CE Marking Certification
Demonstrate compliance with European Union safety, health, and environmental requirements and legally place your products on the EU market with CE Marking.
What is CE Marking Certification?
CE Marking Certification is a mandatory conformity marking that confirms a product complies with European Union (EU) safety, health, and environmental protection requirements. It is legally required for products covered under specific EU Directives before being placed on the European market.
Legal Compliance
CE Marking is required by law for many product categories. Without CE compliance, products cannot be legally sold or distributed within the EU and EEA markets.
Not a Quality Label
The CE Mark is not a quality certification. It represents the manufacturer’s declaration that the product meets all applicable EU regulatory requirements.
Manufacturer Responsibility
By affixing the CE Mark, the manufacturer takes full responsibility for the product’s conformity, safety, and compliance with EU legislation.
Why is CE Marking Mandatory?
CE Marking is mandatory under European Union (EU) law. Products covered under EU Directives and Regulations must comply with CE requirements before they can be placed on the European market.
Legal Market Access
Without CE Marking, products cannot be legally sold, distributed, or imported into the European Union and European Economic Area (EEA).
Customs & Regulatory Approval
EU customs authorities verify CE compliance. Non-compliant products may be detained, rejected, or banned from entering the European market.
Consumer Safety Protection
CE Marking ensures products meet essential safety, health, and environmental protection requirements, reducing risks to users.
Manufacturer Responsibility
By applying the CE Mark, the manufacturer takes full legal responsibility for product compliance with applicable EU legislation.
Avoid Penalties & Product Recall
Non-compliant products may face fines, forced recalls, legal action, or permanent market withdrawal.
Free Movement Across EU
CE Marking allows compliant products to move freely across all EU and EEA member states without additional national approvals.
Products Covered Under CE Marking
CE Marking is mandatory for various products regulated under European Union (EU) Directives and Regulations. These products must comply with CE requirements before being placed on the European market.
Electrical & Electronic Equipment
Electrical products within defined voltage limits requiring LVD and EMC compliance.
Machinery & Industrial Equipment
Machines and mechanical equipment covered under EU Machinery safety requirements.
Medical Devices
Medical products regulated under EU MDR to ensure patient safety and performance.
Construction Products
Construction materials and products covered under EU Construction Products Regulation.
Personal Protective Equipment (PPE)
Safety equipment such as helmets, gloves, and protective clothing.
Toys & Children’s Products
Toys regulated under strict EU safety directives to protect children.
Pressure Equipment
Pressure vessels, boilers, and related equipment covered under EU safety rules.
Gas Appliances
Gas-fired appliances requiring EU safety and performance compliance.
Applicable EU Directives & Regulations
CE Marking compliance depends on identifying the correct European Union (EU) Directives and Regulations applicable to your product. Each directive defines specific safety, health, and performance requirements.
Low Voltage Directive (LVD)
Applies to electrical equipment operating within defined voltage limits to ensure protection against electrical hazards.
EMC Directive
Ensures that electrical and electronic equipment does not generate or suffer from electromagnetic interference.
Machinery Directive
Covers machinery and industrial equipment to ensure essential health and safety requirements are met.
Medical Device Regulation (MDR)
Regulates medical devices to ensure patient safety, performance, and clinical reliability.
PPE Regulation
Applies to personal protective equipment designed to protect users against health and safety risks.
Pressure Equipment Directive (PED)
Covers pressure vessels, boilers, and related equipment operating under pressure.
Construction Products Regulation (CPR)
Applies to construction products placed on the EU market with declared performance.
CE Marking Certification Process
The CE Marking Certification process follows a structured step-by-step approach to ensure products comply with applicable European Union (EU) Directives and Regulations before entering the European market.
Product Identification
Identify the product type, intended use, and applicable EU Directives or Regulations.
Directive & Compliance Route
Determine the correct conformity assessment route and Notified Body involvement.
Risk Assessment
Identify potential hazards and ensure essential safety and health requirements.
Product Testing & Evaluation
Conduct required testing as per applicable EU harmonised standards.
Technical Documentation
Prepare the technical file including design data, test reports, and risk analysis.
Declaration & CE Marking
Issue EU Declaration of Conformity and affix the CE Mark to the product.
Documents Required for CE Marking
To obtain CE Marking, manufacturers must prepare and maintain specific technical and compliance documents. These documents demonstrate that the product meets applicable European Union (EU) Directives and Regulations.
Technical File
A complete technical file including product design details, drawings, specifications, and compliance evidence as required by EU Directives.
Risk Assessment Report
Documentation identifying potential hazards and measures taken to eliminate or reduce risks in accordance with EU safety requirements.
Test Reports
Reports from accredited laboratories confirming compliance with applicable EU standards and directive requirements.
User Manual & Instructions
Operating instructions, safety information, and warnings provided in the required EU languages.
Declaration of Conformity (DoC)
A formal declaration issued by the manufacturer stating that the product complies with all applicable EU Directives and Regulations.
Quality Control Records
Internal production control or quality system records demonstrating consistent product conformity.
Role of Notified Body in CE Marking
A Notified Body is an independent organization designated by an EU member state to assess product conformity under specific EU Directives and Regulations. Not all products require Notified Body involvement; it depends on the product category and risk level.
What is a Notified Body?
A Notified Body is authorized by the European Union to perform conformity assessments, testing, inspections, and certification for products covered under specific EU Directives.
When is Notified Body Required?
Notified Body involvement is mandatory for high-risk products such as medical devices, PPE Category III, pressure equipment, and certain machinery as defined by EU regulations.
When is Self-Declaration Allowed?
For low-risk products, manufacturers may issue a self-declaration of conformity without involving a Notified Body, provided all applicable EU requirements are fulfilled.
Responsibilities of a Notified Body
The Notified Body reviews technical documentation, conducts assessments or audits, and issues certificates where required under applicable conformity assessment modules.
CE Mark with Notified Body Number
When a Notified Body is involved, its four-digit identification number must be displayed next to the CE Mark on the product, label, or packaging.
DSB Cert Support
DSB Cert assists manufacturers in determining whether Notified Body involvement is required and coordinates with appropriate EU Notified Bodies to ensure compliance.
CE Marking Validity & Market Surveillance
CE Marking does not expire automatically. However, manufacturers must ensure ongoing compliance with applicable EU Directives. EU authorities actively monitor products through market surveillance to verify continued conformity.
CE Marking Validity
CE Marking remains valid as long as the product design, manufacturing process, and applicable EU legislation remain unchanged. Any modification may require reassessment to maintain compliance.
Ongoing Manufacturer Responsibility
Manufacturers are legally responsible for maintaining CE compliance even after the product is placed on the market. Compliance is a continuous obligation, not a one-time approval.
Market Surveillance by EU Authorities
EU authorities may inspect products, review technical documentation, and request evidence of compliance at any time.
Technical File Maintenance
The technical file must be maintained and made available to authorities for the minimum period specified in the applicable EU Directive.
Product Changes & Reassessment
Changes in design, materials, suppliers, or harmonised standards may require re-evaluation to ensure continued CE compliance.
Penalties for Non-Compliance
Failure to maintain CE compliance may result in fines, product withdrawal, recalls, or market restrictions imposed by EU authorities.
Why Choose DSB Cert for CE Marking?
Choosing the right certification partner is critical for successful CE Marking. DSB Cert provides structured, transparent, and end-to-end CE Marking support to help manufacturers achieve EU compliance without unnecessary delays or costs.
CE Compliance Done Right
CE Marking is not just documentation — it is a legal responsibility. At DSB Cert, we focus on accuracy, regulatory clarity, and long-term compliance, not shortcuts that create future risks.
Our consultants work closely with manufacturers and exporters to ensure that every CE Marking decision is technically correct, cost-efficient, and aligned with EU law.
End-to-End CE Marking Support
From product identification and directive mapping to technical documentation and Declaration of Conformity, we manage the complete CE Marking process.
Correct Directive Mapping
We identify the exact EU Directives and Regulations applicable to your product, avoiding incorrect testing, delays, and unnecessary compliance costs.
Notified Body Coordination
Where required, we coordinate with appropriate EU Notified Bodies to ensure smooth, compliant, and timely certification.
Export-Focused Approach
Our CE Marking solutions are designed specifically for manufacturers and exporters targeting the European market.
Time & Cost Efficiency
Structured processes and expert guidance reduce certification timelines and eliminate avoidable compliance costs.
Transparent & Reliable Support
Clear communication, practical guidance, and reliable support throughout the entire certification journey.
Frequently Asked Questions (FAQ)
Common questions related to CE Marking certification, process, compliance, and audit requirements explained clearly.
Is CE Marking mandatory for all products?
Can an Indian manufacturer apply for CE Marking?
How long does CE Marking certification take?
What documents are required for CE Marking?
What is the validity of CE Marking?
Is testing always required for CE Marking?
Can small food businesses apply for CE Marking certification?
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CE Marking Certification
CE Marking is a mandatory conformity marking required for products placed on the European Union (EU) market, ensuring compliance with safety, health, and environmental regulations.
Why CE Marking is Mandatory
Legal Market Access
Mandatory for selling products in EU & EEA.
Consumer Safety
Ensures essential safety and health protection.
Manufacturer Responsibility
Legal declaration of product compliance.
Products Covered
Electrical & Electronic
LVD & EMC regulated products.
Machinery
Industrial & mechanical equipment.
Medical Devices
Products regulated under EU MDR.
PPE
Protective equipment for user safety.
CE Marking Process
Product Identification
Identify applicable EU directives.
Risk Assessment
Identify and mitigate hazards.
Testing
Testing as per EU standards.
Documentation
Prepare technical file.
Declaration
Issue EU Declaration of Conformity.
Frequently Asked Questions
Only for products under EU directives.
Yes, CE Marking is open to non-EU manufacturers.
