European Union
European Union compliance review and CE marking
CE marking is a declaration you make, not a certificate someone issues to you — which is precisely why it goes wrong. The obligation is to identify every applicable instrument, apply the right harmonised standards, hold a complete technical file, and have an economic operator established in the Union. We build that file and take the representative role.
What applies to your product
The starting point is never the mark — it is which regimes your product falls under, and what evidence each one accepts.
| Area | What applies | Practical effect |
|---|---|---|
| Electrical safety | Low Voltage Directive 2014/35/EU for equipment rated 50–1000 V AC or 75–1500 V DC. | Self-declaration only — there is no Notified Body route. The evidence has to stand on its own in the technical file. |
| EMC | EMC Directive 2014/30/EU, or the Radio Equipment Directive where the product transmits. | Immunity testing is required, which has no direct FCC equivalent — a common gap in files brought over from a US programme. |
| Radio | Radio Equipment Directive 2014/53/EU, including the cybersecurity requirements mandatory since 1 August 2025. | Where the harmonised standards are not applied in full, or a cybersecurity restriction is triggered, a Notified Body must be involved. |
| Substances | RoHS Directive 2011/65/EU and REACH, including SVHC communication and SCIP notification. | Supplier declarations alone are usually not an adequate evidence chain. Materials declarations and test evidence are expected. |
| Consumer product safety | General Product Safety Regulation (EU) 2023/988, applicable since December 2024. | Adds a responsible person requirement, traceability, internal risk analysis and prescribed recall handling — and without a responsible person, online sale is not lawful. |
| Energy and environment | Ecodesign and energy labelling with EPREL registration, WEEE, packaging and batteries. | WEEE, battery and packaging obligations are national, not EU-wide. Each member state where you sell needs its own registration. |
You need an economic operator established in the Union
Under Article 4 of Regulation (EU) 2019/1020, listed products may not be placed on the EU market unless there is an economic operator established in the Union. The covered legislation includes the Low Voltage, EMC, Radio Equipment, RoHS, Machinery and Ecodesign instruments — which is to say, essentially everything an electrical or electronic product touches.
That operator must verify that the declaration of conformity and technical documentation exist and keep them available, provide authorities with information demonstrating conformity in a language they readily understand, inform authorities of any product believed to present a risk, and cooperate on corrective action.
For consumer products the GPSR adds a parallel responsible person requirement. Both roles are commonly outsourced. We can arrange the EU Authorised Representative and responsible person appointments, and advise on where the importer's own liability begins — because appointing a representative does not move design responsibility away from the manufacturer.
Recent changes that catch people out
What has changed, and what is coming
EU product law has moved substantially since 2024. A technical file assembled a few years ago is very unlikely to be complete today.
| Instrument | Status | Why it matters |
|---|---|---|
| RED cybersecurity Delegated Regulation (EU) 2022/30 |
Mandatory since 1 August 2025 | Activates the network protection, privacy and fraud requirements of the Radio Equipment Directive. The harmonised EN 18031 standards are cited with restrictions, so some products lose the presumption of conformity and need a Notified Body. |
| General Product Safety Regulation (EU) 2023/988 |
Applies since 13 December 2024 | Requires a responsible person established in the EU for consumer products, adds traceability, internal risk analysis, accident notification and prescribed recall content, and imposes duties on online marketplaces. |
| Cyber Resilience Act (EU) 2024/2847 |
Vulnerability and incident reporting from 11 September 2026; main obligations from 11 December 2027 | Applies to products with digital elements, in addition to the Radio Equipment Directive and the safety and EMC directives. Worth designing for now rather than retrofitting later. |
| Machinery Regulation (EU) 2023/1230 |
Applies from 20 January 2027, replacing Directive 2006/42/EC | Introduces substantial modification rules, digital instructions and provisions on software safety and cybersecurity, with a revised high-risk annex. |
| Batteries Regulation (EU) 2023/1542 |
CE marking and conformity assessment since 18 August 2025; removability and the battery passport from 18 February 2027 | Replaces the old batteries directive and adds design obligations for portable batteries in appliances. |
Dates and standard citations are checked at the time of each project. Where a position is genuinely unsettled — and several currently are — we say so rather than presenting it as certain.
What we provide
- Applicability assessment — identifying every directive and regulation that applies to the product, its intended use and its supply arrangement
- Harmonised standards selection against the citations currently in force, so the presumption of conformity actually holds
- Risk assessment facilitation and test plan development
- Coordination of accredited laboratories, and Notified Body selection and liaison where the pathway requires it
- RED cybersecurity assessment against the EN 18031 series, including whether a restriction removes the presumption of conformity for your product
- Technical file compilation and maintenance for the required retention period
- EU Declaration of Conformity drafting
- EU Authorised Representative, Article 4 economic operator and GPSR responsible person arrangements
- CE marking, label and multi-language instruction review
- EPREL registration, and coordination of WEEE, battery and packaging registrations in each member state where you sell
Where these programmes usually stall
- Assuming an RCM/EESS or FCC file transfers — EN and AS/NZS differ, and EU immunity testing has no FCC equivalent
- The RED cybersecurity assessment missed entirely, which is now the single most common gap for connected products
- No EU-established economic operator named, which makes the product unlawful to place on the market regardless of the testing behind it
- Instructions not provided in every required national language
- A technical file citing superseded standard editions
- Declarations of conformity that are aspirational rather than evidenced
- WEEE, battery and packaging registration treated as EU-wide when it is member state by member state
- EPREL registration left until after the product is on sale
Common questions
European Union compliance — frequently asked questions
Who issues the CE mark?
Nobody. CE marking is a declaration made by the manufacturer under its own responsibility, supported by a technical file. For most electrical products no third party is involved at all. That is why the risk sits in the file rather than in a certificate — if the evidence is incomplete or cites the wrong standards, the declaration is not sound, however professional the paperwork looks.
When do we need a Notified Body?
When harmonised standards do not exist for your product, are not applied, or are applied only in part; when a Radio Equipment Directive cybersecurity restriction applies to your product; when machinery falls within the high-risk annex without full harmonised standard coverage; or when a higher conformity assessment module is chosen. The Low Voltage Directive has no Notified Body route at all.
Can Universal Approvals act as our EU Authorised Representative?
We arrange EU Authorised Representative and Article 4 responsible person appointments as part of the market access programme, and we manage the documentation obligations that attach to the role. The appointment itself must sit with a party established in the Union — we set that up and remain the technical point of contact behind it.
Does CE marking cover the United Kingdom too?
For Great Britain, CE is currently accepted alongside UKCA for the main product regulations, so an EU file usually does most of the work. It is not automatic, though: Great Britain requires its own GB-established economic operator named on the product, and the PSTI security requirements for consumer connectable products have no EU equivalent. Northern Ireland follows EU rules under the Windsor Framework. See our United Kingdom compliance review.
Want to learn more?
Speak to a Chartered Professional Engineer about your product, your target market and the approval pathway that actually applies to it.
Talk to an engineer
Planning a European Union launch?
Send us the product and whatever test evidence you already hold. We will set out what transfers, what has to be added, and what the pathway costs — in writing.