Quick answer: CE marking is a manufacturer’s declaration that a product meets the applicable EU health, safety and environmental requirements. The process has six steps: identify every applicable directive or regulation, identify the harmonised standards, verify the product against the essential requirements, decide whether a notified body is required, compile the technical file and sign the EU Declaration of Conformity, then affix the mark. For most industrial products, no third party is involved — you self-certify.
That last sentence surprises people. CE marking is not a certificate somebody issues you. There is no “CE approval body” for most products. It is a legal declaration you make about your own product, and you carry the liability for it.
Note on scope: this guide covers the general New Legislative Framework process that applies to most industrial and engineering products. Medical devices, construction products and a few other sectors run on their own regimes. Where your product sits in one of those, the principles below still apply but the specific procedure will not.
Step 1: Find every directive or regulation that applies
“Half our export team’s time goes to compliance paperwork instead of talking to customers.”
That usually starts here, because this step is done badly once and then re-done repeatedly. The mistake is assuming one product means one directive.
A single industrial machine with a control panel and a wireless remote can simultaneously fall under the Machinery Regulation, the Low Voltage Directive, the EMC Directive, the Radio Equipment Directive and RoHS. Each brings its own essential requirements, and the CE mark covers all of them at once.
Key instruments for industrial products:
| Instrument | Scope | Status note |
|---|---|---|
| Machinery Regulation (EU) 2023/1230 | Machinery and related products | Replaces Directive 2006/42/EC; applies from 20 January 2027 |
| Low Voltage Directive 2014/35/EU | Electrical equipment within defined voltage limits | In force |
| EMC Directive 2014/30/EU | Electromagnetic compatibility | In force |
| Radio Equipment Directive 2014/53/EU | Products with intentional radio transmission | In force |
| Pressure Equipment Directive 2014/68/EU | Pressure equipment above thresholds | In force |
| ATEX Directive 2014/34/EU | Equipment for explosive atmospheres | In force |
| RoHS Directive 2011/65/EU | Hazardous substances in EEE | In force |
The Machinery Regulation transition is the one to plan for now, not later. If your product is machinery and your technical file is built around 2006/42/EC, you have a documented migration to complete before January 2027 — including new requirements around software, cybersecurity of safety functions and digital instructions.
The authoritative list is maintained on the European Commission’s single market for goods pages. Treat any third-party list, including this one, as a starting point rather than the final word.
CE marking sits alongside, not instead of, horizontal rules. REACH obligations, the General Product Safety Regulation, WEEE, packaging and extended-producer-responsibility schemes often apply to the same product and are separate compliance tracks.
Step 2: Identify the harmonised standards
Harmonised standards are European standards cited in the Official Journal of the European Union. They matter for one reason: applying them gives you a presumption of conformity with the essential requirements they cover.
You are not legally obliged to use them. You can demonstrate conformity another way. In practice, doing so means proving from first principles what a harmonised standard would have proven by reference — expensive, slower, and harder to defend if a market-surveillance authority comes calling.
Two practical points that catch manufacturers out:
- Standards get withdrawn and superseded. A technical file citing a standard that has since been withdrawn from the OJEU no longer carries presumption of conformity. Diarise a review.
- A standard bought is not a standard applied. Buying EN ISO 12100 does not make your risk assessment compliant. The evidence that you applied it has to exist in the file.
Step 3: Verify the product and document the risk assessment
“The customer’s engineer asked a spec question and our rep froze.”
The technical file is where that stops happening — it is the single source of truth about why your product is safe.
Testing can be done in-house if you have the competence and equipment, or at an external accredited laboratory. Either way, retain the full test reports. What matters to an authority is not who did the testing but whether the evidence is complete, traceable and matches the product actually on the market.
The risk assessment is the part most often under-documented. It should identify hazards, assess risk, describe the measures taken to eliminate or reduce it, and show the residual risk that remains and how it is communicated to the user. “We’ve been making these for twenty years without an incident” is not a risk assessment.
Step 4: Decide whether a notified body is required
“We assumed we’d need to pay a certification body. Turns out we didn’t.” — and sometimes the reverse, which is worse.
A notified body is a conformity assessment body designated by an EU member state and listed in the European Commission’s NANDO database. Whether you need one is determined by the directive, based on product risk — not by your preference, and not by your customer’s.
Where a notified body is not required, you follow the self-certification route (Module A): assess conformity internally, compile the technical file, sign the Declaration of Conformity, affix the mark.
Where one is required, its four-digit identification number must appear next to the CE marking. Typical triggers include most medical devices above Class I, Category II and III PPE, certain pressure equipment, lifts, gas appliances, ATEX equipment, and machinery listed in Annex IV of the machinery legislation where harmonised standards have not been fully applied.
Two failure modes, both expensive:
- Using a notified body that is not designated for your specific directive and product category. The assessment is worthless and the CE marking is invalid.
- Assuming you need one when you don’t, and paying for third-party assessment you were entitled to do yourself.
Always verify designation scope in NANDO before engaging anyone.
Step 5: Compile the technical file and sign the Declaration of Conformity
The technical file (sometimes technical construction file, or technical documentation) is the legal backbone. It must contain, at minimum:
- A full description of the product, including variants
- Design and manufacturing drawings, and schematics
- Descriptions and explanations necessary to understand those drawings
- The risk assessment
- A list of the harmonised standards applied, in full or in part
- Test reports and results of design calculations
- The instructions for use
- Any notified body certificates and correspondence
- A copy of the signed EU Declaration of Conformity
Retention: at least ten years from the date the last unit was placed on the market. Market surveillance authorities can request it at any point in that window, and they will request it in the language of the member state asking.
The EU Declaration of Conformity is a short document, and it is the one with your signature on it. It names the manufacturer, identifies the product unambiguously, states that the declaration is issued under the sole responsibility of the manufacturer, lists the Union legislation the product conforms to and the standards applied, includes notified body details where relevant, and is signed by an authorised person with name, function, place and date.
That phrase — sole responsibility of the manufacturer — is why CE marking is a commercial risk decision and not just an administrative one.
Step 6: Affix the mark
The CE marking must be visible, legible and indelible, applied to the product itself, or where that isn’t possible because of the nature of the product, to the packaging and accompanying documents. The letters have a defined form and proportions; if resized, proportions must be maintained. Where a notified body was involved in the production control phase, its identification number goes alongside.
What’s changed recently — and what’s coming
The UK recognises CE marking indefinitely for most goods. In August 2023 the UK government announced an indefinite extension to CE recognition, given legal effect by the Product Safety and Metrology etc. (Amendment) Regulations 2024, made on 23 May 2024 and in force from 1 October 2024. It covers 21 product regulations including machinery, radio equipment, toys, ecodesign and RoHS. It does not cover medical devices, construction products, marine equipment, rail products, cableways, transportable pressure equipment or unmanned aircraft, which have sector-specific arrangements.
The same regulations introduced an optional fast-track UKCA route: where a manufacturer meets the EU essential requirements and has completed the relevant EU conformity assessment, the corresponding GB requirements are treated as satisfied.
For most industrial exporters this means one technical file can serve both markets. That is a genuine cost saving — and one a surprising number of manufacturers have not yet acted on, still maintaining duplicate documentation for a divergence that was reversed.
Machinery Regulation (EU) 2023/1230 applies from 20 January 2027, with the notified-body provisions already applying since 20 January 2024.
Notified body capacity is a real constraint. In sectors where third-party assessment is mandatory, lead times have been long since the MDR transition. If your product needs a notified body, engage one before you finalise your launch timeline, not after.
How long does CE marking actually take?
An honest answer, because the vague ones waste your time:
| Situation | Realistic timeline |
|---|---|
| Self-certification, product already tested, standards clear | 4–8 weeks to compile a defensible file |
| Self-certification, testing required at external lab | 3–6 months, driven by lab scheduling |
| Notified body required, straightforward category | 6–12 months |
| Notified body required, high-risk category or capacity-constrained sector | 12–24 months |
The variable that moves the timeline most is not the regulator. It is how quickly your engineering team can produce documentation that already exists in their heads.
Free download — CE Marking Readiness Checklist. A file-by-file audit of what your technical documentation needs before a market-surveillance request. Request the checklist.
Frequently asked questions
Do our certifications transfer across EU countries, or do we need new ones per market? They transfer. CE marking is a single-market instrument: a compliant, CE-marked product can be placed on the market in any EU member state without further certification. Separate national registrations — packaging, WEEE, batteries — are administrative and do apply per country.
Is there such a thing as a CE certificate? Not for most products. For self-certified products, the closest thing is your own EU Declaration of Conformity. Where a notified body is involved it issues certificates, but those are inputs to your declaration, not a substitute for it. Be sceptical of any company offering to “issue CE certification” for a product that self-certifies.
Can we get compliance help on a project basis instead of hiring? Yes, and for most SMEs that is the sensible route. The combined technical-plus-regulatory skill set is genuinely hard to hire — it sits between engineering and export administration, which is precisely why the role stays open for months. Project-based support gets the file built and the process documented so your own team can maintain it.
Who is responsible if a distributor sells a non-compliant product? The manufacturer carries primary responsibility. But importers and distributors have their own verification duties under EU law, and a distributor that fails to check will not shield you. This is one reason distributor agreements should address compliance explicitly — covered in our guide to structuring a distributor agreement.
What happens if we get it wrong? Market surveillance authorities can require corrective action, prohibit sale, order withdrawal or recall, and refer for penalties that vary by member state. Commercially, the bigger cost is usually the customer relationship and the stop-ship while you rebuild a file you should have had.
Compliance shouldn’t eat your selling time
The pattern we see repeatedly: an export team spending half its week on compliance paperwork, and a technical team that knows the product but not the regulatory framework. Nobody owns both — so it gets done slowly, twice.
IndustrySpan works with industrial manufacturers to get the compliance route mapped and documented once, so commercial resources go back to revenue-generating work.
Talk to us about your compliance route →
Related reading: Export Documentation Checklist for Selling Into the EU · Exporting to the EU After Brexit · How to Find & Appoint Industrial Distributors Abroad · Our services
Sources cited
- European Commission — CE marking, single market for goods
- European Commission — NANDO notified bodies database
- GOV.UK — UK Government announces extension of CE mark recognition for businesses
- Hogan Lovells — CE marking to remain indefinitely recognised in the UK