Insights from RAPS European Clinical, Risk and Postmarket Surveillance Conference
Purdie Pascoe Post Market Clinical Follow-up (PMCF) Survey experts, Marcus Torr and Chris Webb recently attended the RAPS European Clinical, Risk and Postmarket Surveillance Conference in Barcelona, Spain.
More than 100 regulatory professionals convened for a two-day event to delve into the latest and most critical policies and updates concerning clinical practices, risk management, and postmarket surveillance.
Marcus and Chris, along with Gavin Quigley MBChB FRCS (Neurosurgery) MBA, an internal clinician in BSI’s Clinical Oversight group, presented a paper titled ‘How to Effectively Collect Level 4 Clinical Data with High Quality PMCF Surveys.’ A wide range of delegates attended the session to learn about what constitutes a high-quality Level 4 PMCF survey, when such surveys are appropriate, and the steps required to implement them effectively to obtain high-quality PMCF data.
Key conference takeaways from our PMCF experts:
Harmonisation across the MDR
There is a significant need for improved harmonization within the Medical Device Regulation (MDR) framework. The recent announcement that the EU Commission is considering reforms to MDR principles highlights this need, and steps are being taken to foster a more unified approach. Better communication across the industry, such as structured dialogue between manufacturers and Notified Bodies can help provide clear guidance on navigating the complex regulatory landscape for medical devices.
Clinical Evaluation
The timeline for bringing a medical device to market is long and complex, requiring extensive effort. The work, however, doesn’t end there....once in the post-market phase, it is crucial to continuously monitor, assess, and update the clinical evaluation for each device. The benefit-risk assessment and PMCF requirements under the MDR are clear but can be an ongoing challenge for MedTech manufacturers. To enhance the robustness of PMCF, real-world evidence and data should be harnessed, such as cost-effective PMCF surveys. It is important to structure PMCF data collection approaches based upon each individual device; therefore, adequate time and resources must be allocated during the planning stages.
State of the Art (SOTA)
This is a crucial aspect of clinical evaluation and must be clearly defined and justified through a strong appraisal process. A well determined SOTA will have a huge impact on the safety and performance endpoints and acceptance criteria that are set. Notified Bodies continue to receive plans that lack clear justification, including ambiguous search terms and unclear inclusion an/or exclusion criteria for literature searches that are being used for SOTA assessments.
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.
