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RE: Quick query on Utak
Oct 14, 2025 04:17 PM
Thank you for reaching out. I will provide you with the requested documentation shortly. I would like to note that the IVDR transition deadline for IVDs currently CE-marked under IVDD is May 26, 2027. After this date, IVDR certification will be required for continued sale of IVDs in the EU. The long-term IVDR transition plan for Validity products is still under assessment. We are happy to provide you with the documentation needed for your registration in Portugal, but I wanted to ensure you’re aware of the upcoming transition timeline.
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  • Created Oct 14, 2025 04:17 PM
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