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
Ensuring that a medical device remains safe and effective whilst on the market is an essential part of complying with the EU vigilance and post-marketing surveillance requirements outlined in the Directive 94/42/2 EC.
Competent authorities carry out market surveillance activities to certify that all devices comply with the latest regulations, ensuring that all devices in the market are safe for users. Post-marketing surveillance requires the manufacturer to monitor and review their devices to identify any need for corrective action. This activity is carried out in conjunction with authorised representatives, importers and distributors and is a key element of the manufacturer’s quality control system. It forms part of a PMS plan, which if carried out effectively can reduce the risk of adverse events. Manufacturers are then legally obliged, as part of a vigilance process, to report any serious incidents or correction measures to the relevant competent authorities.
This seminar will give you practical advice on how to comply with the EU vigilance and post-market surveillance requirements. It will highlight manufacturers’ legal obligations and the risks associated with litigation, as well as providing essential guidance on how to report incidents in order to remain compliant. You will also gain practical advice and guidance on how to handle adverse event reporting during medical device clinical studies.
Attending these two days will offer you a unique opportunity to meet and network with Competent Authorities, Notified Bodies, lawyers, consultants and manufacturers to share good practice and experience.
This seminar will be of importance to all those involved in the medical device industry in the following roles and departments:
Chairmen’s Welcome and Introduction
Introduction to Post Marketing Surveillance
In Depth Review of the EU Vigilance Process
Dr Ekkehard Stösslein
DiscussionApplication of the Reporting Rules
DiscussionLegal Aspects of Manufacturers Reporting Obligations
Field Safety Corrective Actions (FSCA): Expectations from Authorities
Dr Ekkehard Stösslein
Handling of Field Safety Corrective Actions (FSCA) – Industry Perspective
Role of Notified Bodies in vigilance
DiscussionUK and vigilance: MHRA
Medical device regulation changes affecting PMS
Dr Ekkehard Stössleinn
PMS and adverse event reporting during medical device studies
Discussion and closing remarks
Adverse Event Management During Medical Device Clinical Studies on 28 January 2016
We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.