CS MEDICA Achieves MDR Classification, Setting New Standards in Substance-Based Medical Devices

Leading Healthcare Innovation with Stringent Compliance

CS MEDICA, a pioneer in MedTech specializing in pain management, autoimmune diseases, and stress-related disorders, has reached a significant regulatory milestone:

• Class IIa Classification: Confirmed under Europe's Medical Device Regulation (MDR) for 3 substance-based medical devices with CBD under Rule 21.
• Notified Body: A certification by BSI, the notified body (authority) that defines the classification and certifies the products, underscoring our stringent compliance and market readiness.

 
Responding to Consumer Trends:The compliance focus aligns with growing consumer demand for alternative, evidence-based self-care treatments, positioning CS MEDICA to lead in developing alternative, safe, and effective healthcare solutions.

Key Highlights:

• Evidence-Based Innovation: Over 15 clinical trials with more than 1450 subjects, coupled with feedback from over 2000 users, validate the safety and effectiveness of our CBD-infused treatments.
• Regulatory Excellence: Detailed compliance to MDR standards showcases our commitment to compliance and patient safety.

Lone Henriksen, CEO at CS MEDICA comments: "Our 'hybrid' approach not only adheres to stringent regulations but also embraces consumer-centric innovations, paving the way for the future of healthcare. These regulatory milestones are not just achievements; they are a testament to our dedication to advancing healthcare globally."

 
Navigating Regulatory Transitions: The transition from the Medical Device Directive (MDD) to the stricter MDR is reshaping the industry landscape. As companies face this regulatory transition, the market awaits the launch of classified and certified MDR products. Some companies are challenged to meet these new requirements and are forced to exit the market, creating opportunities for prepared firms.

Lone continues: "We are on track to meet MDR compliance deadlines, diligently certifying our products under stringent MDR regulations with BSI as our notified body," Lone emphasizes. "Our patient-first approach is deeply committed to transparency, responsiveness to feedback, and educational efforts, all of which strengthen our collaborations with industry partners and stakeholders that want to be first to capture the market potential."

 
Strategic Advantages:

• Industry Leadership: By merging traditional treatments with innovative cannabinoid therapy, still within a strict regulatory landscape - we aim to challenge and redefine healthcare norms.
• Patient-Centric Approach: Our commitment to transparency, responsiveness to feedback, and educational efforts solidify robust partnerships and enhance patient trust with proof of concept.
• Addressing Critical Medical Needs: Our products target chronic pain, inflammation, and neurological disorders, meeting critical healthcare demands.