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IVDR and Health Institute Status

Accelerate performance studies for assays subject to IVDR, including early phase clinical trials that test European patient samples.

In clinical trials involving European patients or their samples, adherence to IVDR is mandatory. IVDR necessitates performance studies to provide analytical and clinical evidence, which can lead to increased time and costs in early-phase trials, even when companion diagnostics development is not planned.

Discovery’s Kassel, Germany facility, operating under GCLP/CAP-CLIA standards and aligned with ISO 15189, holds the status of a Health Institution. This unique classification enables our clients to:

Our Kassel, Germany service laboratory provides molecular pathology and genomics services and is fully compliant with the criteria defined in IVDR Article 5, encompassing an appropriate quality management system, ISO 15189 compliance, and adherence to processes and documentation, including general safety and performance requirements outlined in IVDR Annex I.

A Single Global Partner

Discovery provides complete continuity across our global testing sites by using the same standard operating procedures (SOPs), the same laboratory information management system (LIMS), and one project manager for every global clinical trial.

Discovery US

Discovery Germany

IVDR Article 5 and Health Institution Status applies for institutions established in the EU only.

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