The In Vitro Diagnostics Regulation (IVDR) took effect in May 2022 and has introduced substantial changes in the regulatory framework for in vitro diagnostic medical devices (IVDs) in Europe. IVD manufacturers are expected to meet more rigorous standards for clinical evidence, with up to 80% of IVDs requiring Notified Body certificates under IVDR.
Dr. Sarah Chavez, Criterion Edge Director of IVD Writing Services, will discuss key insider insights gleaned from the 2024 DIA meeting to share and discuss the key take-aways from the Symposium, including clinical evidence requirements and strategies to keep your report writing and data collection on track.
Join us for this webinar to discuss differences in EU and US regulations for IVD clinical performance studies and potential implications for companion diagnostic developers. The goals of this webinar are to:
1. Understand how new regulatory requirements apply to CDx and what are potential implications from both the IVD and Pharma partners’ perspectives.
2. Develop a strategic approach to ensure compliance with IVDR requirements for CDx, covering essential aspects such as quality management, documentation, and early interactions with your notified body.
3. Address common challenges faced during the implementation of IVDR requirements for CDx, exploring potential solutions and proactive measures to streamline the regulatory compliance process.