1. Manfred Kochsiek Wilfried Schulz Physikalisch-Technische Bundesanstalt Braunschweig und Berlin Modernisation of Legal Metrology in Germany

2. 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. 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. 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. 5 Type approval Calibration of standards Consultancy for the authorities PTB Responsible Body Main tasks Enforcement of legal metrology today Verification offices Approved testing laboratories Initial verification and subsequent verification (electricity, gas, water, heat) Initial verification Periodic re-verification Market surveillance Approval of testing laboratories

6. 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. 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. 8 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

9. 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. 10 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

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

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

13. 13 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

14. 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. 15 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 ≡

16. 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. 17 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

18. 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. 19 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

20. 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. 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. 22 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

23. 23 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

24. 24 Thank you for your attention