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CE Certification

CE certification mark affixed on the product indicates health, safety and environmental protection standards of those products sold within the European Economic Area (EEA).

  • Designing a product that touches relevant standards
  • Making a Technical File
  • Building a Declaration of Conformity
  • Hunt out a professional EC REP to serve as your partner
  • Testing of your product
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Overview of CE Certification

CE stands for European Conformity. CE certification works as a proof of mark affixed on the product which reflects health, safety and climate protection standards of products sold within the European Economic Area (EEA). The CE mark can also be developed on products which are sold outside the EEA that are produced in or designed to be sold in EEA. The CE marking signifies that the manufacturer has fulfilled all the details of the applicable EC directives. The applicant will have to submit all the pre-requisite documents of CE marking to the distributor or importer. It is essential to obtain CE marking for those products which are located within the European Economic Area. The manufacturers and importers must make sure that the EC marked goods comply with the standards.  

People often think that getting a CE certification is very tough and marinated with complicated regulations. But, actually getting a CR certification is an easy task. All you have to do is go after specific rules and regulations to get your CE certification within your pocket.

Types of CE marking

Manufacturer or authorised representative of the product affixes CE marking to the product. CE marking is given when the product successfully meets all the CE requirements.

Minimal Risks

A minimal risk product requires a self-declaration along with the Declaration of Conformity from the hand of the manufacturer for affixing CE marking to their product.

Greater Risks

Directives say that the products which revolve around a greater degree of risk should independently get their product certified through a notified body. European Commission notifies such body. Plus the notified body has gathered all the necessary information to meet the requirements outlined in the directives. Either a private organization or government agency can act as a notified body.   

Registration Procedure for getting CE Certification in India

Getting CE Certification involves four main elements:

  • Designing a product that touches relevant  standards
  • Making a Technical File
  • Building a Declaration of Conformity
  • Hunt out a professional EC REP to serve as your partner

How to Get CE Marking?

  • Go through the specific requirement of your product
  • Be aware of the EU requirements for your product
  • Make sure whether your product requires testing by a national body
  • Test your product
  • Assemble technical requirement of your product
  • Affix the CE marking and draft a declaration of conformity

Hence, the stairs don't end here; check out the detailed CE certification procedure

Identifies the applicable directives

Pin down the products whether the product is a medical device, electronic gadget, machine, toy or something else. You have to research and establish which of the various directives falls under this. Not only are these, the manufacturer of the products that don’t require explicit CE certification such as cosmetic product also liable under CE Certification regulations.

Identify the applicable standards for CE Marketing

From these directives, manufacturers are required to apply which essential safety and health requirements are applied and demonstrate their compliances with the appropriate harmonized standards for the product.

Certify your Product

If the manufacturer itself cannot certify the CE Certification, then they can take the help of the appropriate notified body for an audit that can help the manufacturer in their technical documentation, quality management system etc.

Clear the test

If your product does not pass the compliance test at first chance, then you can correct the issue that resulted in non- compliance without comprising the function of the product. You can easily re-submit it for testing. If your problem is still not solved, then you can ask for the reason of rejection, and the notified body will soon reply to you with the justification for why the product is not meeting the compliance. CE Certification is not availed until the product passes the compliance test.

Complete the Technical file

A technical file should contain information about all the devices that you are proposing to do. Unfortunately, there are no vision paths on the rule of the technical file for a device, but several guidance documents do exist to support the manufacturer, including the followings:

  • Technical documentation related to the product
  • Guidance notes for manufacturers of Class I Medical Device
  • Guidance on NB tasks of technical Documentation Assessment on a representative basis
  • Summary Technical Documentation for Demonstrating Conformity of the Essential Principals of Safety and Performance of product

Issue a Declaration of Conformity

Now, this is the most important document because it states the essential health and safety requirements of the relevant legislation of the product. The creation and signing of this document also state that the manufacturer assumes responsibility for the CE marketing compliance of the product.

Appoint a European Authorized Representative

Brand owners who are sitting outside the border are obliged to appoint European Authorized Representatives. They ensure the compliances before entry in the market. They also serve as an ongoing vigilance contact point to provide manufacturer with the regulations updates as the law evolves for as long as the products remain available.

Affix the CE certification

Once the CE certification is your product, pop up the champion, you are free to circulate it throughout the world.

Frequently Asked Questions

CE stands for European Conformity. This certification works as a proof of mark affixed on the product which reflects health, safety and climate protection standards of products sold within the European Economic Area (EEA).

  • Designing a product that touches relevant  standards
  • Making a Technical File
  • Building a Declaration of Conformity
  • Hunt out a professional EC REP to serve as your partner
  • i) Minimal Risks
  • ii) Greater Risks
  • Technical documentation related to the product
  • Guidance notes for manufacturers of Class I Medical Device
  • Guidance on NB tasks of technical Documentation Assessment on a representative basis
  • Summary Technical Documentation for Demonstrating Conformity of the Essential Principals of Safety and Performance of product

This document states the essential health and safety requirements of the relevant legislation of the product. The creation and signing of this document also state that the manufacturer assumes responsibility for the CE marketing compliance of the product.

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