In this free webinar, see how Health Institution designation under IVDR Article 5(5) enables streamlined testing of EU and UK clinical trial samples. Attendees will learn ways to accelerate clinical trial timelines and reduce costs by leveraging in-house assay development and eliminating certain regulatory approvals. The featured speakers will share how flexible, compliant testing strategies can support precision medicine programmes across European patient cohorts. Attendees will gain insight into the quality, regulatory framework and validated technologies needed to support reliable clinical trial data.
TORONTO, June 17, 2026 /PRNewswire/ — Clinical trial sponsors expanding studies across Europe often face complex regulatory pathways for sample testing, particularly when assays must support EU and UK patient cohorts within compliant timelines. This webinar explores how Health Institution designation under the IVDR Health Institution Exception, Article 5(5), can support a more efficient approach to testing EU and UK clinical trial samples.
Following alignment with the MHRA in 2025, a Northern Ireland-based Health Institution model can provide an alternative to the requirement for a Performance Study Application and Competent Authority approval for certain in-house devices. This creates an opportunity to accelerate study start-up timelines, reduce administrative burden and lower overall costs while maintaining regulatory compliance.
This webinar will examine how health institution status can benefit clinical trial sponsors through in-house assay development, assay protocol transfers and flexible test adaptation. Attendees will gain insight into how these approaches can support precision medicine strategies, particularly for EU patient cohorts, while enabling internal development and validation of diagnostic solutions tailored to specific study needs.
The session will also outline the quality and regulatory framework required to support this model, including a Quality Management System aligned with ISO 13485 and ISO 14971, alongside compliance with ISO 15189 and CAP standards. The webinar will discuss how assay verification and validation activities can align with IVDR General Safety and Performance Requirements and how sample testing can be conducted in accordance with IVD medical device Good Clinical Practice to support data integrity and patient safety.
Register for this webinar to learn how sample testing can be streamlined across EU and UK clinical trials while maintaining quality, compliance and operational efficiency.
Join Dr. Lindsey Bennie, Laboratory Manager, ARC Regulatory; and James Lappin, Director, Global Regulatory Compliance, Translational Biomarkers, for the live webinar on Wednesday, July 8, 2026, at 10am EDT (4pm CEST/EU-Central).
For more information, or to register for this event, visit Effectively Streamlining EU & UK Clinical Trial Sample Testing.
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