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:
- Clinical investigations on the device itself (carried out by the manufacturer),
- Published scientific literature on the device or an equivalent device (from peer-reviewed journals),
- Clinically relevant information from post-market surveillance (PMS), particularly Post-Market Clinical Follow-up (PMCF).
By starting early on data collection, manufacturers can build a proactive strategy. Key questions to guide this process include:
- What evidence is already available?
Are there existing clinical studies, published literature, registry data, or data from equivalent devices?
- Is the evidence sufficient?
Does it support the intended purpose, indications, clinical benefits, and all device claims? Is the data high-quality and representative of the target population?
- Are there gaps?
What data is missing, and how can it be addressed? Is a new clinical investigation required, or would a robust PMCF survey be sufficient?
Key Benefits of Starting Data Collection Early
- Supports Article 61 & Annex XIV requirements
Early data ensures sufficient clinical evidence to prove conformity with General Safety and Performance Requirements (GSPRs). - Straightforward Notified Body review
Robust, well-documented data reduces the risk of major non-conformities and delays during conformity assessment. - Facilitates Clinical Evaluation Report (CER) writing
Early evidence is an essential input for the CER, which also must be maintained as a living document throughout the device lifecycle. - Feeds design and risk management
Collecting data during product development highlights potential safety or performance issues, allowing corrective actions before design freeze. - Solid foundation for PMCF activities
Early data collection sets up meaningful Post-Market Clinical Follow-up (PMCF) plans, ensuring ongoing compliance. - Reduces time-to-market risks
Avoids last-minute evidence gaps that could delay CE marking. - Cost efficiency
Identifying evidence gaps early prevents expensive redesigns or additional trials later.
Risks of Delaying Clinical Data Collection
- Regulatory setbacks
Insufficient clinical evidence often leads to major non-conformities, delaying CE marking or triggering costly remediation. - Extended timelines for clinical studies
If a new investigation is required, planning and execution can take months or years, significantly delaying market entry. - Economic losses
Delays in CE marking translate into postponed commercialization and lost revenue opportunities. - Dropped claims or indications
If data is insufficient to support a specific claim, it must be removed, reducing the device’s market potential and competitiveness.
Takeaway
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.
Looking to strengthen your clinical data collection strategy?
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.