PMCF expertise published in Journal of Medical Device Regulation 2026
Sufficient clinical evidence for medical devices – What is the role of post-market real-world data?
Published in the JMDR May 2026 Issue
Authors: Marcus Torr, Isobel Bradshaw, Timothy Wong, Breda Kearney and Fintan Bergin
Learning objectives:
An understanding of what real-world data (RWD) is, where it comes from, and how it fits into Medical Device Regulation (MDR) clinical evidence and Post-Market Clinical Follow-up (PMCF) obligations – including a Notified Body perspective on what makes RWD acceptable for conformity assessment.
Practical case study examples showing how patient char reviews, surveys, and registry studies have been used to bridge evidence gaps for legacy device CE marketing 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
Complete the form below to receive the complimentary article:
Privacy Note: At Purdie Pascoe, we occasionally share the latest MedTech news and insights that we believe may be of interest to you. We will only contact you about topics relevant to your preferences. Your privacy is important to us — you can unsubscribe from our communications at any time. For more information, please see our Privacy Policy.