In Vitro Diagnostic Regulation (IVDR)

Overcome the complexities of your In Vitro Diagnostic Regulation (IVDR) transition. We’re with you through the rough terrain.

The IVDR transition will bring positive changes to EU regulation of medical devices and lab-developed tests. It also presents potential obstacles, which we can help you conquer quickly. With our ability to help ensure your compliance, supply consistency, validation, and scalability, we offer clarity and confidence for your IVDR transition.

IVDR webinars

The following two webinars may help you better prepare for IVDR:

Analytical Validation and Performance Verification—Key Components for IVDR Compliance

IVDR Transition—Impact and Opportunities for a Molecular Pathology Laboratory

Resources

Support

Clinical Testing Solutions

Overcome the complexities of your In Vitro Diagnostic Regulation (IVDR) transition. Stay up to date on clinical testing solutions for infectious diseases according to the new IVDR regulation.

Clinical Microbiology

We are committed to working with our customers on the transition to IVDR compliance for Clinical Microbiology products, and are well underway with our readiness program. Find the latest information on how we are preparing for compliance and supporting our customers. 

Genetic Sciences OEM and Commercial Supply Team

Molecular Diagnostics Commercial Supply. Partner with us during this transition for the quality, security of supply, customization, and expertise you can expect from the world leader in serving science.

Sample Prep and Molecular Biology

We are committed to supporting clinical laboratories in the transition to IVDR compliance.

Review updates on our Sample Prep and Molecular Biology solutions for infectious disease testing according to the new IVDR Regulation.