IVDR Status Update – What This Means for You

IVDR Status Update – What This Means for You

Empire Genomics is moving full speed ahead in our transition to EU IVDR (Regulation (EU) 2017/746)—and we’re excited to share our progress with you.

We are currently finalizing and preparing the submission of our IVDR technical documentation, with submissions targeted for completion by the end of Q1 2026. These submissions include comprehensive technical files fully aligned with IVDR requirements, covering device classification, performance evaluation, risk management, and post-market surveillance planning.

What you can expect during this transition:

• Our products continue to be legally supplied under applicable transitional provisions

• No changes to product design, intended use, or quality controls

• Manufacturing and quality operations remain fully supported by our ISO 13485-certified Quality Management System

Our priority is clear: maintain uninterrupted product availability while achieving full IVDR compliance. As we reach key milestones and certifications are granted, we’ll keep you informed every step of the way.

If you have questions about the IVDR status of a specific product or need documentation support, our team is here to help—please don’t hesitate to reach out.