Dr. Mark Da Costa
Cardiac Surgeon, TUV-SUD Consultant
With over 30 years of clinical experience and expertise in medical device review, Dr. Da Costa provides practical and actionable insights to help you navigate EU MDR compliance.
Understanding MDR Requirements for Clinical Evaluation
Learn what Notified Bodies expect from medical device manufacturers regarding clinical evidence, outcome parameters, and compliance strategies for MDR submissions.
In this presentation, Dr. Mark Da Costa from TUV-SUD breaks down the key requirements for clinical evaluation under EU MDR and provides practical, actionable tips to help you achieve compliance.
Watch the Presentation
Fill out the form below to access the presentation and gain expert insights on MDR compliance.
Watch the Presentation
Fill out the form below to access the presentation and gain expert insights on MDR compliance.
Key Topics
Clinical Evaluation Requirements
Understand EU MDR Article 61 and learn how to identify and justify the level of clinical data required based on the nature and intended purpose of your medical device.
Plan and Report Alignment
The importance of aligning your Clinical Evaluation Plan (CEP) with your Clinical Evaluation Report (CER). Ensure that parameters identified in the CEP are properly executed in the CER.
Defining Outcome Parameters
Correctly define outcomes for clinical safety, performance, and clinical benefit.
Understand how performance translates to benefit and recognize the clear distinction between the two.
State of the Art (SOTA)
Conduct comprehensive literature analysis on similar products and alternative treatments to identify acceptance criteria for outcome parameters.
Advice for Medical Device Manufacturers
Engage with a CRO or consulting company early to support your CEP/CER strategy and structure in accordance with EU MDR.
Always ensure alignment between your Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER).
Define clear outcome parameters for clinical safety, performance, and clinical benefit.
Conduct thorough SOTA analysis before finalizing your parameters.
Plan for PMCF studies from the outset. This is especially critical when claiming equivalence.
Don't try to achieve everything at once. First, obtain CE marking for your product, then pursue expansion of indications for a more reliable approach.
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