PMCF Under MDR: Generating Robust and Defensible Post-Market Clinical Evidence

PMCF Under MDR: Generating Robust and Defensible Post-Market Clinical Evidence
The European Medical Device Regulation (MDR) has fundamentally reshaped Post-Market Clinical Follow-Up (PMCF), transforming it from a reactive or occasional activity into a mandatory, continuous, and proactively scrutinized process. Today, PMCF is no longer assessed in isolation, but as a core element feeding clinical evaluation, risk management, post-market surveillance, and, where applicable, the Summary of Safety and Clinical Performance (SSCP).

Within this regulatory framework, many medical device manufacturers continue to face significant challenges in translating MDR requirements into effective and sustainable PMCF strategies. Common pain points include defining proportionate PMCF activities, identifying appropriate real-world data sources, ensuring methodological rigor and data integrity, and maintaining alignment across PMCF, PMS, and clinical documentation: often under tight budget and resource constraints.

This webinar will explore PMCF under MDR from multiple complementary perspectives.
First, it will address the main criticalities encountered by manufacturers, highlighting where PMCF strategies most frequently fail to meet regulatory expectations, particularly in relation to legacy devices, survey-based data collection, and the use of real-world clinical evidence.

Second, the session will incorporate the Notified Body perspective, drawing on Bureau Veritas’ experience in reviewing technical documentation. This part will focus on the most common deficiencies observed during PMCF assessments, including gaps in methodological justification, insufficient traceability and data governance, weak integration of PMCF outputs into clinical evaluation and risk management, and the misuse or over-reliance on low-quality real-world data.

Finally, 1MED will present practical and sustainable strategies to design PMCF activities that are both compliant and defensible, without imposing unnecessary operational or financial burden on manufacturers. Emphasis will be placed on proportionate, risk-based approaches; the correct use of surveys and real-world data; early alignment with Notified Bodies; and the implementation of structured, integrity-assured data collection models capable of withstanding regulatory scrutiny.

By combining regulatory insight, Notified Body experience, and hands-on implementation strategies, this webinar aims to provide manufacturers with a clear and realistic roadmap for generating robust post-market clinical evidence under MDR: evidence that is not only compliant, but credible, defensible, and sustainable over the entire device lifecycle.