What MDR means for your light therapy device: navigating the new medical regulation

If you are developing a light therapy device for the European market, chances are you have come across MDR. But what does this regulation actually mean for your product, your launch timeline and your responsibilities for a manufacturer?

Here is what you need to know to stay compliant, credible and commercially ready.

MDR in short

MDR refers to the Medical Device Regulation (EU 2017/745). It replaced the older MDD framework and came fully into effect in 2021. Its goal is clear: to raise the standard for medical devices sold in the European Union by tightening rules around classification, testing, documentation and post-market monitoring.

If your light therapy device is designed to achieve therapeutic results such as pain relief, acne treatment, wound healing or muscle recovery, MDR most likely applies.

What has changed with MDR?

MDR is more than an update. It brings a different mindset. Devices that were once treated as low risk now require deeper scrutiny. Documentation is no longer optional. Clinical evidence needs to be real, recent and relevant. And the responsibilities as a manufacturer continue after market launch.

A few key shifts:

Stricter classification rules
Devices are now more often classified as Class IIa or higher, especially those with therapeutic claims. This means involvement from a Notified Body and more detailed technical evidence.

Expanded regulatory scope
Products that were previously seen as cosmetic may now fall under MDR, depending on the claims you make and how your device functions.

Greater focus on clinical data
You must demonstrate that your device is safe and effective. That means providing clinical evaluation through literature, studies or real-world performance data.

Ongoing compliance
MDR is not a one-time check. You are expected to continuously monitor your product, respond to feedback and keep your technical file up to date.

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Does MDR apply to your device?

It depends on the claims you make.

If your product is intended for general wellness, such as relaxation or mood support, it may fall outside MDR and be classified under cosmetic or consumer product regulations.

But if you claim that it treats or prevents medical conditions, such as joint pain, inflammation or acne, your product becomes a medical device. And that means full MDR compliance is required.

Even subtle shifts in language can change how your product is classified. That is why defining intended use early in the development process is critical.

What MDR compliance really means

Meeting MDR requirements is not just about passing a test. It is about showing that your product performs as promised, and that every part of your development and production process is built for safety, consistency and traceability.

You need to classify your device accurately, support your claims with solid evidence and operate under a certified quality system such as ISO 13485. After launch, you must continue to monitor product performance and be ready for inspections or updates at any time.

It is a full-lifecycle commitment. But with the right systems and expertise, it becomes a natural part of building a reliable product.

How LTV simplifies MDR for your brand

At LTV, compliance is not an afterthought. It is integrated into every step of product development and Manufacturing.

We help you define your product’s intended use, navigate classification and assemble the documentation you need to move forward. Our facilities in The Netherlands, India and China are ISO 13485 certified, and our team is experienced in developing and manufacturing products that meet MDR standards from the inside out.

Whether you are adapting an existing white label device or creating something entirely new, we support your journey with:

• Strategic input on intended use and classification
  
• Technical file development tailored to MDR expectations
  
• Development and Manufacturing in ISO 13485 certified environments
• Planning and execution support for clinical data collection
• Guidance on post-market surveillance and audits
  
  

The result? A product that is compliant by design, not just on paper.

Conclusion: treat compliance as strategy

MDR is not just regulation. It is a filter for quality and a signal to the market that your device is built to perform.

For light therapy brands entering or growing in Europe, understanding MDR is essential. With the right partner, it becomes a powerful part of your product strategy.

Want to know what MDR means for your next device?
Let’s explore how LTV can support you from first idea to final certification.

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