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CE Certification- An Overview

Are you a manufacturer, an importer or a distributor dealing in consumer goods? If yes, you must secure CE certification to market your products in the EU.

The CE certification marking shows that a product meets European health, safety, and environmental standards, allowing it to be sold freely in the European Economic Area (EEA). While mandatory for EEA products, it is not a quality certification mark. The marking includes the CE logo and, if needed, a four-digit code for the notified body involved in the conformity assessment.

Standing for "conformité européenne" (European conformity), the CE marking acts as a passport for products in the European market. It confirms compliance with essential directives, ensuring the product can be legally traded across the EEA.

Get Fastzeal expert guidance to secure CE marking certification and expand your business in the vibrant, business-friendly climate of the European Economic Area (EEA).

Promoting Fair Competition

CE marking certification ensures all companies follow the same rules, fostering a level playing field.

Confirming Legal Compliance and Safety

CE compliance certificate verifies that a product meets legal requirements and is safe for sale in the EEA market.

Enabling Free Trade within the EEA

CE mark certification ensures that certified products can be freely traded across the EEA without restrictions.

Protecting Consumers

CE marking certification upholds health, safety, and environmental standards, safe-guarding consumers across the entire EEA.

Ensuring Legal Requirement Fulfilment

CE marking certification demonstrates that all legal requirements are met, making products ready for challenges in the European market.

Facilitating Free Movement of Products

CE compliance certificate enables the free movement of products across European coun-tries

Allowing Withdrawal of Non-Conformity

CE mark certification allows authorities to withdraw non-conforming products from customs and vigilance authorities.

List of Products for CE Certification

The list of products eligible for CE certification Europe includes, but is not limited to, the following:

Checklist of Products for CE Marking Certification

  • Electronics
  • Medical Devices
  • Toys
  • Household refrigerators and freezers
  • Personal protective equipment
  • Radio and telecommunications terminal equipment
  • Hot-water boilers
  • Lifts
  • Measuring instruments
  • Pressure equipment
  • Simple pressure vessels

    Checklist to Obtain CE Marking Certification

    • An applicant must ensure to meet or comply with all relevant EU-wide requirements.
    • An applicant must identify if one can assess the product by themselves or if a notified body has to be engaged.
    • An applicant needs to prepare and put together a technical dossier for document compliance.
    • An applicant must draft and sign an EU declaration of conformity to get CE marking certification.

What are the Documents Required for CE Certification?

The list of documents required for CE certification Europe is as follows:

  • Product details or description
  • Product Test Report
  • Manufacturer Declaration
  • Proof of Product Conformity
  • Copy of Risk Assessment

How to Apply for CE Certification?

The step-by-step guide to apply for CE certification is given below:

  Regulatory Standard

Firstly, identify the applicable directives and products harmonized standards
Collection of Data

This is the stage where the applicable supply chain data are collected for necessary technical data.
Assessment
The applicant must decide whether the product requires an independent conformity assessment by a notified body or if they can conduct the assessment themselves.


Testing

In this stage of CE certification, the product needs to be tested and check its conformity as per the EU regulations and directives.
Management

The applicant needs to create and maintain all the important and necessary technical documentation for CE certification.


EU Declaration

Lastly, affix the CE marking certification and accordingly draw up an EU Declaration of Conformity.





Do you Need an Independent Assessment for CE Certification?

Here are the reasons to determine whether an independent assessment for CE certification online is required:

  • Check if the product requires testing by a notified body according to the relevant legislation.
  • If a notified body is required, the CE marking certification must include its identification number.
  • The CE mark and identification number can be affixed separately, as long as they are clearly linked.
  • Use the Nando database to find a notified body that can certify your product.
  • If the product doesn't require testing by a notified body, the manufacturer must perform self-verification.
  • This self-verification must ensure compliance with the relevant technical requirements.

Purpose
It sets standards for quality management, environmental practices, and safety to improve business operations.
It ensures products comply with European standard regulations and are eligible to sell in the European Economic Area (EEA).


Why Do Products Need CE Certification Europe?

Let's see the key points why products need CE certification Europe:

  • CE marking certification is mandatory for manufacturers and importers selling products in the European Economic Area (EEA).
  • CE certification acts as a trade passport, allowing certified products to move freely across all 30 EEA countries.
  • CE mark certification unifies regulations with a single set of rules for all EEA member states, replacing individual national requirements.
  • It simplifies the CE compliance certificate process, making it easier for manufacturers and importers to sell products in the EU.

Frequently Asked Questions:


A CE certification is obtained by the manufacturer after assessing a product according to relevant European product legislation, ensuring it meets health, safety, and environmental requirements.


No, CE certification is not valid in India as CE mark certification only applies to the European market, and it may be accepted for certain products.


No, CE marking certification is not accepted in the United States.



No license is required to affix the CE marking to a product for sale in the European market. However, the manufacturer is solely responsible for declaring that the product meets all necessary requirements.


A CE certification Europe is mandatory for manufacturers that want to sell products in the European Economic Area (EEA).


FDA approval means a device is authorized for use worldwide, while the CE mark may have restrictions, even within the EU. The FDA's stricter regulations are often considered a sign of higher safety for consumers.


Yes, medical devices intended for sale in the EU must have a CE marking certification. This marking confirms that the device complies with relevant EU directives and allows it to be sold in European countries.


Yes, machinery intended for sale in the European or UK market must have a CE marking under the Machinery Directive before it can be used. This Directive applies to new equipment, as well as machines that are modified or rebranded.


Under CE certification, products with minimal risk can be self-certified. The manufacturer prepares a Declaration of Conformity and affixes the CE mark to the product(s).


The declaration of conformity serves as a formal declaration made by the manufacturer's representative, assuring that the product meets all the underlying requirements of safety directives underpinned by the law in question.

Why Choose Fastzeal for Your CE certification

We make technical compliance certifications effortless and convenient.

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