CE Certification

CE Mark certification to export products to the European Union and EEA countries

Validity: 1–3 years (re-assessed on design changes)

What is CE Certification?

The CE Mark is a mandatory conformity mark for products exported to the European Union and European Economic Area. It confirms that the product meets EU safety, health, and environmental requirements. We identify the applicable Directive, select a Notified Body where required, and manage the technical file compilation.

The CE Mark (Conformité Européenne) is required on a wide range of products sold in the European Union and European Economic Area — including machinery, electrical equipment, medical devices, personal protective equipment, toys, pressure equipment, and construction products. The mark indicates that the product meets the essential requirements of the applicable EU Directive(s) and that the manufacturer has completed the conformity assessment procedure for that Directive. For low-risk products, CE marking can be self-declared by the manufacturer after completing an internal production control process and compiling the required technical file. For higher-risk products (Class II medical devices, certain machinery, PPE Category III), a Notified Body must be involved in the conformity assessment. The technical file must be retained for 10 years after the last product is placed on the market.

Who Needs CE Certification?

Indian exporters of goods to the EU/EEA in regulated product categories, including electronics, machinery, medical devices, toys, PPE, and construction materials.

What's Included

Applicable EU Directive(s) identified for the product
Technical File compiled meeting Directive requirements
Declaration of Conformity drafted
CE Mark legally applied on product and packaging
EU Authorised Representative appointed (required for non-EU manufacturers)

⚠️ Penalty for Non-Compliance

Placing CE-marked products on the EU market without a valid Declaration of Conformity and technical file is a criminal offence in member states and leads to product recall and market bans. Misuse of the CE Mark on products that do not conform to the applicable Directive is also an offence.

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How It Works

1
Directive identification
We identify which EU Directives apply to the product (e.g., LVD + EMC Directive for electrical equipment, MDR for medical devices).
2
Gap analysis
The product is assessed against the essential requirements of each applicable Directive.
3
Testing
Where required, the product is tested at an EU-recognised laboratory against the relevant harmonised standards.
4
Technical file
The complete technical file is compiled: product description, drawings, test reports, risk assessment, and Declaration of Conformity.
5
Notified Body (if required)
For higher-risk product categories, a Notified Body is engaged for the conformity assessment module required by the Directive.
6
CE Mark applied
The Declaration of Conformity is signed and the CE Mark is affixed to the product and packaging.

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Documents Required

Items marked Required are mandatory; others are situational.

Product

Product technical drawings and specificationsRequired
Bill of materialsRequired
Existing test reports

Regulatory

Applicable Directive list (we identify this)
Risk assessment document

Fees & Pricing

Fees

Testing fee

At an EU-recognised or IECEE lab — varies by product and standards

Varies

Notified Body fee

Only where required — varies by Directive and risk class

Varies

EU Authorised Representative retainer

Annual fee to an EU AR firm — typically €500–€2,000 per year

Varies

Professional fee

Quoted after identifying the applicable Directives and product risk class

Varies

* Government fees may vary. GST applicable on professional fees. Final pricing confirmed after review.

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Frequently Asked Questions

Is a Notified Body always required for CE marking?

No. For low-risk products (Module A — internal production control), the manufacturer self-declares conformity after compiling the technical file. A Notified Body is required for higher-risk categories such as Class IIa/IIb/III medical devices, PPE Category II/III, and certain machinery.

Does an Indian manufacturer need an EU Authorised Representative?

Yes. Non-EU manufacturers must appoint an EU Authorised Representative who is established in an EU member state. The Authorised Representative's name and address appear on the product labelling alongside the CE Mark.

Which products require CE marking for the EU?

Over 25 EU Directives and Regulations require CE marking, including: Low Voltage Directive (LVD), Electromagnetic Compatibility (EMC) Directive, Machinery Directive, Medical Devices Regulation (MDR), Toy Safety Directive, PPE Regulation, Construction Products Regulation, and others.

How long does a CE certificate last?

The Declaration of Conformity is product-specific, not time-limited. However, it must be re-done when the product design changes significantly, or when the Directives are revised (as with MDR replacing MDD for medical devices).

What are harmonised standards?

Harmonised standards are EU standards (EN standards) whose application gives a presumption of conformity with the essential requirements of the applicable Directive. Products tested against harmonised standards are presumed to conform.

Can CE marking be self-declared for electronics?

Yes. Most consumer electronics covered by LVD + EMC Directive + RoHS can be self-declared using Module A (internal production control) based on testing against harmonised standards. No Notified Body is required.