1. Standardisation, regulation, worldwide strategies 1 Modules of conformity assessment

2. Standardisation, regulation, worldwide strategies 2 Conformity Assessment modules and CE marking: The context  Free Movement of Goods is one of the pillars of the Single Market  It is confronted to Tariff and Non-Tariff Barriers  It requires a common regulatory framework  It requires adequate Certification & Testing infrastructures

3. Standardisation, regulation, worldwide strategies 3 Context  In case of Candidate countries, they should adopt the “Acquis Communautaire” in the field of free movement of goods  It includes:  The Old Approach Directives  The New Approach Directives  Directive 83/189/EEC, which is a tool, which prevent the adoption of national technical regulations and standards creating new Barriers to Trade  General Product Safety & Liability Directives ...

4. Standardisation, regulation, worldwide strategies 4 Non Harmonised Area  Old Approach  A product recognised and approved in one EC country should also be imported and sold in other EC countries without the need for any additional approval  Separate directive for each product  Creation of certification and authorisation structures  Mandatory pre-market control  Covers Food stuff, Pharmaceuticals, Chemicals, Cosmetics, Textile & Motor Vehicles

5. Standardisation, regulation, worldwide strategies 5 Harmonised Area (1)  New Approach Principles  Legislative harmonisation is limited to essential requirements that products placed on the Community market must meet, if they are to benefit from free movement within the Community  The technical specifications of products meeting the essential requirements set out in the directives will be laid down in harmonised standards

6. Standardisation, regulation, worldwide strategies 6 Harmonised Area (2)  New Approach Principles  Application of harmonised or other standards remains voluntary, and the manufacturer may always apply other technical specifications  Products manufactured in compliance with harmonised standards benefit from a presumption of conformity with the corresponding essential requirements  Supplier Declaration  Sampling post-market control

7. Standardisation, regulation, worldwide strategies 7 New Approach / Global Approach (1)  Every New Approach directive will use refer to determined modules in accordance with the level of possible risk  The Global approach provides 8 different modules (design and production phases) to perform conformity assessment

8. Standardisation, regulation, worldwide strategies 8 New Approach / Global Approach (2)  The Global Approach lays down the general guidelines and procedures (modules) for conformity assessment that are to be used in New Approach directives <= T & C follow the modules to perform CA

9. Standardisation, regulation, worldwide strategies 9 Conformity assessment procedures of the new approach : the modules B

10. Standardisation, regulation, worldwide strategies 10 Module A  Internal control of production  It covers the design and production phases. This module does not require the intervention of a notified body.

11. Standardisation, regulation, worldwide strategies 11 Module B  EC type-examination  It covers the design phase, and must be followed by a module providing for assessment in the production phase. A notified body issues the "EC type- examination" certificate

12. Standardisation, regulation, worldwide strategies 12 Module C  Conformity to type  It covers the production phase and follows module B. It provides for conformity with the type as described in the EC type- examination certificate issued according to module B. Module C dos not require the intervention of a notified body.

13. Standardisation, regulation, worldwide strategies 13 Module D  Production quality assurance  It covers the production phase and follows module B. It derives from the quality assurance standard EN ISO 9002, with the intervention of a notified body responsible for approving and controlling the quality system for production, final product inspection and testing set up by the manufacturer

14. Standardisation, regulation, worldwide strategies 14 Module E  Product quality assurance  It covers the production phase and follows module B. It derives from quality assurance standard EN ISO 9003, with the intervention of a notified body responsible for approving and controlling the quality system for production, final product inspection and testing set up by the manufacturer

15. Standardisation, regulation, worldwide strategies 15 Module F  Product verification  It covers the production phase and follows module B. A notified body controls conformity to the type as described in the EC type- examination certificate issued according to module B, and issues a certificate of conformity for the product

16. Standardisation, regulation, worldwide strategies 16 Module G  Unit verification  It covers the design and production phases. Each individual product is examined by a notified body, which issues a certificate of conformity

17. Standardisation, regulation, worldwide strategies 17 Module H  Full quality assurance  It covers the design and production phases. It derives from quality assurance standard EN ISO 9001, with the intervention of a notified body responsible for approving and controlling the quality system for design, manufacture, final product inspection and testing set up by the manufacturer.

18. Standardisation, regulation, worldwide strategies 18 Technical documentation  The manufacturer is always required to draw up a technical file (technical documentation).  The technical documentation provides information on the design and manufacturing phases of the product.  The contents of the technical documentation are laid down directive by directive in accordance with the products concerned.

19. Standardisation, regulation, worldwide strategies 19 Technical documentation  The details included in the documentation depend on the nature of the product and on what is considered as necessary, from the technical point of view, for demonstrating the conformity of the product to the essential requirements of the relevant directive.

20. Standardisation, regulation, worldwide strategies 20 Technical documentation  The following might be required to be included in technical documentation:  a general description of the product;  overall drawing of a product, design and manufacture drawings and diagrams of components, sub-assemblies, control circuits, etc., together with descriptions and explanations needed to understand those drawings and diagrams;  risk analysis and a description of methods adopted to eliminate hazards presented by the product;  the essential requirements of the applicable directives;

21. Standardisation, regulation, worldwide strategies 21 Technical documentation  a list of the standards used, in full or in part, and a description of the solutions employed to meet the essential requirements of applicable directives;  other technical specifications, which were used;  results of design calculations and of checks carried out, etc.;  test reports and/or certificates, which may be available, either by the manufacturer or a third party (depending on the requirements of the directives);  a copy of the instructions (for use, for maintenance, other instructions);

22. Standardisation, regulation, worldwide strategies 22 CE Marking  It indicates that a product has been designed and manufactured in conformity with essential requirements  CE marking is mandatory and must be affixed before the product is placed on the market

23. Standardisation, regulation, worldwide strategies 23 CE marking  The objective of New Approach directives is to ensure the free circulation throughout the EEA of products complying with the essential requirements after having been submitted to the relevant conformity assessment procedures. EEA  CE marking is the synthetic way to physically show on a given product that it is presumed to comply with the provisions of the relevant directives and, in most cases, that for it an EC declaration of conformity to the relevant essential requirements has been issued under the responsibility of a manufacturer or his representative

24. Standardisation, regulation, worldwide strategies 24 CE marking  Conformity to essential requirements is indicated physically by the apposition of the CE marking on the products.  The CE marking indicates that the product has been designed and manufactured in conformity with the essential requirements of all relevant directives, and submitted to the relevant conformity assessment procedure.  The CE marking is mandatory and must be affixed before any product subject to it is placed on the market.

25. Standardisation, regulation, worldwide strategies 25 What is the meaning of CE marking  The CE marking consists of a neutral mandatory marking addressed to all economic operators, industries, inspectors and public authorities responsible for the market surveillance. The CE marking gives no indication of which conformity assessment procedure has been followed by the manufacturer. All of them are considered equivalent and appropriate.

26. Standardisation, regulation, worldwide strategies 26 What is the meaning of CE marking  The CE marking is a conformity mark, meaning conformity with the essential requirements by the application of high level technical specifications for the protection of users, consumers and other parties involved. The CE marking is not a guarantee of only minimal safety standards or a border control pass intended for national authorities

27. Standardisation, regulation, worldwide strategies 27 CE marking and EC declaration of conformity  Any reference to elements, which might reintroduce national aspects, has been avoided.  The CE marking is not intended to serve commercial purposes and it is not a mark of origin.  But it could be used, when exporting products outside the EEA, as a signal of the compliance of products with EC provisions, meaning a high level of protection.

28. Standardisation, regulation, worldwide strategies 28 Other marks affixed together with the CE marking  New approach directives expressly forbid marks which might confuse purchasers by suggesting meanings similar to that of the CE marking.  Therefore, EEA States must forbid markings that may create confusion with the CE marking related to the graphics and/or the meaning of the CE marking itself.

29. Standardisation, regulation, worldwide strategies 29 Affixing the CE marking  The CE marking must be affixed visibly, legibly and indelibly to the product or to its data plate, depending on the directive.  However, where this is not possible or not warranted on account of the nature of the product, it must be affixed to the packaging, if any, and to the accompanying documents, where the directive concerned provides for such documents

30. Standardisation, regulation, worldwide strategies 30 Affixing the CE marking  MUST  When the product belongs to one or more New Approach directives.  When the product complies with the provisions of the applicable New Approach directives.  For products under manufacturer self- assessment, the CE marking is affixed on the product without third party intervention. When there is a third party intervention, the manufacturer will affix the CE marking as well. Only when the notified body participates in the control of the production phase, the manufacturer will affix the CE marking plus the number of the notified body

31. Standardisation, regulation, worldwide strategies 31 Affixing the CE marking  MUST NOT  When the product is not covered by a New Approach directive.  When the product does not comply with the provisions of the applicable New Approach directives.  Therefore, if the EEA State’s authorities find out that the CE marking has been wrongly affixed (i.e. wrong conformity assessment procedure, labelling problem...) the manufacturer or his authorised representative will be obliged to put an end to the infringement under conditions imposed by the member state.

32. Standardisation, regulation, worldwide strategies 32 Can other marks be affixed together with the CE marking  Yes, but  The voluntary marks may neither refer to specific certification schemes of conformity assessment (all considered equivalent) nor indicate that a harmonised standard has been used (only one of the means to comply with the essential requirements ).

33. Standardisation, regulation, worldwide strategies 33 Can other marks be affixed together with the CE marking  Yes, but  The use of an additional mark shall not imply a differentiation in levels of protection, because a product is deemed to be safe when it complies with the essential requirements of the relevant directives (safety/protection cannot be qualified).  Additional conformity marks can only be accepted as far as they are voluntary and do not interfere with the scope covered by the directives and do not create any confusion with the CE marking.

34. Standardisation, regulation, worldwide strategies 34 Can other marks be affixed together with the CE marking  Yes, but  Other marks should fulfil a different function from that of the CE marking.  Other marks should provide an added value in signifying conformity with objectives that are different from those to which the CE marking relates.

35. Standardisation, regulation, worldwide strategies 35 Can other marks be affixed together with the CE marking  Yes, but  Voluntary markings may not be used to certify compliance with aspects of security and safety already covered by the directives as well as the conformity assessment procedures foreseen therein.  The procedures leading to the additional marks shall be transparent and shall involve independent certification bodies. The requirements shall be well defined and open to all manufacturers. They should be based on well-defined technical specifications.

36. Standardisation, regulation, worldwide strategies 36 Supplier’s Declaration  The manufacturer, or his authorised representative established within the EEA is obliged to draw up an EC declaration of conformity before the product is placed on the market.

37. Standardisation, regulation, worldwide strategies 37 Declaration of conformity  The EC declaration of conformity is a document that ensure either  that the product satisfies the essential requirements of the applicable directives, OR that the product is in conformity with the type for which a type-examination certificate has been issued and satisfies the essential requirements of the applicable directives.

38. Standardisation, regulation, worldwide strategies 38  The manufacturer is always required to draw up a technical file (technical documentation).  The technical documentation provides information on the design and manufacturing phases of the product.  The contents of the technical documentation are laid down directive by directive in accordance with the products concerned.

39. Standardisation, regulation, worldwide strategies 39  The ‘EC declaration of conformity’ shall specify some elements, ranging from the manufacturer's address to the technical solutions applied.  This declaration is issued after completion of all relevant conformity assessment procedures and it, as a general rule, accompanies the product bearing the CE marking.

40. Standardisation, regulation, worldwide strategies 40  The manufacturer, or his authorised representative established within the EEA is obliged to draw up an EC declaration of conformity before the product is placed on the market.  A manufacturer established outside the EEA is entitled to carry out all the certification procedures at his premises and, therefore, to sign the declaration of conformity, unless otherwise provided for in the directive(s). It is not necessary for the signatory of the EC declaration of conformity to be domiciled in the EEA.

41. Standardisation, regulation, worldwide strategies 41 Market surveillance (1)  Actors:  The manufacturers  Custom officials  Market surveillance authorities  Courts

42. Standardisation, regulation, worldwide strategies 42 Market surveillance (2)  Conformity assessment takes place before the product is put on the market  Market surveillance takes place after the product is placed on the market

43. Standardisation, regulation, worldwide strategies 43 Agreements relating to CA  MRAs with third countries  PECA (Protocol on European Conformity Assessment)  Other Agreements