EC Medical Devices Vigilance System and Post Marketing Surveillance

While the pre-market approval process has been delegated by most of the Competent Authorities to the private sector, Competent Authorities have kept the responsibility for the surveillance of their market. Because of this situation there is transfer of resource and energy to the monitoring of markets including the vigilance system within each Member State. The evaluation of incidents notified by manufacturers and users represents a key source of information for authorities, combined with sophisticated exchange of information between EU Member States, and with other countries like USA, Japan, Canada or Australia, provides a unique insight into the performance of devices in the post production phase.

Full compliance with the vigilance requirements laid down in Article 10 of Directive 93/42/EC is justified by the manufacturers’ legal obligations, risks associated to litigation and increasing scrutiny of Member States, but mainly by the ultimate objective of providing safe devices to patients. It is essential that manufacturers ensure compliance with these requirements.

This conference will provide practical advice on how to comply with these requirements including how to handle adverse event reporting during medical device clinical studies.

This conference provides a unique opportunity to meet Competent Authorities, Notified Bodies, Lawyers, consultants and manufacturers to understand and discuss the regulatory and legal requirements with respect to Post Marketing Surveillance including Vigilance.

This conference will be of importance to all those involved in the Medical Device Industry in the following departments; Manufacturing, Research and Development, Registration, Product Safety, Adverse Event Monitoring, Regulatory Affairs, Distribution and all those interested in Medical Device Vigilance in the European Community.