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Empire Genomics’ IVDR Transition Is Underway
Aug
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
