your partner through a smooth transition from IVDD to IVDR
Navigating the transition to the In Vitro Diagnostic Regulation (IVDR) is one of the most complex regulatory challenges facing the diagnostics industry today.
As of May 26, 2022, manufacturers can no longer issue new certificates under the former IVDD (In Vitro Diagnostic Directive).
All new in vitro diagnostic devices (IVDs) entering the European market must now fully comply with IVDR, a significantly more stringent and detailed framework. This includes expanded requirements around clinical evidence, performance evaluation, traceability, and post-market surveillance—making compliance not only more demanding but also more resource-intensive.
From Biomarker to IVDR-Ready Diagnostics
At IVDIAS, we are proud to be the only CDMO offering full-spectrum support for IVDR transition.
From early-stage concept development to regulatory approval, we guide you through every step of the journey.
We help our partners with analytical validation to ensure accuracy and reliability, clinical performance studies to meet evidence requirements, and complete regulatory documentation and submissions in line with IVDR expectations.
Our cross-functional experts ensure your diagnostic product is not only compliant but also positioned for market success—on time and without compromise.
Whether you’re upgrading an existing product or launching a new one, we help you overcome the regulatory hurdles and deliver safe, effective diagnostics that meet the highest European standards.
Driven by People, Powered by Purpose
Behind every successful project is a team that truly cares.
At IVDIAS, our people are more than experts, they’re passionate problem-solvers dedicated to making a difference.
From scientists and engineers to regulatory specialists and project managers, we bring diverse perspectives and shared commitment to every collaboration. We work closely with our partners, combining technical excellence with genuine partnership—because we believe that trust, transparency, and teamwork are the foundation of innovation.
Shaping the Future of Healthcare, Together
To accelerate the delivery of safe, effective, and compliant diagnostic solutions to market, by empowering innovators to navigate complexity with confidence.
We exist to bridge the gap between scientific discovery and regulatory approval. By offering end-to-end support through the entire lifecycle of in vitro diagnostic products, we enable our partners to focus on what matters most: improving patient outcomes.