Clinical Evaluation for medical devices under MDR

We offer in-depth support for clinical evaluation as required by the MDR. Our expertise covers the entire clinical evaluation lifecycle—from planning and literature searches to clinical data analysis and report writing. Every evaluation is methodologically sound and tailored to fulfill the requirements of Annex XIV of the MDR.

We collaborate closely with clients to understand their device’s intended purpose and clinical application. This approach ensures evaluations are both technically accurate and regulatory compliant—paving the way for CE marking.

Clinical evaluation is an ongoing process of collecting, appraising, and analyzing clinical data to monitor the safety and performance of a medical device. Under the MDR, it is required not only for new devices but also throughout the product lifecycle.

For MDR-compliant evaluations, the following is required:

• Clinical Evaluation Plan (CEP):
  • A systematic literature search to confirm that the device represents the current state-of-the-art
  • A Clinical Development Plan outlining the strategy to generate necessary clinical data to support the claimed performance, safety, and benefit
• Clinical Evaluation Report (CER):
  • Identification of pertinent clinical data (data sets) from multiple sources, such as:
    • Scientific literature,
    • Clinical investigations,
    • Post-market surveillance (PMS) data, and
    • Legacy data from earlier CE marked devices.
  • Appraisal and data extraction following the methodology outlined in the CEP
  • Demonstration of conformity with the General Safety and Performance Requirements (GSPRs), as required in the CEP.
  • Clear documentation of the assessment and conclusions

Our methodology ensures full traceability between data sources, appraisal outcomes, and conclusions.

Clinical benefit refers to the positive impact on patient health, as intended by the manufacturer. MDR requires manufacturers to demonstrate not only device performance but also clinical benefit—particularly in comparison with alternative solutions available on the market.

Examples of clinical benefits are:

• Faster or more effective treatment
• Increased diagnostic accuracy
• Reduced disease risk or severity
• Improved patient quality of life

Our evaluation reports provide clear, evidence-based documentation to support your claimed clinical benefits.

A clinical investigation is a planned, systematic study involving human subjects to generate new clinical data. It is often necessary to demonstrate a device clinical performance, safety, and benefit.

A clinical evaluation, on the other hand, assesses existing clinical data—including investigation reports—to establish the device’s performance, safety, and benefit-risk profile for its claimed intended use.

We support clients in determining whether a clinical investigation is required (per Article 62 of the MDR). If it is, we assist in developing the study protocol, managing submissions, and preparing the final report.