CE certification, step-by-step procedure

Author Hugues Orgitello Last updated 25 May 2026

CE · Pillar

CE certification follows a codified path, but the terrain is denser than it appears. For a typical electronic product the challenge is not the procedure itself; it is the quality of the file it produces, choosing the right assessment module, and chaining with the associated obligations (authorised representative, importer, EU economic operator).

Conformity assessment modules

Decision 768/2008/EC defines eight modules labelled A through H. Each directive picks which ones are allowed. For most electronic products (EMC, LVD, RED, RoHS) the mechanism is as follows:

Module	Name	Third-party involvement?	Typical case
A	Internal production control	No	EMC, LVD, RED article 3.1 (with harmonised standard)
A1	Internal control + supervised tests	Notified Body for specific tests	RED when harmonised standard not fully applied
A2	Internal control + random checks	NB for random audits	Rare in practice for electronics
B	EU-type examination	Yes (NB issues type certificate)	Step before C, D, E, F
C	Conformity to type	No (declaration based on B)	Follow-up to B for self-declaration
C1 / C2	C variants with tests or audits	Yes	Specific cases
D	Production quality assurance	Yes (ISO 9001-like audit)	Series production, full quality
D1	D without prior type examination	Yes	Variant
E	Product quality assurance	Yes	Less common
F	Product verification	Yes (batch tests)	Small series, special products
G	Unit verification	Yes	Single piece, industrial prototype
H	Full quality assurance	Yes	Complete ISO-validated quality system

For a standard electronic product with no specific risk, Module A is overwhelmingly dominant. It is the self-declaration procedure under the manufacturer's own responsibility. EMC and LVD directives offer only Module A; the RED directive offers A, A1, B+C, and H depending on the case.

Each module described in detail

Module A: Internal production control

The manufacturer assumes the entire conformity assessment alone. It performs the tests (in-house or via subcontracting), assembles the technical file, signs the DoC, and affixes the CE marking. No third party intervenes. This is the fastest and least costly route, reserved for products where harmonised standards are fully applicable and applied.

Module A1: Internal control + tests supervised by Notified Body

Module A variant adding NB intervention only for certain specific tests designated by the directive. For RED, it is the default option when the harmonised standard is not fully applicable, the NB intervenes on Article 3.2 radio tests but not on general EMC.

Module B + C: EU-type examination then conformity to type

Two-step procedure. First (Module B), a Notified Body examines a representative sample and issues an EU-type examination certificate attesting design conformity to essential requirements. Then (Module C), the manufacturer declares its production conforms to the certified type. This is the classic route for radio products that do not apply Article 3.2 harmonised standards.

Module D: Production quality assurance

The NB audits the manufacturer's production quality system (close to a product-specific ISO 9001) and surveils it periodically. Suited to large-scale productions with formalised industrial controls. Often combined with B (B+D).

Module F: Product verification

The NB examines and tests each product (or a randomly drawn representative lot) before it can be placed on the market. Suited to small series, custom products, high-criticality equipment. Often combined with B (B+F).

Module G: Unit verification

The NB examines and tests each unit individually. Suited to single pieces (e.g. a high-value industrial prototype). Costly per unit but no other recurring intervention.

Module H: Full quality assurance

The NB audits the quality system covering design, production, final inspection and testing. The manufacturer may then self-declare each product without ad-hoc NB intervention. Reserved for manufacturers with a mature, regularly audited quality system.

When is a Notified Body mandatory?

In common electronic directives the Notified Body becomes mandatory in three cases:

1. The manufacturer does not, or not fully, apply a harmonised standard. In that case, the technical case alone does not suffice: external validation is required (typically Module B). For the RED directive this is the most frequent NB obligation: a sub-GHz product using a modulation not covered by a harmonised standard goes through B+C.
2. The directive imposes it directly for a higher-risk category (non-automatic weighing instruments, Class IIa+ medical devices, ATEX, pressure equipment above thresholds, lifts, etc.).
3. The manufacturer chooses this route to reduce legal risk, less common but possible. A B2B manufacturer may prefer to pay an NB to obtain a type certificate that reassures its industrial customers.

How to find a Notified Body

The European Commission's NANDO database (New Approach Notified and Designated Organisations) lists all NBs by directive and Member State. Selection criteria:

• Effective notification on the directive concerned, an NB may be notified for EMC but not for RED.
• Precise scope, verify the list of tests and examinations covered; some NBs only cover specific product categories.
• Reputation and lead times, the most recognised NBs (TÜV Rheinland, TÜV SÜD, DEKRA, INTERTEK, UL, SGS, LCIE Bureau Veritas, CETECOM...) have 6 to 16 week lead times depending on load.
• Costs, a Module B EU-type examination certificate typically costs between €8,000 and €30,000 depending on product complexity.
• Working language, most work in English; some accept files in French.

The NB carries a four-digit identification number (e.g. 0123 for TÜV SÜD) which appears beside the CE marking when the NB has intervened.

The concrete sequence for a typical electronic product

Here is the sequence of a CE marking project in Module A, without Notified Body, for a Wi-Fi/BLE-connected IoT product:

1. Regulatory scoping. Identify all applicable directives. For this product: EMC (2014/30/EU), LVD if > 50 V AC, RED (2014/53/EU) due to Wi-Fi/BLE, RoHS (2011/65/EU), REACH, ecodesign if relevant. This step decides everything that follows, an error here costs months. See Scope.
2. Harmonised standards selection. For each directive, select the version of the harmonised standards in force (see Standards). Formally document the choice.
3. Risk analysis. The LVD directive imposes a formal risk analysis. RED article 3.1(a) too. For EMC it is not formally mandatory but is good practice that anticipates audit. The HBSE methodology (Hazard-Based Safety Engineering) imposed by EN 62368-1 should be applied systematically.
4. In-house pre-testing. Before the external lab campaign, in-house pre-tests, radiated emissions, ESD immunity, surge, identify gross defects at low cost. Typical gain is 40 to 60% of the test-campaign time if pre-testing is done well. See Required tests.
5. Test campaign. In an ISO/IEC 17025-accredited lab for tests subject to mutual recognition (radiated emissions, immunity, radio). Ecodesign tests can often be done in-house.
6. Modifications and retests. The proportion of products passing EMC on the first attempt is low. Plan a budget and schedule reserve for two to three iterations.
7. Technical file assembly. See Technical file. The file must be complete before signing the DoC.
8. Drafting and signing the EU Declaration of Conformity by an authorised person of the manufacturer (CEO, quality manager, or designated person).
9. Affixing the CE marking to the product, packaging and instructions. The pictogram must be at least 5 mm high (unless directive-specific derogation for small products).
10. Archiving the technical file for 10 years after the last unit was placed on the market.

Typical schedule

For a moderately complex electronic product, count the following chronology from the start of the certification phase:

T0          : Regulatory scoping + standards selection
T0 + 2 wks  : Formalised risk analysis
T0 + 4 wks  : In-house pre-tests + design fixes
T0 + 8 wks  : External lab booking + sample dispatch
T0 + 10 wks : Lab campaign start (~3 weeks)
T0 + 13 wks : Receive preliminary report
T0 + 14 wks : Fixes + partial retests (if needed)
T0 + 16 wks : Final report + file assembly
T0 + 17 wks : DoC drafting + signature
T0 + 18 wks : Affixing marking, production launch

For an LTE/5G cellular product with Notified Body, add 8 to 16 weeks for the Module B type examination.

§ § §

Marking rules: what the directive requires

The CE pictogram is precisely defined graphically:

• Minimum height: 5 mm, unless the relevant directive explicitly provides a derogation for small products. For compact radio modules, the RED authorises a smaller height if still legible.
• Legible, indelible, visible on the product under normal conditions of use.
• If marking on the product itself is impossible (very small object, high IP rating), affix on packaging and accompanying documentation.
• Strict proportions: the "C" and "E" letters must follow the official template defined in Annex II of Regulation (EC) No 765/2008. The "C" and "E" are built on two circles of equal diameter, with a specific spacing between them. Horizontal or vertical deformation of the symbol is a ground for rejection in market surveillance.
• If a Notified Body has been involved, its four-digit identification number is affixed next to the marking, with a typographic height at least equal to that of CE.

The marking must be affixed:

1. On the product itself, indelibly.
2. On its packaging (exterior, visible before purchase).
3. On the accompanying documentation (manual, datasheet, warranty).

This triple affixing ensures that a buyer, a distributor, a customs agent or a market surveillance check can verify conformity at each stage of the product's journey.

The "China Export" trap

The "China Export" marking, often described as a fake CE with very similar aesthetics, has no legal status: its only effect is to attract suspicion. The typographic differences from official CE are subtle (letter spacing, C curvature) but detectable by a trained eye. To be avoided for any product carrying the slightest audit risk.

Special case: modifications after placing on the market

A modification to the product after initial placing on the market raises the question: must the conformity assessment be redone? The answer depends on the nature of the modification:

Modification type	Reassessment required?	Action
Cosmetic (colour, packaging)	No	None
Software optimisation without functional impact	No	Document in file
Software bug fix without ER impact	No	Document
Equivalent component change (same ref., other manufacturer)	Depends on criticality	Impact analysis, retests if critical
Antenna change	Yes for RED	Article 3.2 and 3.1(b) radio retests
Power supply change	Yes for EMC + LVD	Emissions + safety retests
Radio transmit power modification	Yes for RED	New 3.2 assessment + new DoC
Adding a radio band	Yes for RED	Complete new-band assessment
Cybersecurity modification	Yes for RED 3.3	EN 18031 reassessment
Major mechanical redesign	Yes for LVD	New risk analysis + retests

The general criterion is the substantiality of the modification with respect to essential requirements. A non-substantial modification does not trigger reassessment but must be traced in the file (version history, justification of absence of impact).

The role of the authorised representative for non-EU manufacturers

A manufacturer established outside the EU wishing to market a product in the EU must designate an authorised representative established in the EU by a written mandate. The representative:

• keeps the technical file available to authorities for 10 years after the last placing on the market;
• is the official contact point for market surveillance;
• does not sign the DoC, which remains the manufacturer's responsibility;
• must be reachable in the official languages of the country where the product is placed on the market.

The mandate must be written, dated, signed by both the manufacturer and representative. It specifies:

• precise identification of manufacturer and representative,
• the list of products covered (by reference or range),
• the tasks delegated (at minimum those imposed by the relevant directive),
• duration and termination conditions.

Without a formalised mandate, the designation is void and the product cannot be legally marketed.

The European economic operator since 2021

Since 2021, Regulation (EU) 2019/1020 has expanded this obligation: an economic operator established in the EU is now required for most imported products, whether that is an authorised representative, an importer, or a logistics service provider accepting this role. Without this operator:

• the product cannot be legally marketed;
• online sales platforms (Amazon, marketplaces) must refuse the listing;
• customs may block importation.

The economic operator is responsible:

• for verifying that the DoC and technical file are available;
• for communicating with authorities on demand;
• for cooperating in corrective or withdrawal actions in case of failure;
• for affixing its identity (name and contact details) on the product, packaging or manual.

Importer, distributor, manufacturer: who does what

Regulation 2019/1020 distinguishes three economic operator roles in the chain:

Importer

The importer is the EU-established entity placing on the EU market a product from a third country. Obligations:

• verify the manufacturer has carried out the conformity assessment,
• verify the CE marking is correctly affixed,
• verify the DoC is available,
• verify the required documentation (manual, labels) accompanies the product,
• affix its name and contact details on the product or its packaging,
• retain a copy of the DoC for 10 years,
• cooperate in market surveillance actions.

The importer can be held liable as a manufacturer if it modifies the product, markets it under its name, or omits its basic controls.

Distributor

The distributor makes the product available after the manufacturer or importer. Obligations are less extensive:

• visual check of CE marking,
• verification that documentation is provided,
• verification that the product is not manifestly non-compliant,
• cooperation in corrective actions where appropriate.

The distributor does not have to verify the technical file contents but must signal to the authority if it has reasons to believe in non-conformity.

Consequences of failure

Regulation 2019/1020 provides that any economic operator in the chain can be held responsible if it fails its obligations. In practice:

• for a design non-conformity → manufacturer's responsibility (or the importer's if the manufacturer is non-EU and inaccessible);
• for a marking non-conformity → manufacturer and importer responsibility;
• for a visibly damaged product → distributor's responsibility (it should have detected it).

Sanctions vary by Member State: administrative fines, market withdrawal, marketing ban, even criminal proceedings in cases of endangerment.

Practical scoping

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Sources & references

1. Decision No 768/2008/EC, conformity assessment modules , EUR-Lex eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32008D0768
2. NANDO: Notified Bodies database , European Commission single-market-economy.ec.europa.eu/single-market/goods/building-blocks/notified-bodies_en
3. Regulation (EU) 2019/1020, market surveillance , EUR-Lex eur-lex.europa.eu/eli/reg/2019/1020/oj