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Asil Patent ve Danışmanlık — TÜRKPATENT Marka Sicili 188 · Patent Sicili 167

Service

CE Marking Consulting

Duration
3-9 months depending on product module

The CE mark — a "European Conformity" declaration required to place products on the EU single market. Not a certificate but a legal declaration made by the manufacturer; however, independent Notified Body assessment is mandatory for most products. Under the Türkiye-EU Customs Union, CE marking is required for product sales from Türkiye to the EU.

Asil's role: identifying applicable EU directives, harmonised standards, technical file preparation, Notified Body selection and audit accompaniment. The manufacturer applies the CE mark itself; the independent body's role varies by product group.

§1 Which products require CE?

CE marking is mandatory for products covered by EU New Approach Directives:

Product groupDirective
Machinery2006/42/EC Machinery
Electrical equipment2014/35/EU LVD + 2014/30/EU EMC
Medical devices(EU) 2017/745 MDR
Construction products(EU) 305/2011 CPR
Toys2009/48/EC Toy Safety
Personal protective equipment(EU) 2016/425 PPE
Pressure equipment2014/68/EU PED
Lifts2014/33/EU LIFT
Radio equipment2014/53/EU RED

Your product may be subject to multiple directives (e.g., medical electrical device = MDR + LVD + EMC + RED).

§2 Process

StepDuration
Product analysis + applicable directive identification2-3 weeks
Harmonised standard scan (EN norms)1-2 weeks
Risk analysis + essential health/safety requirements (EHSR)3-4 weeks
Technical documentation preparation6-10 weeks
Test requirements list + test laboratory2-4 weeks
Notified Body selection + application1-2 weeks
Testing + assessment (varies by module)4-8 weeks
EC Certificate + EU Declaration of Conformity2-3 weeks
CE mark application + packaging1 week

Total: 3-9 months depending on product complexity.

§3 CE assessment modules

EU directives offer different module paths (Module A-H):

  • Module A — Manufacturer self-declaration (low-risk products)
  • Module B — Type examination (Notified Body prototype approval)
  • Module D — Production quality assurance (similar to ISO 9001)
  • Module H — Full quality assurance (high-risk + medical devices)

Asil plans the appropriate module and Notified Body selection together with you.

§4 Notified Bodies

Main Notified Bodies in Türkiye:

  • TSE (Notified Body no: 1783)
  • TÜV Rheinland Türkiye
  • TÜV SÜD Türkiye
  • Bureau Veritas Türkiye
  • SGS Türkiye
  • DEKRA Türkiye

There are 1,500+ Notified Bodies in Europe; for some niche product groups, no Turkish NB exists → selection from EU. Asil identifies the appropriate NB based on your product type and budget.

§5 CE vs TSE — do you need both?

  • CE = mandatory for EU market, not sufficient alone for Turkish domestic market
  • TSE = for Turkish domestic market, not recognised in the EU
  • For exporter + domestic firms, both make sense (shared technical file)

See our TSE Certification page.

§6 Counterfeit CE warning

"China CE" — fake marking seen on customs-evading products. Identical look but stands for "China Export" — not legitimate. Using a CE mark without Notified Body certification results in administrative fines (10,000-300,000 TRY) under TGM product safety inspection in Türkiye.

§7 Ministry of Trade support

Exporter firms can receive support for CE certification expenses from the Ministry of Trade:

  • Market Access Certificate Support
  • Overseas Brand + Certification Support

Detailed matching available in our Incentive Guide.

Sources

  1. EU Regulation 765/2008 on Accreditation
  2. EU New Approach Directives (New Legislative Framework)
  3. T.C. Ministry of Industry and Technology, Product Safety and Inspection guides
  4. Türkiye-EU Customs Union Association Council Decision 1/95

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