Use of artificial intelligence in literature screening for regulatory compliance
£50.00
Discover how AI tools can streamline literature reviews for clinical evaluation
English
Abstract:
Scientific literature discovery and evaluation are integral to medical device regulatory decision-making. Artificial intelligence (AI) has emerged as an effective tool to facilitate the laborious scientific literature screening process and provide key outputs that will ultimately affect safety and efficacy determination in clinical evaluation. The screening step of a literature review process can be monotonous and made overwhelming by large quantities of diverse articles. Efficiencies may be gained with the use of AI, including platforms that incorporate features for semi-automated literature review such as:
- continuous article reordering,
- duplicate detection,
- evidence synthesis,
- exclusion recommendation,
- Population, Intervention, Comparison, Outcomes (PICO) framework detection,
- and more.
Fully automated literature review platforms are additionally available but are best applied for exploratory investigations.
In this article, commonly available tools for literature review are expounded upon with a special focus on their utility for completing guidance-derived, methodologically-sound procedures for collection, screening, and analysis of data for clinical evaluation.
The purpose of this article is to consider the impact of AI-powered features of literature review platforms on medical device regulatory compliance, including adherence to the systematic methods identified in MEDDEV 2.7/1 revision 4.
Learning objectives:
- Discover which article screening processes for filtration and appraisal may be assisted by semi-automated, AI-powered features of literature review platforms.
- Learn how fully automated literature review tools may be employed to gain additional efficiencies through exploratory investigation of the article screening, data collection, and evidence synthesis steps.
About the authors:
Sara VanWyk, MPH, CCRP, RAC-Devices, MWC
Principal Medical Writer at Arthrex, Inc.
She has 10 years of experience in writing for compliance with the EU Medical Device Directive 93/42/EEC and Regulation (EU) 2017/745. Her area of expertise includes drafting clinical evaluation plans and reports.
Anthony N. Khoury, PhD
Senior Scientific Specialist at Arthrex, Inc.
He provides expert scientific guidance and technical support for biomechanical engineering and clinical research studies. He also contributes to strategic research and regulatory initiatives that are critical to new product development and the safety and efficacy of orthopaedic medical devices.
Elaine Schmidt, MSc, MWC
Senior Medical Writer at Arthrex, Inc.
She has more than five years of experience in writing for compliance with the EU Medical Device Directive 93/42/EEC and Regulation (EU) 2017/745 and conducting systematic literature reviews for clinical evaluation plans and reports.
This article is intended for educational purposes only and does not replace independent professional judgement. The authors have no relevant financial or non-financial relationship with any of the products or services described, evaluated, or reviewed in the article. This work was supported by Arthrex, Inc.
Specification:
11 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the May 2026 issue of the Journal of Medical Device Regulation.
