CE Certification (Europe)

REGISTRATION

Key EU Directives & CE Mark Coverage

LVDLow Voltage Directive (2014/35/EU)

EMC DirectiveElectromagnetic Compatibility (2014/30/EU)

REDRadio Equipment Directive (2014/53/EU)

Machinery Directive2006/42/EC — Industrial machinery

MD/MDRMedical Device Regulation (EU) 2017/745

RoHS2Restriction of Hazardous Substances (2011/65/EU)

ATEXExplosive Atmospheres equipment

PPE Reg.Personal Protective Equipment Regulation

What is CE Certification?

CE Marking (Conformité Européenne — French for "European Conformity") is a mandatory conformity mark for products placed on the market in the European Economic Area (EEA). The CE mark indicates to regulators, retailers, and consumers that the product has been assessed against and found compliant with the applicable EU requirements covering safety, health, environmental protection, and consumer protection.

CE certification is not a voluntary quality seal — it is a legal prerequisite for placing regulated products on the EU market. European market surveillance authorities can withdraw products without CE marking, impose fines on manufacturers and importers, and in serious cases, seek criminal prosecution. As Indian manufacturers increasingly target export to Europe, CE marking is an essential step in market access planning.

FGMS provides complete CE certification support: from directive identification and testing coordination through technical file preparation, Declaration of Conformity drafting, Notified Body liaison, and post-market surveillance compliance.

Enquire Now Start Application Call an Expert

Our Process

Directive Identification

We identify all applicable EU Directives/Regulations for your product (LVD, EMC, RED, MD, ROHS, Machinery, PPE, etc.) and define the conformity assessment route.

Technical File Preparation

We compile the Technical File: product description, design & manufacturing drawings, list of standards applied, test reports, risk assessment, and Declaration of Conformity (DoC).

Product Testing

Products are tested at an accredited EU-Notified Body or ISO 17025 laboratory against applicable EU harmonised standards to verify conformity.

Declaration of Conformity

We prepare and sign the EU Declaration of Conformity (DoC), declaring that the product meets all applicable EU requirements. The DoC must be retained for 10 years.

CE Mark Affixing

Once conformity is established, the CE Marking is affixed to the product and packaging. For certain product categories, a Notified Body identification number is also required alongside the mark.

Market Surveillance Compliance

We assist with post-market obligations: monitoring for regulatory changes, updating technical files, and notifying authorities of found risks.

Documents Required

The following documents are generally required. Exact requirements may vary based on your product, entity type, and applicable standard. Our team provides a precise checklist after consultation.

Product technical description and intended use

Full product specifications and technical drawings

Test reports from accredited laboratory (matching EU harmonised standards)

Risk assessment document

List of applicable EU Directives and harmonised standards

Declaration of Conformity (DoC) — to be prepared

Labelling and marking artwork showing CE mark placement

Notified Body certificate (if applicable — for high-risk products)

Frequently Asked Questions

CE Marking (Conformité Européenne) is a mandatory certification mark for products sold within the European Economic Area (EEA — 30 countries). It indicates the product meets EU safety, health, and environmental requirements. CE is required for electrical equipment, machinery, medical devices, toys, PPE, construction products, radio equipment, and pressure vessels, among others.

For many low-risk products (e.g., general electrical equipment under LVD, EMC Directive), CE is self-declared by the manufacturer based on internal testing against EU harmonised standards. For higher-risk products (medical devices, lifts, gas appliances, certain machinery), a Notified Body must be involved. FGMS identifies the correct route for your product.

The DoC is a mandatory document in which the manufacturer formally declares that the product complies with all applicable EU Directives. It must list the product, applicable directives, standards used, name and signature of the authorized person, and must be kept for 10 years. It must be made available to market surveillance authorities on request.

Yes. Post-Brexit, the UK has its own UKCA (UK Conformity Assessed) mark for products sold in Great Britain (England, Scotland, Wales). Products sold in Northern Ireland still require CE marking. FGMS assists with both CE and UKCA certification.

For self-declaration products: 4–8 weeks (testing and documentation). For products requiring Notified Body involvement: 8–16 weeks or more depending on the Notified Body schedule and product complexity. FGMS coordinates efficient testing and documentation to minimise time-to-market.

Why Choose FGMS?

15+ Years Experience

Deep domain expertise spanning BIS, ISO, WPC, EPR, and 50+ certification schemes

Pan-India & Global Reach

Offices across India and liaison in 50+ countries for overseas market certifications

Fast Turnaround

Dedicated case managers accelerate every step to save you critical market time

Transparent Pricing

Fixed professional fees with no hidden costs — clear cost breakdowns from day one

Expert Team

Chartered engineers, legal experts, and ex-government consultants on your case

High Success Rate

99%+ certification success record built on thorough preparation and rigorous quality checks

Request a Free Callback

Or call us directly:

+91-9818571192

All Services

BIS (ISI Mark) For Foreign Manufacturers (FMCS) Domestic Product Certification (ISI Mark) BIS Scheme X Certification BIS Certificate of Conformity (CoC) BIS Hallmarking BIS Licence For Toys REACH Certification - India (Chemical Management) CDSCO Licence (Drug & Medical Device) ECOMARK Certification Laboratory Recognition Scheme (LRS) World Manufacturer Identifier (WMI) Code TAC Approval For Automobile PESO Certification SASO Certification (Saudi Arabia) CDSCO Drug Licence BIS (CRS) Registration For Electronic Products WPC-ETA Approval (Wireless Products) BEE Star Rating Certification E-Waste Management (EPR) EPR Registration - Plastic Waste Management EPR Registration - Battery Waste Management EPR Registration - Used Oil Management Legal Metrology - LMPC Registration TEC / MTCTE Approval CE Certification (Europe) UL Certification (USA) RoHS Licence (Restriction of Hazardous Substances) Drone Registration (UAS) MoEF Licence (Environment Clearance) Standardization (Scientific) Division Training Services - National & International Import / Export Licence (IEC) Brand Representation Laboratory Equipment and Setup Trademark Registration Make In India Support AG-Mark Licence (Agricultural Products) Third Party Inspection & Monitoring Services Collaboration Services FSSAI Certification (Food Safety) MSME / SSI / NSIC Registration ISO Registration / Certification

Accreditations

BIS Approved Consultant

ISO 17021 Compliant Process

MoMSME Registered

FICCI & CII Member

D&B Verified Company

CE Certification (Europe)