Dr. Mark Da Costa
Consultant Cardiac & Cardiovascular Surgeon, TÜV SÜD
With over 30 years of clinical experience and expertise in medical device assessment, Dr. Da Costa shares insights on what notified bodies expect in clinical evaluations for MDR compliance.
Understanding MDR Clinical Evaluation Requirements
Learn what notified bodies expect from manufacturers regarding clinical evidence, outcome parameters, and compliance strategies for successful MDR submissions.
In this comprehensive presentation, Dr. Mark Da Costa from TÜV SÜD breaks down the key requirements for clinical evaluations under the MDR, providing practical insights for medical device manufacturers navigating the regulatory landscape.
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Key Topics Covered
Clinical Evidence Requirements
Understanding Article 61 and how to specify and justify the level of clinical data needed for your device based on its characteristics and intended purpose.
Plan & Report Alignment
The importance of aligning your clinical plan with your clinical report, ensuring parameters defined in planning are properly executed and reported.
Defining Outcome Parameters
Defining safety, performance, and clinical benefit parameters correctly. Understanding how performance leads to benefit and why this distinction matters.
State of the Art (SOTA)
Conducting thorough SOTA searches to benchmark your device against similar devices and establish appropriate threshold values for your parameters.
Critical Advice for Manufacturers
- Engage a CRO or consultancy firm early to help structure your clinical plan and report
- Ensure alignment between your clinical plan and clinical report at all times
- Define clear outcome parameters for safety, performance, and clinical benefit
- Conduct comprehensive SOTA analysis before finalizing parameters
- Plan for PMCF studies from the start, especially if claiming equivalence
- Avoid trying to do everything at once—get your device on market first, then expand indications
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