# EUR-Lex - 52011PC0769 - EN

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# 52011PC0769

**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 measuring instruments /* COM/2011/0769 final - 2011/0353 (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 2004/22 EC is an example of that
Union harmonisation legislation, ensuring the free movement of measuring
instruments. It sets out essential requirements that measuring instruments must
comply with in order to be made available on the EU market. Manufacturers must
demonstrate that a measuring instrument has been designed and manufactured in
compliance with the essential requirements and affix the CE marking and the M
supplementary metrology 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

(1)
the presence of non-compliant or dangerous
products on the market and consequently a certain lack of trust in CE marking

(2)
competitive disadvantages for economic operators
complying with the legislation as opposed to those circumventing the rules

(3)
unequal treatment in the case of non-compliant
products and distortion of competition amongst economic operators due to
different enforcement practices

(4)
differing practices in the designation of
conformity assessment bodies by national authorities

(5)
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 2004/22/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 2004/22/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 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.

External expertise was also used to obtain
some basic data on the measuring instruments sector. In
their evaluation report external experts[2]
have estimated that Directive 2004/22/EC applies to around 345 million units of
measuring instruments (MIs) sold annually in the European market with a total
sales value of around €3.25 billion. The evaluation showed that the quality of market surveillance appears as an important concern
of industry and it is an area where most authorities recognise that their
effort until recently has been limited. Furthermore,
there appear to be inconsistencies among the notified bodies in terms of
interpreting the Directive’s requirements and other guidance as well as
differing levels of capacity. A subsequent public consultation[3] showed that the evaluation of
Directive 2004/22/EC can be deemed to be complete as regards the evaluation and
is generally supported by stakeholders as regards its analysis.

The weaknesses remarked in market
surveillance and quality of notified bodies will be addressed in part by the
alignment of Directive 2004/22/EC to the NLF decision.

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
modifies a number of definitions which are commonly used throughout Union
harmonisation legislation in order to harmonise their 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 measuring instruments are correctly
marked and accompanied by the 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 a measuring 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 measuring instruments.

Enhanced traceability obligations are introduced for all economic operators. Measuring instruments
have to bear the manufacturer’s name and address and a number allowing to
identify and link the measuring instrument to its technical documentation. When
a measuring instrument is imported, the importer’s name and address must also
be on the measuring instrument. Furthermore, every economic operator must be
able to identify towards authorities the economic operator who has supplied him
with a measuring instrument or to whom he has supplied a measuring 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[4]
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 Organisation, on
the procedure for objections to harmonised standards and on stakeholder
participation in the standardisation process. Consequently the provisions of
Directive 2004/22/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 2004/22/EC has selected the
appropriate conformity assessment procedures which manufacturers have to apply
in order to demonstrate that their measuring instruments comply with the
essential requirements. The proposal aligns these procedures to their updated
versions set out in the NLF Decision. It also keeps some sector specific
elements already provided for in Directive 2004/22/EC such as the mandatory
metrology M marking in addition to the CE marking.

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 measuring
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 measuring 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 measuring instrument. Where there is no disagreement on
the restrictive measure taken, all Member States must take the appropriate
action on their territory.

3.7.
Comitology and Delegated acts

The provisions on the operation of the
Measuring Instruments Committee have been adapted to the new rules on delegated
acts laid down in Article 290 of the Treaty on the Functioning of the EU and to
the new provisions on implementing acts laid down in Regulation (EU) No
182/2011 of the European Parliament and of the Council of 16 February 2011
laying down the rules and general principles concerning mechanisms for control
by the Member States of the Commission's exercise of implementing powers[5].

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 2004/22/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 2004/22/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[6].

The changes made to the provisions of
Directive 2004/22/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 2004/22/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 2004/22/EC.

European Economic Area

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

ê 2004/22/EC
(adapted)

2011/0353 (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 measuring
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[7],

Acting in accordance with the ordinary
legislative procedure,

Whereas:

ê 2004/22/EC
recital 1 (adapted)

A number of measuring instruments are covered by
specific Directives, adopted on the basis of Council Directive 71/316/EEC of
26 July 1971 on the approximation of the laws of the Member States
relating to common provisions for both measuring instruments and methods of
metrological control[8].
Specific Directives that are technically outdated should be repealed and
replaced by an independent Directive reflecting the spirit of the Council
Resolution of 7 May 1985 on a new approach to technical harmonisation and
standards[9].

ò new

(1)
Directive 2004/22/EC
of the European Parliament and of the Council of 31 March 2004 on measuring
instruments[10]
has been substantially amended several times. Since further amendments are to
be made, it should be recast in the interests of clarity.

(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[11] 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[12]
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 2004/22/EC should therefore be adapted
to that Decision.

ê 2004/22/EC
recital 2

(4)
Correct and traceable measuring instruments can
be used for a variety of measurement tasks. Those responding to reasons of
public interest, public health, safety and order, protection of the environment
and the consumer, of levying taxes and duties and of fair trading, which
directly and indirectly affect the daily life of citizens in many ways, may
require the use of legally controlled measuring instruments.

ê 2004/22/EC
recital 3 (adapted)

(5)
Legal metrological control should not lead to
barriers to the free movement of measuring instruments. The provisions
concerned should be the same in all Member States and proof of conformity
accepted throughout the Community Ö Union Õ .

ê 2004/22/EC
recital 4

(6)
Legal metrological control requires conformity
with specified performance requirements. The performance requirements that the
measuring instruments must meet should provide a high level of protection. The
conformity assessment should provide a high level of confidence.

ê 2004/22/EC
recital 5

(7)
Member States should as a general rule prescribe
legal metrological control. Where legal metrological control is prescribed,
only measuring instruments complying with common performance requirements
should be used.

ê 2004/22/EC
recital 6 (adapted)

(8)
The principle of optionality introduced by this
Directive Ö 2004/22/EC
allows Õ , whereby
Member States may
Ö to Õ exercise their
right to decide whether or not to regulate any Ö prescribe
the use Õ of the
instruments covered by this Directive, should be applicable only to the extent that this
will not cause unfair competition.

ê 2004/22/EC
recital 7

The
responsibilities of the manufacturer for compliance with the requirements of
this Directive should be specifically stated.

ê 2004/22/EC
recital 8 (adapted)

(9)
The performance of measuring instruments is
particularly sensitive to the environment, Ö in Õ particular the
electromagnetic environment. Immunity of measuring instruments to
electromagnetic interference Ö should Õ forms
an integral part of this Directive and the immunity requirements of Council
Directive 89/336/EEC 2004/108/EC of the European Parliament and of
the Council of 3 May 1989 15 December 2004 on the approximation of
the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC[13] should
therefore not apply.

ê 2004/22/EC
recital 17 (adapted)

ð new

(10)
ð In order to ensure the free
circulation of measuring instruments in the Union, ï Member States should not impede the placing on the market
and/or putting into use of measuring instruments that carry the ‘CE’ Ö CE Õ marking and
supplementary metrology marking in accordance with the provisions of this
Directive.

ê 22/2004
recital 18 (adapted)

(11)
Member States should take appropriate action to
prevent non-complying measuring instruments from being placed on the market
and/or put into use. Adequate cooperation between the competent authorities of
the Member States is therefore necessary to ensure a Community-wide Ö Union-wide Õ effect of this
objective.

ò new

(12)
Economic operators
should be responsible for the compliance of measuring instruments, in relation
to their respective roles in the supply chain, so as to ensure a high level of
protection of public interests, such as health and safety and the protection of
users, and to guarantee fair competition on the Union market.

(13)
All economic operators
intervening in the supply and distribution chain should take appropriate
measures to ensure that they only make available on the market measuring
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.

(14)
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.

(15)
It is necessary to
ensure that measuring
instruments from third
countries entering the Union market comply with the requirements of this
Directive, and in particular that the appropriate assessment procedures have
been carried out by manufacturers with regard to those measuring instruments. Provision should therefore be made for importers to
make sure that the measuring
instruments they place on the
market comply with the requirements of this Directive and that they do not
place on the market measuring
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.

(16)
The distributor makes
a measuring 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 measuring instrument does not adversely affect the compliance of the
measuring instrument.

(17)
When placing a
measuring instrument on the market, every importer should indicate on the
measuring 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
product does not allow it. This includes cases where the importer would have to
open the packaging to put his name and address on the product.

(18)
Any economic operator
that either places a measuring instrument on the market under its own name or
trademark or modifies a measuring 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.

(19)
Distributors and
importers, being close to the market place, should be involved in market
surveillance tasks carried out by competent national authorities, and should be
prepared to participate actively, providing those authorities with all
necessary information relating to the measuring instrument concerned.

(20)
Ensuring traceability
of a measuring 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 measuring instruments available on the market.

ê 2004/22/EC
recital 9 (adapted)

ð new

(21)
Community legislation should specify Ö This
Directive should be limited to the expression of Õ essential
requirements that do not impede technical progress, preferably performance
requirements. Provisions to remove technical barriers to trade
should follow the Council Resolution of 7 May 1985 on a new approach to
technical harmonisation and standards. ð In order to facilitate conformity
assessment with those requirements it is necessary to provide for presumption
of conformity for measuring instruments which are in conformity with harmonised
standards 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[14] for the purpose of expressing
detailed technical specifications of those requirements. ï

ò new

(22)
Regulation (EU) No
[.../...] [on European Standardisation] provides for a procedure for objections to
harmonised standards where those standards do not entirely satisfy requirements
of this Directive.

ê 2004/22/EC
recital 12 (adapted)

(23)
The technical and performance specifications of
internationally agreed normative documents may also comply, in part or in full,
with the essential requirements laid down by this Directive. In those cases the
use of these internationally agreed normative documents can be Ö should be
allowed as Õ an alternative
to the use of harmonised standards and, under specific conditions, give rise to
a presumption of conformity.

ê 2004/22/EC
recital 13

(24)
Conformity with the essential requirements laid
down by this Directive can also be provided by specifications that are not
supplied by a European technical standard or an internationally agreed
normative document. The use of European technical standards or internationally
agreed normative documents should therefore be optional.

ò new

(25)
In order to enable
economic operators to demonstrate and the competent authorities to ensure that
measuring instruments made available on the market comply with 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.
However, it is necessary to adapt those modules in order to reflect specific
aspects of metrological control.

ê 2004/22/EC
recital 14 (adapted)

(26)
The conformity assessment of sub-assemblies
should Ö be
carried out in accordance with Õ respect the provisions of
this Directive. If sub-assemblies are traded separately and independently of an
instrument, the exercise of conformity assessment should be undertaken
independently of the instrument concerned.

ê 2004/22/EC
recital 15

(27)
The state of the art in measurement technology
is subject to constant evolution which may lead to changes in the needs for
conformity assessments. Therefore, for each category of measurement and, where
appropriate, sub-assemblies, there must be an appropriate procedure or a choice
between different procedures of equivalent stringency. The procedures adopted are as required by Council
Decision 93/465/EEC of 22 July 1993 concerning the modules for the various
phases of the conformity assessment procedures and the rules for the affixing
and use of the ‘CE’ marking, which are intended to be used in the technical
harmonisation Directives[15]. However, derogations may have to be made for
these modules in order to reflect specific aspects of metrological control.
Provision should be made for the ‘CE’ marking to be affixed during the
fabrication process.

ò new

(28)
Manufacturers should
draw up an EU declaration of conformity to provide detailed information on the
conformity of a measuring instrument with the requirements of this Directive
and of other relevant Union harmonisation legislation.

(29)
The CE marking and the
supplementary metrology marking, indicating the conformity of a measuring instrument, are 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. Rules governing the affixing of the CE
marking and the supplementary metrology marking should be laid down in this
Directive.

ê 2004/22/EC
recital 10 (adapted)

ð new

(30)
In order to take account of differences in
climatic conditions or of different levels of consumer protection that may
apply at national level, Ö it is
necessary to establish Õ essential requirements
may give rise to the establishment of environmental or
accuracy classes ð as essential requirements ï .

ê 2004/22/EC
recital 11

In order to ease
the task of proving conformity with the essential requirements and to enable
conformity to be assessed, it is desirable to have harmonised standards. Such
harmonised standards are drawn up by private-law bodies and should retain
their status as non-mandatory texts. To this end, 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 on cooperation between the Commission and the European
Standardisation bodies signed on 13 November 1984.

ò new

(31)
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 2004/22/EC
recital 16 (adapted)

Continued development in measurement technology
as well as concerns expressed by stakeholders about certification, stress the
need to ensure consistent conformity assessment procedures for industrial
products, as requested by the Council Resolution adopted on 10 November
2003[16].

ò new

(32)
Experience has shown
that the criteria set out in Directive 2004/22/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. Those requirements should take into account continued development in
measurement technology.

(33)
In order to ensure a
consistent level of quality in the performance of conformity assessment of measuring instruments, it is also necessary to set
requirements for notifying authorities and other bodies involved in the
assessment, notification and monitoring of notified bodies.

(34)
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.

(35)
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.

(36)
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.

(37)
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 measuring 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.

(38)
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.

(39)
            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.

ê 22/2004
recital 17 (adapted)

Member States should not impede the placing on
the market and/or putting into use of measuring instruments that carry the ‘CE’
marking and supplementary metrology marking in accordance with the provisions
of this Directive.

ê 22/2004
recital 18

Member States should
take appropriate action to prevent non-complying measuring instruments from
being placed on the market and/or put into use. Adequate cooperation between
the competent authorities of the Member States is therefore necessary to ensure
a Community-wide effect of this objective.

ò new

(40)
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.

(41)
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 measuring instruments.

(42)
Directive 2004/22/EC
already provides for a safeguard procedure allowing the Commission to examine
the justification for a measure taken by a Member State against measuring
instruments it considers to be non-compliant. In order to increase transparency
and to reduce processing time, it is necessary to improve the existing
safeguard clause procedure, with the view to making it more efficient and
drawing on expertise available in Member States.

(43)
The existing system
should be supplemented by a procedure under which interested parties are
informed of measures intended to be taken with regard to measuring instruments
presenting a risk to the aspects of public interest protection covered by this
Directive. It should also allow market surveillance authorities, in cooperation
with the relevant economic operators, to act at an earlier stage in respect of
such measuring instruments.

(44)
Where Member States
and the Commission agree as to the justification for a safeguard 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.

ê 2004/22/EC
recital 19

Manufacturers
should be informed of the grounds on which negative decisions in respect of
their products were taken, and of the legal remedies available to them.

ê 2004/22/EC
recital 20

Manufacturers
should be offered the possibility to exercise the rights obtained before the
entry into force of this Directive, during a reasonable transitional period.

ê 2004/22/EC
recital 21

(45)
National specifications concerning the
appropriate national requirements in use should not interfere with the
provisions of this Directive on ‘putting into use’.

ê 2004/22/EC
recital 22 (adapted)

The measures necessary for the implementation
of this Directive should be adopted in accordance with Council Decision
1999/468/EC of 28 June 1999 laying down the procedures for the exercise of
implementing powers conferred on the Commission[17].

ê 2004/22/EC
recital 23

The activity of the Measuring Instruments Committee should include proper consultations with
representatives of interested parties.

ê 2004/22/EC
recital 24 (adapted)

Directives 71/318/EEC, 71/319/EEC, 71/348/EEC,
73/362/EEC, 75/33/EEC, as concerns the meters defined in Annex MI-001 of
this Directive, 75/410/EEC, 76/891/EEC, 77/95/EEC, 77/313/EEC, 78/1031/EEC and
79/830/EEC should therefore be repealed,

ò new

(46)
It is necessary to
provide for transitional arrangements that allow making available on the market
and putting into use measuring instruments that
have already been placed on the market in accordance with Directive 2004/22/EC.

(47)
The 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.

(48)
In order to ensure
uniform conditions for the implementation of this Directive, implementing
powers should be conferred to the Commission. Those powers should be exercised
in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16
February 2011 laying down the rules and general principles concerning
mechanisms for control by the Member States of the Commission's exercise of
implementing powers[18].

(49)
The examination
procedure should be used for the implementing decisions with respect to the
objections to the internationally agreed normative documents whose references
were already published in the Official Journal of the European Union and
which the Commission considers justified, given that such decisions could have
consequences on the presumption of conformity with the applicable essential
requirements.

(50)
In order to take into
account the developments in the measurement technology, the power to adopt acts
in accordance with Article 290 of the Treaty on the Functioning of the European
Union should be delegated to the Commission in respect of amendments to the
instrument-specific Annexes. It is of particular importance that the Commission
carry out appropriate consultations during its preparatory work, including at
expert level.

(51)
The Commission, when
preparing and drawing-up delegated acts, should ensure a simultaneous, timely
and appropriate transmission of relevant documents to the European Parliament
and Council.

(52)
Since
the objective of this Directive, namely to ensure that measuring instruments on
the market fulfil the requirements providing a high level of protection of the
public interests covered by this Directive 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.

(53)
The
obligation to transpose this Directive into national law should be confined to
those provisions which represent a substantive change as compared with earlier
Directives. The obligation to transpose the provisions which are unchanged
arises under earlier Directives.

(54)
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 XIII, Part B,

ê 2004/22/EC
(adapted)

ð new

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER 1

Ö GENERAL PROVISIONS Õ

Article 31

Object Ö Subject matter Õ

This Directive establishes the requirements
that the devices
and systems referred to in Article 1 Ö measuring
instruments Õ have to
satisfy with a view to their being placed
ð made available ï on the market and/or put into use for those Ö the measuring Õ tasks mentioned
Ö referred to Õ in Article 23(1).

Article 12

Scope

1.         This Directive applies to the Ö measuring
instruments Õ devices and systems with
a measuring function defined in the
instrument-specific aAnnexes III
to XII Ö ,
hereinafter instrument-specific Annexes, Õ concerning
water meters (MI-001), gas meters and volume conversion devices (MI-002),
active electrical energy meters (MI-003), heat meters (MI-004), measuring
systems for continuous and dynamic measurement of quantities of liquids other
then water (MI-005), automatic weighing instruments (MI-006), taximeters
(MI-007), material measures (MI-008), dimensional measuring instruments
(MI-009) and exhaust gas analysers (MI-010).

ê 2004/22/EC

2.         This Directive is a specific Directive in respect of
requirements for electromagnetic immunity in the sense of Article 21(24) of Directive 2004/108/EC 89/336/EEC.
Directive 2004/108/EC 89/336/EEC
continues to apply with regard to emission requirements.

ê 2004/22/EC
(adapted)

Article 23

Ö Optionality Õ

1.         Member States may prescribe the
use of measuring instruments mentioned in Article 1 for measuring tasks for
reasons of public interest, public health, public safety, public order,
protection of the environment, protection of consumers, levying of taxes and
duties and fair trading, where they consider it justified.

ê 2004/22/EC

2.         Where Member States do not
prescribe such use, they shall communicate the reasons therefore to the Commission and the other Member
States.

ê 2004/22/EC
(adapted)

Article 4

Definitions

For the purposes of this Directive Ö the
following definitions apply Õ :

ê 2004/22/EC

(a1) ‘measuring instrument’ means any
device or system with a measurement function that is covered by Articles
1
and 32(1);

(b2) ‘sub-assembly’ means a hardware device,
mentioned as such in the specific annexes, that functions independently and
makes up a measuring instrument together with other sub-assemblies with which
it is compatible, or with a measuring instrument with which it is compatible;

(c3) ‘legal metrological control’ means
the control of the measurement tasks intended for the field of application of a
measuring instrument, for reasons of public interest, public health, public
safety, public order, protection of the environment, levying of taxes and duties,
protection of the consumers and fair trading;

ê 2004/22/EC
(adapted)

(i4)    ‘normative document’ means a
document containing technical specifications adopted by the Ö International Õ Organisation Ö of Legal
Metrology, hereinafter “OIML” Õ Internationale de
Métrologie Légale (OIML), subject to the
procedure stipulated in Article 16(1).

(e5)   ‘placing on the market’ means Ö the
first Õ making
available for the first
time Ö of a
measuring instrument on Õ in the Community
Ö Union
market Õ an instrument intended
for an end user, whether for reward or free of charge;

ò new

(6)     ‘making
available on the market‘ means any supply of a measuring 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;

ê 2004/22/EC

(f7)    ‘putting into use’ means the first
use of an instrument intended for the end user for the purposes for which it
was intended;

ê 2004/22/EC
(adapted)

ð new

(d8) ‘manufacturer’ means a Ö any Õ natural or
legal person responsible for the conformity of the
ð who manufactures a measuring
instrument or has a ï measuring instrument ð designed or manufactured, and ï with this Directive with a view to either placing
it on the market
ð markets that measuring
instrument ï under his own name ð or trademark ï and/or
putting
Ö puts Õ it into use
for his own purposes;

ê 2004/22/EC
(adapted)

(g9) ‘authorised representative’ means a Ö any Õ natural or
legal person who is
established within the Community Ö Union Õ and authorised by
Ö who has
received a written mandate from Õ a manufacturer, in writing,
to act on his behalf for Ö in
relation to Õ specified
tasks within the
meaning of this Directive;

ò new

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

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

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

(13) ‘technical specification’ means a document
that prescribes technical requirements to be fulfilled by a measuring
instrument;

ê 2004/22/EC

ð new

(h14) ‘harmonised standard’ means ð harmonised standard as defined in
Article 2(1)(c) of Regulation (EU) No [.../...] [on European Standardisation] ï a technical specification adopted by CEN,
CENELEC or ETSI or jointly by two or all of these organisations, at the request
of the Commission pursuant to 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 and of rules on Information Society services[19] and prepared in accordance with the General
Guidelines agreed between the Commission and the European standards
organisations ;

ò new

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

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

(17) "conformity
assessment" means the process demonstrating whether the requirements of
this Directive relating to a measuring instrument have been fulfilled;

(18) "conformity
assessment body" means a body that performs conformity assessment
activities including calibration, testing, certification and inspection;

(19) "recall"
means any measure aimed at achieving the return of a measuring instrument that
has already been made available to the end user;

(20)   "withdrawal"
means any measure aimed at preventing a measuring instrument in the supply chain
from being made available on the market;

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

(22)   "Union
harmonisation legislation" means any Union legislation harmonising the
conditions for the marketing of products.

ê 2004/22/EC

Article 5

Applicability to sub-assemblies

ê 2004/22/EC
(adapted)

Where specific annexes exist, laying down
the essential requirements for sub-assemblies, the provisions of this Directive
shall apply mutatis mutandis to such sub-assemblies.

ê 2004/22/EC

Sub-assemblies and measuring instruments
may be assessed independently and separately for the purpose of establishing
conformity.

Article 6

Essential requirements and
assessment of conformity

ê 2004/22/EC
(adapted)

1. A measuring instrument shall meet the essential requirements laid down
Ö set
out Õ in Annex I and
in the relevant instrument-specific Annex.

ê 2004/22/EC

ð new

Member States may require, if it is needed
for correct use of the instrument, the information referred to in point 9 of Annex I or in the relevant
instrument-specific aAnnexes to be provided in the official
language(s) of the Member State in which the instrument is placed ð made available ï on the market.

2. The conformity
of a measuring instrument with the essential requirements shall be assessed
in accordance with Article 9.

ê 2004/22/EC
(adapted)

Article 87

Placing Ö Making
available Õ on
the market and putting into use

ê 2004/22/EC
(adapted)

ð new

1. Member States shall not impede for
reasons covered by this Directive the placing
ð making available ï on the market and/or putting into use of any measuring instrument
that carries the ‘CE’
Ö CE Õ marking and
supplementary metrology marking in accordance with Article 723.

2. Member States shall take all appropriate
measures to ensure that measuring instruments be placed
ð are made available ï on the market and/or put into use only if they satisfy the
requirements of this Directive.

ê 2004/22/EC
(adapted)

3. A Member State may require a measuring
instrument to satisfy provisions governing its putting into use that are
justified by local climatic conditions. In such a case, the Member State shall
choose appropriate upper and lower temperature limits from Table 1 of Annex I
and, in addition,
may specify humidity conditions (condensing or non-condensing) and whether the
intended location of use is open or closed.

ê 2004/22/EC

4. When different accuracy classes are
defined for a measuring instrument:

(a) the instrument-specific aAnnexes under the heading ‘Putting into
use’ may indicate the accuracy classes to be used for specific applications,;

(b) in all other cases a Member
State may determine the accuracy classes to be used for specific applications
within the classes defined, subject to allowing the use of all accuracy classes
on its territory.

ê 2004/22/EC
(adapted)

ð new

In either case falling under Ö For the
purposes of point Õ (a) or (b),
measuring instruments of a better accuracy class may be used if the owner so
chooses.

5. At trade fairs, exhibitions, demonstrations, etc. Ö or
similar events Õ , Member
States shall not prevent the showing of Ö measuring Õ instruments
not in conformity with this Directive, provided that a visible sign clearly
indicates their non-conformity and their non-availability for placing ð making available ï on the market and/or putting into use until Ö they
are Õ brought into
conformity.

ò new

CHAPTER 2

OBLIGATIONS OF ECONOMIC OPERATORS

Article 8 [Article
R2 of Decision No 768/2008/EC]

Obligations of manufacturers

1.           When
placing their measuring instruments on the market and/or putting them into use,
manufacturers shall ensure that they have been designed and manufactured in
accordance with the essential requirements set out in Annex I and in the
relevant instrument specific Annexes.

2.           Manufacturers
shall draw up the required technical documentation referred to in Article 19
and carry out the relevant conformity assessment procedure referred to in
Article 18 or have it carried out.

Where compliance of a
measuring instrument with the applicable requirements of this Directive has
been demonstrated by that procedure, manufacturers shall draw up an EU
declaration of conformity and affix the CE marking and the supplementary
metrology marking.

3.           Manufacturers
shall keep the technical documentation and the EU declaration of conformity for
10 years after the measuring 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 measuring instrument design or characteristics and
changes in the harmonised standards, normative documents or in technical
specifications by reference to which conformity of a measuring instrument is
declared shall be adequately taken into account.

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

5.           Manufacturers shall ensure that their measuring instruments bear a type, batch or serial number or other
element allowing their identification, or, where the size or nature of the measuring
instrument does not allow it, that the
required information is provided on the packaging or in a document accompanying
the measuring instrument.

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

7.           Manufacturers
shall ensure that the measuring instrument
is accompanied by instructions and information in accordance with point 9.3 of
Annex I, in a language which can be easily understood by end‑users, as
determined by the Member State concerned.

8.           Manufacturers
who consider or have reason to believe that a measuring 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 measuring
instrument into conformity, to withdraw it or recall it, if appropriate.
Furthermore, where the measuring instrument
presents a risk, manufacturers shall immediately inform the competent national
authorities of the Member States in which they made the measuring 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 measuring 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 measuring instruments
which they have placed on the market.

Article 9 [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 8(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 measuring 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 a measuring instrument;

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

Article 10 [Article
R4 of Decision No 768/2008/EC]

Obligations of importers

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

2.           Before
placing a measuring instrument on
the market and/or putting a measuring
instrument into use 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 measuring instrument bears the CE marking and the supplementary
metrology marking and is accompanied by the required documents, and that the
manufacturer has complied with the requirements set out in Article 8(5)
and (6).

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

3.           Importers
shall indicate their name, registered trade name or registered trade mark and the address at
which they can be contacted on the measuring instrument or, where that is not
possible, on its packaging or in a document accompanying the measuring
instrument in accordance with point 9.2 of Annex I.

4.           Importers
shall ensure that the measuring instrument is accompanied by instructions and
information in accordance with point 9.3 of Annex I, in a language which can be
easily understood by end-users, as determined by the Member State concerned.

5.           Importers
shall ensure that, while a measuring instrument is under their responsibility,
storage or transport conditions do not jeopardise its compliance with the
requirements set out in Annex I and in the relevant instrument specific
Annexes.

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

7.           Importers
who consider or have reason to believe that a measuring 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 measuring instrument
into conformity, to withdraw it or recall it, if appropriate. Furthermore,
where the measuring instrument presents a risk, importers shall immediately
inform the competent national authorities of the Member States in which they
made the measuring instrument available to that effect, giving details, in
particular, of the non-compliance and of any corrective measures taken.

8.           Importers
shall, for 10 years after the measuring 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 a measuring 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 measuring
instruments which they have placed on the market.

Article 11 [Article
R5 of Decision No 768/2008/EC]

Obligations of distributors

1.           When
making a measuring instrument available on the market and/or put into use,
distributors shall act with due care in relation to the requirements of this
Directive.

2.           Before
making a measuring instrument available on the market and/or putting a
measuring instrument into use distributors shall verify that the measuring
instrument bears the CE marking and the supplementary metrology marking, that
it is accompanied by the required documents and by instructions and information
in accordance with point 9.3 of Annex I, in a language which can be easily
understood by end-users in the Member State in which the measuring instrument
is to be made available on the market and/or put into use, and that the
manufacturer and the importer have complied with the requirements set out in
Article 8(5) and (6) and Article 10(3).

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

3.           Distributors
shall ensure that, while a measuring instrument is under their responsibility,
storage or transport conditions do not jeopardise its compliance with the
essential requirements set out in Annex I and in the relevant instrument
specific Annexes.

4.           Distributors
who consider or have reason to believe that a measuring instrument which they
have made available on the market or put into use is not in conformity with
this Directive shall make sure that the corrective measures necessary to bring
that measuring instrument into conformity, to withdraw it or recall it, if
appropriate, are taken. Furthermore, where the measuring instrument presents a
risk, distributors shall immediately inform the
competent national authorities of the Member States in which they made the
measuring 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 a measuring instrument. They shall cooperate with that
authority, at its request, on any action taken to eliminate the risks posed by
measuring instruments which they have made available on the market.

Article 12 [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 8, where he places a measuring instrument on the market under his
name or trademark or modifies a measuring instrument placed on the market in
such a way that compliance with the requirements of this Directive may be
affected.

Article 13 [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,
for 10 years:

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

(b)     any economic
operator to whom they have supplied a measuring 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
measuring instrument and for a period of 10 years after they have supplied the measuring
instrument.

ê 2004/22/EC
(adapted)

CHAPTER 3

Ö CONFORMITY
OF MEASURING INSTRUMENTS Õ

Article 1314
[Article R8 of Decision 768/2008/EC]

Harmonised
standards and normative documents Ö Presumption of conformity Õ

ê 2004/22/EC

1. Member States
shall presume conformity with the essential requirements referred to in
Annex I and in the relevant instrument-specific Annexes in respect of a
measuring instrument that complies with the elements of the national standards
implementing the European harmonised standard for that measuring instrument
that correspond to those elements of this
European harmonised standard the references in respect of which have been
published in the Official Journal of the European Union, C series.

Where a measuring
instrument complies only in part with the elements of the national standards
referred to in the first subparagraph, Member States shall presume conformity
with the essential requirements corresponding to the elements of the national
standards with which the instrument complies.

Member States
shall publish the references to the national standards referred to in the
first subparagraph.

2. Member States
shall presume conformity with the essential requirements referred to in Annex I
and in the relevant instrument-specific Annexes in respect of a measuring
instrument that complies with the corresponding parts of the normative
documents and lists referred to in Article 16(1)(a), the references in respect
of which have been published in the Official Journal of the European Union, C series.

Where a measuring
instrument complies only in part with the normative document referred to in
the first subparagraph, Member States shall presume conformity with the
essential requirements corresponding to the normative elements with which the
instrument complies.

Member States
shall publish the references of the normative document referred to in the
first subparagraph.

ò new

1.           Measuring
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
and in the relevant instrument specific Annexes.

2.           Measuring
instruments which are in conformity with the normative documents or parts there
of, the references of which have been published in the Official Journal of
the European Union, shall be presumed to be in conformity with the
requirements covered by those normative documents or parts thereof, set out in
Annex I and in the relevant instrument specific Annexes.

ê 2004/22/EC
(adapted)

3.           A manufacturer may choose
to use any technical solution that complies with the essential requirements
referred to in Annex I and in the relevant instrument-specific Annexes (MI-001 to
MI-010) III to XII.
In addition, to benefit from the presumption of conformity, the manufacturer
must correctly apply solutions mentioned either in the relevant European
harmonised standards, or in the corresponding parts
of the normative documents and lists as referred to in
paragraphs 1 and 2.

ê 2004/22/EC

4.           Member States shall
presume compliance with the appropriate tests mentioned in point (i) of Article
1019(3) if the corresponding test
programme has been performed in accordance with the relevant documents
mentioned in paragraphs 1 to, 2 and 3 and if the test results ensure
compliance with the essential requirements.

ò new

[Article 15]

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

ê 2004/22/EC
(adapted)

ð new

Article 16

Functions of the
Measuring Instruments Committee Ö Publication of the references of normative
documents Õ

1.         ð Where a normative document satisfies
the requirements which it covers and which are set out in Annex I and in the
relevant instrument specific Annexes, the Commission may ï , on request by a Member State or on its own
initiative, the Commission, acting in accordance with the procedure referred to
in Article 15(2), may take any appropriate measure to:

(a)          identify
normative documents drawn up by OIML and, in a list, indicate the parts thereof
compliance with which gives rise to a presumption of conformity with the
corresponding essential requirements of this
Directive;

(b)          publish the reference of the Ö that Õ normative
documents and the list referred to in point (a)
in the Official Journal of the European Union, C series.

ê 2004/22/EC
(adapted)

Article
17

Ö Withdrawal of the references of normative
documents Õ

3. Where Ö When Õ a Member State
or the Commission considers that a normative document whose references
have
Ö has Õ been published
in the Official Journal of the European Union, C series, in accordance with paragraph 1(b), does
not fully meet
Ö entirely
satisfy Õ the essential
requirements Ö which it
covers and which are set out Õ referred to
in Annex I and in the relevant instrument-specific Annexes, that Member State or the
Commission shall Ö decide Õ bring the matter before
the Measuring Instruments Committee, giving the reasons for doing so.

The Commission, acting
in accordance with the procedure referred to in Article 15(2), shall inform the
Member States whether or not it is necessary
to withdraw the references to Ö of Õ the Ö that Õ normative
document concerned
from publication in
the Official Journal of the European Union.

ò new

Those decisions
shall be adopted in accordance with the examination procedure referred to in
Article 46(2).

ê 2004/22/EC
(adapted)

Article 918

Conformity assessment Ö procedures Õ

ê 2004/22/EC

Conformity assessment of a measuring
instrument with the relevant essential requirements shall be carried out by the
application, at the choice of the manufacturer, of one of the conformity
assessment procedures listed in the instrument-specific aAnnex. The manufacturer
shall provide, where appropriate, technical documentation for specific
instruments or groups of instruments as set out in Article 10.

ê 2004/22/EC
(adapted)

The conformity assessment modules making up the
procedures are described
Ö set
out Õ in Annexes
A to H1 Annex II.

ê 2004/22/EC

Records and correspondence relating to conformity
assessment shall be drawn up in the official language(s) of the Member State
where the notified body carrying out the Conformity assessment procedures is
established, or in a language accepted by that body.

Article 1019

Technical Documentation

1. The technical documentation shall render
the design, manufacture and operation of the measuring instrument intelligible
and shall permit an assessment of its conformity with the appropriate
requirements of this Directive.

ê 2004/22/EC
(adapted)

2. The technical documentation shall be
sufficiently detailed to ensure Ö compliance
with the following requirements Õ :

ê 2004/22/EC

(a)     the definition of the metrological characteristics,;

ê 2004/22/EC
(adapted)

(b)     the reproducibility of the metrological performances of
produced instruments when properly adjusted using appropriate intended means, and;

(c)     the integrity of the instrument.

3. The technical documentation shall include
insofar as relevant for assessment and identification of the type and/or
instrument Ö include the
following information Õ:

ê 2004/22/EC

(a) a general description of the
instrument;

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

(c) manufacturing procedures to
ensure consistent production;

(d) if applicable, a description
of the electronic devices with drawings, diagrams, flow diagrams of the logic
and general software information explaining their characteristics and
operation;

(e) descriptions and
explanations necessary for the understanding of paragraphs (b), (c) and (d),
including the operation of the instrument;

(f) a list of the standards
and/or normative documents referred to in Article 1314, applied in full or in part;

(g) descriptions of the
solutions adopted to meet the essential requirements where the standards and/or
normative documents referred to in Article 1314 have not been applied;

(h) results of design
calculations, examinations, etc;

ê 2004/22/EC
(adapted)

(i) the appropriate test
results, where necessary, to demonstrate that the type and/or instruments
comply with Ö the
following Õ :

ê 2004/22/EC

–
the requirements of this Directive under
declared rated operating conditions and under specified environmental
disturbances,

–
the durability specifications for gas-, water-,
heat-meters as well as for liquids other than water.

ê 2004/22/EC
(adapted)

(j) the Ö EU-type Õ EC-type
examination certificates or Ö EU Õ EC
design examination certificates in respect of instruments containing parts
identical to those in the design.

ê 2004/22/EC

4. The manufacturer shall specify where
seals and markings have been applied.

5. The manufacturer shall indicate the
conditions for compatibility with interfaces and sub-assemblies, where
relevant.

ê 2004/22/EC

Article 11

Notification

1. Member States
shall notify to the other Member States and the Commission the bodies under
their jurisdiction, which they have designated to carry out the tasks
pertaining to the conformity assessment modules referred to in Article 9,
together with the identification numbers given to them by the Commission in
accordance with paragraph 4 of this Article, the kind(s) of measuring
instrument for which each body has been designated and in addition, where
relevant, the instrument accuracy classes,
the measuring range, the measurement technology, and any other instrument
characteristic limiting the scope of the notification.

2. Member States
shall apply the criteria set out in Article 12 for the designation of such
bodies. Bodies that meet the criteria laid down in the national standards
which transpose the relevant harmonised standards, the references of which have
been published in the Official Journal of the European Union, shall be presumed to meet the corresponding
criteria. Member States shall publish the references to these national
standards.

3. A Member State
that has notified a body shall:

–
ensure that the
body continues to meet the criteria set out in Article 12,

–
withdraw such
notification if it finds that the body no longer meets those criteria.

It shall forthwith
inform the other Member States and the Commission of any such withdrawal.

4. Each of the
bodies to be notified shall be given an identification number by the
Commission. The Commission shall publish the list of notified bodies, together
with the information in respect of the scope of the notification referred to in
paragraph 1, in the Official
Journal of the European Union, C series, and shall ensure that the list is kept
up to date.

Article 12

Criteria to be
satisfied by designated bodies

Member States
shall apply the following criteria for the designation of bodies in accordance
with Article 11(1).

1.
The body, its director and staff involved in conformity assessment tasks shall
not be the designer, manufacturer, supplier, installer or user of the
measuring instruments that they inspect, nor the authorised representative of
any of them. In addition, they may not be directly involved in the design,
manufacture, marketing or maintenance of the instruments, nor represent the
parties engaged in these activities. The
preceding criterion does not, however, preclude in any way the possibility of
exchanges of technical information between the manufacturer and the body for
the purposes of conformity assessment.

2.
The body, its director and staff involved in conformity assessment tasks
shall be free from all pressures and inducements, in particular financial
inducements, that might influence their judgement or the results of their
conformity assessment, especially from persons or groups of persons with an interest in the results of the
assessments.

3.
The conformity assessment shall be carried out with the highest degree of
professional integrity and requisite competence in the field of metrology.
Should the body subcontract specific tasks, it shall first ensure that the
subcontractor meets the requirements of this Directive, and in particular of
this Article. The body shall keep the relevant documents assessing the
subcontractor's qualifications and the work carried out by him under this Directive at the disposal of the notifying authority.

4.
The body shall be capable of carrying out all the conformity assessment tasks
for which it has been designated, whether those tasks are carried out by the
body itself or on its behalf and under its responsibility. It shall have at
its disposal the necessary staff and shall have access to the necessary
facilities for carrying out in a proper manner the technical and administrative
tasks entailed in conformity assessment.

5.
The body's staff shall have:

–
sound technical
and vocational training, covering all conformity assessment tasks for which the
body was designated;

–
satisfactory
knowledge of the rules governing the tasks which it carries out, and adequate
experience of such tasks;

–
the requisite
ability to draw up the certificates, records and reports demonstrating that
the tasks have been carried out.

6.
The impartiality of the body, its director and staff shall be guaranteed. The
remuneration of the body shall not depend on the results of the tasks it carries
out. The remuneration of the body's director and staff shall not depend on the
number of tasks carried out or on the results of such tasks.

7.
The body shall take out civil liability insurance if its civil liability is not
covered by the Member State concerned under national law.

8.
The body's director and staff shall be bound to observe professional secrecy
with regard to all information obtained in the performance of their duties
pursuant to this Directive, except vis-à-vis the authority of the Member
State which has designated it.

Article 14

Standing Committee

Where a Member
State or the Commission considers that a European harmonised standard as
referred to in Article 13(1) does not fully meet the essential requirements
referred to in Annex I and in the relevant instrument-specific Annexes, the
Member State or the Commission shall bring the matter before the Standing
Committee set up under Article 5 of Directive 98/34/EC, 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 the references to the national standards
from the publication referred to in the third subparagraph of Article 13(1).

ò new

Article 20 [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 and in the relevant instrument specific Annexes
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 measuring instrument is placed or made available.

3.           Where a
measuring instrument is subject to more than one Union acts requiring an EU
declaration of conformity, a single EU declaration of conformity shall be drawn
up on 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 measuring instrument.

ê 2004/22/EC
(adapted)

Article 721

Conformity marking

1. The conformity of a measuring instrument with all the provisions of
this Directive shall be indicated by the presence on it of the ‘CE’ Ö CE Õ marking and
the supplementary metrology marking as specified in Article 1722.

2. The ‘CE’ marking and supplementary metrology
marking shall be affixed by, or under the responsibility of, the
manufacturer. These markings may be affixed to the instrument during the
fabrication process, if justified.

ê 2004/22/EC

3. The affixing of markings on a measuring
instrument that are likely to deceive third parties as to the meaning and/or
form of the ‘CE’ marking and the supplementary metrology marking shall be
prohibited. Any other marking may be affixed on a measuring instrument,
provided that the visibility and legibility of the ‘CE’ marking and the supplementary metrology marking is not thereby
reduced.

4. Where the measuring instrument is subject to
measures adopted under other Directives covering other aspects which require
the affixing of the ‘CE’ marking, the marking shall indicate that the
instrument in question is also presumed to conform to the requirements of those
other Directives. In such a case, the publication reference of the said
Directives, in the Official
Journal of the European Union, must be given in the documents, notices or
instructions required by those Directives and accompanying the measuring
instrument.

Article 17

Markings

1. The ‘CE’
marking referred to in Article 7 consists of the symbol ‘CE’ according to the
design laid down in paragraph I.B(d) of the Annex to Decision 93/465/EEC.
The ‘CE’ marking shall be at least 5 mm high.

ê 2004/22/EC
(adapted)

2. The supplementary metrology marking consists of
the capital letter ‘M’ and the last two digits of the year of its affixing,
surrounded by a rectangle. The height of the rectangle shall be equal to the
height of the ‘CE’ marking. The supplementary metrology marking shall
immediately follow the ‘CE’ marking.

ê 2004/22/EC

3. The
identification number of the notified body concerned referred to in Article
11, if prescribed by the conformity assessment procedure, shall follow the ‘CE’
marking and supplementary metrology marking.

ê 2004/22/EC
(adapted)

4. When a measuring instrument consists of a set
of devices, not being sub-assemblies, operating together, the markings shall
be affixed on the instrument's main device.

ê 2004/22/EC

When a measuring
instrument is too small or too sensitive to carry the ‘CE’ marking and
supplementary metrology marking, the markings shall be carried by the
packaging, if any, and by the accompanying documents required by this
Directive.

5. The ‘CE’
marking and supplementary metrology marking shall be indelible. The
identification number of the notified body concerned shall be indelible or
self destructive upon removal. All markings shall be clearly visible or easily
accessible.

ò new

Article 22 [Article
R11 of Decision No 768/2008/EC]

General principles of the CE marking and of the supplementary metrology
marking

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

ê 2004/22/EC
(adapted)

17.2.      The
supplementary metrology marking shall consist of the capital letter ‘M’ and the
last two digits of the year of its affixing, surrounded by a rectangle. The
height of the rectangle shall be equal to the height of the ‘CE’ Ö CE Õ marking. The supplementary
metrology marking shall immediately follow the ‘CE’ marking.

ò new

Article 23 [Article
R12 of Decision No 768/2008/EC]

Rules and conditions for affixing the CE marking and the supplementary
metrology marking

1.           The
CE marking and the supplementary metrology marking shall be affixed visibly,
legibly and indelibly to the measuring instrument or to its data plate. Where
that is not possible or not warranted on account of the nature of the measuring
instrument, they shall be affixed to the packaging and to the accompanying
documents, where the legislation concerned provides for such documents.

ê 2004/22/EC

4.2.        When a measuring instrument consists of a set of devices,
not being sub-assemblies, operating together, the markings shall be affixed on
the instrument's main device.

ò new

3.           The CE
marking and the supplementary metrology marking shall be affixed before the
measuring instrument is placed on the market.

ê 2004/22/EC
(adapted)

2.4.        The ‘CE’ Ö CE Õ marking and
supplementary metrology marking shall be
affixed by, or under the responsibility of, the manufacturer. These markings
may be affixed to the instrument during the fabrication process, if justified.

5.           The supplementary metrology marking shall immediately
follow the ‘CE’
Ö CE Õ marking.

ò new

The CE marking and
the supplementary metrology marking shall be followed by the identification
number of the notified body, where that body is 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.

6.           The CE
marking, the supplementary metrology marking and, where applicable, the
identification number referred to in paragraph 5 may be followed by a pictogram
or any other mark indicating a special risk or use.

The identification
number of the notified body concerned shall be indelible or self destructive
upon removal.

CHAPTER 4

NOTIFICATION
OF CONFORMITY ASSESSMENT BODIES

Article 24 [Article R13 of Decision No 768/2008/EC]

Notification

1.         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. That notification shall include information on the kind(s) of
measuring instrument(s) for which each body has been designated and, where
relevant, the instrument accuracy classes, the measuring range, the measurement
technology, and any other instrument characteristic limiting the scope of the
notification.

ê 2004/22/EC
(adapted)

2.         If a Member State has not introduced national legislation
for tasks mentioned
under Ö referred
to in Õ Article 23, it shall retain the right to designate and
notify a body for tasks relating to that Ö the
measuring Õ instrument Ö concerned Õ .

ò new

Article 25 [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 the provisions of Article 30.

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 26(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 26 [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 27 [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 28 [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 measuring 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 measuring 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 measuring instruments which they assess, nor the authorised
representative of any of those parties. This shall not preclude the use of
assessed measuring instruments that are necessary for the operations of the
conformity assessment body or the use of such measuring 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 measuring 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.

The second
subparagraph does not, however, preclude the possibility of exchanges of
technical information between the manufacturer and the body for the purposes of
conformity assessment.

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 24 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 measuring
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 measuring 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
and in the relevant instrument specific Annexes, of the applicable harmonised
standards and normative documents 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 24 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 29 [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 28
in so far as the applicable harmonised standards
cover those requirements.

Article 30 [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 28 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 24.

Article 31 [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 measuring
instrument or measuring 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 28.

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 28.

Article 32 [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 28.

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 measuring
instrument or measuring instruments concerned and the relevant attestation of
competence.

4.           Where a
notification is not based on an accreditation certificate as referred to in
Article 31(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 28.

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 33 [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 34 [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 28, 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 35 [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 36 [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
measuring 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 measuring instrument with the provisions of
this Directive.

3.           Where a
notified body finds that the essential requirements set out in Annex I and in
the relevant instrument specific Annexes or corresponding harmonised standards,
normative documents 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 a measuring 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 37

Appeal against decisions of notified bodies

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

Article 38 [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 measuring
instruments with relevant information on issues relating to negative and, on
request, positive conformity assessment results.

Article 39 [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 40 [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.

ê 2004/22/EC
(adapted)

CHAPTER
5

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

ê 2004/22/EC

Article 18

Market
surveillance and administrative cooperation

1. Member States
shall take all appropriate measures to ensure that measuring instruments
that are subject to legal metrological control but do not comply with
applicable provisions of this Directive are neither placed on the market nor
put into use.

2. The competent
authorities of the Member States shall assist each other in the fulfilment of
their obligations to carry out market surveillance.

In particular, the
competent authorities shall exchange:

–
information
concerning the extent to which instruments they examine comply with the
provisions of this Directive, and the results of such examinations;

–
EC-type
examination and design examination certificates and their annexes issued by
notified bodies as well as additions, amendments and withdrawals relating to
certificates already issued;

–
quality system
approvals issued by notified bodies, as well as information on quality
systems refused or withdrawn;

–
evaluation reports
established by notified bodies, when demanded by other authorities.

3. The Member
States shall ensure that all necessary information relating to the certificates
and quality system approvals is made available to bodies they have notified.

4. Each Member
State shall inform the other Member States and the Commission which competent
authorities it has designated for such exchange of information.

ò new

Article 41

Union market surveillance, control of measuring instruments entering
the Union market

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

Article 42 [Article
R31 of Decision No 768/2008/EC]

Procedure for dealing with measuring 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 a measuring 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
measuring 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 measuring
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 measuring instrument into compliance
with those requirements, to withdraw the measuring 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 measuring 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 the measuring instrument’s being made available on their national
market, to withdraw the measuring 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
measuring instrument, the origin of the measuring 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 measuring instrument to meet requirements relating to the aspects of public
interest protection laid down in this Directive;

(b)     shortcomings
in the harmonised standards or normative documents referred to in Article 14
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 measuring 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 measuring instrument concerned.

Article 43 [Article
R32 of Decision No 768/2008/EC]

Union safeguard procedure

1.           Where,
on completion of the procedure set out in Article 42(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 measuring 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
measuring instrument is attributed to shortcomings in the harmonised standards
referred to in Article 42(5)(b) of this Directive, the Commission shall apply
the procedure provided for in Article 8 of Regulation (EU) No [....] [on European
Standardisation].

ê 2004/22/EC
(adapted)

(a)4.       Should
the Commission find that the Ö Where the
national measure Õ measures taken by the Member
State concerned are Ö is
considered Õ justified, it shall immediately inform that Member State
thereof, as well as the other Member States.

The competent
Member State shall take appropriate action against any person who affixed the
markings and shall inform the Commission and the other Member States
thereof.

If Ö and Õ the
non-compliance Ö of the
measuring instrument Õ is attributed
to shortcomings in the standards or normative documents Ö referred
to in Article 42(5)(b) Õ, the
Commission shall,
after consulting the parties concerned, bring the matter as soon as possible
before the appropriate Committee referred to Ö apply the
procedure provided for Õ in Articles
17 14
or 15.

ò new

Article 44 [Article R33 of Decision No 768/2008/EC]

Compliant measuring instruments which present a risk to public interest
protection

1.           Where,
having performed an evaluation under Article 42(1), a Member State finds
that although a measuring 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
measuring instrument concerned, when placed on the market, no longer presents
that risk, to withdraw the measuring 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 measuring 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 measuring instrument concerned,
the origin and the supply chain of the measuring 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 measures are 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 45 [Article
R34 of Decision No 768/2008/EC]

Formal non-compliance

1.           Without
prejudice to Article 42, 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, the supplementary metrology marking or the identification number of
the notified body, where that body is involved in the production control phase,
has been affixed in violation of Article 30 of Regulation (EC) No 765/2008
or of Article 23 of this Directive;

(b)     the CE
marking, the supplementary metrology marking or the identification number of
the notified body, where that body is involved in the production control phase,
has 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 measuring
instrument being made available on the market or ensure that it is recalled or
withdrawn from the market.

ê 2004/22/EC

Article 19

Safeguard clause

1. Where a Member
State establishes that all or part of the measuring instruments of a particular
model that bear the ‘CE’ marking and the supplementary metrology marking do not
satisfy the essential requirements relating to metrological performance set out
in this Directive, when correctly installed
and used in accordance with the manufacturer's instructions, it shall take all
appropriate measures to withdraw these instruments from the market, prohibit or
restrict their further being placed on the market, or prohibit or restrict
their further being used.

When deciding on
the above measures, the Member State shall take account of the systematic or
incidental nature of the non-compliance. Where the Member State has established
that the non-compliance is of a systematic nature, it shall immediately
inform the Commission of the measures taken, indicating the reasons for its
decision.

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

ê 2004/22/EC
(adapted)

(a) Should the Commission find that the
measures taken by the Member State concerned are justified, it shall
immediately inform that Member State thereof, as well as the other Member
States.

The competent Member State shall take appropriate
action against any person who affixed the markings and shall inform the
Commission and the other Member States thereof.

If the non-compliance is attributed to
shortcomings in the standards or normative documents, the Commission shall,
after consulting the parties concerned, bring the matter as soon as possible
before the appropriate Committee referred to in Articles 14 or 15.

ê 2004/22/EC

(b)
Should the Commission find that the measures taken by the Member State
concerned are not justified, it shall immediately inform that Member State
thereof, as well as the manufacturer concerned or his authorised
representative.

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

Article 20

Unduly fixed
markings

1. Where a Member
State establishes that the ‘CE’ marking and supplementary metrology marking
have been affixed unduly, the manufacturer or his authorised representative
shall be obliged:

–
to make the
instrument conform as regards those provisions concerning the ‘CE’ marking
and supplementary metrology marking not covered by Article 19(1) and

–
to end the
infringement under the conditions imposed by the Member State.

2. Should the
infringement described above persist, 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 or
prohibit or restrict its further use in accordance with the procedures laid
down in Article 19.

Article 21

Decisions
entailing refusal or restriction

Any decision taken
pursuant to this Directive entailing the withdrawal from the market of a
measuring instrument, or prohibiting or restricting the placing on the market
or putting into use of an instrument, shall state the exact grounds on which
it is based. The decision shall be notified forthwith to the party concerned,
who shall at the same time be informed of the legal remedies available to him
under the law of the Member State concerned and of the time limits to which such remedies are subject.

ê 2004/22/EC
(adapted)

CHAPTER
6

Ö COMMITTEE
AND DELEGATED ACTS Õ

Article 1546

Measuring Instruments Committee Ö procedure Õ

1. The Commission shall be assisted by the
Measuring Instruments Committee. Ö That
Committee shall be a committee within the meaning of Regulation (EU) No
182/2011. Õ

2. Where reference is made to this
paragraph, Articles 3 and 7 of Decision
1999/468/EC Ö 5 of
Regulation (EU) No 182/2011 Õ shall
apply, having
regard to the provisions of Article 8 thereof.

ò new

3. Where the
opinion of the committee is to be obtained by written procedure, that procedure
shall be terminated without result when, within the time-limit for delivery of
the opinion, the chair of the committee so decides or a simple majority of
committee members so request.

ê 1137/2008

3. Where reference
is made to this paragraph, Article 5a(1) to (4) and Article 7 of
Decision 1999/468/EC shall apply, having regard to the provisions of
Article 8 thereof.

ê 2004/22/EC

5. The Commission
shall ensure that relevant information about envisaged measures, as referred to
in Article 16, is made available to interested parties in due time.

ê 2004/22/EC
(adapted)

Article 1647

Functions of the Measuring Instruments Committee Ö Amendments
of Annexes Õ

ò new

The Commission
shall be empowered to adopt delegated acts in accordance with Article 48
concerning the amendments of the instrument-specific Annexes III to XII.

ê 1137/2008

(2.) At the
request of a Member State or on its own initiative, the Commission may amend
the instrument-specific Annexes (MI-001 to MI-010) iIn
relation to the following:

(a) maximum permissible errors
(MPEs) and accuracy classes;

(b) rated operating conditions;

(c) critical change values;

(d) disturbances.

Those measures,
designed to amend non-essential elements of this Directive, shall be adopted
in accordance with the regulatory procedure with scrutiny referred to in
Article 15(3).

ê 2004/22/EC

4. Member States
may take appropriate measures to consult interested parties at national
level about OIML work relating to the scope of this Directive.

ò new

Article 48

Exercise of the delegation

1.           The
power to adopt delegated acts is conferred on the Commission subject to the
conditions laid down in this Article.

2.           The
delegation of power referred to in Article 47 shall be conferred for an
indeterminate period of time from the [the date set out in the second
subparagraph of Article 51].

3.           The
delegation of power referred to in Article 47 may be revoked at any time by the
European Parliament or by the Council. A decision of revocation shall put an
end to the delegation of the power specified in that decision. It shall take
effect the day following the publication of the decision in the Official
Journal of the European Union or at a later date specified therein.
It shall not affect the validity of any delegated acts already in force.

4.           As
soon as it adopts a delegated act, the Commission shall notify it
simultaneously to the European Parliament and to the Council.

5.           A
delegated act adopted pursuant to Article 46 shall enter into force only if no
objection has been expressed either by the European Parliament or the Council
within a period of 2 months of notification of that act to the European
Parliament and the Council or if, before the expiry of that period, the European Parliament and the
Council have both informed the Commission that they will not object. That period shall be extended by
2 months at the initiative of the European Parliament or the Council.

ê 2004/22/EC
(adapted)

CHAPTER
7

Ö TRANSITIONAL
AND FINAL PROVISIONS Õ

ê 2004/22/EC

Article 23

Transitional
provisions

By way of
derogation from Article 8(2), Member States shall permit, for measurement tasks
for which they have prescribed the use of a legally controlled measuring
instrument, the placing on the market and putting into use of measuring
instruments that satisfy the rules applicable before 30 October 2006 until the
expiry of the validity of the type approval
of those measuring instruments or, in the case of a type approval of indefinite
validity, for a period of a maximum of ten years from 30 October 2006.

ê 2006/96/EC

For the purpose of
this transition period, the monetary values for Bulgaria and Romania
according to point 4.8.1 of Chapter IV of the Annex to Directive 71/348/EEC
shall be fixed at:

1
стотинка (1 stotinka)

1 new leu.

ò new

Article 49

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 51] at the latest and shall notify to it without delay
any subsequent amendment affecting them.

Article 50

Transitional
provisions

1.           Member
States shall not impede the making available on the market and/or the putting
into use of measuring instruments covered by Directive 2004/22/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 51].

Certificates of
conformity issued under Directive 2004/22/EC shall be valid under this
Directive until [the date set out in the second subparagraph of Article 51]
unless they expire before that date.

2.           The
effects of Article 23 of Directive 2004/22/EC shall continue until 30 October
2016.

ê 2004/22/EC
(adapted)

Article 24

Transposition

1. Member States shall adopt and publish the laws,
regulations and administrative provisions necessary to comply with this
Directive before 30 April 2006. They shall forthwith inform the Commission
thereof.

When Member States adopt those measures, they
shall contain a reference to this Directive or shall be accompanied by such a
reference on the occasion of their official publication. The methods of making
such reference shall be laid down by the Member States.

Member States shall apply these provisions from 30
October 2006.

ê

Article 51

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 4(5) to (22), 8,
9, 10, 11, 13, 14, [15], 20, 22, 23(1), 23(3), 23(5), 23(6), 24, 25, 26, 27,
28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 49, 50 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 2004/22/EC
(adapted)

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

Article 2252

Repeals

The following Directives shall be repealed as
from 30 October 2006 without prejudice to Article 23:

–
Council Directive 71/318/EEC of 26 July 1971
on the approximation of the laws of the Member States relating to gas meters[20],

–
Directive 71/319/EEC of 26 July 1971 on the
approximation of the laws of the Member States relating to meters for liquids
other than water[21];

–
Directive 71/348/EEC of 12 October 1971 on
the approximation of the laws of the Member States relating to ancillary
equipment for meters for liquids other than water[22],

–
Directive 73/362/EEC of 19 November 1973 on
the approximation of the laws of the Member States relating to material
measures of length[23],

–
Directive 75/33/EEC of 17 December 1974 on
the approximation of the laws of the Member States relating to cold water
meters, as concerns the meters defined in Annex MI-001 of this Directive[24].

–
Directive 75/410/EEC of 24 June 1975 on the
approximation of the laws of the Member States relating to continuous
totalising weighing machines[25],

–
Directive 76/891/EEC of 4 November 1976 on
the approximation of the laws of the Member States relating to electrical
energy meters[26],

–
Directive 77/95/EEC of 21 December 1976 on
the approximation of the laws of the Member States relating to taximeters[27],

–
Directive 77/313/EEC of 5 April 1977 on
the approximation of the laws of the Member States relating to measuring
systems for liquids other than water[28],

–
Directive 78/1031/EEC of 5 December 1978 on
the approximation of the laws of the Member States relating to automatic
checkweighing and weight grading machines[29],

–
Directive 79/830/EEC of 11 September 1979 on
the approximation of the laws of the Member States relating to hot-water meters[30].

ò new

Without prejudice
to Article 50, Directive 2004/22/EC as amended by the acts listed in Annex XIII
is repealed with effect from [the date set out in the second subparagraph of
Article 51], 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
Part B of Annex XIII.

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 XIV.

ê 2004/22/EC

Article 25

Revision clause

The European
Parliament and the Council invite the Commission to report, before 30 April
2011, on the implementation of this Directive, inter alia, on the basis of
reports provided by the Member States, and, where appropriate, to submit a
proposal for amendments.

The European
Parliament and Council invite the Commission to evaluate whether conformity
assessment procedures for industrial products are properly applied and, where
appropriate, to propose amendments in order to ensure consistent certification.

ê 2004/22/EC
(adapted)

Article 2653

Entry into force

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

Articles 1, 2, 3, 4(1) to (4), 5, 6, 7, 16,
17, 18, 19, 21, 23(2), 23(4) and Annexes I, III, IV, V, VI, VII, VIII, IX, X,
XI, XII shall apply from [the date set out in the second subparagraph of
Article 51].

ê 2004/22/EC

Article 2754

Addressees

This Directive
is addressed to the Member States.

Done at [...],

For the European Parliament                       For
the Council

The
President                                                 The President

ê 2004/22/EC

ANNEX I

ESSENTIAL REQUIREMENTS

A measuring instrument shall provide a high
level of metrological protection in order that any party affected can have
confidence in the result of measurement, and shall be designed and manufactured
to a high level of quality in respect of the measurement technology and
security of the measurement data.

ê 2004/22/EC
(adapted)

The Ö essential Õ requirements
that shall be met by measuring instruments are set out below and are
supplemented, where appropriate, by specific instrument requirements in Annexes
MI-001
to MI-010 III to XII
that provide more detail on certain aspects of the general requirements.

The solutions adopted in the pursuit of the
Ö essential Õ requirements
shall take account of the intended use of the instrument and any foreseeable
misuse thereof.

ê 2004/22/EC

DEFINITIONS

Measurand || || The measurand is the particular quantity subject to measurement.

Influence quantity || || An influence quantity is a quantity that is not the measurand but that affects the result of measurement.

Rated Operating Conditions || || The rated operating conditions are the values for the measurand and influence quantities making up the normal working conditions of an instrument.

Disturbance || || An influence quantity having a value within the limits specified in the appropriate requirement but outside the specified rated operating conditions of the measuring instrument. An influence quantity is a disturbance if for that influence quantity the rated operating conditions are not specified.

Critical change value || || The critical change value is the value at which the change in the measurement result is considered undesirable.

Material Measure || || A material measure is a device intended to reproduce or supply in a permanent manner during its use one or more known values of a given quantity.

Direct sales || || A trading transaction is direct sales if: – the measurement result serves as the basis for the price to pay and; – at least one of the parties involved in the transaction related to measurement is a consumer or any other party requiring a similar level of protection and; – all the parties in the transaction accept the measurement result at that time and place.

Climatic environments || || Climatic environments are the conditions in which measuring instruments may be used. To cope with climatic differences between the Member States, a range of temperature limits has been defined.

Utility || || A utility is regarded as a supplier of electricity, gas, heat or water.

ê 2004/22/EC
(adapted)

Ö ESSENTIAL Õ REQUIREMENTS

ê 2004/22/EC

1. Allowable Errors

1.1. Under rated operating conditions and
in the absence of a disturbance, the error of measurement shall not exceed the
maximum permissible error (MPE) value as laid down in the appropriate instrument-specific
requirements.

Unless stated otherwise in the
instrument-specific annexes, MPE is expressed as a bilateral value of the
deviation from the true measurement value.

1.2. Under rated operating conditions and
in the presence of a disturbance, the performance requirement shall be as laid
down in the appropriate instrument-specific requirements.

Where the instrument is intended to be used
in a specified permanent continuous electromagnetic field the permitted
performance during the radiated electromagnetic field-amplitude modulated test
shall be within MPE.

1.3. The manufacturer shall specify the
climatic, mechanical and electromagnetic environments in which the instrument
is intended to be used, power supply and other influence quantities likely to
affect its accuracy, taking account of the requirements laid down in the
appropriate instrument-specific annexes.

1.3.1. Climatic environments

The manufacturer shall specify the upper
temperature limit and the lower temperature limit from any of the values in
Table 1 unless otherwise specified in the Annexes MI-001
to MI-010 III to XII,
and indicate whether the instrument is designed for condensing or
non-condensing humidity as well as the intended location for the instrument,
i.e. open or closed.

Table 1

|| Temperature Limits

Upper temperature limit || 30 °C || 40 °C || 55 °C || 70 °C

Lower temperature limit || 5 °C || – 10 °C || – 25 °C || – 40 °C

1.3.2. (a) Mechanical
environments are classified into classes M1 to M3 as described below.

M1 || || This class applies to instruments used in locations with vibration and shocks of low significance, e.g. for instruments fastened to light supporting structures subject to negligible vibrations and shocks transmitted from local blasting or pile-driving activities, slamming doors, etc.

M2 || || This class applies to instruments used in locations with significant or high levels of vibration and shock, e.g. transmitted from machines and passing vehicles in the vicinity or adjacent to heavy machines, conveyor belts, etc.

M3 || || This class applies to instruments used in locations where the level of vibration and shock is high and very high, e.g. for instruments mounted directly on machines, conveyor belts, etc.

(b) The following influence
quantities shall be considered in relation with mechanical environments:

–
Vvibration;

–
Mmechanical shock.

1.3.3. (a) Electromagnetic
environments are classified into classes E1, E2 or E3 as described below,
unless otherwise laid down in the appropriate instrument-specific annexes.

E1 || || This class applies to instruments used in locations with electromagnetic disturbances corresponding to those likely to be found in residential, commercial and light industrial buildings.

E2 || || This class applies to instruments used in locations with electromagnetic disturbances corresponding to those likely to be found in other industrial buildings.

E3 || || This class applies to instruments supplied by the battery of a vehicle. Such instruments shall comply with the requirements of E2 and the following additional requirements: – voltage reductions caused by energising the starter-motor circuits of internal combustion engines, – load dump transients occurring in the event of a discharged battery being disconnected while the engine is running.

(b) The following influence
quantities shall be considered in relation with electromagnetic environments:

–
Vvoltage interruptions,;

–
Sshort voltage reductions,;

–
Vvoltage transients on supply lines and/or signal lines,;

–
Eelectrostatic discharges,;

–
Rradio frequency electromagnetic fields,;

–
Cconducted radio frequency electromagnetic fields on supply lines
and/or signal lines,;

–
Ssurges on supply lines and/or signal lines.

1.3.4. Other influence quantities to be
considered, where appropriate, are:

–
Vvoltage variation,;

–
Mmains frequency variation,;

–
Ppower frequency magnetic fields,;

–
Aany other quantity likely to influence in a significant way the
accuracy of the instrument.

ê 2004/22/EC
(adapted)

1.4. When carrying out the tests as
envisaged in this Directive, the following paragraphs points Ö shall Õ apply:

ê 2004/22/EC

1.4.1. Basic rules for testing and the
determination of errors

Essential requirements specified in 1.1 and
1.2 shall be verified for each relevant influence quantity. Unless otherwise
specified in the appropriate instrument-specific annex, these essential
requirements apply when each influence quantity is applied and its effect
evaluated separately, all other influence quantities being kept relatively
constant at their reference value.

Metrological tests shall be carried out
during or after the application of the influence quantity, whichever condition
corresponds to the normal operational status of the instrument when that
influence quantity is likely to occur.

1.4.2. Ambient humidity

(a)          According to the climatic operating environment in which
the instrument is intended to be used either the damp heat-steady state
(non-condensing) or damp heat cyclic (condensing) test may be appropriate.

(b)          The damp heat cyclic test is appropriate where
condensation is important or when penetration of vapour will be accelerated by
the effect of breathing. In conditions where non-condensing humidity is a
factor the damp-heat steady state is appropriate.

2. Reproducibility

The application of the same measurand in a
different location or by a different user, all other conditions being the same,
shall result in the close agreement of successive measurements. The difference
between the measurement results shall be small when compared with the MPE.

3. Repeatability

The application of the same measurand under
the same conditions of measurement shall result in the close agreement of
successive measurements. The difference between the measurement results shall
be small when compared with the MPE.

4. Discrimination and Sensitivity

A measuring instrument shall be
sufficiently sensitive and the discrimination threshold shall be sufficiently
low for the intended measurement task.

5. Durability

A measuring instrument shall be designed to
maintain an adequate stability of its metrological characteristics over a
period of time estimated by the manufacturer, provided that it is properly
installed, maintained and used according to the manufacturer's instruction when
in the environmental conditions for which it is intended.

6. Reliability

A measuring instrument shall be designed to
reduce as far as possible the effect of a defect that would lead to an
inaccurate measurement result, unless the presence of such a defect is obvious.

7. Suitability

7.1. A measuring instrument shall have no
feature likely to facilitate fraudulent use, whereas possibilities for
unintentional misuse shall be minimal.

7.2. A measuring instrument shall be
suitable for its intended use taking account of the practical working
conditions and shall not require unreasonable demands of the user in order to
obtain a correct measurement result.

7.3. The errors of a utility measuring
instrument at flows or currents outside the controlled range shall not be
unduly biased.

7.4. Where a measuring instrument is
designed for the measurement of values of the measurand that are constant over
time, the measuring instrument shall be insensitive to small fluctuations of
the value of the measurand, or shall take appropriate action.

7.5. A measuring instrument shall be robust
and its materials of construction shall be suitable for the conditions in which
it is intended to be used.

7.6. A measuring instrument shall be
designed so as to allow the control of the measuring tasks after the instrument
has been placed on the market and put into use. If necessary, special equipment
or software for this control shall be part of the instrument. The test
procedure shall be described in the operation manual.

When a measuring instrument has associated
software which provides other functions besides the measuring function, the
software that is critical for the metrological characteristics shall be
identifiable and shall not be inadmissibly influenced by the associated
software.

8. Protection against corruption

8.1. The metrological characteristics of a
measuring instrument shall not be influenced in any inadmissible way by the
connection to it of another device, by any feature of the connected device
itself or by any remote device that communicates with the measuring instrument.

8.2. A hardware component that is critical
for metrological characteristics shall be designed so that it can be secured.
Security measures foreseen shall provide for evidence of an intervention.

8.3. Software that is critical for
metrological characteristics shall be identified as such and shall be secured.

Software identification shall be easily
provided by the measuring instrument.

Evidence of an intervention shall be
available for a reasonable period of time.

8.4. Measurement data, software that is
critical for measurement characteristics and metrologically important
parameters stored or transmitted shall be adequately protected against
accidental or intentional corruption.

8.5. For utility measuring instruments the
display of the total quantity supplied or the displays from which the total
quantity supplied can be derived, whole or partial reference to which is the
basis for payment, shall not be able to be reset during use.

9. Information to be borne by and to accompany the instrument

9.1. A measuring instrument shall bear the
following inscriptions:

(a)          manufacturer's mark or name;

(b)          information in respect of its accuracy,

ê 2004/22/EC
(adapted)

plus Ö and Õ , when
applicable:

ê 2004/22/EC

(c)          information in respect of the conditions of use;

(d)          measuring capacity;

(e)          measuring range;

(f)           identity marking;

ê 2004/22/EC
(adapted)

(g)          number of the EC-type Ö EU-type Õ examination
certificate or the EC
Ö EU Õ design
examination certificate;

ê 2004/22/EC

(h)          information whether or not additional devices providing
metrological results comply with the provisions of this Directive on legal
metrological control.

9.2. An instrument of dimensions too small
or of too sensitive a composition to allow it to bear the relevant information
shall have its packaging, if any, and the accompanying documents required by
the provisions of this Directive suitably marked.

9.3. The instrument shall be accompanied by
information on its operation, unless the simplicity of the measuring instrument
makes this unnecessary. Information shall be easily understandable and shall
include where relevant:

(a)          rated operating conditions;

(b)          mechanical and electromagnetic environment classes;

(c)          the upper and lower temperature limit, whether
condensation is possible or not, open or closed location;

(d)          instructions for installation, maintenance, repairs,
permissible adjustments;

(e)          instructions for correct operation and any special
conditions of use;

(f)           conditions for compatibility with interfaces,
sub-assemblies or measuring instruments.

9.4. Groups of identical measuring
instruments used in the same location or used for utility measurements do not
necessarily require individual instruction manuals.

9.5. Unless specified otherwise in an
instrument-specific annex, the scale interval for a measured value shall be in
the form 1×10n, 2×10n, or 5×10n, where n is
any integer or zero. The unit of measurement or its symbol shall be shown close
to the numerical value.

9.6. A material measure shall be marked
with a nominal value or a scale, accompanied by the unit of measurement used.

ê 2004/22/EC
(adapted)

9.7. The units of measurement used and
their symbols shall be in accordance with the provisions of Community
Ö Union Õ legislation on
units of measurement and their symbols.

ê 2004/22/EC

9.8. All marks and inscriptions required
under any requirement shall be clear, non-erasable, unambiguous and
non-transferable.

10. Indication of result

10.1. Indication of the result shall be by
means of a display or hard copy.

10.2. The indication of any result shall be
clear and unambiguous and accompanied by such marks and inscriptions necessary
to inform the user of the significance of the result. Easy reading of the
presented result shall be permitted under normal conditions of use. Additional
indications may be shown provided they cannot be confused with the
metrologically controlled indications.

10.3. In the case of hard copy the print or
record shall also be easily legible and non-erasable.

10.4. A measuring instrument for direct
sales trading transactions shall be designed to present the measurement result
to both parties in the transaction when installed as intended. When critical in
case of direct sales, any ticket provided to the consumer by an ancillary
device not complying with the appropriate requirements of this Directive shall
bear an
appropriate restrictive information.

10.5. Whether or not a measuring instrument
intended for utility measurement purposes can be remotely read it shall in any
case be fitted with a metrologically controlled display accessible without
tools to the consumer. The reading of this display is the measurement result
that serves as the basis for the price to pay.

11. Further processing of data to conclude the trading transaction

11.1. A measuring instrument other than a
utility measuring instrument shall record by a durable means the measurement
result accompanied by information to identify the particular transaction, when:

(a)          the measurement is non-repeatable and;

(b)          the measuring instrument is normally intended for use in
the absence of one of the trading parties.

11.2. Additionally, a durable proof of the
measurement result and the information to identify the transaction shall be
available on request at the time the measurement is concluded.

12. Conformity evaluation

A measuring instrument shall be designed so
as to allow ready evaluation of its conformity with the appropriate
requirements of this Directive.

ê 2004/22/EC
(adapted)

ð new

ANNEX AII

Ö 1. MODULE
A: Õ DECLARATION OF
CONFORMITY BASED ON INTERNAL PRODUCTION CONTROL

1. The ‘declaration of conformity based on
iInternal production control’ is the conformity assessment procedure
whereby the manufacturer fulfils the obligations laid down in this
Annex points 2, 3 and
4, and ensures and declares that the measuring instruments
concerned satisfy the appropriate requirements of this Directive.

2. Technical
documentation

2. The manufacturer shall establish the technical documentation as
described in Article 1019. The documentation shall enable Ö make it
possible to assess Õ assessment of the
conformity of the instrument Ö instrument’s
conformity to the relevant Õ with the appropriate
requirements of
this Directive Ö ,
and Õ . It
shall,
ð include an adequate analysis and
assessment of the risks. ï ð The technical documentation shall
specify the applicable requirements and cover, ï as far as relevant for such Ö the Õ assessment, cover
the design, manufacture and operation of the instrument.

3. The manufacturer shall keep the technical
documentation at the disposal of the national authorities for ten years after
the last instrument has been manufactured.

3.
Manufacturing

4. The manufacturer shall take all measures necessary Ö so that
the manufacturing process and its monitoring Õ to
ensure conformity
Ö compliance Õ of the
manufactured instruments with the appropriate requirements Ö technical
documentation referred to in point 2 and with the requirements Õ of this Directive
Ö the
Directives that apply to it Õ .

4. Written
Ö conformity
marking and Õ
declaration of conformity

54.1. The manufacturer shall affix the ‘CE’ Ö CE Õ marking and
the supplementary metrology marking to each measuring instrument that satisfies
the appropriate requirements of this Directive.

54.2. Ö The
manufacturer shall draw up a Õ A Ö written Õ declaration of
conformity is drawn
up for an instrument model and shall be kept Ö keep it
together with the technical documentation Õ at the
disposal of the national authorities for ten years after the last
instrument has been manufactured
ð placed on the market ï . It
Ö The
declaration of conformity Õ shall identify
the instrument for which it was drawn up.

ò new

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

ê 2004/22/EC

A copy of the declaration shall be supplied
with each measuring instrument that is placed on the market. However, this
requirement may be interpreted as applying to a batch or consignment rather
than individual instruments in those cases where a large number of instruments
is delivered to a single user.

5. Authorised
representative

ê 2004/22/EC
(adapted)

ð new

6. The manufacturer's obligations contained in paragraphs 3 and 5.2
Ö set out
in point 4 Õ may be
fulfilled Ö by his
authorised representative Õ, on his behalf
and under his responsibility, by his authorised representative ð provided that they are specified in
the mandate ï .

ê 2004/22/EC

Where the
manufacturer is not established within the Community and where he does not
have an authorised representative, the obligations contained in paragraphs 3
and 5.2 shall be the responsibility of the person who places the instrument on
the market.

ê 2004/22/EC
(adapted)

ANNEX A1

Ö 2.
MODULE A2: Õ DECLARATION OF CONFORMITY
BASED ON INTERNAL PRODUCTION CONTROL PLUS Ö SUPERVISED
INSTRUMENT CHECKS AT RANDOM INTERVALS Õ PRODUCT TESTING BY A
NOTIFIED BODY

ê 2004/22/EC

1. ‘Declaration of
conformity based on internal production control plus product testing by a
notified body’ is the conformity assessment procedure whereby the manufacturer
fulfils the obligations laid down in this Annex, and ensures and declares that
the measuring instruments concerned satisfy
the appropriate requirements of this Directive.

ò new

1. Internal production control plus supervised
instrument checks at random intervals is the conformity assessment procedure
whereby the manufacturer fulfils the obligations laid down in points 2, 3, 4,
and 5, and ensures and declares on his sole responsibility that the measuring
instruments concerned satisfy the requirements of this Directive that apply to
them.

ê 2004/22/EC
(adapted)

ð new

2. Technical
documentation

2. The manufacturer shall establish the technical documentation as
described in Article 1019. The documentation shall enable Ö make it
possible to assess Õ assessment
of the Ö instrument’s Õ conformity of the instrument
with the appropriate
Ö relevant Õ requirements ð , and shall include an adequate
analysis and assessment of the risk(s) ï of this
Directive. It shall Ö The
technical documentation shall specify the applicable requirements and
cover Õ , as far as
relevant for such
Ö the Õ assessment, cover
the design, manufacture and operation of the instrument.

3. The manufacturer shall keep the technical
documentation at the disposal of the national authorities for 10 years after
the last instrument has been manufactured.

3.
Manufacturing

4. The manufacturer shall take all measures necessary Ö so that
the manufacturing process and its monitoring Õ to
ensure conformity
Ö compliance Õ of the
manufactured instruments with the appropriate requirements Ö technical
documentation referred to in point 2 and with the requirements Õ of this Directive
Ö the
Directives that apply to them Õ .

4. Product
Ö instrument Õ
checks

5. A notified
body, chosen by the manufacturer, shall carry out product Ö instrument Õ checks or have
them carried out in appropriate intervals determined by it Ö the
body Õ , in order to
verify the quality of the internal checks of the product Ö instrument Õ, taking into
account inter alia the technological complexity of the instruments and the
quantity of production. An adequate sample of the final products Ö measuring
instruments Õ , taken Ö on
site Õ by the notified
body before the placing on the market, shall be examined and appropriate tests
as identified by the relevant document(s) referred to in Article 13 Ö parts of
the harmonised standard, normative document and/or technical specifications, Õ or equivalent
tests, shall be carried out to check the conformity of the instruments with the
appropriate
Ö relevant Õ requirements
of this Directive. In the absence of a relevant document, the notified body
concerned shall decide on the appropriate tests to be carried out.

ê 2004/22/EC

In those cases where a relevant number of
instruments in the sample do not conform to an acceptable quality level, the
notified body shall take appropriate measures.

ò new

Where the tests are carried out by a notified body,
the manufacturer shall, under the responsibility of the notified body, affix
the notified body's identification number during the manufacturing process.

ê 2004/22/EC
(adapted)

ð new

5. Written
Ö conformity
marking and Õ
declaration of conformity

65.1. The manufacturer shall affix the ‘CE’ Ö CE Õ marking,
Ö and Õ the
supplementary metrology marking and, under the responsibility of the notified body
referred to in paragraph 5, the latter's identification number
Ö set out
in this Directive Õ to each measuring
Ö individual Õ instrument
that satisfies the appropriate
Ö applicable Õ requirements
of this Directive.

65.2. Ö The
manufacturer shall draw up Õ Aa Ö written Õ declaration of
conformity is drawn
up for each Ö an Õ instrument
model and shall be
kept Ö keep it
together with the technical documentation Õ at the
disposal of the national authorities for ten years after the last
instrument has been manufactured
ð placed on the market ï . It
Ö The
declaration of conformity Õ shall identify
the model of
the instrument Ö model Õ for which it
was drawn up.

ò new

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

ê 2004/22/EC

A copy of the declaration shall be supplied
with each measuring instrument that is placed on the market. However, this
requirement may be interpreted as applying to a batch or consignment rather
than individual instruments in those cases where a large number of instruments
is delivered to a single user.

6. Authorised representative

ê 2004/22/EC
(adapted)

ð new

7. The manufacturer's obligations contained in paragraphs 3 and 6.2
Ö set out
in point 5 Õ may be
fulfilled Ö by his
authorised representative Õ , on his
behalf and under his responsibility, by his authorised representative
ð provided that they are specified in the mandate ï .

ê 2004/22/EC

Where the
manufacturer is not established within the Community and where he does not
have an authorised representative, the obligations contained in paragraphs 3
and 6.2 shall be the responsibility of the person who places the instrument on
the market.

ê 2004/22/EC (adapted)

3. ANNEX Ö MODULE Õ B: Ö EU- Õ TYPE EXAMINATION

1. ‘ Ö EU- Õ Ttype examination’ is the part of a
conformity assessment procedure whereby Ö in which Õ a notified
body examines the technical design of Ö an Õ a measuring
instrument and ensures
and declares Ö verifies
and attests Õ that the
technical design Ö of the
instrument Õ meets the appropriate
requirements of this Directive Ö that
apply to it Õ .

2. Ö EU- Õ Ttype examination may be carried out in
either of the following manners.

ê 2004/22/EC

The notified body decides on the appropriate
manner and the specimens required:

ê 2004/22/EC
(adapted)

(a) examination of a specimen,
representative of the production envisaged, of the complete measuring
instrument Ö (production
type) Õ ,

(b) examination of specimens, representative of the
production envisaged, of one or more critical parts of the measuring
instrument, plus assessment of the adequacy of the
technical design of the other parts of the measuring instrument through
examination of the technical documentation and supporting evidence referred to
in paragraph
point 3, Ö 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) Õ ;

(c) assessment of the adequacy of the
technical design of the measuring instrument through examination of the
technical documentation and supporting evidence referred to in paragraph
point 3, without examination of a
specimen Ö (design
type) Õ .

3. The Ö manufacturer Õ application for type
examination shall Ö lodge an
application for EU-type examination Õ be lodged by the
manufacturer with a Ö single Õ notified body
of his choice.

ê 2004/22/EC

The application shall include:

ê 2004/22/EC
(adapted)

–
the name and address of the manufacturer and, if
the application is lodged by the authorised representative, his name and
address in addition
Ö as well Õ ;

ê 2004/22/EC

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

ê 2004/22/EC
(adapted)

ð new

–
the technical documentation as described
in Article 1019.
The Ö technical Õ documentation
shall enable
assessment of Ö make it
possible to assess Õ the Ö instrument’s Õ conformity of the instrument
with the appropriate
Ö applicable Õ requirements
of this Directive.
It Ö and Õ shall Ö include
an adequate analysis and assessment of the risk(s). The technical documentation
shall specify the applicable requirements and cover, Õ as far as
relevant for such
Ö the Õ assessment, cover
the design, manufacture and operation of the instrument;.

Ö The
technical documentation shall in addition contain, wherever applicable: Õ

–
the specimens, representative of the production
envisaged,.
as required by
tThe notified body ð may request further specimens if
needed for carrying out the test programme ï ;

–
the supporting evidence for the adequacy of the
technical design Ö solution Õ of those parts of the
measuring instrument for which no specimens are required.
This supporting evidence shall mention any relevant documents that have
been applied
Ö used Õ , in
particular where the relevant Ö harmonised
standards, normative Õ documents Ö and/or
technical specifications Õ referred to in Article 13
have not been applied in full,. and Ö The
supporting evidence Õ 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.

ê 2004/22/EC

4. The notified body shall:

ò new

For the instrument:

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

ê 2004/22/EC
(adapted)

For the specimen(s):

4.12. examine the technical documentation,
verify that the specimen(s) have been manufactured in conformity
with it
Ö the
technical documentation Õ and identify
the elements which have been designed in accordance with the relevant
Ö applicable Õ provisions of
the relevant Ö harmonised
standards, normative Õ documents Ö and/or
technical specifications Õ referred to in Article 13,
as well as the elements which have been designed without applying the relevant
provisions of those documents
Ö standards Õ ;

4.23. carry out the appropriate examinations and
tests, or have them carried out, to check whether, where the manufacturer has
chosen to apply the solutions in the relevant Ö harmonised
standards, normative Õ documents Ö and/or
technical specifications Õ referred to in Article 13,
these have been applied correctly;

4.34. carry out the appropriate examinations and
tests, or have them carried out, to check whether, where the manufacturer has chosen not to apply
the solutions in the relevant Ö harmonised
standards, normative Õ documents Ö and/or
technical specifications have not been applied Õ referred to in Article 13,
the solutions adopted by the manufacturer meet the corresponding essential
requirements of this Directive;

4.45. agree with the applicant Ö manufacturer Õ on the
location where the examinations and tests shall Ö will Õ be carried
out.

ê 2004/22/EC

For the other parts of the measuring
instrument:

4.56. examine the technical documentation
and supporting evidence to assess the adequacy of the technical design of the
other parts of the measuring instrument.

For the
manufacturing process:

4.6. examine
the technical documentation to assure that the manufacturer has adequate means
to ensure consistent production.

ê 2004/22/EC
(adapted)

5.1. The notified
body shall draw up an evaluation report that records the activities as undertaken
in accordance with paragraph point 4 and their outcomes. Without
prejudice to Article
12(8) Ö its
obligations vis-à-vis, the notifying authorities Õ , the notified
body shall release the content of this report, in full or in part, only with
the agreement of the manufacturer.

5.26. Where the technical design Ö type Õ meets the
requirements of this Directive that apply to the measuring instrument, the notified
body shall issue an EC-type
Ö EU-type Õ examination
certificate to the manufacturer. The certificate shall contain the name and
address of the manufacturer and, if appropriate, of his authorised representative, the
conclusions of the examination, the conditions (if any) for its
validity and the necessary data for identification of the instrument
Ö approved
type Õ . The
certificate may have one or more annexes attached.

The certificate and its annexes shall
contain all relevant information Ö to
allow Õ for the
conformity evaluation
and Ö of
manufactured measuring instruments with the examined type to be evaluated and
to allow for Õ in-service
control. In particular, to allow the conformity of manufactured instruments to
be evaluated with the examined type regarding the reproducibility of their
metrological performances, when they are properly adjusted using appropriate
means, content shall include:

ê 2004/22/EC

–
the metrological characteristics of the type of
instrument;

–
measures required for ensuring the integrity of
the instruments (sealing, identification of software, etc.);

–
information on other elements necessary for the
identification of the instruments and to check their visual external conformity
to type;

–
if appropriate, any specific information
necessary to verify the characteristics of manufactured instruments;

–
in the case of a sub-assembly, all necessary
information to ensure the compatibility with other sub-assemblies or measuring
instruments.

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

ò new

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.

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.

ê 2004/22/EC

5.3. The notified
body shall establish an evaluation report in this regard and keep it at the
disposal of the Member State that designated it.

ê 2004/22/EC
(adapted)

68. The manufacturer shall inform the notified body that holds the
technical documentation concerning the EC-type Ö relating
to the EU-type Õ examination
certificate of all modifications to the Ö approved
type Õ instrument
that may affect the conformity of the instrument with the essential
requirements or the
conditions for validity of the certificate Ö of this
Directive Õ . Such
modifications require additional approval in the form of an addition to the
original EC-type
Ö EU-type Õ examination
certificate.

79. Each notified body shall immediately inform the Member State that designated it about:
Ö its
notifying authorities concerning the Õ

EC-type Ö EU-type Õ examination
certificates and Ö /or Õ annexes issued;

Ö any Õ additions and amendments relating
to certificates already Ö thereto
which it has Õ issued.

ò new

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.

ê 2004/22/EC

Each notified body
shall immediately inform the Member State that designated it of the withdrawal
of an EC-type examination certificate.

ê 2004/22/EC
(adapted)

ð new

The notified body shall hold Ö keep a
copy of the EU-type examination certificate, its annexes and additions, as well
as Õ the technical
file including the documentation submitted by the manufacturer for a period up to the
end Ö until the
expiry Õ of the
validity of the certificate.

89. The manufacturer shall keep a copy of the EC-type Ö EU-type Õ examination
certificate, its annexes and additions Ö together Õ with the
technical documentation Ö at the
disposal of the national authorities Õ for 10 years
after the last
measuring instrument has been manufactured
ð placed on the market ï .

910. The manufacturer's authorised representative may lodge the
application referred to in paragraph point 3 and carry out Ö fulfil Õ the
obligations mentioned
in paragraphs 6 and 8 Ö set out
in points 7 and 9, provided that they are specified in the mandate Õ . Where the manufacturer is not established within
the Communities and where he does not have an authorised representative, the
obligation to make the technical documentation available on request shall be
the responsibility of the person designated by the manufacturer.

ê 2004/22/EC
(adapted)

ð new

4. ANNEX
Ö MODULE Õ C:

DECLARATION OF CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL

1. ‘Declaration of cConformity to type based on internal
production control’ is the part of a conformity assessment procedure whereby
the manufacturer fulfils the obligations laid down in this
Annex points 2 and 3
and ensures and declares that the measuring instruments concerned are in
conformity with the type as described in the EC-type Ö EU-type Õ examination
certificate and satisfy the appropriate requirements of this Directive Ö that
apply to them Õ .

2. Manufacturing

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

3. Written
Ö Conformity
marking and Õ declaration of
conformity

3.1. The manufacturer shall affix the ‘CE’ Ö CE Õ marking and
the supplementary metrology marking Ö set out
in this Directive Õ to each Ö individual Õ measuring
instrument that is in conformity with the type as described in the EC-type
Ö EU-type Õ examination
certificate and satisfies the appropriate Ö applicable Õ requirements
of this Directive.

3.2. Ö The
manufacturer shall draw up Õ Aa Ö written Õ declaration of
conformity is drawn
up for each Ö an Õ instrument
model and shall be
kept Ö keep
it Õ at the
disposal of the national authorities for 10 years after the last
instrument has been manufactured
ð placed on the market ï . It
Ö The
declaration of conformity Õ shall identify
the instrument model for which it was drawn up.

ò new

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

ê 2004/22/EC

A copy of the declaration shall be supplied
with each measuring instrument that is placed on the market. However, this
requirement may be interpreted as applying to a batch or consignment rather
than individual instruments in those cases where a large number of instruments
is delivered to a single user.

4. Authorised representative

ê 2004/22/EC
(adapted)

ð new

4. The manufacturer's obligations contained in paragraph 3.2 Ö set out
in point 3 Õ may be
fulfilled Ö by his
authorised representative Õ , on his
behalf and under his responsibility, by his authorised representative
ð provided that they are specified in
the mandate ï .

ê 2004/22/EC

Where the
manufacturer is not established within the Community and where he does not have
an authorised representative, the obligation mentioned in paragraph 3.2 shall
be the responsibility of the person who places the instrument on the market.

ê 2004/22/EC
(adapted)

5. ANNEX
Ö MODULE Õ C12:

DECLARATION OF CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS PRODUCT TESTING BY A
NOTIFIED BODY Ö SUPERVISED
INSTRUMENT CHECKS AT RANDOM INTERVALS Õ

1. ‘Declaration of cConformity to type based on internal
production control plus product testing by a notified body’ Ö supervised
instrument checks at random intervals Õ is the part of
a conformity assessment procedure whereby the manufacturer fulfils the
obligations laid down in this Annex points 2, 3 and 4, and ensures and
declares Ö on his
sole responsibility Õ that the
measuring instruments concerned are in conformity with the type as described
in the EC-type
Ö EU-type Õ examination
certificate and satisfy the appropriate requirements of this Directive Ö that
apply to them Õ .

2. Manufacturing

2. The manufacturer shall take all measures necessary to Ö so that
the manufacturing process and its monitoring Õ ensure
conformity of the manufactured Ö measuring Õ instruments
with the type as
described in the EC-type
Ö EU-type Õ examination
certificate and with the appropriate requirements of this Directive.

3. Product
Ö Instrument Õ checks

3. A notified body, chosen by the manufacturer, shall carry out product
Ö instrument Õ checks or have
them carried out in appropriate intervals determined by it Ö the
body Õ , in order to
verify the quality of the internal checks of the product Ö on the
instrument Õ , taking into
account inter alia the technological complexity of the Ö measuring Õ instruments
and the quantity of production. An adequate sample of the final products
Ö measuring
instrument Õ , taken Ö on
site Õ by the
notified body before the placing on the market, shall be examined and
appropriate tests, as identified by the relevant Ö parts of
the harmonised standards, normative Õ documents Ö and/or
technical specifications Õ referred to in Article 13,
or equivalent tests, shall be carried out to check the conformity of the product
Ö instrument Õ with the type
as described in the EC-type
Ö EU-type Õ examination
certificate and the
appropriate Ö relevant Õ requirements
of the
Ö this Õ Directive. In the absence of a relevant document, the
notified body concerned shall decide on the appropriate tests to be carried
out.

In those cases wWhere
a relevant number
of instruments in the sample does not conform to an acceptable quality
level, the notified body shall take appropriate measures.

ò new

The acceptance sampling procedure to be applied is
intended to determine whether the manufacturing process of the instrument
performs within acceptable limits, with a view to ensuring conformity of the
instrument.

Where the tests are carried out by a notified body,
the manufacturer shall, under the responsibility of the notified body, affix
the notified body's identification number during the manufacturing process.

ê 2004/22/EC
(adapted)

ð new

4. Ö Conformity
marking and Õ Written
declaration of conformity

4.1. The manufacturer shall affix the ‘CE’ Ö CE Õ marking, the
supplementary metrology marking and, under the responsibility of the notified
body referred to in paragraph 3, the latter's identification number,
Ö set out
in this Directive Õ to each measuring
instrument that is in conformity with the type as described in the EC-type
Ö EU-type Õ examination
certificate and satisfies the appropriate Ö applicable Õ requirements
of this Directive.

4.2. Ö The
manufacturer shall draw a up a written Õ a declaration
of conformity is
drawn up for each Ö an Õ instrument
model and shall be
kept Ö keep
it Õ at the
disposal of the national authorities for 10 years after the last
instrument has been manufactured
ð placed on the market ï. It
Ö The
declaration of conformity Õ shall identify
the model of
the instrument Ö model Õ for which it was Ö has
been Õ drawn up.

ò new

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

ê 2004/22/EC

A copy of the declaration shall be supplied
with each measuring instrument that is placed on the market. However, this requirement
may be interpreted as applying to a batch or consignment rather than individual
instruments in those cases where a large number of instruments is delivered to
a single user.

5. Authorised representative

ê 2004/22/EC
(adapted)

ð new

5. The manufacturer's obligations contained in paragraph
4.2 Ö set out
in point 4 Õ may be
fulfilled Ö by his
authorised representative Õ , on his
behalf and under his responsibility, by his authorised representative
ð provided that they are specified in
the mandate ï .

ê 2004/22/EC

Where the
manufacturer is not established within the Community and where he does not have
an authorised representative, the obligations mentioned in paragraph 4.2
shall be the responsibility of the person who places the instrument on the
market.

ê 2004/22/EC
(adapted)

6. ANNEX
Ö MODULE Õ D:

DECLARATION OF CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION
PROCESS

1. ‘Declaration of cConformity 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 this Annex points 2 and 5, and ensures and declares
Ö on his
sole responsibility Õ that the
measuring instruments concerned are in conformity with the type as
described in the EC-type
Ö EU-type Õ examination
certificate and satisfy the appropriate requirements of this Directive Ö that
apply to them Õ .

2. Manufacturing

2. The manufacturer shall operate an approved quality system for
production, final product
Ö instrument Õ inspection and
testing of the measuring instrument concerned as specified in paragraph
point 3 and shall be subject to
surveillance as specified in paragraph point 4.

3. Quality system

3.1. The manufacturer shall lodge an application
for assessment of the
Ö his Õ quality system
with a notified body of his choice Ö , for the
measuring instruments concerned Õ .

ê 2004/22/EC

The application shall include:

ò new

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

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

ê 2004/22/EC

–
all relevant information for the instrument
category envisaged;

–
the documentation concerning the quality system;

ê 2004/22/EC
(adapted)

–
the technical documentation of the approved type
and a copy of the EC-type
Ö EU-type Õ examination
certificate.

ê 2004/22/EC
(adapted)

ð new

3.2. The quality system shall ensure compliance of
Ö that the
measuring Õ the
instruments Ö are in
conformity Õ with the type as
described in the EC-type
Ö EU-type Õ examination
certificate and Ö comply
with Õ the appropriate
requirements of this Directive Ö that
apply to them Õ .

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.
This quality system documentation must
ð shall ï permit a consistent interpretation of the quality programmes,
plans, manuals and records.

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

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

–
the Ö corresponding Õ manufacturing,
quality control and quality assurance techniques, processes and systematic
actions 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 quality records, such as inspection reports
and test data, calibration data, qualification reports of Ö on Õ the personnel
concerned, etc;

–
the means to monitor Ö of
monitoring Õ the
achievement of the required product Ö instrument Õ quality and
the effective operation of the quality system.

3.3. The notified body shall assess the
quality system to determine whether it satisfies the requirements referred to
in paragraph
point 3.2.

It shall presume conformity with these Ö those Õ requirements
in respect of Ö the
elements of the Õ a
quality system that complies
Ö comply Õ with the
corresponding specifications of the national standard that implements the
relevant harmonised standard, from the moment its references have been published Ö and/or
technical specifications Õ .

In addition to experience in quality
management systems, the auditing team shall possess appropriate Ö have at
least one member with Õ experience Ö of
evaluation Õ in the
relevant Ö instrument Õ field of metrology
and instrument technology Ö concerned Õ , and
knowledge of the applicable requirements of this Directive. The evaluation procedure
Ö audit Õ shall include
an inspection
Ö assessment Õ visit to the
manufacturer's premises.

ò new

The auditing team shall review the technical
documentation referred to in point 3.1, fifth indent, 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.

ê 2004/22/EC
(adapted)

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

ê 2004/22/EC

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.

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

ê 2004/22/EC
(adapted)

The notified body shall evaluate the modifications
Ö any Õ proposed Ö changes Õ and decide
whether the changed
Ö modified Õ quality system
will still
Ö continue
to Õ satisfy the
requirements referred to in paragraph point 3.2 or whether a re-assessment is required
Ö necessary Õ .

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

4. Surveillance under the responsibility of the notified body

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

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

ê 2004/22/EC

–
the quality system documentation;

ê 2004/22/EC
(adapted)

ð new

–
the quality records, such as inspection reports
and test data, calibration data, qualification reports of Ö on Õ the personnel
concerned, etc.

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 Ö the
manufacturer with Õ an audit
report to the
manufacturer.

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

5. Written
Ö Conformity
marking and Õ declaration of
conformity

5.1. The manufacturer shall affix the ‘CE’ Ö CE Õ marking,
Ö and Õ the
supplementary metrology marking Ö set out
in this Directive, Õ and, under the
responsibility of the notified body referred to in paragraph
point 3.1, the latter's
identification number to each measuring Ö individual Õ instrument
that is in conformity with the type as described in the EC-type Ö EU-type Õ examination
certificate and satisfies the appropriate Ö applicable Õ requirements
of this Directive.

5.2. Ö The
manufacturer shall draw up a written Õ A declaration
of conformity is
drawn up for each instrument model and shall be kept
Ö keep
it Õ at the
disposal of the national authorities for 10 years after the last
instrument has been manufactured
ð placed on the market ï . It
Ö The
declaration of conformity Õ shall identify
the Ö instrument Õ model of the instrument
for which it was
Ö has been Õ drawn up.

ò new

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

ê 2004/22/EC

A copy of the declaration shall be supplied
with each measuring instrument that is placed on the market. However, this
requirement may be interpreted as applying to a batch or consignment rather
than individual instruments in those cases where a large number of instruments
is delivered to a single user.

ê 2004/22/EC
(adapted)

ð new

6. The manufacturer shall, for Ö a period
ending at least Õ 10 years after
the last
instrument has been manufactured
ð placed on the market ï, keep at the disposal of the national authorities:

ê 2004/22/EC
(adapted)

–
the documentation referred to in paragraph
point 3.1, second indent;

ê 2004/22/EC

–
the change referred to in paragraph
point 3.5, as approved;

–
the decisions and reports from the notified body
referred to in paragraphs points 3.5, 4.3 and 4.4.

ê 2004/22/EC

7. Each notified
body shall periodically make available to the Member State that designated it
the list of quality system approvals issued or refused, and shall immediately
inform the Member State that designated it of the withdrawal of a quality
system approval.

ò new

7. Each notified body shall immediately
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.

ê 2004/22/EC
(adapted)

ð new

8. Authorised representative

8. The manufacturer's obligations contained in paragraphs Ö set out
in points Õ 3.1, 3.5, 5.2
and 6 may be fulfilled Ö by his
authorised representative Õ , on his
behalf and under his responsibility, by his authorised representative
ð provided that they are specified in
the mandate ï .

7. ANNEX
Ö MODULE Õ D1:

DECLARATION OF CONFORMITY BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS

1. ‘Declaration of conformity based on
qQuality assurance of the production
process’ is the conformity assessment procedure
whereby the manufacturer fulfils the obligations laid down in this
Annex points 2, 4, and
7, and ensures and declares Ö on his
sole responsibility Õ that the
measuring instruments concerned satisfy the appropriate requirements of this
Directive Ö that
apply to them Õ .

2. Technical documentation

2. The manufacturer shall establish the technical documentation as
described in Article 1019. The documentation shall enable assessment of
Ö make it
possible to assess Õ the Ö instrument’s Õ conformity of the instrument
with the appropriate
Ö relevant Õ requirements of this Directive. It
Ö , and
shall include an adequate analysis and assessment of the risk(s). The technical
documentation Õ shall Ö specify
the applicable requirements and cover Õ , as far as
relevant for such
Ö the Õ assessment, cover
the design Ö ,
manufacture Õ and operation
of the instrument.

3. The manufacturer shall keep the
technical documentation at the disposal of the national authorities for 10
years after the last
instrument has been manufactured
ð placed on the market ï .

4. Manufacturing

4. The manufacturer shall operate an approved quality system for
production, final product
Ö instrument Õ inspection and
testing of the measuring instruments
concerned as specified in paragraph point 5 and shall be subject to
surveillance as specified in paragraph point 6.

5. Quality system

5.1. The manufacturer shall lodge an
application for assessment of the Ö his Õ quality system
with a notified body of his choice Ö , for the
measuring instruments concerned Õ .

ê 2004/22/EC

The application shall include:

ò new

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

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

ê 2004/22/EC

–
all relevant information for the instrument
category envisaged;

–
the documentation concerning the quality system;

–
the technical documentation referred to in paragraph
point 2.

ê 2004/22/EC
(adapted)

ð new

5.2. The quality system shall ensure
compliance of the Ö measuring Õ instruments
with the appropriate
requirements of this Directive Ö that
apply to them Õ .

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.
This quality system documentation must
ð shall ï permit a consistent interpretation of the quality programmes,
plans, manuals and records.

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

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

–
the Ö corresponding Õ manufacturing,
quality control and quality assurance techniques, processes and systematic
actions that will be used;

ê 2004/22/EC

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

ê 2004/22/EC
(adapted)

–
the quality records, such as inspection reports
and test data, calibration data, qualification reports of Ö on Õ the personnel
concerned, etc.;

–
the means to monitor Ö of
monitoring Õ the
achievement of the required product Ö instrument Õ quality and
the effective operation of the quality system.

5.3. The notified body shall assess the
quality system to determine whether it satisfies the requirements referred to
in paragraph
point 5.2.

It shall presume conformity with these Ö those Õ requirements
in respect of Ö the
elements of the Õ a
quality system that complies
Ö comply Õ with the
corresponding specifications of the national standard that implements the
relevant harmonised standard, Ö and/or
technical specification Õ from the moment its
references have been published.

In addition to experience in quality
management systems, the auditing team shall possess appropriate Ö have at
least one member with Õ experience Ö of
evaluation Õ in the
relevant Ö instrument Õ field of metrology
and instrument technology Ö concerned Õ , and
knowledge of the applicable requirements of this Directive. The evaluation procedure
Ö audit Õ shall include
an inspection
Ö assessment Õ visit to the
manufacturer's premises.

ò new

The auditing team shall review the technical
documentation referred to in point 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.

ê 2004/22/EC

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

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.

ê 2004/22/EC
(adapted)

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

The notified body shall evaluate the Ö any
proposed Õ changes proposed
and decide whether the changed Ö modified Õ quality system
will still
Ö continue
to Õ satisfy the
requirements referred to in paragraph Ö point Õ 5.2 or whether
a re-assessment is required
Ö necessary Õ .

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

6. Surveillance under the responsibility of the notified body

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

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

ê 2004/22/EC

–
the quality system documentation;

ê 2004/22/EC
(adapted)

ð new

–
the technical documentation referred to in paragraph
point 2;

–
the quality records, such as inspection reports
and test data, calibration data, qualification reports of Ö on Õ the personnel
concerned, etc.

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 Ö the manufacturer
with Õ an audit
report to the
manufacturer.

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

7. Written
Ö Conformity
marking and Õ declaration of
conformity

7.1. The manufacturer shall affix the ‘CE’ Ö CE Õ marking, the
supplementary metrology marking Ö set out
in this Directive, Õ and, under the
responsibility of the notified body referred to in paragraph Ö point Õ 5.1, the
latter's identification number to each measuring instrument that
satisfies the appropriate
Ö applicable Õ requirements
of this Directive.

7.2. A Ö The
manufacturer shall draw up a written Õ declaration of
conformity is
drawn up for each instrument model and shall be kept
Ö keep
it Õ at the
disposal of the national authorities for 10 years after the last
instrument has been manufactured
ð placed on the market ï . It
Ö The
declaration of conformity Õ shall identify
the model of
the instrument Ö model Õ for which it was Ö has been Õ drawn up.

ò new

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

ê 2004/22/EC

A copy of the declaration shall be supplied
with each measuring instrument that is placed on the market. However, this
requirement may be interpreted as applying to a batch or consignment rather
than individual instruments in those cases where a large number of instruments
is delivered to a single user.

ê 2004/22/EC
(adapted)

ð new

8. The manufacturer shall, for Ö a period
ending at least Õ 10 years after
the last
instrument has been manufactured
ð placed on the market ï , keep at the disposal of the national authorities:

–
the documentation referred to in paragraph
point 5.1, second indent;

–
the change referred to in paragraph
point5.5, as approved;

–
the decisions and reports from Ö of Õ the notified
body referred to in paragraph point 5.5, 6.3 and 6.4.

ê 2004/22/EC

9. Each notified
body shall periodically make available to the Member State that designated it
the list of quality system approvals issued or refused, and shall immediately
inform the Member State that designated it of the withdrawal of a quality
system approval.

ò new

9. Each notified body shall immediately 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.

ê 2004/22/EC
(adapted)

ð new

10. Authorised representative

10. The manufacturer's obligations contained in paragraphs
Ö contained
in points Õ 3, 5.1, 5.5, 7.2
and 8 may be fulfilled Ö by his
authorised representative Õ , on his
behalf and under his responsibility, by his authorised representative
ð provided that they are specified in
the mandate ï .

8. ANNEX
Ö MODULE Õ E:

DECLARATION OF CONFORMITY TO TYPE BASED ON Ö INSTRUMENT Õ
QUALITY ASSURANCE OF
FINAL PRODUCT INSPECTION AND TESTING

1. ‘Declaration of cConformity to type based on Ö instrument Õ quality
assurance of final
product inspection and testing’ is the Ö that Õ part of a
conformity assessment procedure whereby the manufacturer fulfils the
obligations laid down in this Annex points 2 and 5, and ensures and declares
Ö on his
sole responsibility Õ that the
measuring instruments concerned are in conformity with the type as described in
the EC-type
Ö EU-type Õ examination
certificate and satisfy the appropriate requirements of this Directive Ö that
apply to them Õ .

2. Manufacturing

2. The manufacturer shall operate an approved quality system as specified in paragraph
3 for final product Ö instrument Õ inspection and
testing of the measuring instruments
concerned Ö as
specified in point 3 Õ and shall be
subject to surveillance, as specified in paragraph Ö point Õ 4.

3. Quality system

3.1. The manufacturer shall lodge an
application for assessment of the Ö his Õ quality system
with a notified body of his choice Ö , for the
measuring instruments concerned Õ .

ê 2004/22/EC

The application shall include:

ò new

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

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

ê 2004/22/EC
(adapted)

–
all relevant information for the instrument
category envisaged;

–
the documentation concerning the quality system;

–
the technical documentation of the approved type
and a copy of the EC-type
Ö EU-type Õ examination
certificate.

3.2. The quality system shall ensure
compliance of the Ö measuring Õ instruments
with the type as
described in the EC-type
Ö EU-type Õ examination
certificate and Ö with Õ the appropriate
Ö applicable Õ requirements
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 policies, procedures and instructions.
This quality system documentation must Ö shall Õ permit a
consistent interpretation of the quality programmes, plans, manuals and
records.

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

ê 2004/22/EC

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

–
the examinations and tests that will be carried
out after manufacture;

ê 2004/22/EC
(adapted)

–
the quality records, such as inspection reports
and test data, calibration data, qualification reports of Ö on Õ the personnel
concerned, etc.;

–
the means to monitor Ö of
monitoring Õ the effective
operation of the quality system.

3.3. The notified body shall assess the
quality system to determine whether it satisfies the requirements referred to
in paragraph
point 3.2.

It shall presume conformity with these Ö those Õ requirements
in respect of Ö the
elements of the Õ a quality
system that complies
Ö comply Õ with the
corresponding specifications of the national standard that implements the
relevant harmonised standard, from the moment its references have been published Ö and/or
technical specification Õ .

In addition to experience in quality
management systems, the auditing team shall possess appropriate Ö have at
least one member with Õ experience Ö of
evaluation Õ in the
relevant Ö instrument Õ field of metrology
and instrument technology Ö concerned Õ , and
knowledge of the applicable requirements of this Directive. The evaluation procedure
Ö audit Õ shall include
an inspection
Ö assessment Õ visit to the
manufacturer's premises.

ò new

The auditing team shall review the technical
documentation referred to in point 3.1, fifth indent, 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.

ê 2004/22/EC
(adapted)

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

ê 2004/22/EC

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.

ê 2004/22/EC
(adapted)

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

The notified body shall evaluate the Ö any
proposed Õ changes proposed
and decide whether the changed Ö modified Õ quality system
will still
Ö continue
to Õ satisfy the
requirements referred to in paragraph point 3.2 or whether a re-assessment is required
Ö necessary Õ .

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

4. Surveillance under the responsibility of the notified body

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

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

ê 2004/22/EC

–
the quality system documentation;

ê 2004/22/EC
(adapted)

ð new

–
the quality records, such as inspection reports
and test data, calibration data, qualification reports of Ö on Õ the personnel
concerned, etc.

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 an audit report to the
manufacturer Ö with an
audit report Õ .

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

5. Written
Ö Conformity
marking and Õ declaration of
conformity

5.1. The manufacturer shall affix the ‘CE’ Ö CE Õ marking, the
supplementary metrology marking Ö set out
in this Directive, Õ and, under the
responsibility of the notified body referred to in paragraph
point 3.1, the latter's
identification number to each measuring Ö individual Õ instrument
that is in conformity with the type as described in the EC-type
Ö EU-type Õ examination
certificate and satisfies the appropriate Ö applicable Õ requirements
of this Directive.

5.2. A Ö The
manufacturer shall draw up a written Õ declaration of
conformity is drawn
up for each instrument model and shall be kept Ö keep Õ at the
disposal of the national authorities for 10 years after the last
instrument has been manufactured
ð placed on the market ï . It
Ö The
declaration of conformity Õ shall identify
the instrument model for which it was Ö has
been Õ drawn up.

ò new

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

ê 2004/22/EC

A copy of the declaration shall be supplied
with each measuring instrument that is placed on the market. However, this
requirement may be interpreted as applying to a batch or consignment rather
than individual instruments in those cases where a large number of instruments
is delivered to a single user.

ê 2004/22/EC
(adapted)

ð new

6. The manufacturer shall, for Ö a period
ending at least Õ 10 years after
the last
instrument has been manufactured
ð placed on the market ï , keep at the disposal of the national authorities:

–
the documentation referred to in the
second indent of paragraph point 3.1;

–
the change referred to in the
second subparagraph of paragraph point 3.5, as approved;

–
the decisions and reports from Ö of Õ the notified
body which are
referred to in paragraph points
3.5, final
subparagraph, paragraph 4.3 and paragraph
4.4.

ê 2004/22/EC

7. Each notified
body shall periodically make available to the Member State that designated it
the list of quality system approvals issued or refused, and shall immediately
inform the Member State that designated it of the withdrawal of a quality
system approval.

ò new

7. Each notified body shall immediately 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.

ê 2004/22/EC
(adapted)

ð new

8. Authorised representative

8. The manufacturer's obligations contained in paragraphs Ö set out
in points Õ 3.1, 3.5, 5.2
and 6 may be fulfilled Ö by his
authorised representative Õ , on his
behalf and under his responsibility, by his authorised representative
ð provided that they are specified in
the mandate ï .

9. ANNEX
Ö MODULE Õ E1:

DECLARATION OF CONFORMITY BASED ON QUALITY ASSURANCE OF FINAL PRODUCT Ö INSTRUMENT Õ
INSPECTION AND TESTING

1. ‘Declaration of conformity based on
qQuality assurance of final product
Ö instrument Õ inspection and
testing’ is the conformity assessment procedure
whereby the manufacturer fulfils the obligations laid down in this
Annex points 2, 4 and
7, and ensures and declares Ö on his
sole responsibility Õ that the
measuring instruments concerned are in conformity with the appropriate
Ö satisfy
the Õ requirements
of this Directive Ö that
apply to them Õ .

2. Technical documentation

2. The manufacturer shall establish the technical documentation as
described in Article 1019. The documentation shall enable assessment of
Ö make it
possible to assess Õ the Ö instrument’s Õ conformity of the instrument
with the appropriate
Ö relevant Õ requirements of this Directive
Ö , and
shall include an adequate analysis and assessment of the risk(s) Õ . It Ö The
technical documentation Õ shall Ö specify
the applicable requirements and cover Õ , as far as
relevant for such
Ö the Õ assessment, cover
the design, manufacture and operation of the instrument.

3. The manufacturer shall keep the
technical documentation at the disposal of the Ö relevant Õ national
authorities for 10 years after the last instrument has been manufactured ð placed on the market ï .

4. Manufacturing

4. The manufacturer shall operate an approved quality system for final
product
Ö instrument Õ inspection and
testing of the measuring instruments
concerned as specified in paragraph point 5 and shall be subject to
surveillance as specified in paragraph point 6.

5. Quality system

5.1. The manufacturer shall lodge an
application for assessment of the Ö his Õ quality system
with a
Ö the Õ notified body
of his choice Ö , for the
measuring instruments concerned Õ .

ê 2004/22/EC

The application shall include:

ò new

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

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

ê 2004/22/EC

–
all relevant information for the instrument
category envisaged;

–
the documentation concerning the quality system;

ê 2004/22/EC
(adapted)

ð new

–
the technical documentation referred to in paragraph
point 2.

5.2. The quality system shall ensure
compliance of the Ö measuring Õ instruments
with the appropriate
requirements of this Directive Ö that
apply to them Õ .

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. This Ö The Õ quality system
documentation must ð shall ï permit a consistent interpretation of the quality programmes,
plans, manuals and records.

This documentation Ö It Õ shall Ö , in
particular, Õ contain in particular
an adequate description of:

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

–
the examinations and tests that will be carried
out after manufacture;

–
the quality records, such as inspection reports
and test data, calibration data, qualification reports of Ö on Õ the personnel
concerned, etc;

–
the means to monitor Ö of
monitoring Õ the effective
operation of the quality system.

5.3. The notified body shall assess the
quality system to determine whether it satisfies the requirements referred to
in paragraph
point 5.2.

It shall presume conformity with these Ö those Õ requirements
in respect of Ö the
elements of the Õ a
quality system that complies
Ö comply Õ with the
corresponding specifications of the national standard that implements the
relevant harmonised standard, from the moment its references have been published
Ö and/or
technical specification Õ .

In addition to experience in quality
management systems, the auditing team shall possess appropriate Ö have at
least one member with Õ experience Ö of
evaluation Õ in the
relevant Ö instrument Õ field of metrology
and instrument technology, and knowledge of the applicable requirements of this
Directive. The evaluation
procedure Ö audit Õ shall include
an inspection
Ö assessment Õ visit to the
manufacturer's premises.

ò new

The auditing team shall review the technical
documentation referred to in point 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.

ê 2004/22/EC
(adapted)

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

ê 2004/22/EC

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.

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

ê 2004/22/EC
(adapted)

The notified body shall evaluate the changes
Ö any Õ proposed Ö changes Õ and decide
whether the changed
Ö modified Õ quality system
will still
Ö continue
to Õ satisfy the
requirements referred to in paragraph point 5.2 or whether a re-assessment is required
Ö necessary Õ .

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

6. Surveillance under the responsibility of the notified body

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

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

ê 2004/22/EC

–
the quality system documentation;

ê 2004/22/EC
(adapted)

ð new

–
the technical documentation referred to in paragraph
point 2;

–
the quality records, such as inspection reports
and test data, calibration data, qualification reports of Ö on Õ the personnel
concerned, etc.

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 an audit report to the manufacturer Ö with an
audit report Õ .

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

7. Written
Ö Conformity
marking and Õ declaration of
conformity

7.1. The manufacturer shall affix the ‘CE’ Ö CE Õ marking, the
supplementary metrology marking Ö set out
in this Directive, Õ and, under the
responsibility of the notified body referred to in paragraph
point 5.1, the latter's
identification number to each measuring Ö individual Õ instrument
that satisfies the appropriate
Ö applicable Õ requirements
of this Directive.

7.2. A Ö The
manufacturer shall draw up a written Õ declaration of
conformity is drawn
up for each instrument model and shall be kept Ö keep
it Õ at the
disposal of the national authorities for 10 years after the last
instrument has been manufactured
ð placed on the market ï . It
Ö The
declaration of conformity Õ shall identify
the model of
the instrument Ö model Õ for which it was Ö has
been Õ drawn up.

ò new

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

ê 2004/22/EC

A copy of the declaration shall be supplied
with each measuring instrument that is placed on the market. However, this
requirement may be interpreted as applying to a batch or consignment rather
than individual instruments in those cases where a large number of instruments
is delivered to a single user.

ê 2004/22/EC
(adapted)

ð new

8. The manufacturer shall, for Ö a period
ending at least Õ 10 years after
the last
instrument has been manufactured
ð placed on the market ï , keep at the disposal of the national authorities:

–
the documentation referred to in paragraph
point 5.1, second indent;

–
the change referred to in paragraph
point 5.5, as approved;

–
the decisions and reports from the notified body
referred to in paragraphs points 5.5, 6.3 and 6.4.

ê 2004/22/EC

9. Each notified
body shall periodically make available to the Member State that designated it
the list of quality system approvals issued or refused, and shall immediately
inform the Member State that designated it of the withdrawal of a quality
system approval.

ò new

9. Each notified body shall immediately 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.

ê 2004/22/EC
(adapted)

ð new

10. Authorised representative

10. The manufacturer's obligations contained in paragraphs
Ö set out in
points Õ 3, 5.1, 5.5, 7.2
and 8 may be fulfilled Ö his
authorised representative, Õ , on his
behalf and under his responsibility, by his authorised representative
ð provided that they are specified in
the mandate ï .

10. ANNEX
Ö MODULE Õ F:

DECLARATION OF CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION

1. ‘Declaration of cConformity to type based on product
verification’ is the part of a conformity assessment
procedure whereby the manufacturer fulfils the obligations laid down in this
Annex points 2, 5.1 and
6, and ensures and declares Ö on his
sole responsibility Õ that the
measuring instruments Ö concerned,
which Õ that
have been subjected to the provisions of paragraph
point 3, are in conformity with the type as
described in the EC-type
Ö EU-type Õ examination
certificate and satisfy the appropriate requirements of this Directive Ö that
apply to them Õ .

2. Manufacturing

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

3. Verification

3. A notified body chosen by the manufacturer shall carry out the
appropriate examinations and tests, or have them carried out, to check the
conformity of the instruments with the type as described in the EC-type
Ö EU-type Õ examination
certificate and the approporate requirements of this Directive.

The examinations and tests to check the
conformity Ö of the
measuring instruments Õ with the metrological
Ö appropriate Õ requirements will Ö shall Õ be carried
out, at the choice of the manufacturer, either by examination and testing of
every instrument as specified in paragraph point 4, or by examination and testing
of the Ö measuring Õ instruments on
a statistical basis as specified in paragraph point 5.

4. Verification of conformity with the
metrological requirements by examination and testing of every instrument.

4.1. All Ö measuring Õ instruments
shall be individually examined and appropriate tests as set out in the relevant Ö harmonised
standard(s), normative Õ documents Ö and/or
technical specifications Õ referred to in Article 13,
or equivalent tests, shall be carried out in order to verify their
conformity with the Ö approved
type described in the EU-type examination certificate and with the
appropriate Õ metrological
requirements that
apply to them Ö of this
Directive Õ .

In the absence of a relevant Ö harmonised
standard or normative Õ document, the
notified body concerned shall decide on the appropriate tests to be carried
out.

ê 2004/22/EC

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.

ê 2004/22/EC
(adapted)

ð new

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

5. Statistical verification of conformity with
the metrological requirements.

5.1. The manufacturer shall take all
measures necessary in
order Ö so Õ that the
manufacturing process Ö and its
monitoring ensure Õ ensures the
homogeneity of each lot produced, and shall present his Ö measuring Õ instruments
for verification in the form of homogeneous lots.

5.2. A random sample shall be drawn Ö taken Õ from each lot
according to the requirements of paragraph 5.3 this Directive. All Ö measuring Õ instruments in
the
Ö a Õ sample shall
be individually examined and appropriate tests as
set out in the relevant Ö harmonised
standard(s), normative Õ document(s)
referred to in
Article 13 Ö and/or
technical specifications Õ , or
equivalent tests, Ö shall be
carried out in order to Õ ð verify their conformity with the
type as described in the EU-type examination certificate and to ensure ï to
establish their conformity with the metrological Ö applicable Õ requirements that apply to them shall
be carried out Ö of this
Directive and Õ to determine
whether the lot is accepted or rejected. In the absence of a relevant
Ö such
harmonised standard or normative Õ document, the
notified body concerned shall decide on the appropriate tests to be carried
out.

ê 2004/22/EC

5.3. The statistical procedure shall meet
the following requirements:

The statistical control will be based on
attributes. The sampling system shall ensure:

–
a level of quality corresponding to a
probability of acceptance of 95 %, with a non-conformity of less than
1 %;

–
a limit quality corresponding to a probability
of acceptance of 5 %, with a non-conformity of less than 7 %.

ê 2004/22/EC
(adapted)

ð new

5.4. If a lot is accepted, all Ö measuring Õ instruments of
the lot are ð shall be considered ï approved, except for those Ö measuring Õ instruments
from the sample that were Ö have
been Õ found not to
satisfy the tests.

ê 2004/22/EC

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.

ê 2004/22/EC
(adapted)

ð new

The manufacturer shall keep the certificates
of conformity Ö at the
disposal of Õ available for inspection
by the national authorities for 10 years after the certification of
the instrument ð has been placed on the market ï .

ê 2004/22/EC

5.5. If a lot is rejected, the notified
body shall take appropriate measures to prevent the placing on the market of
that lot. In the event of frequent rejection of lots the notified body may
suspend the statistical verification and take appropriate measures.

ê 2004/22/EC
(adapted)

ð new

6. Written
Ö Conformity
marking and Õ declaration of
conformity

6.1. The manufacturer shall affix the ‘CE’ Ö CE Õ marking and
the supplementary metrology marking Ö set out
in this Directive , and, under the responsibility of the notified body referred
to in point 3, the latter's identification number Õ to each measuring
Ö individual Õ instrument
that is in conformity with the approved type Ö described
in the EU-type examination certificate Õ and satisfies
the appropriate
Ö applicable Õ requirements
of this Directive.

6.2. A Ö The
manufacturer shall draw up a written Õ declaration of
conformity is drawn
up for each instrument model and shall be kept Ö keep
it Õ at the
disposal of the national authorities for 10 years after the last
instrument has been manufactured
ð placed on the market ï . It
Ö The
declaration of conformity Õ shall identify
the model of
the instrument Ö model Õ for which it was Ö has
been Õ drawn up.

ò new

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

ê 2004/22/EC

A copy of the declaration shall be supplied
with each measuring instrument that is placed on the market. However, this
requirement may be interpreted as applying to a batch or consignment rather
than individual instruments in those cases where a large number of instruments
is delivered to a single user.

ê 2004/22/EC
(adapted)

ð new

If agreed upon by the notified body
referred to in paragraph point
3 Ö agrees
and under its responsibility Õ , the
manufacturer shall
Ö may Õ also affix the
notified body's identification number to the measuring instruments under the notified body's
responsibility.

7. The manufacturer may, iIf agreed upon by the notified body
Ö agrees Õ and under its
responsibility, Ö the
manufacturer may Õ affix the
notified body's identification number to the measuring instruments during the
manufacturing process.

8. Authorised representative

8. The manufacturer's obligations may be fulfilled Ö by his
authorised representative Õ , on his
behalf and under his responsibility, by his authorised representative
ð provided that they are specified in
the mandate. ï except
for the Ö An
authorised representative may not fulfil the manufacturer's Õ obligations contained in paragraphs
Ö set out
in points Õ 2 and 5.1.

11. ANNEX
Ö MODULE Õ F1:

DECLARATION OF CONFORMITY BASED ON PRODUCT VERIFICATION

1. ‘Declaration of cConformity based on product verification’
is the conformity assessment procedure whereby the manufacturer fulfils the
obligations laid down in this Annex points
2, 3, 6.1 and 7 and ensures and declares Ö on his
sole responsibility Õ that the
measuring instruments Ö concerned
which Õ that
have been subjected to the provisions of paragraph
5 point 4,
are in conformity with the appropriate requirements of this Directive Ö that
apply to them Õ .

2. Technical documentation

2. The manufacturer shall establish the technical documentation as
described in Article 1019. The documentation shall enable assessment
Ö make it possible
to assess the instrument’s Õ of the
conformity of the
instrument with the appropriate Ö relevant Õ requirements Ö , and
shall include an adequate analysis and assessment of the risk(s) Õ of this Directive.
It
Ö The
technical documentation Õ shall Ö specify
the applicable requirements and cover Õ , as far as
relevant for such
Ö the Õ assessment, cover
the design, manufacture and operation of the instrument.

3. The manufacturer shall keep the technical documentation at the
disposal of the Ö relevant Õ national
authorities for 10 years after the last instrument has been manufactured ð placed on the market ï .

3. Manufacturing

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

4. Verification

5. A notified body chosen by the manufacturer shall carry out the
appropriate examinations and tests, or have them carried out, to check the
conformity of the Ö measuring Õ instruments
with the appropriate
Ö applicable Õ requirements
of this Directive.

The examinations and tests to check the
conformity with the metrological
Ö those Õ requirements will Ö shall Õ be carried
out, at the choice of the manufacturer, either by examination and testing of
every instrument as specified in paragraph 6 point 5, or by examination and testing
of the Ö measuring Õ instruments on
a statistical basis as specified in paragraph 7 point 6.

65. Verification of conformity with the metrological requirements
by examination and testing of every instrument.

65.1. All Ö measuring Õ instruments
shall be individually examined and appropriate tests, as set out in the relevant Ö harmonized
standards, normative Õ documents Ö and/or
technical specifications Õ referred to in Article 13,
or equivalent tests, shall be carried out to verify their conformity with the metrological
requirements that apply to them. In the absence of a relevant Ö such a
harmonised standard, normative Õ document Ö and/or
technical specification Õ , the notified
body concerned shall decide on the appropriate tests to be carried out.

ê 2004/22/EC

65.2. 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.

ê 2004/22/EC
(adapted)

ð new

The manufacturer shall keep the
certificates of conformity Ö at the
disposal of Õ available for inspection
by the national authorities for 10 years after the certification of
the instrument ð has been placed on the market ï .

76. Statistical verification of conformity with the metrological
requirements.

76.1. The manufacturer shall take all measures necessary in order
Ö so Õ that the
manufacturing process ensures the homogeneity of each lot produced, and shall
present his Ö measuring Õ instruments
for verification in the form of homogeneous lots.

76.2. A random sample shall be drawn Ö taken Õ from each lot
according to the requirements of paragraph 7.3.

6.3. All Ö measuring Õ instruments in
the sample shall be individually examined and appropriate tests as
set out in the relevant Ö harmonised
standards, normative Õ documents referred to in Article 13
Ö and/or
technical specifications Õ , or
equivalent tests, to establish their conformity with the metrological requirements that
apply to them, shall be carried out to determine whether the lot is accepted or
rejected. In the absence of a relevant Ö such
harmonised standard, normative Õ document Ö and/or
technical specification Õ , the notified
body concerned shall decide on the appropriate tests to be carried out.

ê 2004/22/EC

7.36.4. The statistical procedure shall meet the following requirements:

The statistical control will be based on
attributes. The sampling system shall ensure:

–
a level of quality corresponding to a
probability of acceptance of 95 %, with a non-conformity of less than
1 %;

–
a limit quality corresponding to a probability
of acceptance of 5 %, with a non-conformity of less than 7 %.

ê 2004/22/EC
(adapted)

ð new

7.46.5. If a lot is accepted,
all Ö measuring Õ instruments of
the lot are ð shall be considered ï approved, except for those Ö measuring Õ instruments
from the sample that were Ö have
been Õ found not to
satisfy the tests.

ê 2004/22/EC

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.

ê 2004/22/EC
(adapted)

ð new

The manufacturer shall keep the
certificates of conformity available for inspection by Ö at the
disposal of Õ the national
authorities for 10 years after the certification of the instrument ð has been placed on the market ï .

7.5. If a lot is rejected, the notified body shall take appropriate
measures to prevent the
Ö that lot
from being placed Õ placing
on the market of
that lot. In the event of frequent rejection of lots the
notified body may suspend the statistical verification and take appropriate
measures.

7. Written
Ö Conformity
marking and Õ declaration of
conformity

87.1. The manufacturer shall affix the ‘CE’ Ö CE Õ marking and
the supplementary metrology marking Ö set out
in this Directive, and under the responsibility of the notified body referred
to in point 4, the latter's identification number Õ to each measuring
Ö individual Õ instrument
that satisfies the appropriate
Ö applicable Õ requirements
of this Directive.

87.2. A
Ö The
manufacturer shall draw up a written Õ declaration of
conformity is drawn
up for each instrument model and shall be kept Ö keep
it Õ at the
disposal of the national authorities for 10 years after the last
instrument has been manufactured
ð placed on the market ï . It
Ö The
declaration of conformity Õ shall identify
the model of
the instrument Ö model Õ for which it was Ö has
been Õ drawn up.

ò new

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

ê 2004/22/EC

A copy of the declaration shall be supplied
with each measuring instrument that is placed on the market. However, this
requirement may be interpreted as applying to a batch or consignment rather
than individual instruments in those cases where a large number of instruments
is delivered to a single user.

ê 2004/22/EC
(adapted)

ð new

If agreed upon by the notified body
referred to in paragraph point
5 Ö agrees
and under its responsibility Õ , the
manufacturer shall
Ö may Õ also affix the
notified body's identification number to the measuring instruments under the notified body's
responsibility.

98. Ö If the
notified body agrees and under its responsibility, Õ Tthe manufacturer may, if agreed upon by the
notified body and under its responsibility, affix the
notified body's identification number to the measuring instruments during the
manufacturing process.

9. Authorised representative

10. The manufacturer's obligations may be fulfilled Ö by his
authorised representative Õ , on his
behalf and under his responsibility, by his authorised representative
ð provided that they are specified in
the mandate. ï , Ö An
authorised representative may not fulfil the manufacturer’s Õ except for the
obligations contained
in paragraphs 4 and 7.1 Ö set out
in points 3 and 6.1 Õ .

12. ANNEX Ö MODULE Õ G:

DECLARATION OF CONFORMITY BASED ON UNIT VERIFICATION

1. ‘Declaration of cConformity based on unit verification’
is the conformity assessment procedure whereby the manufacturer fulfils the
obligations laid down in this Annex points 2, 3 and 5 and ensures and
declares Ö on his
sole responsibility Õ that a measuring
the instrument Ö concerned, Õ that Ö which Õ has been
subjected to the provisions of paragraph
point 4, is in conformity with the
appropriate
requirements of this Directive Ö that
apply to it Õ .

2. Technical documentation

The manufacturer shall establish the
technical documentation as described in Article 1019 and make it available to the notified
body referred to in paragraph point 4. The technical documentation shall enable assessment of the
Ö make it
possible to assess the instrument's Õ conformity of the instrument
with the appropriate
Ö relevant Õ requirements of this Directive and
Ö , and
shall include an adequate analysis and assessment of the risk(s). The technical
documentation Õ shall Ö specify
the applicable requirements and cover Õ , as far as
relevant for such
Ö the Õ assessment, cover
the design, manufacture and operation of the instrument.

The manufacturer shall keep the technical
documentation at the disposal of the Ö relevant Õ national
authorities for ten years ð after the instrument has been placed
on the market ï .

3. Manufacturing

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

4. Verification

4. A notified body chosen by the manufacturer shall carry out the
appropriate examinations and tests as set out in the relevant Ö harmonised
standards, normative Õ documents Ö and/or
technical specifications Õ referred to in Article 13,
or equivalent tests, to check the conformity of the instrument with the appropriate
Ö applicable Õ requirements
of this Directive, or have them carried out. In the absence of Ö such Õ a relevant
Ö harmonised
standard, normative Õ document Ö and/or
technical specification Õ , the notified
body concerned shall decide on the appropriate tests to be carried out.

ê 2004/22/EC

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

ê 2004/22/EC
(adapted)

ð new

The manufacturer shall keep the
certificates of conformity Ö at the
disposal of Õ available for inspection
by the national authorities for 10 years after the certification of the
instrument ð has been placed on the market ï .

5. Written
Ö Conformity
marking and Õ declaration of
conformity

5.1. The manufacturer shall affix the ‘CE’ Ö CE Õ marking,
Ö and Õ the supplementary
metrology marking Ö set out
in this Directive Õ and, under the
responsibility of the notified body referred to in paragraph
point 4, the latter's
identification number to each measuring instrument that satisfies the appropriate
Ö applicable Õ requirements
of this Directive.

5.2. Ö The
manufacturer shall draw up a written Õ A
declaration of conformity shall be drawn up and kept Ö keep
it Õ at the
disposal of the national authorities for 10 years after the instrument has been
manufactured ð placed on the market ï . It
Ö The
declaration of conformity Õ shall identify
the instrument for which it was Ö has
been Õ drawn up.

ò new

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

ê 2004/22/EC

A copy of the declaration shall be supplied
with the measuring instrument.

6. Authorised representative

ê 2004/22/EC
(adapted)

ð new

6. The manufacturer's obligations contained in paragraphs Ö set out
in points Õ 2 and 4.2
5 may be fulfilled Ö by his
authorised representative Õ , on his
behalf and under his responsibility, by his authorised representative
ð provided that they are specified in
the mandate ï .

13. ANNEX
Ö MODULE Õ H:

DECLARATION OF CONFORMITY BASED ON FULL QUALITY ASSURANCE

1. ‘Declaration of cConformity based on full quality
assurance’ is the conformity assessment procedure
whereby the manufacturer fulfils the obligations laid down in this
Annex points 2
and 5, and ensures and declares Ö on his
sole responsibility Õ that the
measuring instruments concerned satisfy the appropriate requirements of this
Directive Ö that
apply to them Õ .

2. Manufacturing

2. The manufacturer shall operate an approved quality system for
design, manufacture and final product Ö instrument Õ inspection and
testing of the measuring instruments
concerned as specified in paragraph point 3, and shall be subject to
surveillance as specified in paragraph point 4.

3. Quality system

3.1. The manufacturer shall lodge an
application for assessment of the Ö his Õ quality system
with a
Ö the Õ notified body
of his choice Ö , for the
measuring instruments concerned Õ .

ê 2004/22/EC

The application shall include:

all relevant
information for the instrument category envisaged;

ò new

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

–
the technical
documentation for one model of each category of measuring instruments intended
to be manufactured. The technical documentation shall, wherever applicable,
contain at least the following elements:

–
a general description
of the instrument,

–
conceptual design and
manufacturing drawings and schemes of components, sub-assemblies, circuits,
etc.,

–
descriptions and
explanations necessary for the understanding of those drawings and schemes and
the operation of the instrument,

–
a list of the
harmonised standards, normative documents 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 standards have not been applied. In the event of partly applied
harmonised standards, the technical documentation shall specify the parts which
have been applied,

–
results of design
calculations made, examinations carried out, etc.,

–
test reports

ê 2004/22/EC
(adapted)

–
the documentation concerning the quality system,
Ö and Õ

ò new

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

ê 2004/22/EC
(adapted)

ð new

3.2. The quality system shall ensure
compliance of the Ö measuring Õ instruments
with the appropriate
requirements of this Directive Ö that
apply to them Õ .

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.
This quality system documentation must Ö shall Õ permit a
consistent interpretation of the quality programmes, plans, manuals and
records.

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

–
the quality objectives and the organisational
structure, responsibilities and powers of the management with regard to design
and product
Ö instrument Õ quality;

–
the technical design specifications, including
standards, that will be applied and, where the relevant Ö harmonised
standards, normative Õ documents Ö and/or technical
specifications Õ referred to in Article 13
will not be applied in full, the means that will be used to ensure that the
essential requirements of this Directive that apply to the Ö measuring Õ instruments will
be met;

–
the design control and design verification
techniques, processes and systematic actions that will be used when designing
the Ö measuring Õ instruments
pertaining to the instrument category covered;

ê 2004/22/EC

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

ê 2004/22/EC
(adapted)

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

–
the quality records, such as inspection reports
and test data, calibration data, qualification reports of Ö on Õ the personnel
concerned, etc.;

–
the means to monitor Ö of
monitoring Õ the
achievement of the required design and product Ö instrument Õ quality and
the effective operation of the quality system.

3.3. The notified body shall assess the
quality system to determine whether it satisfies the requirements referred to
in paragraph
point 3.2.

It shall presume conformity with these Ö those Õ requirements in
respect of Ö the
elements of the Õ a
quality system that complies
Ö comply Õ with the
corresponding specifications of the national standard that implements the
relevant harmonised standard, Ö and/or
technical specification Õ from the moment its
references have been published.

In addition to experience in quality
management systems, the auditing team shall possess appropriate Ö have at
least one member Õ experienced Ö as an
assessor Õ in the
relevant Ö instrument Õ field of metrology
and instrument technology Ö concerned Õ , and
knowledge of the applicable requirements of this Directive. The evaluation procedure
Ö audit Õ shall include
an inspection
Ö assessment Õ visit to the
manufacturer's premises.

ò new

The auditing team shall review the technical
documentation referred to in point 3.1, second indent, to verify the
manufacturer's ability to identify the applicable requirements of this
Directive and to carry out the necessary examinations with a view to ensuring
compliance of the instrument with those requirements.

ê 2004/22/EC
(adapted)

The decision Ö manufacturer
or his authorised representative Õ shall be
notified to the
manufacturer Ö of the
decision Õ . The
notification shall contain the conclusions of the examination Ö audit Õ and the
reasoned assessment decision.

ê 2004/22/EC

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.

ê 2004/22/EC
(adapted)

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

The notified body shall evaluate the Ö any
proposed Õ changes proposed
and decide whether the changed Ö modified Õ quality system
will still
Ö continue
to Õ satisfy the
requirements referred to in paragraph point 3.2 or whether a re-assessment is required
Ö necessary Õ .

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

ê 2004/22/EC

4. Surveillance under the responsibility of the notified body

ê 2004/22/EC
(adapted)

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

4.2. The manufacturer shall Ö , for
assessment purposes, Õ allow the notified
body entrance for
inspection purposes Ö access to
the design, Õ to the locations of
manufacture, inspection, testing and storage Ö sites Õ , and shall
provide it with all necessary information, in particular:

ê 2004/22/EC

–
the quality system documentation;

ê 2004/22/EC
(adapted)

ð new

–
the quality records as foreseen Ö provided
for Õ by the design
part of the quality system, such as results of analyses, calculations, tests,
etc.;

–
the quality records as foreseen Ö provided
for Õ by the
manufacturing part of the quality system, such as inspection reports and test
data, calibration data, qualification reports of Ö on Õ the personnel
concerned, etc.

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 Ö the
manufacturer with Õ an audit
report to the
manufacturer.

4.4. Additionally Ö In
addition Õ , the notified
body may pay unexpected visits to the manufacturer. During such visits the
notified body may, if necessary, carry out product Ö instrument Õ tests, or have
them carried out under
its responsibility, Ö in order
to check the proper functioning of Õ to verify that
the quality system is
functioning correctly. It shall provide the manufacturer with
a visit report and, if tests have been carried out, with a test report.

5. Written
Ö Conformity
marking and Õ declaration of
conformity

5.1. The manufacturer shall affix the ‘CE’ Ö CE Õ marking, the
supplementary metrology marking Ö set out
in this Directive Õ and, under the
responsibility of the notified body referred to in paragraph
point 3.1, the latter's
identification number to each measuring Ö individual Õ instrument
that satisfies the appropriate
Ö applicable Õ requirements
of this Directive.

5.2. A Ö The
manufacturer shall draw a written Õ declaration of
conformity is drawn
up for an Ö each Õ instrument
model and shall be
kept Ö keep
it Õ at the
disposal of the national authorities for 10 years after the last
instrument has been manufactured
ð placed on the market ï . It
Ö The
declaration of conformity Õ shall identify
the instrument model for which it was Ö has been Õ drawn up.

ò new

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

ê 2004/22/EC

A copy of the declaration shall be supplied
with each measuring instrument that is placed on the market. However, this
requirement may be interpreted as applying to a batch or consignment rather
than individual instruments in those cases where a large number of instruments
is delivered to a single user.

ê 2004/22/EC
(adapted)

ð new

6. The manufacturer shall, for Ö a period
ending at least Õ 10 years after
the last
instrument has been manufactured
ð placed on the market ï , keep at the disposal of the national authorities:

ò new

–
the technical
documentation referred to in point 3.1,

ê 2004/22/EC
(adapted)

–
the documentation concerning the quality system
referred to in paragraph point
3.1, second indent;

–
the change referred to in paragraph
point 3.5, as approved;

–
the decisions and reports from Ö of Õ the notified
body referred to in paragraphs points 3.5, 4.3 and 4.4.

ê 2004/22/EC

7. Each notified
body shall periodically make available to the Member State that designated it
the list of quality system approvals issued or refused, and shall
immediately inform the Member State that designated it of the withdrawal of a
quality system approval.

ò new

7. Each notified body shall immediately 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.

ê 2004/22/EC

8. Authorised representative

ê 2004/22/EC
(adapted)

ð new

8. The manufacturer's obligations contained in paragraphs
points 3.1, 3.5, 5.2
and 6 may be fulfilled Ö by his
authorised representative Õ , on his
behalf and under his responsibility, by his authorised representative
ð provided that they are specified in
the mandate ï .

14. ANNEX
Ö MODULE Õ H1:

DECLARATION OF CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION

1. ‘Declaration of cConformity based on full quality
assurance plus design examination’ is the
conformity assessment procedure whereby the manufacturer fulfils the
obligations laid down in this Annex points 2 and 6, and ensures and declares
Ö on his
sole responsibility Õ that the
measuring instruments concerned satisfy the appropriate requirements of this
Directive Ö that
apply to them Õ .

2. Manufacturing

2. The manufacturer shall operate an approved quality system for
design, manufacture and final product Ö instrument Õ inspection and
testing of the measuring instrument concerned as specified in paragraph
point 3, and shall be subject to
surveillance as specified in paragraph point 5.

The adequacy of the technical design of the
measuring instruments shall have
been examined according
Ö in
accordance Õ to
the provisions of paragraph with point 4.

3. Quality system

3.1. The manufacturer shall lodge an
application for assessment of the quality system with a Ö the Õ notified body
of his choice Ö for the
measuring instruments concerned Õ .

ê 2004/22/EC

The application shall include:

ò new

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

ê 2004/22/EC

–
all relevant information for the instrument
category envisaged;

–
the documentation concerning the quality system,

ò new

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

ê 2004/22/EC
(adapted)

3.2. The quality system shall ensure
compliance of the Ö measuring Õ instruments
with the appropriate
requirements of this Directive Ö that
apply to them Õ .

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.
This quality system documentation must Ö shall Õ permit a
consistent interpretation of the quality programmes, plans, manuals and records.

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

–
the quality objectives and the organisational
structure, responsibilities and powers of the management with regard to design
and product
Ö instrument Õ quality;

–
the technical design specifications, including
standards, that will be applied and, where the relevant Ö harmonised
standards and/or technical specifications Õ documents referred to
in Article 13 will not be applied in full, the means that
will be used to ensure that the essential requirements of this Directive that
apply to the Ö measuring Õ instruments
will be met;

–
the design control and design verification
techniques, processes and systematic actions that will be used when designing
the Ö measuring Õ instruments
pertaining to the instrument category covered;

ê 2004/22/EC

–
the corresponding manufacturing, quality control
and quality assurance techniques, processes and systematic actions 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;

ê 2004/22/EC
(adapted)

–
the quality records, such as inspection reports
and test data, calibration data, qualification reports of Ö on Õ the personnel
concerned, etc.;

–
the means to monitor Ö of
monitoring Õ the
achievement of the required design and product Ö instrument Õ quality and
the effective operation of the quality system.

3.3. The notified body shall assess the
quality system to determine whether it satisfies the requirements referred to
in paragraph
point 3.2. It shall presume
conformity with these
Ö those Õ requirements
in respect of Ö the
elements of the Õ a
quality system that complies
Ö comply Õ with the
corresponding specifications of the national standard that implements the
relevant harmonised standard, Ö and/or
technical specifications Õ from the moment its
references have been published in the Official Journal.

In addition to experience in quality
management systems, the auditing team shall possess appropriate Ö have at
least one member Õ experienced in the relevant Ö instrument Õ field of metrology
and instrument technology Ö concerned Õ , and
knowledge of the applicable requirements of this Directive. The evaluation procedure
Ö audit Õ shall include
an inspection
Ö assessment Õ visit to the
manufacturer's premises.

The decision Ö manufacturer
or his authorised representative Õ shall be
notified to the
manufacturer Ö of the
decision Õ . The
notification shall contain the conclusions of the examination Ö audit Õ and the
reasoned assessment decision.

ê 2004/22/EC

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.

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

ê 2004/22/EC
(adapted)

ð new

The notified body shall evaluate the Ö any
proposed Õ changes proposed
and decide whether the changed Ö modified Õ quality system
will still
Ö continue
to Õ satisfy the
requirements referred to in paragraph point 3.2 or whether a re-assessment is required
Ö necessary Õ .

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

3.6. Each notified body shall periodically make
available to the Member State that designated it the list Ö immediately
inform its notifying authorities Õ of quality
system approvals issued or refused
ð withdrawn ï , and shall Ö periodically
or upon request, make available to its notifying authorities the list of Õ immediately inform the Member
State that designated it of the withdrawal of a quality
system approvals ð refused, suspended or otherwise
restricted ï .

4. Design examination

4.1. The manufacturer shall lodge an
application for examination of the design with the notified body referred to in
paragraph
point 3.1.

4.2. The application shall enable Ö make it
possible to understand Õ understanding of
the design, manufacture and operation of the instrument, and shall enable assessment
Ö to assess
the Õ of
conformity with the appropriate
requirements of this Directive Ö that
apply to it Õ .

ê 2004/22/EC

It shall include:

–
the name and address of the manufacturer;

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

ê 2004/22/EC
(adapted)

ð new

–
the technical documentation as described in
Article 1019.
The documentation shall enable Ö make it
possible to Õ assessment of the Ö instrument’s Õ conformity of the instrument
with the appropriate
Ö relevant Õ requirements Ö , and
shall include an adequate analysis and assessment of the risk(s) Õ of this Directive.
It shall, as far as relevant for such assessment, cover the design and
operation of the instrument;

–
the supporting evidence for the adequacy of the
technical design. This Ö supporting Õ evidence shall
mention any documents that have been applied Ö used Õ , in
particular where the relevant Ö harmonised
standards, normative Õ documents Ö and/or
technical specifications Õ referred to in Article 13
have not been applied in full, and 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.

4.3. The notified body shall examine the
application, and where the design meets the provisions of the Directive Ö requirements
of this Directive Õ that apply to
the measuring
instrument it shall issue an EC Ö EU Õ design
examination certificate to the manufacturer. The certificate shall contain
Ö give Õ the name and
address of the manufacturer, the conclusions of the examination, any conditions
Ö (if any) Õ for its
validity and the Ö data Õ necessary data
for identification of the approved instrument Ö design Õ . Ö The
certificate may have one or more annexes attached. Õ

4.3.1. All relevant parts of the technical
documentation shall be annexed to the certificate.

4.3.2.
The certificate or ð and ï its annexes shall contain all relevant information for Ö to allow
the Õ conformity Ö of
manufactured measuring instruments with the examined design to be
evaluated Õ evaluation
and Ö to allow
for Õ in-service
control. It shall to allow the evaluation of conformity of the manufactured
instruments with the examined design regarding the reproducibility of their
metrological performances, when they are properly adjusted using appropriate
means, including:

ê 2004/22/EC

–
the metrological characteristics of the design
of the instrument;

–
measures required for ensuring the integrity of
the instruments (sealing, identification of software ...);

–
information on other elements necessary for the
identification of the instrument and to check its visual external conformity to
the design;

–
if appropriate, any specific information
necessary to verify the characteristics of manufactured instruments;

–
in the case of a sub-assembly, all necessary
information to ensure the compatibility with other sub-assemblies or measuring
instruments.

4.3.3. The notified body shall establish an evaluation report in this
regard and keep it at the disposal of the Member State that designated it.
Without prejudice to Article 12(8) 28(10), the notified body shall release
the content of this report, in full or in part, only with the agreement of the
manufacturer.

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

ê 2004/22/EC
(adapted)

ð new

If the manufacturer is denied Ö Where the
design does not satisfy the applicable requirements of this Directive, the
notified body shall refuse to issue Õ a design
examination certificate, the notified body Ö and Õ shall Ö inform
the applicant accordingly, giving Õ provide
detailed reasons for the denial Ö its
refusal Õ .

4.4. ð The notified body shall keep itself
apprised of any changes in the generally acknowledged state of the art which
indicate that the approved design may no longer comply with the applicable
requirements of the legislative instrument, and shall determine whether such
changes require further investigation. If so, the notified body shall inform
the manufacturer accordingly. ï

The manufacturer shall keep the notified
body that has issued the ‘EC’ Ö EU Õ design
examination certificate informed of any fundamental modification to the
approved design.
Modifications to the approved design must receive additional approval from the
notified body that issued the ‘EC’ design examination certificate where such
changes Ö that Õ may affect the
conformity with the essential requirements of this Directive,
Ö or Õ the conditions
for validity of the certificate. or the prescribed
conditions for use of the instrument. This Ö Such
modifications shall require Õ additional
approval Ö – from
the notified body that issued the EU design examination certificate – Õ is given
in the form of an addition to the original ‘EC’ Ö EU Õ design
examination certificate.

4.5. Each notified body shall periodically make
available to the Member State that designated it: Ö immediately
inform its notifying authorities of the Õ ‘EC’ Ö EU Õ design
examination certificates and annexes issued; Ö and/or
any Õ additions and amendments relating
to certificates issued ð 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 ï .

Each notified body
shall immediately inform the Member State that designated it of the withdrawal
of an EC design examination certificate.

ò new

The Commission, the Member States and the other
notified bodies may, on request, obtain a copy of the EU design examination
certificates and/or additions thereto. On request, the Commission and the
Member States may obtain a copy of the technical documentation and of the
results of the examinations carried out by the notified body.

The notified body shall keep a copy of the EU design
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.

ê 2004/22/EC
(adapted)

ð new

4.6. The manufacturer or his authorised
representative shall keep a copy of the ‘EC’ Ö EU Õ design
examination certificate, its annexes and additions with the technical
documentation Ö at the
disposal of the national authorities Õ for 10 years
after the last
measuring instrument has been manufactured ð placed on the market ï .

ê 2004/22/EC

Where neither the
manufacturer nor his authorised representative is established within the
Community, the obligation to make the technical documentation available on
request shall be the responsibility of the person designated by the
manufacturer.

ê 2004/22/EC
(adapted)

ð new

5. Surveillance under the responsibility of the notified body

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

5.2. The manufacturer shall Ö , for
assessment purposes, Õ allow the
notified body entrance
for inspection purposes Ö access Õ to the locations of
design, manufacture, inspection, testing and storage Ö sites Õ , and shall
provide it with all necessary information, in particular:

–
the quality system documentation;

–
the quality records as foreseen Ö provided
for Õ by the design
part of the quality system, such as results of analyses, calculations, tests,
etc;

–
the quality records as foreseen Ö provided
for Õ by the
manufacturing part of the quality system, such as inspection reports and test
data, calibration data, qualification reports of Ö on Õ the personnel
concerned, etc.

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

5.4. Additionally Ö In addition Õ , the notified
body may pay unexpected visits to the manufacturer. During such visits the
notified body may, if necessary, carry out product Ö instrument Õ tests, or have
them carried out under
its responsibility, Ö in order
to check the proper function of Õ to verify that
the quality system is
functioning correctly. It shall provide the manufacturer with
a visit report and, if tests have been carried out, with a test report.

6. Written
Ö Conformity
marking and Õ declaration of
conformity

6.1. The manufacturer shall affix the ‘CE’ Ö CE Õ marking,
and the supplementary metrology
marking Ö set out
in this Directive, Õ and, under the
responsibility of the notified body referred to in paragraph
point 3.1, the latter's
identification number to each measuring Ö individual Õ instrument
that satisfies the appropriate
Ö applicable Õ requirements
of this Directive.

6.2. A Ö The
manufacturer shall draw up a written Õ declaration of
conformity is drawn
up for each instrument model and shall be kept Ö keep
it Õ at the
disposal of the national authorities for 10 years after the last
instrument has been manufactured
ð placed on the market ï . It
Ö The
declaration of conformity Õ shall identify
the Ö instrument Õ model of the instrument
for which it was
Ö has
been Õ drawn up and
shall mention the number of the design examination certificate.

ò new

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

ê 2004/22/EC

A copy of the declaration shall be supplied
with each measuring instrument that is placed on the market. However, this
requirement may be interpreted as applying to a batch or consignment rather
than individual instruments in those cases where a large number of instruments
is delivered to a single user.

ê 2004/22/EC
(adapted)

ð new

7. The manufacturer shall, for Ö a period
ending at least Õ 10 years after
the last
instrument has been manufactured
ð placed on the market ï , keep at the disposal of the national authorities:

–
the documentation Ö concerning
the quality system Õ referred to in
point 3.1, second indent;

ê 2004/22/EC

–
the change referred to in paragraph
point 3.5, as approved;

–
the decisions and reports of the notified body
referred to in paragraphs points 3.5, 5.3 and 5.4.

8. Authorised representative

ê 2004/22/EC
(adapted)

ð new

8. The manufacturer's Ö authorised
representative may lodge the application referred to in points 4.1 and 4.2 and
fulfil the Õ obligations contained in
paragraphs Ö set out
in points Õ 3.1, 3.5, 4.4, 4.6, 6.2
and 7 may be
fulfilled, on his behalf and under his responsibility, by his authorised
representative ð provided that they are specified in
the mandate ï .

ê 2004/22/EC
(adapted)

ANNEX MI-001
III

WATER METERS Ö (MI-001) Õ

ê 2004/22/EC

The relevant requirements of Annex I, the
specific requirements of this Annex and the conformity assessment procedures
listed in this Annex, apply to water meters intended for the measurement of
volumes of clean, cold or heated water in residential, commercial and light
industrial use.

DEFINITIONS

Water Meter || || An instrument designed to measure, memorise and display the volume at metering conditions of water passing through the measurement transducer.

Minimum Flowrate (Q1) || || The lowest flowrate at which the water meter provides indications that satisfy the requirements concerning the maximum permissible errors (MPEs.)

Transitional Flowrate (Q2) || || The transitional flowrate is the flowrate value occurring between the permanent and minimum flowrates, at which the flowrate range is divided into two zones, the ‘upper zone’ and the ‘lower zone’. Each zone has a characteristic MPE.

Permanent Flowrate (Q3) || || The highest flowrate at which the water meter operates in a satisfactory manner under normal conditions of use, i.e. under steady or intermittent flow conditions.

Overload Flowrate (Q4) || || The overload flowrate is the highest flowrate at which the meter operates in a satisfactory manner for a short period of time without deteriorating.

SPECIFIC
REQUIREMENTS

Rated Operating Conditions

The manufacturer shall specify the rated
operating conditions for the instrument, in particular;

1. The flowrate range of the water.

The values for the flowrate range shall
fulfil the following conditions:

Q3/Q1 ≥ 10

Q2/Q1 = 1,6

Q4/Q3 = 1,25

For 5 years from
the date of entry into force of this Directive the ratio Q2/Q1 may be: 1,5, 2,5, 4 or 6,3.

2. The temperature range of the water.

The values for the temperature range shall
fulfil the following conditions:

0,1 °C to at least 30 °C, or

30 °C to at least 90 °C.

The meter may be designed to operate over
both ranges.

3. The relative pressure range of the
water, the range being 0,3 bar to at least 10 bar at Q3.

4. For the power supply: the nominal value
of the AC voltage supply and/or the limits of DC supply.

MPE

5. The MPE, positive or negative, on
volumes delivered at flowrates between the transitional flowrate (Q2)
(included) and the overload flowrate (Q4) is:

2 % for water having a temperature
≤ 30 °C,

3 % for water having a temperature
> 30 °C.

6. The MPE, positive or negative, on
volumes delivered at flowrates between the minimum flowrate (Q1) and
the transitional flowrate (Q2) (excluded) is 5 % for water
having any temperature.

ê 2009/137/EC

6a. The meter shall not exploit the MPE or
systematically favour any party.

ê 2004/22/EC

Permissible Effect of Disturbances

7.1. Electromagnetic immunity

7.1.1. The effect of an electromagnetic
disturbance on a water meter shall be such that:

–
the change in the measurement result is no
greater than the critical change value as defined in 8.1.4
7.1.3, or

–
the indication of the measurement result is such
that it cannot be interpreted as a valid result, such as a momentary variation
that cannot be interpreted, memorised or transmitted as a measuring result.

7.1.2. After undergoing an electromagnetic
disturbance the water meter shall:

–
recover to operate within MPE, and

–
have all measurement functions safeguarded, and

–
allow recovery of all measurement data present
just before the disturbance.

7.1.3. The critical change value is the
smaller of the two following values:

–
the volume corresponding to half of the
magnitude of the MPE in the upper zone on the measured volume;

–
the volume corresponding to the MPE on the
volume corresponding to one minute at flowrate Q3.

7.2. Durability

After an appropriate test, taking into
account the period of time estimated by the manufacturer, has been performed,
the following criteria shall be satisfied:

7.2.1. The variation of the measurement
result after the durability test, when compared with the initial measurement
result, shall not exceed:

–
3 % of the metered volume between Q1
included and Q2 excluded;

–
1,5 % of the metered volume between Q2
included and Q4 included.

7.2.2. The error of indication for the
volume metered after the durability test shall not exceed:

–
± 6 % of the metered volume between Q1
included and Q2 excluded;

–
± 2,5 % of the metered volume between
Q2 included and Q4 included for water meters intended to
meter water with a temperature between 0,1 °C and 30 °C,

–
± 3,5 % of the metered volume between
Q2 included and Q4 included for water meters intended to
meter water with a temperature between 30 °C and 90 °C.

Suitability

8.1. The meter shall be able to be
installed to operate in any position unless clearly marked otherwise.

8.2. The manufacturer shall specify whether
the meter is designed to measure reverse flow. In such a case, the reverse flow
volume shall either be subtracted from the cumulated volume or shall be
separately recorded. The same MPE shall apply to both forward and reverse flow.

Water meters not designed to measure
reverse flow shall either prevent reverse flow or shall withstand an accidental
reverse flow without any deterioration or change in metrological properties.

Units of Measurement

9. Metered volume shall be displayed in
cubic metres.

Putting into Use

ê 2004/22/EC
(adapted)

10. The Member State shall ensure that the
requirements under 1, 2 and 3 are determined by the distributor Ö utility Õ or the person
legally designated for installing the meter, so that the meter is appropriate
for the accurate measurement of consumption that is foreseen or foreseeable.

ê 2004/22/EC

CONFORMITY
ASSESSMENT

The conformity assessment procedures
referred to in Article 918 that the manufacturer can choose
between are:

B + F or B + D or H1.

ê 2004/22/EC
(adapted)

ANNEX MI-002
IV

GAS METERS AND VOLUME CONVERSION
DEVICES Ö (MI-002) Õ

ê 2004/22/EC

The relevant requirements of Annex I, the
specific requirements of this Annex and the conformity assessment procedures
listed in this Annex, apply to gas meters and volume conversion devices defined
below, intended for residential, commercial and light industrial use.

DEFINITIONS

Gas meter || || An instrument designed to measure, memorise and display the quantity of fuel gas (volume or mass) that has passed it.

Conversion device || || A device fitted to a gas meter that automatically converts the quantity measured at metering conditions into a quantity at base conditions.

Minimum flowrate (Qmin) || || The lowest flowrate at which the gas meter provides indications that satisfy the requirements regarding maximum permissible error (MPE.)

Maximum flowrate (Qmax) || || The highest flowrate at which the gas meter provides indications that satisfy the requirements regarding MPE.

Transitional flowrate (Qt) || || The transitional flowrate is the flowrate occurring between the maximum and minimum flowrates at which the flowrate range is divided into two zones, the ‘upper zone’ and the ‘lower zone’. Each zone has a characteristic MPE.

Overload Flowrate (Qr) || || The overload flowrate is the highest flowrate at which the meter operates for a short period of time without deteriorating.

Base conditions || || The specified conditions to which the measured quantity of fluid is converted.

PART
I — SPECIFIC REQUIREMENTS — GAS METERS

1. Rated operating conditions

The manufacturer shall specify the rated
operating conditions of the gas meter, taking into account:

1.1. The flowrate range of the gas shall
fulfil at least the following conditions:

Class || Qmax/Qmin || Qmax/Qt || Qr/Qmax

1,5 || ≥150 || ≥10 || 1,2

1,0 || ≥20 || ≥5 || 1,2

1.2. The temperature range of the gas, with
a minimum range of 40 °C.

1.3. The fuel/gas related conditions

The gas meter shall be designed for the
range of gases and supply pressures of the country of destination. In
particular the manufacturer shall indicate:

–
the gas family or group;

–
the maximum operating pressure.

1.4. A minimum temperature range of
50 °C for the climatic environment.

1.5. The nominal value of the AC voltage
supply and/or the limits of DC supply.

2. Maximum permissible error (MPEs)

2.1. Gas meter indicating the volume
at metering conditions or mass

Table 1

Class || 1,5 || 1,0

Qmin ≤ Q < Qt || 3 % || 2 %

Qt ≤ Q ≤ Qmax || 1,5 % || 1 %

ê 2009/137/EC

The gas meter shall not exploit the MPEs or
systematically favour any party.

ê 2004/22/EC

2.2. For a gas meter with temperature
conversion, which only indicates the converted volume, the MPE of the meter is
increased by 0,5 % in a range of 30 °C extending symmetrically around
the temperature specified by the manufacturer that lies between 15 °C and
25 °C. Outside this range, an additional increase of 0,5 % is
permitted in each interval of 10 °C.

3. Permissible effect of disturbances

3.1. Electromagnetic immunity

3.1.1. The effect of an electromagnetic
disturbance on a gas meter or volume conversion device shall be such that:

–
the change in the measurement result is no greater
than the critical change value as defined in 3.1.3, or

–
the indication of the measurement result is such
that it cannot be interpreted as a valid result, such as a momentary variation
that cannot be interpreted, memorised or transmitted as a measuring result.

3.1.2. After undergoing a disturbance, the
gas meter shall:

–
recover to operate within MPE, and

–
have all measurement functions safeguarded, and

–
allow recovery of all measurement data present
just before the disturbance.

3.1.3. The critical change value is the
smaller of the two following values:

–
the quantity corresponding to half of the
magnitude of the MPE in the upper zone on the measured volume;

–
the quantity corresponding to the MPE on the
quantity corresponding to one minute at maximum flowrate.

3.2. Effect of upstream-downstream
flow disturbances

Under installation conditions specified by
the manufacturer, the effect of the flow disturbances shall not exceed one
third of the MPE.

4. Durability

After an appropriate test, taking into
account the period of time estimated by the manufacturer, has been performed,
the following criteria shall be satisfied:

4.1. Class 1,5 meters

4.1.1. The variation of the measurement
result after the durability test when compared with the initial measurement
result for the flow rates in the range Qt to Qmax-shall
not exceed the measurement result by more than 2 %.

4.1.2. The error of indication after the
durability test shall not exceed twice the MPE in paragraph 2.

4.2. Class 1,0 meters

4.2.1. The variation of the measurement
result after the durability test when compared with the initial measurement
result shall not exceed one-third of the MPE in paragraph 2.

4.2.2. The error of indication after the
durability test shall not exceed the MPE in paragraph 2.

5. Suitability

5.1. A gas meter powered from the mains (AC
or DC) shall be provided with an emergency power supply device or other means
to ensure, during a failure of the principal power source, that all measuring
functions are safeguarded.

5.2. A dedicated power source shall have a
lifetime of at least five years. After 90 % of its lifetime an appropriate
warning shall be shown.

5.3. An indicating device shall have a
sufficient number of digits to ensure that the quantity passed during 8000
hours at Qmax does not return the digits to their initial values.

5.4. The gas meter shall be able to be
installed to operate in any position declared by the manufacturer in its
installation instruction.

5.5. The gas meter shall have a test
element, which shall enable tests to be carried out in a reasonable time.

5.6. The gas meter shall respect the MPE in
any flow direction or only in one flow direction clearly marked.

6. Units

Metered quantity shall be displayed in
cubic metre, or in kilogram.

PART
II — SPECIFIC REQUIREMENTS — VOLUME CONVERSION DEVICES

ê 2004/22/EC
(adapted)

A volume conversion device constitutes a
sub-assembly according
to Article 4, definition (b), second indent Ö when it
is together with a measuring instrument with which it is compatible Õ .

ê 2004/22/EC

For a volume conversion device, the
essential requirements for the gas meter shall apply, if applicable. In
addition, the following requirements shall apply:

7. Base conditions for converted quantities

The manufacturer shall specify the base
conditions for converted quantities.

8. MPE

–
0,5 % at ambient temperature 20 °C ±
3 °C, ambient humidity 60 % ± 15 %, nominal values for power
supply;

–
0,7 % for temperature conversion devices at
rated operating conditions;

–
1 % for other conversion devices at rated
operating conditions.

Note:

The error of the gas meter is
not taken into account.

ê 2009/137/EC

The volume conversion device shall not
exploit the MPEs or systematically favour any party.

ê 2004/22/EC

9. Suitability

9.1. An electronic conversion device shall
be capable of detecting when it is operating outside the operating range(s)
stated by the manufacturer for parameters that are relevant for measurement
accuracy. In such a case, the conversion device must stop integrating the
converted quantity, and may totalise separately the converted quantity for the
time it is operating outside the operating range(s).

9.2. An electronic conversion device shall
be capable to display all relevant data for the measurement without additional
equipment.

PART
III — PUTTING INTO USE AND CONFORMITY ASSESSMENT

Putting into use

10. (a) Where a Member State
imposes measurement of residential use, it shall allow such measurement to be
performed by means of any Class 1,5 meter, and by Class 1,0 meters which have a
Qmax/Qmin ratio equal or greater than 150.

(b) Where a Member State imposes
measurement of commercial and/or light industrial use, it shall allow such
measurement to be performed by any Class 1,5 meter.

ê 2004/22/EC
(adapted)

(c) As regards the requirements
under paragraphs 1.2 and 1.3, Member States shall ensure that the properties be
determined by the distributor
Ö utility Õ or the person
legally designated for installing the meter, so that the meter is appropriate
for the accurate measurement of consumption that is foreseen or foreseeable.

ê 2004/22/EC

CONFORMITY
ASSESSMENT

The conformity assessment procedures
referred to in Article 918 that the manufacturer can choose
between are

ê 2004/22/EC
(adapted)

B + F oder Ö or Õ B + D
or H1.

ANNEX MI-003
V

ACTIVE ELECTRICAL ENERGY METERS Ö (MI-003) Õ

ê 2004/22/EC

The relevant requirements of Annex I, the
specific requirements of this Annex and the conformity assessment procedures
listed in this Annex, apply to active electrical energy meters intended for
residential, commercial and light industrial use.

Note:

Electrical energy meters may be
used in combination with external instrument transformers, depending upon the
measurement technique applied. However, this Annex covers only electrical
energy meters but not instrument transformers.

DEFINITIONS

An active electrical energy meter is a
device which measures the active electrical energy consumed in a circuit.

I || = || the electrical current flowing through the meter;

In || = || the specified reference current for which the transformer operated meter has been designed;

Ist || = || the lowest declared value of I at which the meter registers active electrical energy at unity power factor (polyphase meters with balanced load);

Imin || = || the value of I above which the error lies within maximum permissible errors (MPEs) (polyphase meters with balanced load);

Itr || = || the value of I above which the error lies within the smallest MPE corresponding to the class index of the meter;

Imax || = || the maximum value of I for which the error lies within the MPEs;

U || = || the voltage of the electricity supplied to the meter;

Un || = || the specified reference voltage;

f || = || the frequency of the voltage supplied to the meter;

fn || = || the specified reference frequency;

PF || = || power factor = cosφ = the cosine of the phase difference φ between I and U.

SPECIFIC
REQUIREMENTS

1. Accuracy

The manufacturer shall specify the class
index of the meter. The class indices are defined as: Class A, B and C.

2. Rated operating conditions

The manufacturer shall specify the rated
operating conditions of the meter; in particular:

The values of fn, Un,
In, Ist, Imin, Itr and Imax
that apply to the meter. For the current values specified, the meter shall
satisfy the conditions given in Table 1;

Table 1

|| Class A || Class B || Class C

For direct-connected meters || || ||

Ist || ≤ 0,05 · Itr || ≤ 0,04 · Itr || ≤ 0,04 · Itr

Imin || ≤ 0,5 · Itr || ≤ 0,5 · Itr || ≤ 0,3 · Itr

Imax || ≥ 50 · Itr || ≥ 50 · Itr || ≥ 50 · Itr

For transformer-operated meters || || ||

Ist || ≤ 0,06 · Itr || ≤ 0,04 · Itr || ≤ 0,02 · Itr

Imin || ≤ 0,4 · Itr || ≤ 0,2 · Itr[31] || ≤ 0,2 · Itr

In || = 20 · Itr || = 20 · Itr || = 20 · Itr

Imax || ≥ 1,2 · In || ≥ 1,2 · In || ≥ 1,2 · In

The voltage, frequency and power factor
ranges within which the meter shall satisfy the MPE requirements are specified
in Table 2. These ranges shall recognise the typical characteristics of electricity
supplied by public distribution systems.

The voltage and frequency ranges shall be
at least:

0,9 · Un ≤
U ≤ 1,1 · Un

0,98 · fn ≤
f ≤ 1,02 · fn

power factor range at least from
cosφ = 0,5 inductive to cosφ = 0,8 capacitive.

3. MPEs

The effects of the various measurands and
influence quantities (a, b, c,...) are evaluated separately, all other measurands
and influence quantities being kept relatively constant at their reference
values. The error of measurement, that shall not exceed the MPE stated in Table
2, is calculated as:

Error of measurement = 2√(a2
- b2 + c2 ...)

When the meter is operating under
varying-load current, the percentage errors shall not exceed the limits given
in Table 2.

Table 2

MPEs in percent at rated operating conditions and defined load current levels and operating temperature

|| Operating temperatures || Operating temperatures || Operating temperatures || Operating temperatures

Meter class || + 5 °C ... + 30 °C || - 10 °C ... + 5 °C or + 30 °C ... + 40 °C || - 25 °C ... - 10 °C or + 40 °C ... + 55 °C || - 40 °C ... - 25 °C or + 55 °C ... + 70 °C

A || B || C || A || B || C || A || B || C || A || B || C

Single phase meter; polyphase meter if operating with balanced loads || || || || || || || || || || || ||

Imin ≤ I < Itr || 3,5 || 2 || 1 || 5 || 2,5 || 1,3 || 7 || 3,5 || 1,7 || 9 || 4 || 2

Itr ≤ I ≤ Imax || 3,5 || 2 || 0,7 || 4,5 || 2,5 || 1 || 7 || 3,5 || 1,3 || 9 || 4 || 1,5

Polyphase meter if operating with single phase load || || || || || || || || || || || ||

Itr ≤ I ≤ Imax, see exception below || 4 || 2,5 || 1 || 5 || 3 || 1,3 || 7 || 4 || 1,7 || 9 || 4,5 || 2

For electromechanical polyphase
meters the current range for single-phase load is limited to 5Itr
≤ I ≤ Imax

When a meter operates in different
temperature ranges the relevant MPE values shall apply.

ê 2009/137/EC

The meter shall not exploit the MPEs or
systematically favour any party.

ê 2004/22/EC

4. Permissible effect of disturbances

4.1. General

As electrical energy meters are directly
connected to the mains supply and as mains current is also one of the
measurands, a special electromagnetic environment is used for electricity
meters.

The meter shall comply with the
electromagnetic environment E2 and the additional requirements in 4.2 and 4.3.

The electromagnetic environment and
permissible effects reflect the situation that there are disturbances of long
duration which shall not affect the accuracy beyond the critical change values
and transient disturbances, which may cause a temporary degradation or loss of
function or performance but from which the meter shall recover and shall not
affect the accuracy beyond the critical change values.

When there is a foreseeable high risk due
to lightning or where overhead supply networks are predominant, the
metrological characteristics of the meter shall be protected.

4.2. Effect of disturbances of long
duration

Table 3

Critical change values for disturbances of long duration

Disturbance || Critical change values in percent for meters of class

A || B || C

Reversed phase sequence || 1,5 || 1,5 || 0,3

Voltage unbalance (only applicable to polyphase meters) || 4 || 2 || 1

Harmonic contents in the current circuits[32] || 1 || 0,8 || 0,5

DC and harmonics in the current circuit[33] || 6 || 3 || 1,5

Fast transient bursts || 6 || 4 || 2

Magnetic fields; HF (radiated RF) electromagnetic field; Conducted disturbances introduced by radio-frequency fields; and Oscillatory waves immunity || 3 || 2 || 1

4.3. Permissible effect of transient
electromagnetic phenomena

4.3.1. The effect of an electromagnetic
disturbance on an electrical energy meter shall be such that during and
immediately after a disturbance

–
any output intended for testing the accuracy of
the meter does not produce pulses or signals corresponding to an energy of more
than the critical change value

and in reasonable time after the
disturbance the meter shall

–
recover to operate within the MPE limits, and

–
have all measurement functions safeguarded, and

–
allow recovery of all measurement data present
prior to the disturbance, and

–
not indicate a change in the registered energy
of more than the critical change value.

The critical change value in kWh is
m · Un · Imax · 10-6

(m being the number of measuring elements
of the meter, Un in Volts and Imax in Amps).

4.3.2. For overcurrent the critical change
value is 1,5 %.

5. Suitability

5.1. Below the rated operating voltage the
positive error of the meter shall not exceed 10 %.

5.2. The display of the total energy shall
have a sufficient number of digits to ensure that when the meter is operated
for 4000 hours at full load (I = Imax, U = Un
and PF = 1) the indication does not return to its initial value and
shall not be able to be reset during use.

5.3. In the event of loss of electricity in
the circuit, the amounts of electrical energy measured shall remain available
for reading during a period of at least 4 months.

5.4. Running with no load

When the voltage is applied with no current
flowing in the current circuit (current circuit shall be open circuit), the
meter shall not register energy at any voltage between 0,8 · Un
and 1,1 Un.

5.5. Starting

The meter shall start and continue to
register at Un, PF = 1 (polyphase meter with balanced
loads) and a current which is equal to Ist.

6. Units

The electrical energy measured shall be
displayed in kilowatt-hours or in megawatt-hours.

7. Putting into use

(a) Where a Member State imposes
measurement of residential use, it shall allow such measurement to be performed
by means of any Class A meter. For specified purposes the Member State is
authorised to require any Class B meter.

(b) Where a Member State imposes
measurement of commercial and/or light industrial use, it shall allow such
measurement to be performed by any Class B meter. For specified purposes the
Member State is authorised to require any Class C meter.

ê 2004/22/EC
(adapted)

(c) The Member State shall
ensure that the current range be determined by the distributor Ö utility Õ or the person
legally designated for installing the meter, so that the meter is appropriate
for the accurate measurement of consumption that is foreseen or foreseeable.

ê 2004/22/EC

CONFORMITY
ASSESSMENT

The conformity assessment procedures
referred to in Article 918 that the manufacturer can choose
between are:

B + F or B + D or H1.

ê 2004/22/EC
(adapted)

ANNEX MI-004
VI

HEAT METERS Ö (MI-004) Õ

ê 2004/22/EC

The relevant requirements of Annex I, the
specific requirements and the conformity assessment procedures listed in this
Annex, apply to heat meters defined below, intended for residential, commercial
and light industrial use.

DEFINITIONS

A heat meter is an instrument designed to
measure the heat which, in a heat exchange circuit, is given up by a liquid
called the heat-conveying liquid.

A heat meter is either a complete
instrument or a combined instrument consisting of the sub-assemblies, flow
sensor, temperature sensor pair, and calculator, as defined in Article 4(b2), or a combination thereof

θ || = || the temperature of the heat-conveying liquid;

θin || = || the value of θ at the inlet of the heat exchange circuit;

θout || = || the value of θ at the outlet of the heat exchange circuit;

Δθ || = || the temperature difference θin — θout with Δθ ≥ 0;

θmax || = || the upper limit of θ for the heat meter to function correctly within the MPEs;

θmin || = || the lower limit of θ for the heat meter to function correctly within the MPEs;

Δθmax || = || the upper limit of Δθ for the heat meter to function correctly within the MPEs;

Δθmin || = || the lower limit of Δθ for the heat meter to function correctly within the MPEs;

q || = || the flow rate of the heat conveying liquid;

qs || = || the highest value of q that is permitted for short periods of time for the heat meter to function correctly;

qp || = || the highest value of q that is permitted permanently for the heat meter to function correctly;

qi || = || the lowest value of q that is permitted for the heat meter to function correctly;

P || = || the thermal power of the heat exchange;

Ps || = || the upper limit of P that is permitted for the heat meter to function correctly.

SPECIFIC
REQUIREMENTS

1. Rated operating conditions

The values of the rated operating
conditions shall be specified by the manufacturer as follows:

1.1. For the temperature of the liquid:
θmax, θmin,

–
for the temperature differences: Δθmax,
Δθmin,

subject to the following
restrictions: Δθmax/Δθmin
≥ 10; Δθmin = 3 K or 5 K or 10 K.

1.2. For the pressure of the liquid: The
maximum positive internal pressure that the heat meter can withstand
permanently at the upper limit of the temperature.

1.3. For the flow rates of the liquid: qs,
qp, qi, where the values of qp and qi
are subject to the following restriction: qp/qi
≥ 10.

1.4. For the thermal power: Ps.

2. Accuracy classes

The following accuracy classes are defined
for heat meters: 1, 2, 3.

3. MPEs applicable to complete heat meters

The maximum permissible relative errors
applicable to a complete heat meter, expressed in percent of the true value for
each accuracy class, are:

–
For class 1: E = Ef + Et
- Ec, with Ef, Et, Ec according to
paragraphs 7.1 to 7.3.

–
For class 2: E = Ef + Et
- Ec, with Ef, Et, Ec according to
paragraphs 7.1 to 7.3.

–
For class 3: E = Ef + Et
- Ec, with Ef, Et, Ec according to
paragraphs 7.1 to 7.3.

ê 2009/137/EC

The complete heat meter shall not exploit
the MPEs or systematically favour any party.

ê 2004/22/EC

4. Permissible influences of electromagnetic disturbances

4.1. The instrument shall not be influenced
by static magnetic fields and by electromagnetic fields at mains frequency.

4.2. The influence of an electromagnetic
disturbance shall be such that the change in the measurement result is not
greater than the critical change value as laid down in requirement 4.3 or the
indication of the measurement result is such that it cannot be interpreted as a
valid result.

4.3. The critical change value for a
complete heat meter is equal to the absolute value of the MPE applicable to
that heat meter (see paragraph 3).

5. Durability

After an appropriate test, taking into
account the period of time estimated by the manufacturer, has been performed,
the following criteria shall be satisfied:

5.1. Flow sensors: The variation of the
measurement result after the durability test, when compared with the initial
measurement result, shall not exceed the critical change value.

5.2. Temperature sensors: The variation of
the measurement result after the durability test, when compared with the
initial measurement result, shall not exceed 0,1 °C.

6. Inscriptions on a heat meter

–
Accuracy class

–
Limits of flow rate

–
Limits of temperature

–
Limits of temperature difference

–
Place of the flow sensor installation: flow or
return

–
Indication of the direction of flow

7. Sub-assemblies

The provisions for sub-assemblies may apply
to sub-assemblies manufactured by the same or different manufacturers. Where a
heat meter consists of sub-assemblies, the essential requirements for the heat
meter apply to the sub-assemblies as relevant. In addition, the following
apply:

7.1. The relative MPE of the flow sensor,
expressed in %, for accuracy classes:

–
Class 1: Ef = (1 + 0,01
qp/q), but not more than 5 %,

–
Class 2: Ef = (2 + 0,02
qp/q), but not more than 5 %,

–
Class 3: Ef = (3 + 0,05
qp/q), but not more than 5 %,

where the error Ef relates the
indicated value to the true value of the relationship between flow sensor
output signal and the mass or the volume.

7.2. The relative MPE of the temperature
sensor pair, expressed in %:

–
Et = (0,5 + 3 · Δθmin/Δθ),

where the error Et relates the
indicated value to the true value of the relationship between temperature
sensor pair output and temperature difference.

7.3. The relative MPE of the calculator,
expressed in %:

–
Ec = (0,5 + Δθmin/Δθ),

where the error Ec relates the
value of the heat indicated to the true value of the heat.

7.4. The critical change value for a
sub-assembly of a heat meter is equal to the respective absolute value of the
MPE applicable to the sub-assembly (see paragraphs 7.1, 7.2 or 7.3).

7.5. Inscriptions on the sub-assemblies

Flow sensor: || Accuracy class

Limits of flow rate

Limits of temperature

Nominal meter factor (e.g. litres/pulse) or corresponding output signal

Indication of the direction of flow

Temperature sensor pair: || Type identification (e.g. Pt 100)

Limits of temperature

Limits of temperature difference

Calculator: || Type of temperature sensors – Limits of temperature – Limits of temperature difference – Required nominal meter factor (e.g. litres/pulse) or corresponding input signal coming from the flow sensor – Place of the flow sensor installation: flow or return

PUTTING
INTO USE

8. (a) Where a Member State
imposes measurement of residential use, it shall allow such measurement to be
performed by means of any Class 3 meter.

(b) Where a Member State imposes
measurement of commercial and/or light industrial use, it is authorised to
require any Class 2 meter.

ê 2004/22/EC
(adapted)

(c) As regards the requirements
under paragraphs 1.1 to 1.4, Member States shall ensure that the properties be
determined by the distributor
Ö utility Õ or the person
legally designated for installing the meter, so that the meter is appropriate
for the accurate measurement of consumption that is foreseen or foreseeable.

ê 2004/22/EC

CONFORMITY
ASSESSMENT

The conformity assessment procedures
referred to in Article 918 that the manufacturer can choose
between are:

B + F or B + D or H1.

ê 2004/22/EC
(adapted)

ANNEX MI-005
VII

MEASURING SYSTEMS FOR THE
CONTINUOUS AND DYNAMIC MEASUREMENT OF QUANTITIES OF LIQUIDS OTHER THAN WATER Ö (MI-005) Õ

ê 2004/22/EC

The relevant essential requirements of
Annex I, the specific requirements of this Annex and the conformity assessment
procedures listed in this Annex, apply to measuring systems intended for the
continuous and dynamic measurement of quantities (volumes or masses) of liquids
other than water. If appropriate, the terms ‘volume, and L’ in this Annex can be
read as: ‘mass and kg’.

DEFINITIONS

Meter || || An instrument designed to measure continuously, memorise and display the quantity at metering conditions of liquid flowing through the measurement transducer in a closed, fully charged conduit.

Calculator || || A part of a meter that receives the output signals from the measurement transducer(s) and possibly, from associated measuring instruments and displays the measurement results.

Associated measuring instrument || || An instrument connected to the calculator for measuring certain quantities which are characteristic of the liquid, with a view to make a correction and/or conversion.

Conversion Device || || A part of the calculator which by taking account of the characteristics of the liquid (temperature, density, etc.) measured using associated measuring instruments, or stored in a memory, automatically converts: – the volume of the liquid measured at metering conditions into a volume at base conditions and/or into mass, or – the mass of the liquid measured at metering conditions into a volume at metering conditions and/or into a volume at base conditions Note:               A conversion device includes the relevant associated measuring instruments.

Base conditions || || The specified conditions to which the measured quantity of liquid at metering conditions is converted.

Measuring System || || A system that comprises the meter itself and all devices required to ensure correct measurement or intended to facilitate the measuring operations.

Fuel dispenser || || A measuring system intended for the refuelling of motor vehicles, small boats and small aircraft.

Self-service arrangement || || An arrangement that allows the customer to use a measuring system for the purpose of obtaining liquid for his own use.

Self-service device || || A specific device that is part of a self-service arrangement and which allows one of more measuring systems to perform in this self-service arrangement.

Minimum measured quantity (MMQ) || || The smallest quantity of liquid for which the measurement is metrologically acceptable for the measuring system.

Direct indication || || The indication, either volume or mass, corresponding to the measure and that the meter is physically capable of measuring. Note:               The direct indication may be converted into another quantity using a conversion device.

Interruptible/non interruptible || || A measuring system is considered as interruptible/non interruptible when the liquid flow can/cannot be stopped easily and rapidly.

Flowrate range || || The range between the minimum flowrate (Qmin) and maximum flowrate (Qmax).

SPECIFIC
REQUIREMENTS

1. Rated operating conditions

The manufacturer shall specify the rated
operating conditions for the instrument, in particular;

1.1. The flowrate range

The flowrate range is subject to the
following conditions:

(i) the flowrate range of a measuring
system shall be within the flowrate range of each of its elements, in
particular the meter.

(ii) meter and measuring system:

Table 1

Specific measuring system || Characteristic of liquid || Minimum ratio of Qmax : Qmin

Fuel dispensers || Not Liquefied gases || 10 : 1

Liquefied gases || 5 : 1

Measuring system || Cryogenic liquids || 5 : 1

Measuring systems on pipeline and systems for loading ships || All liquids || Suitable for use

All other measuring systems || All liquids || 4 : 1

1.2. The properties of the liquid to be measured
by the instrument by specifying the name or type of the liquid or its relevant
characteristics, for example:

–
Temperature range;

–
Pressure range;

–
Density range;

–
Viscosity range.

1.3. The nominal value of the AC voltage
supply and/or limits of the DC voltage supply.

1.4. The base conditions for converted
values.

Note:

ê 2004/22/EC
(adapted)

Paragraph 1.4 is without
prejudice to the Member States' obligations to require use of a temperature of
either 15 °C in accordance with Article 3(1)12(2) of Council Directive 92/81/EEC
2003/96/EC of 19
October 1992 27 October
2003 on
the harmonisation of the structures of excise duties on mineral oils
Ö restructuring
the Community framework for the taxation of energy products and electricity Õ[34] or, for heavy fuel oils, LPG and methane, another
temperature pursuant to Article 3(2) of that Directive.

ê 2004/22/EC

2. Accuracy classification and maximum permissible errors (MPEs)

2.1. For quantities equal to or greater
than 2 litres the MPE on indications is:

Table 2

|| Accuracy Class

|| 0,3 || 0,5 || 1,0 || 1,5 || 2,5

Measuring systems (A) || 0,3% || 0,5% || 1,0% || 1,5% || 2,5%

Meters (B) || 0,2% || 0,3% || 0,6% || 1,0% || 1,5%

2.2. For quantities less than two litres
the MPE on indications is:

Table 3

Measured volume V || MPE

V < 0,1 L || 4 × value in Table 2, applied to 0,1 L

0,1 L ≤ V < 0,2 L || 4 × value in Table 2

0,2 L ≤ V < 0,4 L || 2 × value in Table 2, applied to 0,4 L

0,4 L ≤ V < 1 L || 2 × value in Table 2

1 L ≤ V < 2 L || Value in Table 2, applied to 2 L

2.3. However, no matter what the measured
quantity may be, the magnitude of the MPE is given by the greater of the
following two values:

–
the absolute value of the MPE given in Table 2
or Table 3,

–
the absolute value of the MPE for the minimum
measured quantity (Emin).

2.4.1. For minimum measured quantities
greater than or equal to 2 litres the following conditions apply:

Condition 1

Emin shall fulfil the condition:
Emin ≥ 2 R, where R is the smallest scale
interval of the indication device.

Condition 2

Emin is given by the formula: Emin = (2MMQ)
× (A/100), where:

–
MMQ is the minimum measured quantity,

–
A is the numerical value specified in line A of
Table 2.

2.4.2. For minimum measured quantities of
less than two litres, the above mentioned condition 1 applies and Emin
is twice the value specified in Table 3, and related to line A of Table 2.

2.5. Converted indication

In the case of a converted indication the
MPEs are as in line A of Table 2.

2.6. Conversion devices

MPEs on converted indications due to a
conversion device are equal to ± (A — B), A and B being the values
specified in Table 2.

Parts of conversion devices that can be
tested separately

(a)Calculator

MPEs on quantities of liquid
indications applicable to calculation, positive or negative, are equal to
one-tenth of the MPEs as defined in line A of Table 2.

(b)Associated measuring
instruments

Associated measuring instruments
shall have an accuracy at least as good as the values in Table 4:

Table 4

MPE on Measurements || Accuracy classes of the measuring system

0,3 || 0,5 || 1,0 || 1,5 || 2,5

Temperature || ± 0,3 °C || ± 0,5 °C || ± 1,0 °C

Pressure || Less than 1 MPa: ± 50 kPa From 1 to 4 MPa: ± 5 % Over 4 MPa: ± 200 kPa

Density || ± 1 kg/m3 || ± 2 kg/m3 || ± 5 kg/m3

These values apply to the
indication of the characteristic quantities of the liquid displayed by the
conversion device.

c)Accuracy for calculating
function

The MPE for the calculation of
each characteristic quantity of the liquid, positive or negative, is equal to
two fifths of the value fixed in (b).

2.7. The requirement (a) in paragraph 2.6
applies to any calculation, not only conversion.

ê 2009/137/EC

2.8. The measuring system shall not exploit
the MPEs or systematically favour any party.

ê 2004/22/EC

3. Maximum permissible effect of disturbances

3.1. The effect of an electromagnetic
disturbance on a measuring system shall be one of the following;

–
the change in the measurement result is not greater
than the critical change value as defined in paragraph 3.2, or

–
the indication of the measurement result shows a
momentary variation that cannot be interpreted, memorised or transmitted as a
measuring result. Furthermore, in the case of an interruptible system, this can
also mean the impossibility to perform any measurement, or

–
the change in the measurement result is greater
than the critical change value, in which case the measuring system shall permit
the retrieval of the measuring result just before the critical change value
occurred and cut off the flow.

3.2. The critical change value is the
greater of MPE/5 for a particular measured quantity or Emin.

4. Durability

After an appropriate test, taking into
account the period of time estimated by the manufacturer, has been performed,
the following criterion shall be satisfied:

The variation of the measurement result
after the durability test, when compared with the initial measurement result,
shall not exceed the value for meters specified in line B of table 2.

5. Suitability

5.1. For any measured quantity relating to
the same measurement, the indications provided by various devices shall not
deviate one from another by more than one scale interval where devices have the
same scale interval. In the case where the devices have different scale
intervals, the deviation shall not be more than that of the greatest scale
interval.

However, in the case of a self-service
arrangement the scale intervals of the main indicating device on the measuring
system and the scale intervals of the self-service device shall be the same and
results of measurement shall not deviate one from another.

5.2. It shall not be possible to divert the
measured quantity in normal conditions of use unless it is readily apparent.

5.3. Any percentage of air or gas not
easily detectable in the liquid shall not lead to a variation of error greater
than:

–
0,5 % for liquids other than potable
liquids and for liquids of a viscosity not exceeding 1 mPa.s, or

–
1 % for potable liquids and for liquids of
a viscosity exceeding 1 mPa.s.

However, the allowed variation shall never
be smaller than 1 % of MMQ. This value applies in the case of air or gas
pockets.

5.4. Instruments for direct sales

5.4.1. A measuring system for direct sales
shall be provided with means for resetting the display to zero.

It shall not be possible to divert the
measured quantity.

5.4.2. The display of the quantity on which
the transaction is based shall be permanent until all parties in the
transaction have accepted the measurement result.

5.4.3. Measuring systems for direct sales
shall be interruptible.

5.4.4. Any percentage of air or gas in the
liquid shall not lead to a variation of error greater than the values specified
in paragraph 5.3.

5.5. Fuel Dispensers

5.5.1. Displays on fuel dispensers shall
not be capable of being reset to zero during a measurement.

5.5.2. The start of a new measurement shall
be inhibited until the display has been reset to zero.

5.5.3. Where a measuring system is fitted
with a price display, the difference between the indicated price and the price
calculated from the unit price and the indicated quantity shall not exceed the
price corresponding to Emin. However this difference need not be
less than the smallest monetary value.

6. Power supply failure

A measuring system shall either be provided
with an emergency power supply device that will safeguard all measuring
functions during the failure of the main power supply device or be equipped
with means to save and display the data present in order to permit the conclusion
of the transaction in progress and with means to stop the flow at the moment of
the failure of the main power supply device.

7. Putting into use

Table 5

Accuracy Class || Types of Measuring system

0,3 || Measuring systems on pipeline

0,5 || All measuring systems if not differently stated elsewhere in this Table, in particular: – fuel dispensers (not for liquefied gases), – measuring systems on road tankers for liquids of low viscosity (< 20 mPa.s) – measuring systems for (un)loading ships and rail and road tankers[35] – measuring systems for milk – measuring systems for refuelling aircraft

1,0 || Measuring systems for liquefied gases under pressure measured at a temperature equal to or above – 10 °C

Measuring systems normally in class 0,3 or 0,5 but used for liquids – whose temperature is less than - 10 °C or greater than 50 °C – whose dynamic viscosity is higher than 1000 mPa.s – whose maximum volumetric flowrate is not higher than 20 L/h

1,5 || Measuring systems for liquefied carbon dioxide

Measuring systems for liquefied gases under pressure measured at a temperature below – 10 °C (other than cryogenic liquids)

2,5 || measuring systems for cryogenic liquids (temperature below – 153 °C)

Note:

However, the manufacturer may
specify a better accuracy for a certain type of measuring system.

8. Units of measurement

The metered quantity shall be displayed in
millilitres, cubic centimetres, litres, cubic metres, grams, kilograms or
tonnes.

CONFORMITY
ASSESSMENT

The conformity assessment procedures
referred to in Article 918 that the manufacturer can choose
between are:

B + F or B + D or H1 or
G.

ê 2004/22/EC
(adapted)

ANNEX MI-006
VIII

AUTOMATIC WEIGHING INSTRUMENTS Ö (MI-006) Õ

ê 2004/22/EC

The relevant essential requirements of
Annex I, the specific requirements of this Annex and the conformity assessment
procedures listed in Chapter I of this Annex, apply to automatic weighing
instruments defined below, intended to determine the mass of a body by using
the action of gravity on that body.

DEFINITIONS

Automatic weighing instrument || || An instrument that determines the mass of a product without the intervention of an operator and follows a predetermined programme of automatic processes characteristic of the instrument.

Automatic catchweigher || || An automatic weighing instrument that determines the mass of pre-assembled discrete loads (for example prepackages) or single loads of loose material.

Automatic checkweigher || || An automatic catchweigher that subdivides articles of different mass into two or more subgroups according to the value of the difference of their mass and a nominal set-point.

Weight labeller || || An automatic catchweigher that labels individual articles with the weight value.

Weight/price labeller || || An automatic catchweigher that labels individual articles with the weight value, and price information.

Automatic gravimetric filling instrument || || An automatic weighing instrument that fills containers with a predetermined and virtually constant mass of product from bulk.

Discontinuous totaliser (totalising hopper weigher) || || An automatic weighing instrument that determines the mass of a bulk product by dividing it into discrete loads. The mass of each discrete load is determined in sequence and summed. Each discrete load is then delivered to bulk.

Continuous totaliser || || An automatic weighing instrument that continuously determines the mass of a bulk product on a conveyor belt, without systematic subdivision of the product and without interrupting the movement of the conveyor belt.

Rail-weighbridge || || An automatic weighing instrument having a load receptor inclusive of rails for conveying railway vehicles.

SPECIFIC
REQUIREMENTS

CHAPTER I — Requirements common to all types of automatic weighing
instruments

1. Rated Operating Conditions

The manufacturer shall specify the rated
operating conditions for the instrument as follows:

1.1. For the measurand:

The measuring range in terms of its maximum
and minimum capacity.

1.2. For the electrical supply influence
quantities:

In case of AC voltage supply || : || the nominal AC voltage supply, or the AC voltage limits.

In case of DC voltage supply || : || the nominal and minimum DC voltage supply, or the DC voltage limits.

1.3. For the mechanical and climatic
influence quantities:

The minimum temperature range is 30 °C
unless specified otherwise in the following chapters of this Annex.

The mechanical environment classes
according to Annex I, paragraph 1.3.2 are not applicable. For instruments which
are used under special mechanical strain, e.g. instruments incorporated into
vehicles, the manufacturer shall define the mechanical conditions of use.

1.4. For other influence quantities (if
applicable):

The rate(s) of operation.

The characteristics of the product(s) to be
weighed.

2. Permissible effect of disturbances
- Electromagnetic environment

The required performance and the critical
change value are given in the relevant Chapter of this Annex for each type of
instrument.

3. Suitability

3.1. Means shall be provided to limit the
effects of tilt, loading and rate of operation such that maximum permissible
errors (MPEs) are not exceeded in normal operation.

3.2. Adequate material handling facilities
shall be provided to enable the instrument to respect the MPEs during normal
operation.

3.3. Any operator control interface shall
be clear and effective.

3.4. The integrity of the display (where
present) shall be verifiable by the operator.

3.5. Adequate zero setting capability shall
be provided to enable the instrument to respect the MPEs during normal
operation.

3.6. Any result outside the measurement
range shall be identified as such, where a printout is possible.

4. Conformity assessment

The conformity assessment procedures
referred to in Article 918 that the manufacturer can choose
between are:

For mechanical systems:

B + D or B + E or
B + F or D1 or F1 or G or H1.

For electromechanical instruments:

B + D or B + E or
B + F or G or H1.

For electronic systems or systems
containing software:

B + D or B + F or G or
H1.

CHAPTER II — Automatic Catchweighers

1. Accuracy Classes

1.1. Instruments are divided into primary
categories designated by:

X or Y

as specified by the manufacturer.

1.2. These primary categories are further
divided into four accuracy classes:

XI, XII, XIII & XIV

and

Y(I), Y(II), Y(a) & Y(b)

which shall be specified by the
manufacturer.

2. Category X Instruments

ê 2004/22/EC
(adapted)

2.1. Category X applies to instruments used
to check prepackages made up in accordance with the requirements of Council Directive
75/106/EEC of 19 December 1974 on the approximation of the laws of the
Member States relating to the making-up by volume of certain prepackaged
liquids[36] and of
Council Directive 76/211/EEC of 20 January 1976 on the approximation of the
laws of the Member States relating to the making-up by weight or by volume of
certain prepackaged products[37]
applicable to prepackages.

ê 2004/22/EC

2.2. The accuracy classes are supplemented
by a factor (x) that quantifies the maximum permissible standard deviation as
specified in paragraph 4.2.

The manufacturer shall specify the factor
(x), where (x) shall be ≤ 2 and in the form 1 × 10k,
2 × 10k or 5 × 10k, where k is a
negative whole number or zero.

3. Category Y Instruments

Category Y applies to all other automatic
catchweighers.

4. MPE

4.1. Mean error Category X / MPE
Category Y instruments

Table 1

Net Load (m) in verification scale intervals (e) || Maximum permissible mean error || Maximum permissible error

XI || Y(I) || XII || Y(II) || XIII || Y(a) || XIV || Y(b) || X || Y

0 < m ≤ 50000 || 0 < m ≤ 5000 || 0 < m ≤ 500 || 0 < m ≤ 50 || ± 0,5 e || ± 1 e

50000 < m ≤ 200000 || 5000 < m ≤ 20000 || 500 < m ≤ 2000 || 50 < m ≤ 200 || ± 1,0 e || ± 1,5 e

200000 < m || 20000 < m ≤ 100000 || 2000 < m ≤ 10000 || 200 < m ≤ 1000 || ± 1,5 e || ± 2 e

4.2. Standard deviation

Maximum permissible value for the standard
deviation of a class X (x) instrument is the result of the multiplication of
the factor (x) by the value in Table 2 below.

Table 2

Net Load (m) || Maximum permissible standard deviation for class X(1)

m ≤ 50 g || 0,48 %

50 g < m ≤ 100 g || 0,24 g

100 g < m ≤ 200 g || 0,24 %

200 g < m ≤ 300 g || 0,48 g

300 g < m ≤ 500 g || 0,16 %

500 g < m ≤ 1000 g || 0,8 g

1000 g < m ≤ 10000 g || 0,08 %

10000 g < m ≤ 15000 g || 8 g

15000 g < m || 0,053 %

For class XI and XII (x) shall
be less than 1.

For class XIII (x) shall be not
greater than 1.

For class XIV (x) shall be
greater than 1.

4.3. Verification scale interval —
single interval instruments

Table 3

Accuracy classes || Verification scale interval || Number of verification scale intervals n = Max/e

|| || || Minimum || Maximum

XI || Y(I) || 0,001 g ≤ e || 50000 || —

XII || Y(II) || 0,001 g ≤ e ≤ 0,05 g || 100 || 100000

0,1 g ≤ e || 5000 || 100000

XIII || Y(a) || 0,1 g ≤ e ≤ 2 g || 100 || 10000

5 g ≤ e || 500 || 10000

XIV || Y(b) || 5 g ≤ e || 100 || 1000

4.4. Verification scale interval —
multi-interval instruments

Table 4

Accuracy classes || Verification scale interval || Number of verification scale intervals n = Max/e

|| || || Minimum value[38] n = Maxi/e(i+1) || Maximum value n = Maxi/ei

XI || Y(I) || 0,001 g ≤ ei || 50000 || —

XII || Y(II) || 0,001 g ≤ ei ≤ 0,05 g || 5000 || 100000

0,1 g ≤ ei || 5000 || 100000

XIII || Y(a) || 0,1 g ≤ ei || 500 || 10000

XIV || Y(b) || 5 g ≤ ei || 50 || 1000

Where:

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

i || = || partial weighing range

r || = || total number of partial ranges

5. Measurement Range

In specifying the measurement range for
class Y instruments the manufacturer shall take account that the minimum
capacity shall not be less than:

class Y(I) || : || 100 e

class Y(II) || : || 20 e for 0,001 g ≤ e ≤ 0,05 g, and 50 e for 0,1 g ≤ e

class Y(a) || : || 20 e

class Y(b) || : || 10 e

Scales used for grading, e.g. postal scales and garbage weighers || : || 5 e

6. Dynamic Setting

6.1. The dynamic setting facility shall
operate within a load range specified by the manufacturer.

6.2. When fitted, a dynamic setting
facility that compensates for the dynamic effects of the load in motion shall
be inhibited from operating outside the load range, and shall be capable of
being secured.

7. Performance Under Influence Factors
And Electromagnetic Disturbances

7.1. The MPEs due to influence factors are:

7.1.1. For category X instruments:

–
For automatic operation; as specified in Tables
1, and 2,

–
For static weighing in non-automatic operation;
as specified in Table 1.

7.1.2. For category Y instruments

–
For each load in automatic operation; as
specified in Table 1,

–
For static weighing in non-automatic operation;
as specified for category X in Table 1.

7.2. The critical change value due to a
disturbance is one verification scale interval.

7.3. Temperature range:

–
For class XI and Y(I) the minimum range is
5° C,

–
For class XII and Y(II) the minimum range is
15° C.

CHAPTER III — Automatic Gravimetric Filling Instruments

1. Accuracy classes

1.1. The manufacturer shall specify both
the reference accuracy class Ref(x) and the operational accuracy class(es)
X(x).

1.2. An instrument type is designated a
reference accuracy class, Ref(x), corresponding to the best possible accuracy
for instruments of the type. After installation, individual instruments are
designated for one or more operational accuracy classes, X(x), having taken
account of the specific products to be weighed. The class designation factor
(x) shall be ≤ 2, and in the form 1 × 10k,
2 × 10k or 5 × 10k where k is a
negative whole number or zero.

1.3. The reference accuracy class, Ref(x)
is applicable for static loads.

1.4. For the operational accuracy class
X(x), X is a regime relating accuracy to load weight and (x) is a multiplier
for the limits of error specified for class X(1) in 2.2.

2. MPE

2.1. Static weighing error

2.1.1. For static loads under rated
operating conditions, the MPE for reference accuracy class Ref(x), shall be
0,312 of the maximum permissible deviation of each fill from the average; as
specified in Table 5; multiplied by the class designation factor (x).

2.1.2. For instruments where the fill may
be made up from more than one load (e.g. cumulative or selective combination
weighers) the MPE for static loads shall be the accuracy required for the fill
as specified in 2.2 (i.e. not the sum of the maximum permissible deviation for
the individual loads).

2.2. Deviation from average fill

Table 5

Value of the mass, m (g), of the fills || Maximum permissible deviation of each fill from theaverage the average for class X(1)

m ≤ 50 || 7,2 %

50 < m ≤ 100 || 3,6 g

100 < m ≤ 200 || 3,6 %

200 < m ≤ 300 || 7,2 g

300 < m ≤ 500 || 2,4 %

500 < m ≤ 1000 || 12 g

1000 < m ≤ 10000 || 1,2 %

10000 < m ≤ 15000 || 120 g

15000 < m || 0,8 %

Note:

The calculated deviation of each
fill from the average may be adjusted to take account for the effect of
material particle size.

2.3. Error relative to pre-set value
(setting error)

For instruments where it is possible to
pre-set a fill weight; the maximum difference between the pre-set value and the
average mass of the fills shall not exceed 0,312 of the maximum permissible
deviation of each fill from the average, as specified in Table 5.

3. Performance Under Influence Factor
And Electromagnetic Disturbance

3.1. The MPE due to influence factors shall
be as specified in paragraph 2.1.

3.2. The critical change value due to a
disturbance is a change of the static weight indication equal to the MPE as
specified in paragraph 2.1 calculated for the rated minimum fill, or a change
that would give equivalent effect on the fill in the case of instruments where
the fill consists of multiple loads. The calculated critical change value shall
be rounded to the next higher scale interval (d).

3.3. The manufacturer shall specify the
value of the rated minimum fill.

CHAPTER IV — Discontinuous Totalisers

1. Accuracy Classes

Instruments are divided into four accuracy
classes as follows: 0,2, 0,5, 1, 2.

2. MPEs

Table 6

Accuracy class || MPE of totalised load

0,2 || ± 0,10 %

0,5 || ± 0,25 %

1 || ± 0,50 %

2 || ± 1,00 %

3. Totalisation scale interval

The totalisation scale interval (dt)
shall be in the range:

0,01 % Max ≤ dt
≤ 0,2 % Max

4. Minimum Totalised Load (Σmin)

The minimum totalised load (Σmin)
shall be not less than the load at which the MPE is equal to the totalisation
scale interval (dt) and not less than the minimum load as specified
by the manufacturer.

5. Zero Setting

Instruments that do not tare weigh after
each discharge shall have a zero setting device. Automatic operation shall be
inhibited if zero indication varies by:

–
1 dt on instruments with automatic
zero setting device;

–
0,5 dt on instruments with a semi-automatic,
or non-automatic, zero setting device.

6. Operator Interface

Operator adjustments and reset function
shall be inhibited during automatic operation.

7. Printout

On instruments equipped with a printing
device, the reset of the total shall be inhibited until the total is printed.
The printout of the total shall occur if automatic operation is interrupted.

8. Performance under influence factors
and electromagnetic disturbances

8.1. The MPEs due to influence factors
shall be as specified in Table 7.

Table 7

Load (m) in totalisation scale intervals (dt) || MPE

0 < m ≤ 500 || ± 0,5 dt

500 < m ≤ 2000 || ± 1,0 dt

2000 < m ≤ 10000 || ± 1,5 dt

8.2. The critical change value due to a
disturbance is one totalisation scale interval for any weight indication and
any stored total.

CHAPTER V — Continuous Totalisers

1. Accuracy classes

Instruments are divided into three accuracy
classes as follows: 0,5, 1, 2.

2. Measurement Range

2.1. The manufacturer shall specify the
measurement range, the ratio between the minimum net load on the weighing unit
and the maximum capacity, and the minimum totalised load.

2.2. The minimum totalised load Σmin
shall not be less than

800 d for class 0,5,

400 d for class 1,

200 d for class 2.

Where d is the totalisation scale interval
of the general totalisation device.

3. MPE

Table 8

Accuracy class || MPE for totalised load

0,5 || ± 0,25 %

1 || ± 0,5 %

2 || ± 1,0 %

4. Speed of the belt

The speed of the belt shall be specified by
the manufacturer. For single-speed beltweighers, and variable-speed
beltweighers having a manual speed setting control, the speed shall not vary by
more than 5 % of the nominal value. The product shall not have a different
speed than the speed of the belt.

5. General Totalisation Device

It shall not be possible to reset the
general totalisation device to zero.

6. Performance under influence factors
and electromagnetic disturbances

6.1. The MPE due to influence factor, for a
load not less than the Σmin, shall be 0,7 times the appropriate
value specified in Table 8, rounded to the nearest totalisation scale interval
(d).

6.2. The critical change value due to a
disturbance shall be 0,7 times the appropriate value specified in Table 8, for
a load equal to Σmin, for the designated class of the
beltweigher; rounded up to the next higher totalisation scale interval (d).

CHAPTER VI — Automatic Rail Weighbridges

1. Accuracy classes

Instruments are divided into four accuracy
classes as follows:

0,2, 0,5, 1, 2.

2. MPE

2.1. The MPEs for weighing-in-motion of a
single wagon or a total train are shown in table 9.

Table 9

Accuracy class || MPE

0,2 || ± 0,1 %

0,5 || ± 0,25 %

1 || ± 0,5 %

2 || ± 1,0 %

2.2. The MPEs for the weight of coupled or
uncoupled wagons weighing-in-motion shall be one of the following values,
whichever is the greatest:

–
the value calculated according to Table 9,
rounded to the nearest scale interval;

–
the value calculated according to Table 9,
rounded to the nearest scale interval for a weight equal to 35 % of the
maximum wagon weight (as inscribed on the descriptive markings);

–
one scale interval (d).

2.3. The MPEs for the weight of train
weighing-in-motion shall be one of the following values, whichever is the
greatest:

–
the value calculated according to Table 9,
rounded to the nearest scale interval;

–
the value calculated according to Table 9, for
the weight of a single wagon equal to 35 % of the maximum wagon weight (as
inscribed on the descriptive markings) multiplied by the number of reference
wagons (not exceeding 10) in the train, and rounded to the nearest scale
interval;

–
one scale interval (d) for each wagon in the
train, but not exceeding 10 d.

2.4. When weighing coupled wagons; the errors
of not more than 10 % of the weighing results taken from one or more
passes of the train may exceed the appropriate MPE given in paragraph 2.2, but
shall not exceed twice the MPE.

3. Scale interval (d)

The relationship between the accuracy class
and the scale interval shall be as specified in Table 10.

Table 10

Accuracy class || Scale interval (d)

0,2 || d ≤ 50 kg

0,5 || d ≤ 100 kg

1 || d ≤ 200 kg

2 || d ≤ 500 kg

4. Measurement range

4.1. The minimum capacity shall not be less
than 1 t, and not greater than the value of the result of the minimum
wagon weight divided by the number of partial weighings.

4.2. The minimum wagon weight shall not be
less than 50 d.

5. Performance under influence factor
and electromagnetic disturbance

5.1. The MPE due to an influence factor
shall be as specified in Table 11.

Table 11

Load (m) in verification scale intervals (d) || MPE

0 < m ≤ 500 || ± 0,5 d

500 < m ≤ 2000 || ± 1,0 d

2000 < m ≤ 10000 || ± 1,5 d

5.2. The critical change value due to a
disturbance is one scale interval.

ê 2004/22/EC
(adapted)

ANNEX MI-007
IX

TAXIMETERS Ö (MI-007) Õ

ê 2004/22/EC

The relevant requirements of Annex 1I, the specific requirements of this
Annex and the conformity assessment procedures listed in this Annex apply to
taximeters.

DEFINITIONS

Taximeter

A device that works together with a signal
generator[39]
to make a measuring instrument.

This device measures duration, calculates
distance on the basis of a signal delivered by the distance signal generator.
Additionally, it calculates and displays the fare to be paid for a trip on the
basis of the calculated distance and/or the measured duration of the trip.

Fare

The total amount of money due for a trip
based on a fixed initial hire fee and/or the length and/or the duration of the
trip. The fare does not include a supplement charged for extra services.

Cross-over speed

The speed value found by division of a time
tariff value by a distance tariff value.

Normal calculation mode S (single application of tariff)

Fare calculation based on application of
the time tariff below the cross-over speed and application of the distance
tariff above the cross-over speed.

Normal calculation mode D (double application of tariff)

Fare calculation based on simultaneous
application of time tariff and distance tariff over the whole trip.

Operating position

The different modes in which a taximeter
fulfils the different parts of its functioning. The operating positions are
distinguished by the following indications:

‘For Hire’ || : || The operating position in which the fare calculation is disabled

‘Hired’ || : || The operating position in which the fare calculation takes place on the basis of a possible initial charge and a tariff for distance travelled and/or time of the trip

‘Stopped’ || : || The operating position in which the fare due for the trip is indicated and at least the fare calculation based on time is disabled.

DESIGN
REQUIREMENTS

1. The taximeter shall be designed to
calculate the distance and to measure the duration of a trip.

2. The taximeter shall be designed to
calculate and display the fare, incrementing in steps equal to the resolution
fixed by the Member State in the operation position ‘Hired’. The taximeter
shall also be designed to display the final value for the trip in the operating
position ‘Stopped’.

3. A taximeter shall be able to apply the
normal calculation modes S and D. It shall be possible to choose between these
calculation modes by a secured setting.

4. A taximeter shall be able to supply the
following data through an appropriate secured interface(s):

–
operation position: ‘For Hire’, ‘Hired’ or
‘Stopped’;

–
totaliser data according to paragraph 15.1;

–
general information: constant of the distance
signal generator, date of securing, taxi identifier, real time, identification
of the tariff;

–
fare information for a trip: total charged,
fare, calculation of the fare, supplement charge, date, start time, finish
time, distance travelled;

–
tariff(s) information: parameters of tariff(s).

National legislation may require certain
devices to be connected to the interface(s) of a taximeter. Where such a device
is required; it shall be possible, by secured setting, to inhibit automatically
the operation of the taximeter for reasons of the non-presence or improper
functioning of the required device.

5. If relevant, it shall be possible to
adjust a taximeter for the constant of the distance signal generator to which
it is to be connected and to secure the adjustment.

RATED
OPERATING CONDITIONS

6.1. The mechanical environment class that
applies is M3.

6.2. The manufacturer shall specify the
rated operating conditions for the instrument, in particular:

–
a minimum temperature range of 80 °C for
the climatic environment;

–
the limits of the DC power supply for which the
instrument has been designed.

MAXIMUM
PERMISSIBLE ERRORS (MPEs)

7. The MPE, excluding any errors due to
application of the taximeter in a taxi, are:

–
For the time elapsed: ± 0,1 %

minimum value of mpe: 0,2s;

–
For the distance travelled: ± 0,2 %

minimum value of mpe: 4 m;

–
For the calculation of the fare:
± 0,1 %

minimum, including rounding:
corresponding to the least significant digit of the fare indication.

PERMISSIBLE
EFFECT OF DISTURBANCES

8. Electromagnetic immunity

8.1. The electromagnetic class that applies
is E3.

8.2. The MPE laid down in paragraph 7 shall
also be respected in the presence of an electromagnetic disturbance.

POWER
SUPPLY FAILURE

9. In case of a reduction of the voltage
supply to a value below the lower operating limit as specified by the
manufacturer, the taximeter shall:

–
continue to work correctly or resume its correct
functioning without loss of data available before the voltage drop if the
voltage drop is temporary, i.e. due to restarting the engine;

–
abort an existing measurement and return to the
position ‘For Hire’ if the voltage drop is for a longer period.

OTHER
REQUIREMENTS

10. The conditions for the compatibility
between the taximeter and the distance signal generator shall be specified by
the manufacturer of the taximeter.

11. If there is a supplement charge for an
extra service, entered by the driver on manual command, this shall be excluded
from the fare displayed. However, in that case a taximeter may display
temporarily the value of the fare including the supplementary charge.

12. If the fare is calculated according to
calculation mode D a taximeter may have an additional display mode in which
only the total distance and duration of the trip are displayed in real time.

13. All values displayed for the passenger
shall be suitably identified. These values as well as their identification
shall be clearly readable under daylight and night conditions.

14.1. If the fare to be paid or the
measures to be taken against fraudulent use can be affected by the choice of
functionality from a pre-programmed setting or by free data setting, it shall
be possible to secure the instrument settings and data entered.

14.2. The securing possibilities available
in a taximeter shall be such that separate securing of the settings is
possible.

14.3. The provisions in paragraph 8.3 of
Annex I apply also to the tariffs.

15.1. A taximeter shall be fitted with
non-resettable totalisers for all of the following values:

–
The total distance travelled by the taxi;

–
The total distance travelled when hired;

–
The total number of hirings;

–
The total amount of money charged as
supplements;

–
The total amount of money charged as fare.

The totalised values shall include the
values saved according to paragraph 9 under conditions of loss of power supply.

15.2. If disconnected from power, a
taximeter shall allow the totalised values to be stored for one year for the
purpose of reading out the values from the taximeter to another medium.

15.3. Adequate measures shall be taken to
prevent the display of totalised values from being used to deceive passengers.

16. Automatic change of tariffs is allowed
due to the:

–
distance of the trip;

–
duration of the trip;

–
time of the day;

–
date;

–
day of the week.

17. If properties of the taxi are important
for the correctness of the taximeter, the taximeter shall provide means to
secure the connection of the taximeter to the taxi in which it is installed.

18. For the purpose of testing after
installation, the taximeter shall be equipped with the possibility to test
separately the accuracy of time and distance measurement and the accuracy of
the calculation.

19. A taximeter and its installation
instructions specified by the manufacturer shall be such that, if installed
according to the manufacturer's instructions, fraudulent alterations of the
measurement signal representing the distance travelled are sufficiently
excluded.

20. The general essential requirement
dealing with fraudulent use shall be fulfilled in such a way that the interests
of the customer, the driver, the driver's employer and the fiscal authorities
are protected.

21. A taximeter shall be designed so that
it can respect the MPEs without adjustment during a period of one year of
normal use.

22. The taximeter shall be equipped with a
real-timeclock by means of which the time of the day and the date are kept, one
or both can be used for automatic change of tariffs. The requirements for the
real-time clock are:

–
The timekeeping shall have an accuracy of
0,02 %;

–
The correction possibility of the clock shall be
not more than 2 minutes per week. Correction for summer and wintertime shall be
performed automatically;

–
Correction, automatic or manually, during a trip
shall be prevented.

23. The values of distance travelled and
time elapsed, when displayed or printed in accordance with this Directive,
shall use the following units:

Distance travelled:

ê 2004/22/EC (adapted)

–
in the United Kingdom and Ireland: until the date which
will be fixed by these Member States according to Article (1)(b) of Directive
80/181/EEC: kilometres or miles;

ê 2004/22/EC

–
in all other Member States: kilometres.

Time elapsed:

–
seconds, minutes or hours, as may be suitable;
keeping in mind the necessary resolution and the need to prevent
misunderstandings.

CONFORMITY
ASSESSMENT

The conformity assessment procedures
referred to in Article 918 that the manufacturer can choose
between are:

B + F or B + D or H1.

ê 2004/22/EC
(adapted)

ANNEX MI-008
X

MATERIAL MEASURES Ö (MI-008) Õ

ê 2004/22/EC

CHAPTER
I — Material measures of length

The relevant essential requirements of
Annex I, the specific requirements of this Annex and the conformity assessment
procedures listed in this chapter, apply to material measures of length defined
below. However, the requirement for the supply of a copy of declarations of
conformity may be interpreted as applying to a batch or consignment rather than
each individual instruments.

DEFINITIONS

Material measure of length || || An instrument comprising scale marks whose distances are given in legal units of length.

SPECIFIC REQUIREMENTS

Reference Conditions

1.1. For tapes of length equal to or
greater than five metres, the maximum permissible errors (MPEs) are to be met
when a tractive force of fifty newtons or other force values as specified by
the manufacturer and marked on the tape accordingly, or in the case of rigid or
semi-rigid measures no tractive force is needed, is applied.

1.2. The reference temperature is
20 °C unless otherwise specified by the manufacturer and marked on the
measure accordingly.

MPEs

2. The MPE, positive or negative in mm,
between two non-consecutive scale marks is (a + bL), where:

–
L is the value of the length rounded up to the
next whole metre; and

–
a and b are given in Table 1 below.

When a terminal interval is bounded by a
surface, the MPE for any distance beginning at this point is increased by the
value c given in Table 1.

Table 1

Accuracy Class || a (mm) || b || c (mm)

I || 0,1 || 0,1 || 0,1

II || 0,3 || 0,2 || 0,2

III || 0,6 || 0,4 || 0,3

D — special class for dipping tapes[40] Up to and including 30 m[41] || 1,5 || zero || zero

S — special class for tank strapping tapes For each 30 m length when the tape is supported on a flat surface || 1,5 || zero || zero

Dip tapes may also be of Classes I or II in
which case for any length between two scale marks, one of which is on the
sinker and the other on the tape, the mpe is ± 0,6 mm when
application of the formula gives a value of less than 0,6 mm.

The MPE for the length between consecutive
scale marks, and the maximum permissible difference between two consecutive
intervals, are given in Table 2 below.

Table 2

Length i of the interval || MPE or difference in millimetres according to accuracy class

I || II || III

i ≤ 1 mm || 0,1 || 0,2 || 0,3

1 mm < i ≤ 1 cm || 0,2 || 0,4 || 0,6

Where a rule is of the folding type, the
jointing shall be such as not to cause any errors, supplementary to those
above, exceeding: 0,3 mm for Class II, and 0,5 mm for Class III.

Materials

3.1. Materials used for material measures
shall be such that length variations due to temperature excursions up to
± 8 °C about the reference temperature do not exceed the MPE. This
does not apply to Class S and Class D measures where the manufacturer intends
that thermal expansion corrections shall be applied to observed readings where
necessary.

3.2. Measures made from material whose
dimensions may alter materially when subjected to a wide range of relative
humidity, may only be included in Classes II or III.

Markings

4. The nominal value shall be marked on the
measure. Millimetre scales shall be numbered every centimetre and measures with
a scale interval greater than 2 cm shall have all scale marks numbered.

CONFORMITY ASSESSMENT

The conformity assessment procedures referred
to in Article 918
that the manufacturer can choose between are:

F 1 or D1 or B + D or H or G.

CHAPTER
II — Capacity serving measures

The relevant essential requirements of
Annex I, and the specific requirements and the conformity assessment procedures
listed in this chapter, apply to capacity serving measures defined below.
However, the requirement for the supply of a copy of declarations of conformity
may be interpreted as applying to a batch or consignment rather than each
individual instrument. Also, the requirement for the instrument to bear
information in respect of its accuracy shall not apply.

DEFINITIONS

Capacity serving measure || || A capacity measure (such as a drinking glass, jug or thimble measure) designed to determine a specified volume of a liquid (other than a pharmaceutical product) which is sold for immediate consumption.

Line measure || || A capacity serving measure marked with a line to indicate nominal capacity.

Brim measure || || A capacity serving measure for which the internal volume is equal to the nominal capacity.

Transfer measure || || A capacity serving measure from which it is intended that the liquid is decanted prior to consumption.

Capacity || || The capacity is the internal volume for brim measures or internal volume to a filling mark for line measures.

SPECIFIC REQUIREMENTS

1. Reference Conditions

1.1. Temperature: the reference temperature
for measurement of capacity is 20 °C.

1.2. Position for correct indication: free
standing on a level surface.

2. MPEs

Table 1

|| Line || Brim

Transfer measures || ||

< 100 ml || ± 2 ml || – 0 + 4 ml

≥ 100 ml || ± 3 % || – 0 + 6 %

Serving measures || ||

< 200 ml || ± 5 % || – 0 + 10 %

≥ 200 ml || ± (5 ml + 2,5 %) || – 0 + 10 ml + 5 %

3. Materials

Capacity serving measures shall be made of
material which is sufficiently rigid and dimensionally stable to maintain
capacity within the MPE.

4. Shape

4.1. Transfer measures shall be designed so
that a change of contents equal to the MPE causes a change in level of at least
2 mm at the brim or filling mark.

4.2. Transfer measures shall be designed so
that the complete discharge of the liquid being measured will not be impeded.

5. Marking

5.1. The nominal capacity declared shall be
clearly and indelibly marked on the measure.

5.2. Capacity serving measures may also be
marked with up to three clearly distinguishable capacities, none of which shall
lead to confusion one to the other.

5.3. All filling marks shall be
sufficiently clear and durable to ensure that MPEs are not exceeded in use.

CONFORMITY ASSESSMENT

The conformity assessment procedures
referred to in Article 918 that the manufacturer can choose
between are:

A1A2 or F1 or D1 or E1 or B + E or B + D or H.

ê 2004/22/EC
(adapted)

ANNEX MI-009
XI

DIMENSIONAL MEASURING INSTRUMENTS Ö (MI-009) Õ

ê 2004/22/EC

The relevant essential requirements of
Annex I, the specific requirements of this Annex and the conformity assessment
procedures listed in this Annex, apply to dimensional measuring instruments of
the types defined below.

DEFINITIONS

Length measuring instrument || || A length measuring instrument serves for the determination of the length of rope-type materials (e.g. textiles, bands, cables) during feed motion of the product to be measured.

Area Measuring Instruments || || An area measuring instrument serves for the determination of the area of irregular shaped objects, e.g. for leather.

Multi-dimensional Measuring Instruments || || A multi-dimensional measuring instrument serves for the determination of the edge length (length, height, width) of the smallest enclosing rectangular parallelepiped of a product.

CHAPTER
I — Requirements common to all
dimensional measuring instruments

Electromagnetic immunity

1. The effect of an electromagnetic
disturbance on a dimensional measuring instrument shall be such that:

–
the change in measurement result is no greater
than the critical change value as defined in paragraph 2.3;
or

–
it is impossible to perform any measurement; or

–
there are momentary variations in the
measurement result that cannot be interpreted, memorised or transmitted as a
measuring result; or

–
there are variations in the measurement result
severe enough to be noticed by all those interested in the measurement result.

2. The critical change value is equal to
one scale interval.

CONFORMITY
ASSESSMENT

The conformity assessment procedures
referred to in Article 918 that the manufacturer can choose
between are:

For mechanical or electromechanical
instruments:

F1 or E1 or D1 or B + F or
B + E or B + D or H or H1 or G.

For electronic instruments or instruments
containing software:

B + F or B + D or H1 or
G.

CHAPTER
II — Length measuring instruments

Characteristics of the product to be measured

1. Textiles are characterised by the
characteristic factor K. This factor takes the stretchability and force per
unit area of the product measured into account and is defined by the following
formula:

K || = || ε · (GA + 2,2 N/m2), where ε is the relative elongation of a cloth specimen 1 m wide at a tensile force of 10 N, GA is the weight force per unit area of a cloth specimen in N/m2.

Operating conditions

2.1. Range

Dimensions and K-factor, where applicable,
within the range specified by the manufacturer for the instrument. The ranges
of K-factor are given in Table 1:

Table 1

Group || Range of K || Product

I || 0 < K < 2 × 10-2 N/m2 || low stretchability

II || 2 × 10-2 N/m2 < K < 8 × 10-2 N/m2 || medium stretchability

III || 8 × 10-2 N/m2 < K < 24 × 10-2 N/m2 || high stretchability

IV || 24 × 10-2 N/m2 < K || very high stretchability

2.2. Where the measured object is not
transported by the measuring instrument, its speed must be within the range
specified by the manufacturer for the instrument.

2.3. If the measurement result depends on
the thickness, the surface condition and the kind of delivery (e.g. from a big
roll or from a pile), corresponding limitations are specified by the manufacturer.

MPEs

3. Instrument

Table 2

Accuracy class || MPE

I || 0,125 %, but not less than 0,005 Lm

II || 0,25 %, but not less than 0,01 Lm

III || 0,5 %, but not less than 0,02 Lm

Where Lm is the minimum
measurable length, that is to say the smallest length specified by the
manufacturer for which the instrument is intended to be used.

The true length value of the different
types of materials should be measured using suitable instruments (e.g. tapes of
length). Thereby, the material which is going to be measured should be laid out
on a suitable underlay (e.g. a suitable table) straight and unstretched.

Other requirements

4. The instruments must ensure that the
product is measured unstretched according to the intended stretchability for
which the instrument is designed.

CHAPTER
III — Area measuring instruments

Operating conditions

1.1. Range

Dimensions within the range specified by
the manufacturer for the instrument.

1.2. Condition of the product

The manufacturer shall specify the
limitations of the instruments due to the speed, and thickness of the surface
conditions if relevant, of the product.

MPEs

2. Instrument

The MPE is 1,0 %, but not less than
1 dm2.

Other requirements

3. Presentation of the product

In the case of pulling back or stopping the
product, it should not be possible to have an error of measurement or the
display must be blanked.

4. Scale interval

The instruments must have a scale interval
of 1,0 dm2. In addition, it must be possible to have a scale
interval of 0,1 dm2 for testing purposes.

CHAPTER
IV — Multidimensional measuring instruments

Operating conditions

1.1. Range

Dimensions within the range specified by
the manufacturer for the instrument.

1.2. Minimum dimension

The lower limit of the minimum dimension
for all values of the scale interval is given in Table 1.

Table 1

Scale interval (d) || Minimum dimension (min) (lower limit)

d ≤ 2 cm || 10 d

2 cm < d ≤ 10 cm || 20 d

10 cm < d || 50 d

1.3. Speed of the product

The speed must be within the range
specified by the manufacturer for the instrument.

MPE

2. Instrument:

The MPE is ± 1,0 d.

ê 2004/22/EC
(adapted)

ANNEX MI-010
XII

EXHAUST GAS ANALYSERS Ö (MI-010) Õ

ê 2004/22/EC

The relevant requirements of Annex I, the
specific requirements of this Annex and the conformity assessment procedures
listed in this Annex, apply to exhaust gas analysers defined below intended for
inspection and professional maintenance of motor vehicles in use.

DEFINITIONS

Exhaust gas analyser || || An exhaust gas analyser is a measuring instrument that serves to determine the volume fractions of specified components of the exhaust gas of a motor vehicle engine with spark ignition at the moisture level of the sample analysed. These gas components are carbon monoxide (CO), carbon dioxide (CO2), oxygen (O2) and hydrocarbons (HC). The content of hydrocarbons has to be expressed as concentration of n-hexane (C6H14), measured with near-infrared absorption techniques. The volume fractions of the gas components are expressed as a percentage (% vol) for CO, CO2 and O2 and in parts per million (ppm vol). Moreover, an exhaust gas analyser calculates the lambda value from the volume fractions of the components of the exhaust gas.

Lambda || || Lambda is a dimensionless value representative of the burning efficiency of an engine in terms of air/fuel ratio in the exhaust gases. It is determined with a reference standardised formula.

SPECIFIC
REQUIREMENTS

Instrument Classes

1. Two classes (0 and I) are being defined
for exhaust gas analysers. The relevant minimum measuring ranges for these
classes are shown in Table 1.

Table 1

Classes and measuring ranges

Parameter || Classes 0 and I

CO fraction || from 0 to 5 % vol

CO2 fraction || from 0 to 16 % vol

HC fraction || from 0 to 2000 ppm vol

O2 fraction || from 0 to 21 % vol

λ || from 0,8 to 1,2

Rated operating conditions

2. The values of the operating conditions
shall be specified by the manufacturer as follows:

2.1. For the climatic and mechanical
influence quantities:

–
A minimum temperature range of 35 °C for
the climatic environment;

–
The mechanical environment class that applies is
M1.

2.2. For the electrical power influence
quantities:

–
The voltage and frequency range for the AC
voltage supply;

–
The limits of the DC voltage supply.

2.3. For the ambient pressure:

–
The minimum and the maximum values of the
ambient pressure are for both classes: pmin ≤ 860 hPa,
pmax ≥ 1060 hPa.

Maximum permissible errors (MPEs)

3. The MPEs are defined as follows:

3.1. For each of the fractions measured,
the maximum error value permitted under rated operating conditions according to
paragraph 1.1 of Annex I is the greater of the two values shown in Table 2.
Absolute values are expressed in % vol or ppm vol, percentage values are
percent of the true value.

Table 2

MPEs

Parameter || Class 0 || Class I

CO fraction || ± 0,03 % vol ± 5 % || ± 0,06 % vol ± 5 %

CO2 fraction || ± 0,5 % vol ± 5 % || ± 0,5 % vol ± 5 %

HC fraction || ± 10 ppm vol ± 5 % || ± 12 ppm vol ± 5 %

O2 fraction || ± 0,1 % vol ± 5 % || ± 0,1 % vol ± 5 %

3.2. The MPE on lambda calculation is
0,3 %. The conventional true value is calculated according to the formula
defined in point 5.3.7.3 of Annex I of Directive 98/69/EC of the European Parliament
and the Council relating to measures to be taken against air pollution by
emissions from motor vehicles and amending Council Directive 70/220/EEC[42].

For this purpose, the values displayed by
the instrument are used for calculation.

Permissible effect of disturbances

4. For each of the volume fractions
measured by the instrument, the critical change value is equal to the MPE for
the parameter concerned.

5. The effect of an electromagnetic disturbance
shall be such that:

–
either the change in the measurement result is
not greater than the critical change value laid down in paragraph 4;

–
or the presentation of the measurement result is
such that it cannot be taken for a valid result.

Other requirements

6. The resolution shall be equal to or of
one order of magnitude higher than the values shown in Table 3.

Table 3

Resolution

|| CO || CO2 || O2 || HC

Class 0 and class I || 0,01 % vol || 0,1 % vol || [43] || 1 ppm vol

The lambda value shall be displayed with a
resolution of 0,001.

7. The standard deviation of 20
measurements shall not be greater than one third of the modulus of the MPE for
each applicable gas volume fraction.

8. For measuring CO, CO2 and HC,
the instrument, including the specified gas handling system, must indicate
95 % of the final value as determined with calibration gases within 15
seconds after changing from a gas with zero content, e.g. fresh air. For
measuring O2, the instrument under similar conditions must indicate
a value differing less than 0,1 % vol from zero within 60 seconds after
changing from fresh air to an oxygen-free gas.

9. The components in the exhaust gas, other
than the components whose values are subject to the measurement, shall not
affect the measurement results by more than the half of the modulus of the MPEs
when those components are present in the following maximum volume fractions:

6 % vol CO,

16 % vol CO2,

10 % vol O2,

5 % vol H2,

0,3 % vol NO,

2000 ppm vol HC (as n-hexane),

water vapor up to saturation.

10. An exhaust gas analyser shall have an
adjustment facility that provides operations for zero-setting, gas calibration
and internal adjustment. The adjustment facility for zero-setting and internal
adjustment shall be automatic.

11. For automatic or semi-automatic
adjustment facilities, the instrument shall be unable to make a measurement as
long as the adjustments have not been made.

12. An exhaust gas analyser shall detect
hydrocarbon residues in the gas handling system. It shall not be possible to
carry out a measurement if the hydrocarbon residues, present before any
measurement, exceeds 20 ppm vol.

13. An exhaust gas analyser shall have a
device for automatically recognising any malfunctioning of the sensor of the
oxygen channel due to wear or a break in the connecting line.

14. If the exhaust gas analyser is capable
to operate with different fuels (e.g. petrol or liquefied gas), there shall be
the possibility to select the suitable coefficients for the Lambda calculation
without ambiguity concerning the appropriate formula.

CONFORMITY
ASSESSMENT

The conformity assessment procedures
referred to in Article 918 that the manufacturer can choose
between are:

B + F or B + D or H1.

é

ANNEX XIII

PART
A

Repealed Directive with list of its successive amendments

(referred to in Article 52)

Directive 2004/22/EC of the European Parliament and of the Council (OJ L 135, 30.4.2004, p. 1) ||

Council Directive 2006/96/EC (OJ L 363, 20.12.2006, p. 81) ||

Commission Directive 2009/137/EC (OJ L 294, 11.11.2009, p. 7) ||

PART
B

List of time limits for transposition into national law and application

(referred to in Article 19)

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

2004/22/EC || 30 April 2006 || 30 October 2006

2006/96/EC || ||

2009/137/EC || 1 December 2010 || 1 June 2011

é

ANNEX XIV

CORRELATION TABLE

Directive 2004/22/EC || This Directive

||

Article 1 || Article 2(1)

Article 2 || Article 3

Article 3 first paragraph || Article 1

Article 3 second paragraph || Article 2(2)

Article 4 || Article 4(1) to (5)

___ || Article 4(6) to (22)

Article 5 || Article 5

Article 6(1) || Article 6

Article 6(2) || ___

Articles 7(1) || Article 21

Article 7(2) || Article 23(4)

Article 7(3) || ___

Article 7(4) || ___

Article 8 || Article 7

___ || Article 8

___ || Article 9

___ || Article 10

___ || Article 11

___ || Article 12

___ || Article 13

___ || [Article 15]

Article 9 || Article 18

Article 10 || Article 19

Article 11(1) || ___

Article 11(2) first subparagraph || ___

Article 11(2) second subparagraph || Article 24(2)

Article 12 || ___

Article 13(1) || ___

Article 13(2) || ___

___ || Article 14(1)

___ || Article 14(2)

Article 13(3) || Article 14(3)

Article 13(4) || Article 14(4)

Article 14 || ___

Article 15(1) || Article 46(1)

Article 15(2) || Article 46(2)

Article 15(3) || ___

Article 15(4) || ___

Article 15(5) || ___

Article 16(1) || Article 16

Article 16(2) || Article 47

Article 16(3) || Article 17

Article 16(4) || ___

Article 17(1) || ___

Article 17(2) || Article 22 second subparagraph

Article 17(3) ||

Article 17(4) first subparagraph || Article 23(2)

Article 17(4) second subparagraph || ___

Article 17(5) || ___

Article 18 || ___

___ || Article 20

___ || Article 22 first subparagraph

___ || Article 23(1)

___ || Article 23(3)

___ || Article 23(5) second subparagraph

___ || Article 23(5) third subparagraph

___ || Article 23(6)

___ || Article 24

___ || Article 25

___ || Article 26

___ || Article 27

___ || Article 28

___ || Article 29

___ || Article 30

___ || Article 31

___ || Article 32

___ || Article 33

___ || Article 34

___ || Article 35

___ || Article 36

___ || Article 37

___ || Article 38

___ || Article 39

___ || Article 40

Article 19(1) || ___

Article 19(2)(a) first subparagraph || ___

Article 19(2)(a) second subparagraph || ___

Article 19(2)(a) third subparagraph || Article 43(4)

Article 19(2)(b) || ___

Article 20 || ___

Article 21 || ___

Article 22 || ___

Article 23 || ___

___ || Article 41

___ || Article 42

___ || Article 43(1)

___ || Article 43(2)

___ || Article 43(3)

___ || Article 44

___ || Article 45

___ || Article 48

___ || Article 49

___ || Article 50

Article 24 || ___

___ || Article 51

Article 25 || ___

___ || Article 52

Article 26 || Article 53 first subparagraph

___ || Article 53 second subparagraph

Article 27 || Article 54

Annex I || Annex I

Annex A || Annex II, point 1

Annex A1 || Annex II, point 2

Annex B || Annex II, point 3

Annex C || Annex II, point 4

Annex C1 || Annex II, point 5

Annex D || Annex II, point 6

Annex D1 || Annex II, point 7

Annex E || Annex II, point 8

Annex E1 || Annex II, point 9

Annex F || Annex II, point 10

Annex F1 || Annex II, point 11

Annex G || Annex II, point 12

Annex H || Annex II, point 13

Annex H1 || Annex II, point 14

Annex MI-001 || Annex III

Annex MI-002 || Annex IV

Annex MI-003 || Annex V

Annex MI-004 || Annex VI

Annex MI-005 || Annex VII

Annex MI-006 || Annex VIII

Annex MI-007 || Annex IX

Annex MI-008 || Annex X

Annex MI-009 || Annex XI

Annex MI-010 || Annex XII

___ || Annex XIII

___ || Annex XIV

[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]               Centre for Strategic & Evaluation Services (UK), Interim
evaluation of the Measuring Instruments Directive, July 2010:                http://ec.europa.eu/enterprise/sectors/legal-metrology-and-prepack/public-consultation/public-consultation-files/evaluation_report_by_cses_en.pdf

[3]               Public consultation until 1 November 2010:    http://ec.europa.eu/enterprise/sectors/legal-metrology-and-prepack/public-consultation/index_en.htm

[4]               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

[5]               Regulation (EU) No 182/2011 of the European
Parliament and of the Council of 16 February 2011 laying down the rules and the
general principles concerning mechanisms for control by Member States of the
Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p.13).

[6]               OJ C 77, 28.3.2002.

[7]               OJ C [...], [...], p. [...].

[8]               OJ L 202, 6.9.1971, p. 1. Directive as last amended by Regulation
(EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36)

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

[10]             OJ L 135, 30.4.2004, p. 1.

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

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

[13]             OJ L 390, 31.12.2004, p. 24.

[14]             OJ L [...], [...], p. [...].

[15]             OJ L 220, 30.8.1993, p. 23.

[16]             OJ C 282, 25.11.2003, p. 3.

[17]             OJ L 184, 17.7.1999, p. 23.

[18]             OJ L 55, 28.2.2011, p. 13.

[19]             OJ L
204, 21.7.1998, p. 37. Directive as amended by Directive 98/48/EC (OJ L
217, 5.8.1998, p. 18).

[20]             OJ L 202, 6.9.1971, p. 21. Directive as last
amended by Commission Directive 82/623/EEC (OJ L 252, 27.8.1982, p. 5).

[21]             OJ L 202, 6.9.1971, p. 32.

[22]             OJ L 239, 25.10.1971, p. 9. Directive as last
amended by the 1994 Act of Accession.

[23]             OJ L 335, 5.12.1973, p. 56. Directive as last
amended by Commission Directive 85/146/EEC (OJ L 54, 23.2.1985, p. 29).

[24]             OJ L 14, 20.1.1975, p. 1.

[25]             OJ L 183, 14.7.1975, p. 25.

[26]             OJ L 336, 4.12.1976, p. 30.

[27]             OJ L 26, 31.1.1977, p. 59.

[28]             OJ L 105, 28.4.1977, p. 18. Directive as
amended by Commission Directive 82/625/EEC (OJ L 252, 27.8.1982, p. 10).

[29]             OJ L 364, 27.12.1978, p. 1.

[30]             OJ L 259, 15.10.1979, p. 1.

[31]             For Class B electromechanical
meters Imin ≤ 0,4 · Itr shall apply.

[32]             In the case of
electromechanical electricity meters, no critical change values are defined for
harmonic contents in the current circuits and for DC and harmonics in the
current circuit.

[33]             In the case of
electromechanical electricity meters, no critical change values are defined for
harmonic contents in the current circuits and for DC and harmonics in the
current circuit.

[34]             OJ L 316, 31.10.1992, p. 12. Directive abolished
by Directive 2003/96/EC (OJ L 283,
31.10.2003, p. 51).

[35]             However, Member States may
require measuring systems of accuracy class 0,3 or 0,5 when used for the
levying of duties on mineral oils when (un)loading ships and rail and road
tankers.

[36]             OJ L 42, 15.2.1975, p. 1. Directive as last
amended by Directive 89/676/EEC (OJ L 398, 30.12.1989, p. 18).

[37]             OJ L 46, 21.2.1976, p. 1. Directive as last amended
by the EEA Agreement.

[38]             For i = r the
corresponding column of Table 3 applies with e replaced by er.

[39]             The distance signal generator
is outside the scope of this Directive.

[40]             Applies to the tape/dip weight
combinations.

[41]             If the nominal tape length
exceeds 30 m, an additional mpe of 0,75 mm shall be permitted for
each 30 m of tape length.

[42]             OJ L 350, 28.12.1998, p. 17.

[43]             0,01 % vol for measurand
values below or equal to 4 % vol, otherwise 0,1 % vol.