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The global diagnostics and medical device industry continues to evolve at unprecedented speed. New technologies, rapid regulatory changes, increased expectations for real-world evidence, and growing demand for precision diagnostics are reshaping how IVD and device performance studies are designed and executed.

As we enter 2026, sponsors planning analytical or clinical validation studies face a more complex—but also more opportunity-rich—environment. Understanding these shifting requirements is essential for achieving regulatory approval, generating reliable evidence, and accelerating commercial timelines.

This article outlines the key considerations sponsors must know to successfully plan and execute IVD and device performance studies in 2026.

Diagnostics companies now face stronger requirements for demonstrating the real clinical value of their technologies. Regulators and payers expect:

• Evidence of test precision, accuracy, and repeatability
• Demonstrated clinical validity and clinical utility
• Comparative performance against gold-standard methods
• Performance across diverse patient populations
• Real-world evidence following initial clearance

In 2026, high-quality clinical evidence is no longer optional—it is the foundation for market access.

This shift is driven by:

• Increasing global regulatory harmonization
• Growing scrutiny around device reliability
• High-stakes use cases (oncology, infectious diseases, genetic testing)
• Massive growth in point-of-care and self-collection devices

Sponsors must plan studies that can withstand FDA, EMA, and international regulatory review.

FDA continues to strengthen its expectations for:

• Analytical validation
• Clinical validation with statistically significant sample sizes
• Clear intended use population definition
• Robust comparator methodologies
• Post-market performance data

For many tests, especially molecular or AI-driven diagnostics, FDA increasingly expects:

• Multi-site trials
• Diverse demographic representation
• Evidence from both controlled and real-world settings
• Verification of digital algorithms

Sponsors must design protocols that satisfy these evolving standards.

The EU’s In Vitro Diagnostic Regulation (IVDR), implemented in phases, places diagnostics under the most stringent regulatory framework in EU history. Key highlights:

• Up-classification of most IVDs
• Expanded performance evaluation requirements
• Stronger clinical evidence documentation
• Audits by notified bodies
• Mandatory post-market surveillance

Even companies not selling in Europe must understand IVDR, as the global trend points toward greater evidence requirements.

Regulators across Asia and Latin America increasingly follow IVDR- and FDA-like frameworks. This means validation expectations are converging globally.

Successful diagnostics studies in 2026 require careful planning and a deep understanding of clinical, analytical, and operational variables.

For IVD and device studies, sample integrity directly impacts data reliability.
Sponsors must account for:

• Collection technique
• Transport medium
• Temperature control
• Time to processing
• Storage duration
• Chain-of-custody documentation

Even minor inconsistencies can undermine the scientific validity of results.

Biobanking partners and clinical sites must have:

• Validated SOPs
• Temperature-monitored storage
• Controlled labeling and tracking
• Compliance with IATA and biospecimen regulations

In 2026, poor sample management is one of the most avoidable—and costly—risks in device performance studies.

Recruitment remains one of the biggest bottlenecks for diagnostics trials, especially for:

• Infectious diseases with fluctuating prevalence
• Oncology tests requiring specific mutation profiles
• Rare disease diagnostics
• Matched sample or paired-sample designs

To address this, more sponsors use dual-region strategies, recruiting in both:

• The United States (diverse demographics)
• Eastern Europe (fast enrollment, treatment-naïve patients)

This approach accelerates timelines and strengthens statistical validity.

Post-market expectations are expanding. Regulators want:

• Real-world performance data
• Longitudinal outcomes
• Clinical utility evidence

In 2026, RWE is a critical component of ongoing compliance and commercial success.

Studies may include:

• User experience assessments
• Real-world accuracy in busy clinics
• Long-term follow-up for chronic disease diagnostics
• Data from decentralized or remote testing

Companies should plan for RWE early rather than reactively.

Diagnostics studies often involve high-volume sample collection, complex logistics, and rapid recruitment. Integrated CRO + clinical site models dramatically improve:

• Study start-up speed
• Operational consistency
• Sample handling
• Quality oversight
• Recruitment and retention
• Real-time communication

This model is particularly strong for:

• IVD validation
• Device usability studies
• Self-collection device evaluations
• Multi-swab or paired sample studies
• Precision oncology biomarker testing

Integrated environments reduce hand-offs and deliver tighter control—exactly what device studies require.

Based on industry trends, the most frequent issues include:

• Insufficient sample size
• Poor-quality comparators
• Inconsistent sample handling
• Underestimating recruitment timelines
• Lack of multi-site diversity
• Weak data monitoring
• Incomplete documentation for regulators

Early planning, realistic feasibility assessments, and partnerships with experienced CROs and sites can prevent these delays.

The landscape for IVD and medical device performance studies in 2026 is more rigorous, more data-driven, and more globally aligned than ever before. Sponsors must prioritize study quality, regulatory planning, operational consistency, and strategic site partnerships to succeed.

By understanding regulatory expectations, designing robust validation plans, and leveraging integrated CRO–site models, diagnostic companies can significantly accelerate timelines while generating strong, defensible clinical evidence.

A well-executed performance study is no longer just a regulatory requirement—it is a strategic advantage that determines market success.