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Which EU directives apply to my product?

Guide · Directive applicability and product classification

Before any test is booked or any dossier is opened, every certification project answers one question: which rules apply to this product? The European Union does not certify products against a single law. It legislates by hazard and by function, so a single device routinely falls into the scope of several directives and regulations at once. Getting that map right is the foundation of the whole project, an omitted directive is the most common reason a CE marked product is later judged non-compliant. This page explains how to read directive scopes, how multiple texts stack on one product, where the thresholds and exclusions sit, and how the same logic translates to the United States and to global market access.

A conformity assessment can only be as correct as the list of applicable texts that drives it. If a directive is missing from that list, every downstream step (standards selection, testing, technical file, Declaration of Conformity) is built on an incomplete foundation. The product may pass the tests it was given and still be illegal to sell.

The European framework is deliberately modular. Rather than one law per product, the EU writes one text per family of risks or functions, and lets them combine. The Blue Guide, the Commission's reference document on the application of EU product rules, calls this the cumulative or simultaneous application of Union legislation. Classification is the act of finding every text that applies, before you decide how to demonstrate conformity to each.

The CE marking you eventually affix is a single visible symbol, but behind it sits a stack of independent obligations. The mark means "all applicable directives identified and satisfied", not "assessed under one directive".

A useful mental model is to treat the product not as a marketing object but as a bundle of physical hazards and functions. A radio chip is a function. Mains voltage is a hazard. A pressurised vessel is a hazard. A medical claim is a function with its own legal weight. Each hazard or function maps to one or more texts, and the union of those texts is your applicable-rules set. This decomposition is also what makes the classification defensible: a market surveillance authority or a customer audit will ask why each text was kept or set aside, and a hazard-by-hazard table answers that question directly.

EU product law splits into two layers that you almost always combine.

LayerWhat it targetsExamples
Vertical (sectoral)One product familyToy Safety, Machinery, Medical Devices, Pressure Equipment, ATEX
HorizontalA hazard or function across many familiesLVD (electrical safety), EMC, RoHS (substances), Ecodesign

A toy with a Bluetooth speaker, for instance, is a toy (vertical: Toy Safety Directive), an electrical product (horizontal: LVD or RED for the radio), an electromagnetic emitter (horizontal: EMC or RED), and a substance-restricted article (horizontal: RoHS). All four layers must be satisfied. None overrides the others.

The common electrical and radio directives

Section titled “The common electrical and radio directives”

The table below lists the texts that recur most often in electronics, with their scope trigger and the conformity route in the usual case. The reference numbers are the operative legal identities, learn to read the product against each scope.

Directive / RegulationScope triggerNotified body in the usual case
Directive 2014/35/EU (LVD)Electrical equipment 50-1000 V AC or 75-1500 V DCNo (module A)
Directive 2014/30/EU (EMC)Apparatus liable to cause or be affected by disturbanceNo (module A)
Directive 2014/53/EU (RED)Intentionally radiates or receives radio wavesDepends on standards applied
Directive 2011/65/EU (RoHS)Electrical and electronic equipment, restricted substancesNo (internal control)
Directive 2009/48/EC (Toy Safety)Designed or intended for play, under 14Depends on standards applied
Directive 2014/34/EU (ATEX)Equipment for potentially explosive atmospheresYes for most categories
Directive 2014/68/EU (PED)Pressure equipment above 0,5 bar gaugeYes from category II
Regulation 2017/745 (MDR)Medical purpose as defined in the regulationYes from class IIa
Regulation 2023/1230 (Machinery)Assembly with a drive system and moving partsYes for high-risk machines

The LVD voltage band is the textbook example of a numeric threshold. A device powered only at, say, 24 V DC sits below the LVD's 75 V DC floor and is therefore outside the LVD scope on the safety axis, though its safety is then picked up by the EMC directive's immunity logic, by the RED if it radiates, or by the GPSR as a backstop.

The RED absorbs LVD and EMC for radio products

Section titled “The RED absorbs LVD and EMC for radio products”

The single most useful rule in electronic classification: when a product intentionally transmits or receives radio waves, the Directive 2014/53/EU takes over the safety and EMC objectives.

  • Article 3.1(a) of the RED replaces the LVD safety objective, and crucially without any voltage threshold, a 3,3 V Bluetooth tag is in RED safety scope even though it is far below the LVD floor.
  • Article 3.1(b) of the RED replaces the EMC directive's protection requirements.
  • Article 3.2 adds the efficient use of the radio spectrum, the requirement that has no equivalent in the non-radio world.
  • Article 3.3 adds, for connected products, cybersecurity, data protection and fraud prevention (applicable since 1 August 2025).

So a radio product is assessed under the RED for safety, EMC and spectrum, and the standalone LVD and EMC directive normally do not apply in addition. RoHS, ecodesign and packaging rules still apply in parallel because they cover different objectives.

Stacking is the heart of classification. Each applicable text contributes its own essential requirements, its own harmonised standards and its own conformity assessment, and they coexist on the same Declaration of Conformity.

Consider a mains-powered IoT device with Wi-Fi and Bluetooth (a smart thermostat, a connected gateway). Walk its scope axes:

Hazard / functionApplicable textWhat it demands
Electrical safety (mains)RED art. 3.1(a), absorbing LVDInsulation, creepage, fire enclosure (EN 62368-1)
Electromagnetic compatibilityRED art. 3.1(b), absorbing EMCEmissions and immunity (EN 55032, EN 55035)
Radio (Wi-Fi, Bluetooth)RED art. 3.2Spectrum efficiency (EN 300 328, EN 301 489-17)
CybersecurityRED art. 3.3(d)(e)(f)Network security, data protection (EN 18031)
RF exposureRED art. 3.1(a)Field assessment (EN 62311)
Restricted substancesRoHS 2011/65/EULead, cadmium, phthalate limits
Energy / standbyEcodesign + standby regulationOff-mode and networked-standby power

Seven requirement sets, two directives plus ecodesign and a residual safety regulation, one product, one CE marking. The classification step is what surfaces this whole list. Miss the RoHS line and the product is non-compliant the day it ships, even with perfect radio and safety files.

A general principle from the Blue Guide governs overlaps: when two texts cover the same risk, the more specific one applies to that risk, but each text still applies to the risks the other does not cover. The RED being more specific than the LVD for a radio product's electrical safety is exactly this rule in action.

Classification errors cluster around two things: numeric thresholds and explicit exclusions. Read both literally.

Numeric thresholds decide in or out:

  • LVD: only 50-1000 V AC or 75-1500 V DC. Below the floor, no LVD.
  • PED: pressure above 0,5 bar gauge brings the product into scope; below, out.
  • Toy Safety: intended for users under 14 years; a product not intended for play is out even if children might use it.

Explicit exclusions carve products out of an otherwise applicable scope. Examples drawn from the directives themselves:

  • The Machinery Regulation excludes certain vehicles, weapons and specific high-voltage equipment.
  • The Toy Safety Directive excludes, among others, sports equipment, playground equipment for public use and decorative items.
  • The RED excludes equipment used exclusively by radio amateurs that is not made commercially available, and certain aviation and marine equipment governed by other regimes.

A single exclusion clause can move a product from one regime to a completely different one. The discipline is to read the scope article and the exclusion list of every candidate directive, not a summary. EUR-Lex carries the consolidated legal text of each.

A repeatable order of operations keeps the map complete.

Step 1: Describe the product physically and by intended use

Section titled “Step 1: Describe the product physically and by intended use”

Power source and voltage, whether it radiates radio, moving parts, pressure, intended user and environment, medical purpose if any. Intended use is legally decisive, the same hardware can be a toy or an industrial sensor depending on how it is presented.

Is it a toy? A machine? A medical device? Pressure equipment? Equipment for explosive atmospheres? Keep every vertical directive whose scope article it satisfies. Most products match zero or one vertical text.

RoHS applies to essentially all electrical and electronic equipment. Then decide the safety and EMC axis: if the product radiates, the RED governs safety, EMC and spectrum; if it does not radiate, the LVD (within its voltage band) plus the EMC directive govern those axes separately.

Step 4: Add the environmental and residual texts

Section titled “Step 4: Add the environmental and residual texts”

Ecodesign and energy labelling where applicable, packaging rules, WEEE and battery obligations, and the GPSR as a safety backstop for any residual risk no sector directive covers.

Step 5: Resolve overlaps with the Blue Guide

Section titled “Step 5: Resolve overlaps with the Blue Guide”

Where two texts touch the same risk, apply the more-specific rule and confirm with the Blue Guide's worked guidance. Document the reasoning, this is the first thing market surveillance asks to see.

For each retained text, pick the conformity assessment module it allows. See the modular assessment guide and self-declaration vs notified body for how that choice is made.

Case A: USB-powered Bluetooth temperature sensor

Physical: 5 V USB power, Bluetooth Low Energy radio, no moving parts, not a toy, no medical purpose.

  • Radiates, so the RED governs safety (3.1(a)), EMC (3.1(b)), spectrum (3.2) and cybersecurity (3.3). No standalone LVD (5 V is below the floor anyway) and no standalone EMC directive.
  • RoHS applies as electronic equipment.
  • Ecodesign networked-standby rules apply if it draws standby power.

Result: RED + RoHS (+ ecodesign), all module A if the harmonised standards are fully applied. One CE marking, no notified body. This is the most common IoT classification.

Case B: 230 V industrial control cabinet, no radio

Physical: mains-powered, 230 V, contactors and a motor drive, no intentional radio, industrial environment.

  • Does not radiate, so the LVD governs electrical safety (it sits inside 50-1000 V AC) and the EMC directive governs compatibility, as two separate horizontal texts.
  • If it incorporates an assembly with a drive system and moving parts that constitute a machine, the Machinery Regulation Regulation 2023/1230 applies as the vertical text, see the machinery guide.
  • RoHS applies.

Result: LVD + EMC + RoHS, plus Machinery if the assembly is a machine. Module A unless the machine falls in the high-risk list, in which case a notified body enters on the machinery axis only.

Case C: Connected insulin-related accessory (illustrative)

Physical: battery-powered, Bluetooth, with a stated medical purpose.

  • The medical purpose brings the MDR Regulation 2017/745 into scope as the vertical text, with classification driving notified body involvement from class IIa, see the MDR guide.
  • It radiates, so the RED governs the radio, EMC, RF exposure and cybersecurity axes.
  • RoHS applies (medical devices are in RoHS scope since 2014, with specific timelines).

Result: MDR + RED + RoHS. Two heavy regimes stack, the MDR with its own clinical and quality-system demands, the RED with its radio and 3.3 demands. This is a deliberately demanding example to show how a single small device can trigger two major frameworks at once.

The US splits responsibility by hazard as the EU does, but assigns it to different bodies and there is no single mark.

EU axisUS equivalentMechanism
Electrical safety (LVD / RED 3.1(a))NRTL listingUL, Intertek (ETL), CSA mark to a UL standard
EMC, unintentional radiationFCC Part 15 Subpart BSupplier's Declaration of Conformity
Intentional radio (RED 3.2)FCC Part 15 / 22 / 24, etc.Certification via a TCB, an FCC ID is issued
Medical purpose (MDR)FDA510(k) clearance or PMA
Restricted substances (RoHS)No federal analogue (state rules vary)California Proposition 65 and similar

Practically, the US version of "which rules apply" produces a different short list for the same product: an NRTL safety mark, an FCC authorisation for the radio and EMC, and any sector regime (FDA, CPSC). The classification reasoning, by-hazard decomposition, is identical even though the institutions differ. See the CE pillar and the RED pillar for the EU detail.

Most large markets reuse the same by-hazard decomposition, so a clean EU classification is a strong starting point worldwide. The United Kingdom mirrors the EU directives under UKCA with near-identical scopes. Switzerland and the EEA align with the EU regime. Many markets accept the IEC-based ISO/IEC 17025 test reports and the CB Scheme certificate as the safety basis, then layer national radio rules on top.

What changes from market to market is rarely the hazard decomposition and almost always the institutional wrapper: who issues the mark, which body must be involved, and which local quirk (a national radio band plan, a language requirement, an in-country representative) bolts onto the same technical core. That is why experienced teams classify once against hazards, then maintain a per-market matrix that records, for each hazard, the local instrument that satisfies it. The constant across all of them is that classification, not testing, is the first and most error-prone step, get the applicable-rules map right once and it travels far.

Sources & references

  1. The 'Blue Guide' on the implementation of EU product rules 2022 , European Commission ec.europa.eu/docsroom/documents/49457
  2. Directive 2014/35/EU (Low Voltage Directive) , EUR-Lex eur-lex.europa.eu/eli/dir/2014/35/oj
  3. Directive 2014/30/EU (Electromagnetic Compatibility) , EUR-Lex eur-lex.europa.eu/eli/dir/2014/30/oj
  4. Directive 2014/53/EU (Radio Equipment Directive) , EUR-Lex eur-lex.europa.eu/eli/dir/2014/53/oj
  5. CE marking, single market for goods , European Commission single-market-economy.ec.europa.eu/single-market/ce-marking_en
  6. Regulation (EU) 2023/1230 on machinery , EUR-Lex eur-lex.europa.eu/eli/reg/2023/1230/oj