How to tell them apart
Post-Market Performance Follow-up is the IVDR counterpart of clinical follow-up for devices. One page gives the general concept; the other details the specific IVDR Annex XIII requirements.
- Meaning 1 · Post-MarketPost-Market Performance Follow-upThe IVDR counterpart of PMCF: ongoing collection and analysis of performance data after CE certification.Read the full definition
- Meaning 2 · RegulatoryPost-Market Performance Follow-Up (IVDR)Continuous process of proactively collecting and evaluating performance data on an IVD after CE marking, analogous to MDR PMCF.Read the full definition