IVD
IVDR Compliance Made Simple – Expert Guidance for Your Business
The In Vitro Diagnostic Regulation (IVDR – EU 2017/746) aims to ensure safe and effective diagnostic tests in the European market. Adopted in April 2017 and fully applicable from May 26, 2022, it mandates that:
- New IVD devices must comply with IVDR before market entry.
- Existing IVD devices (legacy devices) must transition to IVDR within stipulated timelines.
We offer comprehensive services for both new and legacy IVD devices, helping manufacturers maintain their market position and stay competitive.
Understanding IVDR
IVDR replaces the previous In Vitro Diagnostic Directive (IVDD) to address advances in technology, establish a robust regulatory framework, and enhance patient safety. Key changes include:
- Consideration of modern technologies.
- Enhanced certification with a strict classification system and increased transparency.
- Greater emphasis on patient safety through stringent data requirements and device tracking.
Classification and Timeline
IVDs in the EU are categorized into four risk classes (A, B, C, D), with varying levels of risk to patient and public health. New devices must comply with IVDR before market entry, and legacy devices must transition according to specified timelines.
Six Steps to IVDR Compliance
- Qualification and Classification: Determine if your product is an IVD and classify it (classes A, B, C, D).
- Prepare Technical Documentation: Update technical documentation as per IVDR Annex II.
- Quality Management System (QMS): Update your QMS following IVDR Annex IX, Chapter I.
- Notified Body: Submit documentation for review if your device is class B, C, or D.
- Receive Certification: Obtain a certificate of conformity from the Notified Body.
- Maintain Compliance: Continue to monitor and assess device safety and performance.
Get Expert Help
Contact us for expert assistance with IVDR compliance. Our team helps IVD companies identify necessary changes, develop compliance roadmaps, and guide you through the entire process. We also offer training and workshops to help manufacturers understand and meet IVDR requirements.
To learn more about how we can assist with your IVD needs beyond what's outlined here, we invite you to visit the GBA Key2Compliance website. Discover our full range of services, expert insights, and resources tailored to help your business navigate the complexities of IVDR compliance.