IVDR – In Vitro Diagnostic Regulation
The EU In Vitro Diagnostic Regulation (IVDR, EU 2017/746) introduces stricter requirements for in vitro diagnostic devices on the EU market. The regulation focuses on safety, clinical performance, and traceability to protect patients and ensure the reliability of diagnostic tools.
Our team supports you in navigating the complexities of IVDR by providing:
- Assistance with classification of devices according to the new risk-based system.
- Guidance in creating and updating technical documentation and performance evaluation reports.
- Implementation of robust systems for post-market surveillance and vigilance to maintain compliance.
- Support in managing notified body assessments and ensuring alignment with IVDR timelines.
Whether you are transitioning from IVDD to IVDR or launching a new diagnostic device, we offer tailored solutions to streamline your regulatory journey.
Stay ahead of IVDR requirements – contact us to ensure your in vitro diagnostic device complies with the latest EU regulations.