PMCF is a continuous process under EU MDR Annex XIV Part B that updates the clinical evaluation throughout a device's lifecycle, using methods such as registries, surveys, or post-market studies. A PMCF plan sets out the methods, objectives and timelines, and results go into a PMCF evaluation report that feeds the benefit-risk determination. Manufacturers can justify not running PMCF studies, for example for well-established technologies, but must document why. MDCG 2020-7 and 2020-8 provide templates for the plan and report.

Why it matters

PMCF plans and evaluation reports feed into the CER, PSUR, and SSCP. A weak PMCF plan is a frequent Notified Body audit finding under MDR.

Common pitfalls

•Failing to establish a proactive and systematic PMCF plan is a common deficiency cited by Notified Bodies.
•Treating PMCF as a one-time activity rather than a continuous, iterative process can lead to non-compliance.
•Not adequately justifying why certain data collection methods, or an absence of clinical studies, are appropriate for a device is a frequent pitfall.
•Overlooking the need to update the PMCF plan and report based on new information or risk assessments can result in regulatory issues.
•Collecting data without a clear methodology or statistically sound basis undermines the validity of PMCF efforts.

Sources

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Why compare MedTech terms side by side?

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.

Each comparison on this page pulls from the same vendor-neutral, sourced definitions used throughout the MedTech Terms glossary. You see the one-line summary, the formal definition, why it matters in practice, common pitfalls, and the primary sources (FDA guidance, EU MDR/IVDR articles, ISO/IEC standards, MDCG documents, IMDRF principles) that back each entry. That makes the comparison defensible in regulatory strategy memos, design reviews, and submission narratives.

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.

How to use this tool

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MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice.