CE Marking & Technical File Compliance – Compliance Globally
CE Marking Compliance & Technical Construction File (TCF)
Ensure your products legally carry the CE mark across the European Economic Area (EEA). Utilizing the proven TÜV SÜD 6-step conformity methodology, we determine governing directives, assemble your Technical File, and draft legally binding EU Declarations of Conformity.
TÜV SÜD 6-Step Roadmap
Harmonised EN Standards Audit
Technical Construction File (TCF)
EU Declaration of Conformity (DoC)
EU Regulatory Desk Active
CE Technical Conformity Desk
Guiding manufacturers through Low Voltage (LVD), EMC, RED, Machinery, and RoHS directives.
Transparent European Market Packages
Full conformity with EU Regulations, direct representation, and guaranteed regulatory acceptance across all 27 Member States.
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Identification of governing directives and test report gap analysis.
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Applicable Directives Identification -
Harmonised EN Standards Checklist -
Self-Declaration Route (Module A) Audit -
Standard DoC Template Drafting
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Full Technical Construction File (TCF) assembly and review.
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Complete TCF Compilation & Verification -
Risk Assessment Matrix Documentation -
User Manual & Safety Warnings Review -
CE Label Dimension & Placement Layout -
Official Signed DoC Verification
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High-risk products requiring third-party Notified Body assessment.
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Module B/C/D Notified Body Dossier Packaging -
Notified Body Audit Coordination -
Complex Multi-Directive Integration -
Post-Audit Deficiencies Remediation
Mandatory European Documentation & Dossiers
Ensure smooth market entry and customs clearance across the EU Single Market.
Product Schematics & BOM
Circuit diagrams, mechanical drawings, and comprehensive Bill of Materials (BOM).
Laboratory Test Reports
Accredited test reports covering EMC, electrical safety (LVD), RoHS, or radio tests.
User Instructions & Manual
Manual translated into official languages of the target European distribution countries.
Risk Assessment Analysis
ISO 12100 or ISO 14971 product risk and hazard mitigation documentation.
Conformity & Market Access Roadmap
Structured European compliance verification from technical file review to official market release.
Directive Scoping
Identify every directive that applies to your product (e.g. EMC 2014/30/EU, LVD 2014/35/EU, RED 2014/53/EU).
Standards Verification
Verify testing conforms to the latest European Harmonised Standards published in the Official Journal.
Technical File Assembly
Compile the complete Technical Construction File (TCF) containing test reports, schematics, and risk analysis.
DoC Execution & CE Affixing
Execute the EU Declaration of Conformity and affix the CE marking with compliant typography and dimensions.
Frequently Asked Questions
Key regulatory guidance covering EU-REP mandates, CE marking directives, and EUDAMED requirements.
What are the 6 steps to CE marking?
1. Identify applicable directives; 2. Identify harmonised standards; 3. Determine conformity assessment route; 4. Compile Technical Construction File; 5. Draft Declaration of Conformity; 6. Affix CE mark.
Do all products require a Notified Body for CE marking?
No. Most consumer electricals, electronics, and toys fall under self-declaration (Module A). Only high-risk categories (medical devices, gas appliances, machinery with high hazard risk) require an authorized Notified Body.