Navigating Clinical Performance for In Vitro Diagnostics
At Bioexcel, we provide comprehensive services to help manufacturers of In Vitro Diagnostic (IVD) devices comply with the stringent requirements of the EU In Vitro Diagnostic Regulation (IVDR 2017/746). Our specialized team ensures a seamless pathway for clinical performance studies, technical documentation, and post-market compliance, enabling your diagnostic products to succeed in the EU market.
What is IVDR, and Why is it Important?
The IVDR introduced stricter regulatory requirements for IVD devices, focusing on clinical performance, risk classification, and post-market surveillance. Compliance with IVDR ensures that your diagnostic product is safe, effective, and supported by robust clinical evidence.
Key Changes Under IVDR:
Comprehensive Studies for Regulatory Compliance
We design and conduct clinical performance studies to generate robust evidence for your IVD device, ensuring compliance with IVDR Annex XIII requirements.
Key Features:
Ensuring Diagnostic Accuracy and Reliability
We assess the analytical and clinical performance of your device to demonstrate safety and effectiveness.
Key Features:
Regulatory-Ready Documentation for CE Marking
We prepare clinical evidence and technical documentation to support your device’s compliance with IVDR.
Key Features:
Continuous Monitoring for Long-Term Compliance
Our PMS and Post-Market Performance Follow-Up (PMPF) services ensure your device remains compliant after market approval.
Key Features:
Minimizing Risks Through Proactive Assessment
We integrate risk management and usability testing into your IVDR compliance strategy, ensuring patient safety and user-friendliness.
Key Features:
Challenge:
A manufacturer needed to validate the analytical and clinical performance of their HIV diagnostic test to meet IVDR Annex XIII requirements.
Solution by Bioexcel:
Outcome:
Challenge:
A manufacturer of an HBsAg detection kit needed clinical and analytical performance data to secure IVDR compliance.
Solution by Bioexcel:
Outcome:
Challenge:
A startup required clinical performance validation for their Syphilis diagnostic device, targeting both EU MDR and IVDR compliance.
Solution by Bioexcel:
Outcome:
End-to-End Support:
Comprehensive services from study design to post-market compliance.
Global Expertise:
In-depth knowledge of EU IVDR requirements and Notified Body expectations.
Tailored Solutions:
Customized compliance strategies based on device classification and risk level.
Proven Success:
A track record of successful clinical performance studies and regulatory submissions.
Yes, IVDR compliance is mandatory for all IVD devices seeking CE marking in the EU. The regulation replaces the previous IVDD and introduces stricter requirements.
The timeline varies based on device classification and readiness, but clinical performance studies and documentation preparation typically require 6–12 months.
Yes, we help manufacturers transition devices from IVDD to IVDR compliance by updating clinical evidence, PMS plans, and technical documentation.
Navigate the complexities of IVDR with confidence. Bioexcel provides expert guidance to ensure your IVD devices meet the highest regulatory standards, from clinical performance studies to post-market compliance.
TO BREAK THE BARRIERS OF TRADITIONAL CLINICAL INVESTIGATION FOR MEDICAL DEVICE INDUSTRY
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