CE Certification

October 6, 2026

CE Certification

The European Union is currently a political and economic organization comprising 28 member states with a population of more than 500 million people. One of the four fundamental freedoms granted by this union is the free movement of CE-certified goods in European markets. The CE marking indicates that products and goods bearing the mark meet all the technical requirements and regulations of the European Union and can be distributed and sold in the markets of EU member states without any technical issues.

CE Marking

The CE marking, or European conformity marking, on a product indicates that products sold in the European market (EEA) have met the European Union’s high requirements and standards for safety, health, and environmental protection, and that the goods or products comply with European safety standards.

However, the CE marking can also be found on products sold outside the European Economic Area that have been manufactured in accordance with EEA standards. This makes the CE marking recognizable worldwide, even to people who are not familiar with the European Economic Area. In this respect, it is similar to the FCC marking, which is used to indicate compliance for the sale of certain electronic devices in the United States.

In brief, the CE marking is a declaration by the product manufacturer indicating the full conformity of the product or goods being supplied with European Union standards relating to health, safety, and environmental protection.

What Is CE Certification?

The CE marking is an abbreviation of the English term European Community. The CE marking, displayed in capital letters, can be seen on many products in the markets of the European Economic Area. As mentioned above, this marking signifies that products comply with European requirements and indicates that the goods have been inspected and audited with regard to minimum requirements for safety, health, and environmental protection. Products bearing the CE marking include new telephones, food production equipment, televisions, and even colored pencils available in stores, as well as many other goods purchased in European countries. The CE marking also indicates fair competition among manufacturers of these goods, as it demonstrates the manufacturer’s accountability and the product’s compliance with a defined set of requirements.

In the past, to obtain the CE marking, manufacturers had to send their products to Europe for the required testing. However, due to existing political and economic considerations, this process involved considerable time and expense. ISQI has made it possible for manufacturers to obtain an original CE certificate from a valid Notified Body (NB) with significantly less time and cost.

What Is the Purpose of CE Certification?

A manufacturer that obtains the CE marking for its products and affixes the mark to them is effectively declaring that its products comply with all applicable requirements, including the relevant European regulations and standards, and may be sold within the European Economic Area. CE certification guarantees two major benefits for both manufacturers and consumers. The European Union market confirms that goods bearing the CE marking can be sold throughout the European Economic Area without any barriers, while consumers can be assured that the goods, they purchase meet all essential health, safety, and environmental requirements.

It is the manufacturer’s responsibility to carry out the conformity assessment of its products, prepare the technical files for those goods, obtain the CE certificate and/or the EU Declaration of Conformity, and ultimately affix or mark the CE marking on the products.

When Is CE Certification Mandatory for a Product?

CE marking is mandatory only for products for which European Union specifications exist and which require the CE marking to be affixed. Some products are subject to several EU requirements at the same time. Before affixing the CE marking, you must ensure that your product complies with all applicable requirements. Affixing the CE marking to products for which no EU specifications exist or for which CE marking is not required is prohibited. CE certification cannot be issued for products such as pharmaceutical, food, and beverage products.

The countries in which CE certification is required for placing products on the market in the European Economic Area are:

Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom. The three EFTA member states are Iceland, Liechtenstein, and Norway. Switzerland is neither a member of the European Union nor a member of the European Economic Area, but it is part of the single market; that is, Swiss nationals, like other EEA nationals, enjoy similar rights to live and work in the United Kingdom.

How to Obtain CE Certification

All conformity assessment procedures (modules), including the required testing, inspections, and/or issuance of CE certification, must be completed before the product is placed on the market. Manufacturers must identify the regulations applicable to their products and use Notified Bodies that are accredited to provide conformity assessment and CE certification services for the relevant product.

Steps for Obtaining CE Certification

Step 1: Select the directives or regulations relevant to the product’s field of application.
Step 2: Identify and extract the test methods specified in the relevant European Harmonized Standards.
Step 3: Assess the risks and select the appropriate conformity assessment procedure.
Step 4: Apply the relevant standards or technical regulations and conduct the required tests and audits.
Step 5: Compile the technical documentation (Technical File), including test results and product specifications.
Step 6: Prepare the Declaration of Conformity.
Step 7: Conduct the final audit of the submitted documentation by organizations approved by the European Union.
Step 8: Affix the CE marking and obtain the certificate with the specified validity period.

What Information Must Be Included in the EU Declaration of Conformity?

The EU Declaration of Conformity documentation must include complete information related to the product concerned, its manufacturer or authorized representative, the NB company (where required), and the Harmonized Standards, as outlined below:

Unique identification information for the product
Name and address of the manufacturer or its authorized representative
A letter accepting the manufacturer’s responsibility for the declaration
Product documentation that allows its authenticity to be traced, along with a suitably clear photograph of the product (where applicable)
The applicable European Union directive for the product
The applicable Harmonized Standards and/or reference specifications
Where applicable, the name and identification number of the Notified Body, as well as details of the conformity assessment module and CE certification information
Any other additional information, signature, name and position of the person signing the documents, and the place and date of issuance

How Can We Display the CE Marking on Our Products?

The CE marking must conform to the form shown below. Even if its dimensions are changed, the proportions must remain consistent with the form shown below. The CE marking must consist of the initial letters “CE”; both letters must have the same vertical dimensions and must not be smaller than 5 millimeters, unless otherwise specified in the requirements applicable to the relevant product.

The CE marking must be affixed to the product or its rating plate in a clear, legible, and indelible manner. However, if the nature or shape of the product makes it impossible to affix or print the marking on the product, the CE marking must be placed on the packaging and the accompanying documents.

Essential Requirements

A fundamental feature of European Union legislation is that it ensures a high level of health and safety protection for products bearing the CE marking. Specific essential requirements apply to the inherent risks associated with a product. Therefore, if the product concerned is not covered by Harmonized Standards (Harmonized STD), manufacturers must conduct a risk analysis and assessment of the product and include the results in their technical files.

While the essential requirements specify the results to be achieved and the risks to be eliminated, they do not provide any indication of the technical solutions or how these risks should be eliminated.

Manufacturers can use the relevant Harmonized Standards and/or specifications to identify practical solutions and applicable details.

Different CE Certification and Conformity Assessment Modules

Conformity assessment modules cover both the design phase and the production phase. However, some of these modules cover only one of these phases, while others can cover both. Conformity assessment modules generally include the following categories:

Notified Bodies

Where third-party approval is required, Notified Bodies perform calibration, testing, auditing, inspection, and certification activities specified in the conformity assessment directives.

Notified Bodies are designated and accredited by official European accreditation bodies (or relevant ministries) under different directives.

Notified Bodies may provide conformity assessment services within the European Union or in third countries. They must submit information and reports on their inspections and audits to the relevant accreditation authority and the market surveillance authorities for the product, and must perform their activities impartially, independently, without discrimination, and with the required competence. They must hold a valid accreditation certificate for the product concerned for which CE certification is being obtained.

Iran Standard & Quality Inspection Company (ISQI) and FQC STANDARD signed a strategic cooperation agreement to expand the scope of CE certification services on August 31, 2023.

This cooperation enables the two organizations to provide a wide range of services to their customers. Our colleagues in the ISQI Inspection Services Unit provide development services tailored to your business, from initial assessments through to the completion of certification processes, to ensure that manufactured products comply with CE certification standards.

To verify our Notified Body, you can visit the European Commission website and search for Body Number 2674.

European Commission Website:

https://commission.europa.eu/index_en

Iran Standard & Quality Inspection Company (ISQI), through reputable Notified Bodies in the European Union, provides CE certification services for the following directives:

Essential Requirements of European Union Legislation

A fundamental characteristic of European Union legislation is that it ensures a high level of health and safety protection for products bearing the CE marking. Specific essential requirements apply to the inherent risks associated with a product. Therefore, if the product concerned is not covered by Harmonized Standards (Harmonized STD), manufacturers must conduct a risk analysis and assessment of the product and include the results in their technical files.

Manufacturers can use the relevant Harmonized Standards and/or specifications to identify practical solutions and applicable details.

What Should a Technical File Include?

EU harmonization legislation requires manufacturers to prepare a Technical File for their products containing information demonstrating the conformity of their products with the essential requirements of the relevant directives and standards, and to retain it in their records for at least 10 years.

The preparation of this Technical File is the responsibility of the manufacturer or its authorized representative. It may form part of the quality system documentation in conformity assessment procedures based on a quality management system.

Although the information to be included in the Technical File is described in detail and specifically in each regulation, it generally consists of information and documents relating to the definition of the product, its intended use, design, production, and operation. You can find detailed information in the standards for manufacturing your product and in the relevant directive. Alternatively, contact our experts for free consultation and help obtaining CE marking for your products.

Telephone:
021-43904170

Email:
N.Khalaj@isqi.co.ir