IVD Contract Research Organization
To comply with the EU IVD Regulation 2017/746, a Performance Evaluation must include three core elements that together demonstrate that your device is safe, effective, and clinically relevant throughout its life cycle.
- A Scientific Validity Report establishes the association between the analyte and the clinical condition, typically based on a structured literature review, clinical guidelines, and, where relevant, epidemiological data.
- An Analytical Performance Report documents how reliably and accurately the device measures the analyte, summarizing results from analytical performance studies (e.g. precision, accuracy, sensitivity and specificity, linearity, and stability).
- A Clinical Performance Report then shows how the test performs in the intended clinical context, using data from literature, clinical performance studies, prospective or retrospective evaluations, and, when available, routine‑use or post‑market data.
As your Contract Research Organization (CRO), we provide comprehensive solutions covering all activities related to the design, start‑up, and follow‑up of clinical trials and research studies. We can manage the entire process of bringing your IVD device to EU market.
Analytical performance studies
Analytical performance is shown with studies that assess things like precision and reproducibility, accuracy and bias, analytical sensitivity and specificity, limit of detection/quantitation, linearity and measuring range, interference and cross‑reactivity, and reagent/sample stability.
Performance Evaluation
Studies that assess how well the IVD performs in its intended clinical use, by measuring parameters such as sensitivity, specificity, predictive values, and impact on clinical decision‑making.
Lay-Person Studies
Studies that evaluate whether non‑professionals (people without medical training) can correctly and safely use an IVD, understand the instructions, and interpret the test results.
POCT
Studies performed in near‑patient settings (e.g. doctor’s office, ward, pharmacy) to show that the IVD works reliably outside a central lab, under routine clinical conditions.
Our Clinical Services
Medunion delivers comprehensive Contract Research Organization (CRO) support to fast-track your medical device development and approval. Our experienced team ensures every stage runs smoothly—with full regulatory compliance, operational efficiency, and reliable, high-quality outcomes.
- Design & Planning
- Regulatory Submissions
- Clinical Monitoring
- Data Management
- ISO 15189 Compliance
- Site Selection
- Project Management
- ERP
- Medical Writing
- Registration