Article 61.10

Clinical Evaluation based on non-clinical data.

Learn more on the applicability of MDR Article 61.10

By reading this white paper, you will gain valuable insights, including:

Article 61.10 permits, in rare cases, reliance on non-clinical data for lower-risk devices.
How to justify when clinical data is not suitable to show device safety and performance.
Documentation required to support a Clinical Evaluation based fully on non-clinical data.
Scenarios to guide application, avoid pitfalls, and stay aligned with regulatory expectations.

Reach out and see how we can help guide you on your path to sustainable operational success.