Description: This presentation, offering insights from both the Notified Body and the manufacturer’s perspective, focusses on application of article 61(10), non-clinical data, in relation to Software as a Medical Device (SaMD) in general and AI specifically. It aims to provide guidance on how to translate the general MDR requirements for clinical evaluation to a situation where non-clinical data forms the basis of a clinical evaluation report.
We will explore the definition of clinical data under the MDR and what this means for retrospective datasets, as typically used for training and validation of AI. The presentation will conclude with a discussion on how to compose a clinical evaluation report based on Article 61(10) that aligns with the expectations of the Notified Body, supplemented with practical case studies to illustrate the approach.
Learning Objectives:
How to use article 61(10) of the MDR in relation to SaMD and AI
To be able to make the translation between the general MDR articles 61(1) and 61(3) on clinical evaluation, and article 61(10) on using non-clinical data for clinical evaluation
To write your clinical evaluation report based on article 61(10) in such a way that it meets Notified Body expectations
