Swiss Medtech Webinar

Is my medical app becoming an AI-Act regulated device?


Medical device software (MDSW) increasingly incorporates artificial intelligence (AI) or machine learning (ML) capabilities. Such MDSW finds itself at the intersection of the EU AI Act and the MDR/IVDR. Now that the final AI Act has been published, it is time to take a closer look…


This webinar shall give the stakeholders a concise overview of the regulatory background to understand when a medical app will potentially fall under the AI Act (and when not) and what the implications are. This will be illustrated with practical examples. On top BSI will represent the view of a Notified Body and, at last but not least, the actual situation in Switzerland will be reflected.
 

Target group

This training is aimed at all interested stakeholder of the Medtech industry, e-Health and the AI community, from management to RA/Q to developers.


The entire event will be held in English, starting at 11.30 am and ending at 12.45 pm. It is free of charge for members of Swiss Medtech and ASD. All others can register for a fee of CHF 60. Please send us your most pressing questions when you register.

Swiss Medtech Webinar
10th September 2024

Webinar
11h30 – 12h45

Moderation

Dr. Daniel Delfosse

Vice Director

Head of Regulation & Innovation

+41 31 330 97 74

E-Mail

Program

11.30 – 11.35 h
Introduction
→ Daniel Delfosse, Swiss Medtech
11.35 – 11.45 h
Basic ideas & concepts of the AI act
→ Hansjörg Riedwyl, VR Decomplix AG
11.45 – 12.00 h
When do AI/ML-enabled medical apps fall under the AI-Act? Some practical examples
→ Rob Mentink & Tom Hueting, Evidencio Netherlands
12.00 – 12.15 h
View of a NB: How to best integrate AI Act into MDR or IVDR requirements
→ Mark Thirlwell & Aris Tzavaras, BSI
12.15 – 12.25 h

Current situation in Switzerland and outlook 
→ Helena Lacalle, Decomplix AG

12.25 – 12.45 h

Q&A session
→ Participants 

Recording

 

 

Organisation

Angela D’Aranno

Project Manager

+41 31 330 97 70

E-Mail

Supported by