is being presented by Salma Michor, CEO and Principal Consultant, with Michor Consulting EU and airs on Wednesday, September 1st, 2010. For more details or to register, please visit our site at www.fxconferences.com
Manufacturers placing medical devices on the European 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 devices directive (MDD) establishes the principal mechanisms for providing feedback about medical devices. The revision of the MDD has had an impact on clinical evaluations/investigations and vigilance reporting. The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. New clauses added to Annex X of the MDD stipulate that all serious adverse events must be fully recorded and immediately reported to all Competent Authorities of the Member States in which the clinical investigation is being performed.
This audio conference takes a detailed look at EU provisions for post-marketing surveillance and vigilance for medical device trials under the revised Directive.
