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CE Marking

Your gateway to the European market

What is it?

What is CE Marking?

CE Marking (Conformité Européenne) is a mandatory conformity marking for products placed on the market within the European Economic Area (EEA).

By affixing the CE marking, the manufacturer declares that the product complies with all applicable EU health, safety and environmental protection requirements. It allows the free movement of products across all EEA member states.

Importantly, CE marking is not a quality mark, nor does it indicate the product's origin or that it was made in Europe. It is a legal declaration of conformity made by the manufacturer under their own responsibility.

CE Marking
Obligations

Who must comply?

CE marking is required for any product that falls under one or more EU directives or regulations that provide for it — before it can be sold in the EEA. Different economic operators carry different responsibilities:

Manufacturers

Bear the primary responsibility: ensure conformity, compile the technical file, draw up the Declaration of Conformity and affix the CE marking.

Authorised Representatives

Appointed in writing by a non-EU manufacturer to act on their behalf for specified tasks within the Union.

Importers

Must verify the manufacturer has carried out conformity assessment, the technical file exists and the CE marking is correctly affixed.

Distributors

Must act with due care, checking that the CE marking and required documents (e.g. instructions) are present before making products available.

Note: A product that is not covered by any EU directive must not bear the CE marking. Affixing it incorrectly is itself a breach of the rules.
Supply-chain responsibility: If the manufacturer has not affixed the CE marking — or is established outside the EU and has appointed no authorised representative — the obligation shifts onto the next operator in the supply chain. An importer or distributor who places such a product on the market under their own name or trademark, or who supplies a non-compliant product, is then treated as the manufacturer and assumes the full corresponding responsibilities.
Legal Framework

EU Directives & Harmonised Standards

Each product category is governed by specific EU directives or regulations (often called "New Approach" / New Legislative Framework legislation). A single product may fall under several of them at the same time — for example a powered machine may need to meet the Machinery, Low Voltage and EMC requirements simultaneously.

Machinery Low Voltage (LVD) Electromagnetic Compatibility (EMC) Toys Safety Personal Protective Equipment (PPE) Medical Devices (MDR) Construction Products (CPR) Pressure Equipment (PED) Radio Equipment (RED) ATEX Gas Appliances … and more

Harmonised standards (EN standards whose references are published in the Official Journal of the EU) translate the legal requirements into concrete technical specifications. Applying them is voluntary — but a product manufactured in accordance with a harmonised standard benefits from a "presumption of conformity" with the corresponding essential requirements, greatly simplifying the route to compliance.

In practice: identifying every applicable directive and the right harmonised standards is the most critical — and most error-prone — step. This is where expert support saves time and avoids costly mistakes.
Step by step

The CE Marking Process

Identify the applicable directives & regulations

Determine which EU legislation applies to the product, based on its type, intended use and characteristics.

Identify the relevant harmonised standards

Find the EN standards that cover the essential requirements and provide presumption of conformity.

Determine the conformity assessment route

Establish whether self-assessment is sufficient or whether a Notified Body must be involved, according to the product's risk module.

Test & assess the product

Carry out the required testing, examinations and risk assessment to demonstrate conformity with the applicable essential requirements. Testing may be performed:

  • In-house — where the manufacturer possesses the necessary test equipment, technical competence and calibrated instruments. The most cost-effective route when internal capability exists.
  • At an external accredited laboratory — required when (a) the applicable directive or module mandates independent third-party testing, (b) the manufacturer lacks the equipment or accredited competence, or (c) the evidential value of the Technical File needs reinforcement. External testing fees vary considerably by product type, test method and scope; they are charged directly by the laboratory and are separate from MBO's consulting fee and from any Notified Body fees.

For higher-risk product categories (e.g. medical devices, ATEX, pressure equipment), the conformity assessment module assigned by the directive may specifically require testing at a laboratory designated or approved by the Notified Body — an additional cost factor to budget for at the outset.

Compile the technical file

Assemble the technical documentation (design, manufacturing, test reports, risk analysis, manuals) and keep it available for the authorities.

Draw up the Declaration of Conformity

Issue and sign the EU Declaration of Conformity (DoC) — or Declaration of Performance (DoP) for construction products.

Affix the CE marking

Apply the CE marking visibly, legibly and indelibly to the product — adding the Notified Body's number where one was involved.

Third-party assessment

When is a Notified Body involved?

The conformity assessment route depends on the risk level of the product. For lower-risk products the manufacturer may self-declare conformity; for higher-risk products the applicable directive requires the involvement of a Notified Body — an independent organisation officially designated by an EU member state to carry out conformity assessment tasks (e.g. EC type-examination, audits, certificate issuance).

Self-declaration

  • Lower-risk products
  • Manufacturer performs internal production control
  • Manufacturer assumes full responsibility
  • No third party required

Notified Body required

  • Higher-risk products
  • Independent, designated organisation
  • EC type-examination, audits, certification
  • Its 4-digit number appears next to the CE marking
Budgeting your compliance

Understanding Testing & Verification Costs

One of the most variable — and often underestimated — components of CE marking is the cost of product testing. Understanding what drives these costs early in the project avoids unpleasant surprises.

Testing by the manufacturer

  • Applies when the applicable conformity assessment module permits internal testing
  • Manufacturer uses its own test equipment and qualified personnel
  • Calibrated and traceable instruments are mandatory
  • Results are documented in the Technical File
  • Lowest direct cost — but requires investment in test capability

External accredited laboratory

  • Required when the directive mandates independent testing or when in-house capability does not exist
  • Laboratory must be accredited (ESYD or equivalent ILAC member)
  • Costs vary significantly by product category, test standard and number of samples
  • For Notified Body routes, the NB may designate a specific laboratory or conduct testing itself
  • Test reports form a critical part of the Technical File
MBO's role: We identify which tests are required under each applicable directive, assess whether they can be performed in-house or must go to an external laboratory, and connect you with suitable accredited facilities where needed. This assessment is carried out during the initial project scoping phase so that testing costs are known before they are incurred — not discovered after the Technical File is already drafted.
European Conformity CE mark vs China Export symbol
Watch out

The genuine CE mark vs look-alikes

The authentic European Conformity mark has precisely defined proportions and spacing between the two letters. A visually similar "China Export" symbol — with the letters placed closer together — is sometimes found on products and does not signify European conformity.

When applying the CE marking, the official geometric grid and minimum dimensions must be respected so the mark is correct, legible and legally valid.

Need help with CE Marking?

We handle the full process — directive analysis, harmonised standards, technical file, risk assessment and Declaration of Conformity — so your product reaches the market with confidence.

Talk to our experts