CE mark applies to many product groups falling under the scope of EU legal acts designed to unify product requirements on the single market (Union harmonisation legislation). The requirement for the CE mark does not depend on where the product is manufactured; therefore, products manufactured in Vietnam must also meet the corresponding requirements when placed on the European Economic Area (EEA) market, which includes EU member states along with Iceland, Liechtenstein, and Norway.
 
I. WHAT IS THE CE MARK?
 
CE stands for "Conformité Européenne", which means "European Conformity". According to the European Commission's guidelines on CE Marking, by affixing the CE mark, the manufacturer declares and takes responsibility that the product meets the requirements of the applicable EU legislation. Depending on the product group, these requirements may relate to safety, health, environmental protection, electromagnetic compatibility, or performance.
 
The CE mark is not a quality certification, does not indicate the origin of the product, and does not mean the product has been inspected or approved by the European Commission or any EU agency. Businesses do not need to submit dossiers to a central EU agency to apply for "CE mark issuance."
 
The manufacturer is responsible for organizing the conformity assessment of the product. Depending on the applicable regulations, the manufacturer may conduct the assessment themselves or must involve a Notified Body—a conformity assessment body designated and notified by a competent authority under EU regulations.
 
Properly affixing the CE mark provides the basis for the product to be placed and circulated on the EEA market. However, products may still be inspected by customs or market surveillance authorities, who may request documentation proving conformity.
 

LEGAL BASIS FOR CE MARKING The CE mark is not governed by a single document applicable to all products. Businesses need to simultaneously consider: General legal framework, including Regulation (EC) No 765/2008 on the principles of using the CE mark and accreditation; Decision No 768/2008/EC on the responsibilities of economic operators and conformity assessment modules; and Regulation (EU) 2019/1020 on market surveillance and product compliance. Sector-specific directives and regulations, which identify the products within the scope of application, essential requirements, conformity assessment procedures, required documentation, and rules for affixing the CE mark. Guidance documents and standards, including the Blue Guide 2022 (not legally binding) and European harmonized standards, which are often applied voluntarily to create a presumption of conformity for the requirements covered by the standards.

 
LEGAL BASIS FOR CE MARKING
 
The CE mark is not governed by a single document applicable to all products. Businesses need to simultaneously consider:

• General legal framework, including Regulation (EC) No 765/2008 on the principles of using the CE mark and accreditation; Decision No 768/2008/EC on the responsibilities of economic operators and conformity assessment modules; and Regulation (EU) 2019/1020 on market surveillance and product compliance.
• Sector-specific directives and regulations, which identify the products within the scope of application, essential requirements, conformity assessment procedures, required documentation, and rules for affixing the CE mark.
• Guidance documents and standards, including the Blue Guide 2022 (not legally binding) and European harmonized standards, which are often applied voluntarily to create a presumption of conformity for the requirements covered by the standards.

II. WHICH PRODUCTS REQUIRE CE MARKING?
 
The CE mark is only mandatory for products falling within the scope of one or more EU harmonisation legislations that explicitly require this mark. The European Commission publishes a list of product legislation (Alignment of product legislation), outlining the directives and regulations applicable to each product group.
 
Some common product groups that fall under this scope include:

• Machinery and certain safety components;
• Electrical, electronic, and radio equipment;
• Toys and personal protective equipment;
• Medical devices and in vitro diagnostic medical devices;
• Pressure equipment, gas appliances, and equipment used in potentially explosive atmospheres;
• Lifts, cableway installations, and non-automatic weighing instruments;
• Construction products;
• Recreational craft, pyrotechnic articles, and certain types of unmanned aircraft (drones);
• Certain types of batteries and battery systems.

Note: The list above is for reference only. Not all products in these groups require CE marking. Whether a product requires the CE mark must be determined based on its characteristics, intended use, scope, and exclusions defined in each sector-specific legal act.
 
A product may simultaneously fall under the scope of multiple EU legal acts. In this case, the manufacturer must identify all applicable documents and prove that the product meets all relevant requirements.
 
If a product does not fall under the scope of any legal document requiring the CE mark, it must not be affixed with this mark. However, the product may still have to comply with Regulation (EU) 2023/988 on General Product Safety (GPSR) and other relevant regulations (e.g., chemicals, labeling, environment, or safety). The GPSR is not a basis for affixing the CE mark.
 
Responsibilities of Vietnamese Manufacturers
 
For Vietnamese businesses, if a product is placed on the market under the business's name or trademark, that business is considered the manufacturer and bears responsibility for the entire process of assessing, affixing the mark, and maintaining product conformity, even if the manufacturing process is outsourced.
 
The manufacturer may appoint an authorized representative in the EU/EEA in writing to carry out specified tasks, such as keeping records and coordinating with competent authorities. This does not shift the responsibility for ensuring conformity away from the manufacturer. Importers in the EU/EEA must also verify the documentation, CE mark, identification information, instructions, and warnings before placing the product on the market.
 
III. WHEN IS A NOTIFIED BODY REQUIRED?
 
A Notified Body is a conformity assessment body designated by an EU/EEA country and notified to the European Commission to perform specific tasks under a specific legal act.
 
Not all CE-marked products require assessment by a Notified Body:

• If the law permits internal control, the manufacturer can conduct the conformity assessment themselves.
• If the law requires third-party assessment, the manufacturer must select a Notified Body with the correctly notified scope.
• An organization with testing capabilities or accreditation certificates is not automatically a Notified Body.
• You must check the NANDO database for the organization's validity status, legal acts, product groups, and assessment modules it is authorized to perform.

A Notified Body may issue a certificate or assessment decision according to prescribed legal procedures. However, the manufacturer remains the entity that draws up the EU Declaration of Conformity and holds ultimate responsibility for the product.
 
All "voluntary CE certificates" issued by organizations without the proper status or scope of a Notified Body do not replace the legal conformity assessment process and do not prove the product has met all requirements for CE marking.
 
IV. CONFORMITY ASSESSMENT AND CE MARKING PROCESS
 
Step 1. Identify the product and the role of the business
Determine the product type, intended use, target user group, operating environment, configuration, version, accessories, software, and variants. Simultaneously, businesses must determine whether they are classified as a manufacturer under EU law, especially when the product is manufactured by another entity but placed on the market under the business's name or trademark.
 
Step 2. Identify all applicable legal acts
Compare the product's characteristics and intended use with the scope of each EU directive or regulation. You must simultaneously consider requirements relating to safety, electricity, electromagnetic compatibility, radio, restricted chemicals, energy efficiency, batteries, cybersecurity, and other sector-specific requirements, if any.
 
Step 3. Identify essential requirements, standards, and evidence
Create a linking matrix between legal acts, essential requirements, standards or technical solutions, tests, and evidence. When using harmonized standards, check the reference number, version, scope, and citation status in the Official Journal of the EU. Not all EN standards are harmonized, and a single test report is insufficient to prove all CE requirements. If other technical solutions are used, the manufacturer must prove that the solution meets the corresponding legal requirements.
 
Step 4. Select the conformity assessment procedure
Sector-specific legislation specifies whether the manufacturer can self-assess or must involve a Notified Body. Businesses must apply the correct assessment module prescribed for the product (usually modules A to H or their variants). If a Notified Body is required, verify their scope on NANDO before signing a contract.
 
Step 5. Risk assessment, testing, and production control
Manufacturers must identify hazards, assess risks, and apply control measures for both the intended use and reasonably foreseeable misuse. Testing, calculations, design inspections, and production controls must provide sufficient evidence of conformity; self-assessment does not mean exemption from these activities.
 
Step 6. Compile the technical file
Depending on the product and applicable legislation, technical documentation typically includes:

• Description, identification information, intended use, configurations, and product versions;
• Design drawings, diagrams, technical specifications, and manufacturing process information;
• List of applied legal acts, essential requirements, and standards or technical solutions used;
• Results of hazard identification, risk assessment, tests, calculations, and inspections;
• List of critical components, materials, and evidence of conformity control for mass production;
• Product labels, packaging, user manuals, and warnings;
• Certificates, reports, or decisions from a Notified Body, if applicable.

The file must be updated and kept for a period defined by sector-specific legislation, usually at least 10 years after the product is placed on the market. Some sectors have specific timeframes or requirements.
 
Step 7. Draw up and sign the EU Declaration of Conformity
The EU Declaration of Conformity is a legal document drawn up and signed by the manufacturer or their authorized representative within the permitted scope. The document typically must include:

• Name and address of the manufacturer and product identification information;
• A declaration stating the manufacturer's sole responsibility;
• The applied legal acts, standards, or technical documents;
• Notified Body information and relevant certificates, if any;
• Full name, position, signature of the authorized person, and the place and date of issue.

The declaration must be translated into the language(s) required by the national market where the product is supplied and kept alongside the technical documentation for the legally required period. Some sectors, especially construction products, use a specific type of declaration and document structure; a generic Declaration of Conformity template should not be applied mechanically.
 
Step 8. Affix the CE mark and complete product information
In principle, the CE mark must:

• Have the correct official shape and proportions;
• Be visible, legible, and indelible, usually with a minimum height of 5 mm, unless sector-specific legislation allows otherwise;
• Be affixed to the product or its data plate; if this is impossible due to the nature of the product, it can be affixed to the packaging or accompanying documents according to applicable regulations;
• Not be obscured by or confused with other marks.

The four-digit identification number of the Notified Body is only placed next to the CE mark when required by law and when that organization is involved in the corresponding production control phase. Possessing a report or certificate from a Notified Body does not automatically grant permission to place their identification number next to the CE mark.
 
Step 9. Maintain conformity after placing the product on the market
The manufacturer must ensure that mass-produced products continue to comply with the assessed documentation; monitor complaints, incidents, and non-conforming products; and issue warnings, reports, corrections, or recalls when necessary.
 
Re-evaluation should be considered when there are significant changes to the design, materials, components, software, intended use, manufacturing process, legal acts, standards, or conformity assessment methods.
 
The CE mark does not have a general validity period (like a standard three-year or five-year certificate). However, certificates issued by a Notified Body may carry specific validity conditions; the technical file and Declaration of Conformity must always accurately reflect the current status of the product.
 
V. WHERE SHOULD BUSINESSES START?
 
Businesses should start by clearly identifying the product, its intended use, configuration, target market, and existing technical documentation before ordering tests or selecting an assessment body. Correctly identifying the legal requirements and assessment methods right from the beginning helps minimize redundant testing, selecting the wrong organization, or having to redo documentation after the product has already been exported.
 
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