Medical Device Software is a rapidly evolving field in the MedTech industry and requires specific considerations for the Clinical Evaluation Report and the State of the Art Evaluation.
MDCG 2019-11 helps with the specific classification rules for Medical Device Software, whereas MDCG 2020-1 provides recommendations for the clinical evaluation strategy. However, clinical evaluations for medical software can be less straightforward than for hardware devices.
The workshop will start with an introduction to the requirements of MDR 2017/745 on the clinical evaluation, including an overview of the relevant documents.
Participants will get a brief overview of the regulatory framework in the European Union for Medical Device Software. After that, we will take an in-depth look at how to discuss valid clinical association, technical performance, and clinical performance of Medical Device Software in the clinical evaluation.
The workshop will also discuss the challenges of writing State of the Art Evaluations, identifying benchmark parameters, and defining clinical benefits for Medical Device Software.
It will be an interactive training with team exercises and room for questions and discussions.