CE Marking: Scope, Conformity Assessment, and Technical File

CE marking requirements come from EU product legislation: to place a covered product on the market in the European Economic Area, the manufacturer must confirm which directive or regulation applies, run the conformity assessment that law prescribes, build a technical file, sign an EU Declaration of Conformity, and affix the CE mark according to strict design rules. Non-EU manufacturers additionally need a responsible person physically established in the EU. The mark is a manufacturer’s declaration of compliance with EU health, safety, and environmental rules, and it is what allows a product cleared in one of the 27 member states plus Iceland, Liechtenstein, and Norway to move freely to the others.

Confirm Your Product Is In Scope

CE marking applies only to product categories covered by specific EU legislation, part of what has been called the New Legislative Framework since 2008. If no directive or regulation covers your product, you must not affix the mark, and applying it improperly can trigger enforcement action.

Coverage is broad. Common examples include electrical equipment operating between 50 and 1,000 volts AC or 75 and 1,500 volts DC under the Low Voltage Directive 2014/35/EU¹; toys under Directive 2009/48/EC²; medical devices under Regulation (EU) 2017/745, classified in risk classes I, IIa, IIb, and III³; personal protective equipment under Regulation (EU) 2016/425⁴; machinery under Directive 2006/42/EC⁵; radio equipment under Directive 2014/53/EU⁶; gas appliances under Regulation (EU) 2016/426⁷; and construction products under Regulation (EU) No 305/2011.⁸ Construction products are slightly different: the CE mark signals conformity with the manufacturer’s declared performance rather than a fixed set of mandatory minimums, and it must be backed by a Declaration of Performance covering characteristics such as mechanical resistance and fire safety.⁹

If more than one law applies, you must comply with all of them before affixing the mark. If none applies, you should not use the mark at all.

Choose the Right Conformity Assessment Route

Each piece of EU legislation assigns one or more conformity assessment “modules” to its product category. Picking the wrong module can invalidate the whole certification, so start by reading the applicable law to see which options are open to you.

Module A: Self-Assessment

For lower-risk products where the legislation allows it, Module A (internal production control) lets the manufacturer do the work in-house: design analysis, risk assessment, testing, technical file, and Declaration of Conformity, with no third party involved.¹⁰ You carry the full burden of defending the assessment if authorities challenge it later.

Modules That Require a Notified Body

Higher-risk products need evaluation by a Notified Body, an organization officially designated by an EU member state to perform third-party assessments. The modules typically work in combinations:

Module B (type examination): a Notified Body examines the technical design and issues a type-examination certificate. Module B is always paired with a production-phase module.
Module C (conformity to type): the manufacturer internally verifies that production units match the approved type.
Module D (production quality assurance): a Notified Body audits and approves the production quality system.
Module F (product verification): a Notified Body tests individual products or statistical samples from each batch.
Module G (unit verification): a Notified Body examines every individual product, covering design and production. Usually reserved for one-off or very low-volume items.
Module H (full quality assurance): a Notified Body audits the quality system across design, production, and final inspection. Common for high-risk medical devices.

Find qualified Notified Bodies through the European Commission’s NANDO database, which lists each organization along with the specific legislation and product categories it is authorized to assess.¹¹ Each Notified Body has a four-digit identification number that must appear next to the CE marking whenever it was involved in the assessment.¹² Using an organization not listed in NANDO for a required assessment invalidates the certification.

Timelines vary widely. Self-assessment is the fastest and cheapest. When a Notified Body is involved, expect months rather than weeks; medical device conformity assessment typically takes between 9 and 24 months depending on device class and complexity, and can run longer for novel products. Notified Body fees depend on scope, product category, and current demand, so getting quotes from more than one is worthwhile.

Build the Technical File

Every CE-marked product needs a technical file assembled before it reaches the market. This is the evidence package that proves the product was designed and manufactured to comply. When market surveillance authorities ask for proof, this is what they ask for first.

At minimum, the file contains:

Design documentation, including drawings of the physical construction, components, and circuits.
A risk analysis identifying hazards and showing how the design addresses them.
A list of harmonized standards applied, demonstrating how each essential requirement is met.
Test reports covering areas such as electrical resistance, chemical composition, mechanical stress, or electromagnetic compatibility.
For batch or serial production, a description of the quality control processes that keep units consistent.
Instructions, safety warnings, and all labeling intended to accompany the product.

The file can be stored digitally, but it must be organized and available on request, and you should be able to show where and how it is maintained.¹³

The standard retention period is 10 years from the date the product is placed on the market, even if you discontinue it during that time. Implantable medical devices are an exception: technical documentation must be kept for at least 15 years after the last device covered by the declaration was placed on the market. If you appoint an authorized representative, they share the record-keeping obligation.¹⁴

Draft and Sign the EU Declaration of Conformity

The Declaration of Conformity is the legal document in which the manufacturer accepts responsibility for compliance. It has to include:

The manufacturer’s full name and registered business address.
A unique product identifier such as a serial number, model number, or type designation.
Every directive or regulation the product complies with, cited by number.
The harmonized standards or technical specifications used to demonstrate compliance.
The name and four-digit identification number of any Notified Body involved.
The signature of a person with legal authority to bind the manufacturer.

The declaration must be translated into the language or languages required by each member state where the product is sold, and requirements differ by country.¹⁵ Some accept English; others insist on the national language. For medical devices, the European Commission publishes a detailed language requirement table by country.¹⁶ Any discrepancy between the declaration and the actual product can result in goods being seized at the border. Update the declaration whenever the design changes materially or new legislation comes into effect.

Affix the Mark Correctly

The initials “CE” must follow official proportions. The mark can be different colors or solid or hollow lettering as long as it stays visible and legible. Minimum height is 5 millimeters unless product-specific legislation says otherwise, and any resizing must preserve the proportional relationship between the letters.¹²

The mark must be permanent and indelible under normal use. If the product is too small or its surface makes direct marking impractical, put the mark on the packaging, on a label attached to the product, or in the accompanying documentation. Where a Notified Body was involved, its four-digit number goes directly next to the CE mark.

One trap to know about: a “China Export” logo uses the same “CE” letters but with noticeably less spacing between them. The two are not interchangeable, and inspectors are trained to spot the difference.

If You Manufacture Outside the EU, Appoint a Responsible Person

Since July 16, 2021, Article 4 of Regulation (EU) 2019/1020 requires that a “responsible person” be physically established in the EU for products covered by the market surveillance framework.¹⁷ “Established” means a real physical presence such as a registered office or permanent place of business, not just a mailing address.

The responsible person can be the manufacturer (if it has an EU presence), an importer, an authorized representative appointed in writing, or a fulfilment service provider if none of the others exist in the EU. Their name and contact details must appear on the product, its packaging, or an accompanying document.

An authorized representative typically holds the technical file and Declaration of Conformity, answers requests from market surveillance authorities, and flags safety risks through the EU’s Safety Business Gateway.¹⁴ You can also authorize them to affix the CE mark or draft the Declaration of Conformity, but the manufacturer keeps ultimate responsibility for the product’s safety and design.

What Happens After the Product Reaches the Market

Enforcement shifts to surveillance authorities operating under Regulation (EU) 2019/1020.¹⁸ They conduct spot checks at retail and at the border, and they can demand your technical file at any time. Powers on finding non-compliance range from ordering corrective action to mandating a full recall. Customs can detain shipments over missing or suspicious markings, with storage costs and delivery delays falling on the manufacturer. Serious cases involving dangerous products can bring criminal prosecution and permanent market exclusion.

There is no single EU-wide fine schedule. Each member state sets its own penalty framework, and several authorize imprisonment for serious violations. Amounts vary significantly across the EU.

Changes Coming to the Framework

Several developments will change what CE marking requires over the next few years. Building them into your compliance planning now is cheaper than retrofitting later.

Cyber Resilience Act

The Cyber Resilience Act covers “products with digital elements,” meaning hardware and software with a connectable component. It entered into force on December 10, 2024. From September 11, 2026, manufacturers must report actively exploited vulnerabilities and security incidents. The main obligations, including CE marking to indicate cybersecurity compliance, apply from December 11, 2027.¹⁹ Scope is wide, running from baby monitors and smart watches to standalone software applications.

Ecodesign for Sustainable Products

The Ecodesign for Sustainable Products Regulation adds sustainability and circularity requirements that will gradually attach to CE-marked products. A central element is the Digital Product Passport, a digital record of a product’s environmental footprint, repairability, durability, and end-of-life handling, accessible through a data carrier on the product or packaging such as a QR code.²⁰ Rules on disclosing unsold consumer products that are destroyed apply from February 2027.²¹

New Machinery Regulation

Regulation (EU) 2023/1230 will replace the current Machinery Directive 2006/42/EC in 2027. Under the new regulation, only machinery listed in Annex I requires Notified Body involvement; all other in-scope machinery can use Module A self-assessment. Manufacturers designing machinery today should aim to satisfy both the current directive and the incoming regulation to avoid re-certification shortly after launch.

AI Act

The EU AI Act extends CE marking to high-risk AI systems, and if the AI is delivered digitally, a digital version of the mark must be accessible through the system’s interface.²² Rules for standalone high-risk AI systems listed in Annex III apply from August 2, 2026. Rules for high-risk AI embedded in already-regulated products, such as medical devices or machinery, apply from August 2, 2027.

New Toy Safety Regulation

A new Toy Safety Regulation entered into force on January 1, 2026 and will fully replace Directive 2009/48/EC on August 1, 2030.²³

A Note on Great Britain

CE marking is the EU/EEA regime. After Brexit, Great Britain (England, Scotland, and Wales) created its own UK Conformity Assessed (UKCA) marking, though the UK government has repeatedly extended recognition of CE marking rather than requiring an immediate switch. For medical devices, CE-marked devices compliant with EU MDR or IVDR can be placed on the GB market until June 30, 2030, with a consultation underway on indefinite recognition.²⁴ Northern Ireland continues to follow EU rules under the Windsor Framework, so CE marking remains valid there. A product can carry both marks if it meets both sets of rules.²⁵ Deadlines have shifted several times since Brexit, so anyone selling into GB should track UK policy separately.

1
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2
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3
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4
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5
European Agency for Safety and Health at Work. Directive 2006/42/EC – Machinery Directive
6
European Commission. Radio Equipment Directive (RED)
7
European Commission. Gas Appliances Regulation
8
Legislation.gov.uk. Regulation (EU) No 305/2011 – Laying Down Harmonised Conditions for the Marketing of Construction Products
9
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10
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11
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12
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13
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14
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15
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16
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17
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18
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19
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20
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21
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22
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23
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24
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25
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