The Radio Equipment Directive (RED) (Directive 2014/53/EU) is the European Union’s regulatory framework for radio equipment. It ensures that devices placed on the market meet essential requirements for safety, health, electromagnetic compatibility, and the efficient use of the radio spectrum.
While the directive has been in place since 2014, recent amendments have significantly expanded its scope to address cybersecurity concerns. One of the most critical aspects of the RED is Article 3.3, which introduces additional essential requirements to any equipment that intentionally transmits or receives radio waves for communication or radiodetermination purposes. This includes a wide range of devices, from smartphones and tablets to IoT sensors and connected appliances. The scope is deliberately broad to encompass the rapidly evolving landscape of connected devices.
As the August 1, 2025, compliance deadline approaches, IoT manufacturers must ensure their products align with these new requirements to avoid regulatory, financial, and reputational risks and maintain market access in the European Economic Area (EEA).
Article 3.3 of the RED directive mandates additional cybersecurity and safety measures for radio equipment. It introduces three key provisions that IoT manufacturers must comply with:
For IoT manufacturers, this means integrating security mechanisms at both the hardware and software levels to meet compliance standards.
The implementation of Article 3.3 represents a significant shift in IoT device regulation. While compliance requires investment and resource allocation, it ultimately benefits both manufacturers and consumers by:
To comply with Article 3.3, manufacturers must implement the following security measures:
Connected devices must incorporate safeguards to protect networks from harm.
Privacy considerations are at the forefront of Article 3.3.
The directive requires measures to prevent financial fraud through or against these devices.
Achieving compliance with Article 3.3 requires a comprehensive approach to device security. Manufacturers must prepare detailed technical documentation demonstrating how their devices meet these requirements. This includes:
Additionally, IoT manufacturers must undergo a conformity assessment procedure before a product is released to the market. Depending on the device category and risk level, this may involve self-assessment or review by a notified body. The assessment verifies that all essential requirements are met, leading to CE marking authorization.
The European Commission has set a mandatory compliance deadline of August 1, 2025, for Articles 3.3(d), 3.3(e), and 3.3(f). After this date, non-compliant devices will not be permitted for sale in the EU.
Manufacturers should act now to implement these security measures, as compliance assessments and certification processes can take months to complete.
Failing to comply with RED Article 3.3 can result in significant consequences for IoT manufacturers:
To achieve compliance, manufacturers should adopt these key practices:
Integrate security features from the earliest stages of product development. This proactive approach is more cost-effective than retrofitting security features and helps ensure comprehensive protection.
Implement ongoing security testing and validation procedures. Regular assessments help identify and address vulnerabilities before they can be exploited.
Maintain detailed records of all security measures, test results, and risk assessments. Good documentation practices are crucial for demonstrating compliance and facilitating future updates.
Article 3.3 of the RED directive represents a crucial step toward securing the IoT ecosystem. While compliance may require significant effort, it establishes essential safeguards for networks, personal data, and fraud prevention. Manufacturers who embrace these requirements and implement robust security measures will be well-positioned for success in the evolving IoT landscape.
Finite State is committed to helping IoT manufacturers navigate these evolving regulations by providing industry-leading software supply chain security solutions. Contact us today to learn more about how we can support your compliance efforts.