Amended proposal for a Directive of the European Parliament and of the Council on measuring instruments (presented by the Commission pursuant to Article 250 (2) of the EC-Treaty)
Date: 2002-02-06
Institutions: European Commission
Subjects: EC conformity marking, approximation of laws, harmonisation of standards, measuring equipment, metrology

C 126 E/368

EN

Official Journal of the European Communities

28.5.2002

Amended proposal for a Directive of the European Parliament and of the Council on measuring
instruments (1)

(2002/C 126 E/14)

(Text with EEA relevance)

COM(2002) 37 final — 2000/0233(COD)

(Submitted by the Commission pursuant to Article 250(2) of the EC Treaty on 6 February 2002)

(1) OJ C 62 E, 27.2.2001, p. 1.

INITIAL PROPOSAL

AMENDED PROPOSAL

THE EUROPEAN PARLIAMENT AND THE COUNCIL
OF THE EUROPEAN UNION,

Unchanged

Having regard to the Treaty establishing the European
Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the Economic and Social
Committee,

Acting in accordance with the procedure laid down in Article
251 of the Treaty,

Whereas:

(1) A number of measuring instruments are covered by
specific Directives, adopted on the basis of Directive
71/316/EEC on common provisions for both measuring
instruments and methods of metrological control (1).
Specific directives that are technically outdated should
be repealed and replaced by an independent directive,
which is in the spirit of Council Resolution of 7 May
1985 on a new approach to technical harmonisation
and standards (2).
that
are not
by Directive
should
outdated
71/316/EEC.

Specific Directives
governed
remain

(2) Measuring instruments can be used for a variety of
tasks. Those responding to reasons of
measurement
public the daily life of citizens in many ways directly
and indirectly,
legally controlled
measuring instruments.

require the use of

___________
(1) OJ L 202, 6.9.1971, p. 1.
(2) OJ C 136, 4.6.1985, p. 1.

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

require

legally

the

of

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INITIAL PROPOSAL

AMENDED PROPOSAL

(3) Legal metrological control should not lead to barriers to
the
the
free movement of measuring instruments,
provision concerned should be the same in all Member
States and proof of conformity accepted throughout the
Community.

Unchanged

(4) 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 assessment
of conformity should provide a high level of confidence.

(5) The performance of measuring instruments is particularly
sensitive to the electromagnetic environment. Immunity
of measuring instruments to electromagnetic interference
forms an integral part of this Directive and the immunity
requirements of Council Directive 89/336/EEC of 3 May
1989 on electromagnetic
last
amended by Directive 93/68/EEC (2), would therefore
not apply.

compatibility (1),

as

(6) Member States should retain the option to prescribe legal
metrological control. Where legal metrological control is
prescribed, only measuring instruments complying with
common requirements should be used.

(7) The responsibilities of the ‘manufacturer’ for compliance
should be

requirements of

this directive

with the
specifically stated.

(6) Community

should

should

specify

legislation

requirements

essential
requirements that do not impede technical progress. The
be
legal
performance
remove
technical barriers
should follow the new
in the Council Resolution of
approach provided for
7 May 1985 on a new approach to technical harmon-
isation and standards.

requirements. Regulations

preferably

to trade

therefore

to

(8) Community

should

should

specify

legislation

requirements

essential
requirements that do not impede technical progress. The
be
legal
performance
remove
technical barriers
should follow the new
in the Council Resolution of
approach provided for
7 May 1985 on a new approach to technical harmon-
isation and standards.

requirements. Regulations

preferably

to trade

therefore

to

___________
(1) OJ L 139, 23.5.1989, p. 19.
(2) OJ L 220, 30.8.1993, p. 1.

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INITIAL PROPOSAL

AMENDED PROPOSAL

technical

and performance

(7) European technical standards should therefore be drawn
up whose
specifications
comply with the essential requirements laid down by
this Directive. Conformity with the specifications of
those standards would give rise to a presumption of
conformity with the essential requirements laid down by
this Directive. Standards harmonised at European level are
retain their
drawn up by private bodies and must
non-mandatory status. For this purpose,
the European
Committee for Standardisation (CEN) and the European
Committee for Electrotechnical Standardisation (Cenelec)
are recognised as being the bodies that are competent to
follow the general
adopt harmonised standards
guidelines for cooperation between the Commission and
those two bodies signed on 13 November 1984.

that

technical

and performance

(9) European technical standards should therefore be drawn
up whose
specifications
comply with the essential requirements laid down by
this Directive. Conformity with the specifications of
those standards would give rise to a presumption of
conformity with the essential requirements laid down by
this Directive. Standards harmonised at European level are
retain their
drawn up by private bodies and must
non-mandatory status. For this purpose,
the European
Committee for Standardisation (CEN) and the European
Committee for Electrotechnical Standardisation (Cenelec)
are recognised as being the bodies that are competent to
follow the general
adopt harmonised standards
guidelines for cooperation between the Commission and
those two bodies signed on 13 November 1984.

that

the request of
to Directive 98/34/EC of

(8) The drawing up of harmonised standards by CEN and
the
Cenelec is to be carried out at
the
Commission pursuant
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 regu-
lations and of rules on Information Society services (1), as
amended by Directive 98/48/EC (2). In relation to stan-
is advisable for the Commission to be
dardisation,
set up under Directive
assisted by the Committee
if necessary, consult
98/34/EC. The Committee will,
technical experts.

it

the request of
to Directive 98/34/EC of

(10) The drawing up of harmonised standards by CEN and
the
Cenelec is to be carried out at
the
Commission pursuant
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 regu-
lations and of rules on Information Society services (1), as
amended by Directive 98/48/EC (2). In relation to stan-
is advisable for the Commission to be
dardisation,
set up under Directive
assisted by the Committee
if necessary, consult
98/34/EC. The Committee will,
technical experts.

it

of

(9) In certain specialised fields the technical and performance
specifications
normative
internationally
documents can also comply, in part or in full, with the
product specifications laid down in legislation. In those
cases the use of these internationally agreed normative
documents can be an alternative to the use of European
technical standards.

agreed

of

(11) In certain specialised fields the technical and performance
specifications
normative
internationally
documents can also comply, in part or in full, with the
product specifications laid down in legislation. In those
cases the use of these internationally agreed normative
documents can be an alternative to the use of European
technical standards.

agreed

(10) 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
internationally agreed normative document. The use of
European technical standards or internationally agreed
normative documents should therefore be optional.

(12) 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
internationally agreed normative document. The use of
European technical standards or internationally agreed
normative documents should therefore be optional.

___________
(1) OJ L 204, 21.7.1998, p. 37.
(2) OJ L 217, 5.8.1998, p. 18.

___________
(1) OJ L 204, 21.7.1998, p. 37.
(2) OJ L 217, 5.8.1998, p. 18.

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INITIAL PROPOSAL

AMENDED PROPOSAL

(11) The state of the art in measurement technology is subject
to constant evolution which may lead to changes in the
for each
needs for conformity assessments. Therefore,
category of measurement 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 (1).

(13) The state of the art in measurement technology is subject
to constant evolution which may lead to changes in the
for each
needs for conformity assessments. Therefore,
category of measurement 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 (1). Provision should be made that
the CE
marking can be affixed during the fabrication process.

(12) In accordance with Article 2 of the Council Decision
1999/468/EC of 28 June 1999 laying down the
procedures
implementing powers
conferred on the Commission (2), measures necessary for
the implementation of this Directive should be adopted by
use of the advisory procedure provided for in Article 3 of
that Decision.

the exercise of

for

for

the exercise of

(14) In accordance with Article 2 of the Council Decision
1999/468/EC of 28 June 1999 laying down the
procedures
implementing powers
conferred on the Commission (2), measures necessary for
the implementation of this Directive should be adopted by
use of the advisory procedure provided for in Article 3 of
that Decision or by use of
the regulatory procedure
provided for in Article 2 of that Decision.

all

take

appropriate measures

(13) The Member States should actively survey their markets
and
prevent
non-complying instruments from being placed on their
markets or being used. Adequate cooperation among
the market surveillance authorities of the Member States
is therefore necessary to ensure a Community-wide effect
of the market surveillance activities.

to

all

take

appropriate measures

(15) The Member States should actively survey their markets
and
prevent
non-complying instruments from being placed on their
markets or being used. Adequate cooperation among
the market surveillance authorities of the Member States
is therefore necessary to ensure a Community-wide effect
of the market surveillance activities.

to

and supplementary marking

(14) Member States should take all appropriate measures to
ensure that measuring instruments that carry the CE
correctly
marking
placed
be
the market. Manufacturers
informed of the grounds on which negative decisions in
respect of
their products were taken, and the legal
remedies available to them.

should

are

on

and supplementary marking

(16) Member States should take all appropriate measures to
ensure that measuring instruments that carry the CE
correctly
marking
placed
be
the market. Manufacturers
informed of the grounds on which negative decisions in
respect of
their products were taken, and the legal
remedies available to them.

should

are

on

(15) This Directive should repeal the Community legislation in
the measuring instruments covered by the

respect of
following Council Directives:

(17) This Directive should repeal the Community legislation in
the measuring instruments covered by the

respect of
following Council Directives:

— 71/318/EEC of 26 July 1971 on the approximation of
relating to gas
the Member States
the laws of
meters (3), as last amended by Commission Directive
82/623/EEC (4);

— 71/318/EEC of 26 July 1971 on the approximation of
relating to gas
the Member States
the laws of
meters (3), as last amended by Commission Directive
82/623/EEC (4);

___________
(1) OJ L 220, 30.8.1993, p. 23.
(2) OJ L 184, 17.7.1999, p. 23.
(3) OJ L 202, 6.9.1971, p. 21.
(4) OJ L 252, 27.8.1982, p. 5.

___________
(1) OJ L 220, 30.8.1993, p. 23.
(2) OJ L 184, 17.7.1999, p. 23.
(3) OJ L 202, 6.9.1971, p. 21.
(4) OJ L 252, 27.8.1982, p. 5.

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INITIAL PROPOSAL

AMENDED PROPOSAL

— 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 (1);

— 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 (1);

— 71/348/EEC of 12 October 1971 on the approxi-
mation of the laws of the Member States relating to
ancillary equipment for meters for liquids other than
water (2), as last amended by the Act of Accession of
Austria, Finland and Sweden;

— 71/348/EEC of 12 October 1971 on the approxi-
mation of the laws of the Member States relating to
ancillary equipment for meters for liquids other than
water (2), as last amended by the Act of Accession of
Austria, Finland and Sweden;

— 73/362/EEC of 19 November 1973 on the approxi-
mation of the laws of the Member States relating to
material measures of length (3), as last amended by
Commission Directive 85/146/EEC (4);

— 73/362/EEC of 19 November 1973 on the approxi-
mation of the laws of the Member States relating to
material measures of length (3), as last amended by
Commission Directive 85/146/EEC (4);

— 75/33/EEC of 17 December 1974 on the approxi-
mation of the laws of the Member States relating to
cold water meters (5);

— 75/33/EEC of 17 December 1974 on the approxi-
mation of the laws of the Member States relating to
cold water meters (5);

— 75/410/EEC of 24 June 1975 on the approximation of
the laws of the Member States relating to continuous
totalizing weighing machines (6);

— 75/410/EEC of 24 June 1975 on the approximation of
the laws of the Member States relating to continuous
totalizing weighing machines (6);

— 76/891/EEC of 4 November 1976 on the approxi-
mation of the laws of the Member States relating to
electrical energy meters (7);

— 76/891/EEC of 4 November 1976 on the approxi-
mation of the laws of the Member States relating to
electrical energy meters (7);

— 77/95/EEC of 21 December 1976 on the approxi-
mation of the laws of the Member States relating to
taximeters (8);

— 77/95/EEC of 21 December 1976 on the approxi-
mation of the laws of the Member States relating to
taximeters (8);

— 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 (9) as amended by
Commission Directive 82/625/EEC (10);

— 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 (9) as amended by
Commission Directive 82/625/EEC (10);

— 78/1031/EEC of 5 December 1978 on the approxi-
mation of the laws of the Member States relating to
automatic
grading
machines (11);

checkweighing

and weight

— 78/1031/EEC of 5 December 1978 on the approxi-
mation of the laws of the Member States relating to
automatic
grading
machines (11);

checkweighing

and weight

___________
(1) OJ L 202, 6.9.1971, p. 32.
(2) OJ L 239, 25.10.1971, p. 9.
(3) OJ L 335, 5.12.1973, p. 56.
(4) OJ L 54, 23.2.1985, p. 29.
(5) OJ L 14, 20.1.1975, p. 1.
(6) OJ L 183, 14.7.1975, p. 25.
(7) OJ L 336, 4.12.1976, p. 30.
(8) OJ L 26, 31.1.1977, p. 59.
(9) OJ L 105, 28.4.1977, p. 18.
(10) OJ L 252, 27.8.1982, p. 10.
(11) OJ L 364, 27.12.1978, p. 1.

___________
(1) OJ L 202, 6.9.1971, p. 32.
(2) OJ L 239, 25.10.1971, p. 9.
(3) OJ L 335, 5.12.1973, p. 56.
(4) OJ L 54, 23.2.1985, p. 29.
(5) OJ L 14, 20.1.1975, p. 1.
(6) OJ L 183, 14.7.1975, p. 25.
(7) OJ L 336, 4.12.1976, p. 30.
(8) OJ L 26, 31.1.1977, p. 59.
(9) OJ L 105, 28.4.1977, p. 18.
(10) OJ L 252, 27.8.1982, p. 10.
(11) OJ L 364, 27.12.1978, p. 1.

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INITIAL PROPOSAL

AMENDED PROPOSAL

— 79/830/EEC of 11 September 1979 on the approxi-
mation of the laws of the Member States relating to
hot-water meters (1).

— 79/830/EEC of 11 September 1979 on the approxi-
mation of the laws of the Member States relating to
hot-water meters (1).

(16) Manufacturers should be offered the possibility to exercise
the rights obtained before the entry into force of this
reasonable period. Transitional
Directive,
arrangements are therefore necessary,

during

a

(18) Manufacturers should be offered the possibility to exercise
the rights obtained before the entry into force of this
reasonable period. Transitional
Directive,
arrangements are therefore necessary,

during

a

HAVE ADOPTED THIS DIRECTIVE:

Unchanged

Article 1

Scope

This Directive applies to the devices and systems with a
measuring
specific
annexes. MI-001 to MI-011

function defined in the

instrument

instrument

(MI-003), heat meters

concerning water meters

function defined in the

This Directive applies to the devices and systems with a
measuring
specific
annexes
(MI-001), gas meters
(MI-002), active electrical energy meters and measurement
transformers
(MI-004), measuring
systems for the continuous and dynamic measurement of
quantities of
liquids other than water (MI-005), automatic
weighing instruments (MI-006), taximeters (MI-007), material
measures
instruments
(MI-009), evidential breath analysers (MI-010) and exhaust
gas analysers (MI-011).

dimensional measuring

(MI-008),

Article 2

Subject matter

Unchanged

This Directive establishes the essential requirements that the
devices and systems referred to in Article 1 have to satisfy if
in a Member
they are subject to legal metrological control
State, and the conformity assessment
they have to
that
undergo in those circumstances, with a view to their placing
on the market and putting into use.

This Directive establishes the essential requirements that the
devices and systems referred to in Article 1 have to satisfy
and the conformity assessment that they have to undergo in
those circumstances, with a view to their placing on the market
and putting into use, for those tasks for which a Member State
prescribes legal metrological control
for reasons of public
interest, such as public health, safety and order, protection of
the environment and the consumer, levying taxes and duties
and fair trading.

It is a specific Directive in respect of requirements for electro-
magnetic immunity in the sense of Article 2(2) of Directive
89/336/EEC.

Unchanged

Article 3

Definitions

For the purposes of this Directive:

(a) ‘measuring instrument’ means any device or system with a
measurement function that is covered by the scope and
object of this Directive, as laid down in Articles 1 and 2;

___________
(1) OJ L 259, 15.10.1979, p. 1.

___________
(1) OJ L 259, 15.10.1979, p. 1.

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INITIAL PROPOSAL

AMENDED PROPOSAL

(b) ‘sub-assembly’ means a hardware device that functions inde-
pendently and together with other sub-assemblies, with
which it is compatible, makes up a measuring instrument,

(b) ‘sub-assembly’ means a hardware device that functions inde-
pendently and together with other sub-assemblies and/or
compatible,
measuring instruments, with which it
makes up a measuring instrument,

is

(c) ‘legal metrological control’ means

the
measurement tasks of a measuring instrument, prescribed
by the Member States for reasons of public health, public
safety, public order, protection of the environment, levying
of taxes and duties, protection of the consumers and fair
trading;

the control of

(d) ‘manufacturer’ means the physical or legal person who

Unchanged

(d) ‘manufacturer’ means the physical or legal person who has
the measuring
this

requirements of

conformity of

appropriate

the

for
responsibility
instrument
to the
Directive, and who

— carries out

the

technical design of a measuring

Unchanged

instrument, or has it carried out on his behalf, and

— manufactures

the measuring instrument, or has

it

manufactured on his behalf, and

— places it lawfully on the market under his own name,

— places it on the market,

or,

Unchanged

the physical or legal person who

— takes responsibility for the conformity of the measuring
this

to the appropriate requirements of

instrument
Directive, and

— has taken all necessary measures to bear those respon-

sibilities, and

— places the measuring instrument lawfully on the market

— places the measuring instrument on the market;

under his own name;

(e) ‘placing on the market’ means the first passing of

the
product from the stage of manufacture to the stage of
distribution and/or use on the Community market

(e) ‘placing on the market’ making available for the first time
in the Community an instrument intended for an end user,
whether for reward or free of charge;

(f)

‘putting into use’ means the first use of a product for the
purposes for which it was intended;

Unchanged

(g) ‘authorised representative’ means

legal
person authorised by manufacturer,
in writing, to act on
his behalf for specified tasks. An authorised representative
must be established within the Community if he is to act
under this Directive;

the physical or

(h) ‘harmonised standard’ means a technical

specification
adopted by the European Committee for Standardisation
the European Committee for Electrotechnical
(CEN) or
Standardization (Cenelec) or
the
request
to Directive
the Commission pursuant
98/34/EC, and prepared in accordance with the General
Guidelines
agreed between the Commission and the
European standards organisations;

jointly by both, at

of

(g) ‘authorised representative’ means

legal
person who is established within the Community and is
authorised by the manufacturer, in writing, to act on his
behalf
and
provisions of this Directive.

specified tasks within the meaning

the physical or

for

Unchanged

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INITIAL PROPOSAL

AMENDED PROPOSAL

(i)

‘normative document’ means
containing
normative elements drawn up by the Organisation Inter-
nationale de Métrologie Légale.

a document

Article 4

Essential requirements and assessment of conformity

A measuring

1.
essential
requirements laid down in Annex I and the relevant instrument
specific Annex.

shall meet

instrument

the

2.
The conformity of a measuring instrument with the
essential requirements shall be assessed in accordance with
the provisions of Article 7.

3. Where a measuring instrument consists of a number of
sub-assemblies and where specific annexes exist laying down
the essential requirements for all of these sub-assemblies that
together make up the measuring instrument, the provisions of
this Directive shall apply mutatis mutandis to each of these
sub-assemblies.

Article 5

Conformity marking

1.
The conformity of a measuring instrument with all the
obligations contained in this Directive shall be indicated by the
presence on it of
the CE marking and the supplementary
metrology marking as specified in Article 13.

2.
The CE marking and supplementary metrology marking
shall be affixed by, or under the responsibility of the manu-
facturer.

2.
The CE marking and supplementary metrology marking
shall be affixed by, or under the responsibility of the manu-
facturer. The CE marking may be affixed on the instrument
during the fabrication process. The supplementary metrology
marking shall be affixed after the assessment of conformity
specified in Article 7.

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

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 or the supplementary metrology
marking shall be prohibited. Any other marking may be
affixed to a measuring instrument, provided that the visibility
and legibility of
the CE marking and the supplementary
metrology marking is not thereby reduced.

Article 6

Unchanged

Placing on the market and putting into use

1.
A Member States shall not impede for reasons covered by
this Directive the placing on the market and putting into use of
any measuring instrument
that carries the CE conformity
marking and supplementary metrology marking in accordance
with Article 5.

1.
A Member States shall not impede for reasons covered by
this Directive the placing on the market and putting into use of
any measuring instrument that carries the CE marking and
supplementary metrology marking in accordance with Article 5.

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INITIAL PROPOSAL

AMENDED PROPOSAL

2. Member States shall ensure that the use of any measuring
the CE conformity marking and
instrument
that carries
accordance with
supplementary metrology marking
Article 5 shall not be impeded by rules or conditions in
respect of aspects covered by this Directive which are
imposed by contracting entities in pursuit of
the relevant
activities, as referred to in Article 2 of Council Directive
93/38/EEC (1).

in

that measuring

take all appropriate measures to
2. Member States shall
ensure
the CE
instruments
conformity marking and supplementary metrology marking
according to Article 5 may be placed on the market and put
into use only if they satisfy the requirements of this directive.

carry

that

3.
A Member State requiring legal metrological control as
referred to in Article 2 may require a measuring instrument to
satisfy provisions for its putting into use, which are duly
justified by local climatic conditions and/or by requirements
in relation to the measuring characteristics. These provisions
are specified in the relevant
specific annexes
referred to in Article 1.

instrument

4. Member States shall ensure that rules or conditions by
public bodies or private bodies acting as a public undertaking
or acting as a public body on the basis of a monopoly position,
do not impede the putting into use of measuring instruments
referred to in paragraph 1 which satisfy the provisions referred
to in paragraph 3.

Article 7

Unchanged

Assessment of conformity

Assessment of conformity of a measuring instrument with its
essential requirements shall be carried out by the application, at
the choice of
the conformity
the manufacturer, of one of
assessment procedures listed in the specific annex concerning
that instrument.

The manufacturer shall provide technical documentation as set
out in Annex IV.

The conformity assessment modules making up the procedures
are described in Annexes A to H1.

Unchanged

Article 8

Notification

1. Member States shall notify to the other Member States
and the Commission the bodies which they have designated to
carry out the tasks pertaining to the conformity assessment
modules referred to in Article 7, together with the identifi-
cation numbers given by the Commission according to
paragraph 4, the kind(s) of measuring instrument for which
each body has been designated and in addition, where
the
relevant,
measurement
instrument char-
acteristic limiting the scope of the notification.

technology, and any other

the instrument classes,

the measuring range,

___________
(1) OJ L 199, 9.8.1993, p. 84.

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2. Member States shall apply the criteria set out in Annex III
for the designation of such bodies.

2. Member States shall apply the criteria set out in Annex III
for the designation of such bodies. Bodies that meet the criteria
laid down in the national standards which transpose the
relevant harmonised standards shall be presumed to meet the
corresponding criteria. If a Member State does not prescribe
legal metrological control, as referred to in Article 2, which
would require the use of an instrument defined in Article 1, it
may legislate to enable the designation of a body competent for
such an instrument.

3.
A Member State that has notified a body shall withdraw
such notification if it finds that the body no longer meets the
criteria referred to in paragraph 2. It shall forthwith inform the
other Member States and the Commission of any such with-
drawal of a notification.

Unchanged

list of bodies notified,

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

the scope of
in the C series of

Article 9

Harmonised standards and normative documents

1. Member States
conformity with the
shall presume
essential requirements referred to in Article 4 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 whose
references have been published in the C series of the Official
Journal of the European Communities.

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

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

the national

2. Member States
conformity with the
shall presume
essential requirements referred to in Article 4 in respect of a
measuring instrument
that complies with the normative
document referred to in Article 11(2)(c), whose references
have been published in the C series of the Official Journal of
the European Communities.

2. Member States
conformity with the
shall presume
essential requirements referred to in Article 4 in respect of a
measuring instrument
that complies with the normative
document referred to in Article 12(1)(a), whose references
have been published in the C series of the Official Journal of
the European Communities.

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.

Unchanged

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

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AMENDED PROPOSAL

INITIAL PROPOSAL

Article 10

Committee on standards and technical regulations

Where a Member State or the Commission considers that a
European harmonised standard as referred to in Article 9(1)
does not fully meet the essential requirements referred to in
Article 4, the Member State or the Commission shall bring the
matter before the Standing Committee set up under 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 of the national standards from the
publication referred to in the third subparagraph of Article
9(1).

Article 11

Measuring Instruments Committee

The Commission shall be

1.
assisted by a Standing
Committee, the Measuring Instruments Committee, composed
of representatives of the Member States and chaired by the
representative of the Commission.

2. Where reference is made to this paragraph, the advisory
procedure laid down in Article 3 of Decision 1999/468/EC
shall apply,
in compliance with Article 7(3) and Article 8
thereof.

3. Where reference is made to this paragraph, the regulatory
procedure laid down in Article 5 of Decision 1999/468/EC
shall apply,
in compliance with Article 7(3) and Article 8
thereof.

Article 12

Unchanged

Functions of the Measuring Instruments Committee

1.
On request by a Member State or on its own initiative,
the Commission, acting in accordance with the procedure
referred to in Article 11(2), may take any appropriate
measure to:

(a) amend instrument specific annexes in respect of:

Deleted

— the maximum permissible errors and accuracy classes,

— the rated operating conditions,

— the critical change values,

— the list of conformity assessment procedures [referred
to in Article 7] — reference is unnecessary here;

(b) amend the test programmes laid down in Annex II;

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(c) request

the Organisation Internationale de Métrologie
Légale to draw up a normative document containing
conformity with which provides
normative
presumption of
corresponding
essential requirements of this Directive;

conformity with the

elements

(a) identify normative documents drawn up by the Organi-
sation Internationale de Métrologie Légale or
indicate
parts thereof conformity with which provides presumption
of
essential
the
conformity with
requirements of this Directive;

corresponding

(d) publish the references of the normative document referred
to in point (c) in the C series of the Official Journal of the
European Communities.

(b) publish the references of the normative document referred
to in point (a) in the C series of the Official Journal of the
European Communities.

2.
On request by a Member State or on its own initiative,
the Commission, acting in accordance with the procedure
referred to in Article 11(3), may take any appropriate
measure to take into account international developments and
to:

(a) amend instrument specific annexes in respect of:

— the maximum permissible errors and accuracy classes,

— the rated operating conditions,

— the critical change values,

— the list of conformity assessment procedures;

(b) amend the test programmes laid down in Annex II;

Where a Member State or the Commission considers that a
normative document whose references have been published
in the C series of the Official Journal of the European Communities
in accordance with paragraph 2(d), does not fully meet the
essential requirements referred to in Article 4, that Member
State or the Commission shall bring the matter before the
Measuring Instruments Committee, giving its
for
doing so.

reasons

3. Where a Member State or the Commission considers that
a normative document whose references have been published
in the C series of the Official Journal of the European Communities
in accordance with paragraph 1(b), does not fully meet the
essential requirements referred to in Article 4, that Member
State or the Commission shall bring the matter before the
Measuring Instruments Committee, giving its
for
doing so.

reasons

The Commission, acting in accordance with the procedure
referred to in Article 11(2), shall
inform the Member States
whether or not it is necessary to withdraw the references of
the normative document concerned from the publication
referred to in the third subparagraph of Article 9(2).

Unchanged

Article 13

Markings

1.
The CE conformity marking referred to in Article 5
consists of the letters 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.

1.
The CE marking referred to in Article 5 consists of the
letters 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.

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INITIAL PROPOSAL

AMENDED PROPOSAL

The supplementary metrology marking referred to in
2.
Article 5 consists of the capital
letter M and the year of its
affixing, surrounded by a rectangle. The height of the rectangle
the CE marking. The
shall be equal
supplementary metrology marking shall
immediately follow
the CE marking.

to the height of

Unchanged

shall

follow the CE

The identification number of the notified body concerned
3.
if prescribed by the conformity
referred to in Article 8,
conformity
assessment procedure,
marking
The
and
measuring instrument shall carry no identification number of
a notified body where that is not prescribed by the conformity
assessment procedure. The measuring instrument shall carry no
identification number of a notified body where that is not
prescribed by the conformity assessment procedure.

supplementary metrology marking.

The identification number of the notified body concerned
3.
if prescribed by the conformity
referred to in Article 8,
follow the CE marking and
assessment procedure,
supplementary metrology marking. The measuring instrument
shall carry no identification number of a notified body where
that is not prescribed by the conformity assessment procedure.

shall

4. When a measuring instrument consists of a set of devices
operating together,
the markings shall be present on the
instrument's main device.

4. When a measuring instrument consists of a set of devices
and/or sub-assemblies operating together, the markings shall be
present on the instrument's main device.

When a measuring instrument is too small or too sensitive to
carry the markings referred to in paragraph 1, the markings
shall be carried by the packing in which the instrument is
offered for sale or,
if applicable, the container in which the
instrument is supplied.

When a measuring instrument is too small or too sensitive to
carry the markings referred to in paragraph 1-3, the markings
shall be indicated on the technical documentation.

The CE

conformity marking

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

indelible. The

and

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.

Article 14

Unduly affixed marking

1. Where a Member State establishes that the CE marking
and/or supplementary metrology marking has been affixed
unduly,
the manufacturer or his authorised representative
established within the Community shall be obliged to make
the instrument conform as regards the provisions concerning
the CE marking and/or supplementary metrology marking and
to end the infringement under the conditions imposed by the
Member State.

2.
The Member State must take all appropriate measures to
restrict or prohibit the placing on the market of the instrument
in question or to ensure that it is withdrawn from the market
in accordance with the procedures laid down in Article 16.

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INITIAL PROPOSAL

Article 14

Market surveillance

that

carry

that measuring

take all appropriate measures to
1. Member States shall
ensure
the CE
instruments
conformity marking and supplementary metrology marking
according to Article 5 shall be placed on the market and put
into use only if, when correctly installed and used in
accordance with the manufacturer's instructions, they satisfy
the essential requirements referred to in Article 4, and they
in accordance with
have undergone conformity assessment
Article 7.

AMENDED PROPOSAL

Article 15

Unchanged

Deleted

The competent authorities of the Member States shall
their obligations to

2.
assist each other in the fulfilment of
carry out market surveillance.

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

the

competent

exchange
In particular,
information concerning the extent to which instruments they
examine comply with the obligations of this Directive, and the
results of such examinations.

authorities

shall

Unchanged

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

Information exchanged shall be kept confidential.

Deleted

Article 16

Safeguard clause

3.
the
If a Member State establishes that all or part of
measuring instruments of a particular model, that bear the
CE conformity marking and the supplementary metrology
marking, do not satisfy the conditions set out in paragraph 1
it shall
take all appropriate measures to withdraw those
instruments from the market, prohibit or restrict their further
being placed on the market, or prohibit or restrict their further
being used.

1.
the
If a Member State establishes that all or part of
measuring instruments of a particular model, that bear the
CE marking and the supplementary metrology marking, do
not satisfy the metrological characteristics set out
in this
directive, when correctly installed and used in accordance
with the manufacturer's instructions,
it shall take all appro-
priate measures
to withdraw those instruments from the
market, prohibit or restrict their further being placed on the
market, or prohibit or restrict their further being used.

the

systematic or

When deciding on the measures, the Member State shall take
account 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.

incidental nature of

Unchanged

The Commission shall enter into consultation with the

4.
parties concerned as soon as possible.

The Commission shall enter into consultation with the

2.
parties concerned as soon as possible.

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INITIAL PROPOSAL

AMENDED PROPOSAL

Should the Commission find that the measures taken by the
Member State concerned are justified,
immediately
took the action thereof, as
inform the Member State that
well as the other Member States.

it shall

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

The competent Member State shall take appropriate action
against whomsoever has affixed the markings and shall
inform the Commission and the other Member States thereof.

Unchanged

If the non-compliance is attributed to shortcomings in the
standards or normative documents, the Commission shall,
after having consulted the parties concerned, bring the
appropriate
soon as possible before
matter
Committee referred to in Article 10 or Article 11.

the

as

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

State

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

it

If the non-compliance is attributed to shortcomings in the
the Commission shall,
standards or normative documents,
after having consulted the parties
concerned, bring the
matter as soon as possible before the appropriate Committee
referred to in Article 10.

Deleted

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

Unchanged

Article 15

Article 17

Decisions entailing refusal or restriction

Unchanged

Any decision taken by a Member State pursuant
to this
Directive which requires the withdrawal from the market of
a measuring instrument, or prohibits or restricts the placing on
the market or putting into use of an instrument, shall state the
exact grounds on which it is based. Such a 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 laws in force in the Member State concerned and of
the time limits to which such remedies are subject.

Article 16

Repeals

Article 18

Unchanged

The following Directives are repealed as from [1 July 2002]
without prejudice to Article 17:

The following Directives are repealed as from [1 July 2002]
without prejudice to Article 19:

— Directive 71/318/EEC;

— Directive 71/319/EEC;

— Directive 71/348/EEC;

— Directive 73/362/EEC;

— Directive 75/33/EEC;

Unchanged

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INITIAL PROPOSAL

AMENDED PROPOSAL

— Directive 75/410/EEC;

— Directive 76/891/EEC;

— Directive 77/95/EEC;

— Directive 77/313/EEC;

— Directive 78/1031/EEC;

— Directive 79/830/EEC.

Article 17

Article 19

Transitional provisions

Unchanged

By way of derogation from Article, 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
the
satisfy the rules applicable before [1 July 2002] until
expiration of
those
measuring instruments or,
in case of a type approval of
indefinite validity, for a period of ten years from [1 July 2002].

the type approval of

the validity of

By way of derogation from Article 6.2, 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 [two years
after 1 July 2002] until the expiration of the validity of the
type approval of those measuring instruments or, in case of a
type approval of indefinite validity, for a period of five years
from [1 July 2002].

Article 18

Transposition

Article 20

Unchanged

Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this
Directive by [1 July 2002] at the latest. They shall forthwith
inform the Commission thereof.

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.
Member States shall determine how such reference is to be
made.

Article 19

Article 21

Entry into force

Unchanged

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

Article 20

Addressees

Article 22

Unchanged

This Directive is addressed to the Member States.

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INITIAL PROPOSAL

AMENDED PROPOSAL

ANNEX I

ESSENTIAL REQUIREMENTS

No change from the proposal in COM(2000) 566 other than in the
following paragraphs:

Unchanged

5.

Durability

stability of

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

A measuring instrument shall be designed to maintain an
adequate stability of
its metrological characteristics over the
taking into
time specified by the manufacturer,
period of
account normal conditions of use when the device is properly
installed, maintained and used according to the manufacturer's
instruction in the environmental conditions for which it
is
intended.

6.

Reliability

Unchanged

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 or can be easily and simply checked using devices
apart from the instrument itself.

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

Unchanged

7.2. A measuring instrument shall be suitable for its intended use
taking account of the practical working conditions and bearing
in mind the intended user
require unreasonable
demands of the user in order to obtain a correct measurement
result.

shall not

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.

8.

Protection against corruption

Unchanged

8.1. The metrological characteristics of a measuring instrument shall
not be inadmissibly influenced by the connection to it of another
device, by any feature of the connected device itself or by any
remote
the measuring
instrument.

communicates with

device

that

8.1. The metrological characteristics of a measuring instrument shall
not be influenced in an 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.

10.

Indication of result

Unchanged

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.

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 primary indication.

10.5. A measuring

for

intended

instrument

utility
measurement purposes from which the measurement data can
read either by a mobile data capture unit or remotely via a
transmission link shall be fitted with a display accessible to the
consumer. The reading of this display is the measurement result
that serves as the basis for the price to pay.

domestic

10.5. A measuring

intended

instrument

utility
measurement purposes from which the measurement data can
remotely read shall also be fitted with a display accessible to the
consumer. The reading of this display is the measurement result
that serves as the basis for the price to pay.

domestic

for

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INITIAL PROPOSAL

AMENDED PROPOSAL

ANNEX MI-001

WATER METERS

No change from the proposal in COM(2000) 566 other than to add
the following paragraphs.

Unchanged

Add after point 10:

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 1 meter.

it

industrial use,

shall allow such measurement

(b) Where a Member State imposes measurement of commercial and/or
to be
light
performed by any Class 1 meter. The Member State shall ensure
that the flowrate range be determined by the distributor 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 reasonably foreseeable.

(c) As regards the requirements under 2, 3, 4 and 5 above a Member
State may define the conditions for putting into use of instruments
on the grounds given in Article 6.3.

Add after Conformity Assessment Paragraph:

The maximum permissible error shall be verified in the conformity
assessment procedure on the basis of the class and flowrate range
declared by the manufacturer.

ANNEX MI-002

GAS METERS

No change from the proposal in COM(2000) 566 other than to add
the following paragraphs.

Unchanged

Add after point 10:

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 1.5 meter.

it

industrial use,

shall allow such measurement

(b) Where a Member State imposes measurement of commercial and/or
to be
light
performed by any Class 1 and/or Class 1.5 meter. The Member
State shall ensure that the flowrate range be determined by the
installing the
the person legally designated for
distributor or
meter,
accurate
the
for
is
measurement of consumption that is foreseen or reasonably fore-
seeable.

appropriate

the meter

so that

(c) As regards the requirements under 2, 3, 4 and 5 above a Member
State may define the conditions for putting into use of instruments
on the grounds given in Article 6.3.

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INITIAL PROPOSAL

AMENDED PROPOSAL

Add after Conformity Assessment Paragraph:

The maximum permissible error shall be verified in the conformity
assessment procedure on the basis of the class and flowrate range
declared by the manufacturer.

ANNEX MI-003

ELECTRICITY METERS

No change from the proposal in COM(2000) 566 other than to add
the following paragraphs.

Unchanged

Add after point 10:

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 2 meter.

it

industrial use,

shall allow such measurement

(b) Where a Member State imposes measurement of commercial and/or
light
to be
performed by any Class 1 and/or Class 2 meter. The Member
State shall ensure that the flowrate range be determined by the
installing the
the person legally designated for
distributor or
accurate
the
for
is
meter,
measurement of consumption that is foreseen or reasonably fore-
seeable.

appropriate

the meter

so that

(c) As regards the requirement under 4 above a Member State may
define the conditions for putting into use of instruments on the
grounds given in Article 6.3.

Add after Conformity Assessment Paragraph:

The maximum permissible error shall be verified in the conformity
assessment procedure on the basis of the class and flowrate range
declared by the manufacturer.

ANNEX MI-004

HEAT METERS

No change from the proposal in COM(2000) 566 other than to add
the following paragraphs.

Unchanged

Add after point 10:

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 3 meter.

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INITIAL PROPOSAL

AMENDED PROPOSAL

it

industrial use,

shall allow such measurement

(b) Where a Member State imposes measurement of commercial and/or
light
to be
performed by any Class 2 and/or Class 3 meter. The Member
State shall ensure that the flowrate range be determined by the
installing the
the person legally designated for
distributor or
meter,
accurate
the
for
is
measurement of consumption that is foreseen or reasonably fore-
seeable.

appropriate

the meter

so that

(c) As regards the requirements under 1 above a Member State may
define the conditions for putting into use of instruments on the
grounds given in Article 6.3.

Add after Conformity Assessment Paragraph:

The maximum permissible error shall be verified in the conformity
assessment procedure on the basis of the class and flowrate range
declared by the manufacturer.

ANNEX MI-008

MATERIAL MEASURES

No change from the proposal in COM(2000) 566 other than to add
the following paragraphs.

Unchanged

Add in Chapter I to the introduction:

However, the requirement for the supply of a copy of the declaration
of conformity may be interpreted as applying to the batch or
consignment rather than each individual instrument.

Add in Chapter II to the introduction:

However, the requirement for the supply of a copy of the declaration
of conformity may be interpreted as applying to the batch or
consignment
instrument. Also the
than each individual
requirement for the instrument to bear an accuracy class shall not
apply.

rather