CE marking & your legal obligations This 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 Market CE marking & your legal obligations Presented by Richard Poate Compliance Services Manager, TÜV Product Service TÜV Product Service Ltd 1
Who Am I? Name Richard Poate Title: Compliance Services Manager Employer: TÜV Product Service Ltd Experience: 16 years experience in product compliance Telephone: 01489 558215 E-mail: rpoate@tuvps.co.uk TÜV Product Service Ltd
Contents CE marking and your legal obligations – What is CE marking? – What are EU Directives? – What is Due diligence? – How is CE marking enforced? – 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 market Technical documentation required to demonstrate compliance – Technical file contents – Technical file format TÜV Product Service Ltd
What is CE marking? TÜV Product Service Ltd
What 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). TÜV Product Service Ltd
What is CE marking? CE marking = Guaranteed no hangover? Guaranteed to get drunk? Guaranteed good quality beer TÜV Product Service Ltd
What 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 • TÜV Product Service Ltd
CE Conformity Marking The 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 respected The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5mm TÜV Product Service Ltd
CE marking = Quality? Consumers and retailers may associate CE marking with “quality”. Actually it has nothing to do with quality! TÜV Product Service Ltd
What are EU Directives? TÜV Product Service Ltd
What are EU Directives? • "New Approach" Directives (Community Law) set out the essential requirements (on safety for example) • Written 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) TÜV Product Service Ltd
New Approach CE marking Directives There are 21 CE marking Directives Directive Amended by Title of directive 2006/95/EC Low Voltage 87/404/EEC 90/488/EEC Simple Pressure Vessels 93/68/EEC 88/378/EE 93/68/EEC Safety of toys 89/106/EEC 93/68/EEC Construction products 2004/108/EC Electromagnetic compatibility (EMC) 2006/42/EC Machinery 89/686/EEC 93/68/EEC Personal protective equipment (PPE) 93/95/EEC 96/58/EC 90/384/EEC 93/68/EEC Non-automatic weighing instruments 93/42/EEC 90/385/EEC Active implantable medical devices 93/68/EEC 2007/47/EC 90/396/EEC 93/68/EEC Appliances burning gaseous fuels TÜV Product Service Ltd
CE marking Directives Directive Amended by Title of directive 93/68/EEC 92/42/EEC Efficiency requirements for new hot-water boilers fired 2004/8/EC with liquid or gaseous fuels 2005/32/EC 93/15/EEC Explosives for civil uses 93/42/EEC 98/79/EC Medical devices 2000/70/EC 2001/104/EC 2007/47/EC 94/9/EC Equipment explosive atmospheres (ATEX) 94/25/EC 2003/44/EC Recreational 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 Equipment 2000/9/EC Cableway installations designed to carry persons 2004/22/EC Measuring instruments TÜV Product Service Ltd
Summary of applicable Directives The CE marking Directives listed below are the ones that would most typically be applicable to your products. Directive Title of Directive 2006/95/EC Low Voltage Directive (LVD) 2004/108/EC Electromagnetic compatibility (EMC) 1999/5/EC Radio Equipment and Telecommunications Terminal Equipment TÜV Product Service Ltd
Other applicable Directives “Just because a Directive does not call for CE marking does not mean the Directive is not applicable.” Other typically applicable directives:- Directive Title of Directive 2001/95/EC General Product Safety Directive (GPSD) 2002/96/EC Waste from Electrical and Electronic Equipment (WEEE) 2002/95/EC Restriction of Hazardous Substances (RoHS) TÜV Product Service Ltd
What is Due Diligence? TÜV Product Service Ltd
What 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 TÜV Product Service Ltd
How is CE marking enforced? TÜV Product Service Ltd
Legal status of Directives • 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 country Directive UK Law 2006/95/EC The Electrical Equipment (Safety) Low Voltage Directive Regulations 1994 (SI 1994/3260) 2004/108/EC EMC Regulations 2006 (SI 2006/3418) EMC Directive 1999/5/EC The Radio Equipment and Telecommunications Terminal Equipment RTTE Directive Regulations 2000 (SI 2000 No.730) TÜV Product Service Ltd
Who enforces the Law? 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 TÜV Product Service Ltd
Market surveillance The 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 3 rd party test laboratories to test or check products • • Respond to public complaints Notify other member states (e.g. RAPEX) • • Instigate criminal proceedings resulting in potential: – Banning of products from sale – Ordering product recalls – Payment of fines – Imprisonment of responsible persons TÜV Product Service Ltd
Enforcement examples Both the examples shown below were notified to ALL Member States using Safeguard Clauses of the relevant Directives. Electric police car (toy) "Biltema Electric police car" (battery operated) Type/model: 26-941. Country of origin: China/Hong Kong. Risk 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 all. The toy does not comply with the Toys Directive and the European Standards. Voluntary withdrawal of the product from the market and consumers by importer. AC-DC electrical adapter "CELLY" Type/model: CBR8310. Country of origin: China. Risk 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. TÜV Product Service Ltd
Declaration of Conformity (DoC) TÜV Product Service Ltd
What is a DoC? 1. A formal statement that products comply with: applicable Directives • • applicable standards 2. Signed by responsible person within the organisation (e.g. company director) 3. It is not evidence of compliance in itself 4. Minimum legal requirement TÜV Product Service Ltd
What 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, e.g. – High risk medical devices – High risk machinery TÜV Product Service Ltd
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