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CE marking is a mandatory regulatory requirement for placing products on the European market. It confirms that a product complies with EU safety, health, performance, environmental, and consumer protection standards. Without CE marking, products cannot be legally sold in the EU, EEA, Iceland, Norway, Liechtenstein, and Türkiye.

What is CE Marking?

CE stands for Conformité Européenne (European Conformity). It is a declaration by the manufacturer that their product meets all applicable EU directives and harmonized standards./br The CE mark is not a quality symbol, it is a legal compliance mark. Manufacturers outside the EU may appoint an authorized EU representative to handle compliance and documentation on their behalf.
CE marking opens access to a market of 500+ million consumers.
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Who is a Manufacturer under CE Rules?

A manufacturer is the entity responsible for designing, manufacturing, packaging, and labeling a product before it enters the market under their own name.

When is CE Marking Required?

CE marking is mandatory if your product falls under any of the designated EU directives, such as:

Low Voltage (electrical products)

EMC (Electromagnetic Compatibility)

Toy Safety

Pressure Equipment

Machinery

Construction Products

Medical Devices

Radio Equipment

Multiple directives may apply to a single product, requiring full compliance.

Understanding EU Directives

A directive is an EU legislative framework that requires member states to align national laws to achieve standardized outcomes — such as safety or emission control.

Each directive outlines essential requirements that products must meet.

Example:
 The EMC Directive demands that electrical products do not emit excessive electromagnetic interference and remain immune to external interference.

Medical Devices

Radio Equipment

Essential Requirements & Harmonized Standards
Directives contain broad legal requirements, but not specific designs.
To help manufacturers demonstrate compliance, the EU develops harmonized standards (EN standards) through bodies like:

CEN

CENELEC

ETSI

Using harmonized standards presumes compliance, but alternative standards may also apply, depending on the regulation.

Do You Need Third-Party Certification?

Some directives allow self-certification, while others mandate testing through an EU-approved Notified Body (NB)
. Notified Body involvement is required for products under:

Medical Devices

Pressure Equipment

Gas Appliances

PPE

Machinery (if harmonized standards are not used)

Toy Safety (if standards are not used)

Where NB assessment is not mandatory, manufacturers may still opt for third-party testing for reliability and credibility.

How CE Conformity is Verified?

Conformity assessment may include:

Product testing

Documentation review

Risk assessment

Quality system audits

Sample verification

Labeling and manual review

Assessment modules range from self-declaration to full quality assurance (ISO 9001 aligned).

Registration Process

CE Marking Process for Manufacturers in India

Identify Applicable EU Directives

Determine which CE directives apply to your product (e.g., EMC, LVD, RED, Medical Devices, Toys, Machinery etc.).

Apply Harmonized European Standards

Select EU harmonized standards that support compliance with the directives.

Perform Conformity Assessment & Testing

Evaluate design risks and operational hazards. ⚠️ If third-party assessment required, you must involve a Notified Body

Affix the CE Marking

Print/engrave CE logo on the product and packaging as per EU rules.

Issue the EU Declaration of Conformity (DoC)

The manufacturer (Indian company) legally declares that the product meets all CE requirements.

Prepare Technical Documentation (Technical File)

Final approval is granted if all requirements are met; otherwise, queries must be clarified.

Maintain Ongoing Compliance

• Keep records for 10 years
• Update CE compliance if the product changes
• Comply with EU market surveillance
Quality Standards
Quality Standards

Requirements for BIS CRS Registration

To apply successfully, the manufacturer must:
  • Register products covered under CRS before market launch
  • Ensure compliance with Indian Standards (IS Specification)
  • Declare conformity via Self-Declaration Format (SDoC)
  • Maintain adequate testing and manufacturing infrastructure

This self-declaration forms the basis of BIS issuing the licence.

Documents Required

Technical Documents for CE Registration

Every CE-marked product must have a technical file, retained for at least 10 years.
It proves compliance and must be available to authorities on request. It includes:
  • Product description
  • Design & manufacturing details
  • Drawings, schematics & calculations
  • Applied standards
  • Testing records
  • Risk assessments
  • User manuals
  • Any Notified Body certificates (if applicable)

The technical file does not have to be stored in Europe but the Declaration of Conformity must be accessible to EU authorities.

Timeline for BIS Certification

On average, BIS CRS approval takes 30 working days, including:
15 Days
For Testing
15 Days
For Scrutiny And Registration

Total 30 working days on average

On average, BIS CRS approval takes 30 working days, including:

Declaration of Conformity & CE Marking

The manufacturer issues a Declaration of Conformity (DoC), affirming full compliance with applicable directives.
The CE mark itself must be:

  • ✔ visible
     ✔ durable
     ✔ minimum 5 mm height
     ✔ proportional in both letters

    If marking cannot be placed directly on the product, it may be applied on packaging or documentation.

    CE marking has no expiry date, but the Declaration must be updated whenever:

    • product design changes
    • standards or directives change
    • manufacturer details change

Responsibilities of Importers / Distributors

Importers must:

verify the product complies

hold the Declaration of Conformity for 10 years

supply it when requested

If the product is manufactured in the EU, liability cannot be shifted to outsiders.

Why Choose

Global Consulting Services for CE Certification?

At Global Consulting Services, we provide end-to-end CE certificate registration support, including:
  • Directive identification
  • Gap analysis against essential requirements
  • Technical file creation & maintenance
  • Testing coordination (internal or NB-based)
  • Notified Body selection and liaison
  • Declaration of Conformity drafting
  • CE marking guidance
Consulting
Consulting 80%

Our expertise in compliance, strong industry network, and hands-on knowledge help manufacturers and importers achieve faster licensing and hassle-free execution.

We ensure your products meet all safety standards so you can enter the market confidently.

📩 For BIS CRS assistance, contact us today — our team will guide you through the latest regulations, updates, and requirements.

PARTNER WITH GCS — WE HANDLE YOUR CE MARKING FROM DOCUMENTATION TO AUDITS FOR SMOOTH MARKET ENTRY.

Ready to Enter the European Market? Apply for CE Certification Now

Consult Today

Frequently Asked Questions (FAQs) – BIS Registration / BIS Certification

 It signifies that a product complies with European safety, health, and environmental legislation.

 Yes — for products sold in the EU/EEA.

Yes, but compliance must be maintained, and the Declaration updated as needed.

Products may be seized, banned, or subject to heavy penalties.

Manufacturers or their EU authorized representatives; importers assume responsibility for non-EU products.