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
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What is CE marking?
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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).
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What is CE marking?
CE marking =
Guaranteed no hangover?
Guaranteed to get drunk?
Guaranteed good quality beer
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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
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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
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CE marking = Quality?
Consumers and retailers may associate CE marking
with “quality”. Actually it has nothing to do with quality!
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What are EU Directives?
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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)
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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
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
Electromagnetic compatibility (EMC)
2006/42/EC
Machinery
89/686/EEC
93/68/EEC
93/95/EEC
96/58/EC
Personal protective equipment (PPE)
90/384/EEC
90/385/EEC
93/68/EEC
Non-automatic weighing instruments
Active implantable medical devices
90/396/EEC
93/68/EEC
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93/42/EEC
93/68/EEC
2007/47/EC
Appliances burning gaseous fuels
CE marking Directives
Directive
Amended by
Title of directive
92/42/EEC
93/68/EEC
2004/8/EC
2005/32/EC
Efficiency requirements for new hot-water boilers fired
with liquid or gaseous fuels
93/15/EEC
93/42/EEC
94/9/EC
94/25/EC
95/16/EC
97/23/EC
98/79/EC
1999/5/EC
2000/9/EC
2004/22/EC
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98/79/EC
2000/70/EC
2001/104/EC
2007/47/EC
2003/44/EC
Explosives for civil uses
Medical devices
Equipment explosive atmospheres (ATEX)
Recreational craft
Lifts
Pressure equipment
In vitro diagnostic medical devices
Radio Equipment and Telecommunications Terminal
Equipment
Cableway installations designed to carry persons
Measuring instruments
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
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Radio Equipment and Telecommunications Terminal Equipment
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)
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What is Due Diligence?
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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
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How is CE marking enforced?
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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
Low Voltage Directive
The Electrical Equipment (Safety)
Regulations 1994 (SI 1994/3260)
2004/108/EC
EMC Regulations 2006 (SI 2006/3418)
EMC Directive
1999/5/EC
RTTE Directive
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The Radio Equipment and
Telecommunications Terminal Equipment
Regulations 2000 (SI 2000 No.730)
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
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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 3rd 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
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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.
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Declaration of Conformity (DoC)
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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
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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
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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
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Example Declaration of Conformity (DoC)
EU DECLARATION OF CONFORMITY
Date of Issue:
Date of DoC
Reference Number:
Serial Number for this DoC
Directive:
Relevant Directive's
Conforming Apparatus:
Equipment Title, Part Number (and Serial Numbers as
applicable)
Manufacturer:
Authorised Representative:
Harmonised Standards
Referenced or Applied:
Relevant standards, amendments and dates of issues
Specifications with which Conformity is
Declared:
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:
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Technical Files
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Technical Files
“Technical files are your documented evidence to
show that products properly comply with the
requirements of the directives which apply to it.”
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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!
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Low Voltage, EMC, RTTE Directives
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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; http://europa.eu/
The official source of information relating to all European Directives
UK
BIS – Department for Business Innovation & Skills website
http://www.bis.gov.uk/policies/business-sectors/environmental-andtechnical-regulations/technical-regulations
Provides a range of on line and downloadable guidance to the
directives written in plain English
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Harmonised Standards
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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
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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.
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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
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Placing products on the market
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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
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CE marking or not...?
If one or more CE marking Directives
apply then you must apply CE marking!
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CE marking or not...?
Low Voltage Directive: applies to all electrical equipment having input
OR output voltages between 50-1000Vac and between 75-1500Vdc
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.
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Technical file contents
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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.
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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
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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
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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!
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Thanks for Listening
Any Questions?
Richard Poate
Compliance Services Manager, TÜV Product Service
Tel: +44(0) 1489 558215
rpoate@tuvps.co.uk
www.tuvps.co.uk
TÜV Product Service Ltd