---
title: "State-of-the-Art Literature Review: Kick Off the Clinical Evaluation of Your Medical Device"
description: "A solid clinical evaluation starts with a solid understanding of the state of the art. For medical device manufacturers, a State-of-the-Art (SOTA) literature review is a crucial part of the clinical evaluation process and a requirement for CE marking under the EU MDR. But what should your review cover? How do you build a robust search strategy? And how do you turn the available literature into meaningful evidence for your device? This white paper walks you through the SOTA literature review process, from planning and literature searches to appraisal, reporting and ongoing updates."
url: https://qbdgroup.com/en/downloads/state-of-the-art-literature-review
type: "White paper"
language: en
published: 2024-12-23
publisher: "QbD Group"
citation: "QbD Group, \"State-of-the-Art Literature Review: Kick Off the Clinical Evaluation of Your Medical Device\", https://qbdgroup.com/en/downloads/state-of-the-art-literature-review"
---
# State-of-the-Art Literature Review: Kick Off the Clinical Evaluation of Your Medical Device
> A solid clinical evaluation starts with a solid understanding of the state of the art. For medical device manufacturers, a State-of-the-Art (SOTA) literature review is a crucial part of the clinical evaluation process and a requirement for CE marking under the EU MDR. But what should your review cover? How do you build a robust search strategy? And how do you turn the available literature into meaningful evidence for your device? This white paper walks you through the SOTA literature review process, from planning and literature searches to appraisal, reporting and ongoing updates.

A solid clinical evaluation starts with a solid understanding of the state of the art.

For medical device manufacturers, a State-of-the-Art (SOTA) literature review is a crucial part of the clinical evaluation process and a requirement for CE marking under the EU MDR.

But what should your review cover? How do you build a robust search strategy? And how do you turn the available literature into meaningful evidence for your device?

This white paper walks you through the SOTA literature review process, from planning and literature searches to appraisal, reporting and ongoing updates.

## About This White Paper

A SOTA literature review is much more than a search for publications. It is a structured and objective process used to identify, critically appraise, analyze and summarize the clinical evidence relevant to your medical device.

Done properly, it helps establish the medical and technological context in which your device is used, benchmark its safety, performance and usability against similar devices or alternative treatments, define benefit-risk acceptability criteria and identify gaps in the clinical evidence. Those findings feed directly into the clinical evaluation, risk management and other essential documentation.

This white paper provides a practical overview of how to plan, conduct, document and maintain a systematic SOTA literature review in line with EU MDR 2017/745 and MEDDEV 2.7/1 Rev. 4. It also highlights common pitfalls that can compromise your clinical evaluation and ultimately jeopardize CE marking.

## Key Takeaways

✓ **Understand Why SOTA Matters for Clinical Evaluation.** Discover how the literature review helps establish the clinical background of your device, define safety and performance benchmarks, identify clinical evidence gaps and support your overall clinical evaluation strategy.

✓ **Build a Robust Literature Review Plan.** Learn what should be included in your Literature Review Plan (LRP), from the scope and research questions to your methodology for identifying, selecting and appraising relevant publications.

✓ **Develop a Reproducible Search Strategy.** Explore how to structure systematic searches using approaches such as PICO, select appropriate databases and search terms, apply Boolean logic and filters, and document your methodology so searches can be reproduced and verified.

✓ **Screen, Appraise and Weigh Clinical Evidence.** Understand how publications should be selected and how clinical data should be assessed for scientific validity, relevance, quality and contribution to your device's safety, performance and usability evidence.

✓ **Benchmark Your Device Against the State of the Art.** Learn how to identify similar devices and alternative treatments, extract relevant safety and performance data and use them to establish meaningful acceptability criteria for your own device.

✓ **Avoid Common Literature Review Pitfalls.** Discover why poor search strategies, inconsistencies between clinical documents, insufficient clinical expert involvement and underestimating the required time and resources can create problems during clinical evaluation and CE marking.

✓ **Keep Your SOTA Current Throughout the Device Lifecycle.** Understand why the literature review does not stop after CE marking, and how PMS and PMCF data feed into ongoing updates of your clinical evaluation and benefit-risk assessment.
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Source: https://qbdgroup.com/en/downloads/state-of-the-art-literature-review — © QbD Group. Quote freely with attribution and a link back.