Brussels, Belgium (hosted by European Commission on behalf of the EU)

Meeting no

Jurisdictional updates

Working group updates

Regulated Product Submissions
Good Regulatory Review Practice
Adverse Event Terminology
Personalized Medical Devices
Medical Device Cybersecurity Guide
Software as a Medical Device
Good Machine Learning Practice
Quality Management Systems

Joint IMDRF/DITTA Workshop - the life cycle of medical devices: the importance of post-market-related activities

Lifecycle Approaches to Medical Devices - M Neumann (EU)
The life cycle of medical devices - P. Auclair (Abbott, GMTA
Safety notices and Vigilance - M. Tanakasemsub (DITTA)
Safety notices and Vigilance - Industry's perspective - N. Smith (GMTA)
Safety Notices and Vigilance - Healthcare professional perspective -You Kyoung Lee
Safety notices and Vigilance - Regulator's perspective - M.Torres (US)
Safety notices and Vigilance -Regulator's perspective - C.Driesmans (EU)
Safety Notices and Vigilance -Healthcare professional perspective - T. Wilton
Status of Global Acceptance of RWDRWE - H. Colvin (GMTA)
In vitro diagnostic perspective on RWD - E. Baumfeld Andre (GMTA)
Real World Evidence - T. Melvin (Trinity College Dublin)
Uses of Real World Evidence - E. Cutts (US)
Real World Evidence - S. Hoekstra (TUV SUD, EU NB)
Real World Evidence - Lyu Yunfeng (China)
PMS for software - K. Maquelin (GMTA)
Challenges and Opportunities when collecting or generating data for Digital medical devices - P. Baird (GMTA)
17. Common post-market issues faced with software and how to address them - R. Oberlin (EU)
AI specific post-market clinical follow-up endpoints - L Hovestadt (DITTA)
Bias in post-market phase - P. Baird (GMTA)
Specific post-market considerations for AI MDs - R. Sethuraman (SG)
Specific post-market considerations for AI MDs -Change Management - M Finocchio (GMTA)
Specific post-market considerations for AI MDs - L-A. Farmer (AU)
Specific post-market considerations for AI MDs - Hae Ung Lee (DITTA)