Introduction to IVDR
In Vitro Diagnostic Regulation (IVDR) 2017/746 represents a significant shift in regulatory requirements for in vitro diagnostic medical devices (IVDs) within the European Union. Replacing the previous In Vitro Diagnostic Medical Devices Directive (IVDD), IVDR introduces stricter compliance measures, including enhanced clinical performance data, post-market surveillance and quality management system requirements. Manufacturers must navigate these changes to ensure their products remain available in the market.
To facilitate a smooth transition, the EU has granted extended deadlines for legacy devices, but compliance remains a multistep, time-sensitive challenge.
What's inside this white paper?
This white paper provides a detailed roadmap for manufacturers looking to transition their legacy IVDs from IVDD to IVDR compliance. It covers key areas such as:
- Understanding the transitional provisions – learn about the latest extensions and deadlines under Regulation (EU) 2024/1860
- Risk classification changes – identify how your device classification has evolved under IVDR and what it means for compliance
- Technical documentation updates – discover the new requirements for clinical performance data, labeling and unique device identification (UDI)
- Quality management system compliance – understand the necessary steps to upgrade your QMS
- Engaging with Notified Bodies – get insights into the application process, key deadlines and best practices for securing timely IVDR certification
Proactively managing these regulatory changes is crucial for maintaining market access and avoiding last-minute bottlenecks.
