Clinical data is the backbone of medical device compliance under the EU MDR, and yet it is still one of the most neglected aspects during product development. Too often, manufacturers channel their energy into engineering milestones, technical testing, and regulatory submissions, only to discover late in the process that their clinical evidence strategy is underdeveloped. In the course of EU MDR, this oversight doesn’t just slow progress, it can result in costly delays, lost claims, and serious compliance risks.
Clinical evaluation is a continuous process throughout the device lifecycle. Data collection must begin during product development, not just at the point of regulatory submission. Clinical data collection is often overlooked early in development stages, but under EU MDR this oversight is a major compliance risk.
As highlighted in our recent blog How to Smartly Write a Clinical Evaluation Under the EU MDR, one of the most effective strategies is to start early. The primary goal of clinical evaluation under MDR is to demonstrate sufficient evidence to support conformity with the General Safety and Performance Requirements (GSPRs). This evidence must confirm that the device delivers safety, performance, and an acceptable benefit-risk ratio under normal conditions of use. Notified Bodies frequently flag insufficient data collection as a major non-conformity. To counter this, early planning significantly reduces the risk of findings that can delay CE marking.
It is also important to recognize that clinical data is broader than clinical studies alone. According to EU MDR Article 2(48), clinical data includes information on safety and performance and can be sourced from:
By starting early on data collection, manufacturers can build a proactive strategy. Key questions to guide this process include:
Are there existing clinical studies, published literature, registry data, or data from equivalent devices?
Does it support the intended purpose, indications, clinical benefits, and all device claims? Is the data high-quality and representative of the target population?
What data is missing, and how can it be addressed? Is a new clinical investigation required, or would a robust PMCF survey be sufficient?
Early clinical data collection under EU MDR is more than a regulatory obligation: it is a strategic advantage. Forward-thinking manufacturers now integrate clinical evidence planning into product development, to build stronger compliance foundations, reduce risk, and position their devices for a faster, more successful market entry.
Get in touch with us today. Whether you’re still in the product development stage or already navigating later phases of the device lifecycle, our experts can help you design a proactive, compliant, and cost‑effective approach to clinical evidence under EU MDR. Partnering with us means fewer risks, smoother reviews, and faster market access.