Center for Testing and
European Certification
 CE marking of technical products –
bridge to the European market
 CTEC – general overview
www.ctec-sz.com
www.ctec-sz.com
MARKING
 Principles of the New Approach and the related regulations of the
European Union facilitate the free movement of goods within the
European market and ensure protection of life and health of
people, domestic animals, consumer protection and protection of
the environment and property.
 Any product that is covered by one or more New Approach
Directives, must conform to their applicable requirements.
 Proof of this is the affixation of the CE marking to the product
and/ or its packaging.
www.ctec-sz.com
WHAT IS
MARKING?
 The CE marking indicates a product’s compliance with EU
legislation and so enables the free movement of products within the
European market.
 By affixing the CE marking to a product, a manufacturer declares,
on his sole responsibility, that the product meets all the legal
requirements for the CE marking, which means that the product
can be sold throughout the European Economic Area (EEA) and in
Turkey. This also applies to products made in other countries which
are sold in the EEA and Turkey.
 However, not all products must bear the CE marking, only product
categories mentioned in specific EU directives on the CE marking.
 There are more than 20 New Approach Directives.
www.ctec-sz.com
NEW APPROACH DIRECTIVES
89/686/EEC
Personal protective equipment
90/385/EEC
Active implantable medical devices
92/42/EEC
Hot-water boilers
93/15/EEC
Explosives for civil uses
93/42/EEC
Medical devices
94/25/EC
Recreational craft
94/9/EC
Equipment and protective systems intended for use in potentially explosive atmospheres
95/16/EC
Lifts
97/23/EC
Pressure equipment
98/79/EC
In vitro diagnostic medical devices
99/5/EC
Radio and telecommunications terminal equipment
2000/9/EC
Cableway installations designed to carry persons
2004/108/EC
Electromagnetic compatibility
2004/22/EC
Measuring Instruments Directive
2006/42/EC
Machinery
2006/95/EC
Low voltage directive
2009/105/EC (ex-87/404/EEC)
Simple pressure vessels
2009/48/EC
Safety of toys
2009/23/EC (ex-90/384/EEC)
Non-automatic weighing instruments
2009/142/EC (ex-90/396/EEC)
Appliances burning gaseous fuels
Regulation (EU) No 305/2011
Construction products
www.ctec-sz.com
MAIN PRINCIPLES OF THE
MARKING IN ACCORDANCE WITH
REGULATION No 765/2008
 СE marking is the only marking which attests
conformity of the product with the applicable
requirements of the relevant legislation of the
European Community.
 Member States shall ensure correct application of the
regime governing the CE marking and shall take
appropriate action in the event of improper use of that
marking.
www.ctec-sz.com
AFFIXATION OF THE
MARKING TO YOUR PRODUCT

The CE marking must be affixed by the manufacturer after
completion of the requirements of the relevant directive/s.

CE marking must be affixed according to its
legal format visibly, legibly and indelibly.

If a Notified Body was involved in the
production control phase, its identification
number must also be displayed.
www.ctec-sz.com
MARKING DIRECTIVE 93/68/EEC
www.ctec-sz.com
EC DECLARATION OF
CONFORMITY
It is the manufacturer’s
responsibility to draw up and
sign an “EC declaration of
conformity” proving that the
product meets the
requirements.
After that your CE-marked
product is ready for the
market.
Declaration of performance under
Regulation (EU) 305/2011 on
Constriction products
www.ctec-sz.com
RESPONSIBILITIES OF THE
ECONOMIC OPERATORS
MANUFACTURER:
DISTRIBUTOR:
IMPORTER:
It is the manufacturer’s responsibility to carry out
the conformity assessment, to set up the technical
file, to issue the EC declaration of conformity and
to affix CE marking on a product.
Distributors must verify the presence of both the
CE marking and the necessary supporting
documentation.
If the product is being imported from a third
country, the importer has to verify that the
manufacturer outside the EU has undertaken the
necessary steps and that the documentation is
available upon request.
www.ctec-sz.com
NOTIFIED BODIES
 Notified bodies are nominated by governments and approved by the European
Commission.
 The manufacturer may apply to any notified body approved for the relevant
Directive within the European Economic Area.
 The notified body must be selected according to its impartiality, competence and
authority.
 Each notified body obtains an identification number by the European Commission.
 NANDO (Information System) – official journal or the European commission where
the notified bodies are listed.
New Approach Notified and Designated Organizations
www.ctec-sz.com
CTEC IN BRIEF
 Private organization founded in 2002 in the town of Stara Zagora as
a body for conformity assessment of technical products
 Recognized company on the Bulgarian market in the field of
laboratory testing and certification of construction products, machinery
and electrical equipment
 Increasing market share of the foreign market (Serbia, Turkey,
Greece, UK, Russia, China, South Korea, etc.)
 Notified body under 4 European Directives with identification number
NB 1871
 Two on-site testing laboratories accredited according to EN ISO/IEC
17025
 Notified laboratory for reaction to fire testing of construction products
 50 people permanent staff more than half of them engineers and
15 external auditors
www.ctec-sz.com
CTEC LOCATION
Great location in
the central part
of Bulgaria,
at an equal
distance
to all Balkan
neighbors.
www.ctec-sz.com
MEMBERSHIP
CTEC is a member of:
 Association of Notified Bodies for Construction Products;
 Forum of Notified Bodies;
 25 technical committees for standardization
as an active member;
 Bulgarian Industrial Capital Association;
 Bulgarian Association of Electrical
Engineering and Electronics (BASSEL).
 Bulgarian Branch Chamber of Machines
Building
 Bulgarian Chamber of Commerce and
Industry
Manager of the CTEC is:
 Board member of the Bulgarian Institute for Standardization
 Chairwoman of the Forum of Notified Bodies in Bulgaria
 Member of the National Council of Metrology
www.ctec-sz.com
NOTIFIED BODY NB 1871
www.ctec-sz.com
OUR SERVICES
As a Notified Body with accredited laboratories CTEC performs:
1. Conformity assessment / certification of:
 Construction products – Regulation (EU) 305/2011
 Machinery – Directive 2006/42/EC
 Low voltage equipment - Directive 2006/95/EC
 Noise emission in the environment by equipment for
use outdoors - Directive 2000/14/EC
2. Voluntary certification
3. Testing of construction products
4. Testing of machinery, electrical equipment and devices
www.ctec-sz.com
OUR SERVICES
CTEC is accredited by Bulgarian Accreditation Service according to
EN ISO/IEC 17021 to perform:
5. Management systems certification
 ISO 9001:2008 - quality management system
 ISO 14001:2004 – environmental management
 BS OHSAS 18001:2007 - occupational health
and safety management system
Certificates issued by CTEC are valid in all countries members of the EU.
6. Professional education, specialized seminars and trainings in
European technical legislation, Product certification, CE marking,
Quality management, etc.
www.ctec-sz.com
The CTEC office and laboratory equipment
www.ctec-sz.com
THANK YOU FOR YOUR ATTENTION!
eng. Blagovesta Shineva – Мanaging Director
Center for Testing and European Certification Ltd.
Stara Zagora 6006, 2, Industrialna Str.
tel..: +359 42 620 368, mob. +359 887 598 697
e-mail: [email protected] , website: www.ctec-sz.com
www.ctec-sz.com