EC Medical Devices Vigilance System And Post Marketing Surveillance

INTRODUCTION

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 and 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 and legal requirements with respect to Post Marketing Surveillance including Vigilance.

WHO SHOULD ATTEND

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.

PREPARATION

It is advisable to read the EC Medical Device Vigilance Guidelines prior to attending this conference.

BENEFITS IN ATTENDING:

• Understand the EU Vigilance Process
• Realise the Legal Obligations
• Know How to Handle Field Safety Corrective Actions (FSCAs)
• Discover What a Notified Body Expects from an Audit on PMS Systems
• Discuss Risk Management
• Hear How Various Member States Handle Vigilance Reports
• Clarify the Role of Notified Bodies in Vigilance and FSCAs
• Gain a Better Understanding of Adverse Incident Reporting during Clinical Studies