CE marking & your legal obligations

Transcription

1 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 1

2 Who Am I? Name Title: Employer: Experience: Richard Poate Compliance Services Manager 16 years experience in product compliance Telephone:

3 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

4 What is CE marking?

5 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).

6 What is CE marking? CE marking = Guaranteed no hangover? Guaranteed to get drunk? Guaranteed good quality beer

7 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

8 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

9 CE marking = Quality? Consumers and retailers may associate CE marking with quality. Actually it has nothing to do with quality!

10 What are EU Directives?

11 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)

12 New Approach CE marking Directives There are 21 CE marking Directives Directive 2006/95/EC Amended by Title of directive Low Voltage 87/404/EEC 90/488/EEC 93/68/EEC Simple Pressure Vessels 88/378/EE 93/68/EEC Safety of toys 89/106/EEC 93/68/EEC Construction products 2004/108/EC 2006/42/EC Electromagnetic compatibility (EMC) Machinery 89/686/EEC 93/68/EEC 93/95/EEC 96/58/EC Personal protective equipment (PPE) 90/384/EEC 93/68/EEC Non-automatic weighing instruments 90/385/EEC 93/42/EEC 93/68/EEC 2007/47/EC Active implantable medical devices 90/396/EEC 93/68/EEC Appliances burning gaseous fuels

13 CE marking Directives Directive Amended by Title of directive 92/42/EEC 93/15/EEC 93/42/EEC 94/9/EC 93/68/EEC 2004/8/EC 2005/32/EC 98/79/EC 2000/70/EC 2001/104/EC 2007/47/EC Efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels Explosives for civil uses Medical devices 94/25/EC 2003/44/EC Recreational craft 95/16/EC 97/23/EC 98/79/EC 1999/5/EC 2000/9/EC 2004/22/EC Equipment explosive atmospheres (ATEX) Lifts Pressure equipment In vitro diagnostic medical devices Radio Equipment and Telecommunications Terminal Equipment Cableway installations designed to carry persons Measuring instruments

14 Summary of applicable Directives The CE marking Directives listed below are the ones that would most typically be applicable to your products. Directive 2006/95/EC Title of Directive Low Voltage Directive (LVD) 2004/108/EC Electromagnetic compatibility (EMC) 1999/5/EC Radio Equipment and Telecommunications Terminal Equipment

15 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 2001/95/EC Title of Directive General Product Safety Directive (GPSD) 2002/96/EC Waste from Electrical and Electronic Equipment (WEEE) 2002/95/EC Restriction of Hazardous Substances (RoHS)

16 What is Due Diligence?

17 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

18 How is CE marking enforced?

19 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 2006/95/EC Low Voltage Directive 2004/108/EC EMC Directive 1999/5/EC RTTE Directive UK Law The Electrical Equipment (Safety) Regulations 1994 (SI 1994/3260) EMC Regulations 2006 (SI 2006/3418) The Radio Equipment and Telecommunications Terminal Equipment Regulations 2000 (SI 2000 No.730)

20 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

21 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

22 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: 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.

23 Declaration of Conformity (DoC)

24 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

25 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

26 The DoC must include Name & address of manufacturer (or their authorised representative) Description of the electrical equipment including type, model and any other information that clearly relates the equipment to the Declaration A reference to harmonised standards applied and when harmonised standards have not been applied, references to International or National standard(s) with which conformity is declared. If standards have not been applied, reference should be made to other specifications adopted or to the safety objectives that have been applied and satisfied Identification of the signatory empowered to enter into commitments on behalf of the manufacturer (or their authorised representative) The last two digits of the year in which CE marking was affixed

27 Example Declaration of Conformity (DoC) EU DECLARATION OF CONFORMITY Date of Issue: Reference Number: Directive: Conforming Apparatus: Date of DoC Serial Number for this DoC Relevant Directive's Equipment Title, Part Number (and Serial Numbers as applicable) Manufacturer: Authorised Representative: Harmonised Standards Referenced or Applied: Specifications with which Conformity is Declared: Relevant standards, amendments and dates of issues If Harmonised Standards are not used then insert standards used and reference number of Notified Body Certificate. xxxxltd hereby declare that the equipment named has been designed (alternative:) tested and found to comply with the relevant sections of the above referenced specifications. The unit complies with all essential requirements of the Directives. Signed: Name: Position:

28 Technical Files

29 Technical Files Technical files are your documented evidence to show that products properly comply with the requirements of the directives which apply to it.

30 Technical Files Technical documentation must be such as to enable enforcement authorities to assess the conformity of the electrical equipment to the requirements of the Regulations It must cover the design, manufacture and operation of electrical equipment It can be the same document as your design file for the equipment Most importantly, it forms the basis of your safety case!

31 Low Voltage, EMC, RTTE Directives

32 Identification of applicable Directives Review the scope of the Directives Seek the assistance of Notified Bodies (if applicable) Refer to official guidance on-line European Union Europa the official website of the European Union; The official source of information relating to all European Directives UK BIS Department for Business Innovation & Skills website Provides a range of on line and downloadable guidance to the directives written in plain English

33 Harmonised Standards

34 What are Harmonised Standards? A "Harmonised Standard" is a standard that: supports one or more Directives has been produced by CEN or CENELEC has been published in the Official Journal of the EC (OJ) has been published by at least one national standards body provides a presumption of conformity with the EHSRs These standards, produced under a mandate from Member States through the Commission, provide the technical measures to meet the EHSRs

35 What are Harmonised Standards? In other words the: Directives state the legal objectives (EHSR s) to be met (*1) and Harmonised Standards identify the technical means (requirements) to meet these legal objectives. Harmonised Standards are one way of meeting the EHSRs and are never intended to be mandatory, however compliance with them does give a presumption of conformity *1 The EHSRs of the Machinery Directive do contain technical requirements.

36 Presumption of conformity Products are presumed to conform to the objectives of the Directives where the equipment has been manufactured and tested in accordance with a harmonized standard Alternatively, the manufacturer may construct the product in conformity with the essential requirements of the Directives, without applying harmonised, international or national standards In such a case the product will not benefit from presumption of conformity The manufacturer must include in the technical documentation a description of the solutions adopted to satisfy the requirements of the Directives

37 Placing products on the market

38 Placing products on the market Before a product is placed on the market: manufacturer must compile technical documentation which makes it possible to assess product compliance with relevant Directives manufacturer or authorised representative must draw up the DoC manufacturer or authorised representative must affix the CE marking

39 CE marking or not...? If one or more CE marking Directives apply then you must apply CE marking!

40 CE marking or not...? Low Voltage Directive: applies to all electrical equipment having input OR output voltages between Vac and between Vdc EMC Directive: applies to all electrical and electronic apparatus which are liable to cause electromagnetic disturbance or the performance of which is liable to be affected by such disturbance RTTE Directive: applies to all radio and telecommunication terminal equipment (with certain exclusions) as defined in the Directive Machinery Directive: applies to an assembly of linked parts or components at least one of which moves, with appropriate actuators, control and power circuits joined together for a specific application. In particular for processing, treatment, moving or packaging of material.

41 Technical file contents

42 Technical file contents A general description of the electrical equipment This requirement can normally be met by the description (including model number etc.) found in the equipment manual Conceptual design This can be met by a general assembly drawing and / or photographs plus a block diagram. The drawings should relate to a particular model number and year of manufacture. Circuit diagrams are also required.

43 Technical file contents Descriptions and explanations necessary for the understanding of the drawings and schemes referred to previously and the operation of the electrical equipment To some extent the equipment manual may meet this requirement but it may be necessary to include a schematic operation description A list of standards applied in full (or in part), and descriptions of the solutions adopted to satisfy the safety requirements of the Regulations / Directive where standards have not been applied. If no standards have been applied references should be made as to how the safety requirements have been satisfied List of components complete listing of all components, materials and parts used in the product (i.e. complete Bill of Materials) Safety approval information on critical components and materials

44 Technical file contents Results of design calculations made, examinations carried out, etc In many cases test reports will meet this requirement if they can demonstrate that the design calculations have been made correctly Test reports. This could include test reports drawn up by the manufacturer, a Notified Body or any other person the manufacturer considers to be competent These reports will demonstrate how the product complies with the relevant directives Typically this will be by the application of harmonised standards A copy of the EC Declaration of Conformity

45 Technical file format Must be controlled Must contain all the required information Can be a traditional paper file Information may be stored electronically Hyperlinks can be used to link documents Needs to be backed-up Must be easy to produce all documentation at short notice Must be easy to maintain and must be kept up to date You can t just do it then forget about it!

46 Thanks for Listening Any Questions? Richard Poate Compliance Services Manager, TÜV Product Service Tel: +44(0)