Post Market Clinical Follow-Up (PMCF) Surveys

Post Market Clinical Follow-up (PMCF)

The European Medical Device Regulation (EU-MDR) has raised the level of regulatory requirements across the Medical Device industry, particularly when it comes to clinical data and evidence collection. There are increased expectations for Post Market Surveillance (PMS), resulting in a greater emphasis on Post Market Clinical Follow-up (PMCF).

PMCF Surveys

PMCF requires manufacturers to proactively assess the safety and performance of their devices, once on the market, and record this data throughout the product’s lifecycle. Although randomised clinical trials and registries provide higher levels of evidence, they may not be possible for certain devices. On the other hand, PMCF surveys require less work, money and time.

What We Do?

Purdie Pascoe has developed a best-practice approach, approved by EU regulators and compliant with GDPR regulations, for high quality PMCF surveys (both general end user level (Level 8) and high-quality / patient level (Level 4) surveys). 

We have already completed more than 350 bespoke PMCF surveys, across a variety of device types and risk classifications.

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

IVDR / PMPF

For information about PMPF surveys and how they can support your IVDR submission, click here