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 products, multiple regulatory requirements often apply simultaneously. In addition to the Radio Equipment Directive (RED), the Electromagnetic Compatibility Directive (EMCD), the Low Voltage Directive (LVD), or other product-specific EU legislation may also apply.
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). For manufacturers outside the EU, an Authorised Representative is often appointed.
Implementation Support
IB-Lenhardt AG supports manufacturers in implementing CE requirements for radio equipment, including test coordination, technical documentation, conformity assessment, and preparation of the EU Declaration of Conformity (DoC).
Regulatory Framework
Main EU Directives for Radio Equipment
Radio equipment in the European Economic Area is typically subject to several European directives. Depending on the product type and technical design, different requirements from the respective legal acts may apply.
| Directive | Scope |
|---|---|
| RED | Radio equipment and devices with radio functionality |
| EMCD | Electromagnetic compatibility of electronic devices |
| 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 electronic devices |
| Low Voltage Directive (LVD) | Electrical equipment within defined voltage limits |
Other Relevant EU Legislation
In addition to the main directives for radio equipment, additional European legislation may apply depending on the product type. These may relate to substance restrictions, batteries, medical devices, or specific safety requirements.
RoHS Directive (2011/65/EU) – Restriction of hazardous substances in electrical and electronic equipment
Battery Regulation (EU) 2023/1542 – Requirements for devices with integrated or replaceable batteries
Medical Device Regulation (EU) 2017/745 (MDR) – Devices with a medical purpose
Machinery Regulation (EU) 2023/1230 – Radio components integrated into machines or industrial systems
Ecodesign Directive (2009/125/EC) – Requirements for energy-related products (to be replaced by the ESPR Regulation in the future)
Typical Combinations of EU Legislation
In practice, multiple EU legal acts often apply simultaneously to many products. The exact combination depends on the technical design, the intended use, and the integration of radio functions into the overall product.
| Product Example | Typical EU Legislation |
|---|---|
| Wi-Fi router | RED + RoHS |
| Washing machine with Wi-Fi | RED + LVD + RoHS |
| Radio module in a machine | RED + Machinery Regulation (EU) 2023/1230 + LVD (if applicable) |
| Product Example | Typical EU Legislation |
|---|---|
| Wi-Fi router | RED + RoHS |
| Washing machine with Wi-Fi | RED + LVD + RoHS |
| Radio module in a machine | RED + Machinery Regulation (EU) 2023/1230 + LVD (if applicable) |
Responsibilities in the CE Conformity Process
Within the CE conformity assessment process, different economic operators assume defined regulatory responsibilities. These primarily include manufacturers, authorised representatives, importers, and distributors.
Primary responsibility for product conformity lies with the manufacturer. Other economic operators assume supporting or verificatory roles 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 within the EU on the manufacturer's behalf |
| Importer | Ensures that the manufacturer has carried out the conformity assessment, that the product is correctly marked and that an EU Declaration of Conformity is available; affixes their own contact details to the product and takes action in the event of non-conformity |
| Distributor | Ensures that products are only made available on the market if they comply with applicable EU requirements and are correctly marked |
| 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 within the EU on the manufacturer's behalf |
| Importer | Ensures that the manufacturer has carried out the conformity assessment, that the product is correctly marked and that an EU Declaration of Conformity is available; affixes their own contact details to the product and takes action in the event of non-conformity |
| Distributor | Ensures that products are only made available on the market if they comply with applicable EU requirements and are correctly marked |
The specific obligations of each economic operator are set out in the applicable EU legislation and in Decision No 768/2008/EC on a common framework for the marketing of products.
Further Information
Detailed requirements for the most important European directives for radio equipment can be found in 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
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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.
Note: All sources were last reviewed in March 2026. For the most up-to-date version of the legislation, consult the EUR-Lex database and the official websites of the European Commission.