Selling an IoT product in Europe and the US, dual certification

Author Hugues Orgitello Last updated 25 May 2026

Guide · Multi-market strategy

Launching an IoT product simultaneously in Europe and the United States is not a matter of stacking two regulatory dossiers side by side. It is a single project with four parallel regimes, CE, RED, FCC, PTCRB, that overlap partially and contradict each other occasionally. Run sequentially, the journey is expensive and stretches to 12-14 months. Run in parallel with a clear test-sharing strategy, the schedule drops to 5-7 months and the budget shrinks by about 30%. This page is the concrete playbook: who does what, what can be shared, what cannot, and the pitfalls that wipe out the savings.

The four-regime landscape

For a typical IoT product combining Wi-Fi, BLE and cellular (LTE Cat-M or Cat-1), four regulatory frameworks apply in parallel. Each one covers a different surface of the product.

Regime	Covers	Article / Part	Decision-maker
CE, 2014/30/EU	EMC (emission + immunity)	art. 6	Manufacturer (self-declaration module A)
CE, 2014/35/EU	Electrical safety LVD	art. 3	Manufacturer (module A)
RED, 2014/53/EU	Radio: 3.1(a) health, 3.1(b) radio EMC, 3.2 spectrum, 3.3 cybersecurity	art. 3	Manufacturer or Notified Body
FCC	Intentional and unintentional emitters in the US	47 CFR Parts 15, 22, 24, 27	TCB (Telecommunication Certification Body)
PTCRB	Cellular conformance on US/CA carrier networks	TS 36.521, TS 38.521	PVG (PTCRB Validation Group)

CE and RED both fall under the European regime (single DoC, CE marking). FCC and PTCRB are independent: FCC certifies the equipment, PTCRB certifies that it works correctly on operator networks. All four apply at the same time for a cellular product sold on both sides of the Atlantic.

A classic mistake: assuming FCC certification covers everything on the US side. It covers neither Canada (which requires a separate ISED certificate) nor carrier homologation (PTCRB or proprietary programmes such as AT&T NDD, Verizon OPC, T-Mobile).

See CE pillar, RED pillar, FCC pillar and PTCRB pillar for the deep dives on each regime.

What can be shared between EU and US

Optimising a dual campaign rests on precisely identifying which tests can be reused. Three areas can be shared substantially; everything else needs dedicated work.

3GPP RF Conformance tests (cellular)

For a cellular product, 3GPP TS 36.521-1 (RF), TS 36.521-2 (RRM) and TS 36.521-3 (signalling) tests are defined identically for RED article 3.2 (via EN 301 908) and for FCC. A single MRA lab report (Anritsu MT8821C, Keysight UXM, Rohde TS-RRM benches) covers both regimes, provided that:

• The lab is ISO/IEC 17025 accredited with RED-notified scope and FCC recognition under the EU-US MRA.
• The tested bands cover both EU (B1, B3, B7, B8, B20, B28...) and US (B2, B4, B5, B12, B13, B66, B71...) operator bands.
• The Carrier Aggregation configurations exercised are relevant on both markets.

Typical saving: 60-70% of RF Conformance cost shared.

Electrical safety IEC 62368-1

The harmonised standard EN 62368-1 for EU LVD is a direct transposition of IEC 62368-1. The FCC does not certify electrical safety, but recognition programmes (UL, ETL) accept IEC reports. A safety report produced in the EU is typically accepted as-is by North American programmes, with the addition of national deviation cards (US/CA differences).

Typical saving: 80-90% of safety effort shared.

SAR, partially

SAR measurement methods are similar (probe, phantom, measurement sequence) but the limits differ: 2 W/kg averaged over 10 g of tissue in the EU (EN 50360 / EN 62209), 1.6 W/kg averaged over 1 g of tissue in the US (IEEE C95.1 / KDB 447498). A single lab with a modern SAR cell can produce both reports from one measurement campaign by post-processing the data for each limit.

Typical saving: 40-50% of SAR cost shared (post-analysis is quick but the two reports remain distinct).

§ § §

What cannot be shared

EU EMC immunity

Immunity: ESD per IEC 61000-4-2, surge per IEC 61000-4-5, radiated RF per IEC 61000-4-3, etc., is required by EU EMC but has no FCC equivalent for consumer unintentional emitters. The FCC checks emission (Part 15 Subpart B) but not immunity. These tests are run once, but their result only counts toward the EU DoC.

Diverging Wi-Fi power limits

At 2.4 GHz, the FCC allows up to 1 W conducted power (Part 15.247), reaching 36 dBm EIRP with a 6 dBi antenna. RED caps EIRP at 100 mW (EN 300 328). At 5 GHz UNII-1/UNII-3, FCC allows 1 W conducted, EU 200 mW EIRP.

Consequences:

• A single firmware build cannot serve both markets. A country-code mechanism is required to adjust power and bands per operating region.
• DFS channels differ (UNII-2 / UNII-2-Extended). DFS tests must be carried out separately by region.
• The product must either be region-locked at first provisioning or detect its region automatically (geolocation, BSSID scan, cellular operator).

Cybersecurity: RED 3.3 with no US counterpart

RED article 3.3, applicable since 1 August 2025, mandates EN 18031-1 through EN 18031-3 for connectable IoT products. No equivalent FCC obligation exists in 2026. NIST IR 8425 and the US Cyber Trust Mark are voluntary programmes. Article 3.3 conformance is therefore an EU-only effort, to be planned at design time, without any hope of mutualisation.

What it means in effort percentage

For a Wi-Fi/BLE + LTE Cat-M IoT product, the typical effort split:

Category	Total effort	Shareable EU+US
Cellular RF Conformance	35%	60-70%
Cellular OTA	15%	30% (methods differ)
EMC emissions	8%	50% (limits differ slightly)
EMC immunity	7%	0% (EU only)
Wi-Fi/BLE radio	12%	30% (regional firmware)
SAR	6%	40-50%
Safety 62368-1	8%	80-90%
Cybersecurity 3.3	9%	0% (EU only)

Aggregated, 35 to 45% of the testing effort can be mutualised in a well-designed programme.

Sequence of a combined campaign

Here is the schedule for a parallel programme on a Wi-Fi/BLE + LTE Cat-M product targeted at EU + US, starting at T0 (hardware-stable, final board revision).

T0          : Hardware-stable + regional firmware operational
T0 + 2 wk   : Internal pre-tests EMC + radio + OTA + SAR
T0 + 4 wk   : Lab bookings (MRA for cellular and SAR)
T0 + 6 wk   : EMC emissions start — single EU/US lab
T0 + 8 wk   : 3GPP RF Conformance start — MRA lab, dual report
T0 + 10 wk  : Wi-Fi/BLE radio — separated EU (EN 300 328) and US (Part 15.247)
T0 + 12 wk  : SAR — single campaign, post-processed for EU+US
T0 + 14 wk  : Safety 62368-1 (LVD) — single report reused
T0 + 16 wk  : EMC immunity (EU only) + cybersecurity 3.3 (EU)
T0 + 18 wk  : Dossier assembly — EU (RED annex V) + US (TCB + PVG)
T0 + 20 wk  : FCC submission (TCB) + PTCRB submission (PVG) in parallel
T0 + 22 wk  : EU DoC signed + CE mark applied
T0 + 24 wk  : FCC ID + PTCRB approval + IMEI range received
T0 + 26 wk  : US carrier homologations (AT&T, Verizon, T-Mobile)
T0 + 28 wk  : Simultaneous EU and US launch

Total: 6 to 7 months from hardware stabilisation to dual-market launch. For per-regime details, see CE procedure, RED procedure, FCC procedure and PTCRB procedure.

The "this test counts for what" table

Test	CE/EMC	RED	FCC	PTCRB
Conducted/radiated emissions (EN 55032 / Part 15B)	yes	yes (3.1(b))	yes	,
Immunity (EN 55035)	yes	yes (3.1(b))	,	,
3GPP RF Conformance (TS 36.521)	,	yes (3.2)	yes (Part 22/24/27)	yes
Cellular OTA (CTIA 01.10 / 3GPP 34.114)	,	yes (partial)	,	yes
Wi-Fi 2.4 GHz (EN 300 328 / 15.247)	,	yes (3.2)	yes	,
Wi-Fi 5 GHz DFS (EN 301 893 / 15.407)	,	yes (3.2)	yes	,
BLE (EN 300 328 / 15.247)	,	yes (3.2)	yes	,
SAR 10 g (EN 50360)	,	yes (3.1(a))	,	,
SAR 1 g (KDB 447498)	,	,	yes	,
Safety (EN 62368-1)	yes (LVD)	yes (3.1(a))	recogn.	,
Cybersecurity (EN 18031)	,	yes (3.3)	,	,
IMS / VoLTE	,	,	,	yes
Battery life PSM/eDRX	,	,	,	yes

§ § §

Budget optimisation

The gap between a naive sequential strategy and a well-orchestrated parallel campaign is significant. On a typical Wi-Fi/BLE + LTE Cat-M product:

Approach	Testing budget + fees	Schedule
Sequential (EU first, then US)	~ €120k	12-14 months
Parallel, no sharing (two separate labs)	~ €105k	7-8 months
Parallel with MRA sharing	~ €85k	5-7 months

The 30% saving comes from five main levers:

1. A single MRA-recognised lab capable of producing reports usable for both RED 3.2 and FCC Parts 22/24/27: Element Materials Technology, CETECOM, TÜV Rheinland Asia, 7Layers... Check their NANDO notified scope and FCC recognition.
2. One SAR report post-processed for both limits (10 g EU, 1 g US).
3. One 62368-1 report reused for LVD and UL/ETL recognition.
4. Combined TCB and PVG fees when the same consulting firm runs both submissions.
5. A single retest cycle: if the product fails radiated emissions, you fix once and retest once for both regimes.

Prerequisites to capture the saving

• Pick the lab early, before final design freeze. The MRA lab only helps if engaged before pre-tests.
• Multi-region firmware working at pre-test time, without a country code, the radio phase has to be redone per region.
• Unified dossier from day one, test reports must be structured so they can be referenced both in the EU DoC and in the TCB submission.
• Locked schedule: TCB and PVG submissions run in parallel, so any slippage on one side delays the other.

Roles and economic operators

Dual certification requires two mandatory legal structures, set up before any submission.

EU side, authorised representative and economic operator

A non-EU manufacturer must designate an authorised representative established in the Union via a written mandate (see CE procedure). Since 2021, Regulation (EU) 2019/1020 additionally requires a European economic operator named on the product, it can be the authorised representative, the importer, or a fulfilment service provider accepting that role.

Practical consequences:

• The full name and address of the economic operator must appear on the product, packaging or instructions.
• Without that mention, customs can block the product and marketplaces (Amazon, Cdiscount, etc.) are required to remove the listing.

US side: US Agent for Service

A non-US manufacturer must designate a US Agent for Service of Process named to the FCC in form 731 (the equivalent of the EU authorised representative). It is the official contact for any FCC dispute or investigation. The US Agent must be a physically US-located entity, typically a law firm or an FCC consultant.

PTCRB side, cellular operators

PTCRB is more than a technical certificate: each operator layers on its own post-PTCRB homologation requirements (AT&T NDD, Verizon OPC, T-Mobile programme). Cost: $5k to $20k per operator, schedule 4 to 12 weeks per programme.

And Canada?

The Canadian market is covered by neither FCC nor CE. Innovation, Science and Economic Development Canada (ISED, formerly IC) issues IC IDs based on the RSS standards (RSS-247 for 2.4 GHz, RSS-130 for cellular). Most FCC labs produce IC reports in the same run (tests are about 80% identical), making the Canadian addition economical: +$5k to +$10k and +2 to 3 weeks of schedule if planned upfront.

Documentation strategy

A single dossier, or two regional ones? The practical answer is a unified design file with two regulatory wrappers.

Layer 1, single design file

• Architecture and schematics
• BOM and component list
• Risk analysis (usable for LVD, RED 3.1(a), FCC RF exposure)
• Functional description, radio modes, country codes
• Cybersecurity strategy (usable for RED 3.3 and NIST best practices)
• Change history

This base is shared and feeds both regimes.

Layer 2a: EU wrapper (RED annex V)

• Single DoC covering RED + EMC + LVD + RoHS
• List of harmonised standards applied (with versions and dates)
• Referenced test reports (EU reports and shared MRA reports)
• Authorised representative and economic operator identification
• Notified Body number where applicable

Layer 2b: FCC + PTCRB wrapper

• Application form (731) with US Agent
• Cover letter per TCB
• FCC + PTCRB test reports (shared MRA + US-only reports)
• External / Internal photos with FCC ID labelling
• User manual with Part 15.19 / 15.105 notices
• Modular Approval letter if applicable
• IMEI range request for PTCRB

This architecture delivers:

• Single-source traceability of design decisions (one internal audit covers both);
• Independent maintenance of each submission (an FCC update doesn't disturb the EU dossier);
• Faster regional variants built off the shared base.

See CE technical file and FCC technical file for each wrapper's details.

§ § §

Common pitfalls

A single firmware for both markets

Pitfall number one. A product running the same RF power on both sides is always non-compliant: either it exceeds the EU EIRP limit, or it under-uses the FCC-allowed power, or it violates one region's DFS channels. Fix: dynamic country code, per-batch factory provisioning, or automatic region detection via cellular or Wi-Fi scanning.

Missing EU authorised representative or US Agent

A RED dossier submitted without an identified authorised representative is technically receivable but the product cannot be placed on the market. An FCC dossier without a US Agent is rejected by the TCB. Both designations must exist before the first submission, not after.

Citing CE in an FCC dossier (or vice versa)

Citing "CE marked" as an FCC compliance argument is treated as a misleading declaration by the FCC. Symmetrically, citing "FCC certified" in an EU DoC suggests reliance on a framework outside EU scope. Test reports are neutral; the DoC and the 731 application are separate documents that don't reference each other.

Confusing FCC and Canada

An FCC-certified product is not legally marketable in Canada. A separate IC ID via ISED is needed, and the test report must explicitly reference the Canadian RSS (RSS-Gen, RSS-247, RSS-130). Many manufacturers add IC alongside FCC because the tests overlap heavily, forgetting it costs 2-3 months and an extra dossier.

Believing FCC + PTCRB are enough for carriers

PTCRB is a necessary but not sufficient condition for selling a cellular product in the US. Each operator stacks its own programme (AT&T NDD, Verizon OPC, T-Mobile 5G SA Certification since 2024). Without operator homologation the product will technically work but be filtered out by their equipment-management systems.

Underestimating cybersecurity 3.3

Since August 2025, EN 18031 is mandatory for RED 3.3 on every connectable product. With no US counterpart, this is an EU-only cost (€20-€60k for a typical IoT product) that does not appear in budgets framed around the FCC perimeter. See RED tests for details.

Sub-contracting without synchronisation

Hiring a French consultancy for RED and an American one for FCC without coordination yields incompatible test reports (formats, structure, accreditations). One firm with dual-certification expertise, or a dedicated coordinator, is more efficient.

Worked example: Wi-Fi/BLE + LTE Cat-M IoT sensor

Consider an industrial sensor: Wi-Fi 2.4 GHz, BLE 5.2, LTE Cat-M (US + EU bands), 230 V mains powered, IP65, with a secure web interface and cloud connectivity. Target volume: 50k units/year, markets EU + US + CA.

Months 1-4: Design and stabilisation

• Regulatory scoping: CE (EMC 2014/30/EU + LVD 2014/35/EU + RoHS), RED (3.1(a/b), 3.2, 3.3), FCC Part 15B + 15.247 + 15.407 + Part 22/24/27, PTCRB EPC, ISED RSS-247 + RSS-130.
• Pre-certified cellular module chosen (e.g. Quectel BG770A-GL or u-blox SARA-R5) → modular approval and inherited IMEI range reused.
• Wi-Fi/BLE/cellular antennas chosen and dimensioned.
• Country-code firmware operational with regional power table.

Month 5: Pre-tests

• Internal EMC pre-tests in a semi-anechoic chamber (internal or local provider).
• Wi-Fi/BLE radio pre-tests in TEM cell.
• Cellular OTA pre-tests in OTA chamber.
• EN 18031 pre-assessment: architecture review, code audit.

Months 6-8: Parallel external campaign

• Main MRA lab (e.g. CETECOM or Element): shared EU/US 3GPP RF Conformance, US OTA, multi-limit SAR.
• EMC lab: shared EU/US emissions, EU-only immunity.
• Safety lab: single EN 62368-1 report.
• Cybersecurity lab: EN 18031 audit (EU-only).
• Wi-Fi/BLE lab: EN 300 328 + Part 15.247 on regional firmware.

Months 9-10: Submissions

• TCB submission → 4-6 week turnaround, FCC ID granted.
• PVG PTCRB submission → 6-8 week turnaround, EPC obtained.
• Parallel ISED submission → IC ID obtained.
• RED + EMC + LVD DoC signed, CE mark applied.

Months 11-12: Carrier homologations and launch

• AT&T NDD, Verizon OPC, T-Mobile programme.
• First marked production runs.
• Distribution rollout EU + US + CA.

Budget

Item	Amount
Internal pre-tests + corrections	€15k
Shared MRA 3GPP RF Conformance	€25k
Cellular OTA	€12k
EMC emissions + immunity	€8k
Wi-Fi/BLE radio EU + US	€10k
Multi-limit SAR	€6k
Safety 62368-1	€5k
Cybersecurity EN 18031	€25k
TCB + PVG fees	€8k
EU authorised rep + US Agent	€5k/year
Operator homologations (3 carriers)	€20k
Project and dossier management	€15k
Total	~€154k

Compared with a sequential equivalent (~€210k), that's a saving on the order of €55k and a 4-to-6 month schedule gain. The ROI of a parallel strategy is measured on time-to-market at least as much as on direct budget.

EU + US dual programme

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Sources & references

1. Directive 2014/53/EU (RED): consolidated text , EUR-Lex eur-lex.europa.eu/eli/dir/2014/53/oj
2. Directive 2014/30/EU (EMC): consolidated text , EUR-Lex eur-lex.europa.eu/eli/dir/2014/30/oj
3. 47 CFR Part 2 Subpart J: Equipment Authorization , FCC www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-2/subpart-J
4. FCC Equipment Authorization System (EAS) , FCC www.fcc.gov/oet/ea/fccid
5. PTCRB Certification Program , PTCRB www.ptcrb.com/
6. EU-US MRA on Conformity Assessment , European Commission policy.trade.ec.europa.eu/eu-trade-relationships-country-and-region/countries-and-regions/united-states/mutual-recognition-agreements_en