CE Certification

What are the steps involve in CE Marking Certification process?

CE Marking is product passport to Europe and other countries market. There is 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 plan and then follow it.

CE Marking Certification can be taken up by either the Manufacturer or an Applicant organization, who takes responsibility about 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 EU legislations will apply?
  • What are the requirements in applicable legislations?
  • 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 hos safe the product is.

Step 2- Identification

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

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 risk the Certification. It is wise to contact local CE Marking consultants because they will 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 Marking Certification.

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.

CE Certification

 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 questions are 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 indelibly 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 looked at after completing the CE Mark process and before entering the market.

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