CE Certification in India
People often think that getting a CE certification is very tough and marinated with complicated regulations. But, actually getting a CR certification is a very easy task you can easily get your CE certification within your pocket. Today, in this article we aim to examine how much truth and validity stands in that statement.
Steps to be taken for getting CE Certification in India
Getting CR Certification involves 4 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
Hence, the stairs don't end here; check out the detailed CE certification procedure
1. 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 this, the manufacturer if the products that don't require explicit CE certification such as cosmetic product are also liable under CE Certification regulations.
2. 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.
3. Certify your Product
Although we have two hands we cannot do everything, so if the manufacturer itself cannot certify the CE Certification then they can take the help of the appropriate Notified body for an audit if their technical documentation, quality management system etc.
4. 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.
5. Complete the Technical file
A technical file should contain the 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
6. 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.
7. Appoint a European Authorized Representative
Brand owners who are sitting outside the border are obliged to appoint European Authorized Representatives. They ensure the compliances prior to entry in the market and also serve as an ongoing vigilance contact point to provide the manufacturer the regulations updates as the law evolves for as long as the products remain available.
8. Affix the CE certification
Once the CE certification is your product, pop up the champion you are free to circulate it throughout the world.