1. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 The Directive on Measuring Instruments - the experience of Member States Nataša Mejak Vukovič WELMEC Chairperson MIRS – Metrology Institute of the Republic of Slovenia Seminar on Metrology & Conformity Assessment (for EU neighbouring countries) INT MARKT 34468 organised in co-operation with Directorate General for Enterprise and Industry Brussels 1,2 March 2010

2. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 2 Directive 2004/22/EC of the European Parliament and of the Council on measuring instruments M I D OJ L 135 of 30.04.2004 Entry into force: 30 April 2004 Deadline for transposition: 30 April 2006 Application from: 30 October 2006 1 May 2004 Enlargement of EU

3. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 MS may prescribe the use of measuring instruments for measuring tasks for reasons of Public interest Public health Public safety Public order Protection of the environment Protection of consumers Fair trading Levying of taxes and duties

4. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 Devices and systems with measuring function defined in the instruments specific annexes: MI 001 – MI 010 Utility Meters (Clean Water, Gas and volume conversion devices, Heat, Electricity) Systems for the continuous and dynamic measurement of quantities of liquids other than water Automatic Weighing Instruments Taximeters Material measures Dimensional Measuring Instruments Exhaust Gas Analysers

5. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 European Directives - metrology 1. Units of measurement Directive 80/181/EEC (2 amendments) 2. Common provisions Directive 71/316/EEC (5 amendments) 3. Non-automatic weighing instruments Directive 90/384/EEC 4. Totalizing weighing machines and automatic check weighing and weight grading machines Totalizing weighing machines Directive 75/410/EEC (*) Automatic check weighing and weight grading machines Directive 78/1031/EEC (*) 5. Water meters Cold-water meters Directive 75/33/EEC (* - for clean water) Hot-water meters Directive 79/830/EEC (*) 6. Measuring systems for liquids other than water Meters for liquids other than water Directive 79/319/EEC (*) Measuring systems for liquids other than water Directive 77/313/EEC (*) Ancillary equipment for meters for liquids other than water Directive 71/348/EEC (*) 7. Gas meters Directive 71/318/EEC (*) 8. Electricity meters Directive 76/891/EEC (*) 9. Material measures of length Directive 73/362/EEC (*) 10. Alcohol meters, alcohol hydrometers and alcohol tables Alcohol meters and alcohol hydrometers Directive 76/765/EEC Alcohol tables Directive 76/766/EEC 11. Medium and above medium accuracy weights 5 to 50 kilogramme medium accuracy rectangular bar weights and 1 gramme to 10 kilogramme medium accuracy cylindrical weights Directive 71/317/EEC Weights from 1 milligramme to 50 kilogramme of Above medium accuracy Directive 74/148/EEC 12. Taximeters Directive 77/95/EEC (*) 13. Type pressure gauges for motor vehicles Directive 86/217/EEC 14. Standard mass of grain Directive 71/347/EEC 15. Calibration of tanks of vessels (ships’ tanks) Directive 71/349/EEC (*) – directives replaced by MID MID NAWI MID

6. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 Should the non-automatic weighing instruments covered by Directive 2009/23/EC (known as NAWID) be included in the scope of the MID? Expected benefits? Simplification of the legislation Access to modules not foreseen in the NAWI directive Expected disbenefits? More costs foreseen by manufacturers because of the optionality

7. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 Can the eight Old Approach measuring instruments Directives be incorporated into the instrument-specific annexes of the MID with the requirements up dated at the same time? 71/317/EEC: 5 to 50 kilogram medium accuracy and 1 to 10 kilogram medium accuracy weights 71/347/EEC: Standard mass per storage volume of grain 71/349/EEC: Calibration of tanks of vessels (ships’ tanks) 75/33/EEC: Cold-water meters (only for unclean water) 74/148/EEC: 1 mg to 50 kg above-medium accuracy weights 76/765/EEC: Alcoholometers and alcohol hydrometers 76/766/EEC: Alcohol tables 86/217 EEC: Tyre pressure gauges for motor vehicles

8. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 The principle of optionality/subsidiarity The principle of Optionality means that Member States decide which MID instruments to regulate - the provisions of the MID are not universally binding The principle of Subsidiarity requires that Member States remain responsible for their legal metrology control The MID therefore leaves it to the Member States to decide whether to issue regulations, but if they do, the regulations must comply with the provisions of the MID The obligation of Member States to communicate to the Commission the reasons for not prescribing the use of measuring instruments in MID

9. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 94 %MI-005 Fuel dispensers 90 %MI-008 Material Measures: Length 88 %MI-005 Systems on Road Tankers 88 %MI-005 Systems for Milk 72 % - 88 %MI-006 Automatic Weighing Instruments 84 %MI-007 Taximeters 68 %MI-010 Exhaust Gas Analysers 56 %MI-008 Capacity measures 34 % - 63 %MI-009 Dimensional Measuring Instruments Res. I Com. I Ind.Utility Meters: 88 %, 88 %, 88 %MI-003 Active Electrical Energy Meters 84 %, 81 %, 69 %MI-002 Gas Meters 78 %, 69 %, 56 %MI-001 Clean cold Water Meters 72 %, 69 %, 50 %MI-001 Clean warm Water Meters 59 %, 62 %, 59 %MI-004 Heat Meters Results of the WELMEC questionnaire on scope of legal metrology in application of MID in the EU-, EFTA States and the Candidate Countries

10. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 10 year of transitional period from 30 October 2006 30 October 2016 Measuring instruments with pre-MID type approvals may be placed on the market and put into use until the expiry of the validity of the type approval or in the case of indefinite validity, for the period of maximum of 10 years from October 2006 Updating of pre-MID type approvals should be administrative and should not lead to any technical updating or upgrading of metrological performance of the instrument

11. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 10 year of transitional period gradual transitional period to adapt to the new conformity assessment procedures and comply with the MID essential and specific requirements If an approved model has undergone modifications which must be mentioned in the type approval, this model is no longer subject to the transitional period and the type approval can no longer be completed/updated Consequently, measuring instruments manufactured in accordance with the modified model are subject to the applicable conformity assessment procedures laid down by MID

12. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 Criteria for updating of pre-MID type approvals -Formal changes (changes of the name or of legal form of the manufacturer) -Replacing of the components with the equivalent ones -Corrections of the software (without the technical upgrading or change of metrological characteristics)

13. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 Common Interpretation Common Application European UnionDirectives Member States Implementation National Law WELMEC Stakeholders Participation Comission Working MID Group

14. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 Working Group Measuring Instruments COORDINATION National authorities of MS, EFTA and candiadate countries WELMEC Manufacturers Notified Bodies European Standards bodies (CEN,CENELEC) ADMINISTRATIVE COOPERATION CONSULTATION Guidance documents Reports (e.g. revision) Preparation of measures to be adopted under the Comitology procedures Endorsement standards programs, preparation of mandates Exchange of info and feedback on implementation MID Monitoring of and feedback on OIML MID related issues

15. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 Measuring Instruments Committee set up in Article 15 of MID Functions (Article 16 of MID): Regulatory procedure for modification of Annexes (Commission submits draft measures for scrutiny by EP and the Council; 3 months period for EP and the Council for opposing the measures) Example: Commission Directive 2009/137/EC of 10 November 2009 amending Directive 2004/22/EC in respect of exploitation of the maximum permissible errors, as regards the instrument-specific annexes MI-001 to MI-005 Advisory procedure for normative documents related issues The procedures which govern the work of the Committee follow the standard procedures established in Council Decision 1999/468/EC of 28 June 1999 as amended by the Decision 2006/512/EC

16. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 WELMEC Guidance documents, endorsed by the Commission's Working Group, represent the reference documents for ensuring consistent application of MID by all stakeholders involved and are published on Commission’s website http://ec.europa.eu/enterprise/prepack/ms_inst/index_measin_en.htm Guidance documents are not legally binding interpretation of the Directive (MID) Commission statement to WELMEC on cooperation Commission takes into consideration the existence of effective cooperation between national authorities through WELMEC Stakeholders are able to participate in preparatory WELMEC work related to the MID

17. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 MID opened a new EC route for presumption of conformity by using OIML Recommendations (instead of only European harmonised standards) - Conditions and process : identification of IR’s and their requirements which give presumption of conformity to the essential requirements of MID advice of MI Committee - Publication of simplified tables in Official Journal of the EU - JO 2006/C 269 of 4 November 2006 (OIML R49-1, OIML R49-2, OIML R75-1, OIML R75- 2, OIML R117, OIML D11, OIML R51-1, OIML R61-1, OIML R107-1, OIML R50-1, OIML R106-1, OIML R29, OIML R66, OIML R136-1, OIML R129, OIML R99) - JO 2009/C 268 of 11 November 2009 (OIML R 21, OIML R 138, OIML R 137-1) Normative Documents

18. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 New Normative documents to be agreed in the near future MI 010 gas exhaust analisers OIML R 99 MI 005 measuring system for liquid other than water OIML R117 MI 006 automatic weighing instruments OIML R 51 and OIML R 107 MI 006 discontinuous totalizing automatic weighing instruments OIML R107

19. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 Taximeter Cross Reference Table 2004/22/EC vs. OIML R 21 (2007) Notes: The column “Comments” indicates when necessary the relevant text of OIML R 21 and related explanations concerning the compliance with relevant MID requirement. The column “Conclusion” gives the conclusion on the compliance between MID and OIML R 21 for the relevant requirement. The indication “Covered” means that: The requirement of OIML R 21 is identical to the one of MID; or The requirement of OIML R 21 is more severe than the one of MID; or All the requirement of OIML R 21 fulfils MID requirements (even when MID allows other alternatives), In case the requirement is not fully covered, a short statement explains what is covered. The indication “Not Covered” means that the MID requirement is either not compatible with the relevant OIML R 21 requirement or not included in OIML R 21. The indication “Not relevant” means that the MID Annex 1 requirement is not relevant for taximeters. Directive 2004/22/EC Essential requirements of Annex 1 and Annex MI- 007 Chapter IV OIML R 21 (2007) CommentsConclusion ANNEX 1 Allowable Errors Under rated operation conditions and in absence of a disturbance, the error of measurement shall not exceed the maximum permissible error (MPE) value as laid down in the appropriate instrument-specific requirements. Unless stated otherwise in the instrument- specific annexes, MPE is expressed as a bilateral value of the deviation from the true measurement value. 2.4.5.4 2.5.5 “Extreme values of an error permitted by specifications, regulations, etc, for a given instrument.” “Conditions of use (e.g. reference conditions applicable in the IEC Standard) giving the range of values of the influence factors, for which the errors (of indication) of the EUT are required to be within the maximum permissible errors.” Covered

20. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 Harmonised standards to provide conformity with essential requirements of MID and to enable conformity to be assessed JO 2007/C162 of 14 July 2007 (gas meters, heat meters, water meters) JO 2008 /C47 of 20 February 2008 (electricity metering equipment)

21. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 WELMEC guides on NAWI and MID are useful tool for: -manufacturers of measuring instruments -notified bodies responsible for conformity assessment -member state for the designation of notified bodies -market surveillance presenting no additional technical requirements beyond EC Directives and harmonised best practice solutions

22. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 54 guides available free of charge on : www.welmec.org 37 for implementation of MID (directly or indirectly) WG 2 : technical aspects on modular approach, guide on AWI’s WG 4 : guide on decision in legal metrology (uncertainty) WG 5 : market surveillance guide WG 7 : software guides WG 8 : application of modules, (coresponding tables OIML/MID) WG 10 : type examination of a family of meters, conversion devices, marking of fuel dispensers, testing of calculators WG 11 : utility meters

23. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 THE MODULES IN MID A, A1 INTERNAL PRODUCTION B, EC TYPE EXAMINATION C, C1 CONFORMITY TO TYPE D, D1 PRODUCTION QUALITY ASSURANCE E, E1 PRODUCT QUALITY ASSURANCE F, F1 PRODUCT VERIFICATION G UNIT VERIFICATION H, H1 FULL QUALITY ASSURANCE

24. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010

25. MI (if requested by notified body)Technical documentation Manufacturer Notified body Review of demand Technical and administrative examination Testing or recognition of test reports Examination of test report Decision making procedure Certification or notification of the refusal EC TYPE EXAMINATION

26. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 EC TYPE EXAMINATION – the methods: (a) examination of a specimen, representative of the production envisaged, of the complete measuring instrument; (b) examination of specimens, representative of the production envisaged, of one or more critical parts of the measuring instrument, plus assessment of the adequacy of the technical design of the other parts of the measuring instrument through examination of the technical documentation and supporting evidence referred to in paragraph 3; (c) assessment of the adequacy of the technical design of the measuring instrument through examination of the technical documentation and supporting evidence referred to in paragraph 3, without examination of a specimen

27. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 QS: EN ISO/IEC 17021 DEC: EN 45011 EN ISO/IEC 17021 EN 45011 or EN ISO/IEC 17020 or EN 45011 EN ISO/IEC 17020 or EN 45011 EN ISO/IEC 17021 EN ISO/IEC 17020 or EN 45011 No NB EN 45011 EN ISO/IEC 17020 or EN 45011 No NB QS of Notified Bodies according to EN ISO 9001 + EN ISO/IEC 17025 for tests H1 EN ISO 9001 + EN ISO/IEC 17025 for testsH Not applicableG F1 Not applicableF EN ISO 9001 + EN ISO/IEC 17025 for testsE1 EN ISO 9001 + EN ISO/IEC 17025 for testsE D1 EN ISO 9001 + EN ISO/IEC 17025 for testsD Not applicableC1 Not applicableC B A1 Not applicable A QS of Manufacturer according to MODULE

28. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 Types of notified bodies Certification bodies for products Certification bodies for quality systems Testing laboratories Inspection bodies Relevant standard EN 45011EN ISO/IEC 17021EN ISO/IEC 17025EN ISO/IEC 17020 ModulesB, G, H1D, D1, E, E1, H, H1F, F1B, F, F1, G, H1

29. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 Conformity marking The “CE” marking Supplementary metrology marking Identification number of notified body

30. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 Article 12 MID WELMEC Guide Member State Surveillance EA Notification National Accreditation Body Assessment Notified Body

31. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 Notified Bodies Information System The information on notified bodies which have been designated per Directive by Member States, EFTA countries and other countries with which the EC has concluded MRAs and PECAs can be searched on the NANDO web site http://ec.europa.eu/enterprise/newapproach/nando/ The information includes: the identification number of each notified body the tasks for which the notification has been made

32. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 Number of Notified Bodies by States

33. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 Information exchange EC type examination and design examination certificates and their annexes issued by notified bodies Quality system approvals issued by notified bodies Evaluation reports established by notified bodies, when demanded by other authorities

34. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 MID Certificates – Links to National Databases

35. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 Article 25 of MID Revision clause The European Parliament and the Council invite the Commission to report, before 30 April 2011, on the implementation of this Directive, inter alia, on the basis of reports provided by Member States, and, where appropriate, to submit a proposal for amendments The European Parliament and the Council invite the Commission to evaluate whether conformity assessment procedure for industrial products are properly applied and, where appropriate, to propose amendments in order to ensure consistent certification

36. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 Main features Commission Directive 2009/137/EC of 10 November 2009 amending Directive 2004/22/EC in respect of exploitation of the maximum permissible errors, as regards the instrument-specific annexes MI-001 to MI-005 The corrupt exploit of МРЕ's could be used in case of most measuring instruments subject to MID The requirement that the instrument shall not exploit the MPEs or systematically favour any party is not the specific, but more essential requirement of MID

37. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 Main features All four annexes (MI 001 – MI 004) related to utility meters apply to … meters intended for residential, commercial and light industrial use The reason why light industry is singled out from other branches of industry is still unclear. In future a clear demarcation should be given or the restriction should be removed. There is also no definition of residential or commercial use

38. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 Main features Include: cold meters, combined heat-cold meters and meters to measure solar heat, summarised as ‘meters for thermal energy of heat exchange’ automatic road weighbridges as they are already covered by national regulations. The result will be less cost for manufacturers to obtain approvals and free circulation of instruments length measuring instruments not yet covered by MID (electronic length measuring instrument, road measuring wheels) The result will be less cost for manufacturers to obtain approvals and free circulation of instruments

39. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 Main features Include requirements for additional metrologicaly relevant functions from the area of smart metering, e.g. load profile, clock function, calendar function It seems sensible to include requirements for additional functions so that utility meters do not have to meet further (differing) national requirements in addition to the requirements of the MID The only areas that should be included are those which are necessary to monitoring of the bill in terms of the measured values to be shown on the bill (Annex I 10.5)

40. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 Main features Add requirements on the sealing, similar to those for the CE marking (non transferability) to prevent fraud on the sealing

41. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 Main features Modification of the exhaust gas analyser (MI-010) need to be considered From the definition of an exhaust gas analyser in MID, the instrument has to have 4 channels for the 4 components mentioned - there is a need for gas analysers with less than 4 channels

42. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 Main features Need for the request to draw detailed table of correspondence for harmonised standard (similar to normative document) We should have similar treatment between harmonised standard and normative document concerning the presentation of the correspondence between essential requirements and the standard requirements Result Clearer information about presumption of conformity for manufacturers and notified body Better implementation of MID.

43. Seminar ”Metrology & Conformity Assessment”, Brussels, 1 -2 March 2010 Thank you for your kind attention e-mail: welmec.mirs@gov.si