Manfred KochsiekWilfried Schulz

Physikalisch-Technische BundesanstaltBraunschweig und Berlin

Modernisation of Legal Metrology in Germany

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Content

• Legal Metrology in Germany

• Political, economic and technical developments

• Principles of the Measuring Instruments Directive (MID)

• Conformity assessment

• Requirements for notified bodies

• National changes• Consequences for PTB and verification

authorities

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Legal Metrology in Germany

Basis

• European Directives

• National Law on Metrology and Verification

Fields of application

• Commercial transactions

• Official transactions

• Environment

• Labour

• Health

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Legislation for Metrology

Responsible Body

Parliament

Federal Ministry

Regulation

National Law• Metrology and Verification

Act• Units of Measurement Act

Ordinance• Metrology and Verification• Pre-packages• Fees

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Type approvalCalibration of standardsConsultancy for the authorities

PTB

Responsible Body Main tasks

Enforcement of legal metrology today

Verification offices

Approved testinglaboratories

Initial verification and subsequent verification(electricity, gas, water, heat)

Initial verificationPeriodic re-verificationMarket surveillanceApproval of testing laboratories

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Political, economic and technical developments

• Measuring Instruments Directive 2004/22/EEC (MID)

• Liberalization of the markets (energy)

• Private bodies for testing and assessment of instruments

• Software-controlled instruments

• Measuring data transfer in in open systems

• Remote displays without access to the consumer

• Measuring systems with exchangeable components

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Principles of the Measuring Instruments Directive 2004/22/EC (MID)

• Free movement of measuring instruments

• Requirements up to placing on the market

• Essential requirements for measuring instruments

• Presumption of conformity for compliance with harmonised EN or OIML-IR

• Conformity assessment procedures

• Notified bodies

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• Water meters• Gas meters and volume conversion devices• Active electrical energy meters• Heat meters• Measuring systems for liquids other than

water• Automatic weighing instruments• Taximeters• Material measures• Dimensional measuring instruments• Exhaust gas analysers

Instruments covered by MID

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The MID does not prescribe:

• Legal metrological control

• Legal status of the notified bodies

• Requirements for instruments after putting into use

• Maximum permissible error in service

• Subsequent verification

• Period of validity for conformity assessment

• Fees

Subject to national legal control

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European Law

• All instruments covered by MID• Non-automatic weighing instruments (NAWI)

German Law (Examples):

• Electricity meters for U <= 123 kV

• Instruments for speed control

• Breath analysers

• Sound level meters

• Radiation protection measuring instruments

Instruments subject to legal control

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MID-Conformity assessment

Product verification (F)

QM-systemProduction (D)

CompleteQM-system

Final product

Conformity assessment + markings

Conformity assessment procedureManufacturing process

Module B+F Module B+D Module H1

Design Prototype

Type Type evaluation (B)

Type evaluation (B)

Serial production

Design examination

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MID Annexes MI-001...MI-010

Instrument specific

requirements

Annexes MI-001...MI-010

Instrument specific

requirements

Article1 to 27Article1 to 27

Annexes of the OrdinanceAnnexes of the Ordinance

Metrology ActMetrology Act

National transposition

Annex IAnnexes A -H1

Horizontal

requirements

Annex IAnnexes A -H1

Horizontal

requirements

Metrology OrdinanceMetrology Ordinance

Transposition of the MID into national law

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1) “Old Approach” - Directives (1971 – 1986)2) Directive on Non-automatic weighing

instruments (1990)3) MID Instruments (2006)

Legal frame in Germany

4) German Law on Metrology and Verification (2006)

4 Categories of regulations as from 30 October 2006

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German legislation takes account of

• Complex measuring systems in open networks

• Software requirements and testing of software

• Distinction of measuring instrument, measuring system, sub-assembly and peripheral equipment

• Measuring instruments and measuring systems with separate displays

• Correct measurements not only measuring instruments

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• MID-conformity assessment procedures also applicable to devices subject to national legal control

• MID-conformity assessment by Notified Bodies (NB)

• National conformity assessment by Conformity assessment Body (CAB)

• Requirements for CAB and NB equivalent

National and EC requirements harmonized

≡

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Privatisation of conformity assessment

• Private Notified Bodies (NAWI and MID) possible

• Private CABs (national) possible

• Stronger involvement of private bodies for subsequent verification, e.g. weighing instruments

• Private bodies shall be independent from development, production and repair of the instruments

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• Periodical subsequent verification to ensure durability

• Subsequent verification for all instruments

• MPE in service = 2 x MPE for initial verification

• Sampling procedures for re-verification possible

• Metrological surveillance

Measures after putting into use

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Metrological surveillance

• Obligation for users to notify their instruments

• Metrological surveillance under the responsibility of the verification authorities

a) Market surveillance of measuring instruments after placing on the market

b) Surveillance of the users of measuring instruments

c) Surveillance of private bodies

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Metrological surveillance

Target group

Requirements for the use of instrument

Surveillance of the user

Requirements for placing on the

market

User of the instrument

Market surveillance

Manufacturer

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Effects on the verification authorities

• Decreasing number of initial verifications as a consequence of the MID

• Decreasing number of re-verifications as a national political consequence

• Considerable loss of fees and staff cuts

• Strengthening of market surveillance

• Surveillance of private bodies

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Effects on PTB

• Role as Notified Body for the MID-modules B, D and H1

• Type examinations and design examinations (B, H1)

• Approval and surveillance of QM-systems (D, H1)

• Competition with NB in other European countries

• Competition with national bodies (if there are candidates)

• PTB designated as co-ordinator of national bodies

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Transitional period

• Previous national approvals valid until 30.10.2016

• National initial verifications valid until 30.10.2016

• EEC-approvals are valid according to validity of approval

• EEC-initial verifications valid until expiring date

• Amendments of approvals (national) until 30.10.2016

• Re-verifications possible for an unlimited period

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Co-operation with the EU Commission:

• Determination of the normative documents (OIML IR)

• Harmonization of notified bodies

• Information exchange concerning market surveillance

• Elaboration of WELMEC-guidelines endorsed by the EU Commission

WELMEC

European cooperation in legal metrology

Harmonization of MID-application

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Thank you for your attention