We are regularly asked about CE marking, how long it takes, and how costly it is. The only real answer that we can provide is that it depends on a number of variables because each product is different. We can, however, help you understand the overall process for CE marking prior to taking your product global, including what variables are involved, and point you toward more information, as well as assistance with the process, should you need it.
What is CE Marking?
According to the simplest definition using Wikipedia, CE marking is a manufacturer’s declaration that a product meets the requirements of the applicable European Community directives. The European Commission describes CE marking as:
“The letters ‘CE’ appear on many products traded on the extended Single Market in the European Economic Area (EEA). They signify that products sold in the EEA have been assessed to meet high safety, health, and environmental protection requirements. When you buy a new phone, a teddy bear, or a TV within the EEA, you can find the CE mark on them. CE marking also supports fair competition by holding all companies accountable to the same rules.”
Basically, CE marking allows goods to move within the European market.
The price and time required will depend on what procedures apply to your product including:
- How your product is intended to be used
- The specific standards that apply to the directive your product falls under
- Whether you can do some or all of the conformity assessments yourself
- Whether the category you are applying for requires third-party assessments
- The level of support you will need if assistance is desired or required for the compliance documentation
- Whether you are able to provide acceptable technical specifications, user manuals and product labeling
Post-Brexit ppdate for businesses in the UK: The UKCA (UK Conformity Assessed) marking is the UK’s product marking used for goods being placed on the market in Great Britain (England, Scotland, and Wales) following Brexit. It replaces the CE marking for most products in this market. The UKCA marking covers most products that previously required CE marking, including electronics, machinery, and medical devices. While the process for obtaining UKCA marking is similar to CE marking, it involves different conformity assessments, notified bodies, and technical documentation requirements specific to the UK. Manufacturers must ensure their products comply with UK regulations and affix the UKCA mark to continue selling in Great Britain. However, CE marking is still recognized in Northern Ireland, which follows different rules under the Northern Ireland Protocol.
Below is a brief explanation of the six-step process for CE marking in the EU.
Step 1—Identify the relevant directive for each product category
There are 20 different categories of directives. It is important that you select the directive that is appropriate for the intended use of your product, since products can be covered by more than one CE directive. You should explore the listing of categories and downloadable PDFs outlining each one, to identify which category your product best fits in.
Step 2—Verify the specific requirements for each category
In order to identify the certification requirements for your product, it is important to review the European harmonized standards, which are developed by recognized Standards Organizations, for that category. CE marking harmonized European Standards
Step 3—Determine whether an independent conformity assessment from a notified body is required
Many products do not require a conformity assessment from a notified body. This is where a lot of companies that are unclear about the requirements will spend unnecessary time and money leading to higher CE marking costs. Here is a list of companies that are approved as notified bodies if your category requires an assessment as per the directives. CE marketing manufacturer responsibilities
Often, and when the product category allows, the manufacturers can perform a conformity assessment themselves. Refer to the EU Conformity Assessment ‘Blue Guide,’ downloadable at the bottom of this link for additional information.
Tip: You may want to consider combining CE marking with other markings or certifications, including ENEC14, TUV, GS, NEMKO, DEMKO, SEMKO, among others, since some of the testing and certification bodies are licensed to do more than CE marking.
Step 4—Test your products and check conformity to EU legislation
Depending on the product category, and with the appropriate documentation, you can, at times, test products in-house rather than use expensive third-party testing centers. While using harmonized standards is voluntary, it is recommended. You can assess your risk by comparing your testing results to the harmonized standards.
You will need to provide a Declaration of Conformity and some member states will require the document to be translated into their language. Here is an example and template of a Declaration of Conformity.
Tip: One way to reduce the cost, complexity and time required for CE marking is to use components that already have CE marks and other certifications.
Step 5—Draw up and make the required documentation available
All of the directives require that the technical documentation, also known as the Technical File, provide all of the information necessary to demonstrate that the product conforms to the directives and required standards. Many of the directives provide examples of the data that must be included in the Technical File to prove compliance. Data includes the product design, product manufacturing specifications, components, and how to operate the product.
It is recommended that the Technical File be written in English, although you can use the language of the country in which you intend to file. You will also need to make the Technical File available before you enter the market for the next 10 years in most categories. The Technical File needs to be held within the EU, which means that if your office is not located in the EU, you will need to have a representative you trust to secure the information.
Tip: Consider carefully who you will trust as a host for all of your technical data and other documentation.
Step 6—Affix the CE marking
You are not allowed to use the CE mark on any product that is not compliant with EU directives. By using the CE mark, the manufacturer takes full responsibility for compliance with all of the EU-relevant directives. The mark itself has format requirements, including visibility, legibility and permanence so it can’t be removed from the product or data plate. You may have other compliance marks in addition to CE marking as long as they don’t cover or in any way hinder the visibility of the CE marks.
Tip: Save yourself long-term problems by doing it right from the beginning. While there is not an EU enforcement agency, the individual member states have authorities charged with investigating product compliance and can require product recalls, severe penalties and even criminal charges if they find infringements.
For many companies with products that are not a safety risk, and are able to provide appropriate technical documentation and stay compliant with appropriate EU directives, CE marking can be implemented quickly and cost-effectively, often without requiring assistance from notified bodies or experienced agents. For companies that require and/or desire assistance, there are vetted agents within the Globig Marketplace who can assist you with this process.
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