If you want to sell products in the EU or EEA, and your product falls under one or more EU Directives, the CE mark is mandatory. It is not a quality mark — it is a legal declaration that your product meets EU technical and safety requirements. Without it, your product cannot be legally placed on the EU market.
EU Directives
Your product may fall under multiple directives
DoC
Declaration of Conformity — you sign it
Technical file
10-year retention from last manufacture
CE marking is a regulatory requirement for products sold in the EU. The CE mark on a product means the manufacturer has declared it meets the EU's health, safety, and environmental requirements. If you work in product development or export, understanding which directives apply to your products is part of your job.
Harmonised standards
The technical specifications CE is tested against
Technical file
The evidence that proves conformity
DoC
The legal declaration that triggers CE marking
Quick reference. CE marking required under applicable EU Directives — not a single regulation. Common directives: Low Voltage Directive (LVD) 2014/35/EU, EMC Directive 2014/30/EU, Machinery Directive 2006/42/EC, RoHS Directive 2011/65/EU, Medical Device Regulation (MDR) 2017/745, PPE Regulation 2016/425. Harmonised standards presumption of conformity. Notified Bodies required for higher-risk categories (Annex IV machinery, implantable medical devices). UKCA mark for Great Britain post-Brexit.
LVD + EMC
Most electrical products
Harmonised standards
Presumption of conformity
UKCA
Great Britain — post-Brexit
The CE mark (Conformité Européenne — European Conformity) was introduced by the EU to enable the free movement of goods across the single market. It indicates that a product complies with EU legislation covering health, safety, and environmental protection. CE marking is a manufacturer's self-declaration in most cases, verified by market surveillance authorities in EU member states.
1993
CE marking introduced
Single market
Free movement across EU
Self-declaration
Manufacturer declares conformity
Mandatory for regulated products sold in the EU, EEA, and UK (UKCA for GB)Self-declaration possible for most product categories — Notified Body required for higher-riskTechnical file must be retained for 10 years from last manufacture
What’s on this page
01 —What it isUnderstanding CE Marking
The EU's product conformity mark — a legal requirement, not a quality award.
The CE mark is not a quality certification. It is a mandatory conformity mark indicating that a product meets the requirements of the applicable EU Directives. Without it, your product cannot legally be sold in the EU, EEA, or Northern Ireland.
CE marking is based on EU Directives, not a single standard. Your product may fall under multiple directives simultaneously. An electrical tool, for example, may need to comply with the Low Voltage Directive, the EMC Directive, and the Machinery Directive — each with its own requirements.
For most products, CE marking is a self-declaration — you assess conformity yourself, compile a technical file, sign a Declaration of Conformity (DoC), and affix the CE mark. For higher-risk products (certain machinery, medical devices, PPE), a Notified Body must be involved.
Brexit created UKCA for Great Britain. The CE mark still applies to EU and Northern Ireland. For England, Scotland, and Wales, the UKCA (UK Conformity Assessed) mark is now required for most product categories. If you export to both EU and UK, you may need both marks. Confirm current requirements with your UK importer.
👥 Illustrative case — details changed for confidentiality
The business
Industrial switchgear manufacturer Pune · 90 employees, planning EU market entry
The trigger
Their distributor in Germany asked for CE marking before placing the first order. The manufacturer had no experience with EU technical regulations and no idea which directives applied.
The challenge
Initial assessment found their product was subject to three EU Directives: Low Voltage Directive, EMC Directive, and potentially the Machinery Directive. Test reports from Indian labs were not from EU-recognised laboratories. The technical file did not exist.
Where Clicarity came in
They managed the CE marking project in Clicarity. LVD and EMC conformity assessment ran as separate sub-jobs — different test standards, different test labs, different engineers responsible. The DoC was signed only after both sub-jobs completed. Technical file retention was tracked as a separate stage with a 10-year review trigger.
The result
CE marking achieved. German distributor order placed.
We had no idea where to start. Treating it as a project with stages and owners — one directive at a time — made it manageable.
02 —Who needs itIs it right for you?
Do you actually need it? Honest answer.
✓ CE marking required
Electrical and electronic equipment for EU/EEA markets
Machinery and powered equipment exported to EU
Medical devices sold in EU/EEA
PPE, toys, construction products, and many other regulated categories
∼ Verify directive applicability
Some product categories are excluded from CE marking requirements
Products for industrial use only may have different requirements
— CE not required
Products not sold in EU/EEA/Northern Ireland
Certain product categories explicitly excluded from CE Directives
03 —What it requiresWhat is checked
The CE marking process — from directive identification to technical file retention.
1
Identify all applicable EU Directives
Determine which EU Directives apply to your product. A product can fall under multiple directives simultaneously — all must be satisfied.
E.g. An industrial electric motor: Low Voltage Directive 2014/35/EU + EMC Directive 2014/30/EU + possibly Machinery Directive 2006/42/EC.Most common gap: One applicable directive missed. If product is subject to three directives and only two are declared, the CE mark is not valid.
2
Identify harmonised standards and conduct conformity assessment
For each directive, identify the relevant harmonised European standards (EN standards). Testing against these standards creates a presumption of conformity.
E.g. For LVD: test against EN 60335 (household appliances) or EN 61010 (measurement equipment). Test report from an accredited laboratory.Most common mistake: Using Indian IS standards as evidence for CE marking. CE requires testing against harmonised EN standards.
3
Compile the technical file
A structured file of technical evidence: product description, design drawings, risk assessment, test reports, and conformity with each applicable directive.
E.g. Technical file for a motor: drawings, wiring diagram, BOM, risk assessment, LVD and EMC test reports, applicable standards used.
4
Notified Body involvement for higher-risk products
For certain product categories (Annex IV machinery, implantable medical devices, some PPE), a EU Notified Body must conduct the conformity assessment.
E.g. A chainsaw (Annex IV machinery) requires a Notified Body to approve the type. An industrial safety helmet (PPE Category III) requires NB involvement.
5
Sign the Declaration of Conformity (DoC)
The DoC is the legal document where the manufacturer declares conformity. Signed by an authorised person, listing all applicable directives and harmonised standards.
E.g. "We, [Company Name], declare that the product [description] is in conformity with Directives 2014/35/EU and 2014/30/EU, tested against standards EN 60335-1:2012 and EN 55014-1:2017."
6
Affix CE mark and retain technical file for 10 years
Apply CE mark to product, packaging, and accompanying documents. Technical file must be retained for 10 years from the date the last product was manufactured.
E.g. CE mark on product label, CE mark on shipping carton, DoC included in product documentation.
What inspectors really check
EU market surveillance authorities can request the technical file at any time for up to 10 years after the last product was manufactured. If the file is incomplete or test reports are not from accredited laboratories, the product can be withdrawn from the EU market and the importer fined.
Gap analysis checklist — tick what you already have
All applicable EU Directives identified for this product
Not just the obvious ones — check the European Commission's New Approach website.
Harmonised EN standards identified for each directive
Not Indian IS standards — EN harmonised standards.
Test reports from accredited laboratories (ILAC MLA or equivalent)
Indian labs must be NABL accredited AND recognised for CE purposes.
Technical file compiled — drawings, risk assessment, test reports
For every applicable directive.
Declaration of Conformity signed by authorised person
Lists all applicable directives and harmonised standards.
CE mark correctly applied to product, packaging, and documents
Minimum CE mark dimensions followed.
Technical file retention arranged — 10 years from last manufacture
Physical or digital. Location and owner documented.
0 of 7 complete
04 —Official bodyWho certifies in India
Who issues this in India — and how to verify it.
CE marking is administered by the European Commission. Notified Bodies are designated by EU member state competent authorities and listed on the NANDO database (New Approach Notified and Designated Organisations).
For Indian exporters: Your EU importer is legally responsible for CE marking in the EU if you are the non-EU manufacturer. Confirm with your importer whether you or they are the "manufacturer" for CE marking purposes. This affects who signs the DoC and who retains the technical file.
European Commission new approach website + your EU importer.
Step 2
Identify harmonised EN standards
For each directive. These are your test criteria.
Step 3
Commission testing from accredited labs
EN standard testing. NABL-accredited lab with CE-recognised scope.
Step 4
Compile technical file
Drawings, risk assessment, test reports.
Step 5
Sign DoC and affix CE mark
DoC lists all directives and standards.
Retain
Technical file — 10 years
From date of last manufacture.
▶Where to begin: Use the checklist in Section 3 to assess your readiness before contacting any CB.
Self-declaration
Most product categories
Manufacturer signs DoC.
Notified Body
Higher-risk categories
Required for Annex IV machinery, implantable devices, Category III PPE.
Technical file retention
10 years
From last manufacture date.
UKCA
Great Britain only
Separate mark from CE. Required for England, Scotland, Wales.
Indian test reports are not automatically valid for CE marking. The test laboratory must be accredited to ISO 17025 and recognised for CE conformity assessment purposes. NABL accreditation is a starting point — confirm CE scope with the lab before commissioning tests.
06 —Find certified companiesHow to verify
How to find and verify certified organisations.
CE mark legitimacy can be verified by checking whether the product's technical file is available and whether the applicable directives and harmonised standards are correctly cited in the DoC. Market surveillance authorities in EU member states investigate complaints about CE marked products.
How to verify: To confirm whether any organisation holds a current CE Marking certification, use the official register. Verify the issuing CB's accreditation at nabcb.qci.org.in.
List every EU Directive that could apply to your product — start at ec.europa.eu
The European Commission's new approach website lists all CE Directives by product category. Don't rely on your importer's assumption — verify yourself.
Confirm with your EU importer who is the legal "manufacturer" for CE purposes
If you are the non-EU manufacturer, your EU importer may be the legal "manufacturer" and responsible for signing the DoC. This has significant legal implications — clarify before proceeding.
08 —How Clicarity fitsProcess tracking
Good records are the foundation. A process tracker builds them automatically.
Clicarity — Live Job Process Tracker & Bottleneck Identifier
Clicarity doesn't assess your CE conformity. It tracks the CE marking project — ensuring each directive's technical assessment is completed, documented, and signed off before the Declaration of Conformity is issued.
CE marking involves parallel technical assessments across multiple EU Directives, each with their own harmonised standards, test requirements, and documentation. In Clicarity, the CE marking project is a job. Each applicable directive runs as a sub-job — separate test reports, separate engineer sign-offs, separate conformity confirmation. The Declaration of Conformity is issued only when all directive sub-jobs are complete. Technical file retention is tracked with a review trigger so the file stays current through the 10-year retention period.
Each EU Directive assessed as a sub-job — LVD and EMC tested independently with separate reports and sign-offs before the DoC is signed.
Conformity assessment stage captures: test lab name, standards met, report references — the technical file evidence that supports the DoC.
DoC signing stage: all applicable directives listed and confirmed complete — no DoC issued until every directive sub-job is closed.
Clicarity timestamps every stage — the DoC date, first despatch date, and 10-year technical file retention period are all traceable from the job record.
📄 Job tracked in Clicarity
#CE-2026-01 — CE marking — new electrical product launch
Project initiated
✎Product name
✎EU Directives applicable
▼Technical file owner
▼Notified Body engaged (if req.)
📅Target launch date
→
Applicable directives identified
✎Directive 1
✎Directive 2
▼Harmonised standards identified
▼Legal review confirmed
▼Assigned engineer
→
Technical file compiled
✎Product description
▼Design drawings included
▼Risk assessment done
▼Test reports included
📷Technical file ref.
→
Conformity assessment
▼Assessment route — self / NB
▼EMC test done
▼Safety test done
▼Test lab name
✎Test report refs.
▼ Job splits — each component tracked independently
#CE-2026-01-A
Low Voltage Directive (LVD) conformity
▼Tests passed
▼Standards met
✎Report ref.
#CE-2026-01-B
EMC Directive conformity
▼Tests passed
▼Standards met
✎Report ref.
▲
Components rejoin as #CE-2026-01 — complete record of every branch, every data point, every sign-off preserved.
Declaration of Conformity signed
▼Signed by authorised person
✎DoC ref. no.
📅Date
▼All directives listed
▼Legal review
→
CE mark applied
▼CE mark on product
▼CE mark on packaging
▼Importer details on label
▼Manual/instructions included
📅First despatch date
→
Technical file retained
✎Storage location
#Retention period (years)
▼File owner
▼Update trigger identified
📅Next review date
Wastage tracked:▰ LVD and EMC conformity assessed independently — separate test reports▰ DoC lists all applicable directives — both must be passed before signing▰ Technical file retained for 10 years from last manufacture date
ⓘ Fields and stage names are fully customisable. This illustrates a typical electrical product — CE marking under LVD and EMC Directive setup.
👥 Illustrative case — details changed for confidentiality
The business
Industrial switchgear manufacturer Pune · 90 employees, planning EU market entry
The trigger
Their distributor in Germany asked for CE marking before placing the first order. The manufacturer had no experience with EU technical regulations and no idea which directives applied.
The challenge
Initial assessment found their product was subject to three EU Directives: Low Voltage Directive, EMC Directive, and potentially the Machinery Directive. Test reports from Indian labs were not from EU-recognised laboratories. The technical file did not exist.
Where Clicarity came in
They managed the CE marking project in Clicarity. LVD and EMC conformity assessment ran as separate sub-jobs — different test standards, different test labs, different engineers responsible. The DoC was signed only after both sub-jobs completed. Technical file retention was tracked as a separate stage with a 10-year review trigger.
The result
CE marking achieved. German distributor order placed.
We had no idea where to start. Treating it as a project with stages and owners — one directive at a time — made it manageable.
Clicarity is a process tracking tool. It does not provide certification, consulting, or audit services.