Few topics generate more uncertainty for software manufacturers than clinical evidence. Development teams often arrive at the clinical evaluation stage expecting that a prospective clinical investigation is either unavoidable or entirely unnecessary, and the reality sits somewhere in between. The MDR was written with physical devices in mind, and applying its clinical requirements to Software as a Medical Device raises questions that the regulation does not answer directly.
Join ASPHALION MedTech expert Patricia Marmol and Scarlet expert Ed Millgate for a practical webinar that will bring together the consultancy and the assessor perspective on what clinical data is genuinely expected for MDSW, and where the room for exemption actually lies.
We will cover:
- What a clinical investigation looks like for MDSW, and in which situations a Notified Body will expect one
- The legal grounds for exemption under Article 61, including equivalence, well-established technologies and legacy devices, and how each performs in practice for software
- The full range of clinical data available to software manufacturers beyond a prospective study: retrospective data, real-world evidence, registry and cohort data, literature, algorithm performance studies and post-market clinical follow-up
- The relationship between technical performance, clinical performance and clinical benefit for MDSW, and how they map onto the clinical evaluation
- A focused discussion on Article 61(10): what it was designed for, whether it is an appropriate route for MDSW, the arguments manufacturers most often make, and how those arguments are received in assessment
- The most common reasons software clinical evaluations receive non-conformities, and what the assessor is looking for in the file
The session closes with a live Q&A with both the regulatory consultant and the Notified Body reviewer.
Register here for the webinar: https://bit.ly/4xRtjsf
If you have any questions, please contact us at [email protected]
