Medical Device Literature Search Protocol and Review

Accurate, structured, and regulator aligned literature review is a cornerstone of global medical device and IVD compliance. Masuu Global Solutions provides tailored literature search protocol and evidence review services designed to meet the stringent requirements of EU MDR (2017/745) and EU IVDR (2017/746).

Our scientific and regulatory teams specialize in clinical, performance, and scientific literature analysis—ensuring your device development, clinical evaluation, and lifecycle documentation are grounded in robust, high quality evidence.

IVD & Medical Device Literature Search Protocol and Review – Overview

In the complex world of medical devices and IVDs, a well structured literature search protocol is not just a research activity—it is a regulatory requirement. MDR and IVDR demand full transparency, traceability, and reproducibility in evidence collection and review, making literature search an essential pillar of:
  • Clinical Evaluation Reports (CER)
  • Performance Evaluation Reports (PER)
  • Clinical Evaluation Plans (CEP)
  • Performance Evaluation Plans (PEP)
  • Post Market Surveillance (PMS)
  • PMCF & PMPF activities

Masuu’s literature review methodologies ensure regulatory acceptance, scientific credibility, and seamless integration into your overall evaluation strategy.

State of the Art (SOTA) Requirements Under EU MDR & IVDR

Under MDR and IVDR, establishing State of the Art (SOTA) is mandatory. SOTA represents the current, widely accepted level of clinical and technical knowledge relevant to the device.
A strong SOTA aligned literature search protocol helps you:
  • Identify benchmark technologies
  • Assess accepted safety & performance standards
  • Compare your device against current alternatives
  • Justify benefit risk conclusions
  • Support CER, PER, PMS, PMCF/PMPF documentation

Masuu ensures your entire evidence package meets SOTA expectations, significantly improving Notified Body acceptance.

EU MDR / EU IVDR Literature Review

A compliant MDR/IVDR literature review is a systematic, structured process that provides the evidence base for:
  • Clinical evaluations (CER)
  • Performance evaluations (PER)
  • PMS, PMCF & PMPF
  • Risk benefit analysis
  • Device comparisons
  • Technical documentation

Masuu develops reproducible literature review protocols using internationally accepted standards. Our framework incorporates search strategy design, dual reviewer screening, critical appraisal, and full traceability.

Key Differences Between MDR & IVDR Literature Evidence Requirements

MDR focuses on:

  • Clinical evaluation & clinical evidence
  • Safety & performance claims
  • PMCF strategies
  • Benefit–risk justification
  • MEDDEV 2.7/1 Rev. 4 principles

IVDR focuses on:

  • Scientific validity
  • Analytical performance
  • Clinical performance
  • PER & PEP documentation
  • PMPF data generation
  • Expanded reclassification rules

Masuu customizes literature strategies based on whether the device follows the MDR or IVDR pathway.

Strength of a Scientific Literature Synthesis Team

High quality literature review requires:

  • Therapeutic and diagnostic domain expertise
  • Advanced search methodology
  • Structured scientific appraisal
  • Consistent traceability
  • Precise interpretation of regulatory expectations

Masuu Global Solutions transforms complex data into clear, defensible, and regulator ready evidence supporting your CERs, PERs, and PMS/PMCF/PMPF processes.

Our scientific literature review teams ensure:

  • Depth and rigor expected by Notified Bodies
  • Alignment with MDR/IVDR expectations
  • Defensible methodology and results
  • Clear contribution to benefit risk and performance claims

EU MDR / EU IVDR Literature Search Protocol – Masuu’s Approach

A compliant literature search protocol must provide:

  • Clear structure
  • Reduced reviewer bias
  • Reproducible methodology
  • Full traceability for audits

Masuu follows a comprehensive MDR/IVDR aligned methodology using advanced global database search strategies. Publications are systematically retrieved, screened, appraised, and synthesized into regulatory ready evidence.

Masuu’s IVD & Medical Device Literature Search Expertise

  • Systematic identification, collection, and synthesis of scientific literature
  • Development of MDR/IVDR aligned literature search protocols
  • Formulation of device specific research questions
  • Database selection & query creation (PubMed, Embase, Cochrane, etc.)
  • Critical appraisal of clinical, analytical, and scientific literature
  • Evidence summarization for CERs, CEPs, PERs, and PEPs
  • Gap assessment of existing CER/CEP/PEP/PER documentation
  • Advanced search techniques for comprehensive global evidence capture

Advantages of Partnering with Masuu Global Solutions

  • Guaranteed compliance with MDR/IVDR literature requirements
  • Structured, reproducible, and audit defensible search methodology
  • Evidence strategies tailored to device type, class, and intended purpose
  • Highly skilled clinical, regulatory, and scientific specialists
  • Scalable team capacity for high volume evidence generation
  • Cross functional expertise from medical, analytical, and regulatory domains
  • End to end support—search, screening, appraisal, synthesis, and documentation
  • Enhanced credibility, readiness, and acceptance of regulatory submissions
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