Market access · European Union

Product certification for European Union

CE marking — directives, standards, DoC, and Notified Bodies

Deep-dive EU market access: which regulations apply, who regulates safety / EMC / radio / FuSa / ATEX, what reports and marks you need, and how Member States enforce.

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How European Union regulates products

The EU uses New Legislative Framework (NLF) product law. Manufacturers (or importers) demonstrate conformity to essential requirements, usually via harmonized EN standards, compile a technical file, draw up an EU Declaration of Conformity, and affix the CE mark before placing the product on the market. Non-EU manufacturers typically appoint an EU Authorized Representative. Market surveillance is national; Notified Bodies appear on NANDO when third-party assessment is required.

Key frameworks

CE marking
LVD 2014/35/EU
EMC 2014/30/EU
RED 2014/53/EU
Machinery Directive / Regulation 2023/1230
ATEX 2014/34/EU
RoHS / REACH / Battery Regulation / GPSR

Regulatory bodies

Who sets the rules, who certifies, and who enforces — by role.

European Commission (DG GROW / NANDO)

Product legislation policy; Notified Body listing

Notified Bodies (per directive)

Third-party conformity assessment when legally required

ECHA

REACH, SCIP, chemical restrictions

National market surveillance authorities

Enforcement, recalls, border controls in each Member State

CEN / CENELEC / ETSI

European standards organizations (EN / ETSI EN)

Safety, EMC, wireless, FuSa & more

For each domain: authority, regulations, typical standards, reports, and marking.

Electrical safety

Manufacturer self-declaration; market surveillance by Member State authorities; Notified Bodies when required by other legislation

Regulations

Low Voltage Directive 2014/35/EU (LVD)
General Product Safety Regulation (EU) 2023/988 (GPSR) where consumer products apply

Standards

EN IEC 62368-1 (AV/IT)
EN 60335 series (household)
EN 61010-1 (lab/measurement)
EN 60598 (luminaires)

Reports / evidence

Safety test report to harmonized EN
Risk assessment / construction review
EU Declaration of Conformity

Marking

CE mark on product / packaging / instructions as applicable

LVD is typically Module A (internal production control) — no mandatory Notified Body for most products.

EMC

Manufacturer; optional EMC Notified Body; national market surveillance

Regulations

EMC Directive 2014/30/EU

Standards

EN 55032 / EN 55035 (multimedia)
EN IEC 61000-6-x (generic)
EN 61326 (industrial/lab)
EN 50121 (rail) when applicable

Reports / evidence

EMC emissions & immunity test reports
EMC assessment / technical construction file if used

Marking

CE (EMC is part of overall CE claim)

Wireless / radio

Manufacturer; Notified Body for certain radio modules / unavailable harmonized standards; national spectrum authorities for use conditions

Regulations

Radio Equipment Directive 2014/53/EU (RED)
Delegated cyber acts under RED Art. 3(3) where in force for product classes

Standards

EN 300 328 (2.4 GHz)
EN 301 893 (5 GHz)
EN 301 489 series (EMC for radio)
EN 62311 / EN 50385 (RF exposure)
EN 18031 series (cyber, where mandated)

Reports / evidence

RF test reports
RED DoC
Notified Body EU-type examination certificate when Module B applies

Marking

CE; Notified Body number on label if Module B/C used

Intentional radiators are assessed under RED (not separately under LVD+EMC for radio aspects).

Machinery & robotics

Manufacturer; Notified Body for Annex I / high-risk categories

Regulations

Machinery Directive 2006/42/EC (current)
Machinery Regulation (EU) 2023/1230 (applies from 20 Jan 2027)

Standards

EN ISO 12100
EN ISO 13849-1
EN IEC 62061
EN ISO 10218 / ISO/TS 15066 (robots/cobots)

Reports / evidence

Risk assessment
Technical file
EU DoC or Declaration of Incorporation (partly completed machinery)

Marking

CE on complete machinery; partly completed machinery uses DoI, not CE

Functional safety (FuSa)

No single EU “FuSa mark”; evidence via Machinery / sector directives and customer SIL/PL requirements; Notified Bodies for certain safety components

Regulations

Machinery Directive / Regulation essential requirements
Sector rules (rail, process, medical) as applicable

Standards

IEC 61508
ISO 13849
IEC 62061
IEC 61511 (process)

Reports / evidence

FMEA / FMEDA
SIL/PL assessment reports
Safety manual / safety case excerpts

Marking

Usually no standalone FuSa mark — claimed via DoC + safety documentation

Explosive atmospheres (ATEX)

Notified Bodies for Category 1 / M1 and many Category 2 paths; manufacturer + NB for production QA (QAN)

Regulations

ATEX Directive 2014/34/EU
ATEX workplace Directive 1999/92/EC (user side)

Standards

EN IEC 60079 series
EN ISO 80079-36/-37 (non-electrical)

Reports / evidence

EU-type examination certificate
QAN / quality assurance notification
Ignition hazard assessment

Marking

CE + Ex hexagon + equipment group/category + EPL marking

Materials / substances

ECHA (REACH); national enforcement for RoHS / packaging

Regulations

RoHS Directive 2011/65/EU (as amended)
REACH Regulation (EC) 1907/2006
POPs, SCIP database obligations

Standards

EN IEC 63000 (technical documentation for RoHS)
IEC 62321 series (test methods)

Reports / evidence

Material declarations / IPC-1752
Test reports for restricted substances
SCIP notification where required

Marking

CE claim includes RoHS where in scope; no separate RoHS logo required

Batteries & energy

Manufacturer; Notified Bodies for certain Battery Regulation conformity modules

Regulations

Battery Regulation (EU) 2023/1542
UN 38.3 (transport — often paired)

Standards

EN IEC 62133
EN IEC 62619
relevant EN for chargers / ESS

Reports / evidence

Battery conformity assessment evidence
UN 38.3 test summary
carbon footprint / due diligence where phased in

Marking

CE; battery labeling / passport requirements per timeline

Documents & reports typically needed

EU Declaration of Conformity referencing all applicable Union acts
Technical documentation retained typically 10 years after placing on the market
Risk assessment and list of applied standards
Test reports from competent / accredited laboratories
Notified Body certificates / QAN when required (ATEX, certain machinery, MDR, etc.)
EU Authorized Representative details when manufacturer is outside EU/EEA
User instructions and safety information in required languages

Marking summary

CE mark must be visible, legible, and indelible. When a Notified Body is involved in production control, its 4-digit number accompanies the CE mark. ATEX adds the Ex hexagon. Separate logos (e.g. optional GS) are not substitutes for CE.

Typical pathway

1
Applicability matrix
Map LVD, EMC, RED, Machinery, ATEX, RoHS, Battery, GPSR, and others to each SKU.
2
Conformity module
Self-declaration vs EU-type examination + production QA — driven by Annexes of each act.
3
Evidence pack
Safety, EMC, RF, materials, and (if needed) FuSa / Ex reports aligned to current EN dates.
4
Place on market
Sign DoC, affix CE, register economic operators / passports where required, prepare for MSAs.

Common pitfalls

Issues that delay customs, retail acceptance, or lab projects.

Treating CE as a single “certificate” instead of a multi-legislation claim

Using withdrawn EN standards that no longer give presumption of conformity

Missing RED when a product has Wi-Fi/BLE/cellular even if “mainly” industrial

No EU economic operator contact details after GPSR / NLF enforcement focus

Confusing IECEx with ATEX — related standards, different legal mark and NB path

FAQ

Is a Notified Body always required for CE?

No. LVD and EMC are usually manufacturer self-declaration. RED, Machinery (certain categories), ATEX, medical devices, and others often require a Notified Body depending on the module and risk class.

Do Germany, France, Italy, and Spain have different CE rules?

Core product law is EU-wide. What changes locally is language of instructions, national market surveillance practice, and optional national marks (e.g. GS in Germany). See each country page for local authorities.

What about UKCA?

Great Britain uses UKCA under UK law (see United Kingdom page). Northern Ireland retains CE for many goods under the Windsor Framework.

Related services

Engagements that commonly unlock this market.

CE Marking

Directives, harmonized standards, testing coordination, and technical documentation — handled end to end for EU and UK market access.

EMC

Emissions and immunity strategy across residential, commercial, and industrial environments — consulting, pre-compliance, and accredited lab coordination for FCC, CE, UKCA, ISED, and global markets.

RF / Wireless

FCC, RED, ISED, MIC, ACMA, and multi-country radio paths for modules, hosts, and custom radios — including antenna and SAR considerations.

Product Safety

UL, CSA, IECEE CB Scheme, and IEC/EN safety standards — construction review, critical components, and NRTL project management.

Other markets

Planning European Union market entry?

We map regulations, build the test matrix, coordinate labs, and prepare marking and declarations — including multi-market stacks with EU, US, and beyond.

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