RedETS postlaunch evidence-generation approach for medical devices
The RedETS approach generates real-world evidence after a medical device is launched to better understand its actual performance, safety, costs, and use in routine healthcare. It helps decision makers in Spain make informed choices about medical devices when pre-market data is limited.
At a glance
Use when
There are significant uncertainties about a medical device's real-world performance after market approval; when policy or clinical decisions require additional evidence beyond clinical trials
Avoid when
Sufficient high-quality real-world or postmarket data already exists; when rapid assessment is needed and resources for longitudinal monitoring are unavailable
Inputs
New or insufficiently assessed medical devices with identified evidence gaps; stakeholder input; health system data; clinical registries; regional and national health authority support
Outputs
Real-world evidence reports on effectiveness, safety, cost, and utilization patterns to inform health policy, clinical practice, and patient decisions
How it works
The Monitoring Studies (MS) program by RedETS is a structured, transparent, and participative method to conduct postlaunch observational studies on selected medical devices. It addresses uncertainties in clinical effectiveness, safety, cost, and implementation in real-world settings. The method integrates stakeholder input and aims to complement traditional HTA. Challenges in implementation have been noted, but alignment with EUnetHTA frameworks could enhance efficiency and cross-national comparability.
- HTA domains
- Clinical Effectiveness, Costs & Economic Evaluation, Safety
- Assumptions
- Postmarket data is necessary to address limitations of pre-approval studies; collaboration across regions and stakeholders improves study quality and relevance; existing methodological frameworks (e.g., EUnetHTA) can support standardized RWE generation
- Strengths
- Structured and transparent process; stakeholder engagement; focuses on high-impact devices; supports policy and clinical decisions with real-world data; aligned with European HTA initiatives
- Limitations
- Implementation delays due to regional coordination challenges; dependency on data availability and quality across regions; resource-intensive setup and execution
- Also known as
- RedETS Monitoring Studies, MS program, RedETS postlaunch RWE approach
Questions this answers
- › What is the real-world clinical effectiveness of a newly adopted medical device?
- › What are the safety outcomes of a medical device in routine use?
- › How does the device impact healthcare costs post-approval?
- › How is the device being used in daily clinical practice?
- › What are the organizational implications of integrating the device into healthcare systems?
- › How can real-world evidence be systematically generated to support health policy decisions?
References & sources
Similar by meaning
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