IllustrationIn the US, a device with a Bluetooth or Wi-Fi radio needs FCC certification: a recognized lab tests it and a TCB grants it. In the EU, the manufacturer declares conformity with the Radio Equipment Directive and affixes CE. A notified body joins only when harmonized radio standards are not fully applied.
Teams that plan to sell a connected device in the US and Europe often hear "FCC and CE" as one task. They are two legal systems with different authorities, procedures and test standards. This guide compares them for a Bluetooth or Wi-Fi device: legal basis, who tests, who signs off, and what the two test campaigns can share. Rules are as of November 2026 and link to the page we read.
This is an engineering summary and not legal advice. Have a regulatory lawyer or your test lab confirm how the rules apply to your product.
What is the difference between FCC and CE certification?
The FCC runs an approval system: most radio transmitters need a third-party grant before US marketing. The EU runs a declaration system: the manufacturer declares that the product meets the RED's essential requirements, keeps the evidence and affixes the CE marking.
| Topic | FCC (United States) | CE under the RED (EU) | Source, as of November 2026 |
|---|---|---|---|
| Legal basis | 47 CFR Part 2 (equipment authorization) and Part 15 (radio frequency devices). | Radio Equipment Directive 2014/53/EU (the RED), applicable since June 13, 2016. | 47 CFR 2.907, EC RED page |
| Route for a Bluetooth or Wi-Fi radio | Certification by a Telecommunication Certification Body (TCB) before marketing. | Declaration of conformity by the manufacturer. A notified body is needed for the radio requirements when harmonized standards are not fully applied. | 47 CFR 15.201, RED Guide 2.8 |
| Who issues the approval | The FCC or a TCB, based on the applicant’s test data. | The manufacturer draws up the declaration of conformity on its sole responsibility. A notified body issues a certificate only on the routes that involve one. | 47 CFR 2.907, EC CE marking steps, EC RED page |
| Who runs the tests | A lab accredited to ISO/IEC 17025 and recognized by the FCC. Labs abroad can qualify under an MRA. | Under Module A, the manufacturer runs the assessment with no notified body. Annex III and IV involve one. | 47 CFR 2.948, RED Guide 7.1 |
| Self-declaration | Supplier’s Declaration of Conformity (SDoC) for many digital devices. The responsible party must be in the United States. | Module A, always available for health and safety and for EMC. | 47 CFR 2.906, 2.909 |
| What is assessed | Radio emissions under Part 15, and RF exposure. | Health and safety (including RF exposure), EMC, spectrum use, and for some devices cybersecurity. | 47 CFR 2.1093, RED Guide 3.2 |
| Mark | FCC ID label, permanently affixed. | CE marking at least 5 mm high, on the device and the packaging. | 47 CFR 2.925, RED Guide 2.8 f |
| Records | Under SDoC, nothing is filed unless the FCC asks. | Technical file and declaration kept at least 10 years. | 47 CFR 2.906, Your Europe |
People say "CE certification", but the EU texts talk about a declaration of conformity and the CE marking. The Commission's RED page says only notified bodies may issue certificates of compliance for these products, and that voluntary or other additional certificates are not a recognized way to prove compliance.
Who tests the device and who signs off?
The FCC side
A TCB or the FCC grants certification based on test data from a lab accredited to ISO/IEC 17025 and recognized by the FCC (47 CFR 2.907, 2.948, as of November 2026). The party that holds the grant is responsible for compliance (47 CFR 2.909), and our guide to what FCC certification is walks through the full process.
Some labs are barred. The SDoC rule bars testing at a facility owned, controlled or directed by a prohibited entity (47 CFR 2.906). That term includes the FCC Covered List and entities named as foreign adversaries by the Department of Commerce (47 CFR 2.902). Ask any lab to confirm in writing that it is eligible before you send samples.
The EU side
The RED offers Module A (internal production control), Module B+C (EU-type examination) and Module H (full quality assurance). The last two involve a notified body. For health and safety (Article 3.1(a)) and EMC (Article 3.1(b)), Module A is always available. For spectrum use (Article 3.2) and Article 3(3), Module A works only when harmonized standards are applied in full. Otherwise a notified body must be involved (Guide to the RED, October 2026, sections 2.8 and 7.1, as of November 2026).
The EU treats a company that has a product made and sells it under its own name as the manufacturer (Your Europe). A US brand that sells in the EU under its own name is that manufacturer. The importer must check the conformity work and add its own name and address to the product (RED Guide, section 2.5).
Which FCC and CE rules apply to a Bluetooth or Wi-Fi device?
A typical AI wearable has a 2.4 GHz radio and a processor. For the FCC, the transmitter needs certification, and the digital circuitry falls under Part 15 Subpart B, where most digital devices may use SDoC or certification (47 CFR 15.101). When a product needs both, both sets of rules apply (2.909(c)). Our Part 15B vs 15C guide covers that split for a BLE wearable.
The RED covers the whole radio product. Article 3.1(a) brings in the safety objectives of the Low Voltage Directive with no voltage limit, so battery devices are covered, including the limits for human exposure to electromagnetic fields. Article 3.1(b) brings in the EMC objectives of Directive 2014/30/EU. Article 3.2 covers efficient use of spectrum (RED Guide, section 3.2).
RF exposure for body-worn devices
The FCC treats a transmitter used within 20 cm of the body as portable. Above the exemption thresholds, it is evaluated against SAR limits (47 CFR 2.1093). For the general population the limits are 1.6 W/kg over any 1 gram of tissue, and 4 W/kg over 10 grams for extremities such as wrists (47 CFR 1.1310(c), as of November 2026). In the EU, exposure is part of the Article 3.1(a) assessment. This guide quotes no EU limit, because we did not review those standards.
EU cybersecurity requirements
Articles 3(3)(d), (e) and (f) cover network harm, personal data and privacy, and fraud. Delegated Regulation (EU) 2022/30 made them apply to some classes of radio equipment from August 1, 2025. The classes include internet-connected radio equipment and wearables that monitor and record sensitive data, such as fitness trackers, smart watches and smart rings. Delegated Regulation (EU) 2026/339 repeals Regulation 2022/30 as of December 11, 2027, when the Cyber Resilience Act's main obligations apply (RED Guide, sections 1.7.2, 3.3 and 10.9.4; EC RED page, as of November 2026). The FCC rules cited here have no matching requirement.
Same band, different power limits
Both rules cover 2400 to 2483.5 MHz, but they measure power differently. Figures as of November 2026:
| Rule | Limit | What is measured | Source |
|---|---|---|---|
| FCC 15.247, digital modulation, 2400–2483.5 MHz | 1 watt | Peak conducted output power, or maximum conducted output power as an alternative. Antenna gain above 6 dBi reduces the limit. | 47 CFR 15.247(b)(3) |
| EN 300 328 V2.2.2, non-FHSS, 2.4 GHz band | 20 dBm | Mean e.i.r.p. during a burst, for any combination of power level and intended antenna. | EN 300 328, 4.3.2.2 |
A peak conducted figure and a mean e.i.r.p. figure do not compare one to one. The EU figure includes the antenna, so check the firmware power table against both limits with your real antenna gain. A product may need a region setting in firmware. Ask your lab which edition of EN 300 328 is cited in the Official Journal when you test.
Can one test campaign cover FCC and CE certification?
Expect two sets of reports, because the rules and test standards differ. The preparation can still be shared, and that is where a team saves time. This table is our engineering reading of the rules above, not a statement from either regulator.
| Work item | Share or separate | Why |
|---|---|---|
| Samples and build | Share | Freeze one hardware and firmware build for both labs. A later change can force a retest in either market. |
| Test-mode firmware | Share | Both labs need to set channel, power and continuous transmit. Build one test mode with a documented command set. |
| Schematics, block diagram, BOM, antenna data, manual | Share as inputs | The same files feed the FCC exhibits and the EU technical file. |
| Radio tests | Separate | FCC tests to Part 15. The EU self-declared route uses the harmonized standard, such as EN 300 328 for 2.4 GHz. |
| EMC tests | Separate | Part 15B covers the digital circuitry. EU EMC objectives come from Directive 2014/30/EU. |
| RF exposure | Separate | FCC SAR limits are in 47 CFR 1.1310. In the EU, exposure sits under Article 3.1(a). |
| Cybersecurity | EU only | Article 3(3)(d) to (f) apply to the classes the delegated act names. |
| Lab | Can be one firm | The FCC recognizes labs under MRAs, and MRA countries can designate EU notified bodies. Check each scope. |
The lab row has a legal basis. The Commission lists the EU-US mutual recognition agreement as operational for EMC and telecommunication equipment (EC MRA page, as of November 2026). The FCC accepts labs recognized under such agreements (2.948(f)), and the RED Guide says MRA countries can designate notified bodies (section 7.2). One firm may be able to test for both markets.
A certified module changes the FCC side. See our guide on pre-certified LTE modules for what a modular grant covers.
What goes on the label and in the box?
Small wearables run out of surface fast, so plan markings with the industrial design.
- FCC ID. "FCC ID" plus the identifier, legible without magnification and permanently affixed. A device too small for four-point type and with no display carries it in the manual and on the packaging or a removable label. Electronic labeling is allowed under 2.935 (47 CFR 2.925, as of November 2026).
- SDoC statement. Parts authorized by SDoC ship with a compliance statement naming a responsible party in the United States (47 CFR 2.1077).
- CE marking. At least 5 mm high on the device or data plate, and on the packaging. A smaller mark is allowed if the device cannot take 5 mm and the mark stays legible. A mark in the battery compartment or under a watch bracelet fails the visibility rule. Under Annex IV, the notified body's four-digit number follows the mark (RED Guide, section 2.8 f).
- EU radio information. A transmitter ships with the frequency bands and maximum output power it uses in the EU, without a "less than" sign or a power class (RED Guide, section 2.8 j).
What should you ask your hardware team before FCC and CE testing?
- Which markets launch first? Write the order down at Gate 0.
- Is each radio a certified module or chip-down?
- Do both labs get one frozen build, with the version on every report?
- Does the test firmware set channel, power and continuous transmit for each radio?
- Do our power tables meet the FCC and EN 300 328 limits with our real antenna gain?
- Will we apply harmonized standards in full for the EU radio requirements? If not, which notified body?
- Is the device internet-connected or a wearable under the EU cybersecurity definitions?
- Who is the EU importer, and where do the FCC ID, CE marking and importer address fit on the enclosure?
- Has the lab confirmed in writing that it is eligible under the FCC prohibited-entity rules?
Our approach is on the certification planning page: FCC, lab and module rules are planned from Gate 0.
Questions about FCC and CE certification
Does FCC certification count for CE marking?
No. The systems use different rules and test standards, and even the 2.4 GHz power limits are measured differently (47 CFR 15.247, EN 300 328, as of November 2026). Samples, test firmware and design files can be shared.
Is CE marking a self-certification?
It can be. The manufacturer can use Module A when it applies harmonized standards in full. If they are partly applied, not applied or missing, the radio and Article 3(3) requirements need a notified body (RED Guide, as of November 2026).
Can a US company be the manufacturer for CE purposes?
Yes. The EU treats a company that has a product made and sells it under its own name as the manufacturer (Your Europe, as of November 2026). An EU importer also has duties. This is an engineering summary and not legal advice.
How could Duobay help with FCC planning?
Duobay develops custom devices for US companies. FCC, lab and module rules are planned from Gate 0, a paid fixed-fee feasibility study, and the client pays certification and lab fees. If the EU is on your roadmap, raise it on the first call. Tell us about your device.
Where do these rules come from?
All pages accessed November 5, 2026. eCFR sections were read through the eCFR content service. Confirm the current text before you decide.
- 47 CFR 2.902, 2.906, 2.907, 2.909, 2.925, 2.948, 2.1077, 2.1093, 15.101, 15.201, 15.247 and 1.1310, eCFR, for example https://www.ecfr.gov/current/title-47/part-2/section-2.907
- European Commission, Guide to the Radio Equipment Directive 2014/53/EU, October 2026: https://ec.europa.eu/docsroom/documents/33162
- European Commission, Radio Equipment Directive: https://single-market-economy.ec.europa.eu/sectors/electrical-and-electronic-engineering-industries-eei/radio-equipment-directive-red_en
- European Commission, CE marking for manufacturers: https://single-market-economy.ec.europa.eu/single-market/ce-marking/manufacturers_en
- Your Europe, CE marking: https://europa.eu/youreurope/business/product-requirements/labels-markings/ce-marking/index_en.htm
- European Commission, mutual recognition agreements: https://single-market-economy.ec.europa.eu/single-market/goods/international-aspects-single-market/mutual-recognition-agreements_en
- ETSI EN 300 328 V2.2.2 (2019-07), wideband data transmission in the 2.4 GHz band: https://www.etsi.org/deliver/etsi_en/300300_300399/300328/02.02.02_60/en_300328v020202p.pdf
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