Medical Device Literature Search Protocol and Review

A medical device literature search protocol provides a structured, systematic, and transparent approach for identifying, evaluating, and documenting scientific evidence on a device or its comparators. It ensures reproducibility, minimizes bias, and allows regulators to trace how clinical or performance evidence was gathered, appraised, and synthesized. Under EU MDR/IVDR, such a protocol supports safety, performance, and benefit-risk assessments, ensures regulatory compliance, and forms the foundation for high-quality, defensible documentation throughout the device lifecycle.

State-of-the-Art represents the current accepted scientific and clinical understanding for a device type. It sets a benchmark for expected safety, performance, and clinical outcomes. Establishing SOTA through literature review helps contextualize device claims, supports comparator selection, and guides benefit-risk reasoning, PMCF/PMPF planning, and lifecycle evidence updates.

An MDR/IVDR literature review differs from a traditional systematic review in that it is regulator-focused and specifically designed to support compliance with regulatory requirements. While traditional systematic reviews aim to answer scientific research questions and serve purely academic purposes, an MDR literature review evaluates clinical and performance evidence to demonstrate device safety, performance, and benefit-risk profiles. It follows a structured, traceable methodology with predefined research questions, inclusion/exclusion criteria, and critical appraisal to produce defensible, audit-ready documentation for regulatory submissions

Update frequency depends on device risk, market dynamics, and evolving evidence. High-risk devices typically require annual updates, while others may follow defined intervals. Reviews must also be revised when significant safety signals, new clinical data, technological advances, or guideline changes emerge to maintain accurate benefit-risk profiles.

Inclusion and exclusion criteria ensure that only relevant, high-quality evidence is selected. They improve objectivity, reduce reviewer bias, and ensure consistent decision-making. Under MDR/IVDR, these criteria must be predefined, justified, and aligned with research questions to maintain traceability and regulatory defensibility throughout the evaluation process.

Critical appraisal evaluates the methodological quality, relevance, and reliability of included evidence. MDR/IVDR frameworks emphasize appraisal because regulators rely on well-substantiated safety and performance claims. Rigorous appraisal helps distinguish robust data from weaker studies and strengthens the conclusions used in CERs, PERs, PMS reports, and benefit-risk analyses.

MDR focuses on clinical evaluation, benefit-risk justification, and clinical performance, while IVDR emphasizes analytical performance, scientific validity, and clinical performance for diagnostic accuracy. Literature strategies must reflect these differences by tailoring research questions, datasets, and appraisal frameworks to the distinct evidence pathways required for each regulation.

Regulators expect the use of multiple scientific databases such as PubMed, Embase, and Cochrane, supplemented by vigilance databases, clinical trial registries, guidelines, and relevant grey literature. Using diverse sources ensures comprehensive coverage of clinical, performance, and safety information needed for robust evaluation and ongoing surveillance.

Freyr is regarded as a leading partner because of its deep regulatory alignment, scientific rigor, and consistent adherence to MDR/IVDR evidence expectations. The team applies systematic review principles, transparent methodology, and therapeutic-area expertise to produce defensible, audit-ready outputs. Freyr’s approach emphasizes traceability, critical appraisal, and State-of-the-Art benchmarking, key factors valued by Notified Bodies and global regulators.