Join experts from BSI and Purdie Pascoe for this complimentary webinar to explore the correct application of Article 61(10) under the EU MDR and the critical role of PMCF surveys in supporting compliance.
Register now for our upcoming 60-minute live webinar in which PMCF Manger from Purdie Pascoe, Chris Webb, will be joined by Breda Kearney Clinical Regulatory Lead from BSI.
Why attend?
Many manufacturers misapply Article 61(10), risking non-compliance. This session will clarify when and how it should be used, what documentation is still required, and how PMCF surveys can support your regulatory strategy—especially when pre-market data collection is not feasible or ethical.
These leading experts unpack critical PMCF strategies, share real-world survey experiences, and offer insights on bridging data gaps to achieve regulatory success.
Key takeaways
Notified Body Perspective: Gain regulatory insights into the correct interpretation and application of Article 61(10).
Effective PMCF Strategies: Learn how to implement PMCF surveys, including real-world case studies (Level 8 and Level 4 surveys) where market data collection is ethically challenging.
Strategic MDR Submissions: Understand why collecting data on legacy devices now is essential for successful MDR submissions.
Ready to unpack Article 61(10) and strengthen your PMCF strategy?
Don’t miss this opportunity to gain practical, insider insights from leading experts.
Purdie Pascoe PMCF survey expertise
Purdie Pascoe has developed a best-practice approach, approved by EU regulators and compliant with ISO requirements and GDPR regulations, for PMCF surveys. We can support you with the design, implementation, data collection and reporting of your PMCF surveys to ensure you collect appropriate PMCF data to be used within your MDR submissions.