Clinical Evaluation and Performance Evidence Support

Why Clinical Evaluation Matters

Clinical evaluation is a core requirement under the EU MDR and IVDR and is fundamental to demonstrating that a medical device or IVD achieves its intended purpose while maintaining an acceptable benefit-risk profile. Under the MDR, clinical evaluation must be a continuous process supported by clinical data that is relevant, sufficient, and proportionate to the device’s risk class and intended use. For IVDs, performance evaluation fulfils a similar role, combining scientific validity, analytical performance, and clinical performance.

The regulatory expectations for clinical evidence have increased significantly compared to the former directives. Regulators and Notified Bodies now expect manufacturers to demonstrate not only that clinical data exists, but that it has been systematically identified, critically appraised, and clearly linked to device risks and claims. Clinical evaluation documentation must be consistent with the intended purpose, labelling, risk management file, and post-market surveillance plans. Where these elements are misaligned, regulatory findings are common.

One of the most frequent challenges faced by manufacturers is reliance on legacy clinical documentation that does not meet current MDR or IVDR expectations. Clinical Evaluation Reports prepared under the MDD often lack sufficient depth, critical appraisal, or documented methodology. Under the MDR, clinical evaluation must follow a defined process, including a Clinical Evaluation Plan, structured literature review, appraisal of data quality, and clear conclusions supported by evidence. Similar principles apply to IVD performance evaluation, where clinical performance claims must be supported by robust data.

Another area of regulatory focus is equivalence. While equivalence is still possible under the MDR, the requirements are strict and difficult to meet in practice. Manufacturers must demonstrate technical, biological, and clinical equivalence, and access to data from the equivalent device must be justified. In many cases, regulators expect a clear explanation of why equivalence is appropriate, or alternatively, why additional clinical data is not required.
Clinical evaluation is also closely linked to post-market obligations. The MDR and IVDR require
manufacturers to actively collect and evaluate post-market data to confirm ongoing safety and performance. This means that the Clinical Evaluation Report is not a one-time document. It must be reviewed and updated in light of post-market surveillance data, complaints, vigilance reports, and changes to the device or its intended use.

From a practical standpoint, weak clinical evaluation documentation can result in prolonged Notified Body reviews, requests for additional data, or non-conformities that delay certification. Conversely, a well-structured and proportionate clinical evaluation supports efficient review and provides a defensible basis for regulatory decision-making.