Koite Health Secures EU MDR Quality Management System Certification for Lumoral Devices

Stockholm, 12 November 2025 
Koite Health Oy today announced that it has received the EU Quality Management System Certificate under the European Medical Device Regulation. The certificate covers the company’s Class IIa equipment for the treatment and prevention of oral diseases caused or exacerbated by dental plaque, including its Lumoral and Lumoral Junior devices and their accessories. This certification follows a rigorous evaluation process involving a thorough audit of Koite Health’s quality management system and an in-depth technical documentation assessment of the covered devices. 

Significance of the Certification

Achieving this MDR certification marks a significant milestone for Koite Health. The EU Medical Device Regulation (MDR) imposes strict requirements to ensure that medical products fulfill high standards of safety and performance. By meeting these enhanced regulatory criteria, Koite Health demonstrates that its Lumoral product line adheres to the highest quality and safety requirements, reinforcing trust among clinicians, regulatory bodies, and patients. The certification authorises Koite Health to continue affixing the CE mark to its Lumoral devices under the new regulation, securing their availability to patients across Europe also in the future and underscoring the company’s commitment to regulatory compliance and patient well-being. 

Importantly, Lumoral represents an innovative solution in oral health technology. Introduced by Finnish scientists, it is the first antibacterial photodynamic therapy device designed for home use, using photobiomodulation and antibacterial treatment to combat oral diseases. Lumoral provides an effective at-home adjunct to brushing and flossing, helping to prevent common plaque-related conditions such as tooth decay and gum disease. Gaining MDR certification for this technology confirms its clinical safety and efficacy, lending further credibility to Lumoral’s role as a revolutionary advancement in oral hygiene.  

"This MDR certification marks a substantive step forward for the entire field of photodynamic therapy, confirming our approach meets the highest regulatory bar for medical devices in Europe. This achievement provides crucial, standardised assurance regarding the quality and compliance of our technology. Koite Health is positioned as a preeminent leader in navigating the complex transition to MDR compliance within the photodynamic space.", says Koite Health CEO Peter Rådqvist. 

Multi-Disciplinary Effort and Certification Process

The path to obtaining the EU QMS certificate required a comprehensive, multi-disciplinary effort within Koite Health. The certification process under MDR is renowned for its rigour.It entails detailed audits of the company’s processes, quality systems, and product technical files. Koite Health’s team underwent multiple phases of scrutiny, from quality system inspections to the performance of new analyses on the Lumoral device, to satisfy the MDR’s exhaustive standards. This endeavour drew on expertise across various fields,  including biomedical engineering, microbiology, clinical research, and regulatory affairs, to ensure that every aspect of device design, manufacturing, and validation met the necessary criteria. 

Dr. Hannele Eerikäinen, Chief Product Officer at Koite Health, reflected on the journey to certification: 

“This was truly a great learning process for the whole team. The certification process included many phases. The greatest efforts had to be invested into performing new analyses for the device, which took more time than expected. Cooperation with the notified body was, however, smooth and easy. Developing, documenting, and certifying a medical device requires expertise from many professionals in different fields. It cannot be overstated how important interdisciplinary collaboration is to ensure the best possible outcome. Understanding the regulatory requirements and ensuring sufficient documentation is crucial to demonstrating compliance.” 

Dr. Eerikäinen’s insights highlight the collaborative nature of the certification project and the value of close cooperation with the Notified Body. The new MDR certificate is a testament to the diligent work of Koite Health’s cross-functional team and their dedication to meeting the highest standards in medical device development. 

Focus on Pediatric Use and PMCF

The new certification not only covers the standard Lumoral device for adults, but also Lumoral Junior, a version tailored for children’s oral care needs. Lumoral Junior was developed to suit children’s needs by eliminating harmful bacteria in the mouth to treat and prevent oral diseases. With the MDR certificate in hand, Koite Health is moving forward with plans to complete a Post-Market Clinical Follow-up (PMCF) study specifically for pediatric use of Lumoral Junior. This PMCF will collect real-world clinical data on the device’s performance and safety in children, in line with regulatory requirements for ongoing clinical evaluation. 

By undertaking a dedicated pediatric PMCF, Koite Health reaffirms its commitment to evidence-based improvement and patient safety. The study’s findings are expected to further validate the benefits of Lumoral Junior for younger patients and guide any future enhancements, ensuring that the device continues to deliver safe and effective outcomes for children. This proactive approach to post-market surveillance reflects the company’s broader ethos of continuous improvement and vigilance in medical device innovation.