EC MEDICAL DEVICES
VIGILANCE SYSTEM AND
POST MARKETING
SURVEILLANCE

Conference Date: 20 Jan 2009-21 Feb 2009
Conference Ref: N1-8009
Fee: £1200 + VAT
Venue: The Cavendish Hotel, London

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 the manufacturers and users represents a key source of information for Authorities. Combined with sophisticated exchange of information between EU Member States, and also with other countries like USA, Japan, Canada or Australia, this 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 provides a unique opportunity to meet Competent Authorities, Notified Body representatives, manufacturers and a lawyer in this key area to  understand and discuss the regulatory ad legal requirements with respect to Post Marketing Surveillance including Vigilance.