IoT product in EU and US: dual certification

Hugues Orgitello updated 7 Oct 2026 15 min read

Launching a connected product in the European Union and the United States at the same time means running two legal systems that do not know each other, plus, for a cellular device, an industry certification and the operators behind it. The EU side is the RED, a declaration and the CE marking; the US side is 47 CFR, a TCB grant and an FCC ID; the operator side is PTCRB and the carrier programmes. What the two governments do share is a mutual recognition agreement (MRA) that lets one laboratory or certification body work for both. This page reads the texts as they stand on 7 October 2026: what the US-EU MRA actually allows (47 CFR 2.948(f), 2.960(d)), which limits differ parameter by parameter, who must exist on each side, how the two files are built, and the common claims the texts contradict. It gives no costs, durations or savings percentages, because no text supports them.

What applies to a Wi-Fi, BLE and LTE product

Take a product combining Wi-Fi, BLE and LTE (Cat-M or Cat-1), mains or battery powered, sold in both markets.

Topic	EU text	US text	Industry
Electrical safety	RED 2014/53/EU Article 3(1)(a), the LVD objectives with no voltage limit	No FCC rule; OSHA workplace approval through an NRTL where the product is used in workplaces
EMC	RED Article 3(1)(b): emission and immunity	Part 15 Subpart B for the digital device: emission only
Spectrum	RED Article 3(2), Decisions 2006/771/EC and (EU) 2022/179	Part 15 Subpart C and E (Wi-Fi, BLE), Parts 22, 24, 27 (LTE)
RF exposure	Article 3(1)(a), Council Recommendation 1999/519/EC	47 CFR 1.1310, 2.1091 (mobile), 2.1093 (portable)
Cybersecurity	RED Article 3(3)(d), (e), (f) since 1 August 2025; CRA from 11 December 2027	No mandatory rule; US Cyber Trust Mark is voluntary (47 CFR Part 8)
Procedure	Article 17: internal production control, or a notified body	Certification through a TCB for the transmitters (15.201(b)); SDoC or certification for the digital device
Network acceptance			PTCRB, then each operator programme

Two consequences come straight from the texts. First, a radio product is not placed under the LVD and the EMC Directive in parallel: RED Article 1(4) takes it out of the LVD "except as set out in point (a) of Article 3(1)", and Article 2(2)(a) of 2014/30/EU excludes it from the EMC Directive. Safety and EMC are assessed under the RED, in one DoC that also names every other act (RoHS, and the others that apply), as Article 18(3) requires. Second, the US has three separate layers: the FCC grant, the PTCRB certification, and each operator acceptance. None of them implies the others.

The pillar pages go deeper on each regime: CE pillar, RED pillar, FCC pillar and PTCRB pillar.

What the US-EU MRA does, and does not do

The Agreement on mutual recognition between the European Community and the United States was signed in London on 18 May 1998 and published in OJ L 31 of 4 February 1999. Its sectoral annexes include telecommunication equipment, electromagnetic compatibility and electrical safety. The telecommunication annex covers, on the US side, "all radio transmitters subject to an equipment authorisation requirement".

The FCC rules give the MRA its practical effect:

Rule	What it says	What it means for a dual programme
47 CFR 2.948(a)	Certified equipment is tested in a laboratory that is accredited and recognised by the Commission	Applies to every FCC certification, wherever the laboratory is
2.948(e)	Accreditation to ISO/IEC 17025 by a body recognised by the FCC, with reassessment at intervals not exceeding two years	The accreditation scope must cover the FCC measurements
2.948(f)(1)	A laboratory outside the US is acceptable if designated by a foreign Designating Authority and recognised by the Commission under a government-to-government MRA	An EU laboratory designated under the US-EU MRA can produce FCC test data
2.948(f)(2)	In a country without an MRA, the laboratory is accredited by a body recognised under 2.949	The non-MRA route
2.960(d)	Outside the US, a TCB is designated under an effective MRA to which the US is a party; no recognition for a TCB in an economy that does not let US TCBs certify to its own requirements	An EU-designated TCB can grant FCC certifications
2.906(a)(1)	SDoC testing needs no accredited laboratory, only one not owned, controlled or directed by a prohibited entity	The MRA is irrelevant for an SDoC digital device

What the MRA does not do: it does not turn an EN test report into an FCC report, or an FCC grant into a CE declaration. A designated laboratory still measures to the FCC rules and procedures. On the EU side, internal production control asks for test reports without saying who performs the tests, so the MRA matters there only where a notified body is involved (EU-type examination under RED Article 17). The CE vs FCC EMC comparison and the getting started guide give the same reading.

Same parameter, two texts

This is the table to keep open while writing the test plan. Each row compares what the EU text and the US text require for the same parameter.

Parameter	EU	US	What it means for one design
2.4 GHz wideband data, power	100 mW e.i.r.p., 10 mW/MHz for non-hopping modulations (Decision 2006/771/EC, band 57c); tested with EN 300 328	1 W conducted for digital modulation (15.247(b)(3)), with a 6 dBi antenna allowance and a reduction above it (15.247(b)(4))	A US power setting at the 1 W ceiling is not legal in the EU; an EU setting is legal in the US
5 150 to 5 250 MHz	200 mW mean e.i.r.p., no DFS or TPC (Decision (EU) 2022/179)	Access points 1 W conducted, client devices 250 mW, no DFS (15.407)	Different ceilings, same band
5 250 to 5 350 and 5 470 to 5 725 MHz	200 mW and 1 W e.i.r.p., TPC and DFS; 3 dB lower without TPC	DFS; TPC from 500 mW e.i.r.p. (15.407)	DFS tested against EN 301 893 in the EU and the 15.407 procedures in the US
5 725 to 5 850 MHz	Not an RLAN band; 25 mW e.i.r.p. non-specific SRD only (Decision 2006/771/EC)	1 W conducted (15.247(b)(3), 15.407)	US channels 149 to 165 must be disabled in the EU configuration
Who may change the region	DFS settings, including the country of operation, must not be user-accessible where changing them breaks compliance (Decision (EU) 2022/179)	U-NII software must prevent operation outside the certified parameters, and DFS cannot be disabled (15.407(i)); the application describes the security (2.1033)	A factory-locked region in one firmware image satisfies both; a user-selectable country does not
SAR (body-worn, hand-held)	2 W/kg averaged over 10 g, head and trunk (1999/519/EC); EN 50360, EN 50566	1.6 W/kg averaged over 1 g; 4 W/kg over 10 g for extremities (1.1310(c))	Two evaluations against two limits and two averaging masses
RF exposure, device kept away from the body	Assessment such as EN 62311 or EN 62479 against 1999/519/EC	Mobile device: at least 20 cm normally maintained (2.1091(b))	A fixed or mobile product usually needs no SAR on either side
Immunity	Essential requirement under Article 3(1)(b), shown with EN 301 489-1 and the relevant part	No immunity test in Part 15	EU-only test work
Electrical safety	Article 3(1)(a); EN 62368-1:2014 + AC:2015 is the edition cited under the LVD, used as another specification	No FCC requirement; NRTL listing to UL 62368-1 edition 4 (July 31, 2025), which adopts IEC 62368-1 edition 4	One test campaign only if both editions are covered
Cybersecurity	EN 18031-1, -2, -3 cited with restrictions (Decision (EU) 2025/138)	Voluntary Cyber Trust Mark; mandatory Covered List statements in every application (2.911(d)(5))	EU-only technical work; US-only declarations
Manual and label	Frequency bands and maximum RF power in the instructions (RED Article 10(8)); CE marking	FCC ID label, 15.19 statement, 15.21 warning, 15.105 text for digital devices	Two sets of statements; one manual can carry both
Party on each side	Economic operator in the Union (2019/1020 Article 4)	US agent for service of process (2.911(d)(7))	Both must exist before the product is placed on each market

The spectrum rows come from the verified tables in the license-free bands guide; the SAR rows from the SAR procedures guide.

Where the work overlaps, and where it does not

Emissions: same physics, different limits

Radiated and conducted emissions are measured on both sides, but against different documents: EN 55032 (or the radio EMC standard) in the EU, 15.107 and 15.109 with ANSI C63.4-2014 in the US, and ANSI C63.10-2020 for unlicensed transmitters. The limits do not line up: at 3 m for Class B, 230 to 960 MHz, the FCC limit is 46 dB(µV/m) while CISPR 32 gives 47 dB(µV/m) in its own 3 m rows, and other bands go the other way. Neither side is uniformly stricter, so a dual product designs to the lower limit in each band. The full comparison is in CE vs FCC EMC.

Cellular: three references for one radio

For the LTE part, each layer has its own reference:

• RED Article 3(2): EN 301 908-1 with EN 301 908-13 for LTE user equipment. V13.3.1 is cited with a restriction on total radiated sensitivity and power for devices narrower than 56 mm or wider than 72 mm; V13.2.1 loses its citation on 15 November 2026.
• FCC Parts 22, 24, 27: the Part 2 measurements (2.1046 RF power output, 2.1049 occupied bandwidth, 2.1051 spurious emissions at antenna terminals, 2.1053 field strength of spurious radiation, 2.1055 frequency stability) against the limits of each rule part.
• PTCRB: NAPRD03 builds on the 3GPP conformance specifications (3GPP TS 36.521-1 for LTE RF, TS 36.523, TS 36.124) and CTIA test plans, with RF performance (OTA) evaluation mandatory for all device types.

3GPP specifications are not harmonised standards: passing TS 36.521-1 gives no presumption under the RED. The 3GPP RF conformance test plan maps the parts.

A cellular module with its own FCC grant can be reused within the conditions of that grant; the RED has no modular approval, so the EU assessment covers the final product in all its configurations (Article 17(1)). See the worked example for an IoT sensor under RED and FCC.

Safety: one IEC base, two editions

An IECEE CB Scheme report against IEC 62368-1 can be the common base: an NRTL can take it and assess the US national differences instead of repeating the shared tests. The catch is the edition. The EU list still cites EN 62368-1:2014 + AC:2015, while UL 62368-1 edition 4 adopts IEC 62368-1 edition 4 (2023). Ask the laboratory, before testing, which editions and which national differences the report will cover. See NRTL and UL product safety.

What stays on one side only

• EU only: immunity, the EN 18031 cyber assessment under Article 3(3), the e.i.r.p. and DFS configuration of Decision (EU) 2022/179, the Article 10(8) band and power information, the economic operator.
• US only: the TCB grant and FCC ID, the Covered List and prohibited-entity statements (2.911(d)(5)), the US agent, PTCRB and carrier acceptance.

Roles on each side

EU: the Article 4 economic operator

Since 16 July 2021, a product subject to the RED, the EMC Directive or the LVD (among others) may be placed on the EU market only if an economic operator established in the Union is responsible for the Article 4 tasks of Regulation (EU) 2019/1020: a manufacturer in the Union, an importer, an authorised representative with a written mandate, or a fulfilment service provider where none of the others exists. Its name, registered trade name or mark and contact details, including the postal address, appear "on the product or on its packaging, the parcel or an accompanying document" (Article 4(4)). The authorised representative and importer guide and the CE procedure cover the mandate.

US: grantee and US agent

The applicant for FCC certification becomes the grantee and the party responsible for compliance. Since FCC 22-84 (6 February 2023), every applicant designates an agent located in the United States for service of process (2.911(d)(7)); a US applicant may name itself. The application also carries the signed statements that the equipment is not prohibited under 2.903 and whether the applicant is on the Covered List (2.911(d)(5)). The FCC procedure lists the steps.

Operators: PTCRB and carrier programmes

PTCRB is administered by CTIA Certification and is not a legal requirement; the requirement comes from each operator. On 7 October 2026, ptcrb.com listed 17 participating operators, US and Canadian. Each carrier then runs its own acceptance: see AT&T Network Ready, Verizon Open Development and T-Mobile US. The PTCRB procedure covers the IMEI TAC and the submission.

Canada

An FCC grant does not cover Canada. A Category I radio apparatus needs ISED certification by a recognised certification body (or the ISED Certification and Engineering Bureau), an "IC:" number and a Radio Equipment List entry, under RSS-Gen issue 6 and the specific RSS (RSS-247 for 2.4 and 5 GHz digital transmission systems, the RSS-130 to RSS-139 series for cellular bands). Canada and the United States recognise each other's laboratories and certification bodies under the APEC TEL MRA. See ISED vs FCC.

Two files built from one design base

The texts ask for different documents, but they draw on the same engineering facts.

Common design base	EU file (RED Annex V, DoC Annex VI)	US file (47 CFR 2.1033 exhibits)
Schematics, block diagram, parts list	Technical documentation	Schematics, block diagram, operational description
Radio configuration per region and its lock	Assessment in all possible configurations (Article 17(1))	U-NII security description (2.1033), operational description
Test reports	Reports against the harmonised standards and other specifications	Test report to the FCC rules
Risk and exposure analysis	Article 3(1)(a) assessment	RF exposure exhibit (1.1310, 2.1091 or 2.1093)
Cyber design	EN 18031 assessment	Not required
Labels and manual	CE marking, Article 10(8) information, DoC or simplified DoC	FCC ID label, external and internal photos, user manual statements
Parties	Economic operator, notified body number where one is used	Applicant, US agent, Covered List statements

The EU declaration is a single document for every Union act that applies to the product (RED Article 18(3)). The US file is submitted to a TCB, and the grant is the FCC record. The two files never need to cite each other. For the details, see CE technical file and FCC technical file.

Order of work

No text sets a schedule, so this is an order, not a calendar:

1. Map the requirements per market: the table at the top of this page, plus Canada if relevant.
2. Fix the regional radio configuration and how it is locked, since both sides require that the user cannot change it.
3. Choose laboratories with the right scopes: FCC recognition under 2.948 (or an MRA designation), notified-body status if Article 17 requires one, PTCRB recognition for cellular.
4. Run pre-compliance on emissions, radio parameters and OTA, to the lower limit of the two markets in each band.
5. Test for each reference, reusing measurement setups where the laboratory can, and keeping the reports separate.
6. Assemble and submit: EU technical documentation and DoC; FCC application to a TCB; PTCRB request with the regulatory IDs; ISED if Canada is in scope.
7. Carrier acceptance after PTCRB, per operator.

For the procedures, see CE procedure, RED procedure, FCC procedure and PTCRB procedure; for the RED tests, RED tests.

Dated changes that affect a dual programme

Date	Change	Source
18 May 1998	US-EU MRA signed, with telecommunication, EMC and electrical safety annexes	OJ L 31, 4 February 1999
16 July 2021	Article 4 economic operator applies	Regulation (EU) 2019/1020, Article 44
6 February 2023	US agent for every FCC applicant; Covered List statements	FCC 22-84
31 July 2025	UL 62368-1 edition 4 published	UL Standards & Engagement catalogue
1 August 2025	RED Article 3(3)(d), (e), (f) applies; EN 18031-1, -2, -3 cited with restrictions	Delegated Regulation (EU) 2022/30; Decision (EU) 2025/138
19 December 2025	UL Solutions withdraws as Cyber Trust Mark Lead Administrator	FCC, DA 26-18
13 April 2026	ioXt Alliance selected as Cyber Trust Mark Lead Administrator	FCC, DA 26-354
11 September 2026	Cyber Resilience Act reporting obligations apply	Regulation (EU) 2024/2847
13 October 2026	FCC 26-50: a change made by a Covered List entity needs a new grant; marketing rules reach online marketplaces	FCC 26-50
15 November 2026	EN 301 908-13 V13.2.1 loses its citation; V13.3.1 remains, with a restriction	Decision (EU) 2025/893
11 December 2027	Cyber Resilience Act applies in full; Delegated Regulation (EU) 2022/30 repealed by (EU) 2026/339	Regulation (EU) 2024/2847

Claims the texts contradict

Claim	What the text says
"A parallel EU and US campaign takes 5 to 7 months and saves about 30 %"	No text gives a duration or a saving. The only fixed timers are procedural (30-day set-aside of a grant under 2.962(f), 120-day TAC reservation in PTCRB).
"3GPP TS 36.521 tests are defined identically for the RED and the FCC, so one report covers both"	The RED reference is EN 301 908-13; the FCC measures under 2.1046 to 2.1055 and the limits of Parts 22, 24 and 27. TS 36.521-1 feeds PTCRB and gives no presumption under the RED.
"An IoT radio product declares under RED, EMC and LVD in parallel"	RED Article 1(4) excludes radio equipment from the LVD except through Article 3(1)(a); Article 2(2)(a) of the EMC Directive excludes it from that directive. One RED declaration covers safety, EMC and spectrum.
"The RED caps 2.4 GHz at 100 mW, so the EU and the FCC differ by a factor ten in the same unit"	The EU limit is 100 mW e.i.r.p.; the FCC limit is 1 W conducted with a 6 dBi antenna allowance. The units differ, which is why a conversion is needed before comparing.
"At 5 GHz UNII-3 the EU allows 200 mW e.i.r.p."	5 725 to 5 850 MHz is not an RLAN band in the EU; Decision 2006/771/EC allows 25 mW e.i.r.p. for non-specific SRDs.
"A product with the same RF settings on both sides is always non-compliant"	A setting within the EU limits is also within the US limits at 2.4 GHz. What both texts forbid is a configuration the user can change (Decision (EU) 2022/179; 15.407(i)).
"US SAR is set by IEEE C95.1 and KDB 447498"	The limit is in 47 CFR 1.1310(c): 1.6 W/kg over 1 g, 4 W/kg over 10 g for extremities. KDB documents carry procedures and are not binding.
"An IEC 62368-1 report made for the EU is accepted as is in North America"	An NRTL can use a CB report as a base and add the national differences; the edition must match the one UL 62368-1 adopts (edition 4), while the EU still cites EN 62368-1:2014 + AC:2015.
"Citing CE in an FCC file is treated as a misleading declaration"	No rule says so. The FCC file is the list of exhibits in 2.1033 and tests to FCC rules; a CE marking is simply not part of it.
"Only non-US manufacturers need a US agent"	Every certification applicant designates a US agent for service of process; a US applicant may name itself (2.911(d)(7)).
"Without an EU authorised representative the product cannot be placed on the market"	Article 4 of Regulation (EU) 2019/1020 accepts any of four economic operators: manufacturer in the Union, importer, authorised representative, or fulfilment service provider.
"No US cyber requirement, but NIST IR 8425 applies"	NIST IR 8425 binds no one by itself; the Cyber Trust Mark built on it is a voluntary programme (47 CFR Part 8). See NIST IR 8425 and the Cyber Trust Mark.
"PTCRB is an FCC requirement"	PTCRB is an industry certification administered by CTIA Certification; the FCC grant (2.1033) does not list a PTCRB letter.

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Sources & references

1. Directive 2014/53/EU (RED), Articles 1(4), 3, 10(8), 17 and 18, EUR-Lex eur-lex.europa.eu/eli/dir/2014/53/oj
2. Directive 2014/30/EU (EMC), Article 2(2)(a), EUR-Lex eur-lex.europa.eu/eli/dir/2014/30/oj
3. Agreement on mutual recognition between the European Community and the United States of America (OJ L 31, 4.2.1999), EUR-Lex eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:21999A0204(01)
4. EU-US trade relations, mutual recognition agreement, European Commission policy.trade.ec.europa.eu/eu-trade-relationships-country-and-region/countries-and-regions/united-states_en
5. 47 CFR Part 2 Subpart J: Equipment Authorization, eCFR www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-2/subpart-J
6. 47 CFR 2.948, measurement facilities (MRA laboratories in paragraph (f)), eCFR www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-2/subpart-J/section-2.948
7. 47 CFR 2.960, recognition of TCBs (MRA TCBs in paragraph (d)), eCFR www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-2/subpart-J/section-2.960
8. 47 CFR 2.911, application requirements (US agent in paragraph (d)(7)), eCFR www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-2/subpart-J/section-2.911
9. 47 CFR 15.247, operation within 902-928 MHz, 2400-2483.5 MHz and 5725-5850 MHz, eCFR www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-15/subpart-C/subject-group-ECFR2f2e5828339709e/section-15.247
10. 47 CFR 15.407, U-NII general technical requirements (device security in paragraph (i)), eCFR www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-15/subpart-E/section-15.407
11. 47 CFR 1.1310, radiofrequency radiation exposure limits, eCFR www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-1/subpart-I/section-1.1310
12. Council Recommendation 1999/519/EC on the limitation of exposure of the general public to electromagnetic fields, EUR-Lex eur-lex.europa.eu/eli/reco/1999/519/oj
13. Commission Decision 2006/771/EC on short-range devices, consolidated text of 23 January 2025, EUR-Lex eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02006D0771(01)-20250123
14. Commission Implementing Decision (EU) 2022/179 on 5 GHz WAS/RLAN, consolidated text of 25 November 2022, EUR-Lex eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02022D0179-20221125
15. Regulation (EU) 2019/1020 on market surveillance, Article 4, EUR-Lex eur-lex.europa.eu/eli/reg/2019/1020/oj
16. Commission Implementing Decision (EU) 2025/138, EN 18031 citation with restrictions, EUR-Lex eur-lex.europa.eu/eli/dec_impl/2025/138/oj
17. 47 CFR Part 8 Subpart B, IoT labeling program (US Cyber Trust Mark), eCFR www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-8/subpart-B
18. UL 62368-1 edition 4 (July 31, 2025), UL Standards & Engagement www.shopulstandards.com/ProductDetail.aspx?productId=UL62368-1_4_S_20250731
19. RSS-Gen, issue 6: General Requirements for Compliance of Radio Apparatus, ISED Canada ised-isde.canada.ca/site/spectrum-management-telecommunications/en/devices-and-equipment/radio-equipment-standards/radio-standards-specifications-rss/rss-gen-general-requirements-compliance-radio-apparatus
20. FCC Equipment Authorization System (EAS), FCC www.fcc.gov/oet/ea/fccid
21. PTCRB Certification Program, PTCRB www.ptcrb.com/