ISO 23640 : Stability Studies for IVDs Under the IVDR
ISO 23640 is the standard every IVD manufacturer cites for stability, and it is not harmonised under Regulation (EU) 2017/746. That is not a technicality.…
MD Regulatory Blog
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EU IVDR Transition Deadlines 2027, 2028 and 2029
The IVDR transition is discussed almost entirely in terms of three dates in December — 2027, 2028 and 2029 — and that framing is the…
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ISO 20916 : Good Study Practice for IVD Performance Studies
ISO 20916 stopped being optional reading the moment EN ISO 20916:2024 was cited in the Official Journal in support of the IVDR, and most manufacturers…
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ANVISA Registration: The Complete Guide for Medical Devices
ANVISA registration is where confident manufacturers discover that a CE certificate is not a passport. The file that satisfied your Notified Body — the same…
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EUDAMED Registration Requirements: Step-by-Step Guide for Medical Device Manufacturers
Understanding the EUDAMED registration requirements for medical devices is now urgent rather than optional. On 27 November 2025 the European Commission published Commission Decision (EU)…
