Description: Complying with the EU Risk Management requirements can be very challenging for IVD manufacturers. Manufacturers must assess risk from a system, instrument and assay perspective and link it seamlessly with Performance Evaluation, the Technical File and Post-market Surveillance. The leaving point for many manufacturers is still the IVD Directive that came into force in the year 2003 and the current EN ISO 14971:2012. In the updated ISO 1497:2019 standard, more attention is given to the benefits that are expected from the use of the (IVD) medical device. The term benefit-risk analysis has now been aligned with terminology used in some regulations, a.o. the IVDR. If, during risk control option analysis, the manufacturer determines that risk reduction is not practicable, the manufacturer shall conduct a benefit-risk analysis of the of the intended use and residual risk. This may lead to the assumption that conducting a benefit-risk analysis is only needed when risk reduction measures are not practical. On the other hand, the EU 2017/746 (IVDR) published in May 2017 does now consider a benefit-risk analysis to be mandatory, at all times. Even more so, this analysis is thoroughly embedded into different elements of the new IVD regulation, a.o. Post Market Surveillance / PMPF, vigilance and PSURs for Class C and Class D IVD’s.
This session will briefly discuss tools and methods for creation of a comprehensive Risk Management program that addresses the requirements of EU IVDR and ISO 14971:2019. It will cover the basics of the risk management process, focused on different types of IVD’s and how this is different from medical devices. It will include an example of linkage between design, manufacturing and the complaints/post-market surveillance processes. It will in addition cover the biggest similarities and differences between Risk Management for IVD devices as depicted in ISO 14971:2019 and the IVDR. More specifically, it will cover where the BRA is covered in the IVDR and why. The presentation will cover one example how to prepare a BRA for an IVD and the challenges seen in practice, especially how to address indirect risks and benefits that are inherent to IVD devices.
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.
Describe a practical Risk Management program for IVDs including tools that can be used to link Risk Management to Performance Evaluation, Labelling, Post-Market Surveillance and Post-Market Performance Follow-up
Understand the most important differences of risk management for IVD’s and the role of the benefit-risk analysis in the IVDR and ISO 14971:2019.
Understand the challenges when conducting a BRA for IVD’s and possibilities to overcome these.
Leverage learnings from the experiences from manufacturers that are implementing BRA’s in their risk management file for IVD’s, covering important do’s and don’ts.