CE Marking - Webinar

TÜV SÜD Việt Nam | Buối chia sẻ trực tuyến về dấu chứng nhận CE 21/7/2022
Content
1 What is CE Mark
2 Where is CE Mark mandatory?
3 When is CE Mark mandatory?
4 CE Mark directives
5 The CE Marking process
6 Q&A
TÜV SÜD Việt Nam | Buối chia sẻ trực tuyến về dấu chứng nhận CE 21/7/2022 2
CE Marking
 indicates conformity with health, safety, and environmental
protection standards for products sold within the European
Economic Area (EEA)
 manufacturer's declaration that the product meets EU standards
 CE logo affixed on the product and gift box and, if applicable, the
four digits ID of the Notified Body involved in the assessment
 "CE" is the abbreviation of "Conformité Européenne" (French for

"European Conformity")
 CE marking is mandatory for certain product groups
Content
1 What is CE Mark
6 Q&A
Where is CE Marking mandatory?
547.000.000 potential customers
27 member states of the EU
Population: 448 Million
EFTA members Iceland, Liechtenstein, Norway and

Switzerland
Population: 14.42 Million
Turkey
Population: 84.4 Million
European Economic Area (EEA)
 The EEA includes EU countries and also Iceland, Liechtenstein and
Norway are part of member states in the single market.
 Switzerland is not an EU or EEA member but is part of the single
market.
The United Kingdom withdrew from the European Union on 31 January

TÜV SÜD Việt Nam | Buối chia sẻ trực tuyến về dấu chứng nhận CE
2020. 21/7/2022 5
Content
1 What is CE Mark
6 Q&A
When is CE Marking Mandatory?
 For products where CE directives exists
 Some products are subject to several CE directives at the same time, make sure that your product
complies with all the relevant requirements before affixing the CE mark
It is forbidden to put the CE mark onto products if no CE directives exist
How do you affix the CE Marking

 The CE marking must consist of the initials "CE", both letters should have the same vertical
dimension and be no smaller than 5mm (unless specified differently in the relevant product
requirements).
 CE mark must be visible, legible, and indelible
 Keep proportions of the two letters
TÜV
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nhận CE
CE 21/7/2022
21/7/2022 7
Content
1 What is CE Mark
6 Q&A
CE Mark Directives Machines Directive
2006/42/EC
ATEX Directives 2014/34/EU 2014/35/EU Low Voltage Directives
Waste from
Electrical and Electronic 2012/19/EU 2014/33/EU Lifts Directives
Equipment Directives
Pressure Equipment
Personal Protective 2016/425 2014/68/EU
Directives
Equipment Directives CE
Construction Products Directives 305/2011 2014/53/EU Radio Equipment Directives
Toys Directives 2009/48/EU 93/42/EEC Medical Devices Directives
2000/14/EC 2014/30/EU
Outdoor / Noise emission Directives Electromagnetic Compatibility Directives
… and many more Product Directives

TÜV SÜD Việt Nam | Buối chia sẻ trực tuyến về dấu chứng nhận CE 21/7/2022 ‹Nr.›
Content
1 What is CE Mark
6 Q&A
The CE Marking process
Self certification is an option
Examples of product directives you can self-certify:

 EMC Directive
 Low Voltage Directive
 Most products covered by the Radio Equipment Directive
Self certification not allowed

 Simple Pressure Vessels Directive
 Appliances Burning Gaseous Fuels Directive
 Most products covered by the Pressure Equipment Directive
Self certifying manufacturers must verify the standards by which their product must
comply
Note CE Marking might require compliance to more than one directive.
CE Mark compliance is the responsibility of the manufacturer
must continually review standards and ensure compliance even as standards change
must regularly review EU website (CE Mark standards and directives listed)
assists with CE Mark compliance
Steps to affix CE Marking
It is the sole responsibility of the manufacturer to declare CE-Mark conformity. Follow these 5 steps to
affix a CE marking to your product
1. Identify the
applicable
directive(s)
6. Make an EC 2. Identify the

declaration of applicable
conformity and requirements of
affix the CE mark directive(s)
5. Compilation of 3. Identify an
the technical appropriate route
documentation for conformity
4. Assessment of
the product‘s
conformity
Harmonized standards is a European standard developed by a recognised European
Organisation
 CENELEC (European Committee for Electrotechnical Standardization)
 CEN (another abbreviation for CENELEC)
 ETSI (European Telecommunications Standards Institute)
Conformity assessment by Notified Body

 organisation designated by an EU country to assess conformity of certain products
Technical documentation (for reference)

 Risk assessment
 Circuit diagrams
 Construction drawings
 Test Reports
 Bill of Material
 Declaration of Conformity
Example for CE Marking LED + Driver
LVD Directive
Electrical equipment designed for use with a voltage rating between 50 and 1000 V for AC and between 75
and 1500 V DC
EMC Directive
Products generating electromagnetic disturbance, or can be affected by such disturbance
Products that contain electronics or active electrical components
Regardless whether these are mains powered or battery powered products
RoHS Directive
Electronic and electrical equipment without the use of six different hazardous materials:
 Lead (Pb)
 Mercury (Hg)
 Cadmium (Cd)
 Hexavalent chromium (Cr6+): Used in chrome plating, chromate coatings, and primers
 Polybrominated biphenyls (PBB): Flame retardant in plastic
 Polybrominated diphenyl ether (PBDE): Flame retardant in plastic
Ecodesign Directive ErP Directive
Requirements for energy-using and energy-related products
Example for CE Marking for Radio equipment
RED Directive (LVD & EMC)
Electrical or electronic product, which intentionally emits and/or receives radio waves
The previous Directive (R&TTE) also covered ‘Telecommunications Terminal Equipment’, but
no longer under RE-Directive
• Wi-Fi Enabled Devices
• Bluetooth Enabled Devices
• 4G/LTE/5G Enabled Devices
• RFID Devices
• Televisions and Radio Receivers
• GPS Transceivers
RoHS Directive
Electronic and electrical equipment
Ecodesign Directive ErP Directive
Requirements for energy-using and energy-related products
Example for selecting corresponding standards
LCD TV (DVB-T2/S2, 2.4G & 5G, Bluetooth, RC with Bluetooth)
LVD & EMC + RED

Safety EN 62368-1:2014/A11:2017
Health EN 62311:2008 + EN 50665:2017
EMC EN 55032:2015/A11:2020 + EN 55035:2017/A11:2020 + EN IEC 61000-3-2:2019/A1:2021 +
EN 61000-3-3:2013/A1:2019 + EN 301 489-1 V2.2.3 + ETSI EN 301 489-3 V2.2.0 +
EN 301 489-17 V3.2.4
RF EN 300 328 V2.2.2
5G EN 301 893 V2.1.1
2.4G EN 300 440 V2.1.1
DVB EN 303 340 V1.1.2 + EN 303 372-2 V1.1.1
ErP
EC 62087 + IEC 62301:2011
RoHS
2011/65/EU and its amendment regulation 2015/863
Example for CE DoC (Declaration of Conformity)
1 Number (Unique identification of the declaration)

2 Name and address of the manufacturer
(representative)
4 Object of the declaration (Description allow
identification of product for traceability purposes and
could include a photograph where appropriate)
5 Directive used
6 Standards used
Example for CE DoC (Declaration of Conformity)
8 Additional information
7 Notified Body (name, ID number)
3 Statement of manufacturer
9 Place, Date
10 Name, Function and signature
CE DoC (Declaration of Conformity)
 CE Declaration of Conformity (DoC) is a mandatory document
 Manufacturer take full responsibility for his product's compliance with the applicable EU law.
 DOC is a legal entity enforceable under EU law
 Companies not registered in the EU it is difficult to enforce EU laws.
 In this case the authorised agent within the EU or the importer are legally responsible for
compliance
 Documentation must be kept for at least 10 years
The company placing the product on the EU market is responsible to ensure

compliance.
Example for TUV SUD CE AoC (Attestation of Conformity)
For Switch, Electronics For LED down light For Power supply (LED Driver)
Responsibilities of authorized agent
 Legal person established in the EU
 Can represent manufacturers from inside and outside the EU
 Must reside within the EU
 Acts on behalf of manufacturer
 Formerly appointed
 Contract or employed
 Responsibilities, task and limitation must be defined
 Can not modify products
Responsibilities of importer
If manufacturer is not based and not represented in the EU
Importer must
 make sure products placed on the market must comply
 manufacturer has taken necessary steps and documentation is available
 confirm conformity to CE mark directive(s)
 refrain from placing products on the market if in doubt
 take corrective actions if non conform products already on the market
 ensure manufacturer has met their obligation
 Conformity assessment
 Markings
 Technical documentation
 Traceability
 Safety instructions and instruction manual supplied
Market Surveillance enforces the law
Enforcement authority can:
 Challenge products on the market
 Pull samples from the market for examination
 Request technical documentation
 Enlist 3’rd party laboratories to check the products
 Respond to public complains
 Notify other member states
 RAPEX
 Instigate legal proceedings
 Banning from sale
 Product recall
 Fines
 Imprisonment
Person who signs the Declaration of Conformity is personally liable
RAPEX
Risk type
Chemical
Notifying country
Estonia
Alert number
A12/00937/22
The plastic material of the dolls contains an excessive amount of bis(2-ethylhexyl) phthalate (DEHP) (measured
values: up to 28.3% by weight). This phthalate may harm the health of children, possibly causing damage to their
reproductive system.
The product does not comply with the REACH Regulation.
Measures ordered:
 Recall of the product from end-user
 Ban on marketing of the product
RAPEX
Risk type
Electric shock
Notifying country
Finland
Alert number
A12/01799/21
In the power supply unit provided with the air cooler, the insulation is not sufficient and the creepage distance
between the live primary and accessible secondary circuits is not adequate. A user could touch accessible live
parts and receive an electric shock. The product does not comply with the requirements of the Low Voltage
Directive and the European standards EN 60335-1 and EN 60335-2-98.
Measures ordered:
 Recall of the product from end-user
 Ban on marketing of the product
Others Certification Mark for EU Market

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TÜV SÜD Việt Nam | Buối chia sẻ trực tuyến về dấu chứng nhận CE 21/7/2022

2 Where is CE Mark mandatory?

3 When is CE Mark mandatory?

5 The CE Marking process

 manufacturer's declaration that the product meets EU standards

 "CE" is the abbreviation of "Conformité Européenne" (French for

 CE marking is mandatory for certain product groups

2 Where is CE Mark mandatory?

3 When is CE Mark mandatory?

5 The CE Marking process

EFTA members Iceland, Liechtenstein, Norway and

The United Kingdom withdrew from the European Union on 31 January

2 Where is CE Mark mandatory?

3 When is CE Mark mandatory?

5 The CE Marking process

It is forbidden to put the CE mark onto products if no CE directives exist

How do you affix the CE Marking

2 Where is CE Mark mandatory?

3 When is CE Mark mandatory?

5 The CE Marking process

Construction Products Directives 305/2011 2014/53/EU Radio Equipment Directives

Toys Directives 2009/48/EU 93/42/EEC Medical Devices Directives

Outdoor / Noise emission Directives Electromagnetic Compatibility Directives

… and many more Product Directives

2 Where is CE Mark mandatory?

3 When is CE Mark mandatory?

5 The CE Marking process

Examples of product directives you can self-certify:

Self certification not allowed

assists with CE Mark compliance

6. Make an EC 2. Identify the

Conformity assessment by Notified Body

Technical documentation (for reference)

LVD & EMC + RED

1 Number (Unique identification of the declaration)

The company placing the product on the EU market is responsible to ensure

 Can not modify products

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