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Modernisation of Legal Metrology in Germany

Modernisation of Legal Metrology in Germany. 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

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Modernisation of Legal Metrology in Germany

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  1. Modernisation of Legal Metrology in Germany

  2. 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

  3. Legal Metrology in Germany Basis • European Directives • National Law on Metrology and Verification Fields of application • Commercial transactions • Official transactions • Environment • Labour • Health

  4. 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

  5. Enforcement of legal metrology today Main tasks Responsible Body Type approval Calibration of standards Consultancy for the authorities PTB Initial verification Periodic re-verification Market surveillance Approval of testing laboratories Verification offices Approved testing laboratories Initial verification and subsequent verification (electricity, gas, water, heat)

  6. 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

  7. 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

  8. Instruments covered by MID • 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

  9. 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

  10. Instruments subject to legal control 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

  11. Conformity assessment procedure Manufacturing process Module B+F Module B+D Module H1 Design examination Design Prototype Type evaluation (B) Type evaluation (B) Type Complete QM-system QM-system Production (D) Serial production Product verification (F) Final product Conformity assessment + markings MID-Conformityassessment

  12. Annex I Annexes A -H1 Horizontal requirements Annexes of the Ordinance Metrology Act Metrology Ordinance Annexes MI-001...MI-010 Instrument specific requirements Transposition of the MID into national law MID Article 1 to 27 National transposition

  13. Legal frame in Germany 1) “Old Approach” - Directives (1971 – 1986) 2) Directive on Non-automatic weighing instruments (1990) 3) MID Instruments (2006) 4 Categories of regulations as from 30 October 2006 4) German Law on Metrology and Verification (2006)

  14. 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

  15. National and EC requirements harmonized • 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 ≡

  16. 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

  17. Measures after putting into use • 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

  18. 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

  19. Metrological surveillance Target group Manufacturer User of the instrument Market surveillance Surveillance of the user Requirements for placing on the market Requirements for the use of instrument

  20. 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

  21. 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

  22. Transitionalperiod • 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

  23. WELMECEuropean cooperation in legal metrology Harmonization of MID-application • 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

  24. Thank you for your attention

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