There is a paradox in medical device research that is rarely discussed openly.
The most controlled, expensive and rigorously monitored method of generating clinical evidence (the interventional trial) often produces evidence that becomes less useful once the device enters real clinical practice.
Clinical trials typically ask: Does the device work under optimal conditions, with selected patients, expert investigators and intensive follow-up?
Healthcare systems ask something else: Does it work in routine practice, with real patients and real constraints?
This is the question Real-World Evidence (RWE) answers.
MDR and the rise of post-market data
The EU Medical Device Regulation (EU) 2017/745 has unintentionally accelerated the development of real-world data infrastructures.
Through requirements such as PMCF programs, periodic safety reporting and active post-market surveillance, manufacturers have been pushed to collect and analyze data on device performance in real clinical settings.
However, most of these systems were designed with a single objective: MDR compliance.
As a result, many post-market programs collect data that satisfies regulatory requirements but does not address the questions that determine market adoption, reimbursement and clinical value.
Why HTA is shifting the focus
With the introduction of the EU Health Technology Assessment Regulation (EU) 2021/2282, the evaluation of health technologies in Europe is increasingly focused on comparative clinical value.
Decision makers want to understand how a device performs relative to existing alternatives, across broader patient populations and within real healthcare systems.
Pre-market trials rarely provide a complete answer. Many are single-arm studies, involve selected populations or take place in specialized centers that do not reflect everyday clinical practice.
Real-world evidence fills that gap by capturing how devices perform in routine care and across diverse clinical contexts.
Turning post-market data into a strategic asset
A well-designed post-market evidence strategy can support both MDR requirements and HTA evaluations. But this requires thinking beyond compliance.
Collecting only safety outcomes may satisfy regulatory surveillance, yet decision makers also expect evidence on clinical effectiveness, quality of life and healthcare resource use. Designing data collection with these outcomes in mind significantly increases the strategic value of the evidence generated.
Equally important is ensuring that data can support meaningful comparisons with existing treatments and that the data infrastructure guarantees transparency and traceability.
This includes careful attention to data governance and data lineage, the ability to track how data moves from the clinical setting through registries, databases and analytical systems to the final evidence dossier.
Evidence that grows in value
When post-market evidence is designed strategically, it becomes more than a regulatory obligation. It becomes an asset that supports regulatory compliance, market access discussions, clinical adoption and even product development.
Over time, as datasets expand and follow-up increases, the value of that evidence compounds.
In today’s healthcare environment, real-world evidence is becoming the currency of clinical value.
Manufacturers able to generate it rigorously, and use it strategically, will have a clear advantage over competitors relying solely on pre-market trials.