Empire Genomics IVDR Transition Strategy
Empire Genomics is proud to share that we have officially implemented a strategic plan to bring our product portfolio into full compliance with Regulation (EU) 2017/746 (IVDR). This transition marks a major milestone in our commitment to product quality, patient safety, and uninterrupted access to high-performing genomic solutions in the EU.
Key Points
- Partnering with GMED as our Notified Body.
- Current IVDD‑labeled products will remain on the market during the transition.
- Products submitted, including FISH probes and ancillary reagents, are expected to be IVDR‑certified by Q4 2026.
Our Commitment to Continuity
We understand the importance of consistency in clinical and research environments. As we move from IVDD to IVDR, most of our probe designs will remain unchanged, ensuring laboratories can continue to rely on the same trusted performance they have come to expect from Empire Genomics.
Partnering for the Future
In a changing diagnostics industry, laboratories need a supplier who can deliver:
- High‑quality products
- Uninterrupted product access
- Industry‑leading customer support
- Regulatory foresight
Press Release
Empire Genomics’ IVDR Transition Is Underway
Empire Genomics is proud to share that we have officially implemented a strategic plan to bring our product portfolio into full compliance with Regulation (EU) 2017/746 (IVDR). This transition is a major milestone in our continued commitment to product quality, patient safety, and uninterrupted access to high-performing genomic solutions in the EU.
We are partnering with GMED as our Notified Body and, because this agreement was established ahead of key regulatory deadlines, our current IVDD-labeled products will remain on the market during the transition. We anticipate our products, including FISH probes and ancillary reagents, will be IVDR-certified by Q4 2026.
As mergers and acquisitions reshape the diagnostics industry, many labs are looking for a single-source supplier they can trust for both consistency and long-term compliance. Empire Genomics is proud to be that partner, offering not only a comprehensive portfolio of FISH solutions, but also the regulatory foresight and infrastructure to support uninterrupted access for years to come.
We will continue to keep you informed as we progress through these important regulatory transitions. If you have any questions regarding current product availability or regulatory status, please don’t hesitate to reach out.
Sincerely,
John Steel | General Manager
Empire Genomics
IVDR FAQ
A: No. All current IVDD-labeled products from Empire Genomics can continue to be supplied during the transition period. Our agreement with GMED ensures uninterrupted availability until their respective IVDR certification dates.
A: No revalidation is required if you use our IVDR-labeled probes in accordance with their intended use. This ensures a smooth transition without workflow disruptions.
A: We anticipate our products, including FISH probes and ancillary reagents, will be IVDR-certified by Q4 2026.
A: Our FISH probes fall into Class B and Class C. Ancillary reagents are Class A.
A: IVDD (In Vitro Diagnostic Directive) is the previous EU regulation for diagnostic devices. IVDR (In Vitro Diagnostic Regulation) replaces it with stricter requirements for performance, quality, and post-market monitoring to enhance product safety and reliability.
A: By moving early, we ensure continuous compliance, maintain uninterrupted product supply, and give our customers confidence in long-term access to our solutions.
A: Please reach out to our regional sales director or fill out the form below to submit your questions directly to our team.
