New Approach Directives
Legal metrology
and the
Measuring Instruments Directive
(MID)
Christian Mengersen
Physikalisch-Technische Bundesanstalt (PTB)
Working group Q.31 „Legal Metrology“
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MID
Directive of the European Parliament and of the Council
on Measuring Instruments
with EEA relevance (2004/22/EC)
=
Measuring Instruments Directive
=
MID
European Directives?
 bind Member States to the objectives to be achieved within
a certain time-limit while leaving the national authorities
the choice of form and means to be used.
 have to be implemented in national legislation in accordance
with the procedures of the individual Member States.
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Legal Metrology in the European Union
Intention:
Legal metrological control should not lead to barriers to
free movement of measuring instruments!
Starting point (before 1995):
→ 15 Member States with own ideas about *)
„fair trade“ and „consumer protection“
→ 11 “Old Approach” technical Directives
→ 1 “New Approach” Directive (NAWI)
→ WELMEC-Type approval
agreements on the basis
of 7 OIML-Recommendations
*) 2008: 27 Member-(+ 3 Candiate-), 3 EEA-States, Switzerland, Turkey
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Legal Metrology World Wide
International Organisation of Legal Metrology (OIML)
for
Global harmonisation of legal metrology procedures
– 59 member states, 57 corresponding members (2008)
– about 130 specific OILM-Recommendations
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Legal Metrology in Europe (2008)
WELMEC (European Co-operation in Legal Metrology):
30 Members (NMI’s), 3 Associate members,
7 Observer Organisations (European Commission, OIML,...),
5 Corresponding Organisations (COOMET, APLMF, ..)
Aim:
Establishment of a harmonised and consistent approach to
European Legal Metrology, Harmonisation of legal metrology
activities, e.g.
MID-Activities:
WG 8 Measuring Instruments Directive
+ 9 Working Groups (specific measuring quantities, procedures)
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Concerned measuring instruments in the MID:
MI-001 Water Meters
MI-002 Gas Meters and Volume Conversion Devices
MI-003 Active Electrical Energy Meters
MI-004 Heat Meters
(MI-001 to MI-004: for utility measuring purposes)
MI-005 Measuring Systems for the Measurement of
Quantities of Liquids other than Water
MI-006 Automatic Weighing Instruments
MI-007 Taximeters
MI-008 Material Measures (length, capacity measure)
MI-009 Dimensional Measuring Instruments “Cables”
MI-010 Exhaust Gas Analysers
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MID - Basic principles:
Subsidiarity / Optionality:
Regulations for legally controlled instruments are limited until
“placing on the market” and/or “putting into use”
– Member states remain responsible for their legal metrological
control (choice of controlled instruments, market surveillance),
but
– National metrological control should not lead to barriers
to free movement of measuring instruments
Preservation of the existing degree of protection in all
member states:
– Adequate requirements for the measuring instruments
are necessary
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Regulated Instruments in % Member States
100 %
MI-005 Fuel Dispensers
(consum. Prot.)
97 %
MI-006 Automatic Weighing Instrum. (fair trade)
97 %
MI-005 Systems on Road Tankers
(fair trade)
93 %
MI-005 Systems for Milk
(fair trade)
89 %
MI-007 Taximeters
(consum. prot.)
85 %
MI-010 Exhaust Gas Analysers
(environment)
82 %
MI-008 Material Measures: Length
(consum.prot.)
74 %
MI-008 Capacity measures
(taxes)
67 % - 70 %
MI-009 Dimensional Measuring Instruments
Resid.I Com.I Industr.
Utility Meters:
(consum.prot.)
100%, 97 % , 97 % MI-003 Active Electrical Energy Meters
93 % , 83 % , 74 % MI-001 Clean cold Water Meters
93 % , 93 % , 93 % MI-002 Gas Meters
89 % , 85 % , 85 % MI-001 Clean warm Water Meters
85 % , 89 %, 89 % MI-002 Volume conversion devices
82 % , 78 % , 78 % MI-004 Heat Meters
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Basic procedures (Instruments):
The New Approach
– limits Harmonisation to essential requirements without
technical instructions, concerning only the practical use
– allows any technical solution fulfilling the essential
requirements of use
– demands presumption of conformity to the essential
requirements, when EC-harmonised standards*)(CEN/
CENELEC) and EC-accepted Normative Documents*)
(OIML) are the basis of the technical construction
The MID is open for new technical developments
*) published in the Official Journal of the European Union, C series.
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Basic procedures (conformity assessment):
The Global Approach
– is a modular approach, offering harmonised conformity
assessment procedures to the manufacturers
– opens the possibility to take into account the manufacturers
internal design and production control activities
– allows a complete assessment until placing a measuring
instrument on the market / putting into use
– should provide a high level of confidence to the product
MID: The conformity assessment procedures must be
performed under the responsibility of a Notified Body, who
is under the surveillance of a member state
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Ticket for the EU-Market since 30th October 2006
CE marking and supplementary metrology marking, affixed
under the responsibility of the manufacturer:
M 06 0102
= Conformity to applicable technical harmonisation Directives
M
= Conformity to the legal metrology Directive 2004/22/EC
06
= Year of affixing the CE- and the metrology marking
0102 = Identification no. of the notified body, responsible for the
conformity assessment procedure for ‘placing on the
market’ and/or ‘putting into use’
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Valid in 27 EG-, 3 EEA-States, Switzerland, Turkey
Austria
Belgium
Bulgaria
Cyprus
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Ireland
Italy
Latvia
Lithuania
Luxembourg
Malta
Netherlands
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden United
Kingdom
Iceland
Liechtenstein
Norway
Switzerland
Turkey
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Structure of the MID
1) Articles, regulating the procedures:
Definitions, Procedures for implementation, obligations,
regulations,
Criteria to be satisfied by the notified bodies,
Necessary technical documentation from manufacturer,
Safeguard clause in the case of non conformity,
Changes and further development of the MID
2) General Essential Requirements (Annex I)
5) Conformity Assessment Procedures (Annexes A - H1)
6) Instrument Specific Essential Requirements
(Annexes MI-001 to MI-010)
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Essential Requirements: All instruments (Annex I)
 Correct measurement: Allowable Errors, Durability
 Influence Quantities: Mechananic, Climatic, Electromagnetic
 Suitability for use, reproducibility
 Verifiability: Metrolog. relevant parts, also for instruments in use
 Additional functionalities, not under legal control
 Protection against corruption (Hard- and Software)
 Easy identification of metrological relevant Hard- and Software
 Information to accompany the instruments
 Indication of the result: (Metrologically controlled display
for the consumer as the basis of the price to pay)
 Further processing of data to conclude trading transaction
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Instrument specific Essential Requirements
(Annexes MI-001 to MI-010)
 Rated operating conditions (climatic, mechan., electromagn.)
 Maximum permissible Errors (MPE) at rated operating conditions
 Permissible effects of disturbances
 Indication of the result
 Allowed Conformity Assessment Procedures
If applicable:
 Accuracy classes
 Conditions for putting into use
 Suitability
 Durability
 Requirements for sub assemblies with conformity assessment
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European harmonised standards
Presumption of conformity with the essential requirements
in full or in part if the instrument complies with :
–
Harmonised European Standard (CEN/CENELEC)
–
Normative Documents, e.g.drawn up by OIML,
in full or in part referenced in the C series of the
Official Journal of the European Communities
Where an instrument not complies with referenced
standards or documents, the Notified Body is in charge that
the instrument meets the provisions of the Directive
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Simplified flow chart of conformity assessment
procedures (Global Approach)
1 / Module H
(“Blue Book”: www.newapproach.org)
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Essential Conformity Assessment Procedures
Mod F
Product verification
Mod B
Type examination
Manufacturer
Manufacturer
Mod D
M 06 0102
Production
quality assurance
Design examination, Full quality assurance
Mod H1
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Common features for Mod D and H1
– Modules D and H1 do not require a certified quality
system according to e.g. EN ISO 9001, 9002 or 9003
– A certified quality system (EN ISO or equivalent)
provides a useful means of establishing compliance
with the directive
– The quality system must take into consideration the
specific requirements of the product
– The surveillance (first/periodic audits, unexpected
visits, product tests) is under the responsibility of the
Notified Body. The responsibility can not be delegated!
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Demands on the Notified Bodies (Article 12)
– Impartiality, free from all pressures and inducements
– Highest degree of professional integrity and requisite
competence in the field of metrology
– Ability to carry out all the tasks assigned to such bodies
by the Annex for which it has been notified
– Sound technical and vocational training, covering all
conformity assessment tasks for which it is designated
– Professional secrecy with regard to all information
obtained in the course of exercising their duties
– Closing of a civil liability insurance, if its civil liability
is not covered by the Member State under national law
Member States are responsible for the designation of NB‘s:
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Duties of the member states (Articles)
– Appointment of suitable Notified Bodies, Supervision of the
Notified Bodies (11, 12)
– Market surveillance: Check that affixing and use of the CE + M
marking is correct, withdrawing instruments with unduly fixed
marking → safeguard clause (18, 19)
– Notification to the Commission and to the other Member States
about the restriction of free movement of an instrument due to
unduly fixed CE + M markings
– Notification to the “Measuring Instruments Committee”
concerning changes, new normative documents etc (15)
– Notification to the “Standing Committee” concerning new
or invalide European harmonised standards (14)
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Summery:
The MID
– removes barriers of trade for 10 types of instruments
– is open for new technical solutions
– offers European conformity assessment procedures
– considers the competence of the manufacturer
But there is a need of support by
– technical standardisation (CEN/CENELEC, OIML)
– standardisation of the procedures (WELMEC, OIML)
– surveillance of correct use of the European procedures
(Member States, European Commission)
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MID and the Global Market
A manufacturer in a third country is responsible for the design and
production of a measuring instrument in the same way as a
manufacturer established in a Member State.
A physical or legal person, established within the EU, is
responsible for the CE marking and the necessary documentation
(e.g. the manufacturer, his authorised representative, the importer
or the person responsible for placing the product on the
Community market).
The customs authorities will check the formal correctness.
Mutual recognition agreements between the Community and third
countries can facilitate the conditions for the manufacturers of
these countries.
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The perspective:
The MID offers new Conformity Assessment Procedures,
especially applicable for electronic and software controlled
measuring instruments.
The MID removes barriers to free movement of measuring
instruments which are under national legal control.
The European Union is Partner in the Global Market for measuring
instruments.
More valuable information:
www.newapproach.eu (Directives, harm. Standards etc.)
www.welmec.org (Guides, country infos etc.)
www.ptb.de
Thank You !
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