I. INTRODUCTION TO CE MARKING
CE Marking indicates the manufacturer's declaration that a product complies with the applicable European Union (EU) harmonisation legislation requiring the CE marking. Depending on the product group, the applicable requirements may relate to safety, health, environmental protection, electromagnetic compatibility, performance or other public interests protected by EU legislation.
The CE marking may only be affixed to products that fall within the scope of one or more EU legal acts requiring CE marking. Not every product sold in the EU/EEA is required or permitted to bear the CE marking. Before placing a product on the market, the manufacturer must identify all applicable requirements, carry out the relevant conformity assessment, prepare the technical documentation and EU Declaration of Conformity, and only then affix the CE marking when the legal conditions have been fulfilled.
CE is not a “quality certificate”, a certificate of origin or an approval issued by a central EU authority. The EU does not have a single authority that issues a “CE certificate” for all products. In many cases, the manufacturer may carry out the conformity assessment itself; where independent assessment is required by the applicable legislation, a Notified Body with the appropriate notified scope must be involved.
Four key principles to understand about CE Marking
The manufacturer is responsible for identifying the applicable legal requirements, assessing risks and conformity, preparing the technical documentation, drawing up the EU Declaration of Conformity and affixing the CE marking. Using a testing laboratory or other third party does not transfer this legal responsibility to that organization.
The level of third-party involvement depends on the applicable legislation and conformity assessment procedure for the specific product. Where a Notified Body is required, the business must verify the organization's notified scope in the EU NANDO database.
Harmonised standards may provide a presumption of conformity with the corresponding legal requirements when they are officially referenced. However, applying a standard does not replace the need to identify all applicable EU legislation and essential requirements for the product.
The manufacturer must ensure that the product complies when it is placed on the EU market. The technical documentation and EU Declaration of Conformity must be updated when the product, legislation or relevant information changes.
Which product groups are commonly subject to CE Marking?
The list below is for illustration only. A specific product may be subject to several directives/regulations at the same time, as well as other legal requirements beyond CE Marking.
Electrical, electronic and radio equipment
Products may fall under the Low Voltage Directive 2014/35/EU, EMC Directive 2014/30/EU, Radio Equipment Directive 2014/53/EU, RoHS and other related requirements.
Machinery
Machinery Directive 2006/42/EC currently remains applicable; Regulation (EU) 2023/1230 will replace it from 20 January 2027. Businesses should pay particular attention to the transitional provisions.
Personal protective equipment
Personal Protective Equipment Regulation (EU) 2016/425 provides different conformity assessment routes depending on the risk category; some categories require the involvement of a Notified Body.
Medical devices
Medical Devices Regulation (EU) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 establish specific risk classifications and conformity assessment procedures.
Pressure equipment, ATEX, gas appliances, lifts and measuring instruments
These product groups are governed by sector-specific directives/regulations and often have detailed conformity assessment requirements based on modules or product categories.
Toys, construction products, drones and other product groups
CE Marking is also required for many other product groups. EU legislation continues to evolve, so the applicable legal act and application date should always be checked when the product is placed on the market.
Note for businesses outside the EU: Regulation (EU) 2019/1020 requires, for certain product groups covered by EU harmonisation legislation, an economic operator established in the EU to be responsible for specific compliance tasks. Depending on the circumstances, this may be an EU-based manufacturer, importer, authorised representative or fulfilment service provider. The identification and contact details of the economic operator must be provided as required by the applicable legislation.
What is the difference between CE Marking, a Notified Body and a “CE certificate”?
CE Marking
CE Marking indicates the manufacturer's declaration of compliance with the applicable EU legislation. The manufacturer affixes the CE marking after completing the required conformity assessment procedure and related legal obligations.
Notified Body
A Notified Body is a conformity assessment body notified by an EU Member State to the European Commission to perform specific tasks under particular legislation and within the scope published in NANDO.
Voluntary certificate
A voluntary certificate issued by an organization without the appropriate authority cannot replace the legally required CE procedure. Businesses should not treat a commercial “CE certificate” as legal evidence where the applicable legislation does not recognize it or where the issuer is not a Notified Body with the correct scope.
Technical Documentation and EU Declaration of Conformity
Technical documentation must be prepared before the product is placed on the market and must enable the competent authority to assess the conformity of the product's design, manufacture and operation. The exact content depends on the applicable legislation, but it commonly includes:
- Description and identification of the product, model/type/serial number or other appropriate traceability information.
- Design information, drawings, diagrams, technical specifications and information on the manufacturing process.
- Identification of applicable EU legal acts and essential requirements.
- Risk assessment and the design/control measures used to address identified risks.
- List of harmonised standards or other technical solutions used.
- Calculation results, test reports, assessment records and Notified Body documentation where applicable.
- Information on the manufacturer/authorised representative as required.
- Product identification and the manufacturer's statement of responsibility.
- List of applicable EU directives/regulations and referenced standards/technical solutions.
- Information on the Notified Body and relevant certificate where required by the procedure.
- Place and date of issue, name/position and signature of the authorised person.
Document retention: general EU guidance states that Technical Documentation and the EU Declaration of Conformity must normally be kept for at least 10 years after the product has been placed on the market, unless the applicable sector-specific legislation specifies a different period. Businesses should verify the exact requirement for the relevant product group.
- European Commission / Your Europe – CE marking.
- Conformity assessment – EU product rules.
- Preparing technical documentation.
- EU New Legislative Framework – legislation by product sector.
- Regulation (EU) 2019/1020 on market surveillance and compliance of products.
- Regulation (EU) 2023/988 on general product safety, relevant to consumer-product safety where specific harmonised rules do not fully cover the risk.
- NANDO – database of EU Notified Bodies.
II. CONFORMITY ASSESSMENT AND CE MARKING PROCESS
There is no single CE certification process for every product. The specific route depends on the product type, applicable EU legislation, risk level and the conformity assessment module/procedure required by law. The process can be summarized in the following six steps:
Identify the product characteristics, intended use and target market, and review all potentially applicable directives/regulations. A product may be subject to several EU legal acts at the same time. If the product is not covered by legislation requiring CE Marking, the CE marking must not be affixed voluntarily.
Identify the relevant safety, health, environmental, performance or other applicable requirements; verify the harmonised standards referenced for the correct legal act and edition. Where harmonised standards are not applied, or are only partly applied, the manufacturer must demonstrate conformity using other appropriate technical solutions.
Check the conformity assessment module/procedure permitted by the applicable legislation. Where self-assessment is allowed, the manufacturer carries it out under its own responsibility. Where a Notified Body is required, select an organization with the correct identification number and notified scope in NANDO for the relevant product, legislation and procedure.
Carry out the necessary risk analysis, inspections, calculations and testing; collect evidence relating to design and manufacture; and complete the Technical Documentation. Where a Notified Body is involved, complete the applicable assessment activities such as type examination, quality-system assessment or production control according to the required module.
Once sufficient evidence of conformity is available, the manufacturer prepares and signs the EU Declaration of Conformity and assumes legal responsibility for the product's compliance with all EU legislation listed in the declaration. The content and language must meet the requirements of the market where the product is supplied.
Affix the CE marking in the correct form, proportions and location before the product is placed on the market; the normal minimum height is 5 mm unless product-specific legislation provides otherwise. The Notified Body identification number accompanies the CE marking only where required by the applicable procedure. The manufacturer must then continue to control production, update documentation, address non-compliant products and cooperate with market-surveillance authorities.
III. KEY POINTS FOR BUSINESSES
The starting point must be to determine which EU legislation applies to the product. Purchasing a certificate that is outside the relevant scope does not create a right to affix the CE marking and may misrepresent the product's compliance status.
For example, an electrical device with radio connectivity may simultaneously be subject to RED, RoHS and other requirements. The EU Declaration of Conformity should reflect all applicable legislation, not just one testing standard.
The EU regulatory framework changes over time. For example, Machinery Regulation (EU) 2023/1230 will replace the Machinery Directive from 20 January 2027; long-term CE planning should therefore take transitional periods into account.
Standards help demonstrate conformity, but the legal obligations arise from the applicable directive/regulation. Businesses should verify whether the standard is officially referenced and the corresponding scope of the “presumption of conformity”.
Businesses outside the EU should determine the role of the importer, authorised representative or other economic operator under the applicable legislation; contact information and the ability to provide compliance documentation are important elements of market-surveillance checks.
The manufacturer must maintain conformity in series production, update documentation when changes occur, take corrective or recall action where necessary, and cooperate with market-surveillance authorities.
CONTACT INFORMATION
GIC VIETNAM
Hanoi: 12F, 14 Lang Ha Building, Giang Vo Ward
Tel: 024 6275 2268 | Hotline: 0984 609 469
Email: tuandm@gicvn.vn
Ho Chi Minh City: R502, 160 Nam Ky Khoi Nghia
Tel: 028 3930 7936
