Post-Market Surveillance requirements for Medical Devices and IVDs
This 50-minute webinar will focus on the regulatory requirements for post-market surveillance (PMS) under the European Medical Device Regulations 2017/745 (MDR) and In Vitro Diagnostic medical device Regulations 2017/746 (IVDR).
It will explain how PMS includes all the activities carried out by the manufacturer to monitor, measure, and assess the device’s quality, performance and safety to ensure that the benefit-risk profile of the device remains current.
We will also briefly dive into the concept of Post Market Clinical Follow-up (PMCF) for medical devices and Post-Market Performance Follow-up (PMPF) for IVDs.
Access the webinar
Agenda
00:00Â – Introduction
05:40Â – Post-Market Surveillance (PMS)
28:30Â – Post-Market Performance Follow-Up (PMPF) +Â Post-Market Clinical Follow-Up (PMCF)
38:50Â – Conclusion
41:25Â – Q&AÂ
Here's what you'll learn
Understand the PMS requirements imposed by the MDR and IVDR
Gain a basic understanding of PMPF and PMCF
Know what needs to be created in terms of plans and reports
Speakers
Kirsten Van Garsse
Authorised Representative Director & Regulatory Affairs Manager
Anne-Sophie Grell
Regulatory Affairs Manager Medical Device