Why Is CE Marking Required? CE Marking Compliance Services in Vietnam - Updated EU Regulatory Requirements 2026

CE Marking Compliance Services in Vietnam – Updated EU Regulatory Requirements 2026

CE marking is a mandatory conformity marking required for many categories of products placed on the European Union (EU) and European Economic Area (EEA) markets.

The CE marking demonstrates that a product complies with applicable European Union legislation relating to:

• Safety
• Health
• Environmental protection
• Electromagnetic compatibility
• Chemical restrictions
• Consumer protection
• Product performance

Under updated EU regulatory requirements through 2026, CE compliance may be governed by:

• EU Directives
  and/or
• EU Regulations

depending on the applicable product category.

Responsibility for CE Marking

Responsibility for CE marking lies with the economic operator placing the product on the EU market, including:

• EU manufacturers
• Importers
• Authorized Representatives (AR)
• Distributors
• Non-EU manufacturers supplying products into the EU

The responsible party must ensure that the product complies with all applicable EU legislative requirements before the product is placed on the market.

Manufacturer Responsibilities

Before affixing the CE marking, the manufacturer is responsible for:

• Determining applicable EU legislation
• Conducting conformity assessment activities
• Performing product risk assessment
• Preparing and maintaining Technical Documentation (Technical File)
• Issuing the EU Declaration of Conformity (DoC)
• Ensuring product traceability and regulatory compliance

Technical documentation must generally be retained for at least:

• 10 years after the last product is placed on the market

depending on the applicable legislation.

Importer Responsibilities

Importers placing products from outside the EU onto the EU market must verify that:

• The manufacturer has completed the required conformity assessment procedure
• Technical documentation is available upon request
• The product bears required markings and identification
• The EU Declaration of Conformity is available
• Regulatory contact information is maintained

Importers also assume certain regulatory obligations under:

• MDR
• IVDR
• GPSR
• Battery Regulation
• and other EU legislation

Distributor Responsibilities

Distributors must exercise due care to ensure that:

• Products comply with applicable EU requirements
• CE marking and labeling are properly applied
• Required documentation accompanies the product
• Storage and transportation conditions do not compromise compliance

National market surveillance authorities may request evidence demonstrating that distributors have fulfilled their obligations.

Rebranding / Own Brand Labelling (OBL)

If importers or distributors place products on the market under:

• their own brand name,
  or
• modify the product,

they may assume the legal responsibilities of the manufacturer.

In such cases, they must maintain sufficient technical knowledge and documentation related to:

• Product design
• Manufacturing process
• Product conformity
• Technical risk assessment

General Requirements for CE Marking

The following principles apply to CE marking:

• Products subject to applicable EU legislation must comply before being placed on the EU market
• Manufacturers are solely responsible for identifying applicable legislation
• Products may only be marketed if all applicable conformity assessment procedures have been completed
• The manufacturer must prepare:
• EU Declaration of Conformity (DoC)
  or
• Declaration of Performance (DoP) for construction products
• CE marking must be visible, legible, and indelible
• Additional markings must not create confusion with the CE marking

Notified Body (NB) Involvement

Certain higher-risk product categories require mandatory involvement of an EU Notified Body (NB), including:

• Medical devices
• Pressure equipment
• PPE Category III
• ATEX equipment
• Construction products
• Certain machinery and safety products

Depending on applicable legislation and product classification, conformity assessment may involve:

• Product testing
• Technical review
• Factory audit
• Quality system assessment
• Certification review

Notified Bodies are designated by EU Member States and published in the:

• NANDO (New Approach Notified and Designated Organisations) database.

Technical Documentation (Technical File)

Technical Documentation is a critical part of CE compliance and may include:

• Product description
• Technical drawings
• Bill of Materials (BOM)
• Design data
• Risk assessment
• Test reports
• EN harmonised standards
• Manufacturing information
• Labelling and IFU
• Verification & validation records
• Declaration of Conformity
• Post-market surveillance records where applicable

The Technical File must demonstrate compliance with applicable EU requirements.

Updated EU CE Regulations & Directives (2026)

VINTECOM International supports compliance with the latest EU legislation, including:

• RED Directive 2014/53/EU
• LVD Directive 2014/35/EU
• EMC Directive 2014/30/EU
• Machinery Regulation (EU) 2023/1230
• MDR Regulation (EU) 2017/745
• IVDR Regulation (EU) 2017/746
• PED Directive 2014/68/EU
• PPE Regulation (EU) 2016/425
• ATEX Directive 2014/34/EU
• CPR Regulation (EU) No 305/2011
• RoHS Directive 2011/65/EU & (EU) 2015/863
• REACH Regulation (EC) No 1907/2006
• GPSR Regulation (EU) 2023/988
• Battery Regulation (EU) 2023/1542
• WEEE Directive 2012/19/EU
• Energy Labelling Regulation (EU) 2017/1369
• Ecodesign / ESPR framework
  and other applicable EU regulatory requirements.

VINTECOM International CE Compliance Services

VINTECOM International provides:

• CE Marking consulting
• EU regulatory compliance consulting
• Technical file preparation
• Product risk assessment
• EN standard interpretation
• Product testing coordination
• RoHS & REACH consulting
• PED / MDR / IVDR documentation support
• Factory audit preparation
• Independent technical assessment
• Supplier compliance support
• Notified Body coordination support
• EU market access consulting

VINTECOM International supports manufacturers, OEM/ODM suppliers, exporters, industrial companies, and FDI enterprises in achieving EU regulatory compliance and international market access.