July 30, 2021

Can a Customer Survey Be Used as Part of PMCF?

PMCF may not need to be full-blown prospective clinical investigation.  Specifically, I would place such goals under the banner of the general types of non-investigational PMCF that I’ve mentioned before in my prior PMCF post(s).  Indeed, such feedback could certainly be obtained via methods like surveys that are less rigorous than a full-blown prospective clinical investigation.

A few more words regarding surveys:  When comparing a non-PMCF survey to a survey that is PMCF, a key difference is the basic purpose and level of rigor in how the survey data are gathered and used.  In other words, if the survey is being done because the subject device warrants PMCF (see the aforementioned PMCF trigger criteria), then the scientific methods and rigor of EU MDR Annex XIV Part B sections 6.1 and 6.2 apply.  But if instead the survey is being gathered as non-PMCF PMS (like when the subject device doesn’t warrant PMCF), then the organization’s planning for, and analysis/use of, such PMS data may be less formal than the scientific method prescribed by Annex XIV.