2. 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).
Enables free movement of goods around EU member States
(some non EU countries have adopted CE marking procedures)
3. 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
As a rule of thumb, the height of the logo may be reduced to 3 mm if the maximum
dimension of the product is less that 150 mm.
7. What are EU Directives?
• Directives explain how manufacturers are able to demonstrate conformity
with the essential requirements
• European harmonised (EN) standards provide detailed technical
information enabling manufacturers to meet 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)
8. CE marking Directives
There are 21 CE marking Directives
Directive Title of directive
2006/95/EC Low Voltage
87/404/EEC Simple Pressure Vessels
88/378/EE Safety of toys
89/106/EEC Construction products
2004/108/EC Electromagnetic compatibility (EMC)
2006/42/EC Machinery
89/686/EEC Personal protective equipment (PPE)
90/384/EEC Non-automatic weighing instruments
90/385/EEC Active implantable medical devices
90/396/EEC Appliances burning gaseous fuels
9. CE marking Directives
Directive Title of directive
92/42/EEC Efficiency requirements for new hot-water boilers fired with liquid
or gaseous fuels
93/15/EEC Explosives for civil uses
93/42/EEC Medical devices
94/9/EC Equipment explosive atmospheres (ATEX)
94/25/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
11. Countries in European Economic Area
(EEA):
The European Union (EU) is an economic and political union of 28 countries.
The EU countries are:
Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden and the UK.
12. Directive UK Law
93/42/EEC
Medical devices
MHRA Medicines and Healthcare products Regulatory
Agency is the designated competent authority that administers
and enforces the law on medical devices in the UK
2006/95/EC Low Voltage
Directive
The Electrical Equipment (Safety) Regulations 1994 (SI
1994/3260)
2004/108/EC
EMC Directive
EMC Regulations 2006 (SI 2006/3418)
1999/5/EC
RTTE Directive
The Radio Equipment and Telecommunications Terminal
Equipment Regulations 2000 (SI 2000 No.730)
• 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
Who enforces the Law?
13. 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
14. Enforcement examples
Both the examples shown below were notified to ALL Member States using
Safeguard Clauses of the relevant Directives.
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.
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.
16. Technical Files
“Technical files are your documented evidence to show
that products properly comply with the requirements of
the directives which apply to it.”
17. 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!
19. 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.
20. • 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
Technical file contents
21. • 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
Technical file contents
23. 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
24. 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
25. 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
26. Example Declaration of Conformity
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:
27. 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!
29. 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
