
7
min reading time
Recent headlines have shaken the toy industry.
A popular AI-powered plush toy was recently pulled from shelves after it began engaging children in inappropriate, dangerous conversations.
For parents, this is a nightmare scenario: a device trusted to entertain a child suddenly becomes a threat. For manufacturers, it raises a critical question: Are these devices regulated?
The common perception is that "Generative AI" is a Wild West.
However, from a compliance perspective, the reality is different. While the specific rules for AI content generation are still maturing, the device itself; the hardware, the connection, and the data handling, is heavily regulated.
If you are manufacturing a connected, AI-enabled toy today, you are already subject to the Radio Equipment Directive (RED). Ignoring this framework is not just a safety risk, it is a compliance failure.

The confusion often stems from categorization. Is it a toy? Is it an AI model?
Legally, if it communicates wirelessly (Wi-Fi, Bluetooth), it is Radio Equipment.
As we detailed in Radio Equipment Directive in 2025: The 3 Key Pillars for a Successful Market Entry, the cybersecurity obligations of RED apply to all radio-enabled products placed on the EU market, regardless of their target audience.
This means a "smart" teddy bear must meet the same fundamental cybersecurity principles as an industrial sensor:
The recent incidents often highlight a failure in Article 3.3(e). If a toy collects voice data to process an AI response, that data pipeline must be secured against interception and misuse.

While the hardware connectivity is strictly regulated by RED, the "brain" of the toy; the Large Language Model (LLM) , sits in a more complex regulatory space.
This is where the "regulatory gap" exists, but it is closing fast.
Under the incoming EU AI Act, AI systems intended for use as safety components in products, or those covered by specific harmonization legislation (like toys), will face heightened scrutiny.
Article 43 of the AI Act will require rigorous conformity assessments for these high-risk systems. It will no longer be sufficient to rely on third-party APIs without testing how those APIs interact with the child.
Furthermore, the Cyber Resilience Act (CRA) will mandate security across the entire lifecycle. As noted in Beyond 2025: Why RED is the Blueprint for CRA Success, manufacturers will be responsible for patching vulnerabilities for years after the sale.
A toy that "learns" and evolves via the cloud cannot be sold as a static product. It requires a dynamic security maintenance plan.

So, how do we guarantee safety in this environment?
Ensuring a smart toy is market-ready involves more than just physical safety tests (like checking for choking hazards). It requires a comprehensive Cybersecurity Evaluation.
At CCLab, we guide manufacturers through the specific tests required to close the gap between "cool tech" and "compliant product":
The lesson from recent toy recalls is clear: Connectivity brings complexity.
Innovation in the toy sector is moving fast, but the foundational regulations, RED and CRA, are already in place to protect consumers.
Manufacturers who view these smart toys as "unregulated" tech demos risk rigorous enforcement action and reputational damage.
By leveraging RED cybersecurity assessments as a baseline, you serve two purposes: you meet your legal obligations under EU law, and more importantly, you ensure that the technology remains a tool for learning, not a source of harm.
Secure your connected products today.


Read and learn more about the Radio Equipment Directive (RED), download our free material now.


The EU Cyber Resilience Act (CRA) introduces a unified cybersecurity framework for products with digital elements that have direct or indirect, logical or physical data connection to a device or network, including everything from software or hardware products to free and open-source software that is monetized or integrated into commercial products.


Download this comprehensive infographic guide, which deep dive into the key stages of the Radio Equipment Directive (RED). Gain clarity on technical requirements, risk assessment, and strategic decisions to ensure your products meet EU regulations.

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The newly enforced AI Act significantly shifts the regulatory landscape for hardware manufacturers by explicitly listing the Radio Equipment Directive (RED) as critical safety legislation. If a radio device uses AI for mandatory functions like network protection or data privacy, it will likely be classified as a "High-Risk AI System" under these new rules. This classification creates a "Double Lock" on compliance, requiring manufacturers to integrate AI-specific audits into their existing 2025 RED conformity assessments. Failing to plan for this overlap today is a strategic error that could force a total product redesign by 2027 when the regulations fully converge. By adopting an integrated compliance strategy now, manufacturers can ensure long-term market access and avoid the costs of redundant testing.
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