Insights from RAPS Euro Convergence 2026: What the industry is really talking about
Sunshine, seafood, pastel de nata, and some of the biggest regulatory questions facing the medical device industry. This year’s RAPS Euro Convergence in Lisbon delivered all four in equal measure.
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.
The Purdie Pascoe Post Market Survey team attended the conference in full force, with Marcus Torr, Head of Post Market Surveys, joined by Ellie Baker, Commercial Director, Alice Robertson, Research Manager, and Ruby Pogson Jones, Senior Research Executive. Alongside exhibiting throughout the conference, Marcus and Alice delivered a very well-attended presentation titled ‘Real Data, Real Results: Unlocking the Power of Post-Market Surveys’, while Ruby presented a poster exploring ‘How to generate Real-World Data through Post Market Surveys’.
Key takeaways
Off-label use: From compliance challenge to strategic opportunity
A recurring theme throughout the conference was the issue of off-label use, particularly how manufacturers should respond when off-label observations arise from routine post-market data collection. This topic was not confined to the formal presentations; it consistently emerged in corridor conversations and networking discussions, highlighting its significance within the industry.
There was a palpable sense of uncertainty regarding how to address these observations. Key questions included: at what point does off-label use become significant enough to warrant intervention? Is it possible to use off-label data constructively? And, crucially, what constitutes a credible evidence strategy when seeking to support label expansion? These questions underpinned much of the dialogue, reflecting the industry's ongoing efforts to define clear boundaries and best practices.
Our own session, "Real Data, Real Results: Unlocking the Power of Post-Market Surveys", tackled this topic directly. We presented a real-world case study demonstrating how a structured approach to collecting off-label data can underpin a successful label expansion strategy. The high level of engagement and numerous follow-up questions we received underscored the industry's appetite to continue this conversation.
We are committed to driving this dialogue forward. Join us for our upcoming webinar, "Off-Label? Don't Panic: A Strategic Approach to Real-World Data". In this session, Marcus Torr will be joined by Breda Kearney, Clinical Regulatory Lead at BSI, and Edward Nobrega, Principal Clinical Evaluation Scientist at Boston Scientific. Together, they will explore how manufacturers can develop strategic, portfolio-wide approaches to real-world data collection, transforming off-label observations into structured evidence strategies. Register here >
PMPF for IVDs is becoming far more sophisticated
Another big takeaway from Lisbon was the growing maturity of PMPF approaches for IVDs, and how closely they are beginning to align with best-practice PMCF methodologies.
There is still plenty for the industry to explore, particularly around ensuring surveys reaching the right users to accurately capture real-world use. But increasingly, the same principles underpinning high-quality PMCF programmes are proving highly transferable to PMPF evidence generation.
One case study presented during the conference brought this into sharp focus. The example centred on a Next Generation Sequencing (NGS) laboratory service using a single tumour biopsy to generate patient-specific genomic profiles, with results interpreted by healthcare professionals responsible for treatment decisions.
What stood out was not simply the technology itself, but the methodology behind the evidence collection. Before a single clinical question was asked, the survey design validated whether respondents were genuinely positioned to provide meaningful insight, confirming involvement in patient care, prescribing responsibility, and access to patient records. From there, the survey captured not only clinical context and disease stage, but real-world performance outcomes: whether clinically relevant biomarkers were identified, whether treatment decisions changed, and whether patients ultimately improved as a result.
This is where PMPF becomes genuinely valuable. The most effective post-market evidence strategies are no longer simply measuring whether a device works in theory; they are capturing how clinical decision-making changes in practice. And that is increasingly the kind of evidence regulators want to see.
Regulators are scrutinising the process, not just the outcome
One of the strongest themes running throughout the conference was the industry’s growing recognition that regulators are no longer simply assessing whether manufacturers can produce Real-World Data (RWD), they are assessing whether the process used to generate that evidence can withstand scrutiny.
That distinction matters. Real-world environments naturally produce complexity: incomplete datasets, inconsistent reporting, and unstructured information. Yet under the EU MDR and ISO 14155, manufacturers are increasingly expected to demonstrate that their evidence-generation methodologies are structured, traceable, and defensible from end to end.
There was a noticeable shift in conversation this year away from “how much data do we have?” towards “how robust was the process used to generate it?”
For PMCF activities in particular, this places much greater emphasis on survey methodology, respondent validation, auditability, and evidence integrity. Data quality is no longer defined purely by outcome; it is defined by whether manufacturers can demonstrate confidence in the system behind the outcome.
At RAPS this year, the organisations leading the conversation were not necessarily those collecting the most data, but those building the most credible frameworks for generating it.
AI, SaMD, and counterfeit devices are exposing the next surveillance challenges
Another theme was around how quickly post-market expectations are evolving, particularly around AI and Software as a Medical Device (SaMD). The topic repeatedly surfaced throughout poster presentations and speaker sessions around the growing gap between the pace of technological innovation and the readiness of regulatory systems to support it.
For SaMD in particular, continuous updates are often inherent to the product itself. That creates a fundamental challenge for traditional regulatory frameworks, which were not necessarily designed around technologies that evolve so dynamically post-launch.
AI adoption raised similar concerns. Many discussions focused not on whether organisations should adopt AI, but how they can do so consistently and safely across multiple departments and systems. One department may gain efficiency from implementing AI-enabled tools, but fragmented adoption can quickly create operational friction, governance gaps, and evidentiary inconsistencies elsewhere in the business.
Another particularly thought-provoking discussion focused on falsified medical devices and fraudulent certification.
One of the more interesting questions raised during the session was whether post-market surveillance could play a more proactive role in counterfeit detection. Many of the devices best suited for PMCF activities, high-volume, implantable, or transient-use devices, are also among those most vulnerable to duplication within global supply chains.
In several previous PMCF projects conducted by Purdie Pascoe, healthcare professionals reporting adverse events or device performance concerns were asked to return the device to the manufacturer for further investigation. Wider adoption of this type of approach could potentially help manufacturers determine whether failures stem from genuine device issues or counterfeit products entering the supply chain.
It was one of several conversations during the week that highlighted how post-market surveillance is expanding far beyond a purely compliance driven function. Increasingly, it is becoming a source of broader strategic, operational, and even supply chain intelligence.
Looking ahead
This year’s RAPS Euro Convergence was more than just a regulatory conference. The conversation is no longer simply about collecting data, it is about whether manufacturers can generate evidence that is credible, traceable, strategically useful, and reflective of real-world clinical practice.
As regulatory expectations continue to evolve, organisations with the strongest evidence-generation frameworks will be the ones best positioned not only to maintain compliance, but to turn post-market insight into genuine competitive advantage.