IVDR - Post Market Performance Follow-Up (PMPF) Surveys

Post Market Performance Follow-up (PMPF)

The European In Vitro Diagnostics Regulation (EU-IVDR) has raised the level of regulatory requirements across the In Vitro Diagnostics industry, particularly when it comes to performance data and evidence collection. Under IVDR there are increased expectations for Post Market Surveillance (PMS), resulting in a greater emphasis on Post Market Performance Follow-up (PMPF).

PMPF Surveys

PMPF requires In Vitro Manufacturers to proactively assess the safety and performance of their IVD, once on the market, and record this data throughout the product’s lifecycle. PMPF is addressed within the PMCF plan, which in turn is part of the IVDR Post Market Surveillance (PMS) plan.

Although randomised clinical trials and registries provide higher levels of evidence, they may not be possible for certain diagnostics. On the other hand, PMPF surveys require less work, money and time.

What We Do?

Purdie Pascoe has developed a best-practice approach based on extensive experience of MDR/PMCF, approved by EU regulators, to pro-actively assess the experience of your customers with your in vitro diagnostics, for inclusion in your PMPF plan. We have already completed more than 300 PMCF studies for some of the leading medical device manufacturers, and are ready to leverage that extensive experience to support your IVDR PMPF end user surveys.

Purdie Pascoe can help support you with the design, implementation, data collection and reporting of your PMPF surveys.  Make sure that you have everything in place to be compliant with the EU-IVDR, today.