How evidence, regulation and innovation shape safer technologies — and how CROs like Tigermed EMEA support this process.
Introduction
Medical devices are evolving faster than ever: AI-powered diagnostic systems, connected wearables, implantable sensors, robotic surgical tools. But no matter how advanced the design, a device becomes truly valuable only when its safety and performance are demonstrated through clinical evidence.
Under today’s regulatory environment — especially EU MDR 2017/745 — clinical studies are no longer optional or limited to high-risk technologies. They are a strategic and scientific necessity.
At Tigermed EMEA, we support sponsors in navigating this demanding landscape by designing, executing and reporting clinical investigations that meet the highest European and international standards.
Why Clinical Studies Matter More Than Ever
1. Ensuring Patient Safety
Clinical investigations identify risks in real-world conditions — usability issues, device–patient interactions, adverse events, or technical failures.
MDR 2017/745 requires that all claims of safety and performance must be supported by clinical data. This shift has raised the quality bar for all device classes, not only implants.
2. Demonstrating Real Clinical Performance
A medical device must prove it delivers the clinical benefit claimed — whether improving diagnostic accuracy, restoring physiological function, or supporting treatment outcomes.
MHRA’s statistical guidance highlights the need for:
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a clear protocol.
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justification of sample size.
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predefined endpoints.
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validated statistical methods.
Without these elements, evidence is not considered reliable.
3. Regulatory Approval and CE Marking
For many devices, especially Class III and implantable, clinical investigations are mandatory.
The MDCG 2021-6 Guidance details strict expectations for design, authorization, conduct and reporting of clinical studies.
Robust evidence is essential for achieving CE marking under the MDR — and for maintaining it through continuous PMCF activities.
4. Building Trust with Physicians and Patients
Clinical data is more than a regulatory requirement. It is the foundation of credibility:
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Healthcare professionals rely on data to adopt new technologies.
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Patients trust devices with proven outcomes.
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Regulators require transparency and scientific justifications.
Well-designed studies accelerate market acceptance and strengthen the reputation of the sponsor.
5. Evidence-Driven Innovation
Clinical studies often reveal insights that shape future product development — highlighting strengths, limitations, patient subgroups or new use cases.
A 2024 DIHK industry survey shows that 48% of med-tech companies now require additional clinical investigations under MDR for legacy devices, demonstrating how essential clinical evidence has become in Europe.
How Tigermed EMEA Supports Successful Clinical Investigations
As a global CRO with strong European operational capabilities, Tigermed EMEA provides end-to-end support for medical device clinical research, including:
- Study design aligned with MDR, MDCG and ISO 14155
We ensure your clinical strategy meets regulatory expectations from the start.
- Regulatory submissions & ethics approvals
Our teams manage complex EU submissions and communication with Competent Authorities.
-Patient recruitment & site management
We work with experienced investigators across Europe to ensure efficient recruitment and high-quality data collection.
- Monitoring, data management & biostatistics
Our oversight guarantees that every datapoint is accurate, verifiable and statistically robust.
-PMCF studies and real-world evidence
We support sponsors throughout the device lifecycle, ensuring post-market compliance and continuous evidence generation.
Conclusion
In today’s med-tech ecosystem, clinical studies are not just a mandatory step — they are a strategic differentiator.
They ensure safety, validate performance, accelerate CE marking, build market trust and fuel innovation.
Tigermed EMEA stands beside sponsors throughout this journey, offering the scientific expertise, regulatory understanding and operational excellence needed to bring high-quality medical devices to patients safely and efficiently.
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