1. CE Marking and CE Technical Map

2. New Approach Directive Product complies with all applicable NAD (and EN standards), there are no additional requirements in any member state. The product has free access to the internal market of EC. Conformity assessment procedures

3. Flow chart of conformity assessment procedures in EMC directive

4. Flow chart of conformity assessment procedures in Machinery directive

5. List of standards

6. Nbjb Technical documentation 1(7) New Approach directives oblige the manufacturer to draw up technical documentation containing information to demonstrate the conformity of the product to the applicable requirements. This documentation may be part of the quality system documentation where the directive provides for a conformity assessment procedure based on a quality system. This obligation begins when the product is placed on the market, whatever its geographical origin is.New Approach directives oblige the manufacturer to draw up technical documentation containing information to demonstrate the conformity of the product to the applicable requirements. This documentation may be part of the quality system documentation where the directive provides for a conformity assessment procedure based on a quality system. This obligation begins when the product is placed on the market, whatever its geographical origin is. The technical documentation must be kept for at least 10 years from the last date of manufacture of the product, unless the directive expressly provides for any other duration. This is the responsibility of the manufacturer or the authorised representative established within the Community.The technical documentation must be kept for at least 10 years from the last date of manufacture of the product, unless the directive expressly provides for any other duration. This is the responsibility of the manufacturer or the authorised representative established within the Community.

7. Technical documentation 2(7) In some cases the importer or the person placing the product on the Community market must take on this responsibility to prepare the technical documentation.In some cases the importer or the person placing the product on the Community market must take on this responsibility to prepare the technical documentation. As a rule, the documentation should cover the design, manufacture and operation of the product. 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 or, if the harmonised standards have been applied, to these instead by indicating the essential requirements covered by the standards.As a rule, the documentation should cover the design, manufacture and operation of the product. 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 or, if the harmonised standards have been applied, to these instead by indicating the essential requirements covered by the standards.

8. Technical documentation 3(7) The contents of the technical documentation are laid down, directive by directive, in accordance with the products concerned.The contents of the technical documentation are laid down, directive by directive, in accordance with the products concerned. Several directives require that the technical documentation is written in an official language of the Member State where the procedures are to be carried out, or in which the notified body is established, or in a language accepted by it. In order to carry out the conformity assessment procedures requiring third-party verification in a proper way, the documentation should always be in a language understood by the notified body, even if this has not been explicitly mentioned in all New Approach directives.Several directives require that the technical documentation is written in an official language of the Member State where the procedures are to be carried out, or in which the notified body is established, or in a language accepted by it. In order to carry out the conformity assessment procedures requiring third-party verification in a proper way, the documentation should always be in a language understood by the notified body, even if this has not been explicitly mentioned in all New Approach directives.

9. Technical documentation 4(7) Technical documentation includes: Technical information about product: general description of product, schematic diagrams, list of components and sub- assemblies, functional description, intended purpose, environmental conditions, constructional calculations, necessary explanations to understand said, risk analysis, production details;Technical information about product: general description of product, schematic diagrams, list of components and sub- assemblies, functional description, intended purpose, environmental conditions, constructional calculations, necessary explanations to understand said, risk analysis, production details; User and installation manual; a special attention shall be given to safe use and dangerous situations which may occur during the normal and abnormal use of product; photos;User and installation manual; a special attention shall be given to safe use and dangerous situations which may occur during the normal and abnormal use of product; photos; Certificates and test reports regarding the conformity of the product;Certificates and test reports regarding the conformity of the product; Manufacturer’s EC Declaration of Conformity.Manufacturer’s EC Declaration of Conformity.

10. Technical documentation 5(7) Volume of TCF depends on: Product itself and it’s complexity;Product itself and it’s complexity; Requirements of directives involved;Requirements of directives involved; Safety and un-safety regarding the use of product;Safety and un-safety regarding the use of product; Conformity assessment procedure (modules).Conformity assessment procedure (modules).

11. Technical documentation 6(7) Language in the TCF: Use of schematic diagrams, photos, drawings, etc. – as much as possible;Use of schematic diagrams, photos, drawings, etc. – as much as possible; Use of standard technical terms (from standards, professional literature, …);Use of standard technical terms (from standards, professional literature, …); In the TCF we can use one of the official languages of EC;In the TCF we can use one of the official languages of EC; User manual must be in all national languages where the product will put on the market;User manual must be in all national languages where the product will put on the market; TCF – represent the product and our self as manufacturer.TCF – represent the product and our self as manufacturer.

12. Technical documentation 7(7) Design of new productRequirements Directives Standards Adjust product to the requirements Preparation of TCF Assessment of conformity Reports TCF and CE DoC TCF EC DoC CE

13. Risk Management 1(11) Key terms:  Risk: Combination of the probability of occurrence of harm and the severity of that harm.  Harm: physical injury or damage to the health of people, or damage to property or the environment.  Hazard: potential source of harm.  Severity: measure of the possible consequences of a hazard.

14. Risk Management 2(11) Risk analysis (RA) forms a part of Risk Management (RM) Risk management Riskanalysis Risk management upgrades the Risk analysis with: - evaluation - decisions about acceptability - mitigation measures (definition, implementation, verification) - post market surveillance - continuous process

15. Risk Management 3(11) Risk analysis Intended use / intended purpose Hazard identification Risk estimation Risk evaluation Risk acceptability decisions Risk control Option analysis Implementation Residual risk evaluation Overall risk acceptance Post-production information Post production data Post production experience Review of risk management experience Risk Assessment Risk management… process!

16. Risk Management 4(11) The legal person … establish and maintain a process for: Identifying hazardsIdentifying hazards Estimating and evaluating risksEstimating and evaluating risks Controlling these risksControlling these risks Monitoring the effectiveness of controlMonitoring the effectiveness of control RM is documented process and includes: Risk analysisRisk analysis Risk evaluationRisk evaluation Risk controlRisk control Post-production informationPost-production information If a documented design/development process exists, the appropriate parts of the RM are incorporated. Legal person: Legislator,Legislator, Standardization Body,Standardization Body, Manufacturer,..Manufacturer,..

17. Risk Management 5(11) Hazard is the result of a causal chain. By convention it is defined at the first point in the causal chain at which somebody (something) is affected. How to find hazards: - -Standards - -Similar products’ or cases’ analysis - -Experience: design engineer, user, sales people - -Brainstorming - -Incident reports and analysis - -Sales statistics, complaints - -Risk mitigations for similar products

18. Risk Management 6(11) Step 1: Intended use / intended purpose, identification of characteristics related to the safety Step 2: Identify known or foreseeable hazards Step 3: Estimation of the risk(s) for each hazard Risk analysis Step 4: Is risk reduction necessary? Risk evaluation Step 5: Option analysis, risk control measures and requirements; Is the risk reducible? Step 6: Implementation of risk control measures Step 7: Residual risk evaluation; Is residual risk acceptable? Step 8: Risk / benefit analysis Step 9: Are other hazards generated? Identification Step 10: Completeness; Are all identified hazards considered? Risk control

19. Risk Management 7(11) Step 11: Overall residual risk evaluation Overall residual risk evaluation Step 12: Complete risk management report Step 13: Review of post-production information Is reassessment of risk(s) necessary? Post-production information

20. Risk Management 8(11) likelihood severity frequent probable occasional remote improbable incredible negligiblemarginalcriticalcatastrophic intolerable region (N/ACC) ALARP region Broadly acceptable region (ACC) Risk evaluation – graph

21. Risk Management 9(11) Risk evaluation – table / matrix severity 1 negligible2 marginal3 critical4 catastrophic 6 frequentN/ACC 5 probableN/ACC 4 occasionalN/ACC 3 remoteACCN/ACC 2 improbableACC 1 incredibleACC probability N/ACC … not acceptable region ACC … broadly acceptable in between … Risk “As Low As Reasonably Practicable” (ALARP)

22. Risk Management 10(11) Likelihood Frequent6 probable5 occasional4 remote3 improbable2 incredible1 severity catastrophic4 critical3 marginal2 negligible1 severity 1234 6N/ACC 5 4 3ALARP 2 1ACC likelihood Decision table Risk evaluation – assigned categories

23. Risk Management 11(11) Standards which address Risk Analysis – Management: EN 1050: Safety of machinery – Principles for risk assessment;EN 1050: Safety of machinery – Principles for risk assessment; EN ISO 14971: Risk management – medical devicesEN ISO 14971: Risk management – medical devices ISO/IEC Guide 73: Risk management – vocabularyISO/IEC Guide 73: Risk management – vocabulary ISO 14121: Principles of risk assessment – machineryISO 14121: Principles of risk assessment – machinery ISO 14798: Risk assessment – lifts, escalatorsISO 14798: Risk assessment – lifts, escalators ISO/IEC 16085: Risk management – softwareISO/IEC 16085: Risk management – software ISO/TS 16732: Risk assessment – fire safetyISO/TS 16732: Risk assessment – fire safety

24. EC Declaration of Conformity 1(2) The manufacturer or the authorised representative established within the Community must draw up an EC declaration of conformity as part of the conformity assessment procedure provided for in the New Approach directives.The manufacturer or the authorised representative established within the Community must draw up an EC declaration of conformity as part of the conformity assessment procedure provided for in the New Approach directives. The EC declaration of conformity should contain all relevant information to identify the directives according to which it is issued, as well as the manufacturer, the authorised representative, the notified body if applicable, the product, and where appropriate a reference to harmonised standards or other normative documents.The EC declaration of conformity should contain all relevant information to identify the directives according to which it is issued, as well as the manufacturer, the authorised representative, the notified body if applicable, the product, and where appropriate a reference to harmonised standards or other normative documents.

25. EC Declaration of Conformity 2(2) As a minimum the following information should be provided: the name and address of the manufacturer or the authorised representative issuing the declaration;the name and address of the manufacturer or the authorised representative issuing the declaration; the identification of the product (name, type or model number, and any relevant supplementary information, such as lot, batch or serial number, sources and numbers of items);the identification of the product (name, type or model number, and any relevant supplementary information, such as lot, batch or serial number, sources and numbers of items); data about documents according which conformity is declared: directives, harmonized standards or other documents in a precise, complete and clearly defined way;data about documents according which conformity is declared: directives, harmonized standards or other documents in a precise, complete and clearly defined way; all supplementary information that may be required (for example grade, category), if applicable;all supplementary information that may be required (for example grade, category), if applicable; name of Notified Body which performed conformity assessment procedures, if applicable:name of Notified Body which performed conformity assessment procedures, if applicable: the date of issue of the declaration;the date of issue of the declaration; signature and title or an equivalent marking of authorised person;signature and title or an equivalent marking of authorised person; the statement that the declaration is issued under the sole responsibility of the manufacturer and, if applicable, the authorised representative.the statement that the declaration is issued under the sole responsibility of the manufacturer and, if applicable, the authorised representative. the last two digits of the year in which the CE marking was affixed (in the case of LVD Directive).the last two digits of the year in which the CE marking was affixed (in the case of LVD Directive).

26. Principles of CE marking The CE marking symbolises the conformity of the product with the applicable Community requirements imposed on the manufacturer. The CE marking affixed to products is a declaration by the person responsible that: * the product conforms to all applicable Community provisions, and * the appropriate conformity assessment procedures have been completed.

27. Products to be CE marked The CE marking is mandatory and must be affixed before any product subject to it is placed on the market and put into service, save where specific directives require otherwise. Where products are subject to several directives, which all provide for the affixing of the CE marking, the marking indicates that the products are presumed to conform to the provisions of all these directives. A product may not be CE marked, unless it is covered by a directive providing for its affixing

28. Affixing of the CE marking The CE marking must be affixed by the manufacturer, or by the authorised representative established within the Community. The CE marking must take the proper form. If the CE marking is reduced or enlarged the proportions must be respected. The CE marking must be affixed visibly, legibly and indelibly to the product or to its data plate. 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. Where a notified body is involved in the production control phase according to the applicable directives, its identification number must follow the CE marking. The manufacturer or the authorised representative established in the Community affixes the identification number, under the responsibility of the notified body.

29. CE marking and other marks CE marking is the only marking which symbolises conformity to all the obligations incumbent on manufacturers for the product as required by the applicable directives providing for its affixing. Member States shall refrain from introducing any reference to another conformity marking into their national regulations, which would signify conformity with objectives that relate to the CE marking. A product may bear additional markings and marks, provided that they: * fulfil a different function from that of the CE marking, * are not liable to cause confusion with it, and * do not reduce its legibility and visibility.

30. CE marking The CE conformity marking shall consist of the initials ‘CE' taking the following form: If the CE marking is reduced or enlarged the proportions given in the above graduated drawing must be respected. The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm.

31. CE marking The CE marking is like an ice berg. Over the sea we can find CE marking, Declaration of Conformity, user manuals, etc. Bellow the sea all other more complicated and extensive procedures (they need more knowledge, time, resources,..) are hidden: risk assessment, conformity assessment procedures, technical file, special conditions of product use, responsibilities, ….

32. Literature Notranji trg Evropske unije in oznaka CE, dr. Saša Prešern, 2002, ISBN 961-6443-02-XNotranji trg Evropske unije in oznaka CE, dr. Saša Prešern, 2002, ISBN 961-6443-02-X Guide to the implementation of directives based on the New Approach and the Global Approach, Eropean Commission, 2000, ISBN 92-828-700-8Guide to the implementation of directives based on the New Approach and the Global Approach, Eropean Commission, 2000, ISBN 92-828-700-8 The New Approach, Legislation and Standards on the Free Movement of Goods in Europe, CEN CENELEC, 1997, ISBN 2-92-930092-01-7The New Approach, Legislation and Standards on the Free Movement of Goods in Europe, CEN CENELEC, 1997, ISBN 2-92-930092-01-7

33. Technical legislation in EU and Risk Management THANK YOU FOR YOUR ATTENTION! Your questions: E-mail: milan.brezovnik@amis.net milan.brezovnik@amis.net