1 of Annex
III, and, under the
responsibility of the notified body referred to in point 3.5.1, the latter's
identification number to each individual instrument that satisfies the
applicable requirements of this Directive.

3.7.2. The
manufacturer shall draw up a written declaration of conformity for each
instrument model and keep it at the disposal of the national authorities for 10
years after the instrument has been placed on the market. The declaration of
conformity shall identify the instrument model for which it has been drawn up.

A copy of the
declaration of conformity shall be made available to the relevant authorities
upon request.

3.8. The
manufacturer shall, for a period ending at least 10 years after the instrument
has been placed on the market, keep at the disposal of the national
authorities:

(a)     the
documentation referred to in point 3.5.1;

(b)     the change
referred to in point 3.5.5, as approved;

(c)     the decisions
and reports of the notified body referred to in points 3.5.5, 3.6.3 and 3.6.4.

3.9. Each
notified body shall inform its notifying authorities of quality system
approvals issued or withdrawn, and shall, periodically or upon request, make
available to its notifying authorities the list of quality system approvals
refused, suspended or otherwise restricted.

3.10. Authorised
representative

The
manufacturer's obligations set out in points 3.3, 3.5.1, 3.5.5, 3.7 and 3.8 may
be fulfilled by his authorised representative, on his behalf and under his
responsibility, provided that they are specified in the mandate.

ê 2009/23/EC
(adapted)

34. EC Ö MODULE F:
Conformity to type based on product Õ verification

ê 2009/23/EC

3.1. EC
verification is the procedure whereby the manufacturer or his authorised
representative established within the Community ensures and declares that the
instruments which have been checked in accordance with point 3.3 are, where
applicable, in conformity with the type described in the EC type-examination
certificate and that they satisfy the requirements of this Directive.

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
authorised representative established within the Community shall affix the ‘CE’ conformity 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 point 3.5.

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

3.5. Verification
by checking and testing of each instrument

3.5.1. All
instruments shall be individually examined and appropriate tests, as set out in
the relevant harmonised standards referred to in Article 6(1), or equivalent
tests, shall be carried out in order to verify their conformity, where
applicable, with the type as described in the EC type-examination certificate
and the requirements of this Directive.

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 shall draw up a written certificate of conformity relating to
the tests carried out.

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

ò new

4.1. Conformity
to type based on product verification is the part of a conformity assessment
procedure whereby the manufacturer fulfils the obligations laid down in points
4.2, 4.5.1 and 4.6, and ensures and declares on his sole responsibility that
the instruments concerned, which have been subject to the provisions of point
4.3, are in conformity with the type described in the EU-type examination
certificate and satisfy the requirements of this Directive that apply to them.

4.2.
Manufacturing

The manufacturer
shall take all measures necessary so that the manufacturing process and its
monitoring ensure conformity of the manufactured instruments with the approved
type described in the EU-type examination certificate and with the requirements
of this Directive that apply to them.

4.3. Verification

A notified body
chosen by the manufacturer shall carry out appropriate examinations and tests
in order to check the conformity of the instruments with the approved type
described in the EU-type examination certificate and with the appropriate
requirements of this Directive.

The examinations
and tests to check the conformity of the instruments with the appropriate
requirements shall be carried out by examination and testing of every
instrument as specified in point 4.4.

4.4. Verification
of conformity by examination and testing of every instrument

4.4.1. All
instruments shall be individually examined and appropriate tests set out in the
relevant harmonised standard(s) and/or technical specifications, or equivalent
tests, shall be carried out in order to verify conformity with the approved
type described in the EU-type examination certificate and with the appropriate
requirements of this Directive.

In the absence of
such a harmonised standard, the notified body concerned shall decide on the
appropriate tests to be carried out.

4.4.2. The
notified body shall issue a certificate of conformity in respect of the
examinations and tests carried out, and shall affix its identification number
to each approved instrument or have it affixed under its responsibility.

The manufacturer
shall keep the certificates of conformity available for inspection by the
national authorities for 10 years after the instrument has been placed on the
market.

4.5. Conformity
marking and declaration of conformity

4.5.1. The
manufacturer shall affix the CE marking and the inscriptions provided for in point 1 of Annex
III, and, under the responsibility
of the notified body referred to in point 4.3, the latter's identification
number to each individual instrument that is in conformity with the approved
type described in the EU-type examination certificate and satisfies the
applicable requirements of this Directive.

4.5.2. The
manufacturer shall draw up a written declaration of conformity for each
instrument model and keep it at the disposal of the national authorities, for
10 years after the instrument has been placed on the market. The declaration of
conformity shall identify the instrument model for which it has been drawn up.

A copy of the
declaration of conformity shall be made available to the relevant authorities
upon request.

If the notified
body referred to in point 4.3 agrees and under its responsibility, the
manufacturer may also affix the notified body's identification number to the
instruments.

4.6. If the
notified body agrees and under its responsibility, the manufacturer may affix
the notified body's identification number to the instruments during the
manufacturing process.

4.7. Authorised
representative

The
manufacturer's obligations may be fulfilled by his authorised representative,
on his behalf and under his responsibility, provided that they are specified in
the mandate. An authorised representative may not fulfil the manufacturer's
obligations set out in points 4.2 and 4.5.1.

5. MODULE F1:
Conformity based on product verification

5.1. Conformity
based on product verification is the conformity assessment procedure whereby
the manufacturer fulfils the obligations laid down in points 5.2, 5.3, 5.6.1
and 5.7 and ensures and declares on his sole responsibility that the
instruments concerned, which have been subject to the provisions of point 5.4,
are in conformity with the requirements of this Directive that apply to them.

5.2. Technical
documentation

The manufacturer
shall establish the technical documentation. The documentation shall make it
possible to assess the instrument's conformity with the relevant requirements,
and shall include an adequate analysis and assessment of the risk(s). The
technical documentation shall specify the applicable requirements and cover, as
far as relevant for the assessment, the design, manufacture and operation of
the instrument. The technical documentation shall, wherever applicable, contain
at least the following elements:

(a)     a general
description of the instrument;

(b)     conceptual
design and manufacturing drawings and schemes of components, sub-assemblies,
circuits, etc.;

(c)     descriptions
and explanations necessary for the understanding of those drawings and schemes
and the operation of the instrument;

(d)     a list of
the harmonised standards and/or other relevant technical specifications the
references of which have been published in the Official Journal of the
European Union, applied in full or in part, and descriptions of the
solutions adopted to meet the essential requirements of this Directive where
those harmonised standards have not been applied. In the event of partly
applied harmonised standards, the technical documentation shall specify the
parts which have been applied;

(e)     results of
design calculations made, examinations carried out, etc.;

(f)      test
reports.

The manufacturer
shall keep the technical documentation at the disposal of the relevant national
authorities for 10 years after the instrument has been placed on the market.

5.3.
Manufacturing

The manufacturer
shall take all measures necessary so that the manufacturing process and its
monitoring ensure conformity of the manufactured instruments with the
applicable requirements of this Directive.

5.4. Verification

A notified body
chosen by the manufacturer shall carry out appropriate examinations and tests
to check the conformity of the instruments with the applicable requirements of
this Directive.

The examinations
and tests to check the conformity with those requirements shall be carried out by
examination and testing of every instrument as specified in point 5.5.

5.5. Verification
of conformity by examination and testing of every instrument

5.5.1. All
instruments shall be individually examined and appropriate tests, set out in
the relevant harmonised standards and/or technical specifications, or
equivalent tests, shall be carried out to verify conformity with the
requirements that apply to them. In the absence of such a harmonised standard
and/or technical specification the notified body concerned shall decide on the
appropriate tests to be carried out.

5.5.2. The
notified body shall issue a certificate of conformity in respect of the examinations
and tests carried out, and shall affix its identification number to each
approved instrument or have it affixed under its responsibility.

The manufacturer
shall keep the certificates of conformity at the disposal of the national
authorities for 10 years after the instrument has been placed on the market.

5.6. Conformity
marking and declaration of conformity

5.6.1. The
manufacturer shall affix the CE marking and the inscriptions provided for in point 1 of Annex
III, and, under the
responsibility of the notified body referred to in point 5.4, the latter's
identification number to each individual instrument that satisfies the
applicable requirements of this Directive.

5.6.2. The
manufacturer shall draw up a written declaration of conformity for each instrument
model and keep it at the disposal of the national authorities for 10 years
after the instrument has been placed on the market. The declaration of
conformity shall identify the instrument model for which it has been drawn up.

A copy of the
declaration of conformity shall be made available to the relevant authorities
upon request.

If the notified
body referred to in point 5.5 agrees and under its responsibility, the
manufacturer may also affix the notified body's identification number to the
instruments.

5.7. If the
notified body agrees and under its responsibility, the manufacturer may affix
the notified body's identification number to the instruments during the
manufacturing process.

5.8. Authorised
representative

The
manufacturer's obligations may be fulfilled by his authorised representative,
on his behalf and under his responsibility, provided that they are specified in
the mandate. An authorised representative may not fulfil the manufacturer's
obligations set out in points 5.3 and 5.6.1.

ê 2009/23/EC
(adapted)

46. EC Ö MODULE G:
Conformity based on Õ unit
verification

ê 2009/23/EC

4.1. EC unit
verification is the procedure whereby the manufacturer or his authorised
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 point 4.2 conforms to the
requirements of this Directive that apply to it. The manufacturer or his authorised representative shall affix
the ‘CE’ conformity 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 relevant harmonised standard(s) referred to in Article 6(1), or
equivalent tests, in order to ensure its conformity with 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 with 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 authorised representative shall ensure that he is able
to supply the notified body’s certificates of conformity on request.

ò new

6.1. Conformity
based on unit verification is the conformity assessment procedure whereby the
manufacturer fulfils the obligations laid down in points 6.2, 6.3 and 6.5, and
ensures and declares on his sole responsibility that the instrument concerned,
which has been subject to the provisions of point 6.4, is in conformity with
the requirements of this Directive that apply to it.

6.2. Technical
documentation

The manufacturer
shall establish the technical documentation and make it available to the
notified body referred to in point 6.4. The documentation shall make it
possible to assess the instrument's conformity with the relevant requirements,
and shall include an adequate analysis and assessment of the risk(s). The
technical documentation shall specify the applicable requirements and cover, as
far as relevant for the assessment, the design, manufacture and operation of the
instrument.

The technical
documentation shall, wherever applicable, contain at least the following
elements:

(a)     a general
description of the instrument;

(b)     conceptual
design and manufacturing drawings and schemes of components, sub-assemblies,
circuits, etc.;

(c)     descriptions
and explanations necessary for the understanding of those drawings and schemes
and the operation of the instrument;

(d)     a list of
the harmonised standards and/or other relevant technical specifications the
references of which have been published in the Official Journal of the
European Union, applied in full or in part, and descriptions of the
solutions adopted to meet the essential requirements of this Directive where
those harmonised standards have not been applied. In the event of partly
applied harmonised standards, the technical documentation shall specify the
parts which have been applied;

(e)     results of
design calculations made, examinations carried out, etc.;

(f)      test
reports.

The manufacturer
shall keep the technical documentation at the disposal of the relevant national
authorities for 10 years after the instrument has been placed on the market.

6.3.
Manufacturing

The manufacturer
shall take all measures necessary so that the manufacturing process and its
monitoring ensure conformity of the manufactured instrument with the applicable
requirements of this Directive.

6.4. Verification

A notified body
chosen by the manufacturer shall carry out appropriate examinations and tests,
set out in the relevant harmonised standards and/or technical specifications,
or equivalent tests, to check the conformity of the instrument with the
applicable requirements of this Directive, or have them carried out. In the
absence of such a harmonised standard and/or technical specification the
notified body concerned shall decide on the appropriate tests to be carried
out.

The notified body
shall issue a certificate of conformity in respect of the examinations and
tests carried out and shall affix its identification number to the approved
instrument, or have it affixed under its responsibility.

The manufacturer
shall keep the certificates of conformity at the disposal of the national
authorities for 10 years after the instrument has been placed on the market.

6.5. Conformity
marking and declaration of conformity

6.5.1. The
manufacturer shall affix the CE marking and the inscriptions provided for in point 1 of Annex
III and, under the
responsibility of the notified body referred to in point 6.4, the latter's
identification number to each instrument that satisfies the applicable
requirements of this Directive.

6.5.2. The
manufacturer shall draw up a written declaration of conformity and keep it at
the disposal of the national authorities for 10 years after the instrument has
been placed on the market. The declaration of conformity shall identify the
instrument for which it has been drawn up.

A copy of the
declaration of conformity shall be made available to the relevant authorities
upon request.

6.6. Authorised
representative

The
manufacturer's obligations set out in points 6.2 and 6.5 may be fulfilled by
his authorised representative, on his behalf and under his responsibility,
provided that they are specified in the mandate.

ê 2009/23/EC
(adapted)

57. Common provisions

57.1. The EC
declaration of type conformity (guarantee of production quality), the EC
verification, and the EC unit verification Ö conformity
assessment according to Module D, D1, F, F1 or G Õ may be carried
out at the manufacturer’s works or any other location if transport to the place
of use does not require dismantling of the instrument, if the putting into
service at the place of use does not require assembly of the instrument or
other technical installation work likely to affect the instrument’s performance,
and if the gravity value at the place of putting into service is taken into
consideration or if the instrument’s performance is insensitive to gravity
variations. In all other cases, they Ö it Õ shall be
carried out at the place of use of the instrument.

ê 2009/23/EC

57.2. If the instrument’s performance is sensitive to gravity
variations the procedures referred to in point 57.1 may be carried out in two stages,
with the second stage comprising all examinations and tests of which the
outcome is gravity-dependent, and the first stage all other examinations and
tests. The second stage shall be carried out at the place of use of the
instrument. If a Member State has established gravity zones on its territory
the expression ‘at the place of use of the instrument’ may be read as ‘in the
gravity zone of use of the instrument’.

57.2.1. Where a manufacturer has opted for execution in two stages of
one of the procedures mentioned in point 57.1, 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.

57.2.2. The party which has carried out the first stage of the
procedure shall issue for each of the instruments a certificate containing the
data necessary 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 authorised
representative shall ensure that he is able to supply the notified body’s
certificates of conformity on request.

ê 2009/23/EC
(adapted)

57.2.3. A manufacturer who has opted for the EC declaration of type conformity (guarantee
of production quality) Ö Module D
or D1 Õ in the first
stage may either use this same procedure in the second stage or decide to
continue in the second stage with EC verification Ö Module F
or F1 as appropriate Õ .

57.2.4. The ‘CE’ Ö CE Õ conformity
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.

ê 2009/23/EC

ANNEX
III

DESIGN
TECHNICAL DOCUMENTATION

The technical
documentation must render the design, manufacture and operation of the
product intelligible and enable an assessment to be made of its conformity with
the requirements of this Directive.

The documentation
shall include in so far as relevant for assessment:

–
a general
description of the type,

–
conceptual designs
and manufacturing drawings and plans of components, sub-assemblies,
circuits, etc.,

–
descriptions and
explanations necessary for the understanding of the above, including the
operation of the instrument,

–
a list of the
harmonised standards referred to in Article 6(1), applied in full or in
part, and descriptions of the solutions adopted to meet the essential
requirements where the harmonised standards referred to in Article 6(1) have
not been applied,

–
results of design
calculations made and of examinations, etc.,

–
test reports,

–
the EC
type-approval certificates and the results of relevant tests on instruments
containing parts identical to those in the design.

ê 2009/23/EC
(adapted)

ANNEX IVIII

‘CE’Ö CE Õ CONFORMITY
MARKING AND INSCRIPTIONS

1. Instruments subject to the EC Ö EU Õ conformity
assessment procedure

1.1. These instruments must bear:

(a)     - the ‘CE’
Ö CE Õ conformity
marking comprising
the ‘CE’ symbol as described Ö provided
for Õ in Annex VIII of Regulation (EC) No 765/2008, Ö followed
by Õ

-        the identification number(s) of the notified body/bodies that has/have carried out the EC
surveillance or the EC verification Ö involved
in the production control phase Õ.;

ê 2009/23/EC

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

ê 2009/23/EC
(adapted)

(b)     a green sticker at least 12,5 mm ×
12,5 mm square bearing a capital letter ‘M’ printed in black;

(c)     the following inscriptions:

(i)      - the number of the EC type-approval
Ö EU-type
examination Õ certificate,
where appropriate,;

(ii)      - the manufacturer’s mark or name,;

(iii)     - the accuracy class, enclosed in an oval
or in two horizontal lines joined by two half circles,;

(iv)     - maximum capacity, in the form Max ...,;

(v)     - minimum capacity, in the form Min ...,;

(vi)     - verification scale interval, in the
form e = ...,;

(vii)    - the last two digits of the year in
which the ‘CE’
Ö CE Õ conformity
marking was affixed,;

plus, Ö and Õ when
applicable:

ê 2009/23/EC

(viii)   - serial number,;

(ix)     - for instruments consisting of separate
but associated units: identification mark on each unit,;

(x)     - scale interval if it is different from e,
in the form d = ...,;

(xi)     - maximum additive tare effect, in the
form T = + ...,;

(xii)    - maximum subtractive tare effect if it
is different from Max, in the form T = – ...,;

(xiii)   - tare interval if it is different from d,
in the form dT = ...,;

(xiv)   - maximum safe load if it is different
from Max, in the form Lim ...,;

(xv)    - the special temperature limits, in the
form ... °C/... °C,;

(xvi)   - ratio between load receptor and load.

ê 2009/23/EC
(adapted)

1.2. The instruments shall have adequate
facilities for the affixing of the ‘CE’ Ö CE Õ conformity
marking and/or inscriptions. These shall be such that it shall be impossible to
remove the marking and inscriptions without damaging them, and that the marking
and inscriptions shall be visible when the instrument is in its regular
operating position.

ê 2009/23/EC

1.3. Where a data plate is used it shall be
possible to seal the plate unless it cannot be removed without being destroyed.
If the data plate is sealable it shall be possible to apply a control mark to
it.

1.4. The inscriptions Max, Min, e,
and d, shall also be shown near the display of the result if they are
not already located there.

1.5. Each load measuring device which is
connected or can be connected to one or more load receptors shall bear the
relevant inscriptions relating to the said load receptors.

2. Other Instruments

The other instruments must bear:

–
the manufacturer’s mark or name,;

–
maximum capacity, in the form Max ....

Those instruments may not bear the stickers
provided for in point 1.1(b).

3. Restrictive use symbol specified in
Article 1317

That symbol shall be constituted by a
capital letter ‘M’ printed in black on a red background at least 25 mm × 25 mm
square with two intersecting diagonals forming a cross.

ê 2009/23/EC

ANNEX V

The minimum criteria to be applied by member
states when designating
bodies for the carrying-out of
tasks pertaining to the procedures referred to in article 9

1. The bodies
shall have at their disposal the necessary personnel, means and equipment.

2. The personnel
of the bodies shall have technical competence and professional integrity.

3. The bodies
shall work independently of all circles, groups or persons having a direct or
indirect interest in non-automatic weighing instruments as regards the
carrying-out of the tests, the preparation of the reports, the issuing of
the certificates and the surveillance required by this Directive.

4. The personnel
of the bodies shall respect professional confidentiality.

5. The bodies
shall take out a civil liability insurance if their civil liability is not
covered by the State under national law.

The fulfilment of
the conditions under points 1 and 2 shall be periodically verified by the
Member States.

ê 2009/23/EC

ANNEX VI

‘CE’
CONFORMITY MARKING

–
The ‘CE’
conformity marking shall consist of the initials ‘CE’ taking the following
form:

–
If the ‘CE’
conformity marking is reduced or enlarged the proportions given in the above
graduated drawing must be respected.

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

ê 2009/23/EC
(adapted)

ANNEX VII

PART A

Repealed Directive with its amendment

(referred to in Article 17)

Council Directive 90/384/EEC (OJ L 189, 20.7.1990, p. 1) ||

Council Directive 93/68/EEC (OJ L 220, 30.8.1993, p. 1) || Article 1, point 7, and Article 8 only

PART B

List of time limits for transposition into national law and application

(referred to in Article 17)

Directive || Time limit for transposition || Date of application

90/384/EEC || 30 June 1992 || 1 January 1993[18]

93/68/EEC || 30 June 1994 || 1 January 1995[19]

ê 2009/23/EC
(adapted)

ANNEX VIIIIV

CORRELATION TABLE

Directive 90/384/EEC Ö 2009/23/EC Õ || This Directive

Recital 5, last sentence || Article 2, point (3)

Article 1(1), first subparagraph || Article 2, point (1)

Article 1(1), second subparagraph || Article 2, point (2)

Article 1(1), third subparagraph || Article 1(1)

Article 1(2), introductory wording || Article 1(2), introductory wording

Article 1(2), point (a)(1) || Article 1(2), point (a)(i)

Article 1(2), point (a)(2) || Article 1(2), point (a)(ii)

Article 1(2), point (a)(3) || Article 1(2), point (a)(iii)

Article 1(2), point (a)(4) || Article 1(2), point (a)(iv)

Article 1(2), point (a)(5) || Article 1(2), point (a)(v)

Article 1(2), point (a)(6) || Article 1(2), point (a)(vi)

Article 1(2), point (b) || Article 1(2), point (b)

Article 2 || Article 3

Article 3 || Article 4

Article 4 || Article 5

Article 5 || Article 6

Article 6, first paragraph, first sentence || Article 7, first paragraph

Article 6, first paragraph, second sentence || Article 7, second paragraph

Article 6, second paragraph || Article 7, third paragraph

Article 7 || Article 8

Article 8(1) and (2) || Article 9(1) and (2)

Article 8(3), point (a) || Article 9(3), first subparagraph

Article 8(3), point (b) || Article 9(3), second subparagraph

Article 9 || Article 10

Article 10 || Article 11

Article 11 || Article 12

Article 12 || Article 13

Article 13 || Article 14

Article 14, first sentence || Article 15, first paragraph

Article 14, second sentence || Article 15, second paragraph

Article 15(1) to (3) || —

Article 15(4) || Article 16

Article 15(5) || —

— || Article 17

— || Article 18

Article 16 || Article 19

Annexes I to VI || Annexes I to VI

— || Annex VII

— || Annex VIII

Ö Article 1(1) Õ || Ö Article 1(1) Õ

Ö Article 1(2), introductory wording Õ || Ö Article 1(2), introductory wording Õ

Ö Article 1(2), point (a)(i) Õ || Ö Article 1(2), point (a) Õ

Ö Article 1(2), point (a)(ii) Õ || Ö Article 1(2), point (b) Õ

Ö Article 1(2), point (a)(iii) Õ || Ö Article 1(2), point (c) Õ

Ö Article 1(2), point (a)(iv) Õ || Ö Article 1(2), point (d) Õ

Ö Article 1(2), point (a)(v) Õ || Ö Article 1(2), point (e) Õ

Ö Article 1(2), point (a)(vi) Õ || Ö Article 1(2), point (f) Õ

Ö Article 1(2), point (b) Õ || Ö Article 1(2), point (g) Õ

Ö Article 2(1) Õ || Ö Article 2(1) Õ

Ö Article 2(2) Õ || Ö Article 2(2) Õ

Ö Article 2(3) Õ || Ö ____ Õ

Ö ____ Õ || Ö Article 2(3) to (19) Õ

Ö Article 3 Õ || Ö Article 3 Õ

Ö Article 4 Õ || Ö Article 4 Õ

Ö Article 5 Õ || Ö Article 5 Õ

Ö Article 6 Õ || Ö ____ Õ

Ö Article 7 Õ || Ö ____ Õ

Ö Article 8 Õ || Ö ____ Õ

Ö ____ Õ || Ö Article 6 Õ

Ö ____ Õ || Ö Article 7 Õ

Ö ____ Õ || Ö Article 8 Õ

Ö ____ Õ || Ö Article 9 Õ

Ö ____ Õ || Ö Article 10 Õ

Ö ____ Õ || Ö Article 11 Õ

Ö ____ Õ || Ö Article 12 Õ

Ö Article 9(1), introductory wording Õ || Ö Article 13(1), introductory wording Õ

Ö Article 9(1), point (a) Õ || Ö Article 13(1), point (a) Õ

Ö Article 9(1), point (b) Õ || Ö Article 13(1), point (b) Õ

Ö Article 9(2) Õ || Ö Article 13(2) Õ

Ö Article 9(3) Õ || Ö _____ Õ

Ö Article 10 Õ || Ö ____ Õ

Ö Article 11 Õ || Ö ___ Õ

Ö Article 12 Õ || Ö ____ Õ

Ö ____ Õ || Ö Article 14 Õ

Ö ____ Õ || Ö Article 15 Õ

Ö ____ Õ || Ö Article 16 (1) to (4) Õ

Ö Article 13, first sentence Õ || Ö Article 6(2) fourth subparagraph Õ

Ö Article 13, second sentence Õ || Ö Article 17 Õ

Ö ____ Õ || Ö Article 18 Õ

Ö ____ Õ || Ö Article 19 Õ

Ö ____ Õ || Ö Article 20 Õ

Ö ____ Õ || Ö Article 21 Õ

Ö ____ Õ || Ö Article 22 Õ

Ö ____ Õ || Ö Article 23 Õ

Ö ____ Õ || Ö Article 24 Õ

Ö ____ Õ || Ö Article 25 Õ

Ö ____ Õ || Ö Article 26 Õ

Ö ____ Õ || Ö Article 27 Õ

Ö ____ Õ || Ö Article 28 Õ

Ö ____ Õ || Ö Article 29 Õ

Ö ____ Õ || Ö Article 30 Õ

Ö ____ Õ || Ö Article 31 Õ

Ö ____ Õ || Ö Article 32 Õ

Ö ____ Õ || Ö Article 33 Õ

Ö ____ Õ || Ö Article 34 Õ

Ö ____ Õ || Ö Article 35 Õ

Ö ____ Õ || Ö Article 36 Õ

Ö ____ Õ || Ö Article 37 Õ

Ö ____ Õ || Ö Article 38 Õ

Ö ____ Õ || Ö Article 39 Õ

Ö ____ Õ || Ö Article 40 Õ

Ö Article 14 Õ || Ö Article 3(3) Õ

Ö Article 15 Õ || Ö ____ Õ

Ö ____ Õ || Ö Article 41 Õ

Ö ____ Õ || Ö Article 42(1) Õ

Ö Article 16 Õ || Ö Article 42(2) Õ

Ö Article 17 Õ || Ö Article 43 Õ

Ö Article 18 Õ || Ö Article 44, first subparagraph Õ

Ö ____ Õ || Ö Article 44, second subparagraph Õ

Ö Article 19 Õ || Ö Article 45 Õ

Ö Annex I Õ || Ö Annex I Õ

Ö Annex II, point 1 Õ || Ö ____ Õ

Ö ____ Õ || Ö Annex II, point 1 Õ

Ö Annex II, point 2 Õ || Ö ____ Õ

Ö ____ Õ || Ö Annex II, point 2 Õ

Ö ____ Õ || Ö Annex II, point 3 Õ

Ö Annex II, point 3 Õ || Ö ____ Õ

Ö ____ Õ || Ö Annex II, point 4 Õ

Ö ____ Õ || Ö Annex II, point 5 Õ

Ö Annex II, point 4 Õ || Ö ____ Õ

Ö ____ Õ || Ö Annex II, point 6 Õ

Ö Annex II, point 5 Õ || Ö Annex II, point 7 Õ

Ö Annex III Õ || Ö ____ Õ

Ö Annex IV Õ || Ö Annex III Õ

Ö Annex V Õ || Ö ____ Õ

Ö Annex VI Õ || Ö ____ Õ

Ö Annex VII Õ || Ö ____ Õ

Ö Annex VIII Õ || Ö ____ Õ

Ö ____ Õ || Ö Annex IV Õ

[1]               Communication from the Commission to the European
Parliament, the Council, the Economic and Social Committee and the Committee of
the Regions, COM(2011) 206 final.

[2]               Proposal for a Regulation of the European Parliament
and of the Council on European Standardisation and amending Council Directives
89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC,
98/34/EC, 2004/22/EC, 2007/23/EC, 2009/105/EC and 2009/23/EC of the European
Parliament and of the Council. [COM(2011) 315 final]

[3]               OJ C 77, 28.3.2002.

[4]               OJ C [...], [...], p. [...].

[5]               OJ L 189, 20.7.1990, p. 1.

[6]               See Annex VII, Part A.

[7]               OJ L 122, 16.5.2009, p. 6.

[8]               OJ L 218, 13.8.2008, p. 30.

[9]               OJ L 218, 13.8.2008, p. 82.

[10]             OJ L [...], [...], p. [...].

[11]             OJ C 91, 16.4.2003, p. 7.

[12]             OJ C 136, 4.6.1985, p. 1.

[13]             OJ C 267, 19.10.1989, p. 3.

[14]             OJ C 10, 16.1.1990, p. 1.

[15]             OJ L 204, 21.7.1998, p. 37.

[16]             OJ L 39, 15.2.1980, p. 40.

[17]             For i = r, the corresponding
column of Table 1 applies, with e replaced by er.

[18]             In
accordance with Article 15(3) of Directive 90/384/EEC Member States shall
permit, during a period of 10 years from the date on which they apply the laws,
regulations and administrative provisions adopted by the Member States in
order to transpose that Directive into national law, the placing on the market
and/or putting into service of instruments which conform to the rules in force
before 1 January 1993.

[19]             In
accordance with Article 14(2) of Directive 93/68/EEC: ‘Until 1 January 1997,
Member States shall allow the placing on the market and the bringing into
service of products which comply with the marking arrangements in force before
1 January 1995’.