Insights from the RAPS Euro Convergence in Brussels
The Purdie Pascoe Post Market Clinical Follow-up (PMCF) team was out in full force at this year’s Regulatory Affairs Professionals Society (RAPS) convergence in Brussels.
Marcus Torr, PMCF/MDR Lead, attended with newly appointed PMCF Commercial Director, Ellie Baker and PMCF Managers, Chris Webb and Tonika Chester. The team jumped on the Eurostar from our London office to set up our exhibition booth, excited to kick-start conversations with leading regulatory and medical professionals at the biggest regulatory event in Europe.
Marcus’ presentation with Gavin Quigley, MBChB FRCS MBA, Senior Internal Clinician from BSI ‘Mastering PMCF data collection: How to overcome challenges with PMCF Surveys’ was a conference highlight, drawing a packed room of delegates.
Key Takeaways
Post-Market Clinical Data Collection: A Global Imperative
There is growing criticality of real-world clinical data collection in the post-market space. Regulatory expectations continue to evolve, with increasing emphasis not only on pre-market evidence but also on ongoing validation of device safety and performance throughout the product lifecycle.
The level and rigor of post-market clinical data collection must be tailored to the characteristics and intended purpose of the device. High-risk or novel devices often require more robust data, including clearly defined clinical endpoints and statistically powered sample sizes, to ensure meaningful, actionable insights.
While these requirements are strongly emphasised under the EU Medical Device Regulation (EU-MDR)—through activities like Post-Market Clinical Follow-up (PMCF) and Post-Market Performance Follow-up (PMPF)—this is not just a European obligation. Global regulators, including those in the U.S. (FDA) and China (NMPA), are moving towards greater reliance on real-world evidence (RWE) in post-market surveillance.
Importantly, the transferability of data across regions should be proactively considered. Aligning on methodology, endpoints, and patient populations across regulatory jurisdictions can help streamline evidence generation and maximise the value of post-market data globally.
The Cost of Compliance: How the EU-MDR Challenges Innovation
The EU MDR, despite its goal of ensuring patient safety and device performance, is placing significant pressure on industry innovation and competitiveness. The regulations requirements for robust clinical evidence, strict equivalence criteria and continuous post-market surveillance applies equally to new devices and well-established technologies. As a result, manufacturers, especially SMEs, face the pressure of reallocating substantial time, resources and funding away from research and development towards regulatory compliance. This shift is impacting innovation pipelines, and in some cases, leading to the withdrawal of legacy devices from the EU market due to poor return on investment.
The burden is further intensified by the limited availability and capacity of Notified Bodies, creating long certification timelines and market access delays. For many manufacturers, the costs associated with demonstrating EU MDR compliance outweigh the commercial value of certain medical devices, and as such, this is prompting more manufacturers to prioritise innovation-friendly markets like the U.S., where regulatory pathways are relatively faster and more predictable. Without targeted reforms, alignment or better support for manufacturers, the MDR risks undermining the EU’s role as a global leader in medical device innovation.
Article 61(10) within the EU MDR
There is a clear over-reliance or misunderstanding of Article 61(10) within the EU MDR. Multiple talks from Notified Bodies outlined how to interpret Art. 61(10) and how continues to be a hot topic in the Team NB meetings. Art. 61(10) should only be used when the device doesn’t have a direct clinical benefit AND when “Clinical data is not-deemed appropriate” which really means collecting pre-market clinical data is not feasible, ethical, or clinically relevant safety and/or performance endpoints cannot be attributed to the device. A common mistake from manufacturers is claiming their device has an indirect benefit and applying Art. 61(10) even when clinical data on the device is available.
To justify applying Art. 61(10) manufacturers must address, risk management, device-body interaction, intended clinical performance and any claims the device has. That being said, if the use of Art. 61(10) can be justified there is still a need for manufacturers to produce a CEP, CER, PMS and most notably PMCF. In these cases where collecting pre-market clinical data isn’t feasible or ethical, it has been shown that PMCF surveys can be an effective tool to monitor and confirm the safety and performance of Art. 61(10) device once it’s placed onto the market.
Post Market Surveys: Purdie Pascoe in the Lead
Ellie Baker recently joined Purdie Pascoe as PMCF Commercial Director, and it was her first time attending the RAPS Euro Convergence. Ellie commented: “Attending my first RAPS Convergence in Brussels proved invaluable for deepening my understanding of the evolving MDR landscape. The congress reinforced that Post Market Clinical Follow-Up is firmly established as a critical regulatory requirement rather than an optional consideration for medical device manufacturers. There is a growing need for strategic PMCF implementation, and the importance of working with a partner who has true expertise in this area. This is exactly what Purdie Pascoe delivers. It was great to be involved in insightful and meaningful conversations with industry experts and see so many delegates eager to engage and learn from our PMCF specialists, it truly showcased the depth of knowledge in our team and why we are a consistently chosen partner to help clients navigate regulatory complexities. I’m excited to work with such a talented team and be on the journey to further strengthen our service offerings”.