Our Future with MID

MID: The basic ideas and goals, history and present state. Christian Mengersen Physikalisch-Technische Bundesanstalt (PTB) Section Q.31 ÄLegal Metrology³

Mengersen: Malta A


The European Union Principal objectives of the Union are: Establish European citizenship p Fundamental rights; Freedom of movement; Civil and political rights; Ensure freedom, security and justice p Co-operation in the field of Justice and Home Affairs; Promote economic and social progress p Single market; Euro, the common currency; Job creation; Regional development; Environment protection; Assert Europe's role in the world p Common foreign and security; The European Union in the world.
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Mengersen: Malta A 3 . Directives have to be implemented in national legislation in accordance with the procedures of the individual Member States.MID MID = Measuring Instruments Directive = Directive 2004/22/EC of the European Parliament and of the Council of 31 March 2004 on Measuring Instruments Directives bind Member States to the objectives to be achieved within a certain time-limit while leaving the national authorities the choice of form and means to be used.

Legal Metrology in the European Union Intention: Legal metrological control should not lead to barriers to free movement of measuring instruments! Starting point: 15 Member States *) and ideas about Äfair trade³ and Äconsumer protection³ ³Old Approach´ EEC-Directives (11) ³New Approach´ EC-Directive (NAWI) WELMEC-Type approval agreements on the basis of 8 OIML-Recommendations *) 25 Members since 2004-05-01 Mengersen: Malta A 4 .

3 Applicant countries Austria el ium prus zec epublic enmark stonia German Greece Finlan France un ar Irelan Ital at ia it uania uxembour Malta olan ortu al Slo akia Slo enia Spain S e en T e et erlan s nite Kin om ( ul aria) ( omania) (Turke ) Men ersen: Malta A 5   .25 Member States.

Legal Metrology World Wide International Organisation of Legal Metrology (OIML) for Global harmonisation of legal metrology procedures ± 60 member states. 50 corresponding members ± about 130 specific OILM-Recommendations Mengersen: Malta A 6 .

5 Corresponding Organisations (COOMET. MID-Activities (Preparation phase): WG 8 Measuring Instruments Directive (WEMEC-Members.g. OIML. Observers... . Harmonisation of legal metrology activities. e. 12 Associate members. European Industrial Federations..). 7 Observer Organisations (European Commission.Legal Metrology in Europe WELMEC (European Co-operation in Legal Metrology): 18 Members (NMI¶s).) Aim: Establishment of a harmonised and consistent approach to European Legal Metrology. Instrument specific subgroups) Mengersen: Malta A 7 . APLMF.

capacity measure) MI-009 Dimensional Measuring Instruments MI-010 E haust as Analysers (formerly MI-010 Breath Analysers have been taken out) Mengersen: Malta A 8 .Concerned measuring instruments in the MID: MI-001 Water Meters MI-002 as Meters and Volume Conversion Devices MI-003 Active Electrical Energy Meters MI-004 Heat Meters (MI-001 to MI-004: for residential. commercial. light industrial use) MI-005 Measuring Systems for the Measurement of Quantities of Liquids other than Water MI-006 Automatic Weighing Instruments MI-007 Ta imeters MI-008 Material Measures (length.

but ± National metrology control should not lead to barriers to free movement of measuring instruments Optionality: Member States have the right to decide whether or not to regulate any of the instruments covered by the MID Preservation of the existing degree of protection: Adequate requirements for the measuring instruments are necessary Mengersen: Malta A 9 .Basic principles: National Legislation Subsidiarity: Regulations for these legally controlled instruments are limited until ³placing on the market´ and/or ³putting into use´ ± Member states remain responsible for their legal metrology control.

± demands presumption of conformity to the essential requirements. The MID is open for new technical developments Mengersen: Malta A 10 . ± allows any technical solution fulfilling the essential requirements of use. concerning only the practical use.Basic procedures: Instruments The New Approach ± limits Harmonisation to essential requirements without technical instructions. when EC-harmonised standards (CEN/ CENELEC) and EC-accepted normative documents (OIML) are the basis of the technical construction.

who is under the surveillance of a member state. subdividing the whole conformity assessment procedure into a number of modules ± opens the possibility to take into account the manufacturers internal design and production control activities ± allows a complete assessment until placing a measuring instrument on the market / putting into use ± provides a high level of confidence to the product MID: The conformity assessment procedures must be performed under the responsibility of a Notified Body.Basic procedures: Conformity Assessment The Global Approach ± is a modular approach. Mengersen: Malta A 11 .

Basic procedures: Surveillance Market surveillance: Member States shall take all measures to ensure that the MID-marked measuring instruments do comply with the MID. The Commission must be informed about the nature of the non compliance. Safeguard clause: Member States shall withdraw MID-marked instruments from the market and prohibit or restrict the use when these not fulfil the essential requirements. Member States shall assist each other in carrying out market surveillance. Market Surveillance may not have the effect as a barrier of trade! The Commission announced strong resistance if so! p Member States shall presume conformity for instruments with correct MID-markings! MIDMengersen: Malta A 12 .

) Mengersen: Malta A 13 .Basic procedures: Regulatory committees The Standing Committee is responsible when a harmonised standard does not fully meet the essential requirements of the MID.) The Measuring Instruments Committee is responsible in case of ± safeguard procedures ± regulatory procedures (Members are representatives of the Member States. (Members are representatives appointed by the Member States who may call on the assistance of e perts or advisers.

Sept. 2000 Discussion roups: W 8 (WELMEC) (with 11 subgroups) and since 2001 W ³Instruments´(Council) Dec. 2003 Adoption: 2004-03-31 Entry into force: 2004-04-30 (Reference: ³Blue Book´) Mengersen: Malta A 14 .

2006. 10 Years from 30 October 2006. Mengersen: Malta A 15 . 30 months after its publication in the Off. Transitional period for putting into use on the basis of e isting Type Approval Certificates (national/EEC): ma . Journal. independent of their national legal system! Member States shall apply these provisions from 30 Oct.The Entrance Ticket for the European Market Declaration of conformity with the essential requirements: M 06 0102 The declaration is valid in all member states.

H1) 6) Instrument specific essential requirements (Anne es MI-001 to MI-010) Mengersen: Malta A 16 . regulating the procedures: Definitions.Structure of the MID 1) Articles. implementation. regulations 2) Necessary technical documentation (New Article 10) 3) Criteria to be satisfied by bodies designated by the Member States (New Article 12) 4) Horizontal Essential Requirements (Anne I) 5) Conformity assessment procedures (Anne es A . obligations.

Resume: Keywords Essential Requirements Harmonised European Standards/Normative Documents Conformity Assessment Procedures Notified Bodies Market surveillance Safeguard clause Mengersen: Malta A 17 .

Essential requirements (Anne I. Suitability. Results of the W 8) Mengersen: Malta A 18 . Durability etc. ± Reaction on influence quantities and disturbances ± Protection against corruption (Hard. Anne es MI-001 to MI-010) ± Allowable Errors under rated operating conditions (MPE) ± Reproducibility.and Software) ± Information to accompany the instruments ± Indication of the result: (Metrologically controlled display for the consumer as the basis of the price to pay) The MID in the current state allows the member states to preserve their degree of protection (Basis: OIML recommendations.

in full or in part referenced in the C series of the Official Journal of the European Communities Where an instrument not complies with referenced standards or documents.g.European harmonised standards Presumption of conformity with the essential requirements in full or in part if the instrument complies with : ± ± Harmonised European Standard. Normative Documents. e.drawn up by OIML. the Notified Body is in charge that the instrument meets the provisions of the Directive 19 Mengersen: Malta A .

Simplified flow chart of conformity assessment procedures (Global Approach) 1 / Module H (³Blue Book´: www.org) Mengersen: Malta A 20 .newapproach.

Global Approach: Placing on the market Manufact. Design-Construction-Specimen-Production-Prod. design Unit verification M06 0102 Mengersen: Malta A 21 . Type + Techn. design Techn. design (Representative of the product) EC-type examination certificate Product verification: EC-type examination certificate QS production process QS final product test Full quality assurance + Design e amination Doc.control Mod B (a) Mod B (b) Mod B (c) Mod F Mod D Mod E Mod H1 Mod Type e am.: Techn.

Full quality assurance Mengersen: Malta A 22 .Essential Conformity Assessment Procedures Mod F Product verification Representative of the product Mod B Type e amination Manufacturer M 06 0102 Production quality assurance Manufacturer Prototype? Mod D Mod H1 Design e amination.

une pected visits. EN ISO 9001:2000) system provides a useful means of establishing compliance. ± The surveillance (first/periodic audits. product tests) is under the responsibility of the Notified Body. The responsibility of the Notified Body can not be delegated! Mengersen: Malta A 23 .g. ± A certified quality (e. the conformity module (D or H1) and the principles of legal metrology.Common features for Mod D and H1 ± Modules D and H1 do not require a certified quality system. ± The quality system must take into consideration the specific requirements of the product.

12) ± Impartiality. if its civil liability is not covered by the Member State under national law Member States are responsible for the designation and the surveillance of the NBµs! Mengersen: Malta A 24 . covering all conformity assessment tasks for which it is designated ± Professional secrecy with regard to all information obtained in the course of e ercising their duties ± Closing of a civil liability insurance.Demands on the Notified Bodies (NB) (Art. free from all pressures and inducements ± Highest degree of professional integrity and requisite competence in the field of metrology ± Ability to carry out all the tasks assigned to such bodies by the Anne for which it has been notified ± Sound technical and vocational training.

Duties of the member states ± Appointment of suitable Notified Bodies ± Supervision of the Notified Bodies ± Market surveillance to check that the affi ing and use of the CE + M marking is correct and to withdraw instruments with unduly fi ed marking (safeguard clause) ± Notification to the Commission and to the other Member States about the restriction of free movement of an instrument due to unduly fi ed CE + M markings ± Notification to the ³Measuring Instruments Committee´ concerning changes. ± Notification to the ³Standing Committee´ concerning new European harmonised standards Mengersen: Malta A 25 . new normative documents etc.

OIML) ± standardisation of the procedures (WELMEC.Summery: The MID ± removes barriers of trade for 10 types of instruments ± is open for new technical solutions ± offers European conformity assessment procedures ± considers the competence of the manufacturer But there is a need of support by ± technical standardisation (CEN/CENELEC. (OIML)) ± surveillance of correct use of the European procedures (Member States. European Commission) Mengersen: Malta A 26 .

Mengersen: Malta A 27 . Mutual recognition agreements between the Community and third countries can facilitate the conditions for the manufacturers of these countries.MID and the Global Market A manufacturer in a third country is responsible for the design and production of a measuring instrument in the same way as a manufacturer established in a Member State. The manufacturer or an authorised representative. He needs an authorised representative in the EU. The customs authorities check the formal correctness. the importer or the person responsible for placing the product on the Community market is responsible for the CE marking.

If there is any question about the EU or MID: Please use the open internet-EU-information system: WELMEC activities: http://www.eu.html OIML activities: http://www.cenelec.oiml.eu.int/ MID: http://europa.org CENELEC activities: http://www. New and Global Approach: http://europa.org Mengersen: Malta A 28 .welmec.org Entrance for all information of the EU: http://europa.int/ eur-lex/pri/en/oj/dat/2004/l_135/l_13520040430en00010080.pdf Single Market.int/ comm/enterprise/library/lib-regulation/libr-regulation.eu. Regulation.

lobal Thank You ! Mengersen: Malta A 29 .Our Future with MID: The MID offers new Conformity Assessment Procedures. especially applicable for electronic and software controlled measuring instruments The MID will remove barriers to free movement of measuring instruments which are under legal control inside the European Union. The European Union will be strong Partner in the Market for measuring instruments.