CE MarkingCE Marking andandCE Technical MapCE Technical Map

New Approach DirectiveNew Approach Directive

Product complies with all applicable NADProduct complies with all applicable NAD (and EN (and EN standards), there are no additional requirements in any standards), there are no additional requirements in any

member state. The product has free access to the internal member state. The product has free access to the internal market of EC.market of EC.

Conformity assessment proceduresConformity assessment procedures

Flow chart of conformity assessment Flow chart of conformity assessment proceduresprocedures in EMC in EMC directivedirective

MANUFACTURER

Other than radio transmitters

Type of product

Radio transmitters

Aplication of harmonised standards

Full application

Self certificationMODULE A

EC Declaration of conformityby manufacturer

Non-application or partial application of harminised standards

Technical construction file by

manufacturer

Technical report or certificate by a

competent body

EC type examinationMODULE B

EC declaration of conformity with type

approvedMODULE C

Flow chart of conformity assessment Flow chart of conformity assessment proceduresprocedures in in Machinery Machinery directivedirective

MANUFACTURER

Type of machines and

safety components(Annex IV)

Not reffered to in Annex IV

Technical construction file (Annex V)

EC declaration of conformity with essential requirements

MODULE A

Reffered to in Annex IV,without meeting or only

partly meeting the standards, or if such

standards does not exist

EC type examination(Annex VI)MODULE B

Reffered to in Annex IV,

and complying with standards

Typeof machines and

safety components(Annex IV)

Technical file (Annex VI)sent to Notified Body

Technical file (Annex VI)submitted to NB for

certification of adequacyfor the file

EC type examination(Annex VI)MODULE B

EC declaration of conformity covered by the EC type

examinationMODULE A

Safety componentdo not bear CE

marking

List of standardsList of standards

Nbjb Technical documentation 1(Nbjb Technical documentation 1(77))• New Approach directives oblige the manufacturer to drawNew Approach directives oblige the manufacturer to draw

up technical documentation containing information toup technical documentation containing information to demonstrate the conformity of the product to the applicabledemonstrate the conformity of the product to the applicable requirements. This documentation may be part of the qualityrequirements. This documentation may be part of the quality system documentation where the directive provides for asystem documentation where the directive provides for a conformity assessment procedure based on a quality conformity assessment procedure based on a quality system. This obligationsystem. This obligation begins when the product is placed begins when the product is placed on the market, whateveron the market, whatever its geographical origin is.its geographical origin is.

• The technical documentation must be kept for at leastThe technical documentation must be kept for at least 10 10 years from the last date of manufacture of the product,years from the last date of manufacture of the product, unless the directive expressly provides for any other unless the directive expressly provides for any other duration. This is the responsibility of the manufacturer or theduration. This is the responsibility of the manufacturer or the authorised representative established within the authorised representative established within the Community.Community.

Technical documentation Technical documentation 22((77))• In some cases the importer or the person placing the In some cases the importer or the person placing the

product on the Community market must take on this product on the Community market must take on this responsibility to prepare the technical documentation.responsibility to prepare the technical documentation.

• As a rule, the documentation should cover the design, As a rule, the documentation should cover the design, manufacture and operation of the product. The details manufacture and operation of the product. The details included in the documentation depend on the nature of included in the documentation depend on the nature of the product and on what is considered as necessary, from the product and on what is considered as necessary, from the technical point of view, for demonstrating the the technical point of view, for demonstrating the conformity of the product to the essential requirements of conformity of the product to the essential requirements of the relevant directive or, if the harmonised standards the relevant directive or, if the harmonised standards have been applied, to these instead by indicating the have been applied, to these instead by indicating the essential requirements covered by the standards.essential requirements covered by the standards.

Technical documentation Technical documentation 33((77))

• The contents of the technical documentationThe contents of the technical documentation are laid are laid down, directive by directive,down, directive by directive, in accordance with the in accordance with the products concerned. products concerned.

• Several directives require that the technical Several directives require that the technical documentationdocumentation is written in an official language of the is written in an official language of the Member StateMember State where the procedures are to be carried where the procedures are to be carried out, or in which theout, or in which the notified body is established, or in a notified body is established, or in a language accepted bylanguage accepted by it. In order to carry out the it. In order to carry out the conformity assessment proceduresconformity assessment procedures requiring third-party requiring third-party verification in a proper way, theverification in a proper way, the documentation should documentation should always be in a language understoodalways be in a language understood by the notified body, by the notified body, even if this has not been explicitly mentionedeven if this has not been explicitly mentioned in all New in all New Approach directives.Approach directives.

Technical documentation 4(Technical documentation 4(77))Technical documentation includes:Technical documentation includes:• Technical information about product: general description of Technical information about product: general description of

product, schematic diagrams, list of components and sub-product, schematic diagrams, list of components and sub-assemblies, functional description, intended purpose, assemblies, functional description, intended purpose, environmental conditions, constructional calculations, environmental conditions, constructional calculations, necessary explanations to understand said, risk analysis, necessary explanations to understand said, risk analysis, production details;production details;

• User and installation manual; a special attention shall be User and installation manual; a special attention shall be given to safe use and dangerous situations which may given to safe use and dangerous situations which may occur during the normal and abnormal use of product; occur during the normal and abnormal use of product; photos;photos;

• Certificates and test reports regarding the conformity of the Certificates and test reports regarding the conformity of the product;product;

• Manufacturer’s EC Declaration of Conformity.Manufacturer’s EC Declaration of Conformity.

Technical documentation Technical documentation 55((77))

Volume of TCF depends on: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).

Technical documentation Technical documentation 66((77))

Language in the TCF:Language in the TCF:

• Use of schematic diagrams, photos, drawings, etc. – as Use of schematic diagrams, photos, drawings, etc. – as much as possible;much as possible;

• Use of standard technical terms (from standards, Use of standard technical terms (from standards, professional literature, …);professional literature, …);

• In the TCF we can use one of the official languages of In the TCF we can use one of the official languages of EC;EC;

• User manual must be in all national languages where the User manual must be in all national languages where the product will put on the market;product will put on the market;

• TCF – represent the product and our self as manufacturer TCF – represent the product and our self as manufacturer ..

Technical documentation Technical documentation 77((77))

Design of newDesign of new productproduct

RequirementsRequirements

Directives

Standards

Adjust product to Adjust product to the requirementsthe requirements

Preparation of TCF

AssessmentAssessmentof conformityof conformity

Reports

TCF andTCF andCE DoCCE DoC

TCF EC

DoC

CE

Risk Management 1(11)Risk Management 1(11)

Key terms:Key terms:

RiskRisk: Combination of the : Combination of the probabilityprobability of occurrence of occurrence of harm and the of harm and the severityseverity of that harm. of that harm.

HarmHarm: physical injury or damage to the health of : physical injury or damage to the health of people, or damage to property or the environment.people, or damage to property or the environment.

HazardHazard: potential source of harm.: potential source of harm.

SeveritySeverity: measure of the possible consequences : measure of the possible consequences of a hazard.of a hazard.

Risk Management Risk Management 22(11)(11)

Risk analysis (RA) forms a part of Risk Management (RM) Risk analysis (RA) forms a part of Risk Management (RM)

Risk managementRisk management

Risk Risk analysisanalysis Risk management upgrades the Risk management upgrades the

Risk analysis with:Risk analysis with:- evaluation- evaluation- decisions about acceptabilitydecisions about acceptability- mitigation measures (definition,mitigation measures (definition,

implementation, verification) implementation, verification)- post market surveillancepost market surveillance- continuous processcontinuous process

Risk Management Risk Management 33(11)(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 AssessmentRisk Assessment

Risk management… process!Risk management… process!

Risk Management Risk Management 44(11)(11)The legal person … establish and maintain a process for: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: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, If a documented design/development process exists, the appropriate parts of the RM are incorporatedthe appropriate parts of the RM are incorporated..

Legal person:Legal person:• LegislatorLegislator,,• Standardization Standardization

BodyBody,,• Manufacturer, ..Manufacturer, ..

Risk Management Risk Management 55(11)(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

Risk Management Risk Management 66(11)(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

RiskRiskanalysisanalysis

Step 4: Is risk reduction necessary? Risk Risk evaluationevaluation

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 Risk controlcontrol

Risk Management Risk Management 77(11)(11)

Step 11: Overall residual risk evaluation Overall residual Overall residual risk evaluationrisk evaluation

Step 12: Complete risk management report

Step 13: Review of post-production informationIs reassessment of risk(s) necessary?

Post-production Post-production informationinformation

Risk Management Risk Management 88(11)(11)

likelihood

severity

frequent

probable

occasional

remote

improbable

incredible

negligible marginal critical catastrophic

intolerable region (N/ACC)

ALARPregion

Broadly acceptable

region (ACC)

Risk evaluation – graphRisk evaluation – graph

Risk Management 9(11)Risk Management 9(11)

Risk evaluation – table / matrixRisk evaluation – table / matrix

severity

1 negligible 2 marginal 3 critical 4 catastrophic

6 frequent N/ACC N/ACC N/ACC

5 probable N/ACC N/ACC

4 occasional N/ACC N/ACC

3 remote ACC N/ACC

2 improbable ACC ACC

1 incredible ACC ACC ACC ACC

probability

N/ACC … N/ACC … not acceptable regionnot acceptable regionACC … ACC … broadly acceptablebroadly acceptablein between … in between … Risk “As Low As Reasonably Practicable” (ALARP)Risk “As Low As Reasonably Practicable” (ALARP)

Risk Management Risk Management 1010(11)(11)

Likelihood

Frequent 6probable 5occasional 4remote 3improbable 2incredible 1

severity

catastrophic 4critical 3marginal 2negligible 1

severityseverity

1 2 3 4

6 N/ACC

5

4

3 ALARP

2

1 ACC

like

lihoo

dlik

elih

ood

Decision tableDecision table

Risk evaluation – assigned categoriesRisk evaluation – assigned categories

Risk Management Risk Management 1111(11)(11)

Standards which address Risk Analysis – Management:Standards which address Risk Analysis – Management:• EN 1050: Safety of machinery – Principles for risk EN 1050: Safety of machinery – Principles for risk

assessment;assessment;• EN ISO 14971: Risk management – medical devicesEN ISO 14971: Risk management – medical devices• ISO/IEC Guide 73: Risk management ISO/IEC Guide 73: Risk management – – vocabularyvocabulary• 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

EC Declaration of ConformityEC Declaration of Conformity 1(2) 1(2)

• The manufacturer or the authorised representative The manufacturer or the authorised representative established within the Community must draw up an EC established within the Community must draw up an EC declaration of conformity as part of the conformity declaration of conformity as part of the conformity assessment procedure provided for in the New Approach assessment procedure provided for in the New Approach directives.directives.

• The EC declaration of conformity should contain all The EC declaration of conformity should contain all relevant information to identify the directives according to relevant information to identify the directives according to which it is issued, as well as the manufacturer, the which it is issued, as well as the manufacturer, the authorised representative, the notified body if applicable, authorised representative, the notified body if applicable, the product, and where appropriate a reference to the product, and where appropriate a reference to harmonised standards or other normative documents.harmonised standards or other normative documents.

EC Declaration of ConformityEC Declaration of Conformity 2(2) 2(2)As a minimum the following information should be provided:As a minimum the following information should be provided:

• the name and address of the manufacturer or the authorisedthe name and address of the manufacturer or the authorised representative issuing the declaration;representative issuing the declaration;

• the identification of the product (name, type or modelthe identification of the product (name, type or model number, and any relevant supplementary number, and any relevant supplementary information, suchinformation, such as lot, batch or serial number, sources and numbers ofas lot, batch or serial number, sources and numbers of items);items);

• data about documents according which conformity is declared: directives, harmonized standards or data about documents according which conformity is declared: directives, harmonized standards or other documentsother documents inin a precise, complete and clearly defined way;a precise, complete and clearly defined way;

• all supplementary information that may be required (forall supplementary information that may be required (for example grade, category), if applicable;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 authorisedsignature and title or an equivalent marking of authorised person;person;

• the statement that the declaration is issued under thethe statement that the declaration is issued under the sole responsibility of the manufacturer and, if sole responsibility of the manufacturer and, if applicable,applicable, the authorised representative.the authorised representative.

• tthe last two digits of the year in which the CE marking was affixedhe last two digits of the year in which the CE marking was affixed (in the case of LVD Directive) (in the case of LVD Directive)..

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.

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

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.

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.

CE CE markingmarking

The CE conformity marking shall consist of the initials ‘CE' The CE conformity marking shall consist of the initials ‘CE' taking the following form:taking the following form:

If the CE marking is reduced or enlarged the proportions If the CE marking is reduced or enlarged the proportions given in the above graduated drawing must be respected.given in the above graduated drawing must be respected.The various components of the CE marking must have The various components of the CE marking must have substantially the same vertical dimension, which may not be substantially the same vertical dimension, which may not be less than 5 mm.less than 5 mm.

CE markingCE marking

The CE marking is like an The CE marking is like an ice berg. Over the seice berg. Over the seaa we we can find CE marking, can find CE marking, Declaration of Conformity, Declaration of Conformity, user manuals, etc.user manuals, etc.

Bellow the sea all other more complicated and extensive Bellow the sea all other more complicated and extensive procedures (they need more knowledge, time, resources,..) procedures (they need more knowledge, time, resources,..) are hidden: risk assessment, conformity assessment are hidden: risk assessment, conformity assessment procedures, technical file, special conditions of product use, procedures, technical file, special conditions of product use, responsibilities, ….responsibilities, ….

LiteratureLiterature

• Notranji trg Evropske unije in oznaka CENotranji trg Evropske unije in oznaka CE, dr. Saša , dr. Saša Prešern, 2002, ISBN 961-6443-02-XPrešern, 2002, ISBN 961-6443-02-X

• Guide to the implementation of directives based on the Guide to the implementation of directives based on the New Approach and the Global ApproachNew Approach and the Global Approach, Eropean , Eropean Commission, 2000, ISBN 92-828-700-8Commission, 2000, ISBN 92-828-700-8

• The New Approach, Legislation and Standards on the The New Approach, Legislation and Standards on the Free Movement of Goods in EuropeFree Movement of Goods in Europe, CEN CENELEC, , CEN CENELEC, 1997, ISBN 2-92-930092-01-71997, ISBN 2-92-930092-01-7

Technical legislation in EU and Technical legislation in EU and Risk ManagementRisk Management

THANK YOU FOR YOUR ATTENTION!THANK YOU FOR YOUR ATTENTION!

Your questions:Your questions:

E-mail: E-mail: milan.brezovnik@amis.net