What is PMCF?
PMCF (Post-Market Clinical Follow-up) is the process of collecting and updating data on clinical evaluation and is a mandatory requirement of the European Medical Device Regulations (MDR).
It is designed to collect and demonstrate long-term data on performance, safety, and residual risk of medical devices.
The manufacturers shall submit clinical data from the PMCF, such as PMS reports, clinical evaluation reports, and risk assessments.
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The purpose of the PMCF is as follows :- Check safety and clinical performance of medical devices
- Continuous management of identified risks
- Detection of risks based on factual evidence
PMCF can be accomplished through new clinical research, review of data derived from the medical device registry, follow-up of customers who conducted pre-marketing clinical Investigationss, or follow-up of patients who previously used medical devices.