CE Marking is mandatory for any entity placing products on the European market that fall under applicable EU Directives or Regulations. Specifically, it applies to manufacturers – the natural or legal persons responsible for designing and producing goods intended for sale or use within the European Union. The manufacturer is legally obligated to verify that the product meets all essential health and safety requirements, compile the Technical File affix the CE mark and issue the Declaration of Conformity.
What is CE Marking?
CE Marking is a mandatory requirement for a wide range of products placed on the European market. It indicates that a product complies with all applicable European Directives and Regulations, ensuring adherence to essential safety, health, environmental and consumer protection standards. Essentially, the CE mark acts as a "passport", allowing for the free movement of goods throughout the European Union.
Our company provides a comprehensiveCE Marking service tailored to manufacturers, importers and designers. We support our clients at every stage of the process: from identifyingapplicable regulations and conducting conformity assessments to drafting the Technical File and the EC Declaration of Conformity. When required, we also perform laboratory testing through our accredited facilities, ensuring that are recognized across Europe.
Mandatory CE Marking
CE Marking: who is required to comply?
These obligations also extended to authorized representatives, importers and distributors, particularly for products originating from non-EU countries. If an importer introduces a non-compliant product, they assume the same legal liabilities as the manufacturer. Furthermore, CE marking is required for custom-built machinery and equipment intended for in-house, provided they fall within the scope of the Machinery Directive (2006/42/EC), even if they are not intended for sale.
Products we certify
We partner with you throughout the entire journey to achieve CE compliance
Household Appliance
Conformity assessment for both small and large domestic appliances
Radio equipment
Expert support for CE marking in compliance with the RED Directive
Automation & Robotics
Technical consultancy and risks assessment for automated systems and industrial robots
Lighting
Verification of electrical, mechanical and EMC requirements for lighting fixtures and devices
Electrical equipment
Technical analysis and documentation management to ensure full regulatory compliance
Railway Sector
Support for the CE making of railway components in accordance with European standards
Industrial Machinery
Risk assessments, testing and technical documentation for individual machines and entire production lines
Electronic devices
Ensuring compliance with EMC, RoHS and LVD directives for electronic products
Laser Products
Technical analysis and classification according to EN 60825 standards
A small symbol with major benefits
Request a free quoteRequest a free quoteAccess to the EU Market
Enables the free movement and sale of your products across all European Union member states.
Safety Assurance
Certifies that the product has been designed and tested to meet rigorous EU safety requirements.
Competitive Advantage
Enhances product credibility and fosters trusts among customers and commercial partners.
Risk Mitigation
Minimizes the risk of legal penalties, customs delays or product recalls from the market.
How to obtain the CE Mark
(The StaLab Method)
We guide our clients through every step of the journey toward CE certification
Step 1: Identifying relevant European regulations
The first step is to identify the specific European directives applicable to your product. A single product may fall under one or more directives, such as the Machinery Directive, the EMC Directive or the Low Voltage Directive (LVD). This analysis is crucial for determining the mandatory requirements that must be met and whether the involvement of a Notified Body is required.
Correctly identifying the applicable directives is fundamental to setting up the entire compliance process correctly and preventing potential obstacles when placing the product on the market.
Una corretta individuazione delle direttive è fondamentale per impostare tutto il processo di conformità nel modo giusto e prevenire eventuali blocchi in fase di immissione sul mercato.
Step 2: Analysis of legal requirements and procedures
Once the applicable directives have been identified, we analyze the specific requirements of each to determine the best path for demonstrating compliance. During this phase, we evaluate the procedures set out by the regulations, the manufacturer’s specific responsibilities and whether the involvement of a Third-Party Notified Body is required.
Step 3: Selection and implementation of Harmonized Standards
Selecting the correct standards is crucial to addressing all relevant technical aspects, such as electrical safety, electromagnetic compatibility (EMC) or mechanical strength. Utilizing these standards provides a “presumption of conformity”, streamlining the path toward CE Marking.
European harmonized standards provide detailed specifications on how to design and manufacture a compliant product. By applying them, you ensure that the essential requirements of the directives are met through recognized and verifiable methods.
Step 4: Planning and execution of compliance testing
The resulting data supports the Technical File and the Declaration of Conformity. As an accredited laboratory, we perform these tests in-house, ensuring reliable and internationally recognized results.
The final phase involves planning and performing the technical tests required to demonstrate product conformity. These tests are defined based on the applicable standards and may include mechanical, electrical, thermal or environmental assessments.
Why choose StaLab
Selecting the right partner ensures your products gain safe and legal access to the European market.
FAQ
What is CE Marking?
The CE mark is a logo that, once affixed to a product, indicates compliance with all applicable European Union health and safety regulations, allowing it to be sold freely throughout the European Economic Area (EEA). This marking serves as a formal declaration of responsibility by the manufacturer, certifying that the product meets the requirements of all relevant European Directives.
Is CE Marking mandatory?
CE Marking is mandatory for certain products to be legally marketed within the European Economic Area (EEA). This mean that for products falling under specific categories, affixing the CE mark is a strict legal requirement.
Are laboratory tests and trials mandatory to obtain CE Marking?
Yes, in many cases, laboratory testing and trials are mandatory to obtain CE Marking. Many European Directives – such as those governing machinery, medical devices, or toys – explicitly require testing and verification to demonstrate product conformity.
What do i need to do to CE mark my product?
To affix the CE marking to a product, you must verify it conformity with all applicable European Directives, compile the Technical File and draft the EU Declaration of Conformity.
Is the CE Marking service provided by StaLab comprehensive?
Yes, StaLab provides end-to-end support throughout every phase of the process. We assist companies in liaising with accreditation bodies to achieve certification and supervise the creation of all required documentation – including the user manual and the Technical File – to effectively demonstrate compliance with all regulatory requirements.
I have imported a product from abroad: can i apply my own label?
Yes, you can apply your own label to a product imported from abroad, but it is essential to do so in compliance with current regulations and with a full understanding of the significant responsibilities involved.
When you import a product from a non-EU country and place it on the European Union market (including Italy), you legally become the person responsible for placing that product on the market. Consequently, the legal liability for product compliance and the accuracy of the labeling information rests entirely with the importer.
What is the Technical File?
The Technical File is a comprehensive collection of documents that proves a product’s compliance with specific regulations, particularly for CE Marking. Required by various EU directives, this file serves to demonstrate that the product meets all essential health and safety requirements, thereby permitting its sale and distribution within the European market.
What information is required to generate a quote for CE marking?
To receive a quote for CE Marking, you must provide specific details regarding the nature of the product, the applicable European directives and any existing technical documentation.
How much does CE marking cost?
The CE Marking itself does not have fixed cost or administrative fee. The expenses are primarily associated with specialist consultancy and any conformity assessment activities required to obtain the marking.
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