in ,

Get Known About CE Marking and Steps Involve In CE Marking Process

CE Marking is product passport to Europe and other countries market. There is a myth about CE marking in business minds that it is too hard to get CE certification.  Yes, it can appear to be complicated when there is under-knowledge. Understand steps, treat each new product as a project, create a plan and then follow it.

CE Marking Certification can be taken up by either the Manufacturer or an Applicant organization, who takes responsibility for the safety and performance of the product.

CE Marking Process steps 

Step 1- Classification

The questions to ask in it are:

  • What is the product? Is it a family/group? What is the highest range?
  • What is the Application?
  • Define characteristics?
  • Identify the Risk Category of the Product.
  • What will EU legislations apply?
  • What are the requirements in applicable legislation?
  • Identify Harmonised EU standards.
  • What are the requirements in applicable Harmonised standards- including testing requirements?

The most important elements to evaluate are what you eye as a manufacturer/applicant, claim the product is intended to do, how the product is fulfilling its intended purpose, and how safe the product is.

Step 2- Identification

  • Identify essential safety and health requirements
  • Identify conformity assessment procedures.
  • Identify European harmonized standers, ensure product compliance, determine if European authorized representative is required,
  • Determine if a notified body is required and determine if the notification to the authorities is required.

Step 3- Technical Documentation 

Manufacturers / Applicants execute the conformity assessment procedures:

  • testing, assessment, evaluation, audits, inspections etc, as per EU Directives & Harmonised Standards.
  • document all as evidence of conformity, the responsibility to prove conformity is on the manufacturers.
  • Issue EU Declaration of Conformity: technical documentation must be available to the EU for the inspection by the EU authorities.

This is a very critical and stringent stage. As 1 mistake can be a deterrent to the whole exercise. It is wise to contact CE Certification consultants, they shall support you and provide you with a real-time professional guidance (including how to document EU Declaration of Conformity, What questions are asked during Product Conformance Audits etc); on how to achieve compliance and understanding of this Step 3 and finally to achieve CE Certification.

CE Mark

Step 4- Certification 

The questions the Manufacturers / Applicants should ask.

  • What is the certification process?
  • What are the requirements?
  • How to comply with requirements?
  • What are questions to be expected?
  • How to comply with Production Control requirements?
  • What will I receive after the completion of certification?

Step 5- Pre Market Notification

The questions the manufacturers/applicants should ask.

  • What is the notification process?
  • What will I receive after the completion of notification?
  • Where to put, how to put, whom to contact etc?

Step 6- Affix CE Marking 

Affix CE marking to product and/or packaging and a company literature in legibly and indelible manner. CE marking on a product is manufacturer’s declaration to the buyer or a user that this product fulfills all essential safety and environmental requirements as defined in European directives

Step 7- National Provisions

Europe is not yet a single country there are different nations with different implementations and different languages. National requirements must be looked at after completing the CE Mark process and before entering the market.

CE Certification consultants shall support you and provide you with a real-time professional guidance on how to identify and understand National Provisions, if any and achieve compliance and understanding of this Step 7 and finally achieve CE Marking Certification.

This post was created with our nice and easy submission form. Create your post!

What do you think?


Written by Sagar Gore

Leave a Reply

The Do’s And Do not’s Of Modern-Day Press Releases

Hyperbaric Chamber Therapy: A New Ray of Hope to Near-Drowning Patients