EU MDR/IVDR: what post-market surveillance really requires in 2026
PMCF is no longer a box-ticking exercise. A look at what regulators now expect from real-world evidence, and how to build a defensible PMS plan.
Post-market clinical follow-up (PMCF) has shifted from a documentation formality to a genuine evidence-generation exercise. Notified bodies increasingly expect structured, prospective data rather than literature summaries alone.
The practical implication for manufacturers is that PMS planning should begin well before certification — defining the clinical questions, the survey and study design, and the reporting cadence that will keep a device compliant across its lifecycle.
This article outlines a pragmatic PMS framework and the common pitfalls we see in re-certification projects.
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