Manufacturers placing medical devices on the market must have a vigilance system in place to collect and evaluate reported incidents. To prevent the recurrence of such incidents it may be necessary to take corrective actions. At a higher level, the vigilance system forms an integral part of a post-market surveillance system (PMS). In the EU the medical device directives (MDDs) establish the principal mechanisms for providing feedback about medical devices. Provisions regarding vigilance and PMS are outlined in various annexes to the MDDs: Active Implantable Medical Devices Directive (AIMDD); Medical Devices Directive (MDD), as amended; and In Vitro Device Directive (IVDD), as amended.

This audio conference provides information on various aspects of the legislation and how it is affecting medical device manufacturers, including real-life experiences to date and lessons learned from those who have been through the process.

This audio conference covers:

• Main features of a post-marketing surveillance system
• Main features of a vigilance system
• Effect of the MDD revisions on vigilance obligations
• The interaction of the PMS system with EN ISO 13485 and EN ISO 14971

About the speaker:

Salma Michor, PhD, is CEO and Principal Consultant with Michor Consulting EU. Michor acts as an independent expert for the European Commission evaluating industrial and other research projects. She teaches regulatory affairs and clinical strategies at two MBA courses offered by the University of Krems, in Austria. Before starting her own consulting business Michor worked in regulatory with Chiesi-Torrex and Wyeth Whitehall export. In her last assignment as director of supporting operations at Croma Pharma GmbH she supervised diverse departments including regulatory affairs and compliance, change control, pharmaceutical editing and pharmacovigilance, vigilance and medical writing.

Michor received her PhD in Thermal Process Engineering, and her MSc in Food & Biotechnology from the University of Applied life Sciences in Vienna, Austria. She holds the EU RAC and an MBA from the Open University in UK. She is a chartered manager and a fellow of the chartered manager institute. Michor is a member of RAPS Board of Editors for Regulatory Focus magazine and serves on the RAPS European Committee.

Who should attend?

• Regulatory Affairs
• Quality Assurance Mangers
• Vigilance
• Safety Officer/Managers
• General Management