Abstract 

The In Vitro Diagnostic Regulation 2017/746 (IVDR) reshaped the regulatory landscape for in vitro diagnostic manufacturers and clinical trial sponsors conducting clinical trials across the European Union. By introducing stricter requirements for clinical evidence, performance evaluation and risk classification, the Regulation raised the bar for product safety and scientific rigour. Sponsors face increasing regulatory complexity, particularly when performance studies are conducted alongside clinical trials of investigational medicinal products under EU Clinical Trial Regulation 536/2014 (CTR).  

This article examines common regulatory feedback and documentation requests arising from clinical performance study submissions, drawing on recent requests for information (RFIs) from both competent authorities and ethics committees. The authors, subject matter experts in the EU CTR/EU IVDR interface from IQVIA’s Clinical Trials Regulatory Management (CTRM) group, draw on internal regulatory intelligence to analyse recurring themes, such as risk analysis, document consistency, scientific validity and language clarity, and offer practical guidance to help sponsors and regulatory professionals navigate dual submissions under IVDR and CTR. Actionable recommendations and summaries are provided for each key document type to support compliance, reduce delays and improve submission quality.