TL;DR -- CE marking is a manufacturer's self-declaration that a product meets all applicable EU directives. No government agency issues it. No fee to use the mark. You identify the directives that apply, test against harmonized standards, compile a Technical Construction File, sign a Declaration of Conformity, and affix the mark. Most consumer electronics can be self-declared without a Notified Body. The process takes 4 to 12 weeks and costs €3,000 to €40,000 depending on your product's complexity.
CE marking is not a certification
This trips up almost every team coming from the FCC world. FCC certification involves submitting an application to a Telecommunication Certification Body, which reviews your test data and issues a grant. CE marking has no equivalent step for most electronics.
CE marking is a legal declaration by the manufacturer that a product conforms to all applicable EU health, safety, and environmental directives. You make the claim. You sign the Declaration of Conformity. You affix the mark. If the product turns out to be non-compliant, the legal liability is yours -- not the test lab's, not a certification body's.
This makes the process simpler than FCC in one way: there is no submission-and-review bottleneck. But it is also unnerving, because nobody checks your work before products hit the market. EU market surveillance authorities can request your Technical Construction File at any time, and non-compliance can mean product recalls, fines up to €100,000 per violation (varies by member state), and being blocked from the market entirely.
The process at a glance
Ten steps from "we want to sell in Europe" to a product on the shelf. Each is covered in detail below.
flowchart TD
A["1. Identify applicable\nEU directives"] --> B["2. Determine harmonized\nstandards for each directive"]
B --> C["3. Choose conformity\nassessment route"]
C --> D["4. Design for compliance\n(pre-compliance testing)"]
D --> E["5. Formal testing at\naccredited lab"]
E --> F["6. Compile Technical\nConstruction File"]
F --> G["7. Sign Declaration\nof Conformity"]
G --> H["8. Affix CE mark\nto product"]
H --> I["9. Appoint EU Authorized\nRepresentative (if non-EU)"]
I --> J["10. Place on EU market"]
style A fill:#1e3a5f,color:#fff
style E fill:#1e3a5f,color:#fff
style G fill:#1e3a5f,color:#fff
style J fill:#1e3a5f,color:#fff
Step 1: Identify which EU directives apply
The first question is not "what tests do I need?" It is "which EU directives does my product fall under?" Each directive covers a different aspect of product safety and performance, and most electronic products fall under multiple directives simultaneously.
| Directive | Scope | Applies When |
|---|---|---|
| EMC Directive 2014/30/EU | Electromagnetic compatibility | Almost all electronic equipment |
| Low Voltage Directive (LVD) 2014/35/EU | Electrical safety | Equipment rated 50 -- 1000V AC or 75 -- 1500V DC |
| Radio Equipment Directive (RED) 2014/53/EU | Radio and wireless equipment | Any device with an intentional radio transmitter |
| RoHS Directive 2011/65/EU | Hazardous substances restriction | All electrical and electronic equipment |
| WEEE Directive 2012/19/EU | Waste electronics recycling | All EEE placed on the EU market |
| Batteries Regulation (EU) 2023/1542 | Battery safety and sustainability | Any product with embedded batteries |
Two rules simplify this for most hardware teams:
If your product has a radio (WiFi, Bluetooth, cellular, LoRa, Zigbee, NFC), RED applies -- and RED subsumes the EMC Directive. You don't need separate EMC Directive compliance for the radio portions. RED wraps EMC, radio spectrum, and safety into one directive. It does use its own EMC standards though (EN 301 489 series instead of EN 55032/55035), so the testing is different even if you skip the EMC Directive paperwork.
If your product operates below 50V AC / 75V DC, LVD does not apply. Most battery-powered consumer devices fall below this threshold. RED covers basic safety for radio equipment in this voltage range.
Common directive combinations
| Product Type | Directives Required | Typical Total Cost |
|---|---|---|
| USB-powered sensor (no radio) | EMC + RoHS | €3,000 -- €6,000 |
| AC-powered electronics (no radio) | EMC + LVD + RoHS | €6,000 -- €15,000 |
| WiFi/BT consumer device (battery) | RED + RoHS | €8,000 -- €15,000 |
| AC-powered WiFi/BT device | RED + LVD + RoHS | €12,000 -- €25,000 |
| Multi-radio device (WiFi + BT + cellular) | RED + LVD + RoHS | €20,000 -- €40,000 |
Not sure which directives apply to your product? Our requirements tool maps your device profile to the applicable directives and standards.
Step 2: Determine the harmonized standards
Each directive defines "essential requirements" in broad terms -- the product must be safe, must not cause interference, must not contain hazardous substances. Harmonized standards translate those broad requirements into specific, testable criteria.
Using a harmonized standard creates a "presumption of conformity." If your product meets EN 55032, it is presumed to meet the EMC Directive's emissions requirements. You can technically demonstrate conformity through other means, but in practice, everyone uses the harmonized standards. Doing anything else invites scrutiny from market surveillance authorities and may require Notified Body involvement.
The EU publishes the list of harmonized standards for each directive in the Official Journal of the European Union. Here are the standards that matter for most electronics:
| Directive | Key Harmonized Standards | What They Test |
|---|---|---|
| EMC | EN 55032 (emissions), EN 55035 (immunity) | Radiated/conducted emissions; ESD, surge, radiated/conducted immunity |
| LVD | EN 62368-1 (IT/AV/comms equipment) | Electrical safety, fire safety, thermal safety, mechanical safety |
| RED (radio) | EN 300 328 (2.4 GHz), EN 301 893 (5 GHz), EN 303 687 (6 GHz) | Radio parameters: power, bandwidth, frequency accuracy, spurious emissions |
| RED (EMC) | EN 301 489-1 (general), EN 301 489-17 (broadband) | EMC for radio equipment |
| RED (RF exposure) | EN 62311 | SAR or MPE assessment |
| RED (cybersecurity) | EN 18031-1, -2, -3 | Network protection, personal data, fraud prevention |
| RoHS | EN IEC 63000:2018 | Technical documentation for hazardous substance assessment |
Watch the version numbers. Harmonized standards get revised, and using a withdrawn version does not create the presumption of conformity. When you start your project, check the Official Journal to confirm the current version. Your test lab should know, but verify.
Step 3: Choose your conformity assessment route
For most consumer electronics, this step is simple: you self-declare. But you should know when that changes.
Self-declaration (Module A) covers most electronics. You or your test lab run the tests, you compile the documentation, you sign the Declaration of Conformity. Nobody reviews your file before you go to market.
Notified Body involvement is required in specific situations:
- Radio equipment where no harmonized standard exists for a particular essential requirement
- Medical devices classified as Class IIa or above
- Certain categories of machinery, pressure equipment, and marine equipment
- Products where you choose not to follow the harmonized standard (rare for electronics)
For a WiFi sensor, a Bluetooth speaker, an IoT gateway -- self-declaration is almost always sufficient. You don't wait for a government review. You do the work, declare conformity, and go to market.
If a Notified Body is required, expect to add €3,000 to €15,000 and 4 to 8 weeks for their review and EU-type examination certificate. The NANDO database (New Approach Notified and Designated Organisations) on the European Commission website lists Notified Bodies by directive and product category.
Step 4: Design for compliance and pre-compliance testing
This step happens during product development, not after. Teams that bake compliance into their design from the start spend less time and money at the formal test lab. Teams that don't find out the hard way.
EMC design principles that apply equally to FCC and CE:
- Controlled impedance on high-speed signal traces
- Solid, unbroken ground planes under signal layers
- Proper filtering on power inputs and I/O connections
- Shielding for sensitive circuits and high-frequency oscillators
- Short, direct return paths for switching regulators
CE-specific considerations that FCC does not force you to think about:
- Immunity. FCC does not test immunity. CE does. Design for ESD resilience (TVS diodes on exposed ports, proper grounding of connectors), surge protection on AC power inputs, and RF immunity of sensitive analog circuits.
- Safety. If LVD applies, you need adequate creepage and clearance distances, proper fusing, flame-rated enclosure materials, and touch temperature management. EN 62368-1 uses a hazard-based safety engineering approach -- classify your energy sources as ES1/ES2/ES3 and ensure appropriate safeguards exist for each.
- Cybersecurity. Since August 2025, internet-connected radio equipment must meet EN 18031 requirements. Design in secure boot, encrypted communications, password management, and vulnerability update mechanisms from the start.
Pre-compliance testing drops the first-pass failure rate from roughly 50% to under 10%. The same pre-compliance setup that works for FCC works for CE emissions. For immunity, a commercial ESD gun (under €2,000) catches the single most common immunity failure mode. Full immunity pre-compliance is harder to do in-house, but even basic ESD testing saves thousands in rework.
Step 5: Formal testing at an accredited lab
Book time at an ISO/IEC 17025 accredited laboratory. While there is no strict legal requirement to use an accredited lab for self-declared products, accredited results carry much more weight with market surveillance authorities, and most retailers and importers require them.
What the lab will test
The test plan depends on which directives apply. Here is a representative test campaign for a WiFi/BT consumer device with AC power -- the most common profile:
| Standard | What It Tests | Lab Time | Approximate Cost |
|---|---|---|---|
| EN 300 328 | 2.4 GHz radio parameters | 1 -- 2 days | €2,000 -- €3,500 |
| EN 301 893 | 5 GHz radio parameters | 1 -- 2 days | €2,000 -- €3,500 |
| EN 301 489-1/-17 | EMC for radio equipment | 2 -- 3 days | €2,000 -- €5,000 |
| EN 62368-1 | Electrical safety | 2 -- 5 days | €3,000 -- €8,000 |
| EN 62311 | RF exposure (SAR/MPE) | 1 day | €500 -- €2,000 |
| EN 18031-1/2 | Cybersecurity | TBD | Pricing still forming |
| IEC 61000-4-2 | ESD immunity | 0.5 day | €300 -- €600 |
| IEC 61000-4-3 | Radiated immunity | 1 -- 2 days | €1,000 -- €3,000 |
| IEC 61000-4-4 | EFT/Burst | 0.5 day | €300 -- €600 |
| IEC 61000-4-5 | Surge | 0.5 day | €300 -- €600 |
| IEC 61000-4-6 | Conducted immunity | 0.5 day | €300 -- €600 |
| IEC 61000-4-11 | Voltage dips/interruptions | 0.5 day | €300 -- €600 |
| RoHS | Material composition verification | 1 -- 3 days | €500 -- €2,000 |
Total lab time: 10 to 20 days. Total testing cost: €12,000 to €30,000 for this product class.
For a detailed cost breakdown by product type, see our CE marking cost guide.
Practical lab tips
Bring everything. The lab needs your device with all accessories, cables, power supply, and peripherals it ships with. They also need operating mode documentation, a block diagram, and the firmware version you intend to ship.
Run FCC and CE in the same campaign if you can. Emissions measurements use similar setups. A combined campaign at a single lab saves 20 to 30% versus running each market independently. Run the shared emissions tests first, then add CE immunity testing right after.
Budget for failure. Roughly half of products fail EMC testing on their first attempt. That is not a scare tactic; it is an industry-wide number. If you fail, the lab may be able to help troubleshoot on-site. Each fail-fix-retest cycle adds 2 to 6 weeks. This is the single strongest argument for pre-compliance testing.
For guidance on selecting a lab, see our how to choose an EMC test lab guide.
Step 6: Compile the Technical Construction File
The Technical Construction File (TCF) is the documentation package that proves your product meets all applicable directives. You must keep it available for 10 years after the last unit is placed on the EU market. Any market surveillance authority in any EU member state can request it.
The TCF is where CE gets heavy in a way that surprises teams coming from FCC. An FCC filing is a test report, equipment photos, and label artwork. A TCF is everything you know about your product, organized into a binder that someone at a customs office in Romania could theoretically request on a Tuesday.
Required contents
- General product description and intended use -- what the product is, what it does, who uses it
- Design and manufacturing drawings -- mechanical drawings, assembly diagrams
- Circuit schematics and PCB layouts -- full electrical design documentation
- Bill of Materials (BoM) -- component list with manufacturer and part number
- List of harmonized standards applied -- which standards you tested against, full or partial application
- All test reports -- from every applicable standard
- Risk assessment -- required for LVD and RED; documents hazard analysis and safeguard rationale
- User manual and instructions for use -- must be in the language of the destination country
- Labels and packaging details -- CE mark placement, product identification
- Software and firmware description -- version numbers, cybersecurity-relevant architecture
- Quality control procedures -- how you ensure ongoing production matches the tested unit
- Declaration of Conformity -- the signed legal declaration
| TCF Approach | Cost | Best For |
|---|---|---|
| Self-prepared by engineering team | €1,500 -- €3,000 | Simple products, teams with prior CE experience |
| Professional compliance consultancy | €3,000 -- €10,000 | Complex products, first-time CE marking |
| Lab-assisted (testing lab compiles TCF) | Varies | Teams that want a single vendor for testing and documentation |
Do not skip this step. It is the most commonly neglected part of CE marking, especially by teams accustomed to FCC's lighter documentation requirements. Many companies get testing done but never compile the TCF. When a market surveillance authority requests it and you don't have it, you have a serious problem.
Step 7: Sign the Declaration of Conformity
The EU Declaration of Conformity (DoC) is the legal document where the manufacturer states that the product meets all applicable directives. It is the legal core of CE marking -- the CE mark on the product refers back to this document.
Required elements
- Manufacturer name and full postal address
- Product identification: name, type, model number, batch or serial number
- Statement: "This declaration of conformity is issued under the sole responsibility of the manufacturer"
- Complete list of all applicable EU directives with their full reference numbers (e.g., "Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014")
- List of harmonized standards applied with version numbers
- Notified Body name and number (if one was involved)
- Place and date of issue
- Name, function, and signature of the person authorized to sign on behalf of the manufacturer
The DoC must be available to market surveillance authorities on request. For consumer products, it must also be accessible to end users -- many companies include a URL or QR code in the user manual linking to the full document.
Who can sign? Someone with the authority to legally bind the manufacturer. This is typically a director, VP of engineering, or head of regulatory affairs. The signer is personally attesting that the product meets every directive listed.
Step 8: Affix the CE mark
With the DoC signed and the TCF compiled, you can affix the CE mark to the product.
Placement rules:
- The CE mark must be visible, legible, and indelible on the product itself
- If the product is too small, the mark goes on the packaging and accompanying documents
- Minimum height: 5 mm
- The proportions of the official CE symbol must be maintained (the two letters form specific geometric shapes -- this is defined in EU Decision 768/2008)
- The CE mark cannot be placed before the DoC is signed and all conformity assessment procedures are complete
Do not confuse CE with "China Export." The legitimate CE mark has specific letter spacing (the letters are further apart). A "China Export" mark, which is not an official marking, has the letters closer together. Using the wrong proportions invites questions from customs authorities.
Step 9: Appoint an EU Authorized Representative (if non-EU)
Since July 2021, under EU Regulation 2019/1020 (Market Surveillance Regulation), non-EU manufacturers must designate a responsible person established in the EU. This person's contact information must appear on the product or its packaging.
The EU Authorized Representative is the contact point for market surveillance authorities. They must be able to hand over a copy of the DoC and TCF on request, cooperate with authorities on corrective actions, and be physically established in the EU (not just the EEA -- this matters for post-Brexit UK arrangements).
| Service Level | Annual Cost | What You Get |
|---|---|---|
| Basic representation | €500 -- €1,000/yr | Name and address on product, handles authority correspondence |
| Full compliance support | €1,000 -- €2,000/yr | TCF storage, WEEE registration, market surveillance response |
This is an ongoing annual cost. If you sell in the EU, you pay it every year. Companies like EMERGO, Obelis, and ComplianceGate provide EU Authorized Representative services. Many test labs also offer this as an add-on.
Step 10: Place on market and maintain compliance
CE marking is not a one-time event. Once your product is on the EU market, you still need to:
- Register as a WEEE producer in each EU country where you sell
- Keep the TCF available for 10 years after the last unit ships
- Re-test when design changes affect EMC, safety, or radio performance
- Re-test when harmonized standards are revised (the EU does not grandfather old versions indefinitely)
- Track RoHS exemption expiry dates if your product relies on any Annex III/IV exemptions
- Check REACH Candidate List updates every 6 months against your Bill of Materials
- Keep cybersecurity measures current as EN 18031 requirements evolve
Design changes that affect compliance require re-evaluation. A new antenna, a PCB layout change, a different power supply, or a firmware update that changes transmitter characteristics or cybersecurity posture can all trigger partial or full retesting.
Timeline: how long does CE marking actually take?
gantt
title CE Marking Timeline (Typical WiFi Consumer Device)
dateFormat YYYY-MM-DD
axisFormat %W
section Preparation
Identify directives & standards :a1, 2026-01-06, 5d
Requirements analysis :a2, after a1, 5d
section Design
Design for compliance :b1, after a2, 20d
Pre-compliance testing :b2, after b1, 10d
Design fixes :b3, after b2, 10d
section Formal Testing
Book lab time :c1, after b3, 5d
Lab testing :c2, after c1, 15d
Rework & retest (if needed) :c3, after c2, 20d
section Documentation
Compile TCF :d1, after c2, 10d
Sign DoC & affix CE mark :d2, after d1, 2d
Appoint EU representative :d3, after d2, 5d
| Phase | Duration | Notes |
|---|---|---|
| Identify directives and standards | 1 week | Can be done in parallel with product design |
| Design for compliance | 2 -- 4 weeks | Concurrent with product development |
| Pre-compliance testing | 1 -- 2 weeks | Highly recommended; reduces failure risk from ~50% to under 10% |
| Lab booking lead time | 1 day to several weeks | Depends on lab; some have months-long queues |
| Formal testing | 2 -- 4 weeks | For a WiFi/BT device with AC power |
| Rework and retest (if failed) | 2 -- 6 weeks per cycle | Each failure adds a cycle |
| TCF compilation | 1 -- 2 weeks | Can overlap with late-stage testing |
| DoC signing and CE mark | 1 -- 2 days | Once everything else is done |
| EU representative setup | 1 week | Can be done earlier in the process |
| Total (pass first time) | 4 -- 8 weeks | From completed design to market-ready |
| Total (one retest cycle) | 8 -- 14 weeks | Adds 2 -- 6 weeks per failure |
The role of harmonized standards
This concept deserves its own section because it changes how you approach the entire process.
When the EU publishes a reference to a standard in the Official Journal, that standard becomes "harmonized" under the relevant directive. If you apply it correctly, you get a legal presumption of conformity -- meaning market surveillance authorities cannot easily challenge your compliance. That presumption is worth a lot.
Without harmonized standards, you would need to demonstrate -- on your own terms -- that your product meets the directive's essential requirements. That's a much harder argument to make, and it often triggers mandatory Notified Body involvement.
Practical implication: Always use harmonized standards when they exist. The only scenario where you might not is if your product is so novel that no harmonized standard covers it. In that case, talk to a Notified Body early.
When you need a Notified Body (and when you don't)
| Scenario | Notified Body Required? | Notes |
|---|---|---|
| Consumer electronics with WiFi/BT, harmonized standards exist | No | Self-declaration via Module A |
| AC-powered device, tested to EN 62368-1 | No | Self-declaration |
| Radio equipment, no harmonized standard for a specific requirement | Yes | Notified Body performs EU-type examination |
| Medical device (Class IIa+) | Yes | Under Medical Device Regulation, not CE directives above |
| Machinery per Annex IV | Yes | High-risk machinery categories |
| You choose not to apply harmonized standards | Usually yes | Must demonstrate conformity another way |
If you're building consumer electronics or IoT devices, self-declaration covers nearly every case. Notified Bodies become relevant when you're working without harmonized standards, building medical devices, or developing high-risk industrial equipment.
RED cybersecurity: the requirement that did not exist until 2025
Since August 1, 2025, the RED Delegated Act activated three new essential requirements for internet-connected radio equipment:
| Article | Requirement | Applies To |
|---|---|---|
| 3(3)(d) | Network protection -- device must not harm the network or degrade service | All internet-connected radio equipment |
| 3(3)(e) | Privacy -- safeguards for personal data | Devices processing personal data |
| 3(3)(f) | Fraud prevention -- protection against fraud | Devices used for financial transactions |
The harmonized standards are EN 18031-1 (network protection), EN 18031-2 (personal data safeguards), and EN 18031-3 (financial transaction protection).
Any WiFi, Bluetooth, or cellular product placed on the EU market now needs cybersecurity testing and documentation. Lab pricing for EN 18031 is still forming because the requirement is new, but it is not free, and it was not in anyone's budget two years ago.
On top of this, the Cyber Resilience Act (EU) 2024/2847 will add further requirements for products with digital elements. Vulnerability reporting obligations start in September 2026, with full compliance required by December 2027.
Common mistakes and how to avoid them
Assuming FCC compliance transfers to CE. It does not. FCC and CE use different standards, different limit lines, different frequency ranges, and different measurement methods. You cannot hand a lab your FCC test report and ask them to stamp it for CE. Some labs can run both from a single test setup to save time, but the actual tests are distinct.
Forgetting immunity testing. This one catches US-first companies every time. FCC does not test immunity. CE does -- ESD, radiated immunity, EFT/burst, surge, conducted immunity, voltage dips, power frequency magnetic field. That is €3,000 to €8,000 and 1 to 4 extra lab days that were not in your FCC budget.
Neglecting the Technical Construction File. Many teams get testing done and stop. The TCF is not optional -- it is a legal requirement, and market surveillance authorities can request it at any time. Not having it ready when asked means your product is technically non-compliant, regardless of whether it passes every test.
Operating without an EU Authorized Representative. Required since 2021 for non-EU manufacturers. Products can be refused at the EU border without one. It costs €500 to €2,000/year -- cheap insurance against having your shipment stuck in customs.
Missing the cybersecurity requirements. Products that were compliant before August 2025 may not be compliant now. If your product connects to the internet via any radio interface, EN 18031 compliance is mandatory.
Applying the CE mark before the DoC is signed. The mark cannot go on the product until the Declaration of Conformity is signed and all conformity assessment is complete. Jumping the gun is a regulatory violation, and it happens more often than you'd expect.
Using withdrawn harmonized standards. Standards get revised. The presumption of conformity only attaches to the current version in the Official Journal. Your test lab should track this, but check yourself -- testing against a withdrawn version wastes your money and time.
UKCA: do you need it too?
Short answer: no. As of 2026, the UK recognizes CE marking indefinitely for most product categories, including electronics and radio equipment. If you have CE marking, you can sell in Great Britain.
Medical devices have their own transitional deadlines (running through 2028 -- 2030), and the UK could theoretically diverge from EU technical standards down the road. But for consumer electronics right now, CE covers the UK. Save your €5,000 to €15,000.
For the full picture on UK market access, see our UKCA marking guide.
CE marking checklist
Use this as a working checklist. Each item maps back to the detailed steps above.
- Identify all applicable EU directives for your product
- Determine the harmonized standards under each directive
- Confirm your conformity assessment route (self-declaration vs Notified Body)
- Design for compliance: EMC, immunity, safety, cybersecurity
- Run pre-compliance testing during development
- Book an accredited test lab (ISO/IEC 17025)
- Complete formal testing against all applicable standards
- Fix any failures and retest
- Compile the Technical Construction File
- Prepare the EU Declaration of Conformity
- Have an authorized person sign the DoC
- Affix the CE mark to the product (min 5 mm height, correct proportions)
- Appoint an EU Authorized Representative (if non-EU manufacturer)
- Register as a WEEE producer in each EU market
- Verify RoHS compliance through supplier declarations or testing
- Complete REACH SVHC assessment
- Set up a process to monitor standards updates and REACH Candidate List changes
Related guides
- CE marking: the complete guide -- the hub page covering all CE marking topics
- CE marking cost -- detailed cost breakdown by directive and product type
- UKCA marking guide -- UK market access and whether you need separate UKCA
- How to choose an EMC test lab -- lab selection criteria for CE and FCC testing
- EMC pre-compliance testing -- in-house testing to reduce failure rates
- FCC certification cost -- US-side cost comparison
Found an error or something out of date? Let us know.