www.ctec-sz.com
Center for Testing and
European Certification
 CE marking of technical products – bridge to the European market
 CTEC – general overview www.ctec-sz.com

 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

 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

89/686/EEC Personal protective equipment
90/385/EEC
92/42/EEC
93/15/EEC
93/42/EEC
94/25/EC
94/9/EC
95/16/EC
97/23/EC
98/79/EC
99/5/EC
Active implantable medical devices
Hot-water boilers
Explosives for civil uses
Medical devices
Recreational craft
Equipment and protective systems intended for use in potentially explosive atmospheres
Lifts
Pressure equipment
In vitro diagnostic medical devices
Radio and telecommunications terminal equipment
2000/9/EC
2004/108/EC
2004/22/EC
2006/42/EC
Cableway installations designed to carry persons
Electromagnetic compatibility
Measuring Instruments Directive
Machinery
2006/95/EC Low voltage directive
2009/105/EC (ex-87/404/EEC) Simple pressure vessels
2009/48/EC
2009/23/EC (ex-90/384/EEC)
Safety of toys
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.
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 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

DIRECTIVE 93/68/EEC www.ctec-sz.com

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

MANUFACTURER:
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.
DISTRIBUTOR:
Distributors must verify the presence of both the
CE marking and the necessary supporting documentation.
IMPORTER:
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.
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 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

 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

Great location in the central part of Bulgaria, at an equal distance to all Balkan neighbors.
www.ctec-sz.com

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

NB 1871 www.ctec-sz.com

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

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

www.ctec-sz.com

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: ctec@ctec-sz.com
, website: www.ctec-sz.com
www.ctec-sz.com