Sufficient clinical evidence for medical devices – What is the role of post-market real-world data?

English

Abstract:

Generating sufficient clinical evidence under Regulation (EU) 2017/745 on medical devices (MDR) remains a key challenge for manufacturers, particularly for legacy devices transitioning to the MDR, where pre-market data alone may be insufficient to demonstrate safety, performance, and benefit-risk across real-world use. This article by Breda Kearney, Fintan Bergin, Marcus Torr, Isabel Bradshaw and Timothy Wong explores how real-world data (RWD) and real-world evidence, collected through structured Post-Market Clinical Follow-up (PMCF) activities, can be strategically leveraged to address evidence gaps and support CE marking and ongoing compliance. Drawing on Notified Body perspectives and practical case studies – including chart reviews, user surveys, and registry-based analyses – the article illustrates how RWD can be used to strengthen clinical evaluations, support label expansion, and inform regulatory decision-making. The article also provides actionable guidance on designing robust data collection methodologies, with a particular focus on surveys, to ensure sufficient evidence in terms of quality, relevance, and reliability. By adopting a proportionate and methodologically rigorous approach, manufacturers can effectively integrate RWD into their clinical evidence strategy, enabling both compliance and continuous improvement in device performance and patient outcomes.

 

Learning objectives:

• An understanding of what RWD is, where it comes from, and how it fits into MDR clinical evidence and PMCF obligations – including a Notified Body perspective on what makes RWD acceptable for conformity assessment.
• Practical case study examples showing how patient chart reviews, surveys, and registry studies have been used to bridge evidence gaps for legacy device CE marking and label expansion.
• Actionable guidance on designing compliant, high-quality post-market surveys; covering protocol design, sample size, recruitment, data capture, and quality control.
• Advice on how to integrate RWD findings into clinical documentation to support ongoing MDR compliance.

 

About the authors:

Breda Kearney, MSc, is a clinical regulatory lead with the British Standards Institution (BSI). She has over 15 years of experience in Quality Management Systems and regulatory compliance. In recent years, she completed her master’s in medical technology regulatory affairs. Her thesis specialised in clinical evaluation and real-world evidence, leading to the publication of several peer-reviewed articles.

Fintan Bergin, MB BCh BAO FRCSI FRCS (General) is a senior internal clinician at BSI and is also in active practice as a consultant surgeon specialising in general and colorectal surgical procedures. He has worked at BSI for almost eight years, where he provides his clinical expertise and oversight to the clinical conformity assessment of a range of medical devices.

Marcus Torr, MSc, is the Head of Post Market Surveys at Purdie Pascoe, having joined in 2015. He has led and grown the Post Market Survey team at Purdie Pascoe for the last six years, which provides post-market survey solutions to the medical device industry (including PMCF, Post-Market Performance Follow-up and wider real-world data collection). He has extensive knowledge of the specific post-market survey requirements, having overseen over 600 surveys for a variety of manufacturers and device types. These surveys have been approved by several of the leading Notified Bodies and collect both Level 4 and Level 8 data. He has a first-class Master of Science degree in natural sciences from the University of Bath.

Isabel Bradshaw, MSc, is a Senior Research Executive on the Post Market Surveys team at Purdie Pascoe. She has gained experience in implementing high-quality patient/case-specific Level 4 and general/usability Level 8 surveys since 2022. She supports the Post Market Survey team during all survey stages, such as designing questionnaires, data collection, and reporting. She has a bachelor’s degree in politics from the University of Sheffield and a master’s in social research methods from the University of Surrey.

Timothy Wong, MSc, is a Research Executive on the Post Market Surveys team at Purdie Pascoe. He joined in 2024 and gained experience in designing and implementing both high-quality patient/case-specific Level 4 and general/usability Level 8 surveys. He has a bachelor’s degree in medical biosciences from Imperial College London and a master’s degree in pharmacology from the University of Oxford.

 

Specification:

17 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.