Many products require CE marking before they can be sold in the EU. CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health, and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.
When is CE marking mandatory?
CE marking is only obligatory for products for which EU specifications exist and require the affixing of CE marking.
Some products are subject to several EU requirements at the same time. You must make sure that your product complies with all the relevant requirements before affixing the CE marking to it. It is forbidden to affix the CE marking to products for which EU specifications do not exist or do not require the affixing of CE marking.
2. CE marking is a certification mark
that indicates conformity with health,
safety, and environmental protection
standards for products sold within the
European Economic Area (EEA)
02
www.k2amanagement.com
4. 04
Growth really
does matter
CE marking indicates that a product has been
assessed by the manufacturer and deemed to
meet EU safety, health and environmental
protection requirements. It is required for
products manufactured anywhere in the
world that are then marketed in the EU.
5. 05
When is CE
marking
mandatory?
CE marking is only obligatory
for products for which EU
specifications exist and
require the affixing of CE
marking..
www.k2amanagement.com
6. 06
What Products Need
CE Marking?
• Toys
• Machinery
• Electrical /electronic equipment
• Personal protective equipment
• Radio equipment
• Medical devices
• Active implantable medical devices
• In vitro diagnostics
• Simple pressure vessels
• Gas appliances
• Lifts
www.k2amanagement.com
• Recreational craft
• Equipment and protective systems for use in
explosive atmospheres
• Non-automatic weighing instruments
• Cableways
• Construction products
• Explosives for civil use
• New hot water boilers
• Measuring Equipment
• Pressure equipment
7. 07
CE Directive 2006/42/EC on
Machinery
Scope of the Machinery Directive
This Directive applies to the following products:
a. machinery;
b. interchangeable equipment;
c. safety components;
d. lifting accessories;
e. chains, ropes and webbing;
f. removable mechanical transmission devices;
g. partly completed machinery.
www.k2amanagement.com
8. 08
Regulation (EU) No 305/2011
on Construction Products
Scope of the (EU) 305/2011 Regulation
This Regulation applies to Construction Products.
www.k2amanagement.com
9. 09 Regulation (EU) 2017/745 on
Medical Devices
Scope of the (EU) 2017/745 Regulation
This Regulation Scope of the Medical Devices Regulation
www.k2amanagement.com
10. 10 Regulation (EU) 2016/425 on
Personal Protective Equipment
Scope of the Regulation on Personal Protective Equipment
This Directive applies to personal protective equipment (PPE).
www.k2amanagement.com
11. 11 CE Directive 2009/48/EC on Toy
Safety
Scope of the Toy Safety Directive
This Directive applies to products designed or intended, whether or not exclusively,
for use in play by children under 14 years of age.
www.k2amanagement.com
12. 12 CE Directive 98/79/EC on in vitro
diagnostic medical devices
Scope of the In Vitro MD Directive
This Directive applies to in vitro diagnostic medical devices and their accessories.
www.k2amanagement.com
13. 07
How to obtain
CE marking?
As the product's manufacturer, you
bear sole responsibility for
declaring conformity with all
requirements. You don't need a
license to affix the CE marking to your
product, however, before doing so,
you must:
www.k2amanagement.com
14. 1
Identify Applicable
EU Derivative(S)
3
Identify Appropriate
Route of Conformity
5
Write Product
Technical
Documents
2 4
Identify Applicable
EU Derivative
Requirements for
Your Product
Assessment
of the Product
Confirmity
07
www.k2amanagement.com
16. 09
Efficient systems
are put in place
The technical documentation provides
information on the design, manufacture,
and operation of a product and must
contain all the details necessary to
demonstrate the product conforms to the
applicable requirements.
www.k2amanagement.com
17. 10
How to demonstrate
compliance with EU
rules?
Harmonised standards are developed by recognised European
Standards Organisations: CEN, CENELEC, or ETSI.
Following harmonised standards in the design and manufacture of
your products will ensure your products are in line with corresponding
EU rules; this is known as ‘presumption of conformity'.
www.k2amanagement.com
18. 11
Sign off EU declaration of
conformity
As a manufacturer, it is your responsibility to draw
up the EU declaration of conformity
www.k2amanagement.com
20. 13
Tech know-how
Comply with CE Marking is a critical issue
when you place your product in EU market.
We at K2A Management understand the
Process and provide ypu full guidance and
support in complying with EU regulation
requirements.
www.k2amanagement.com
21. 14
CONTACT US
K2A Management
# 94 SPRING PARKLAND, DUDLEY,
BIRMINGHAM, UK
#346 STREET 21 BT, KHAN MEANCHEY,
PHNOM PENH, CAMBODIA
www.iso-
certifications.com
www.k2amanagement.co
m
Find Us on Social