July 15, 2025 – BSI verifies Preventis SmarTest® Calprotectin Home for IBD monitoring under full IVDR compliance.
What Is the SmarTest Calprotectin Test?
Designed for IBD patients and their healthcare professionals, this at-home quantitative fecal calprotectin test empowers users to monitor intestinal inflammation from the comfort of their homes. The intuitive app guides the entire procedure – from sample preparation to result interpretation – supporting patient‑initiated monitoring and enhancing clinical workflows.
In clinical practice, calprotectin is validated as a non-invasive biomarker for IBD diagnosis, disease activity monitoring, and flare prediction – offering a reliable alternative to frequent colonoscopies. SmarTest Calprotectin allows IBD patients to quantitatively measure fecal calprotectin at home and supports them in monitoring disease activity.
Why IVDR Certification Matters
With the introduction of the In Vitro Diagnostic Medical Device Regulation (IVDR), IVD products were reclassified under a risk-based system, requiring Notified Body (BSI) oversight, clinical evidence, post-market surveillance, UDI tracking and app compliance.
Achieving full IVDR status in July 2025 means SmarTest Calprotectin meets all criteria for a Class C app‑guided self‑test—validating Preventis’ regulatory expertise and readiness to introduce robust, compliant home diagnostics.
A Proud Milestone
“I couldn’t be prouder of our team’s dedication to delivering this major IVDR milestone. It’s a testament to Preventis’ capability to bring quantitative, self‑testing diagnostic products to patients’ homes with full regulatory confidence.”
— Leadership, Preventis
Demonstrating Preventis’ IVDR & Product Strength
This certification highlights:
- Deep regulatory know-how in IVDR’s rigorous requirements
- Advanced clinical development and QA, including post-market and vigilance planning
- Proven app + diagnostics integration tailored for home use and professional oversight
- Alignment with our corporate vision: enabling access to IVDR‑compliant home testing
What This Means for Partners
Industry collaborators can now confidently co‑develop or distribute IVDR-compliant, app‑driven self‑tests. Our infrastructure — encompassing QMS, active portal support, UDI traceability, and performance monitoring — offers a fully regulated ecosystem for future product launches. As part of the transition to IVDR, we took the opportunity to further optimize the product. The IVDR-certified version combines regulatory excellence with meaningful product improvements and will be available soon.
Explore more or request a demo on the SmarTest Calprotectin product page.
