Under IVDR Article 81, Class C and D IVDs require a PSUR updated at least annually; Class A and B IVDs instead keep a post-market surveillance report under Article 80. PSURs summarize PMS data, benefit-risk re-evaluation, sales volumes, and PMPF status. For Class D devices, the PSUR is submitted through EUDAMED to the notified body, which adds its evaluation; for Class C, it is made available to the notified body. PSURs include conclusions on benefit-risk, main findings of post-market performance follow-up (PMPF), sales volumes and an estimate of the population using the device. MDCG 2022-21 covers both MDR and IVDR PSURs.

Why it matters

Closely linked to the Summary of Safety and Performance (SSP) for high-risk IVDs and reviewed by Notified Bodies for Class C/D devices.

Common pitfalls

•Confusing the PSUR frequency requirements between IVD classes can lead to non-compliance.
•Failing to include a comprehensive benefit-risk re-evaluation in the PSUR is a common deficiency.
•Inadequate data collection for post-market surveillance (PMS) will result in an incomplete PSUR.
•Omitting the PMPF (Post-Market Performance Follow-up) status update renders the PSUR deficient.
•Assuming Class A devices never require any form of post-market surveillance reporting is incorrect, even if a PSUR is not mandated.

Sources

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MedTech terminology is full of pairs that look interchangeable but carry very different regulatory, clinical, and commercial consequences. Picking the wrong framework, pathway, or standard early in a project can add months to a submission, invalidate clinical evidence, or trigger an audit finding. Side-by-side comparison is the fastest way to surface those differences before they become costly mistakes.

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Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

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