CE Marking

GURANTIED QUALITY

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 .

QCS MANAGEMENT PVT LTD. +918697724963, qcsert56@yahoo.com , www.qcspl.com

 CE Marking

What are the directives that allow for CE

Marking?
Any product that is classified under CE regulations( European health, safety & environmental
legislations) , must bear CE mark before placing it within the EEA market. Not all Products
need to have the CE Mark . The products which need to bear the CE marks are as follows;
1. Active implantable medical devices
2. Appliances burning gaseous fuels
3. Cableway installations designed to carry persons
4. Eco-design of energy related products
5. Electromagnetic compatibility
6. Equipment and protective systems intended for use in potentially explosive
atmospheres
7. Explosives for civil uses
8. Hot-water boilers
9. Household refrigerators and freezers
10. In vitro diagnostic medical devices
11. Lifts
12. Low voltage
13. Machinery
14. Measuring instruments
15. Medical devices
16. Noise emission in the environment
17. Non-automatic weighing instruments
18. Personal protective equipment
19. Pressure equipment
20. Pyrotechnics
21. Radio and telecommunications terminal equipment
22. Recreational craft
23. Safety of toys
24. Simple pressure vessels

What should be the content of “Technical

Construction File” (TCF)?
Generally the technical file requires the following things:
1. Description of the product
2. Conceptual Drawing, Component Drawings etc
3. Result of Risk Analysis
4. Test Reports against applied Harmonised EN Standards
5. Labels
6. Instruction for Use
7. Signed “Declaration of Conformity”(DOC)

QCS MANAGEMENT PVT LTD. +918697724963, qcsert56@yahoo.com , www.qcspl.com

 CE Marking
Can you claim CE Marking without testing
your product?
No. Annex IV of LVD Directive and EMC Directive and Annex VII of the Machinery
Directive clearly asks for test report as a part of the Technical File.

CE Marking Process
Application Review & Certification Contract> Determination of applicable directives &
harmonised standards > Determination of applicable conformity assessment route >
Products testing>
TCF-Technical Construction File > DOC – Declaration Of Conformity.> Self Certification /
Notified body assessment > affix CE mark on products> Post Market Surveillance.

Do you need an independent assessment?

You need to check if your product has to be tested by a notified body. You can find this
information in the relevant legislation applicable to your product: check the rules by product
category. This step is not obligatory for all products.

If you need to involve a notified body, the CE marking must be accompanied by the
identification number of the notified body. The CE mark and the identification number can be
affixed separately, as long as they appear clearly linked to each other.

You can use the Nando database to search for a notified body that can certify your product.
If your product doesn’t need to be verified by an independent body, then it is up to you to
check that it complies with the technical requirements. This includes estimating and
documenting the possible risks when using your product.

How can we help ?

QCS accredited by EUAS USA against ISO 17065 (Products Certifications standard) and our
partner Euro-Tech group hold various accreditations such as ESYD Greece, UKAS ,
approved notified body (NB1128) and NABL, provide the following services to demonstrate
conformity of products against various EU regulations ;
 Determine the regulations & harmonised standards applicable to the product’s
category
 Determine the conformity assessment route (voluntary or notified sector) as per the
regulation
 Test products as per the EN harmonised standards from NABL authorised
laboratories
 Preparation of TCF and DOC
 Assessment by an independent third party notified body ( in notified sectors ) or
 an independent assessment to guarantee the Quality safety and security of products(
in voluntary areas)
 Appointment of European representative
 Affix CE marking on your products.

QCS MANAGEMENT PVT LTD. +918697724963, qcsert56@yahoo.com , www.qcspl.com