{"id":36381,"date":"2026-10-13T09:00:20","date_gmt":"2026-10-13T07:00:20","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=36381"},"modified":"2026-10-13T09:30:00","modified_gmt":"2026-10-13T07:30:00","slug":"ivd-performance-evaluation-per-ivdr","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2026\/10\/13\/ivd-performance-evaluation-per-ivdr\/","title":{"rendered":"IVD Performance Evaluation: best practices for drafting the PER across Analytical, Clinical, and PMS Data"},"content":{"rendered":"

Performance Evaluation<\/strong> is the process by which a manufacturer demonstrates that an in vitro diagnostic medical device (IVD) meets the applicable general safety and performance requirements set out in Regulation (EU) 2017\/746 (IVDR)<\/strong>. The evaluation encompasses scientific validity<\/strong>, analytical performance<\/strong>, and, where applicable, the clinical performance<\/strong> of the device.<\/p>\n

Drafting the Performance Evaluation Report (PER)<\/strong> alone is not enough. Performance Evaluation<\/strong> must begin with structured planning, be maintained throughout the entire life cycle of the device and incorporate newly available evidence, including data originating from Post-Market Surveillance (PMS)<\/strong> and, where appropriate, Post-Market Performance Follow-up (PMPF)<\/strong>.<\/p>\n

For manufacturers, this means designing an evidence strategy strictly aligned with the intended purpose<\/strong>, the technical characteristics <\/strong>of the device, stated claims<\/strong>, and associated risks. Therefore, the overall quality of the Performance Evaluation depends not on sheer data volume, but on data relevance, methodological rigor, and the capacity to robustly substantiate conclusions on device performance.<\/p>\n

IVD Performance Evaluation: where to begin?<\/strong><\/h3>\n

Performance Evaluation<\/strong> should be established as a structured, iterative process where evidence planning, experimental appraisal, and post-market intelligence remain interconnected.<\/p>\n

The starting point is the Performance Evaluation Plan (PEP)<\/strong>, which outlines how the required evidence is to be gathered, appraised, and integrated. The findings and substantiated conclusions are subsequently documented in the Performance Evaluation Report (PER)<\/strong>.<\/p>\n

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Following commercial placement, the manufacturer continuously captures and reviews real-world information through Post-Market Surveillance (PMS)<\/strong> activities (complaints, customer feedback, trending data, vigilance). Where appropriate, Post-Market Performance Follow-up (PMPF)<\/strong> further enables the generation and assessment of clinical performance data in routine operational settings.<\/p>\n

These insights supply fresh evidence for the Performance Evaluation, triggering a formal PER update when indicated. Consequently, Performance Evaluation does not conclude upon initial report issuance; it evolves continuously throughout the entire life cycle of the device.<\/strong><\/p>\n

PEP vs PER: What Is the Difference?<\/strong><\/h3>\n

The PEP<\/strong> and the PER<\/strong> serve distinct yet complementary regulatory functions:<\/p>\n\n\n\n\n\n\n
Document<\/strong><\/td>\nRegulatory Function<\/strong><\/td>\n<\/tr>\n<\/thead>\n
PEP – Performance Evaluation Plan<\/strong><\/td>\nDefines objectives, evaluation strategy, methodology, and evidence sources to be leveraged during Performance Evaluation<\/td>\n<\/tr>\n
PER – Performance Evaluation Report<\/strong><\/td>\nCritically appraises assembled evidence and documents reasoned conclusions regarding device performance<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

In practical terms, the PEP <\/strong>defines how the evaluation is to be conducted, whereas the PER details what was evaluated and the conclusions established.<\/p>\n

The three pillars of Performance Evaluation<\/strong><\/h3>\n

Under the IVDR, Performance Evaluation is a continuous, integrated process designed to verify conformity across three core pillars:<\/p>\n

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  1. Scientific Validity<\/strong><\/li>\n<\/ol>\n

    Demonstrates the biological, physiological, or pathological association between the analyte (or marker) and the clinical condition of interest. Key evidence sources include:<\/p>\n