MD Regulatory Blog
ISO 13485, EU MDR, FDA QMSR, IEC 62304 — practical guidance written by regulatory affairs experts.
IEC 62366 is built on one uncomfortable idea: a patient can be seriously harmed while every component of the device performs exactly as specified. The…
Full conformity with ISO 22442 is the part of an animal-tissue file that nobody argues about, and it is not the part that decides whether…
MDCG 2019-11 is the guidance that decides two things about a piece of software: whether it is a device at all, and if so, which…
ISO 24971 is the document that explains how to do what ISO 14971 requires, and for in vitro diagnostic medical devices it carries something the…
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.…
The IVDR transition is discussed almost entirely in terms of three dates in December — 2027, 2028 and 2029 — and that framing is the…
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…
MDCG 2025-10 is the first guidance to describe what a post-market surveillance system has to do rather than what documents it has to produce, and…
MDCG 2022-2 is the document that tells you what the IVDR means by clinical evidence. The Regulation itself spreads the concept across Article 56, Annex…
Most IVDR technical documentation fails on structure long before anyone reads the science. The assay is validated, the studies are sound, the stability data are…
MDCG 2025-5 exists because the IVDR describes four different kinds of regulated performance study in three separate articles and never explains how they interact —…
The IVDR is where diagnostic manufacturers discover that a product they self-certified for twenty years is now class C, and that nobody in the building…
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