Do Medical Devices Need Real-World Data (RWD) and Evidence (RWE)?
In this blog, we discuss the value of real-world data (RWD) and evidence (RWE) for medical devices, and how to collect RWDs for them. Traditional clinical trials have limitations in capturing all real-life clinical scenarios. Post-Market Surveillance (PMS) is therefore required to ensure safety and efficacy in real-world settings. Here, we focus on when RWD/RWE is needed, and their benefits and limitations.
What is Real-World Data (RWD) and Evidence (RWE)?
Real-World Data (RWD) refers to data relating to patient health status and/or the delivery of healthcare collected outside a research setting. Sources include patients, clinicians, registries, or electronic medical records. Real-World Evidence (RWE) is clinical evidence regarding a product’s use and potential benefits or risks derived from analysis of RWD.
Why Do We Need RWD/RWE?
Controlled clinical trials generate evidence on intended use but cannot cover all patient populations or long-term monitoring. RWD complements controlled trial data by capturing real-life performance and safety.
Two Main Drivers for RWD/RWE in Medical Devices
1. Controlled studies cannot provide lifetime safety and performance evidence or cover all populations. Under EU MDR, manufacturers must provide continuous evidence after CE marking. PMCF activities often rely on RWE.
2. Patient-centric and cost-effective evidence generation. RWD comes from existing medical records, reducing costs compared to new trials. The US FDA recommends its use where suitable.
Benefits of RWD/RWE
Generates unique clinical data: e.g., patient feedback on quality of life or pain via PROs.
Cost-effective: Data is drawn from routine care, reducing costs and enabling long-term monitoring.
Lower patient burden: Participation fits into routine care, easing recruitment and ethical approval.
Supports PMS and PMCF: Enables long-term monitoring of safety, performance, and broader patient populations.
Does EU MDR Require RWD/RWE?
While MDR does not explicitly require RWD/RWE, it mandates PMCF, which encourages real-world data collection as part of continuous monitoring.
Efficient Ways to Collect RWD
Advances in digital technology have made tools like EDC (Electronic Data Capture), eCRF (Electronic Case Report Form), and ePRO (Electronic Patient Reported Outcome) more accessible. These platforms improve data quality, reduce study costs, and can be used for PMCF activities.
