EUROPEAN HARMONISATION IN LEGAL METROLOGY

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EUROPEAN HARMONISATION IN LEGAL METROLOGY

• Presentation by Mairéad Buckley
• 24 June 2004

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CONTEXT

• Member States are allowed to regulate for
  specific reasons under the EC Treaty
• Divergent legislation leads to technical barriers
  to trade
• Barriers to trade impede economic progress

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Milestones in European Policy

• 1970s harmonisation programme
• Jurisprudence
• Notification procedure 83/189/EEC (now 98/34/EC )
• New Approach and Global Approach

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OLD APPROACH

• Product specific
• Technical detail including testing
• Usually optional nature - national legislation
  could apply in parallel
• Member State responsible for conformity

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METROLOGY DIRECTIVES(Old Approach)

• Total
• Framework (71/316/EEC as amended)
• Units of measurement (80/181/EEC as amended)
• Optional (more than 20 directives and amendments)
• - Pre-packaged goods (76/211/EEC and 75/106/EEC)
• - Measuring Instruments
• - Methods of metrological control

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NEW APPROACH - 1

• Essential requirements contained in legislation
• Harmonised European Standards to provide
  technical specifications
• Standards remain voluntary
• Products manufactured in compliance with
  Standards are presumed to conform

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NEW APPROACH - 2

• Manufacturer is responsible for conformity
• Notified bodies to carry out conformity
  assessment
• Coherent set of conformity assessment procedures
  to be used
• Uniform CE marking to apply

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ESSENTIAL REQUIREMENTS

• Mandatory
• Relate to hazards, performance or objectives
• High level of safety and/or protection

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PRESUMPTION OF CONFORMITY

• Reference to the appropriate European Standard
  must be published by the Commission
• Several Standards can relate to the same
  Directive
• Use of Standards is voluntary

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MANUFACTURER

• Must carry out risk assessment
• Can choose any conformity assessment procedure
  allowed by the Directive
• Is fully responsible for conformity
• draws up the declaration of conformity
• affixes the CE marking

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NOTIFIED BODY

• A body designated by a Member State to undertake
  conformity assessment
• Criteria for designation
• impartial
• technically competent
• independent
• integrity

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GLOBAL APPROACH to testing and certification

• 8 modules
• - design phase
• - production phase
• 3 based on quality assurance system approach
• EN ISO 9000 provides presumption of conformity
  for relevant aspects

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Design Phase
Production Phase
MODULE A
MODULE C
MODULE D
MODULE B
MODULE E
Manufacturer
MODULE F
MODULE G
MODULE H
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KEY COMPARISON

• OLD APPROACH
• Mandatory technical specifications
• Optional application
• Member state responsible for conformity

• NEW APPROACH
• Mandatory essential requirements and voluntary
  European standards
• Total application
• Manufacturer responsible for conformity

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NEW APPROACH DIRECTIVES

• Non-automatic weighing instruments (NAWI)
  Directive 90/384/EEC adopted June 1990
• Measuring Instruments Directive proposal by the
  Commission in September 2000 and adopted by
  Council and Parliament in March 2004

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COMPOSITION

• The directive is composed of 4 sections
• - Articles
• - Annex I General Essential Requirements
• - Annexes A to H1 Conformity Assessment
  Procedures
• - Annexes MI-001 to MI-010 Instrument Specific
  Requirements

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Instrument specific annexes

• 10 Annexes each dealing with a different
  category of instrument
• MI-001 - Water meters
• MI-002 - Gas meters
• MI-003 - Electricity meters
• MI-004 - Heat meters

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Instrument specific annexes

• MI-005 Meters and systems for liquids other
  than water
• MI-006 - Automatic weighing instruments
• MI-007 - Taximeters
• MI-008 - Material measures capacity and length
• MI-009 - Dimensional measuring instruments
• MI-010 - Exhaust gas analysers

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IMPACT - positives

• Complete set of objectives and instrument
  requirements
• Mutual recognition of results
• Coherent and expanded set of conformity
  assessment procedures
• Efficiency - Recognition of OIML documents
• Flexibility of control for member state
• Opportunity to rethink service delivery

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IMPACT - negatives

• Knowledge deficit
• Loss of direct contact with manufacturers and
  suppliers
• Demand from private operators to carry out
  in-service controls
• Loss of revenue from initial verifications