IN ONE SIMPLE SENTENCE
Targeted collection of post-market clinical data to confirm safety/performance and address remaining clinical uncertainties.
What is this service?
PMCF is a post-market activity that specifically generates new clinical data about the device to confirm that safety and performance remain acceptable during real-world use and over time.
GOAL
Address remaining clinical evidence gaps, confirm long-term performance and study populations that were under-represented before market entry.
What can MICT do here?
Design the PMCF plan, choose methods such as surveys, registries, follow-up or studies, collect/analyze data and prepare the PMCF Evaluation Report.
TYPICAL INPUTS
What we usually need to start
- CER and clinical evidence gaps
- PMS and complaints
- Risk management
- Market data
- Remaining clinical questions
TYPICAL OUTPUTS
What this stage can deliver
- PMCF plan
- PMCF protocol or questionnaire
- Follow-up data
- Subgroup and signal analyses
- PMCF Evaluation Report
- Recommendations to update CER, PMS or risk management
Important terms in plain language
PMCF
Post-Market Clinical Follow-up; clinical follow-up of a device after market entry.
Follow-up
Tracking users or patients over time.
Registry
A structured database that follows a defined patient or device-user population over time.
PMCF Plan
The plan defining which post-market clinical questions will be addressed and how.
PMCF Evaluation Report
The report that summarizes and interprets PMCF activities and findings.
SIMPLE EXAMPLE — BLOOD PRESSURE MONITOR
If PMS shows that older users repeat measurements more often, PMCF can focus on this subgroup and investigate the reason.