[Home](/)/[Resources](/resources)/CE Marking Overview EUEnd-to-end Compliance Roadmap # CE Marking Overview CE marking is a manufacturer's declaration that a product meets all applicable EU essential requirements. It is mandatory for most electrical, electronic, and mechanical products sold in the EU and EEA — and is self-assessed by the manufacturer, not approved by a government body. Copy Link[Share on WhatsApp](https://wa.me/?text=https%3A%2F%2Fkrono-labs.com%2Fguides%2Fce-marking) At a glance Directives covered 7 Process steps 6 FAQs 6 ## What is CE marking? CE marking (from the French _Conformité Européenne_) is a mandatory conformity mark for products sold within the European Economic Area. The CE mark on a product signals that the manufacturer has assessed the product against all applicable EU directives and declares it meets those requirements. CE marking is not a quality mark and is not awarded by any European institution. It is a self-declaration by the manufacturer — or their EU-based Authorised Representative — and is backed by a technical file retained by the manufacturer. Market surveillance authorities in each Member State can request that file at any time to verify the declaration. Affixing the CE mark without completing the conformity assessment is a criminal offence in all EU Member States and can result in product recalls, market bans, and personal liability for company directors. ## Key CE marking directives RED ### Radio Equipment Directive 2014/53/EU [Guide →](/guides/red-directive-compliance) Any product with intentional radio transmission — Wi-Fi, Bluetooth, Zigbee, LoRa, cellular, NFC. EMC ### EMC Directive 2014/30/EU [Guide →](/guides/emc-directive-compliance) All electrical and electronic equipment that can cause or be affected by electromagnetic disturbances. LVD ### Low Voltage Directive 2014/35/EU [Guide →](/guides/ce-lvd-testing) Equipment operating at 50–1000V AC or 75–1500V DC — mains-powered devices, chargers, and power supplies. RoHS ### RoHS Directive 2011/65/EU [Guide →](/guides/rohs-directive-compliance) All electrical and electronic equipment — restricts 10 hazardous substances in components and materials. MDR ### Medical Device Regulation (EU) 2017/745 [Guide →](/guides/ce-marking-for-medical-devices-mdr) Any device intended to diagnose, monitor, prevent, treat, or alleviate a medical condition. Machinery ### Machinery Regulation (EU) 2023/1230 [Guide →](/guides/eu-machinery-regulation) Machinery, interchangeable equipment, safety components, and lifting accessories. GPSR ### General Product Safety Regulation (EU) 2023/988 [Guide →](/guides/gpsr-compliance-guide) All consumer-facing products not covered by sector-specific safety legislation (from December 2024). Most hardware products are covered by two or more directives simultaneously — for example, a Wi-Fi IoT device sold to consumers typically needs RED, RoHS, and GPSR at minimum. ## How to obtain CE marking 01 Identify applicable directives Determine which EU product directives apply to your product based on its radio capabilities, voltage, intended use, and target users. Most hardware products fall under 2–4 directives simultaneously. 02 Select harmonised standards For each applicable directive, identify the relevant harmonised standards from the Official Journal. Applying these standards gives presumption of conformity — you don't need to prove compliance from first principles. 03 Test at an accredited laboratory Commission the required tests at an ILAC MRA-accredited laboratory. For radio products under RED, formal radio and EMC testing is required. Safety tests under LVD typically need separate accredited lab reports. 04 Compile the CE Technical File Assemble all evidence into a technical file: product description, risk assessment, BOM, test reports, labels, and user instructions. This file is not submitted to any body — it is retained and presented if market surveillance authorities request it. 05 Sign the EU Declaration of Conformity Draft and sign the EU DoC, listing all applicable directives and harmonised standards used. The DoC is a legal document — the manufacturer (or their EU-based Authorised Representative) takes personal responsibility for its accuracy. 06 Affix the CE mark Apply the CE mark to the product, packaging, or instructions. The mark must be at least 5mm high and visually proportional. If a Notified Body was involved in the conformity assessment, their four-digit identification number follows the CE mark. ## What goes in the CE Technical File? The technical file is the evidence package that justifies the CE mark. It is not submitted to any authority — it is compiled and retained by the manufacturer for at least 10 years and made available on request to market surveillance authorities. * Product description and intended use * Bill of materials (BOM) with RoHS-relevant components identified * Essential requirements analysis — article-by-article mapping to evidence * List of harmonised standards applied (with version numbers and OJ status) * Test reports from accredited laboratories * Risk assessment * Conformity assessment procedure followed (Module A, B+C, etc.) * EU Declaration of Conformity * User instructions and labelling artwork * Notified Body certificate (if applicable) ## Frequently Asked Questions ### Is CE marking the same as government approval? No. CE marking is a manufacturer's self-declaration — it means the manufacturer declares that the product meets all applicable EU essential requirements. No EU body reviews or approves products bearing the CE mark (with the exception of certain high-risk categories that require Notified Body involvement, such as Class IIa+ medical devices and Annex I machinery). ### Which products require CE marking? CE marking is required for any product covered by a CE marking directive that is placed on the EU or EEA market. This includes electrical and electronic equipment, radio products, machinery, medical devices, toys, pressure equipment, and personal protective equipment, among others. Purely passive accessories with no electronic content may be outside scope — use the Compliance Requirements tool to check your specific product. ### Do I need a Notified Body for CE marking? For most product types, no. The majority of consumer electronics, IoT devices, and general EEE can self-certify using Module A (internal production control) by applying harmonised standards. A Notified Body is mandatory for: certain radio products where no harmonised standard exists, Class I sterile/measuring and all Class IIa+ medical devices, Annex I high-risk machinery under the Machinery Directive, and some other high-risk categories. ### How long must CE documentation be retained? The EU Declaration of Conformity and technical file must be retained for 10 years after the last unit is placed on the EU market for most directives. Medical devices have a 15-year retention requirement (30 years for implantables). Retention starts from the last manufacturing date, not the first sale date. ### Can I sell a CE-marked product in the UK? CE marking is not valid in Great Britain (England, Scotland, Wales) — you need UKCA marking for those markets. Northern Ireland still accepts CE marking under the Windsor Framework. UKCA technical requirements closely mirror CE, and many test reports are accepted for both, but a separate UK Declaration of Conformity is required. ### What happens if my harmonised standard is updated or withdrawn? When the Official Journal withdraws or restricts a harmonised standard, citing it in a Declaration of Conformity no longer provides presumption of conformity. You must update your DoC to reference the new or replacement standard. Products already on the market before the transition date can typically remain in circulation, but any new units shipped after the deadline must reference a currently listed standard. **Disclaimer:** This page is an educational resource based on official EU sources. It is not legal or engineering advice. Always verify current directive and standard status in the Official Journal before placing any product on the EU market. 🇪🇺 CE Marking roadmap for your product Every standard, document, and test that applies — free, no account required. See your free roadmap Learn this properly In-depth course that teaches the full process, not just this one answer. [Start the course — $149](/courses/01-ce-marking-for-electronics-engineers)[Prefer to read? 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