UKCA Mark Consultants

Why is CE required?


A product can only be marketed to consumers in the countries of the European Union or the European Authorized Representative if the product complies with the requirements of the relevant directive or directives.


To ensure this compliance, manufacturers must first find the relevant directives applied to the product and then choose the best evaluation method to demonstrate compliance.


The next step is to identify and apply harmonized standards. Compliance with these standards is not an obligation, but manufacturers must adhere to harmonized standards to prove their worth.


If the relevant directive or directives deem it necessary to intervene in the CE marking process by a third-party assessment body (notified body), the products must be tested and approved.


The manufacturer must prepare a technical file based on the declaration of conformity to be signed. This file must contain all the information and documentation to demonstrate the conformity of the product.


At this point, the manufacturer can now put the CE mark on the product and can easily present the product to consumers.



There is no obligation to comply with European standards under the New Approach Directives to meet the essential requirements.

The standards are mainly divided into three groups: 

  • Product standards. For example, CISPR 22: EN 55022 EMC standard. This standard is a widely used standard for the electromagnetic compatibility of information technology equipment and provides information on the characteristics of radio disturbances.
  • General rules. For example, IEC 61000-6 Electromagnetic Compatibility Standard. This standard specifies immunity requirements for electrical and electronic equipment manufactured for use in residential, commercial, and light industrial environments.
  • Basic standards. For example, the CISPR 16 EMC standard for test equipment and methods. This set of standards specifies equipment and methods to measure disturbances and immunities at frequencies above 9 kHz. 

The main organizations that set the standards are:

  • International organizations: CISPR (International Special Committee on Radioelectric Disturbances), IEC (International Electrotechnical Commission), ISO (International Standards Organization) and ITU (International Telecommunications Union).
  • Organizations in Europe: CENELEC (European Committee for Standardization of Electronics and Electricity) and ETSI (European Institute of Telecommunications Standards).
  • Organizations in the United States: ANSI (American National Standards Institute), FCC (Federal Communications Commission), and SAE (Society of Automotive Engineers).

If the manufacturer makes Bluetooth and WIFI devices, for example, the standards applicable to these products are:

  • Radius: EN 300 Oriented Strand Board – Standard Definitions, Classification, and Specifications, EN 328 Heat Exchangers – Forced Convection Air Cooling Units for Cooling – Standard for Test Methods for Performance Determination
  • EMC: EN 301 489 Electromagnetic Compatibility (EMC) standard for radio equipment and services
  • Security: EN 60950 information technology standard
  • Health: Standard EN 50364 for electrical installations in buildings.

It is the sole responsibility of the manufacturer to assess the conformity of a product with the requirements of the corresponding directive. As a requirement of this responsibility, manufacturing companies can carry out the necessary tests and analyzes of the product in an authorized laboratory or carry out these tests and analyzes in their own laboratories.


If an impartial third-party approval is not required in the directive, the manufacturer does not need to obtain approval from an official organization. Only by issuing a declaration of conformity can the CE mark be affixed to the product.


Our company also provides CE marking services in the field of certification services. Thanks to these services, companies can produce more efficient, high-performance, and quality products safely, quickly and without interruption.


The CE Marking services provided within the scope of certification services are just one of the services provided by our organization in this regard. Many other certification services are also available.


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