State Of The Art Literature Review – Process and Documentation
State Of The Art Literature Review – Process and Documentation
Sunday, 02 July 2023
Pia Gyselen, Lead Medical Writer at QbD Group
Share
\
\
X (Twitter) 
\
\
LinkedIn 
\
\
WhatsApp 
\
\
Copy link 
\
\
Mail
In this blog post, we would like to share with you the different steps and required documents for the execution of the systematic literature review for the clinical evaluation of your medical device.
Play
State Of The Art Literature Review – Process and Documentation | QbD Group
AI-generated audio
9:11
A comprehensive, objective, and thorough systematic literature review to describe the general State of the Art and identify all relevant clinical safety, performance, and usability data of the device under evaluation (and/or equivalent device) should comply with strict regulatory guidelines as per EU MDR 2017/745 and MEDDEV 2.7/1 Rev. 4.
In this blog post, we would like to share with you the different steps and required documents for the execution of the systematic literature review.
Free whitepaper
State-of-the-art literature review
In this white paper on Systematic Literature Review, we walk you through the different steps of conducting solid systematic SOTA literature searches.
State of the Art Literature Review – Process and Documentation
To plan and document the literature review searches and output, a well-designed and clearly written literature review plan or protocol (LRP) and report (LRR) are key and required for all device classifications, including all new and legacy devices and well-established technology (WET).
These documents are then also part of the technical documentation of a medical device. Both should be dated, version controlled, and signed by the regulatory writer, evaluator (preferably a clinical expert), and manufacturer.
Literature Review Plan
The literature review starts with the development of a literature review plan or protocol that should describe the background and scope of the literature review. This should include at a minimum:
- A rationale for the literature review;
- A description of the device, including the intended purpose, indications, target population, and users;
- The methods for identification, selection, and appraisal of the relevant publications to address the research questions, so the searches can be reproduced, data can be critically appraised, and the results can be verified.
| #### Literature search strategy #### The search strategy should be thorough and objective and identify all relevant favorable and unfavorable data related to the intended use, indication(s), target population, and performance of the device under evaluation and should cover: 1. General SOTA, including clinical practice guidelines in the medical field 2. Safety, performance, and usability data on similar benchmark devices/alternative treatments 3. Safety, performance, and usability data on the device under evaluation and/or equivalent devices if equivalence is claimed Different sources of clinical literature are applied. Multiple searches with different focuses, search criteria (with the correct use of Boolean logic), and filters (such as the publication type and date range) are required to obtain the necessary information and data. MEDLINE (Pubmed) is the most commonly used search engine. Alternative databases are also designated such as but not limited to EMBASE, COCHRANE and Google Scholar. For current practice guidelines in the respective medical field, more specific databases such as TRIP and UpToDate can be of interest. Justification for the selection of the respective databases should be provided. To formulate the research questions to be answered by the literature review, unbiased, systematic, search methods should be used. A PICO-based search strategy is a generally accepted, evidence-based method. After the generation of relevant keywords, the search string for the different searches has to be built. A rationale for the application of any in- and exclusion criteria, limits, and filters should be described in the plan. |
| #### Screening and selection process Then the search output should be documented and tracked. A stepwise selection process should be applied. Selection of relevant literature should be objective and justification for exclusion of records properly documented. Clinical safety, performance and usability data extracted from publications are subject to analysis and appraisal. According to Annex XIV of the EU MDR 2017/745 and MEDDEV 2.7/1 Rev. 4, all clinical data relevant to the device under evaluation should be appraised by evaluating their suitability for establishing the safety and performance of the device. |
Literature Review Report
The output of the literature search and review is described and summarized in the literature review report (LRR). The body of the LRR consists of a description of the state of the art on the one hand and a systematic analysis of published clinical safety, performance, and usability data pertaining to the device and similar devices on the other hand. All data sets should be documented, adequately analyzed, appraised, summarised, and referenced in the LRR.
General SOTA
MEDDEV 2.7/1 rev. 4 appendix A9 provides guidance on the content of the SOTA section, i.e., the clinical background of the device under evaluation, the medical field(s) in which the device is being used, and the target population. Different alternative treatment options and similar competitor devices with (dis)advantages of each alternative should be discussed.
Under EU MDR 2017/745, increased scrutiny of alternative treatment methods for the same indication(s) is perceived. The benefits and risks of the device under evaluation and of similar benchmark devices and/or alternative treatments described in the literature should be detailed. This section also presents clinical practice guidelines and recommendations on the use of the device for the intended medical purpose. Finally, the general SOTA outlines unmet medical needs and the types of users of the device.
Clinical data on similar devices/alternative treatments
One of the objectives of the systematic literature review is to obtain the safety and performance acceptability criteria for the device under study. To this end, similar devices should be identified and listed upfront in the literature review plan at best, and data of similar competitor devices on the market should be extracted, analyzed and summarized in the literature review report.
In case no similar competitor devices are on the market or insufficient safety and performance data of competitor devices is publicly available, data of alternative SOTA treatments, preferentially devices, can be extracted for comparison to the device under evaluation in the clinical evaluation process. Alternative devices can for example concern devices with the same intended use, but different indication, patient population or mode of action.
Clinical data on device under evaluation/equivalent device
Last but not least, a search to retrieve safety, performance, and usability data of the device under evaluation (and equivalent device, if applicable) that is not generated by the manufacturer, should be set up.
A search for clinical literature related to the device under evaluation is typically done post-CE as part of the PMCF data collection in the CER. Obviously, to obtain these data, a separate search string containing the device trade name and manufacturer is compiled. Data extraction, appraisal, and analysis are performed in the same way as for similar competitor devices/alternative treatments.
Conclusion of the literature review
The literature review should draw firm conclusions with regard to the safety and performance of the device under evaluation and discuss this outcome in relation to similar benchmark devices or alternative treatment options.
Identify any gaps in the evidence to confirm compliance with GSPR under the normal conditions of the intended use of the device. Evaluate if the clinical literature supports the intended purpose as stated in the IFU and any benefit and clinical performance claims made for the device under evaluation.
How can we assist in consolidated State of the Art literature reviews?
The SOTA literature review, as part of the clinical evaluation process, is a time-consuming complex process that requires specific reading, writing, and strong analytical skills.
At QbD Clinical, we provide knowledge-based expertise to help you set out the clinical strategy and plan and document the clinical evaluation process throughout the journey of your medical device – from start to finish.
To speed up the preparation of the required documentation and ensure high quality deliverables, a team of regulatory affairs specialists, literature review experts, medical writers, medical advisors and project managers work closely together.
Take advantage of the multi-disciplinary expertise of QbD Clinical to speed up and deliver an MDR compliant SOTA literature review and clinical evaluation in an efficient way.
Our services at a glance:
- Gap analysis of SOTA literature review and clinical evaluation documents
- Systematic literature reviews – literature review plan and report
- Regulatory Medical Writing – CEP, CER, PMS plan and report, PMCF plan and report, PSUR
- Clinical medical writing – CIP and CIR
- Advise in clinical strategy
- Operational management of pre-and post-market clinical investigations and PMCF surveys
For help with any of the above, QbD Clinical can provide a solution. Our medical writers are determined to go the extra mile to serve your needs.
[
Looking for clinical expertise?
Get end-to-end clinical support, from CRO solutions to expert services, tailored to your needs.
Learn how we streamline clinical success.
Stay ahead in life sciences
Keeping up with the fast-paced life sciences industry doesn’t have to be overwhelming.
Our newsletter delivers the latest insights, industry updates, and expert content directly to your inbox, helping you stay informed and make smarter decisions.
Discover more expert content
Webinar
PMS & PMCF Compliance for Medical Devices Under EU MDR
Gain practical insights on PMS & PMCF compliance for medical devices under EU MDR. Watch our webinars on demand.
Case study
Multiplex Respiratory Antigen Test: Accelerating IVDR Market Access
Fast-track your IVDR market access with our expertise. We help clients navigate regulatory hurdles to launch innovative diagnostic solutions efficiently and effectively.
Case study
Faster Market Entry Through Integrated IVDR and WHO Strategy
Accelerate your market entry with our integrated IVDR and WHO strategy, ensuring compliance while minimizing costs and sample size for diagnostic tests.
Case study
Multiplex STI PCR Test: Supporting a Smooth IVDR Journey
Learn how we supported a global IVD manufacturer in achieving IVDR compliance for their multiplex STI PCR test, ensuring timely CE-marking and future regulatory confidence.
Case study
Fast-Tracked Site Qualification for Clinical Trial Submission
QbD Group helped a biotech company complete 5 site qualification visits in just 3 weeks enabling a timely and compliant clinical trial submission.
Webinar
Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation
Discover how to integrate clinical needs into medical device software design to meet MDR requirements. Watch our webinar on demand.
Whitepaper
Clinical Evaluation for Medical Devices under MDR
This whitepaper will guide you through crucial regulatory documents pertaining to the clinical evaluation process of your medical device. Download now!
Whitepaper
IVDR extension: what does this mean for you?
In this whitepaper, you will learn the impact of the IVDR transition extension and receive tips and strategies to navigate these regulatory changes.
Whitepaper
State-of-the-art literature review: kick off the Clinical Evaluation of your Medical Device
This whitepaper will walk you through the steps of conducting solid systematic SOTA literature searches for your clinical evaluation. Download now.
Whitepaper
The pathway from idea to patient under MDR
This guide explains the pathway and steps needed to test your device in human subjects, aiming to get your product to market. Download now.
Whitepaper
Clinical investigations under MDR: key insights and practical experiences
This whitepaper covers clinical investigation authorization under MDR, the EU Legal Representative's role, and the MDR's impact on study conduct and post-market surveillance.
Case study
CE Mark Renewal for bioXtra Products: A Success Story
Discover how Lifestream Pharma successfully renewed the CE mark for their BioXtra Dry Mouth products under the EU MDR. Learn about the challenges faced, the approach taken for compliance, and the results achieved.
.jpg)
Webinar
Getting Started: Overcoming Initial Obstacles in Medical Device Software Development
Watch our webinar on demand and learn about regulatory obstacles, MDR, AI Act, and best practices for medical device software development and market entry.
Webinar
Mastering Clinical Performance Studies under IVDR
In the evolving regulatory landscape of IVDs, demonstrating clinical performance is more crucial and challenging than ever. Discover more in this webinar on demand.
Whitepaper
Clinical evidence for In Vitro Diagnostics under IVDR
In this whitepaper, we will guide you through the documents required for the demonstration of clinical evidence under the IVDR. Download now.
Case study
Ensuring a smooth MDR transition for Oystershell's medical devices
The landscape of medical device regulations is constantly evolving, making it a challenge for companies to keep up. Our collaboration with Oystershell, which began in July 2023, highlights our expertise in transforming complex challenges into success stories, all with a touch of QbD Clinical magic.
Case study
Successful clinical evaluation supports rapid CE marking of Minze Health's Uroflowmeter
QbD Clinical assisted Minze Health, a urology-focused medical devices company, in obtaining CE marking under MDR through clinical evaluation.
Twitter Widget Iframe