CE marking, frequently asked questions
CE · Pillar
Twenty-two questions that come up in virtually every CE marking project, phrased as they are asked in project meetings, with answers you can use without circumlocution. Organised into seven themes: legal status, costs and lead times, geographic scope, standards and tests, sub-assemblies and modifications, online sales and obligations, special cases.
Legal status of CE marking
Section titled “Legal status of CE marking”Is CE marking a certification?
Section titled “Is CE marking a certification?”No, not strictly. For most electronic products it is a self-declaration made by the manufacturer under its own responsibility. No third party "issues" the CE marking. The term "CE certification" is a linguistic shortcut that causes a lot of confusion, including in official tender documents.
The only categories where a third-party (Notified Body) intervention is mandatory are higher-risk products: medical devices from Class IIa, pressure equipment above certain thresholds, non-automatic weighing instruments, ATEX. For most common electronic products (EMC, LVD, RED, RoHS), Module A, self-declaration, is the standard route.
Who can affix the CE marking?
Section titled “Who can affix the CE marking?”The manufacturer itself, or its authorised representative established in the EU if explicitly appointed by written mandate. The importer cannot affix the marking on the manufacturer's behalf; it can only verify that it is correctly affixed and that documentation is provided. The distributor has no responsibility for affixing.
For private label (product designed by A, sold under B's brand), B is the manufacturer in the regulatory sense and affixes the marking in its name. A is the subcontractor that transmits documentation.
Costs and lead times
Section titled “Costs and lead times”How much does CE marking cost?
Section titled “How much does CE marking cost?”For a typical connected electronic product, the budget envelope for first certification is around:
- €6,000 to €15,000, lab EMC tests
- €5,000 to €15,000: LVD safety tests
- €6,000 to €20,000, radio tests if applicable
- €8,000 to €25,000: RED 3.3 cybersecurity tests (since August 2025)
- €2,000 to €6,000, file constitution and formalisation
- €0 to €30,000: Notified Body, if required
Plan a further 30 to 50 % margin for retests after modifications. A simple non-radio certification can land around €10,000 to €15,000; a full cellular IoT certification reaches €60,000 without difficulty.
How long does it take to obtain CE marking?
Section titled “How long does it take to obtain CE marking?”- 4 to 6 weeks: simple product, perfectly applied standards, immediate lab availability.
- 8 to 12 weeks: typical case of a Wi-Fi/BLE IoT product with one or two iterations.
- 3 to 6 months: complex product, Notified Body involved, or multiple major iterations.
Lab lead time alone is 4 to 8 weeks in western Europe in 2026. The most recognised labs (TÜV, DEKRA, Bureau Veritas) sometimes have 12-week waiting times on RED 5G or cybersecurity tests.
Geographic scope
Section titled “Geographic scope”What happens after Brexit for the United Kingdom?
Section titled “What happens after Brexit for the United Kingdom?”CE marking is no longer sufficient for placing products on the market in Great Britain (England, Wales, Scotland); UKCA marking is required. The CE recognition period has been extended several times and some categories have indefinite recognition, notably consumer electronics since the August 2023 government announcement. Northern Ireland remains under the CE regime (Northern Ireland Protocol), with complementary UKNI marking in some cases.
Does Switzerland accept CE marking?
Section titled “Does Switzerland accept CE marking?”Yes for most products covered by the EU-Switzerland MRA. But the gradual erosion of the MRA since 2021 has meant that Switzerland reintroduces its own requirements on certain categories, notably medical devices and machinery. Verify case by case with the Swiss OFCOM for radio equipment and ASIT for pressure equipment.
Standards and tests
Section titled “Standards and tests”Is the "China Export" marking a CE marking?
Section titled “Is the "China Export" marking a CE marking?”No. It is a visually similar acronym used by some Asian manufacturers, with no legal value: it appears in no official European text. Its presence on a product attracts suspicion during checks and can justify suspension of marketing pending verification. To be avoided for any product destined for the European market.
The typographic differences from official CE are subtle (letter spacing, C curvature) but detectable by a trained eye. The rule is simple: retrieve the official vector file from European Commission sources and apply it without deformation.
What if a harmonised standard is withdrawn during marketing?
Section titled “What if a harmonised standard is withdrawn during marketing?”Units already placed on the market remain valid. For units produced after the date of withdrawal of the presumption, two options:
- Apply the updated version of the standard and redo affected tests.
- Demonstrate conformity via an alternative technical case (harder to build and defend).
Rapid transition is generally the reasonable choice, especially for widely used standards. See Standards.
Can I use a CB Scheme report for CE conformity?
Section titled “Can I use a CB Scheme report for CE conformity?”The CB Scheme (Conformity Body Scheme) is an international mutual recognition programme for test reports managed by the IEC. A CB report from a recognised lab can serve as a basis for LVD tests if the underlying IEC standard is harmonised in equivalent EN.
Practically:
- A CB report per IEC 62368-1 can be reused to demonstrate conformity with EN 62368-1, with an addendum covering the national differences (the European Annex Z).
- A CB report does not cover EMC (CISPR/EN 55032 etc.) nor RED, distinct European tests are needed.
Sub-assemblies and modifications
Section titled “Sub-assemblies and modifications”Does a Wi-Fi module already CE-marked exempt me from RED marking for my final product?
Section titled “Does a Wi-Fi module already CE-marked exempt me from RED marking for my final product?”No, this is one of the most common errors. The module's marking covers the module taken in isolation. Once integrated into a final product, it is that product that must be assessed and marked. Radio tests can be partially reused if integration conditions are identical to those tested by the module manufacturer (antenna, power supply, environment), which is rare in practice.
Rule of thumb: if the antenna, ground plane, or power supply of the module differs from the manufacturer's evaluation kit, redo at minimum the Article 3.2 tests (efficient use of spectrum). See also Common pitfalls.
Do I need to redo CE marking after a software update?
Section titled “Do I need to redo CE marking after a software update?”It depends on the impact:
- No impact on essential requirements (bug fix, new application feature): no new assessment.
- EMC impact (clock frequency change, I/O timing modification): new EMC assessment.
- Radio impact (power change, band addition, modulation change): new RED Article 3.2 assessment, updated DoC.
- Safety impact (thermal management change, watchdog, battery protection): new LVD assessment and updated file.
Cybersecurity (RED 3.3) adds since 2025 a requirement for documented update management, the procedure itself must appear in the file.
How do I handle an OTA update that modifies radio firmware?
Section titled “How do I handle an OTA update that modifies radio firmware?”If the update modifies a parameter covered by radio tests (transmit power, frequency band, modulation, duty cycle), it triggers a RED reassessment and a DoC update. The RED directive treats the hardware + firmware as a system, a substantial firmware change may require a new assessment even if the hardware is unchanged.
Practically, mature manufacturers lock radio parameters in firmware with a signature that prevents their modification by developers without going through quality.
What happens for spare parts and accessories?
Section titled “What happens for spare parts and accessories?”Spare parts identical to original parts remain covered by the main product's marking. Replacing a motherboard or battery with an identical reference part does not trigger a new assessment.
Spare parts sold separately to the end user for their own assembly fall under distinct CE marking if they belong to a directive. For example, a mains charger sold separately must have its own LVD CE marking; a battery sold as a replacement must conform to EN 62133.
Online sales and obligations
Section titled “Online sales and obligations”Must the CE marking appear in the user manual?
Section titled “Must the CE marking appear in the user manual?”Yes, in addition to marking on the product itself. The instruction manual must also include the DoC, either the complete declaration or the simplified DoC (Article 10(9) of the RED directive) which may link to a URL where the full DoC is available. All manuals must be translated into the official languages of the Member States of placement.
For France: French is mandatory. A manual exclusively in English is a ground for withdrawal, even if the product is technically conforming otherwise.
Can I sell my product online without an authorised representative in the EU?
Section titled “Can I sell my product online without an authorised representative in the EU?”No since 2021. Regulation 2019/1020 requires an economic operator established in the EU to be responsible for every product placed on the market: EU manufacturer, importer, authorised representative, or a logistics service provider acting in that role. Without this, the marketplace must refuse listing and the product is exposed to withdrawal.
Since the Digital Services Act (2024), very large platforms (Amazon, AliExpress, eBay...) must verify the economic operator before listing a professional seller. Several platforms have been sanctioned in 2024-2025 for control failures.
What if my product is defective after placing on the market?
Section titled “What if my product is defective after placing on the market?”Regulation (EU) 2019/1020 imposes withdrawal and recall procedures based on severity:
- Immediate notification of market surveillance authorities of the affected country.
- Suspension of placing on the market of remaining units.
- Recall procedure for consumers and distributors.
- Traceability: serial numbers, sales records, identification of distribution channels.
The ability to execute a recall rapidly is an implicit obligation of any manufacturer, building it into the quality system from the start avoids panic.
My product is only for professional use, am I exempt from CE marking?
Section titled “My product is only for professional use, am I exempt from CE marking?”No, except for specific provisions of a directive. The EMC, LVD, RED, RoHS directives apply regardless of B2C or B2B status. The only effect of professional use may be to use the industrial EMC emission class (Class A) rather than residential (Class B), which is more permissive on emission limits, but requires an explicit warning to the end user in return.
Special cases
Section titled “Special cases”How do I handle a product covered by multiple directives?
Section titled “How do I handle a product covered by multiple directives?”All applicable directives apply cumulatively. For a typical IoT product, six directives may intervene (EMC, LVD, RED, RoHS, REACH, Ecodesign). Two approaches for the DoC:
- A single DoC covering everything, most practical in B2C. The DoC explicitly cites each directive with its number and year, and lists the harmonised standards applied for each.
- Multiple dedicated DoCs, one per directive, more used in B2B or for products with distinct regulatory lifecycles.
The single CE marking applied to the product covers all applicable directives, there is no CE marking per directive.
How does CE marking work for a product with eSIM?
Section titled “How does CE marking work for a product with eSIM?”A product with eSIM (embedded SIM card remotely reprogrammable) is considered cellular radio equipment under RED 2014/53/EU. The eSIM itself is not CE-marked as such, it is an integrated component without separate commercial existence. But the product as a whole must be assessed against applicable cellular standards (EN 301 908).
Operator profiles installed on the eSIM do not change the product's CE status. An Orange profile replaced by a Vodafone profile by OTA does not impact the assessed radio parameters.
What must I include in the user manual beyond operating instructions?
Section titled “What must I include in the user manual beyond operating instructions?”At minimum:
- Manufacturer and EU representative identification, company name, address, contact.
- Intended use conditions, environment, restrictions, target audience.
- Safety warnings from the risk analysis.
- Technical characteristics, voltage, power, consumption, radio bands.
- WEEE marking for end-of-life (crossed-out bin).
- Simplified DoC for radio products, with URL to full DoC.
- CE marking legible, indelible.
Everything must be translated into the official languages of targeted Member States. A manual in English only for France is a systematic ground for recall.
What is the scope of CE marking compared to GDPR?
Section titled “What is the scope of CE marking compared to GDPR?”CE marking attests conformity to product law (safety, EMC, radio, RoHS, REACH, etc.). GDPR concerns personal data law and is distinct.
However, since RED 3.3(e) in 2025, certain personal data protection requirements integrate the CE scope for connected radio products, without replacing GDPR. A product compliant with RED 3.3(e) remains independently subject to GDPR for actual data processing.
In practice: product design must account for both regimes, which reinforce each other but do not substitute.
How long must I retain the technical file?
Section titled “How long must I retain the technical file?”10 years from the placing on the market of the last unit produced. Concretely, for a product marketed from 2020 to 2024, the file must be available until 2034.
Retention may be physical or electronic, but must be accessible to authorities on request within a reasonable delay. For a non-EU manufacturer, it is the representative who assumes this accessibility.
Beyond the legal obligation, many manufacturers retain files longer to manage warranty returns, range evolutions, and product support. Retention of 15 to 20 years is not exceptional for industrial products.
Sources & references
- Regulation (EU) 2019/1020, market surveillance , EUR-Lex eur-lex.europa.eu/eli/reg/2019/1020/oj
- The European Commission's Blue Guide (2022) , European Commission op.europa.eu/en/publication-detail/-/publication/cc198e36-5957-11ec-91ac-01aa75ed71a1