Post Market Performance Follow-Up (EU IVDR PMPF) (1 hr)

According to Annex XIII, Part B, of the EU IVDR, manufacturers must proactively collect and evaluate performance and relative scientific data from the use of a device which bears a CE mark and is placed on the market or put into service in the European Union (EU) with the aim of confirming the safety, performance and scientific validity throughout the expected lifetime of the device, of ensuring continued acceptability of the benefit-risk ratio and detecting emerging risks on the basis of objective evidence. This course provides insight into the terms associated with PMPF, and requirements relative to the development of a PMPF plan, the analysis of PMPF findings, documenting a PMPF evaluation report, and the nexus between PMPF to performance evaluation and risk management. This brief, fundamental course would benefit anyone planning, conducting, or managing post-market surveillance activities within an IVD manufacturer particularly those new to the industry.

Key learning objectives:

By the end of this course you will be able to:

• Define PMPF and relate terms valuable to implementing a PMPF study
• Explain the purpose of a PMPF and recognize when one is needed
• Identify key steps in the PMPF process
• Recognize key interactions of PMPF with other quality management system processes such as risk management