Complying with the EU Requirements for IVD’s is expected to become very challenging for IVD manufacturers. The leaving point for many manufacturers is the IVD Directive that came into force in the year 2003. In the meantime, much has changed.
One big theme that remains a challenging one are the surveillance requirements; • Post Market Surveillance, including Post Market Performance Follow-up. • Market Surveillance by Competent Authorities.
This session will briefly cover the basics Market Surveillance and Post Market Surveillance and how this translates to the new requirements in the IVD Regulation. The presentation will cover the mechanism of Market Surveillance in EU and the role of the different economic operators in this process, downstream and upstream. In addition, what kinds of regulatory strategies are applied by manufacturers to cover surveillance requirements (MS and PMS): what are the pitfalls and benefits of these strategies and why would someone want to apply these? And what will this mean for legacy devices that have already been placed on the EU market under the IVD Directive? Even more, the following MDCG documents will briefly be covered, and how manufacturers can use these in their advantage when preparing for their Post Market Performance Follow-Up process and reporting: • MDCG 2020-6: Guidance on sufficient clinical evidence for legacy devices • MDCG 2020-7: Post-market clinical follow-up (PMCF) Plan Template: A guide for manufacturers and notified bodies • MDCG 2019-9: Summary of safety and clinical performance A guide for manufacturers and notified bodies
The potential impact of the IVDR for new and existing (legacy) devices will be discussed together with important considerations for determining the appropriate regulatory pathway and application strategy.
We will use a traditional slide presentation combined with practical worked examples and case studies to engage attendees throughout the session as well as encouraging attendees to come forward with their own practical questions. The use of a whiteboard is expected as well.
Understand the basic concept of Market Surveillance and Post Market Surveillance and its relation with the PMCF and SSP’s.
Understand the considerations for carrying out different strategies to address MS and PMS
Leverage learnings from the experiences with challenges manufacturers are facing when implementing IVDR when the leaving point is IVDD / legacy devices.