Six Steps to CE Marking .

Six Steps to CE Marking

A Trade Commissioner Service White Paper
www.tradecommissioner.gc.ca

Table of Contents

Introduction

  1. What is the CE mark?

Six steps to CE marking

  1. Find the CE directive(s) that apply to your product
  2. Know the essential requirements for your product
  3. Determine if you need third-party certification
  4. Assess product conformity
  5. Create and maintain technical documentation
  6. Declaration of Conformity & affixing the CE Mark

Web resources


Introduction to this white paper

CE mark can be confusing, costly, complex, and can take up a lot of a company’s precious time.

This white paper, produced by the Canadian Trade Commissioner Service, is a primer on CE certification. This guide is not comprehensive and companies are strongly encouraged to consult the web resources section.

The six steps of this white paper bring together insight on CE marking from experts and Trade Commissioners alike, as well as key EU resources.

The Canadian Trade Commissioner Service helps companies navigate the complexities of international markets. We provide Canadian companies with on-the-ground insight, and an unbeatable network of contacts in more than 150 cities worldwide.

Visit tradecommissioner.gc.ca

What is the CE mark?

The CE mark (above) is a symbol that a manufacturer (see definition below) affixes to a product so that it can be sold in Europe. The mark is mandatory for products which fall under one of 24 European directives. The CE mark means that the manufacturer takes responsibility for the compliance of a product with all applicable European health, safety, performance and environmental requirements. CE stands for “Conformité Européenne”, the French for European conformity.

The mark is required in all 27 member states of the EU, as well as Iceland, Norway, and Liechtenstein. Switzerland accepts the CE mark for some products and Turkey actually requires that many products be CE marked.

Definition of manufacturer:
The natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under its own name.

The bottom line: CE marking provides access to a market of over 500 million consumers.

CE is not like other certification marks.
The Canadian Standards Association (CSA) or the Underwriters’ Laboratories (UL) marks, for example, can only be used when those organizations have determined that a product meets applicable standards. European organizations do not grant authorization to use the CE mark as it is not owned by any particular body. The manufacturer is responsible for its proper use.

The manufacturer, whether established inside or outside the EU, is ultimately responsible for affixing the CE mark and is also responsible for its proper use. The manufacturer established outside the EU may appoint an authorized representative established in the EU to act on his behalf. CE marking is about more than affixing a symbol to a product.

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