Manfred KochsiekWilfried Schulz

Physikalisch-Technische BundesanstaltBraunschweig und Berlin

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 BodyParliament

Federal Ministry

RegulationNational Law• Metrology and Verification

Act• Units of Measurement Act

Ordinance• Metrology and Verification• Pre-packages• Fees

5

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

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

• 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

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

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

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

12

MID Annexes MI-001...MI-010

Instrument specific

requirements

Article1 to 27

Annexes of the Ordinance

Metrology Act

National transposition

Annex IAnnexes A -H1

Horizontal

requirements

Metrology Ordinance

Transposition of the MID into national law

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

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

• 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

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

• 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

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

Requirements for the use of instrument

Surveillance of the userRequirements for

placing on the market

User of the instrument

Market surveillance

Manufacturer

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

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

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

Thank you for your attention