Webcast now available, featuring expert presenters Edward Nobrega, Principal Clinical Evaluation Scientist at Boston Scientific, Breda Kearney, Clinical Regulatory Lead at BSI, and Marcus Torr, Head of Post Market Surveys at Purdie Pascoe.

This article explores the role of post-market RWD/RWE in establishing sufficient clinical evidence for legacy devices transitioning to the MDR. It outlines key data sources, explains how off-label data can be captured and used, shares Notified Body perspectives and case study examples, and considers how post-market surveys can generate high-quality RWD. It concludes with practical guidance on integrating these data into an ongoing clinical evidence strategy.

With 2026 marking the Regulatory Affairs Professionals Society’s 50th anniversary, the atmosphere felt especially energised. Between packed auditoriums, poster sessions, and many conversations, one thing became increasingly clear: post-market evidence generation is entering a far more mature and strategically important phase.

We are thrilled to announce that Marcus Torr, Head of Post Market Surveys at Purdie Pascoe, has been selected for the MedTech Leading Voice (MLV) list for a second year in a row. Marcus regularly shares his expertise at industry events and on LinkedIn. We are incredibly proud to see him featured in the prestigious MLV100 list. Don't miss his future insights by following him on LinkedIn.

We are delighted to be attending, sponsoring and presenting at the RAPS Euro Convergence from 5-8 April in Lisbon. Purdie Pascoe’s Post Market Survey experts Marcus Torr (Head of Post Market Surveys) Ellie Baker (Commercial Director) Alice Robertson (Research Manager) and Ruby Pogson Jones (Senior Research Executive ) are exhibiting on booth 31.

The 2026 MedTech Clinical Network Conference, hosted by TT Life Sciences in Brussels, brought together clinical leaders from across Europe at a pivotal time for the MedTech sector. Rather than simply revisiting regulatory updates, this year’s discussions focused on a broader challenge: how organisations can navigate uncertainty, strengthen clinical strategy, and generate evidence that delivers both regulatory assurance and commercial value.

Real-World Evidence (RWE) is playing an increasingly important role in global MedTech regulatory decision-making, supporting evidence generation across the product lifecycle, from pre-market submissions to post-market surveillance. Watch this webcast which features industry experts to understand how MedTech manufacturers can build effective, compliant RWE strategies.

As part of compliance with the EU Medical Device Regulation (MDR), the manufacturer of a Class III guidewire needed to generate robust Post Market Clinical Follow-Up (PMCF) data to confirm ongoing safety and performance. The study was designed to evaluate two key endpoints: procedural success, and freedom from adverse events.

As regulators worldwide including the FDA and EU Notified Bodies place greater emphasis on RWD, the industry faces a familiar but intensified challenge: how to generate high-quality, device-specific evidence efficiently, reliably, and without escalating costs. That’s where Post-Market Surveys come in.

In this piece, Marcus Torr, Head of Post Market Surveys, shares his reflections on the discussions shaping the regulatory landscape, the themes emerging across both events, and how continued collaboration can drive meaningful improvements in patient safety and lifecycle management.

By analysing data through a more granular lens, including disaggregation by gender, we can uncover meaningful insights, identify differential responses, and ultimately drive more equitable outcomes for all patient groups. Doing so also supports alignment with regulatory expectations around inclusive and evidence based post-market surveillance.

Are you attending the RAPS European Lifecycle Management Conference from 28-29 October? Purdie Pascoe’s Head of Post Market Surveys, Marcus Torr will be attending and presenting.

Post-Market Clinical Follow-up (PMCF) surveys can help address clinical data gaps that may impact the ongoing assessment of a medical device’s safety and performance. Unearthing clinical gaps requires a systematic approach, including a review of clinical literature, post-market surveillance data, and regulatory compliance standards.

We are delighted to be attending MedDev Day from 13-14 October 2025 in Budapest. Purdie Pascoe’s Head of Post Market Surveys, Marcus Torr will be attending and presenting at the conference.

We are delighted to be the exhibiting at the RAPS Convergence, 7-9 October 2025 in Pittsburgh, US. Purdie Pascoe’s Post Market Survey experts Ellie Baker, Commercial Director and Chris Webb Research Manager | RCC- MDR are exhibiting on Booth 817.

Experts presenters from across the industry; Breda Kearny - Clinical Regulatory Lead, BSI, Diane M. Legere - Senior Clinical Auditor, DNV, Marcus Torr - Head of Post Market Surveys, Purdie Pascoe and Efsthathios Vassiliadis - CEO, Evnia.

In this session, Breda Kearney, Clinical Regulatory Lead from BSI and Chris Webb, Research Manager and PMCF expert from Purdie Pascoe explore the correct application of Article 61(10) under the EU MDR and the critical role of PMCF surveys in supporting compliance.

Harry Thomas is our dedicated Data Quality Assurance Officer at Purdie Pascoe. In this interview, Harry shares insights about his role and key processes from handling discrepancies or anomalies in collected data to how to adapt when working with new or evolving data collection technologies.

Our client’s device is used for a specific indication, however users identified a potential benefit of the device’s design to perform for another indication. This study differs from typical PMCF efforts, with an aim to update the device’s labelling (IFUs) with safety and feasibility data for the expanded use. Find out how we heled out client in collecting retrospective real-world data to support the indication expansion.

Ellie Baker recently joined Purdie Pascoe as PMCF Commercial Director. In this interview, Ellie shares why medical device manufacturers consider PMCF surveys, how she helps guide clients through the complexities of the MedTech landscape and how her first few weeks have been at the business.