CE marking, scope and applicability

Author Hugues Orgitello Last updated 25 May 2026

CE · Pillar

CE marking applies to products covered by at least one EU "new approach" directive or regulation. Outside that scope, affixing it is forbidden; placing a regulated product on the EU market without CE marking exposes the operator to immediate withdrawal sanctions. This page sweeps the boundaries of scope in detail, and they are often not where one would expect.

The single criterion: being covered by a legal act

CE marking is not universal. It only applies to products falling within the scope of at least one European legislative act that explicitly requires it. For electronic and IoT products, six directives or regulations cover the overwhelming majority of cases:

• Directive 2014/30/EU, EMC. All products liable to emit or be disturbed by electromagnetic phenomena.
• Directive 2014/35/EU, LVD. Electrical equipment operating between 50 V and 1,000 V AC, or 75 V and 1,500 V DC.
• Directive 2014/53/EU, RED. Any equipment intentionally transmitting or receiving radio waves for communication or radio determination.
• Directive 2011/65/EU, RoHS. Limits on lead, cadmium, mercury, hexavalent chromium and certain flame retardants and phthalates.
• Regulation (EC) No 1907/2006, chemical substances in articles.
• Directive 2009/125/EC, energy efficiency requirements for many energy-related products.

Other acts apply depending on product type: medical devices Regulation (EU) 2017/745, toys Directive 2009/48/EC, pressure equipment Directive 2014/68/EU, ATEX Directive 2014/34/EU, machinery Directive 2006/42/EC (being replaced by Regulation (EU) 2023/1230 from 2027), lifts Directive 2014/33/EU, simple pressure equipment Directive 2014/29/EU, etc.

Decision tree: is your product subject to CE?

Three questions to ask in order, skipping none:

1. Is my product covered by at least one "new approach" directive requiring CE marking?

   • Yes → continue to question 2.
   • No → CE marking is forbidden on this product; a manufacturer affixing it would be in breach of Regulation (EC) No 765/2008.

2. Is my product placed on the EU or EEA market?

   • Yes → continue to question 3.
   • No (sale only outside EU) → out of scope.

3. On what date does placing on the market occur?

   • That date freezes the applicable obligations (versions of directives in force, eligible harmonised standards, transitional periods).
   • For a product crossing a new requirement's pivot date (e.g. RED 3.3 on 1 August 2025), clearly identify the applicable version.

The sections that follow detail each of these three criteria and their special cases.

Geographic scope: EU, EEA, and beyond

CE marking is required to place products on the market in:

• the 27 EU Member States;
• the three EEA states: Norway, Iceland, Liechtenstein, via the 1994 EEA Agreement;
• Turkey, under the EU-Turkey customs union for harmonised industrial products.

Several special cases deserve attention:

United Kingdom. CE marking has not been sufficient for placing products on the market in Great Britain (England, Wales, Scotland) since 1 January 2021; the UKCA marking is required. The CE recognition period has been extended several times and some categories obtained indefinite recognition (notably consumer electronics under EMC, LVD, RED, RoHS since the August 2023 government announcement). Northern Ireland remains under the CE regime via the Northern Ireland Protocol, with a specific UKNI marking in some cases.

Switzerland. Third country since the gradual erosion of the MRA EU-Switzerland. CE remains accepted for most common electronic products, but for certain categories (notably medical devices), Switzerland has reintroduced its own assessment system since 2021. Verify case by case the list of products covered by the agreement.

Andorra, Monaco, San Marino, Vatican. All recognise CE marking, by bilateral agreement or de facto practice.

Candidate countries (North Macedonia, Montenegro, Albania, Bosnia, Serbia, Ukraine, Moldova, Kosovo). Not in the EU but progressively aligning their law. Some have equivalent national markings (e.g. C-tick Serbian); CE marking is useful but not always sufficient.

Explicit exclusions

Several categories explicitly fall outside the scope of common electronic directives:

Military and defence equipment

Covered by Article 346 TFEU, which allows Member States to derogate from internal market rules for products linked to defence. A military radar, an encrypted tactical communication system, an armed drone are not subject to CE marking, they fall under national defence rules and NATO standards.

Note: a dual-use product (usable both civilian and military) without being specifically designed for defence remains under CE. Thermal binoculars sold to consumers do not benefit from the exception, even if also sold to the army.

Demonstration and prototyping equipment

May be exhibited at trade shows and demonstrations without CE marking, provided they are:

• Visibly identified as non-conforming (indelible label "DEMO", "PROTOTYPE NON-CE", or equivalent);
• not made available commercially;
• not presenting an immediate risk;
• withdrawn from public space at the end of the demonstration.

A pre-production batch distributed to beta-testers for validation falls under CE if it leaves the manufacturer's premises durably, even free of charge, unless framed by an explicit test contract limiting use.

Custom-made products

A unit designed for a specific customer, on a dedicated specification, generally falls under CE marking from delivery. The only explicit exceptions concern:

• Custom-made medical devices under Regulation 2017/745 (Article 2(3)): made for an identified patient under medical prescription; outside classic CE but must meet essential requirements;
• Scientific research equipment not marketed beyond the context of the research project;
• Special machines integrated into an industrial site and not re-deployed elsewhere (excluded from the scope of the Machinery Directive).

Unfinished components incorporated by another manufacturer

A Wi-Fi module sold to an integrator manufacturer is not CE-marked for the final product. It may be CE-marked as a sub-assembly only if:

• it is intended to be made available to end users as is (rare for an electronic module);
• or the relevant directive explicitly covers it (RED covers radio modules placed on the market for manufacturers).

For most electronic modules (OEM power modules, transformers, OEM LED drivers, MCU modules), CE marking belongs to the final product in which the module is integrated. The integrator manufacturer reassesses, redoes affected tests, signs its own DoC.

Equipment placed on the market before entry into force

A product placed on the market before the entry into force of a directive is not obliged to comply, it remains legally marketable in its initial state. The question becomes subtle for products stored before the entry into force date: they must be made available before to benefit from the precedence, not just manufactured.

Working on defining the exact scope of a product in development for a real product? AESTECHNO can audit your design and certification plan. Get in touch →

Placing on the market: at what point?

The notion of "placing on the market" is central. Per Regulation 765/2008, it means the first making available of a product on the EU market, against payment or free of charge, in the course of commercial activity. Practical consequences:

1. The legal status is frozen at the date of placing on the market. Later regulatory evolution does not affect a product already marketed, unless specific transitional provisions apply.
2. Each unit is individually concerned. The marking covers the unit, not the model. A non-trivial modification to a later-produced unit may trigger a new conformity assessment.
3. Storage before marketing is not placing on the market. A product manufactured in 2024 but offered for sale in 2026 must meet 2026 requirements if it was not made available before.

The exact moment of placing on the market differs by channel:

• Direct factory → end customer: at invoicing or delivery, per general terms.
• Manufacturer → distributor sale: at invoicing between manufacturer and distributor.
• Free provision (sample, test, permanent demonstration): on delivery, unless explicit contractual framing.
• Direct online sale to consumer: at order placement, not at delivery.

Transitional periods: the pivot-date trap

Several directives are in evolution. Some 2024-2027 deadlines to anticipate:

Date	Evolution	Impact
1 August 2025	RED 3.3 cybersecurity applicable	All connected radio products concerned
28 December 2024	Universal USB-C deadline	Smartphones, tablets, portable consoles, etc.
2027	Machinery Regulation 2023/1230 replaces directive	All products covered by the Machinery Directive
2027	Ecodesign Regulation SPR replaces directive 2009/125	Expansion to many new categories
Continuous	RoHS annex updates	Substances added or re-assessed every 12 to 24 months

A product placed on the market just before a transition may be marketed under the old regime, but in practice, many manufacturers align their production with the new requirement from the pre-transition phase to avoid running two referentials in parallel.

Used, refurbished and reconditioned products

The EU treats this in a nuanced way:

• Used between private individuals, out of scope. A peer-to-peer sale on Craigslist between two private individuals does not engage the product's CE marking.
• Reconditioned by a professional and placed back on the market, the refurbisher may be considered a new manufacturer if the transformations are substantial:
  • main function change,
  • significant hardware update (battery, screen, motherboard),
  • replacement of more than 30 % of the BOM by value. In that case, CE marking and technical file to redo.
• Identical repair, no new conformity assessment, provided replacement parts are identical to the originals (same reference, same manufacturer, or formal equivalence).
• Import of used goods from a third country, same obligations as an initial placing on the market, regardless of product age. An SME importing used professional equipment from the United States would need to verify CE compliance as if the products were new.
• Certified refurbishment, some programmes (Apple Certified Refurbished, OEM programmes) may maintain original conformity if procedures are documented and auditable. Without these guarantees, the refurbishing operator assumes manufacturer responsibility.

§ § §

Components vs sub-assemblies vs finished products

A boundary often blurred in IoT projects:

Elementary components

Elementary components (resistors, capacitors, bare semiconductors, connectors) are not CE-marked. They are governed by REACH and RoHS at component level, and by the essential requirements of the final products that integrate them.

Sub-assemblies for integration

A Wi-Fi module, a transformer, an OEM power supply, an OEM LED driver, an industrial motherboard are sub-assemblies. They may be:

• CE-marked as such, if the manufacturer places them on the market to integrator manufacturers and the relevant directive provides for it. The OEM power supply's marking covers the supply in isolation (safety, EMC); it does not exempt the integrator from reassessing the final product.
• Not individually CE-marked, when not intended for end users and the directive does not provide for it (common case of OEM MCU sub-modules on PCB).

Finished products

CE marking always belongs to the finished product made available to the end user, independently of individual component marking. The golden rule: each finished product is reassessed in its final configuration, even if all its components are individually CE-marked.

Kits and modular products

A kit sold to an end user (e.g. a development board, an electronics educational kit) falls under CE as a finished product. If the kit is intended for purely educational or prototyping use, some directives provide for specific application terms (RED notably, for radio evaluation kits).

A modular system sold off-the-shelf (e.g. a PLC with extension modules) is CE-marked at each module separately marketed, but also at the system level for the typical combinations envisaged.

OEM, rebranding and private label

When a product is designed and manufactured by company A then resold under company B's brand ("private label"), who is the manufacturer in the directive's sense?

The rule is set by Article R2 of Decision 768/2008/EC: the manufacturer is the person who markets the product under their own name or trademark. So in a private-label scheme:

• Company B (the brand affixing its name) is the manufacturer in the regulatory sense.
• Company A (the physical designer/manufacturer) is the subcontractor, who must transmit all technical documentation to B.

Practical consequences:

• B must be able to present the technical file to the authorities, even if A maintains it day-to-day.
• B signs the DoC in its own name.
• If A sells the same product to several different "brands", each signs its own DoC but may share the same reference file.
• In case of failure, B assumes manufacturer responsibility, including criminal.

Protection comes through a precise OEM contract formalising documentation transmission and each party's responsibilities.

Online sales: an increasingly structural case

Regulation (EU) 2019/1020 explicitly extended CE obligations to e-commerce. Any product offered for sale to an EU consumer, including via a third-party marketplace and even shipped from a third country, must comply with the marking requirements.

The EU economic operator, required since 2021

Article 4 of 2019/1020 requires that an economic operator established in the EU be responsible for each product placed on the market. This function may be fulfilled by:

• the manufacturer if established in the EU;
• the importer if established in the EU and having effectively imported the product;
• the authorised representative appointed by contract for non-EU manufacturers;
• a logistics service provider explicitly accepting this role (rare in practice in 2026).

Without this identifiable operator, the product cannot be legally marketed in the EU, the marketplace must refuse the listing.

The Digital Services Act reinforces platform obligations

Regulation (EU) 2022/2065 requires of marketplaces since 2024:

• verification of economic operators before listing their products (KYC for professional sellers);
• rapid removal of listings reported as non-compliant;
• transparency on advertising and recommendation practices.

Very large platforms (Amazon, AliExpress, Wish, eBay...) are subject to reinforced obligations and Commission audits. Several were sanctioned in 2024-2025 for failures in CE compliance control of listed products.

Complete example: a Wi-Fi LED bulb

To illustrate, here is the scope analysis of a representative product: a Wi-Fi connected LED bulb sold to European consumers.

Aspect	Analysis	Directive(s)
Emits/receives Wi-Fi	Yes	RED 2014/53/EU
Mains-powered 230 V AC	Yes	LVD 2014/35/EU
Electromagnetic emissions	Yes (LED driver + Wi-Fi)	EMC 2014/30/EU (integrated to RED via 3.1(b) for the radio part)
RoHS substances	Yes (LED, driver)	RoHS 2011/65/EU
REACH substances	Yes (electronic components)	REACH (EC) 1907/2006
Standby consumption	Yes	Ecodesign 2009/125/EC + lighting regulation
WEEE / collection	Yes	WEEE 2012/19/EU (outside CE marking but specific marking required)
Radio cybersecurity	Yes (sale after August 2025)	RED 3.3
Personal data (mobile app pairing)	Yes	GDPR (outside CE but relevant for 3.3(e))

Thus six directives apply simultaneously (EMC, LVD, RED, RoHS, REACH, Ecodesign), plus two adjacent regimes (WEEE, GDPR). An incomplete analysis that would forget RED for example would amount to marketing a non-compliant product on the most visible aspect, radio transmission, which is the first thing a check verifies.

In summary

Scope reduces to a three-question grid, coverage by an act, EU placing on the market, date of placing on the market, but behind these simple questions hide special cases that make the difference between a correct certification and a market withdrawal.

Recurring attention points:

1. Always make an exhaustive analysis of applicable directives before starting tests, don't forget any (RED particularly for IoT products).
2. Anticipate regulatory transitions: RED 3.3 cybersecurity, universal USB-C, future Machinery Regulation, etc.
3. Appoint a European economic operator from project start if you are non-EU.
4. Explicitly document sub-assembly status in the final product technical file.
5. Contractually frame OEM / private-label / subcontracting relationships.

Sources & references

1. Regulation (EC) No 765/2008, accreditation and market surveillance , EUR-Lex eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32008R0765
2. Decision No 768/2008/EC, common framework for marketing , EUR-Lex eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32008D0768
3. The European Commission's Blue Guide (2022 edition) , European Commission op.europa.eu/en/publication-detail/-/publication/cc198e36-5957-11ec-91ac-01aa75ed71a1
4. Regulation (EU) 2019/1020, market surveillance , EUR-Lex eur-lex.europa.eu/eli/reg/2019/1020/oj
5. Digital Services Act: Regulation (EU) 2022/2065 , EUR-Lex eur-lex.europa.eu/eli/reg/2022/2065/oj