The new Medical Device Regulation is expected to be adopted in the first half of 2017. The Regulation contains significant changes in requirements in the post-market area, including PMS planning and implementation, vigilance reporting and handling field safety corrective actions.
There are enhanced requirements for PMS plans, including conducting active post-market clinical follow-up (PMCF) when necessary, preparing periodic safety update reports (PSUR) for Class II and Class III devices and submitting or having these available for Notified Body Review at defined intervals depending on the device classification, and maintaining post-market surveillance reports (PMSRs) available for Class I devices.
Vigilance information previously contained in guidance has been included in the Regulations. The timelines for reporting some events has been, reducing the time available to determine whether an event meets the reporting criteria and could lead to submission of more follow-up reports to provide additional information.
This webinar will help you to consider what actions you need to start now to be prepared for the change in requirements; the webinar will allow you to start planning how to meet the new requirements in this area.