Bringing a light therapy device to the European market means more than just having a good product. It requires compliance, credibility and clear evidence that your device is safe, effective and built to meet regulatory standards. At the heart of this process: CE marking.

What is CE marking?

CE marking is a mandatory certification for products sold within the European Economic Area (EEA). It shows that a product meets EU health, safety and environmental protection standards.

For light therapy devices, especially those used in medical, wellness or beauty contexts, CE marking is required. If your device makes therapeutic or health-related claims, it is likely considered a medical device under EU MDR (Medical Device Regulation 2017/745) and must go through the proper conformity assessment process.

Why CE marking matters for light therapy brands

CE marking is more than a symbol on the packaging. It opens access to more than thirty markets across Europe, positions your brand as credible and protects you from both legal and commercial risks.

It confirms that:

• Your product has been developed and tested in line with applicable regulations
• You have full documentation to prove safety and performance
• You are prepared for audits, inspections and market surveillance

Without CE marking, a device cannot be legally sold in the EU. With it, you remove barriers for distributors, gain buyer confidence and demonstrate full regulatory alignment.

Is your light therapy device a medical device?

Not all LED-based devices fall under medical regulation. It depends entirely on intended use. If your product is marketed purely for wellness, such as relaxation or general mood support, it may be considered cosmetic. But if you claim therapeutic effects like pain relief, anti-acne or aging treatment, it likely qualifies as a medical device and must meet MDR requirements.

At LTV, we support the Regulatory pathway for both types of devices. Whether you are building a wellness product or a fully certified medical solution, we guide your development process from idea to compliant release.

What the CE process actually involves

CE marking is not just a formality. It is a structured process that ensures your product meets European safety and performance standards. For light therapy devices, especially those with therapeutic claims, it typically involves several essential phases.

It begins with defining the intended use of your device. This step is critical, as it determines whether your product qualifies as a medical device under MDR and sets the course for the entire regulatory pathway.

The next step is device classification. Most therapeutic light therapy devices are classified as Class IIa, which means they require independent review by a Notified Body. The classification depends on how the product interacts with the body and the level of associated risk.

Once classified, you will need to compile a complete set of technical documentation. This includes product specifications, safety testing, clinical evaluations and a full risk analysis. For Class IIa devices, clinical data is usually required to demonstrate both performance and safety.

A compliant quality management system is also essential. Your manufacturing partner must follow certified procedures that ensure consistent quality and traceability. LTV’s Development and manufacturing facilities in The Netherlands, India and China operate under ISO 13485 and are regularly audited to meet international requirements.

A Notified Body is involved and they will review the documentation, evaluate the quality system of LTV and confirm whether your device meets the necessary standards. Only after receiving this confirmation you can move forward.

The final step is to issue a Declaration of Conformity and apply the CE mark. From that moment, your product is approved for distribution throughout the European market

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How LTV makes CE compliance part of the process

CE compliance doesn’t need to be a separate project or a last-minute scramble. At LTV, regulatory thinking is embedded in every stage of our product development. From the first meeting with our sales team, sketch to the final delivery, we align with MDR requirements and anticipate what your product will need to meet the standards.

Our facilities in The Netherlands, India and China operate under ISO 13485, and our regulatory experts are well-versed in both European and international frameworks. If you choose one of our white label devices, you benefit from a product that’s already CE-certified and backed by complete technical documentation. If you're developing something entirely new, we help you build the compliance path from the ground up—so you can move forward with confidence, knowing the groundwork is solid.

Looking beyond the mark: post-market responsibilities

CE marking is not a one-time milestone. It comes with ongoing responsibilities, including post-market surveillance (PMS), clinical follow-up (PMCF) and technical file maintenance.

LTV remains involved long after launch. We help you respond to regulation changes, manage documentation updates and prepare for audits, so your product stays compliant.

Conclusion: compliance as a competitive advantage

For any light therapy brand aiming to grow in Europe, CE marking is essential. It is more than a legal requirement. It is a strategic asset that builds trust and positions your device for long-term success.

With the right team and the right guidance, CE compliance becomes a catalyst for market entry and growth.

Interested in launching or certifying your next light therapy product?

Let’s talk about how LTV can support your journey toward full CE compliance.

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