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CE Requirements – Overview

Radio equipment may only be placed on the market in the European Economic Area (EEA) if it complies with the applicable EU harmonisation legislation and bears the CE marking.

For radio equipment, several EU legal acts may apply simultaneously. The Radio Equipment Directive (RED) is the primary legal framework and incorporates the relevant safety objectives of the Low Voltage Directive (LVD) and the essential requirements of the Electromagnetic Compatibility Directive (EMCD). Other product-specific EU legislation may apply in parallel, depending on the product.

Key Takeaways

  • The CE marking applies to products that fall under EU harmonisation legislation, regardless of whether they are manufactured within or outside the European Union.

  • Manufacturers are responsible for carrying out the conformity assessment, preparing the technical documentation, and issuing the EU Declaration of Conformity (DoC).

Implementation Support

IB-Lenhardt AG supports manufacturers with CE compliance for radio equipment, including test coordination, technical documentation, support with the conformity assessment process, and preparation of the EU Declaration of Conformity (DoC).

CE Conformity Assessment and Marking

Regulatory Framework

Determine applicable EU legislation
e.g., RED, EMCD, LVD, RoHS, and applicable product-specific legislation
Conformity assessment & technical documentation
Assessment, testing, and supporting documentation
Involve a Notified Body (NB)
May be required depending on the applicable legislation and conformity assessment procedure
Issue the EU Declaration of Conformity (DoC)
Responsibility lies with the manufacturer
Affix the CE marking
Prerequisite for market access in the EEA
Involve a Notified Body (NB)
May be required depending on the applicable legislation and conformity assessment procedure
Note: The CE marking is a manufacturer's declaration, not a government certification. Depending on the product, the RED, EMCD, LVD, and other EU legislation may be relevant. Where the RED applies, the LVD and EMCD normally do not apply separately to the same radio equipment. Notified Body involvement depends on the applicable legislation and conformity assessment procedure.

Main EU Directives Relevant to Radio Equipment

The applicable EU directive depends on the product type, technical design, and whether the product includes radio functionality.

Directive Scope
RED Radio equipment and devices with radio functionality
EMCD Electromagnetic compatibility of electrical and electronic equipment
LVD Electrical equipment within defined voltage limits
Directive Scope
Radio Equipment Directive (RED) Radio equipment and devices with radio functionality
Electromagnetic Compatibility Directive (EMCD) Electromagnetic compatibility of electrical and electronic equipment
Low Voltage Directive (LVD) Electrical equipment within defined voltage limits

Other Relevant EU Legislation

Other EU legislation may apply depending on the product type, including requirements relating to substance restrictions, batteries, medical devices, machinery, or ecodesign.

  • RoHS Directive (2011/65/EU) – Restriction of hazardous substances in electrical and electronic equipment

  • Battery Regulation (EU) 2023/1542 – Requirements for batteries and products incorporating batteries

  • Medical Device Regulation (EU) 2017/745 (MDR) – Requirements for medical devices and accessories with an intended medical purpose

  • Machinery Directive 2006/42/EC and Machinery Regulation (EU) 2023/1230 – Safety requirements for machinery, including machinery incorporating radio equipment; the Regulation applies from 20 January 2027

  • Ecodesign for Sustainable Products Regulation (EU) 2024/1781 (ESPR) and applicable product-specific ecodesign measures – Ecodesign requirements for covered product groups; existing measures under the former framework may continue to apply during the transition

Typical Combinations of EU Legislation

In practice, multiple EU legal acts may apply simultaneously to a product. The exact combination depends on its technical design, intended use, and the integration of radio functionality.

Product Example Typical EU Legislation
Wi-Fi router RED + RoHS
Washing machine with integrated Wi-Fi RED + RoHS + applicable ecodesign and energy-labelling legislation
Machine with integrated radio equipment RED + Machinery Directive 2006/42/EC (until 19 January 2027) / Machinery Regulation (EU) 2023/1230 (from 20 January 2027) + RoHS, where applicable
Product Example Typical EU Legislation
Wi-Fi router RED + RoHS
Washing machine with integrated Wi-Fi RED + RoHS + applicable ecodesign and energy-labelling legislation
Machine with integrated radio equipment RED + Machinery Directive 2006/42/EC (until 19 January 2027) / Machinery Regulation (EU) 2023/1230 (from 20 January 2027) + RoHS, where applicable

Responsibilities in the CE Conformity Process

Within the CE conformity assessment process, different economic operators have defined regulatory responsibilities. These primarily include manufacturers, authorised representatives, importers, and distributors.

Primary responsibility for product conformity lies with the manufacturer. Other economic operators have specific verification and compliance obligations within the supply chain.

Economic Operator Role in the CE Conformity Process
Manufacturer Carries out the conformity assessment, compiles the technical documentation, issues the EU Declaration of Conformity (DoC), and affixes the CE marking
Authorised Representative May be mandated by the manufacturer to carry out specific regulatory tasks on the manufacturer's behalf, within the scope of a written mandate
Importer Verifies that the manufacturer has completed the required conformity assessment, that the product bears the required marking, and that the required documentation is available. Provides its identification and contact details as required and takes corrective action in the event of non-conformity
Distributor Acts with due care and verifies that the product bears the required marking, is accompanied by the required documentation, and includes the required manufacturer and importer information before making it available on the market
Economic Operator Role in the CE Conformity Process
Manufacturer Carries out the conformity assessment, compiles the technical documentation, issues the EU Declaration of Conformity (DoC), and affixes the CE marking
Authorised Representative May be mandated by the manufacturer to carry out specific regulatory tasks on the manufacturer's behalf, within the scope of a written mandate
Importer Verifies that the manufacturer has completed the required conformity assessment, that the product bears the required marking, and that the required documentation is available. Provides its identification and contact details as required and takes corrective action in the event of non-conformity
Distributor Acts with due care and verifies that the product bears the required marking, is accompanied by the required documentation, and includes the required manufacturer and importer information before making it available on the market

The specific obligations of each economic operator are set out in the applicable EU legislation, which is generally aligned with the common framework established by Decision No 768/2008/EC.

Further Information

Detailed requirements for the key EU directives relevant to radio and electronic equipment can be found on the following overview pages:

Official Resources

EU Legislation and Guidance

  • European Commission: Guide to the implementation of EU product rules ("Blue Guide") – 2022

    Available at: eur-lex.europa.eu

  • Decision No. 768/2008/EC on a common framework for the marketing of products

    Available at: eur-lex.europa.eu

  • Overview of CE marking requirements by the European Commission

    Available at: single-market-economy.ec.europa.eu

Additional Resource

  • TAMSys by IB-Lenhardt AG – Type Approval Management System

    Central platform for managing international radio approvals, technical documentation, labeling requirements, and regulatory product information throughout the product lifecycle.

    TAMSys – Type Approval Management System

Note: All sources were last reviewed in July 2026. For the most up-to-date versions of the legislation and guidance, consult the EUR-Lex database and the official websites of the European Commission.

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