Webinar – 2024 IVDR Sprint Series: How to Deal with Regulatory Requirements when Collecting Clinical Performance Data

 

Mastering Time and Compliance
How to Deal with Regulatory Requirements when Collecting Clinical Performance Data

 

IVDR imposes stricter requirements for clinical evidence, including a higher level of scrutiny and more stringent criteria for study design, data collection, and analysis.

Conducting clinical performance studies in the EU under the In Vitro Diagnostic Regulation (IVDR) requires careful planning, resource allocation, and adherence to regulatory requirements to demonstrate the safety and performance of IVD devices and achieve regulatory approval for market access. Manufacturers must ensure that clinical performance studies are conducted in accordance with EN ISO 20916:2024. This affects study protocols, study design, regulatory approval, data collection methods, and reporting.

Along this process, IVD manufacturers often face challenges like:

  • Clinical study complexity and study design: Designing clinical performance studies that meet IVDR requirements while ensuring scientific validity and relevance to clinical practice can be complex. Appropriate study design considerations include selecting appropriate endpoints, comparator tests, patient populations, and statistical methodologies are key for success.
  • Patient recruitment and sample size: Recruiting and retaining suitable study participants can be challenging. Ensuring adequate sample sizes and demographic representation may require extensive outreach efforts and collaborations with healthcare providers.
  • Data quality and integrity: Maintaining the quality and integrity of clinical data is essential for demonstrating the safety and performance of IVD devices. Implementing robust data management processes, ensuring data accuracy and completeness, and adhering to Good Clinical Practice (GCP) standards are critical but challenging tasks.
  • Ethical and regulatory compliance: Obtaining ethical approval and navigating regulatory requirements for clinical studies in multiple EU member states can be complex and time-consuming. Manufacturers must ensure compliance with applicable laws, regulations, and ethical standards governing human subjects research.
  • Data privacy and security: Compliance with data protection regulations, such as the General Data Protection Regulation (GDPR), adds an additional layer of complexity to clinical data collection and management. Ensuring patient privacy, data security, and compliance with GDPR requirements is essential but challenging.

 

Veranex excels in delivering assistance tailored to the quality, regulatory, and clinical aspects specifically associated with IVD devices, enabling your business to flourish in the dynamic landscape of IVDR. Drawing from our knowledge of the latest industry challenges and advancements, we are uniquely positioned to lead and advise you through the journey of IVDR compliance.

 

By watching this webinar, you will:

  • Gain an understanding of the clinical performance study prerequisites outlined in the In Vitro Diagnostic Regulation (IVDR)
  • Improve comprehension of utilizing EN ISO 20916:2024 to ensure clinical performance studies align with IVDR compliance standards
  • Learn best practices and pitfalls to avoid during the preparation and execution of a clinical performance study, drawn from our expertise as CRO

 

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