IVDR Performance Evaluation Report and CE Marking Challenges

Key Issues Confronting Indian IVD Manufacturers

Data and evidence gaps: Many devices require stronger analytical, clinical, and real-world data to demonstrate sensitivity, specificity, reproducibility, and stability across intended-use populations.

Study design and execution hurdles: Limited access to clinical sites, inconsistent study protocols, and variable sample quality slow down performance studies and undermine regulatory submissions.

IVDR regulatory complexity and fragmentation: Notified Bodies demand specific formats, study endpoints, and demonstration of parameters in the EU population, often extending approval timelines.

Resource constraints: Smaller manufacturers often lack in-house regulatory, clinical, and statistical expertise required to design, conduct, and interpret performance evaluations.

Post-market evidence expectations: Authorities increasingly expect post-market surveillance and performance follow-up, creating an ongoing evidentiary burden.

How Reghelps SRC Helps – Tailored Services for Measurable Impact

Reghelps SRC offers a comprehensive suite of services designed to reduce technical and regulatory risk and accelerate approvals:

• Performance Evaluation Protocol Design: Statistically sound analytical and clinical protocols aligned with regulatory expectations and device intended use.
• Clinical Site Identification & Study Management: End-to-end support including site selection, ethics submissions, sample logistics, monitoring, and data management.
• Data Analysis & Biostatistics: Robust analysis plans, power/sample-size calculations, and clear interpretation of performance metrics for submission-ready reports.
• Regulatory Strategy & Dossier Preparation: Guidance on regulator-specific requirements, compilation of performance evidence, and gap assessment for global markets.
• Post-Market Performance Planning: Designing real-world evidence (RWE) and post-market surveillance plans to demonstrate continued safety and effectiveness.
• Training & Capacity Building: In collaboration with I3CGLOBAL, leaders in IVDR regulatory compliance, IQZYME, leaders in production process and quality control conducts workshops and hands on training to strengthen internal capabilities in conducting and documenting performance evaluations and overall IVDR CE Marking

Leadership Statement

“We recognize the tremendous innovation coming from India’s IVD sector. However, innovation must be matched by rigorous performance evidence and a clear regulatory strategy. Reghelps SRC is committed to helping manufacturers bridge that gap, so life-saving diagnostics reach patients faster and with confidence,” said Mr. Soio George and Mr. Nagachandra, founders of Reghelps SRC, in a joint statement.

Why IVD Performance Evaluation Matters Now

Regulatory bodies worldwide are raising the bar for performance evidence, and buyers including hospitals, governments, and international procurement agencies increasingly require demonstrable real-world performance. Indian manufacturers that proactively strengthen their performance evaluations and regulatory dossiers will be better positioned to access export markets and large procurement opportunities.

About Reghelps SRC

Reghelps SRC is a regulatory and IVD performance evaluation moderator support CRO focused on helping diagnostics and medical device companies design and implement performance evaluations, prepare regulatory submissions, and build long-term evidence strategies. The center provides practical, submission-ready solutions aligned with global regulatory expectations.

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