What is the CE Marking Process?

There is a fear among many product manufacturers that the process of obtaining CE Marking is long, complicated and expensive. This blog aims to examine how much truth and validity there is to that statement.

Steps to CE Marking

Obtaining CE Marking involves four main elements –

  1. Designing a product that meets the relevant standards
  2. Building a Technical File
  3. Making a Declaration of Conformity
  4. Identifying a professional EC REP to serve as your EU partner

A more thorough breakdown of the process can be seen below:

1 – Identify the applicable directives: Whether the product is a medical device, electronic gadget, machine, toy or something else, manufacturers need to research and establish which of the various directives it falls under. Other product categories that don’t require explicit CE marking – such as cosmetic products – are also subject to various regulations.

2 – Identify the applicable standards: From these directives, manufacturers need to find which essential safety and health requirements apply and demonstrate their compliance with the appropriate harmonized standards for the product.

3 – Certify the product: If the manufacturer is unable to self-certify the product, they will need to submit the product to an appropriate Notified Body for an audit of the technical documentation, quality management system, etc. Find out more about Notified Bodies here

4 – Pass the test: If the product does not pass the compliance test first time, manufacturers may be able to correct the issues that resulted in non-compliance without compromising the function of the product then resubmit it for testing. If not, they can submit a technical justification for why the product is not meeting compliance. CE Marking cannot be awarded until the product passes the compliance test.

5 – Compile the Technical File: Find out more about the Technical File here.

6Issue a Declaration of Conformity: This document states that the product meets the essential health and safety requirements of the relevant legislation(s). The creation and signing of this document also means the manufacturer assumes responsibility for the compliance of the product.

7Appointing a European Authorized Representative (EC REP):  Brand Owners (legally claimed manufacturer) located outside of the EU are obligated to appoint an EU entity to ensure compliance prior to market entry, to serve as the ongoing vigilance contact point, to provide the manufacturer with ongoing regulatory updates as the laws evolve for as long as the products remain available

8 – Affix the CE marking: Once the CE marking is on the product, it’s free to circulate it throughout the EU!

We are here to make the introduction of your product to the EU market as smooth as possible. With many years of experience and offices at the heart of the EU in Brussels, our consultancy experts are perfectly placed to guide you through the CE Marking process. Get in touch today!

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