CE marking & your legal obligations - TUV SUD

1 T V Product Service Ltd1CE marking & your legal obligationsThis presentation is intended to provide a practical approach guide to what you need to know about the CE marking requirements for electrical and electronic equipment placed on the European MarketCE marking & your legal obligationsPresented by Richard PoateCompliance Services Manager, T V Product Service _____ _____ _____ _____ _____ T V Product Service LtdWho Am I?NameRichardPoateTitle:ComplianceServic es ManagerEmployer:T VProduct Service LtdExperience:16 years experience in productcomplianceTelephone:01489 _____ _____ _____ _____ _____ T V Product Service LtdContentsCE marking and your legal obligations What is CE marking ? What are EU Directives? What is Due diligence? How is CE marking enforced?

2 Declaration of Conformity What is a Technical file?Overview of the LV, EMC and RTTE Directives How to identify which Directives apply Harmonised standards Presumption of conformity Placing products on the marketTechnical documentation required to demonstrate compliance Technical file contents Technical file format _____ _____ _____ _____ _____ T V Product Service LtdWhat is CE marking ? _____ _____ _____ _____ _____ T V Product Service LtdWhat is CE marking ?CE marking = Confusion Everywhere ??? Chinese Export ???CE marking is a declaration by the manufacturer or responsible body that the product(s) meets the requirements of the applicable European Directive(s). _____ _____ _____ _____ T V Product Service LtdWhat is CE marking ?CE marking =Guaranteed no hangover?

3 Guaranteed to get drunk?Guaranteed good quality beer _____ _____ _____ _____ T V Product Service LtdWhat is CE marking ? Enables free movement of goods around EU member States (some non EU countries have adopted CE marking procedures) Places responsibility with the manufacturer or importer of goods; whoever places the equipment on the market Relates to EU Directives (European Law) Primarily self certification Not evidence of compliance in itself _____ _____ _____ _____ _____ T V Product Service LtdCE Conformity MarkingThe CE 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 respectedThe various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5mm _____ _____ _____ _____ T V Product Service LtdCE marking = Quality?

4 Consumers and retailers may associate CE marking with quality . Actually it has nothing to do with quality! _____ _____ _____ _____ T V Product Service LtdWhat are EU Directives? _____ _____ _____ _____ _____ T V Product Service LtdWhat are EU Directives? "New Approach" Directives (Community Law) set out the essential requirements(on safety for example) W ritten in general terms and must be met before products may be sold in the UK or anywhere else in the European Community European harmonised (EN) standards provide detailed technical information enabling manufacturers to meet the essential requirements Directives explain how manufacturers are able to demonstrate conformity with the essential requirements Products which meet essential requirements are to display the CE marking which means they can be sold anywhere in the Community / European Economic Area (EEA)

5 _____ _____ _____ _____ _____ T V Product Service LtdNew Approach CE marking DirectivesThere are 21 CE marking DirectivesDirectiveAmended byTitle of directive2006/95/ECLow Voltage 87/404/EEC90/488/EEC93/68/EECS imple Pressure Vessels 88/378/EE93/68/EECS afety of toys 89/106/EEC93/68/EECC onstruction products 2004/108/EC Electromagnetic compatibility (EMC) 2006/42/EC Machinery 89/686/EEC 93/68/EEC 93/95/EEC 96/58/ECPersonal protective equipment (PPE) 90/384/EEC 93/68/EECNon-automatic w eighing instruments 90/385/EEC 93/42/EEC 93/68/EEC 2007/47/ECActive implantable medical devices 90/396/EEC 93/68/EECA ppliances burning gaseous fuels _____ _____ _____ _____ T V Product Service LtdCE marking DirectivesDirectiveAmended byTitle of directive92/42/EEC 93/68/EEC 2004/8/EC 2005/32/ECEfficiency requirements for new hot-w ater boilers fired with liquid or gaseous fuels 93/15/EEC Explosives for civil uses 93/42/EEC 98/79/EC 2000/70/EC 2001/104/EC2007/47/ECMedical devices 94/9/EC Equipment explosive atmospheres (ATEX)

6 94/25/EC 2003/44/ECRecreational craft 95/16/EC Lifts 97/23/EC Pressure equipment 98/79/EC In vitro diagnostic medical devices 1999/5/EC Radio Equipment and Telecommunications Terminal Equipment2000/9/EC Cablew ay installations designed to carry persons 2004/22/EC Measuring instruments _____ _____ _____ _____ T V Product Service LtdSummary of applicable DirectivesDirectiveTitle of Directive2006/95/EC Low Voltage Directive (LVD)2004/108/EC Electromagnetic compatibility (EMC) 1999/5/EC Radio Equipment and Telecommunications Terminal EquipmentThe CE marking Directives listed below are the ones that would most typically be applicable to your products. _____ _____ _____ _____ _____ T V Product Service LtdOther applicable Directives Just because a Directive does not call for CE marking does not mean the Directive is not applicable.

7 Other typically applicable directives:-DirectiveTitle of Directive2001/95/ECGeneral Product Safety Directive (GPSD)2002/96/ECWaste from Electrical and Electronic Equipment (WEEE)2002/95/ECRestriction of Hazardous Substances (RoHS) _____ _____ _____ _____ T V Product Service LtdWhat is Due Diligence? _____ _____ _____ _____ T V Product Service LtdWhat is Due Diligence? Knowing what is required Declaring that you have met the relevant requirements Demonstrating compliance with applicable Directives Being properly prepared ready to defend yourself in court being able to produce a technical file being confident in your safety case _____ _____ _____ _____ T V Product Service LtdHow is CE marking enforced? _____ _____ _____ _____ T V Product Service LtdDirectiveUK Law2006/95/EC Low Voltage Directive The Electrical Equipment (Safety) Regulations 1994 (SI 1994/3260) 2004/108/ECEMC DirectiveEMC Regulations 2006 (SI 2006/3418)1999/5/EC RTTE DirectiveThe Radio Equipment and Telecommunications Terminal Equipment Regulations 2000 (SI 2000 ) Directives are agreed, adopted & accepted by the governments of the member states into their own national law The Directives are transposed into UK Law as Statutory Instruments Gives the Directives the same status as other laws in this countryLegal status of Directives _____ _____ _____ _____ T V Product Service LtdWho enforces the Law?

8 In Great Britain by:- Local Trading Standards (Great Britain) District Councils (Northern Ireland) The Office of Communications (Ofcom) where responsibility where enforcement relates to the protection and management of the radio spectrum _____ _____ _____ _____ T V Product Service LtdMarket surveillanceThe enforcement authority can: Challenge any product on the market Pull samples from the market for examination Request a manufacturer, importer or retailer to provide their Technical File(s) Contract 3rdparty test laboratories to test or check products Respond to public complaints Notify other member states ( RAPEX) Instigate criminal proceedings resulting in potential: Banning of products from sale Ordering product recalls Payment of fines Imprisonment of responsible persons _____ _____ _____ _____ T V Product Service LtdEnforcement examplesBoth the examples shown below were notified to ALLM ember States using Safeguard Clauses of the relevant electrical adapter "CELLY"Type/model: CBR8310.

9 Country of origin: of electric shock. Risk of electric shock because of insufficient insulation in transformer T1 between the primary and the secondary circuit. This product does not comply with the LVD Directive and the European Standards. Recall from consumers ordered by authority. Electric police car (toy) "Biltema Electric police car" (battery operated) Type/model: 26-941. Country of origin: China/Hong of injury. When released on a tilted surface (10 degrees tilt, 50N applied to the brake pedal)), the toy should not move more than 5cm, however, when tested the toy did not stop at toy does not comply with the Toys Directive and the European Standards. Voluntary withdrawal of the product from the market and consumers by importer.

10 _____ _____ _____ _____ T V Product Service LtdDeclaration of Conformity (DoC) _____ _____ _____ _____ T V Product Service LtdWhat is a DoC? formal statement that products comply with: applicable Directives applicable by responsible person within the organisation ( company director) is not evidence of compliance in legal requirement _____ _____ _____ _____ T V Product Service LtdWhat is the Relevance of a DoC legal claim that products comply with all applicable Directives Manufacturer (or responsible body) attests conformity with all relevant Directives and takes sole legal responsibility Signatory accepts liability for compliance with the Directives Signatory may be subject to prosecution or even imprisonment In some instances Directives may require a Notified Body to issue a Certificate of Conformity in order to verify product compliance, High risk medical devices High risk machinery _____ _____ _____ _____ T V Product Service LtdThe DoC must Name & address of manufacturer (or their authorised representative)