CS MEDICA Achieves Key Milestone in MDR Compliance with Finalized Classification, Solidifying Unique Market Position for Medical Devices
A Strategic Regulatory Pathway Positions CS MEDICA’s CBD-Infused Medical Devices Uniquely Ahead of Competition in Market Access and Compliance, Leveraging a Distinct Hybrid Position in a High-Demand Market
CS MEDICA is pleased to announce that the Notified Body BSI has finalized the classification of all CS MEDICA medical device products. This classification milestone confirms that all CS MEDICA products align with the updated Medical Device Regulation (MDR) standards, following a pathway that reflects CS MEDICA’s initial classification assessments and reinforces its commitment to regulatory excellence.
CS MEDICA’s unique positioning stems from its innovative, compliant range of CBD-infused gels, sprays, and patches. These products align with the trend in self-care, leveraging natural, THC-free ingredients known from cosmetics to reduce side effects while delivering proven efficacy supported by clinical trials. Unlike prescription-based drugs and medical cannabis, CS MEDICA’s products are classified as medical devices, available as over-the-counter products, making the MDR transition a critical growth factor. This distinction offers a unique advantage as they are regulated, evidence-based solutions that are safe, effective, and easily accessible for patients, providing the benefits of CBD with the reliability typically associated with prescription treatments.
“CS MEDICA’s focus on regulatory preparedness has generated strong interest from customers and partners, many of whom are awaiting the MDR transition as confirmation of our trusted, safe, and high-quality offerings. Demand for our portfolio remains high; however, some B2B customers are holding final orders pending the completion of MDR classifications prior investing in new products. Achieving this milestone will undoubtedly accelerate ongoing negotiations and support further growth, as it could potentially double our forecast from partners on especially pain products.” said Lone Henriksen, CEO at CS MEDICA.
CS MEDICA’s substance-based medical devices are now classified as Class IIa, with the exception of the Pain Patch and Psoriasis Gel, which have already achieved Class I MDR classification. The classification for the products as class IIa provides a structured pathway toward full certification. This progress represents a significant advancement in CS MEDICA’s efforts to align with MDR’s demanding requirements and ensures the company remains on track to meet all regulatory timelines.
The MDR transition has raised standards for European medical devices, adding complexity and stricter evaluations. While challenging many companies, these changes safeguard patient health. CS MEDICA’s proactive compliance approach offers a strategic advantage, ensuring timely market entry and strengthening consumer and partner confidence.
“With this milestone, CS MEDICA is, with the assistance of BSI, positioned to achieve timely certification of our product range, thanks to the dedication of our teams and partners who have worked to reach this critical compliance milestone,” said Lone Henriksen, CEO at CS MEDICA.
With the growing regulatory focus on CBD products in Europe as well, CS MEDICA’s position is further strengthened by its unique combination of MDR compliance and expertise in CBD, reinforcing its leadership in delivering trusted, high-quality solutions.