Getting started with certification: where to begin

Hugues Orgitelloupdated 7 Oct 202614 min read

You have a product, or a prototype that is nearly one, and someone has told you it needs to be "certified" before it can be sold. The word covers a lot: a marking on the enclosure, a signed declaration, a folder of test reports, a grant in a regulator database. This page is the map. It gives you the chain behind every certification project, shows how the legal act (not your preference) decides whether you sign for yourself or need a third party, sets out how the EU and the US differ, lists the dated changes a project starting in 2026 must know, and corrects the common shortcuts, including several this page made before October 2026. Read it first, then follow the links into the detailed guides.

The chain

Certification is not one decision, it is a chain. Each link is determined by the one before it:

1. Target markets. The countries (or regions) where you will place the product on the market.
2. Applicable rules. For each market, the legal acts that the product triggers, by what it is and how it works.
3. Standards. For each rule, the technical standards that, when applied, demonstrate compliance.
4. Tests. The measurements made against those standards.
5. Technical documentation. The file that records the design, the standards used, the test reports and the risk analysis.
6. Marking and declaration. The mark on the product (CE, the FCC ID, others) and the signed statement that closes the file.
7. After placing on the market. The obligations that continue for the product commercial life.

The most common first-timer error is starting in the middle, picking a standard or booking a test before the markets and the rules are settled. Markets decide rules, rules decide standards, standards decide tests.

Step	The question it answers	Who owns it
Target markets	Where will I sell?	You (commercial decision)
Applicable rules	Which laws apply to this product?	You, with regulatory input
Standards	How do I prove conformity?	You, often with your test lab
Tests	Does it actually pass?	A laboratory (accreditation depends on the route, see below)
Technical documentation	Can I show my work?	You (the manufacturer)
Marking and declaration	What do I affix and sign?	You
After placing on the market	What happens after launch?	You, ongoing

The manufacturer owns most of the chain. A laboratory runs tests and a Notified Body may examine a design or a quality system, but the responsibility for the CE marking and the declaration stays with the manufacturer (Decision 768/2008/EC, Article R2; Blue Guide 2022, section 3.1).

Step 1: settle the target markets

Geography is the master variable. A connected sensor sold only in France faces EU rules. Add the United States and you add a separate system, the FCC, with its own procedures, identifiers and laboratory rules. Add Japan, and you add the Radio Act and its technical conformity mark. No market accepts another market's marking by default; where mutual recognition agreements exist, they let a designated body in one party apply the other party's rules (for the US, 47 CFR 2.948(f)), they do not merge the files.

So the first deliverable of any project is a short list: the markets at launch, and the markets planned afterwards. If the United States is on the horizon, design the radio for both EN 300 328 and the relevant FCC rules from the start, not after the EU file is closed.

Great Britain is a special case worth knowing early: since 1 October 2024, SI 2024/696 keeps CE marking recognised without an end date for most regimes, including EMC, low voltage and radio equipment. See the UKCA marking guide for the conditions.

Step 2: find the applicable rules

Once the markets are fixed, you list, for each one, the acts the product triggers. The combination depends on whether the product transmits on purpose:

Product	EU acts typically triggered	Why
Device rated for mains voltage, no radio	Directive 2014/30/EU (EMC), Directive 2014/35/EU (LVD), Directive 2011/65/EU (RoHS)	LVD Article 1: voltage rating between 50 and 1 000 V AC or 75 and 1 500 V DC; RoHS covers electrical and electronic equipment
Battery or low-voltage device, no radio	EMC, RoHS	Below the LVD voltage range, safety falls under the General Product Safety Regulation for consumer products
Radio product (Wi-Fi, BLE, cellular), any supply	Directive 2014/53/EU (RED), RoHS	RED Article 1(4) takes radio equipment out of the LVD except through Article 3(1)(a), which applies the LVD safety objectives with no voltage limit; the EMC Directive excludes equipment covered by the RED (EMC Article 2(2)(a), RED Article 50)

These acts are cumulative for what they cover, but the RED replaces the EMC Directive and the LVD for radio equipment: its Article 3(1)(b) carries EMC and its Article 3(1)(a) carries safety and health. Other acts may join depending on the product (ecodesign, batteries, the Cyber Resilience Act from 11 December 2027). The directive applicability guide works through the classification.

In the US, the equivalent exercise lands on FCC Part 15 for unlicensed devices (and Parts 22, 24, 27 and others for licensed services), with RF exposure under Part 2. Product safety is a separate question: OSHA requires electrical equipment used in workplaces to be acceptable, which in practice means NRTL certification, and some state laws require evaluation before sale; there is no FCC safety approval. See the NRTL guide.

A useful tie-break when you are unsure: describe the product by its physical reality (voltages, intentional emissions, substances, environment) and match each property to a rule. A product that does not intentionally emit or receive radio waves for communication or radiodetermination is not radio equipment under the RED (Article 2(1)(1)), even if it contains a crystal oscillator.

Steps 3 to 5: standards, tests, documentation

With the rules fixed, each one points to standards. In the EU, applying a harmonised standard cited in the Official Journal gives the presumption of conformity with the requirements it covers, within any restriction noted in the citation. In the US, the FCC rules name the measurement procedures themselves (for example ANSI C63.4 and C63.10 incorporated by reference in Part 2 and Part 15).

A typical EU standard map for a Wi-Fi/BLE product under the RED:

RED article	What it covers	Standards a first project usually meets
3(1)(a)	Health and safety	EN 62368-1 (cited under the LVD, not in the RED list, used for the safety objectives); for exposure, EN 50566 for hand-held and body-mounted equipment, otherwise an assessment such as EN 62311, which is not cited under the RED and gives no presumption
3(1)(b)	EMC	EN 301 489-17 (the specific part for broadband data equipment), and EN 55035 for immunity of multimedia equipment; EN 55032 is the emission standard a product without radio meets under the EMC Directive
3(2)	Efficient use of spectrum	EN 300 328 V2.2.2 at 2.4 GHz
3(3)(d), (e), (f)	Network protection, personal data, fraud	EN 18031 parts 1 to 3, cited with restrictions by Decision (EU) 2025/138, for the categories of Delegated Regulation (EU) 2022/30

The RED standards page lists editions and restrictions.

Who runs the tests depends on the route, and this is where first projects are often misinformed:

Route	Does the law require an accredited lab?	Text
EU module A (EMC, LVD, RED)	No. The file must contain test reports; the act does not say who performs the tests	Decision 768/2008/EC Annex II; authorities "take due account" of accredited reports (Regulation (EU) 2019/1020, Article 11(5))
EU module B (EU-type examination)	The Notified Body examines the technical documentation; it is itself notified under the act	RED Annex III, EMC Annex III
FCC certification	Yes: accredited and recognised by the Commission	47 CFR 2.948(a)
FCC SDoC	No accreditation required; the facility must not be owned or controlled by a prohibited entity	47 CFR 2.906(a)(1)

You can do pre-compliance measurements on your own bench to flush out problems early. Accredited reports still carry weight with market surveillance and with customers, which is why many manufacturers use them where the law does not require them.

Everything is then assembled into the technical documentation: product description, design and manufacturing drawings, the list of standards applied, the risk analysis and the test reports. Market surveillance authorities can request it, and an incomplete file is itself a formal non-compliance. See the guide on technical documentation contents and the one on the EU declaration of conformity, the document that closes the file.

Step 6: marking and declaration

In the EU it is the CE marking plus a signed declaration of conformity. In the US it is either a grant of certification with an FCC ID on the label, or, under SDoC, a compliance statement and the information required by 2.1077, with the FCC logo optional (2.1074). Each market has its own mark, placement rules and legal weight.

The mark is a claim, not a permit. CE marking is the manufacturer statement that the product meets every applicable requirement, backed by the file. No EU authority grants it. The US differs for certified equipment: a grant is issued by a TCB or by the Commission (47 CFR 2.907(a)), and the FCC ID combines the grantee code assigned by the FCC with a product code chosen by the grantee (2.926).

Step 7: after placing on the market

The mark is the beginning of the regulated life, not the end. Obligations that continue:

• Keep the file available. Ten years after the product is placed on the market under the EMC Directive, the LVD and the RED; for the FCC, the record periods of 2.938.
• Follow the standards. A citation can be replaced or withdrawn with a date after which the old edition no longer gives presumption.
• Assess changes. A new radio module, a different power supply, a firmware change touching the radio: each must be evaluated against the rules, and for the FCC a change to certified equipment follows the permissive change rules of 2.1043.
• Act on non-conformities. Corrective action, up to withdrawal or recall, and cooperation with market surveillance authorities.

Self-declare, or bring in a third party?

The short version: the legal act decides, not the product category or your preference. The dedicated guide on self-declaration versus a Notified Body works through the modules in detail; here is the high-level map.

Situation	Route	Third party?	Text
EU, LVD product	Internal production control (Annex III) only	No body involved in the procedure	LVD Article 6(2) and Annex III
EU, EMC product	Module A, or B+C at the manufacturer choice	Only if B+C is chosen	EMC Article 14
EU, radio product, Article 3(1)	A, B+C or H	Not required	RED Article 17(2)
EU, radio product, 3(2) or 3(3) with cited harmonised standards applied in full	A, B+C or H	Not required	RED Article 17(3)
EU, radio product, 3(2) or 3(3) with standards not applied, applied in part, or not existing	B+C or H	Yes (Notified Body, NB)	RED Article 17(4)
EU, other families (medical devices, ATEX, lifts, pressure equipment)	Per act, depending on class or category	Often, not always (for example MDR class I non-sterile, ATEX category 3)	The sectoral act
US, unintentional radiator (digital device, most receivers)	SDoC or certification	No	47 CFR 15.101(a)
US, scanning receiver, radar detector	Certification	Yes (TCB)	47 CFR 15.101(a)
US, intentional radiator	Certification, except the cases of 15.201(a)	Yes (TCB)	47 CFR 15.201(b)
US, any equipment produced by an entity on the Covered List	Certification only	Yes	47 CFR 2.906(d), 2.907(c)

"Self-declare" means you sign the declaration yourself, it does not mean you skip testing. And the boundary is set by the rules: you cannot self-declare around a Notified Body that an act requires, or around FCC certification for an intentional radiator.

EU vs US, at a glance

Dimension	EU	US
Mark	CE marking	FCC ID (certification); FCC logo optional under SDoC
Who signs off	Manufacturer, with a Notified Body where the act requires one	TCB or Commission grant for certification; responsible party located in the US for SDoC (2.909(b))
Core legal text	Directives and regulations (EMC, LVD, RED, RoHS and others)	Title 47 CFR (Parts 2 and 15 for most electronics); safety outside the FCC
Identifier on product	No central product ID	FCC ID (grantee code + product code) under certification
Standards basis	Harmonised EN standards cited in the Official Journal	Measurement procedures incorporated in the CFR (ANSI C63 series)
Fixed fees set by the text	None for testing or for Notified Body work	$35 grantee code, $50 confidentiality request (1.1103)

The technical measurements sometimes overlap, so test data can be partly reused when the methods match, but the legal wrappers never line up automatically. For a side-by-side on emissions, see CE versus FCC for EMC.

Dated changes a first project must know

Date (applies from)	Change	Text
6 February 2023	FCC: equipment produced by an entity on the Covered List must go through certification, not SDoC	47 CFR 2.906(d), 2.907(c) (88 FR 7592)
1 October 2024	Great Britain: CE recognition no longer expires for most regimes	SI 2024/696
13 December 2024	General Product Safety Regulation applies, replacing Directive 2001/95/EC	Regulation (EU) 2023/988, Articles 50 and 52
1 August 2025	RED Article 3(3)(d), (e) and (f) applies to the categories of the delegated act; EN 18031-1, -2 and -3 cited with restrictions	Delegated Regulation (EU) 2022/30; Decision (EU) 2025/138
8 September 2025	FCC: SDoC testing may not be performed at a facility owned, controlled or directed by a prohibited entity	47 CFR 2.906(a)(1), 2.902 (90 FR 38045)
11 September 2026	Cyber Resilience Act reporting obligations (Article 14) apply	Regulation (EU) 2024/2847, Article 71(2)
20 January 2027	Machinery Regulation applies, Directive 2006/42/EC repealed	Regulation (EU) 2023/1230
11 December 2027	Cyber Resilience Act applies in full to products with digital elements	Regulation (EU) 2024/2847, Article 71(2)

What moves time and cost

No EU or US text sets a test duration or a laboratory price, and the earlier version of this page gave ranges that had no source. They were removed. What the texts and the process do tell you:

• Radio adds third parties in the US. An intentional radiator needs FCC certification by a TCB (15.201(b)) and a laboratory accredited and recognised under 2.948(a).
• A Notified Body is triggered by the act, not by default. Under the RED, only for 3(2) or 3(3) when cited harmonised standards are not applied in full.
• Each market adds its own procedure. The marginal market is rarely free, even when standards overlap.
• Failures send you back. A non-conformity found in formal testing means a design change and a new test, so pre-compliance and a stable design matter more than the queue at any one lab.

For what the texts and scheme owners do publish, see the guides on the certification timeline (durations set by the texts) and the cost of certification.

The typical sequence of a project

1. Scope. Fix markets, map acts, draft the standard list. Identify which act, if any, requires a Notified Body or a TCB.
2. Design for compliance. Choose the radio approach (module or chipset), apply EMC layout rules, plan for safety and exposure from the schematic stage.
3. Pre-compliance. Bench measurements to catch the obvious failures before formal testing.
4. Freeze the design. Test results describe the sample tested; FCC certification and SDoC attach to units identical to it (2.906(b), 2.907(b)).
5. Formal testing. EMC, radio, safety and exposure, in a laboratory that meets the route requirements above. Retest any failures.
6. Assemble the file. Technical documentation, risk analysis, reports.
7. Declaration and marking. Sign the EU declaration, affix the CE marking; obtain the FCC grant or complete the SDoC.
8. Launch and follow-up. Place on the market, keep the file available, assess changes.

Common first-timer mistakes

• Starting from a standard instead of the markets. Booking an EMC test before confirming which acts apply, then discovering the radio scope was never covered.
• Designing the radio for one region only. Optimising for the EU, then finding the FCC limits or channel plan differ after the design is frozen.
• Assuming a certified module removes the project. The module approval helps, but the host manufacturer owns EMC of the whole device, safety, exposure and the declaration.
• Treating CE marking as a permit someone grants you. No one issues it; you affix it on your own responsibility.
• Citing a superseded standard. Check the current Official Journal citation, its restrictions and any date of cessation of presumption.
• Forgetting the obligations after launch. Record retention, change assessment and corrective action are part of the project.
• Building one file and hoping it travels. EU and US data may overlap, the declarations and identifiers do not.

Claims the texts contradict

Claim (several made by this page before October 2026)	What the text says
"A US unintentional radiator uses SDoC, no third party, but an accredited lab"	47 CFR 2.948(a) requires an accredited and recognised laboratory only for certification. For SDoC, the only condition on the facility is that it is not owned, controlled or directed by a prohibited entity (2.906(a)(1))
"The formal evidence has to come from an accredited lab"	EU module A asks for test reports without saying who tests; authorities take due account of accredited reports (Regulation (EU) 2019/1020, Article 11(5))
"A mains-powered connected device triggers EMC, LVD, RED and RoHS at once"	RED Article 1(4) takes radio equipment out of the LVD except through Article 3(1)(a), and the EMC Directive excludes equipment covered by the RED (Article 2(2)(a))
"A partially applicable radio standard means a Notified Body"	Only for Articles 3(2) and 3(3) (RED Article 17(4)); for Article 3(1), module A stays open whatever the standards (Article 17(2))
"RF exposure for a RED product is shown with EN 62311"	EN 62311 is not cited under the RED; the 3(1)(a) citations are EN 50360, EN 50566, EN 50385 and EN 50401
"RED Article 3.3 cybersecurity" applies to every connected radio	Only Article 3(3)(d), (e) and (f), for the categories of Delegated Regulation (EU) 2022/30, from 1 August 2025
"A Wi-Fi/BLE product costs EUR 20 000 to 60 000 and takes 4 to 7 months"	No text or scheme owner publishes such figures; they were removed. The only fixed FCC amounts are those of 1.1103
"The US equivalent includes a separate safety listing through an NRTL"	NRTL certification answers OSHA workplace rules and some state laws, not an FCC requirement

See also

• Environmental compliance: what it asks of a product
• Product cybersecurity: obligation, evaluation, label
• Radio type approval worldwide: how it works
• Worked example: an IoT sensor through RED and FCC
• Which EU directives apply to my product?
• Harmonised standards and presumption of conformity
• Conformity assessment bodies and accreditation
• Technical documentation file: required contents
• CB Scheme (IECEE): global safety via one report
• The CE procedure
• FCC equipment authorization

Working on scoping a first certification project end to end for a real product? AESTECHNO can audit your design and certification plan. Get in touch

Sources & references

1. The Blue Guide on the implementation of EU product rules 2022, European Commission (Official Journal 2022/C 247/01) eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52022XC0629(04)
2. Decision No 768/2008/EC, common framework for the marketing of products, EUR-Lex eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32008D0768
3. Regulation (EC) No 765/2008, accreditation and market surveillance, EUR-Lex eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32008R0765
4. Directive 2014/53/EU (RED), Articles 1(4), 3 and 17, EUR-Lex eur-lex.europa.eu/eli/dir/2014/53/oj
5. Directive 2014/30/EU (EMC), Article 2(2)(a) and Article 14, EUR-Lex eur-lex.europa.eu/eli/dir/2014/30/oj
6. Regulation (EU) 2019/1020 on market surveillance, Articles 4 and 11(5), EUR-Lex eur-lex.europa.eu/eli/reg/2019/1020/oj
7. Regulation (EU) 2023/988, General Product Safety Regulation, Article 52, EUR-Lex eur-lex.europa.eu/eli/reg/2023/988/oj
8. Regulation (EU) 2024/2847, Cyber Resilience Act, Article 71, EUR-Lex eur-lex.europa.eu/eli/reg/2024/2847/oj
9. Commission Implementing Decision (EU) 2025/138, EN 18031 citation, EUR-Lex eur-lex.europa.eu/eli/dec_impl/2025/138/oj
10. Title 47 CFR Part 2, frequency allocations and radio treaty matters, US Government (eCFR) www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-2
11. 47 CFR 2.948, measurement facilities, US Government (eCFR) www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-2/subpart-J/section-2.948
12. 47 CFR 2.906, Supplier's Declaration of Conformity, US Government (eCFR) www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-2/subpart-J/section-2.906
13. 47 CFR 15.101 and 15.201, equipment authorization of Part 15 devices, US Government (eCFR) www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-15
14. 47 CFR 1.1103, schedule of charges for equipment approval, US Government (eCFR) www.ecfr.gov/current/title-47/section-1.1103
15. The Product Safety and Metrology etc. (Amendment) Regulations 2024 (SI 2024/696), UK legislation.gov.uk www.legislation.gov.uk/uksi/2024/696/contents/made
16. CE marking, official Single Market portal, European Commission single-market-economy.ec.europa.eu/single-market/goods/ce-marking_en
17. ISO/IEC 17000, conformity assessment vocabulary and principles, ISO www.iso.org/standard/73029.html