From May 2022 onwards, clinical trial assays being developed as companion diagnostics (CDx) need to meet the requirements of the European Union In Vitro Diagnostics Regulation (EU IVDR; Regulation (EU) 2017/746 (EU IVDR)), which includes more stringent oversight during the clinical performance study (CPS) phase of development.

This raises challenges for global CDx trials that contain EU subject recruitment sites, especially with the delay in the full implementation of the European Database on Medical Devices (EUDAMED) and its clinical investigations and performance studies module.

The clinical investigations and performance studies module is still not functional (as of early 2024); consequently, CPS applications and corresponding ethics committee reviews must be submitted to each competent authority and ethics board, which then necessitates co-ordination across multiple jurisdictions in the EU for trials recruiting across multiple EU countries. This can add significantly to the trial set-up time for interventional and registrational in vitro diagnostics (IVD) trials incorporating EU sites.

In this webinar, the expert speakers will focus on their experience with IVDR and describe strategies for solving the specific challenges faced during the IVDR submission process for clinical trial assays being utilised as CDx, allowing global trials to commence and complete in a timely manner.

Register for this webinar today where experts will share their experience with the EU IVDR and provide insights into solving challenges faced during the EU IVDR submission process.

What You Will Learn

Attendees will learn about the following:

• Challenges associated with the EU IVDR regulation
• Solutions to help overcome some IVDR hurdles for global clinical trials
• Key considerations when planning for CDx trials with EU sites
• Where to look for key information required for CPS submissions
• EU country-specific regulatory intelligence

Presenters:

Dr. Stewart McWilliams, Global VP Quality and Regulatory Affairs, Almac Diagnostic Services

Charlene Robb, IVD Regulatory Affairs Team Leader, Almac Diagnostic Services