The shift from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) marks a significant transformation in the European regulatory landscape. With stricter requirements for clinical evidence, risk classification, performance evaluation, and post-market surveillance, this transition poses new challenges for manufacturers—particularly for small to mid-sized biotech companies and startups.
At IVDIAS, we understand that navigating these regulatory changes can be complex and resource-intensive. That’s why we’ve built a specialized service to guide and support your transition, turning a potential obstacle into a strategic advantage.
End-to-End Support for a Smooth IVDR Transition
- Regulatory Strategy & Gap Analysis: Our team of regulatory experts conducts a comprehensive review of your existing technical documentation to identify gaps between your IVDD compliance and IVDR requirements. We help you build a customized roadmap to achieve conformity, minimizing delays and ensuring your product remains market-ready.
- Assay Design & Performance Evaluation: IVDR places strong emphasis on analytical and clinical performance data. Our assay development specialists work alongside your team to optimize test sensitivity, specificity, and robustness—whether you're working with lateral flow assays, molecular diagnostics, or complex immunoassays. We also design your assay with regulatory expectations in mind, reducing rework and accelerating approval timelines.
- Technical Documentation & CE-Marking Support: We help you prepare or upgrade your technical documentation to meet IVDR Annex II and III requirements, including scientific validity, analytical performance, and clinical evidence. From writing your Performance Evaluation Plan (PEP) to compiling your Summary of Safety and Performance (SSP), we ensure every file is audit-ready.
- Post-Market Surveillance Planning: Compliance doesn’t stop at CE-marking. IVDIAS supports you in developing robust post-market surveillance systems, in line with IVDR expectations, to track real-world performance and manage risk proactively.